LABELS · 8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a

Humira

Open original source → · Download preserved record

Preserved label snapshot, not confirmation of a current approved indication. Approval/withdrawal status must be checked for the exact disease, setting and regimen.

Label effective date: 2025-12-23
Captured: 2026-09-09T23:37:54.830918+00:00
Current indication reconciliation: Not reconciled

Boxed warning in this label

WARNING: SERIOUS INFECTIONS AND MALIGNANCY SERIOUS INFECTIONS Patients treated with HUMIRA are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions ( 5.1 )] . Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Discontinue HUMIRA if a patient develops a serious infection or sepsis. Reported infections include: ● Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Test patients for latent TB before HUMIRA use and during therapy. Initiate treatment for latent TB prior to HUMIRA u se. ● Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Consider empiric anti-fungal therapy in patients at risk for invasive fungal infections who d evelop severe systemic illness. ● Bacterial, viral and other infections due to opportunistic pathogens, including Legionella and Listeria. Carefully consider the risks and benefits of treatment with HUMIRA prior to initiating therapy in patients with chronic or recurrent infection. Monitor patients closely for the development of signs and symptoms of infection during and after treatment with HUMIRA, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy [see Warnings and Precautions ( 5.1 ) and Adverse Reactions ( 6.1 )] . MALIGNANCY Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers including HUMIRA [see Warnings and Precautions ( 5.2 )] . Post-marketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers including HUMIRA. These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF blocker cases have occurred in patients with Crohn's disease or ulcerative colitis and the majority were in adolescent and young adult males. Almost all these patients had received treatment with azathioprine or 6-mercaptopurine (6–MP) concomitantly with a TNF blocker at or prior to diagnosis. It is uncertain whether the occurrence of HSTCL is related to use of a TNF blocker or a TNF blocker in combination with these other immunosuppressants [see Warnings and Precautions ( 5.2 )] . WARNING: SERIOUS INFECTIONS AND MALIGNANCY See full prescribing information for complete boxed warning. SERIOUS INFECTIONS ( 5.1 , 6.1 ): Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens. Discontinue HUMIRA if a patient develops a serious infection or sepsis during treatment. Perform test for latent TB; if positive, start treatment for TB prior to starting HUMIRA. Monitor all patients for active TB during treatment, even if initial latent TB test is negative. MALIGNANCY ( 5.2 ): Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers including HUMIRA. Post-marketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have occurred in adolescent and young adults with inflammatory bowel disease treated with TNF blockers including HUMIRA.

Indications and usage: exact source text

1 INDICATIONS AND USAGE HUMIRA is a tumor necrosis factor (TNF) blocker indicated for: Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis . ( 1.1 ) Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. ( 1.2 ) Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis . ( 1.3 ) Reducing signs and symptoms in adult patients with active ankylosing spondylitis . ( 1.4 ) Treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older. ( 1.5 ) Treatment of moderately to severely active ulcerative colitis in adults and pediatric patients 5 years of age and older. ( 1.6 ) Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers. Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. ( 1.7 ) Treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. ( 1.8 ) Treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. ( 1.9 ) 1.1 Rheumatoid Arthritis HUMIRA is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. HUMIRA can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs). 1.2 Juvenile Idiopathic Arthritis HUMIRA is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. HUMIRA can be used alone or in combination with methotrexate. 1.3 Psoriatic Arthritis HUMIRA is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. HUMIRA can be used alone or in combination with non-biologic DMARDs. 1.4 Ankylosing Spondylitis HUMIRA is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis. 1.5 Crohn’s Disease HUMIRA is indicated for the treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older. 1.6 Ulcerative Colitis HUMIRA is indicated for the treatment of moderately to severely active ulcerative colitis in adults and pediatric patients 5 years of age and older. Limitations of Use The effectiveness of HUMIRA has not been established in patients who have lost response to or were intolerant to TNF blockers [see Clinical Studies ( 14.7 , 14.8 )] . 1.7 Plaque Psoriasis HUMIRA is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. HUMIRA should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician [see Warnings and Precautions ( 5 ) ] . 1.8 Hidradenitis Suppurativa HUMIRA is indicated for the treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. 1.9 Uveitis HUMIRA is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older.

Full extracted label fields

application numbers

BLA125057

boxed warning exact

WARNING: SERIOUS INFECTIONS AND MALIGNANCY SERIOUS INFECTIONS Patients treated with HUMIRA are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions ( 5.1 )] . Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Discontinue HUMIRA if a patient develops a serious infection or sepsis. Reported infections include: ● Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Test patients for latent TB before HUMIRA use and during therapy. Initiate treatment for latent TB prior to HUMIRA u se. ● Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Consider empiric anti-fungal therapy in patients at risk for invasive fungal infections who d evelop severe systemic illness. ● Bacterial, viral and other infections due to opportunistic pathogens, including Legionella and Listeria. Carefully consider the risks and benefits of treatment with HUMIRA prior to initiating therapy in patients with chronic or recurrent infection. Monitor patients closely for the development of signs and symptoms of infection during and after treatment with HUMIRA, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy [see Warnings and Precautions ( 5.1 ) and Adverse Reactions ( 6.1 )] . MALIGNANCY Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers including HUMIRA [see Warnings and Precautions ( 5.2 )] . Post-marketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers including HUMIRA. These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF blocker cases have occurred in patients with Crohn's disease or ulcerative colitis and the majority were in adolescent and young adult males. Almost all these patients had received treatment with azathioprine or 6-mercaptopurine (6–MP) concomitantly with a TNF blocker at or prior to diagnosis. It is uncertain whether the occurrence of HSTCL is related to use of a TNF blocker or a TNF blocker in combination with these other immunosuppressants [see Warnings and Precautions ( 5.2 )] . WARNING: SERIOUS INFECTIONS AND MALIGNANCY See full prescribing information for complete boxed warning. SERIOUS INFECTIONS ( 5.1 , 6.1 ): Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens. Discontinue HUMIRA if a patient develops a serious infection or sepsis during treatment. Perform test for latent TB; if positive, start treatment for TB prior to starting HUMIRA. Monitor all patients for active TB during treatment, even if initial latent TB test is negative. MALIGNANCY ( 5.2 ): Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers including HUMIRA. Post-marketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have occurred in adolescent and young adults with inflammatory bowel disease treated with TNF blockers including HUMIRA.

brand names

Humira

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=608d4f0d-b19f-46d3-749a-7159aa5f933d

generic names

ADALIMUMAB

8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a

indications and usage exact

1 INDICATIONS AND USAGE HUMIRA is a tumor necrosis factor (TNF) blocker indicated for: Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis . ( 1.1 ) Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. ( 1.2 ) Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis . ( 1.3 ) Reducing signs and symptoms in adult patients with active ankylosing spondylitis . ( 1.4 ) Treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older. ( 1.5 ) Treatment of moderately to severely active ulcerative colitis in adults and pediatric patients 5 years of age and older. ( 1.6 ) Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers. Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. ( 1.7 ) Treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. ( 1.8 ) Treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. ( 1.9 ) 1.1 Rheumatoid Arthritis HUMIRA is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. HUMIRA can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs). 1.2 Juvenile Idiopathic Arthritis HUMIRA is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. HUMIRA can be used alone or in combination with methotrexate. 1.3 Psoriatic Arthritis HUMIRA is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. HUMIRA can be used alone or in combination with non-biologic DMARDs. 1.4 Ankylosing Spondylitis HUMIRA is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis. 1.5 Crohn’s Disease HUMIRA is indicated for the treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older. 1.6 Ulcerative Colitis HUMIRA is indicated for the treatment of moderately to severely active ulcerative colitis in adults and pediatric patients 5 years of age and older. Limitations of Use The effectiveness of HUMIRA has not been established in patients who have lost response to or were intolerant to TNF blockers [see Clinical Studies ( 14.7 , 14.8 )] . 1.7 Plaque Psoriasis HUMIRA is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. HUMIRA should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician [see Warnings and Precautions ( 5 ) ] . 1.8 Hidradenitis Suppurativa HUMIRA is indicated for the treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. 1.9 Uveitis HUMIRA is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older.

indications and usage tables exact

is original packager

true

manufacturer names

AbbVie Inc.

matched search terms

tumor

package ndcs

0074-3799-02
0074-3799-71
0074-3799-06
0074-3799-03
0074-4339-02
0074-4339-07
0074-4339-71
0074-4339-73
0074-4339-01
0074-4339-74
0074-9374-71
0074-0243-02

product ndcs

0074-0124
0074-3799
0074-4339
0074-9374
0074-0243
0074-0554
0074-0067
0074-2540
0074-1539
0074-0616
0074-0817

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

Warnings and Precautions, Autoimmunity ( 5.9 ) 7/2025

record type

complete_spl_indications_section_candidate

routes

rxcuis

727703
727705
763564
763565
797544
825169
825170
1594352
1594357
1594358
1655726
1655728

source batch

file

/private/tmp/cancer-full-research/indications/raw/labels-00500.json

Source passages and status connections

Passage classifications are automated and are not treatment recommendations. Connections apply only to their recorded indication scope.

Passage 1 · positive indication candidate

application numbers

BLA125057

brand names

Humira

classification reasons

explicit_positive_indication_predicate
tumor_or_malignant_hematology_words_in_positive_statement

clinical review status

pending

content role

positive_indication_candidate

context span

end: 506
end exclusive: true
exact text: 1 INDICATIONS AND USAGE HUMIRA is a tumor necrosis factor (TNF) blocker indicated for: Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis . ( 1.1 ) Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. ( 1.2 ) Reducing signs and symptoms, inhibiting
label id: 8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 4a691d17c9c295180a2eb7a93f8e84568851de90dc3bf2233da326087f57d6d3
start: 0

current approval status

not_reconciled

duplicate text group

dup-2e458bb24d6c83be7c9f

extraction review status

automated_candidate_pending_source_review

generic names

ADALIMUMAB

ind-span-384aa532256be74f4a96

label id

8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a

positive predicate support span

end: 81
end exclusive: true
exact text: is a tumor necrosis factor (TNF) blocker indicated
label id: 8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 4a691d17c9c295180a2eb7a93f8e84568851de90dc3bf2233da326087f57d6d3
start: 31

qualifier mentions

context exact
on of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis .
kind
age
polarity
not_inferred
span
end
248
end exclusive
true
exact text
adult patients
label id
8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
4a691d17c9c295180a2eb7a93f8e84568851de90dc3bf2233da326087f57d6d3
start
234

regulatory links

schema version

0.1.0

source batch sha256

424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3

source defined aliases

source span

end: 306
end exclusive: true
exact text: 1 INDICATIONS AND USAGE HUMIRA is a tumor necrosis factor (TNF) blocker indicated for: Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis .
label id: 8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 4a691d17c9c295180a2eb7a93f8e84568851de90dc3bf2233da326087f57d6d3
start: 0

source url

https://api.fda.gov/drug/label.json?search=id%3A%228bf84b15-6763-41cf-bfa4-bcee9ad4ef9a%22

spl effective date

2025-12-23

spl set id

608d4f0d-b19f-46d3-749a-7159aa5f933d

spl version

2154

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

tumor_directed_candidate

Passage 2 · unclassified context

application numbers

BLA125057

brand names

Humira

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 657
end exclusive: true
exact text: ymptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis . ( 1.1 ) Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. ( 1.2 ) Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis . ( 1.3 ) Reducing signs and sy
label id: 8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 4a691d17c9c295180a2eb7a93f8e84568851de90dc3bf2233da326087f57d6d3
start: 107

current approval status

not_reconciled

duplicate text group

dup-0ceefdc038bd536a5172

extraction review status

automated_candidate_pending_source_review

generic names

ADALIMUMAB

ind-span-91eae6b673e4ead05421

label id

8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a

positive predicate support span

Source null

qualifier mentions

context exact
ive polyarticular juvenile idiopathic arthritis in patients 2 years of age and older.
kind
age
polarity
not_inferred
span
end
446
end exclusive
true
exact text
2 years of age
label id
8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
4a691d17c9c295180a2eb7a93f8e84568851de90dc3bf2233da326087f57d6d3
start
432

regulatory links

schema version

0.1.0

source batch sha256

424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3

source defined aliases

source span

end: 457
end exclusive: true
exact text: ( 1.1 ) Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older.
label id: 8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 4a691d17c9c295180a2eb7a93f8e84568851de90dc3bf2233da326087f57d6d3
start: 307

source url

https://api.fda.gov/drug/label.json?search=id%3A%228bf84b15-6763-41cf-bfa4-bcee9ad4ef9a%22

spl effective date

2025-12-23

spl set id

608d4f0d-b19f-46d3-749a-7159aa5f933d

spl version

2154

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

unclear

Passage 3 · positive indication candidate

application numbers

BLA125057

brand names

Humira

classification reasons

inherited_predicate_from_same_label_section_requires_review
no_tumor_directed_keyword_in_positive_statement

clinical review status

pending

content role

positive_indication_candidate

context span

end: 827
end exclusive: true
exact text: rately to severely active rheumatoid arthritis . ( 1.1 ) Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. ( 1.2 ) Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis . ( 1.3 ) Reducing signs and symptoms in adult patients with active ankylosing spondylitis . ( 1.4 ) Treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years
label id: 8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 4a691d17c9c295180a2eb7a93f8e84568851de90dc3bf2233da326087f57d6d3
start: 258

current approval status

not_reconciled

duplicate text group

dup-ae154768abbd21ca1250

extraction review status

automated_candidate_pending_source_review

generic names

ADALIMUMAB

ind-span-c06a6303951a0065f558

label id

8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a

positive predicate support span

end: 81
end exclusive: true
exact text: is a tumor necrosis factor (TNF) blocker indicated
label id: 8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 4a691d17c9c295180a2eb7a93f8e84568851de90dc3bf2233da326087f57d6d3
start: 31

qualifier mentions

context exact
on of structural damage, and improving physical function in adult patients with active psoriatic arthritis .
kind
age
polarity
not_inferred
span
end
593
end exclusive
true
exact text
adult patients
label id
8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
4a691d17c9c295180a2eb7a93f8e84568851de90dc3bf2233da326087f57d6d3
start
579

regulatory links

schema version

0.1.0

source batch sha256

424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3

source defined aliases

source span

end: 627
end exclusive: true
exact text: ( 1.2 ) Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis .
label id: 8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 4a691d17c9c295180a2eb7a93f8e84568851de90dc3bf2233da326087f57d6d3
start: 458

source url

https://api.fda.gov/drug/label.json?search=id%3A%228bf84b15-6763-41cf-bfa4-bcee9ad4ef9a%22

spl effective date

2025-12-23

spl set id

608d4f0d-b19f-46d3-749a-7159aa5f933d

spl version

2154

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

non_oncology_or_unclear_candidate

Passage 4 · positive indication candidate

application numbers

BLA125057

brand names

Humira

classification reasons

inherited_predicate_from_same_label_section_requires_review
no_tumor_directed_keyword_in_positive_statement

clinical review status

pending

content role

positive_indication_candidate

context span

end: 918
end exclusive: true
exact text: nts 2 years of age and older. ( 1.2 ) Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis . ( 1.3 ) Reducing signs and symptoms in adult patients with active ankylosing spondylitis . ( 1.4 ) Treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older. ( 1.5 ) Treatment of moderately to severely active ulcerative colitis in
label id: 8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 4a691d17c9c295180a2eb7a93f8e84568851de90dc3bf2233da326087f57d6d3
start: 428

current approval status

not_reconciled

duplicate text group

dup-2420c536eb3728d3bace

extraction review status

automated_candidate_pending_source_review

generic names

ADALIMUMAB

ind-span-cef31ee373bfc0403a81

label id

8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a

positive predicate support span

end: 81
end exclusive: true
exact text: is a tumor necrosis factor (TNF) blocker indicated
label id: 8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 4a691d17c9c295180a2eb7a93f8e84568851de90dc3bf2233da326087f57d6d3
start: 31

qualifier mentions

context exact
( 1.3 ) Reducing signs and symptoms in adult patients with active ankylosing spondylitis .
kind
age
polarity
not_inferred
span
end
681
end exclusive
true
exact text
adult patients
label id
8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
4a691d17c9c295180a2eb7a93f8e84568851de90dc3bf2233da326087f57d6d3
start
667

regulatory links

schema version

0.1.0

source batch sha256

424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3

source defined aliases

source span

end: 718
end exclusive: true
exact text: ( 1.3 ) Reducing signs and symptoms in adult patients with active ankylosing spondylitis .
label id: 8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 4a691d17c9c295180a2eb7a93f8e84568851de90dc3bf2233da326087f57d6d3
start: 628

source url

https://api.fda.gov/drug/label.json?search=id%3A%228bf84b15-6763-41cf-bfa4-bcee9ad4ef9a%22

spl effective date

2025-12-23

spl set id

608d4f0d-b19f-46d3-749a-7159aa5f933d

spl version

2154

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

non_oncology_or_unclear_candidate

Passage 5 · positive indication candidate

application numbers

BLA125057

brand names

Humira

classification reasons

inherited_predicate_from_same_label_section_requires_review
no_tumor_directed_keyword_in_positive_statement

clinical review status

pending

content role

positive_indication_candidate

context span

end: 1044
end exclusive: true
exact text: on of structural damage, and improving physical function in adult patients with active psoriatic arthritis . ( 1.3 ) Reducing signs and symptoms in adult patients with active ankylosing spondylitis . ( 1.4 ) Treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older. ( 1.5 ) Treatment of moderately to severely active ulcerative colitis in adults and pediatric patients 5 years of age and older. ( 1.6 ) Limitations of Use: Effectiveness has not been established in
label id: 8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 4a691d17c9c295180a2eb7a93f8e84568851de90dc3bf2233da326087f57d6d3
start: 519

current approval status

not_reconciled

duplicate text group

dup-ad6baacb24c6896a54c0

extraction review status

automated_candidate_pending_source_review

generic names

ADALIMUMAB

ind-span-ff0828b3dfbec58e4632

label id

8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a

positive predicate support span

end: 81
end exclusive: true
exact text: is a tumor necrosis factor (TNF) blocker indicated
label id: 8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 4a691d17c9c295180a2eb7a93f8e84568851de90dc3bf2233da326087f57d6d3
start: 31

qualifier mentions

context exact
eatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older.
kind
age
polarity
not_inferred
span
end
795
end exclusive
true
exact text
adults
label id
8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
4a691d17c9c295180a2eb7a93f8e84568851de90dc3bf2233da326087f57d6d3
start
789
context exact
moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older.
kind
age
polarity
not_inferred
span
end
818
end exclusive
true
exact text
pediatric patients
label id
8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
4a691d17c9c295180a2eb7a93f8e84568851de90dc3bf2233da326087f57d6d3
start
800
context exact
ely active Crohn’s disease in adults and pediatric patients 6 years of age and older.
kind
age
polarity
not_inferred
span
end
833
end exclusive
true
exact text
6 years of age
label id
8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
4a691d17c9c295180a2eb7a93f8e84568851de90dc3bf2233da326087f57d6d3
start
819

regulatory links

schema version

0.1.0

source batch sha256

424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3

source defined aliases

source span

end: 844
end exclusive: true
exact text: ( 1.4 ) Treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older.
label id: 8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 4a691d17c9c295180a2eb7a93f8e84568851de90dc3bf2233da326087f57d6d3
start: 719

source url

https://api.fda.gov/drug/label.json?search=id%3A%228bf84b15-6763-41cf-bfa4-bcee9ad4ef9a%22

spl effective date

2025-12-23

spl set id

608d4f0d-b19f-46d3-749a-7159aa5f933d

spl version

2154

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

non_oncology_or_unclear_candidate

Passage 6 · unclassified context

application numbers

BLA125057

brand names

Humira

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 1173
end exclusive: true
exact text: signs and symptoms in adult patients with active ankylosing spondylitis . ( 1.4 ) Treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older. ( 1.5 ) Treatment of moderately to severely active ulcerative colitis in adults and pediatric patients 5 years of age and older. ( 1.6 ) Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers. Treatment of adult patients with moderate to severe chroni
label id: 8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 4a691d17c9c295180a2eb7a93f8e84568851de90dc3bf2233da326087f57d6d3
start: 645

current approval status

not_reconciled

duplicate text group

dup-4aefd6fc1ae01a13ddde

extraction review status

automated_candidate_pending_source_review

generic names

ADALIMUMAB

ind-span-b88a3c92e686d85bcef7

label id

8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a

positive predicate support span

Source null

qualifier mentions

context exact
ment of moderately to severely active ulcerative colitis in adults and pediatric patients 5 years of age and older.
kind
age
polarity
not_inferred
span
end
924
end exclusive
true
exact text
adults
label id
8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
4a691d17c9c295180a2eb7a93f8e84568851de90dc3bf2233da326087f57d6d3
start
918
context exact
erately to severely active ulcerative colitis in adults and pediatric patients 5 years of age and older.
kind
age
polarity
not_inferred
span
end
947
end exclusive
true
exact text
pediatric patients
label id
8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
4a691d17c9c295180a2eb7a93f8e84568851de90dc3bf2233da326087f57d6d3
start
929
context exact
active ulcerative colitis in adults and pediatric patients 5 years of age and older.
kind
age
polarity
not_inferred
span
end
962
end exclusive
true
exact text
5 years of age
label id
8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
4a691d17c9c295180a2eb7a93f8e84568851de90dc3bf2233da326087f57d6d3
start
948

regulatory links

schema version

0.1.0

source batch sha256

424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3

source defined aliases

source span

end: 973
end exclusive: true
exact text: ( 1.5 ) Treatment of moderately to severely active ulcerative colitis in adults and pediatric patients 5 years of age and older.
label id: 8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 4a691d17c9c295180a2eb7a93f8e84568851de90dc3bf2233da326087f57d6d3
start: 845

source url

https://api.fda.gov/drug/label.json?search=id%3A%228bf84b15-6763-41cf-bfa4-bcee9ad4ef9a%22

spl effective date

2025-12-23

spl set id

608d4f0d-b19f-46d3-749a-7159aa5f933d

spl version

2154

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

unclear

Passage 7 · limitation of use

application numbers

BLA125057

brand names

Humira

classification reasons

negative_or_not_established_clause

clinical review status

pending

content role

limitation_of_use

context span

end: 1314
end exclusive: true
exact text: n’s disease in adults and pediatric patients 6 years of age and older. ( 1.5 ) Treatment of moderately to severely active ulcerative colitis in adults and pediatric patients 5 years of age and older. ( 1.6 ) Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers. Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate.
label id: 8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 4a691d17c9c295180a2eb7a93f8e84568851de90dc3bf2233da326087f57d6d3
start: 774

current approval status

not_reconciled

duplicate text group

dup-d9cbfa07d825b3d89e56

extraction review status

automated_candidate_pending_source_review

generic names

ADALIMUMAB

ind-span-751f6dc7fb47affbac43

label id

8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3

source defined aliases

source span

end: 1114
end exclusive: true
exact text: ( 1.6 ) Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers.
label id: 8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 4a691d17c9c295180a2eb7a93f8e84568851de90dc3bf2233da326087f57d6d3
start: 974

source url

https://api.fda.gov/drug/label.json?search=id%3A%228bf84b15-6763-41cf-bfa4-bcee9ad4ef9a%22

spl effective date

2025-12-23

spl set id

608d4f0d-b19f-46d3-749a-7159aa5f933d

spl version

2154

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

not_applicable

Passage 8 · unclassified context

application numbers

BLA125057

brand names

Humira

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 1514
end exclusive: true
exact text: in adults and pediatric patients 5 years of age and older. ( 1.6 ) Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers. Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. ( 1.7 ) Treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. ( 1.8 ) Treatment of non-infectious intermediate, posterior, and panuveitis in adults and pedia
label id: 8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 4a691d17c9c295180a2eb7a93f8e84568851de90dc3bf2233da326087f57d6d3
start: 915

current approval status

not_reconciled

duplicate text group

dup-4b3cd7d1bcb147b5f13c

extraction review status

automated_candidate_pending_source_review

generic names

ADALIMUMAB

ind-span-695243eb56f1cfa1e4ea

label id

8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a

positive predicate support span

Source null

qualifier mentions

context exact
Treatment of adult patients with moderate to severe chronic plaque psoriasis who are ca
kind
age
polarity
not_inferred
span
end
1142
end exclusive
true
exact text
adult patients
label id
8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
4a691d17c9c295180a2eb7a93f8e84568851de90dc3bf2233da326087f57d6d3
start
1128

regulatory links

schema version

0.1.0

source batch sha256

424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3

source defined aliases

source span

end: 1314
end exclusive: true
exact text: Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate.
label id: 8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 4a691d17c9c295180a2eb7a93f8e84568851de90dc3bf2233da326087f57d6d3
start: 1115

source url

https://api.fda.gov/drug/label.json?search=id%3A%228bf84b15-6763-41cf-bfa4-bcee9ad4ef9a%22

spl effective date

2025-12-23

spl set id

608d4f0d-b19f-46d3-749a-7159aa5f933d

spl version

2154

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

unclear

Passage 9 · unclassified context

application numbers

BLA125057

brand names

Humira

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 1618
end exclusive: true
exact text: Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. ( 1.7 ) Treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. ( 1.8 ) Treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. ( 1.9 ) 1.1 Rheumatoid Arthritis HUMIRA is indicated for reducin
label id: 8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 4a691d17c9c295180a2eb7a93f8e84568851de90dc3bf2233da326087f57d6d3
start: 1115

current approval status

not_reconciled

duplicate text group

dup-de445f1e3c500b971b4f

extraction review status

automated_candidate_pending_source_review

generic names

ADALIMUMAB

ind-span-fd587da192e914de40af

label id

8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a

positive predicate support span

Source null

qualifier mentions

context exact
of moderate to severe hidradenitis suppurativa in patients 12 years of age and older.
kind
age
polarity
not_inferred
span
end
1407
end exclusive
true
exact text
12 years of age
label id
8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
4a691d17c9c295180a2eb7a93f8e84568851de90dc3bf2233da326087f57d6d3
start
1392

regulatory links

schema version

0.1.0

source batch sha256

424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3

source defined aliases

source span

end: 1418
end exclusive: true
exact text: ( 1.7 ) Treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older.
label id: 8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 4a691d17c9c295180a2eb7a93f8e84568851de90dc3bf2233da326087f57d6d3
start: 1315

source url

https://api.fda.gov/drug/label.json?search=id%3A%228bf84b15-6763-41cf-bfa4-bcee9ad4ef9a%22

spl effective date

2025-12-23

spl set id

608d4f0d-b19f-46d3-749a-7159aa5f933d

spl version

2154

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

unclear

Passage 10 · unclassified context

application numbers

BLA125057

brand names

Humira

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 1753
end exclusive: true
exact text: emic therapy or phototherapy, and when other systemic therapies are medically less appropriate. ( 1.7 ) Treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. ( 1.8 ) Treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. ( 1.9 ) 1.1 Rheumatoid Arthritis HUMIRA is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical functio
label id: 8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 4a691d17c9c295180a2eb7a93f8e84568851de90dc3bf2233da326087f57d6d3
start: 1219

current approval status

not_reconciled

duplicate text group

dup-7e2d7de50a4dc9c61d29

extraction review status

automated_candidate_pending_source_review

generic names

ADALIMUMAB

ind-span-b73a7f7a1d5b2d7ad6e1

label id

8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a

positive predicate support span

Source null

qualifier mentions

context exact
f non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older.
kind
age
polarity
not_inferred
span
end
1504
end exclusive
true
exact text
adults
label id
8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
4a691d17c9c295180a2eb7a93f8e84568851de90dc3bf2233da326087f57d6d3
start
1498
context exact
tious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older.
kind
age
polarity
not_inferred
span
end
1527
end exclusive
true
exact text
pediatric patients
label id
8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
4a691d17c9c295180a2eb7a93f8e84568851de90dc3bf2233da326087f57d6d3
start
1509
context exact
posterior, and panuveitis in adults and pediatric patients 2 years of age and older.
kind
age
polarity
not_inferred
span
end
1542
end exclusive
true
exact text
2 years of age
label id
8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
4a691d17c9c295180a2eb7a93f8e84568851de90dc3bf2233da326087f57d6d3
start
1528

regulatory links

schema version

0.1.0

source batch sha256

424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3

source defined aliases

source span

end: 1553
end exclusive: true
exact text: ( 1.8 ) Treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older.
label id: 8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 4a691d17c9c295180a2eb7a93f8e84568851de90dc3bf2233da326087f57d6d3
start: 1419

source url

https://api.fda.gov/drug/label.json?search=id%3A%228bf84b15-6763-41cf-bfa4-bcee9ad4ef9a%22

spl effective date

2025-12-23

spl set id

608d4f0d-b19f-46d3-749a-7159aa5f933d

spl version

2154

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

unclear

Passage 11 · unclassified context

application numbers

BLA125057

brand names

Humira

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 1761
end exclusive: true
exact text: hidradenitis suppurativa in patients 12 years of age and older. ( 1.8 ) Treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. ( 1.9 ) 1.1 Rheumatoid Arthritis HUMIRA is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adu
label id: 8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 4a691d17c9c295180a2eb7a93f8e84568851de90dc3bf2233da326087f57d6d3
start: 1354

current approval status

not_reconciled

duplicate text group

dup-3e18abe45aeb6ab69e0c

extraction review status

automated_candidate_pending_source_review

generic names

ADALIMUMAB

ind-span-2f5c34a50e9192d40996

label id

8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3

source defined aliases

source span

end: 1561
end exclusive: true
exact text: ( 1.9 )
label id: 8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 4a691d17c9c295180a2eb7a93f8e84568851de90dc3bf2233da326087f57d6d3
start: 1554

source url

https://api.fda.gov/drug/label.json?search=id%3A%228bf84b15-6763-41cf-bfa4-bcee9ad4ef9a%22

spl effective date

2025-12-23

spl set id

608d4f0d-b19f-46d3-749a-7159aa5f933d

spl version

2154

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

unclear

Passage 12 · positive indication candidate

application numbers

BLA125057

brand names

Humira

classification reasons

explicit_positive_indication_predicate
no_tumor_directed_keyword_in_positive_statement

clinical review status

pending

content role

positive_indication_candidate

context span

end: 2029
end exclusive: true
exact text: nitis suppurativa in patients 12 years of age and older. ( 1.8 ) Treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. ( 1.9 ) 1.1 Rheumatoid Arthritis HUMIRA is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. HUMIRA can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs). 1.2 Juvenile Idiopathic Arthritis HUMIRA is indicated for reducing
label id: 8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 4a691d17c9c295180a2eb7a93f8e84568851de90dc3bf2233da326087f57d6d3
start: 1362

current approval status

not_reconciled

duplicate text group

dup-c05b43750b46e0fc513f

extraction review status

automated_candidate_pending_source_review

generic names

ADALIMUMAB

ind-span-db04b10cbe04a3105434

label id

8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a

positive predicate support span

end: 1606
end exclusive: true
exact text: is indicated
label id: 8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 4a691d17c9c295180a2eb7a93f8e84568851de90dc3bf2233da326087f57d6d3
start: 1594

qualifier mentions

context exact
on of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis.
kind
age
polarity
not_inferred
span
end
1772
end exclusive
true
exact text
adult patients
label id
8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
4a691d17c9c295180a2eb7a93f8e84568851de90dc3bf2233da326087f57d6d3
start
1758

regulatory links

schema version

0.1.0

source batch sha256

424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3

source defined aliases

source span

end: 1829
end exclusive: true
exact text: 1.1 Rheumatoid Arthritis HUMIRA is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis.
label id: 8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 4a691d17c9c295180a2eb7a93f8e84568851de90dc3bf2233da326087f57d6d3
start: 1562

source url

https://api.fda.gov/drug/label.json?search=id%3A%228bf84b15-6763-41cf-bfa4-bcee9ad4ef9a%22

spl effective date

2025-12-23

spl set id

608d4f0d-b19f-46d3-749a-7159aa5f933d

spl version

2154

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

non_oncology_or_unclear_candidate

Passage 13 · unclassified context

application numbers

BLA125057

brand names

Humira

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 2161
end exclusive: true
exact text: symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. HUMIRA can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs). 1.2 Juvenile Idiopathic Arthritis HUMIRA is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older
label id: 8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 4a691d17c9c295180a2eb7a93f8e84568851de90dc3bf2233da326087f57d6d3
start: 1630

current approval status

not_reconciled

duplicate text group

dup-e892624c319a208692fa

extraction review status

automated_candidate_pending_source_review

generic names

ADALIMUMAB

ind-span-27c0c2b3699be9e0e03d

label id

8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a

positive predicate support span

Source null

qualifier mentions

context exact
HUMIRA can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs).
kind
biomarker
polarity
not_inferred
span
end
1921
end exclusive
true
exact text
methotrexate or other non-biologic disease-
label id
8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
4a691d17c9c295180a2eb7a93f8e84568851de90dc3bf2233da326087f57d6d3
start
1878
context exact
HUMIRA can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs).
kind
regimen
polarity
not_inferred
span
end
1960
end exclusive
true
exact text
in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs)
label id
8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
4a691d17c9c295180a2eb7a93f8e84568851de90dc3bf2233da326087f57d6d3
start
1858

regulatory links

schema version

0.1.0

source batch sha256

424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3

source defined aliases

source span

end: 1961
end exclusive: true
exact text: HUMIRA can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs).
label id: 8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 4a691d17c9c295180a2eb7a93f8e84568851de90dc3bf2233da326087f57d6d3
start: 1830

source url

https://api.fda.gov/drug/label.json?search=id%3A%228bf84b15-6763-41cf-bfa4-bcee9ad4ef9a%22

spl effective date

2025-12-23

spl set id

608d4f0d-b19f-46d3-749a-7159aa5f933d

spl version

2154

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

unclear

Passage 14 · positive indication candidate

application numbers

BLA125057

brand names

Humira

classification reasons

explicit_positive_indication_predicate
no_tumor_directed_keyword_in_positive_statement

clinical review status

pending

content role

positive_indication_candidate

context span

end: 2362
end exclusive: true
exact text: t patients with moderately to severely active rheumatoid arthritis. HUMIRA can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs). 1.2 Juvenile Idiopathic Arthritis HUMIRA is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. HUMIRA can be used alone or in combination with methotrexate. 1.3 Psoriatic Arthritis HUMIRA is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improvi
label id: 8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 4a691d17c9c295180a2eb7a93f8e84568851de90dc3bf2233da326087f57d6d3
start: 1762

current approval status

not_reconciled

duplicate text group

dup-49b8321073c9cf28e2c8

extraction review status

automated_candidate_pending_source_review

generic names

ADALIMUMAB

ind-span-2ee7631285eb15d77386

label id

8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a

positive predicate support span

end: 2015
end exclusive: true
exact text: is indicated
label id: 8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 4a691d17c9c295180a2eb7a93f8e84568851de90dc3bf2233da326087f57d6d3
start: 2003

qualifier mentions

context exact
ive polyarticular juvenile idiopathic arthritis in patients 2 years of age and older.
kind
age
polarity
not_inferred
span
end
2151
end exclusive
true
exact text
2 years of age
label id
8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
4a691d17c9c295180a2eb7a93f8e84568851de90dc3bf2233da326087f57d6d3
start
2137

regulatory links

schema version

0.1.0

source batch sha256

424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3

source defined aliases

source span

end: 2162
end exclusive: true
exact text: 1.2 Juvenile Idiopathic Arthritis HUMIRA is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older.
label id: 8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 4a691d17c9c295180a2eb7a93f8e84568851de90dc3bf2233da326087f57d6d3
start: 1962

source url

https://api.fda.gov/drug/label.json?search=id%3A%228bf84b15-6763-41cf-bfa4-bcee9ad4ef9a%22

spl effective date

2025-12-23

spl set id

608d4f0d-b19f-46d3-749a-7159aa5f933d

spl version

2154

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

non_oncology_or_unclear_candidate

Passage 15 · unclassified context

application numbers

BLA125057

brand names

Humira

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 2424
end exclusive: true
exact text: .2 Juvenile Idiopathic Arthritis HUMIRA is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. HUMIRA can be used alone or in combination with methotrexate. 1.3 Psoriatic Arthritis HUMIRA is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic a
label id: 8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 4a691d17c9c295180a2eb7a93f8e84568851de90dc3bf2233da326087f57d6d3
start: 1963

current approval status

not_reconciled

duplicate text group

dup-c1de71a0eaa03b64bc74

extraction review status

automated_candidate_pending_source_review

generic names

ADALIMUMAB

ind-span-cd77dbaa264598280bc5

label id

8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a

positive predicate support span

Source null

qualifier mentions

context exact
HUMIRA can be used alone or in combination with methotrexate.
kind
biomarker
polarity
not_inferred
span
end
2223
end exclusive
true
exact text
methotrexate
label id
8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
4a691d17c9c295180a2eb7a93f8e84568851de90dc3bf2233da326087f57d6d3
start
2211
context exact
HUMIRA can be used alone or in combination with methotrexate.
kind
regimen
polarity
not_inferred
span
end
2223
end exclusive
true
exact text
in combination with methotrexate
label id
8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
4a691d17c9c295180a2eb7a93f8e84568851de90dc3bf2233da326087f57d6d3
start
2191

regulatory links

schema version

0.1.0

source batch sha256

424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3

source defined aliases

source span

end: 2224
end exclusive: true
exact text: HUMIRA can be used alone or in combination with methotrexate.
label id: 8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 4a691d17c9c295180a2eb7a93f8e84568851de90dc3bf2233da326087f57d6d3
start: 2163

source url

https://api.fda.gov/drug/label.json?search=id%3A%228bf84b15-6763-41cf-bfa4-bcee9ad4ef9a%22

spl effective date

2025-12-23

spl set id

608d4f0d-b19f-46d3-749a-7159aa5f933d

spl version

2154

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

unclear

Passage 16 · positive indication candidate

application numbers

BLA125057

brand names

Humira

classification reasons

explicit_positive_indication_predicate
no_tumor_directed_keyword_in_positive_statement

clinical review status

pending

content role

positive_indication_candidate

context span

end: 2633
end exclusive: true
exact text: ing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. HUMIRA can be used alone or in combination with methotrexate. 1.3 Psoriatic Arthritis HUMIRA is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. HUMIRA can be used alone or in combination with non-biologic DMARDs. 1.4 Ankylosing Spondylitis HUMIRA is indicated for reducing signs and symptoms in adult patients with active ankylosing spondyliti
label id: 8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 4a691d17c9c295180a2eb7a93f8e84568851de90dc3bf2233da326087f57d6d3
start: 2025

current approval status

not_reconciled

duplicate text group

dup-3b81bbbabbbb470f89f5

extraction review status

automated_candidate_pending_source_review

generic names

ADALIMUMAB

ind-span-77956a31bd6a7be4d19b

label id

8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a

positive predicate support span

end: 2268
end exclusive: true
exact text: is indicated
label id: 8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 4a691d17c9c295180a2eb7a93f8e84568851de90dc3bf2233da326087f57d6d3
start: 2256

qualifier mentions

context exact
on of structural damage, and improving physical function in adult patients with active psoriatic arthritis.
kind
age
polarity
not_inferred
span
end
2400
end exclusive
true
exact text
adult patients
label id
8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
4a691d17c9c295180a2eb7a93f8e84568851de90dc3bf2233da326087f57d6d3
start
2386

regulatory links

schema version

0.1.0

source batch sha256

424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3

source defined aliases

source span

end: 2433
end exclusive: true
exact text: 1.3 Psoriatic Arthritis HUMIRA is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis.
label id: 8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 4a691d17c9c295180a2eb7a93f8e84568851de90dc3bf2233da326087f57d6d3
start: 2225

source url

https://api.fda.gov/drug/label.json?search=id%3A%228bf84b15-6763-41cf-bfa4-bcee9ad4ef9a%22

spl effective date

2025-12-23

spl set id

608d4f0d-b19f-46d3-749a-7159aa5f933d

spl version

2154

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

non_oncology_or_unclear_candidate

Passage 17 · unclassified context

application numbers

BLA125057

brand names

Humira

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 2702
end exclusive: true
exact text: atic Arthritis HUMIRA is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. HUMIRA can be used alone or in combination with non-biologic DMARDs. 1.4 Ankylosing Spondylitis HUMIRA is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis. 1.5 Crohn’s Disease HUMIRA is indicated for the treatment of moder
label id: 8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 4a691d17c9c295180a2eb7a93f8e84568851de90dc3bf2233da326087f57d6d3
start: 2234

current approval status

not_reconciled

duplicate text group

dup-065b385a0991fc47825d

extraction review status

automated_candidate_pending_source_review

generic names

ADALIMUMAB

ind-span-4abeda5040006418d9b8

label id

8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a

positive predicate support span

Source null

qualifier mentions

context exact
HUMIRA can be used alone or in combination with non-biologic DMARDs.
kind
regimen
polarity
not_inferred
span
end
2501
end exclusive
true
exact text
in combination with non-biologic DMARDs
label id
8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
4a691d17c9c295180a2eb7a93f8e84568851de90dc3bf2233da326087f57d6d3
start
2462

regulatory links

schema version

0.1.0

source batch sha256

424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3

source defined aliases

source span

end: 2502
end exclusive: true
exact text: HUMIRA can be used alone or in combination with non-biologic DMARDs.
label id: 8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 4a691d17c9c295180a2eb7a93f8e84568851de90dc3bf2233da326087f57d6d3
start: 2434

source url

https://api.fda.gov/drug/label.json?search=id%3A%228bf84b15-6763-41cf-bfa4-bcee9ad4ef9a%22

spl effective date

2025-12-23

spl set id

608d4f0d-b19f-46d3-749a-7159aa5f933d

spl version

2154

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

unclear

Passage 18 · positive indication candidate

application numbers

BLA125057

brand names

Humira

classification reasons

explicit_positive_indication_predicate
no_tumor_directed_keyword_in_positive_statement

clinical review status

pending

content role

positive_indication_candidate

context span

end: 2835
end exclusive: true
exact text: nhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. HUMIRA can be used alone or in combination with non-biologic DMARDs. 1.4 Ankylosing Spondylitis HUMIRA is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis. 1.5 Crohn’s Disease HUMIRA is indicated for the treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older. 1.6 Ulcerative Colitis HUMIRA is
label id: 8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 4a691d17c9c295180a2eb7a93f8e84568851de90dc3bf2233da326087f57d6d3
start: 2303

current approval status

not_reconciled

duplicate text group

dup-fa737c84766603a6dab3

extraction review status

automated_candidate_pending_source_review

generic names

ADALIMUMAB

ind-span-e54de02dd9356f3d5b0a

label id

8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a

positive predicate support span

end: 2549
end exclusive: true
exact text: is indicated
label id: 8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 4a691d17c9c295180a2eb7a93f8e84568851de90dc3bf2233da326087f57d6d3
start: 2537

qualifier mentions

context exact
itis HUMIRA is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis.
kind
age
polarity
not_inferred
span
end
2599
end exclusive
true
exact text
adult patients
label id
8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
4a691d17c9c295180a2eb7a93f8e84568851de90dc3bf2233da326087f57d6d3
start
2585

regulatory links

schema version

0.1.0

source batch sha256

424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3

source defined aliases

source span

end: 2635
end exclusive: true
exact text: 1.4 Ankylosing Spondylitis HUMIRA is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis.
label id: 8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 4a691d17c9c295180a2eb7a93f8e84568851de90dc3bf2233da326087f57d6d3
start: 2503

source url

https://api.fda.gov/drug/label.json?search=id%3A%228bf84b15-6763-41cf-bfa4-bcee9ad4ef9a%22

spl effective date

2025-12-23

spl set id

608d4f0d-b19f-46d3-749a-7159aa5f933d

spl version

2154

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

non_oncology_or_unclear_candidate

Passage 19 · positive indication candidate

application numbers

BLA125057

brand names

Humira

classification reasons

explicit_positive_indication_predicate
no_tumor_directed_keyword_in_positive_statement

clinical review status

pending

content role

positive_indication_candidate

context span

end: 3001
end exclusive: true
exact text: MIRA can be used alone or in combination with non-biologic DMARDs. 1.4 Ankylosing Spondylitis HUMIRA is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis. 1.5 Crohn’s Disease HUMIRA is indicated for the treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older. 1.6 Ulcerative Colitis HUMIRA is indicated for the treatment of moderately to severely active ulcerative colitis in adults and pediatric patients 5 years of age and older. Limitations of Use The effe
label id: 8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 4a691d17c9c295180a2eb7a93f8e84568851de90dc3bf2233da326087f57d6d3
start: 2436

current approval status

not_reconciled

duplicate text group

dup-9cb768bb62295f40f93b

extraction review status

automated_candidate_pending_source_review

generic names

ADALIMUMAB

ind-span-2bd35d20f76390e8161b

label id

8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a

positive predicate support span

end: 2675
end exclusive: true
exact text: is indicated
label id: 8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 4a691d17c9c295180a2eb7a93f8e84568851de90dc3bf2233da326087f57d6d3
start: 2663

qualifier mentions

context exact
eatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older.
kind
age
polarity
not_inferred
span
end
2752
end exclusive
true
exact text
adults
label id
8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
4a691d17c9c295180a2eb7a93f8e84568851de90dc3bf2233da326087f57d6d3
start
2746
context exact
moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older.
kind
age
polarity
not_inferred
span
end
2775
end exclusive
true
exact text
pediatric patients
label id
8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
4a691d17c9c295180a2eb7a93f8e84568851de90dc3bf2233da326087f57d6d3
start
2757
context exact
ely active Crohn’s disease in adults and pediatric patients 6 years of age and older.
kind
age
polarity
not_inferred
span
end
2790
end exclusive
true
exact text
6 years of age
label id
8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
4a691d17c9c295180a2eb7a93f8e84568851de90dc3bf2233da326087f57d6d3
start
2776

regulatory links

schema version

0.1.0

source batch sha256

424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3

source defined aliases

source span

end: 2801
end exclusive: true
exact text: 1.5 Crohn’s Disease HUMIRA is indicated for the treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older.
label id: 8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 4a691d17c9c295180a2eb7a93f8e84568851de90dc3bf2233da326087f57d6d3
start: 2636

source url

https://api.fda.gov/drug/label.json?search=id%3A%228bf84b15-6763-41cf-bfa4-bcee9ad4ef9a%22

spl effective date

2025-12-23

spl set id

608d4f0d-b19f-46d3-749a-7159aa5f933d

spl version

2154

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

non_oncology_or_unclear_candidate

Passage 20 · positive indication candidate

application numbers

BLA125057

brand names

Humira

classification reasons

explicit_positive_indication_predicate
no_tumor_directed_keyword_in_positive_statement

clinical review status

pending

content role

positive_indication_candidate

context span

end: 3173
end exclusive: true
exact text: th active ankylosing spondylitis. 1.5 Crohn’s Disease HUMIRA is indicated for the treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older. 1.6 Ulcerative Colitis HUMIRA is indicated for the treatment of moderately to severely active ulcerative colitis in adults and pediatric patients 5 years of age and older. Limitations of Use The effectiveness of HUMIRA has not been established in patients who have lost response to or were intolerant to TNF blockers [see Clinical Studies ( 14.7 , 14.8 )] . 1.7 Plaque Ps
label id: 8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 4a691d17c9c295180a2eb7a93f8e84568851de90dc3bf2233da326087f57d6d3
start: 2602

current approval status

not_reconciled

duplicate text group

dup-dda7a4bf04e81e6d0737

extraction review status

automated_candidate_pending_source_review

generic names

ADALIMUMAB

ind-span-f05df861f706efd3af41

label id

8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a

positive predicate support span

end: 2844
end exclusive: true
exact text: is indicated
label id: 8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 4a691d17c9c295180a2eb7a93f8e84568851de90dc3bf2233da326087f57d6d3
start: 2832

qualifier mentions

context exact
ment of moderately to severely active ulcerative colitis in adults and pediatric patients 5 years of age and older.
kind
age
polarity
not_inferred
span
end
2924
end exclusive
true
exact text
adults
label id
8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
4a691d17c9c295180a2eb7a93f8e84568851de90dc3bf2233da326087f57d6d3
start
2918
context exact
erately to severely active ulcerative colitis in adults and pediatric patients 5 years of age and older.
kind
age
polarity
not_inferred
span
end
2947
end exclusive
true
exact text
pediatric patients
label id
8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
4a691d17c9c295180a2eb7a93f8e84568851de90dc3bf2233da326087f57d6d3
start
2929
context exact
active ulcerative colitis in adults and pediatric patients 5 years of age and older.
kind
age
polarity
not_inferred
span
end
2962
end exclusive
true
exact text
5 years of age
label id
8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
4a691d17c9c295180a2eb7a93f8e84568851de90dc3bf2233da326087f57d6d3
start
2948

regulatory links

schema version

0.1.0

source batch sha256

424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3

source defined aliases

source span

end: 2973
end exclusive: true
exact text: 1.6 Ulcerative Colitis HUMIRA is indicated for the treatment of moderately to severely active ulcerative colitis in adults and pediatric patients 5 years of age and older.
label id: 8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 4a691d17c9c295180a2eb7a93f8e84568851de90dc3bf2233da326087f57d6d3
start: 2802

source url

https://api.fda.gov/drug/label.json?search=id%3A%228bf84b15-6763-41cf-bfa4-bcee9ad4ef9a%22

spl effective date

2025-12-23

spl set id

608d4f0d-b19f-46d3-749a-7159aa5f933d

spl version

2154

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

non_oncology_or_unclear_candidate

Passage 21 · limitation of use

application numbers

BLA125057

brand names

Humira

classification reasons

negative_or_not_established_clause

clinical review status

pending

content role

limitation_of_use

context span

end: 3359
end exclusive: true
exact text: s 6 years of age and older. 1.6 Ulcerative Colitis HUMIRA is indicated for the treatment of moderately to severely active ulcerative colitis in adults and pediatric patients 5 years of age and older. Limitations of Use The effectiveness of HUMIRA has not been established in patients who have lost response to or were intolerant to TNF blockers [see Clinical Studies ( 14.7 , 14.8 )] . 1.7 Plaque Psoriasis HUMIRA is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other s
label id: 8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 4a691d17c9c295180a2eb7a93f8e84568851de90dc3bf2233da326087f57d6d3
start: 2774

current approval status

not_reconciled

duplicate text group

dup-94888bc0b015fef1d30d

extraction review status

automated_candidate_pending_source_review

generic names

ADALIMUMAB

ind-span-c5413f03f504cff16ce5

label id

8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3

source defined aliases

source span

end: 3159
end exclusive: true
exact text: Limitations of Use The effectiveness of HUMIRA has not been established in patients who have lost response to or were intolerant to TNF blockers [see Clinical Studies ( 14.7 , 14.8 )] .
label id: 8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 4a691d17c9c295180a2eb7a93f8e84568851de90dc3bf2233da326087f57d6d3
start: 2974

source url

https://api.fda.gov/drug/label.json?search=id%3A%228bf84b15-6763-41cf-bfa4-bcee9ad4ef9a%22

spl effective date

2025-12-23

spl set id

608d4f0d-b19f-46d3-749a-7159aa5f933d

spl version

2154

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

not_applicable

Passage 22 · positive indication candidate

application numbers

BLA125057

brand names

Humira

classification reasons

explicit_positive_indication_predicate
no_tumor_directed_keyword_in_positive_statement

clinical review status

pending

content role

positive_indication_candidate

context span

end: 3608
end exclusive: true
exact text: ge and older. Limitations of Use The effectiveness of HUMIRA has not been established in patients who have lost response to or were intolerant to TNF blockers [see Clinical Studies ( 14.7 , 14.8 )] . 1.7 Plaque Psoriasis HUMIRA is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. HUMIRA should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician [see Warnings and Precautions ( 5 ) ] . 1.8 Hidradenitis Suppurativa HU
label id: 8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 4a691d17c9c295180a2eb7a93f8e84568851de90dc3bf2233da326087f57d6d3
start: 2960

current approval status

not_reconciled

duplicate text group

dup-5342f3e5ee41521fba53

extraction review status

automated_candidate_pending_source_review

generic names

ADALIMUMAB

ind-span-436b945a9c60f49c566b

label id

8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a

positive predicate support span

end: 3200
end exclusive: true
exact text: is indicated
label id: 8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 4a691d17c9c295180a2eb7a93f8e84568851de90dc3bf2233da326087f57d6d3
start: 3188

qualifier mentions

context exact
7 Plaque Psoriasis HUMIRA is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are ca
kind
age
polarity
not_inferred
span
end
3236
end exclusive
true
exact text
adult patients
label id
8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
4a691d17c9c295180a2eb7a93f8e84568851de90dc3bf2233da326087f57d6d3
start
3222

regulatory links

schema version

0.1.0

source batch sha256

424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3

source defined aliases

source span

end: 3408
end exclusive: true
exact text: 1.7 Plaque Psoriasis HUMIRA is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate.
label id: 8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 4a691d17c9c295180a2eb7a93f8e84568851de90dc3bf2233da326087f57d6d3
start: 3160

source url

https://api.fda.gov/drug/label.json?search=id%3A%228bf84b15-6763-41cf-bfa4-bcee9ad4ef9a%22

spl effective date

2025-12-23

spl set id

608d4f0d-b19f-46d3-749a-7159aa5f933d

spl version

2154

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

non_oncology_or_unclear_candidate

Passage 23 · risk or warning

application numbers

BLA125057

brand names

Humira

classification reasons

risk_or_warning_words_without_positive_predicate

clinical review status

pending

content role

risk_or_warning

context span

end: 3776
end exclusive: true
exact text: treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. HUMIRA should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician [see Warnings and Precautions ( 5 ) ] . 1.8 Hidradenitis Suppurativa HUMIRA is indicated for the treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. 1.9 Uveitis HUMIRA is indicated for the treatm
label id: 8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 4a691d17c9c295180a2eb7a93f8e84568851de90dc3bf2233da326087f57d6d3
start: 3209

current approval status

not_reconciled

duplicate text group

dup-01ce7085e36a076a0f3c

extraction review status

automated_candidate_pending_source_review

generic names

ADALIMUMAB

ind-span-68e4ddb1e71200cb76d0

label id

8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3

source defined aliases

source span

end: 3576
end exclusive: true
exact text: HUMIRA should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician [see Warnings and Precautions ( 5 ) ] .
label id: 8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 4a691d17c9c295180a2eb7a93f8e84568851de90dc3bf2233da326087f57d6d3
start: 3409

source url

https://api.fda.gov/drug/label.json?search=id%3A%228bf84b15-6763-41cf-bfa4-bcee9ad4ef9a%22

spl effective date

2025-12-23

spl set id

608d4f0d-b19f-46d3-749a-7159aa5f933d

spl version

2154

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

not_applicable

Passage 24 · positive indication candidate

application numbers

BLA125057

brand names

Humira

classification reasons

explicit_positive_indication_predicate
no_tumor_directed_keyword_in_positive_statement

clinical review status

pending

content role

positive_indication_candidate

context span

end: 3896
end exclusive: true
exact text: are medically less appropriate. HUMIRA should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician [see Warnings and Precautions ( 5 ) ] . 1.8 Hidradenitis Suppurativa HUMIRA is indicated for the treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. 1.9 Uveitis HUMIRA is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older.
label id: 8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 4a691d17c9c295180a2eb7a93f8e84568851de90dc3bf2233da326087f57d6d3
start: 3377

current approval status

not_reconciled

duplicate text group

dup-61be1476ca7990e12786

extraction review status

automated_candidate_pending_source_review

generic names

ADALIMUMAB

ind-span-8528722c3430d0e272db

label id

8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a

positive predicate support span

end: 3625
end exclusive: true
exact text: is indicated
label id: 8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 4a691d17c9c295180a2eb7a93f8e84568851de90dc3bf2233da326087f57d6d3
start: 3613

qualifier mentions

context exact
of moderate to severe hidradenitis suppurativa in patients 12 years of age and older.
kind
age
polarity
not_inferred
span
end
3718
end exclusive
true
exact text
12 years of age
label id
8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
4a691d17c9c295180a2eb7a93f8e84568851de90dc3bf2233da326087f57d6d3
start
3703

regulatory links

schema version

0.1.0

source batch sha256

424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3

source defined aliases

source span

end: 3729
end exclusive: true
exact text: 1.8 Hidradenitis Suppurativa HUMIRA is indicated for the treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older.
label id: 8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 4a691d17c9c295180a2eb7a93f8e84568851de90dc3bf2233da326087f57d6d3
start: 3577

source url

https://api.fda.gov/drug/label.json?search=id%3A%228bf84b15-6763-41cf-bfa4-bcee9ad4ef9a%22

spl effective date

2025-12-23

spl set id

608d4f0d-b19f-46d3-749a-7159aa5f933d

spl version

2154

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

non_oncology_or_unclear_candidate

Passage 25 · positive indication candidate

application numbers

BLA125057

brand names

Humira

classification reasons

explicit_positive_indication_predicate
no_tumor_directed_keyword_in_positive_statement

clinical review status

pending

content role

positive_indication_candidate

context span

end: 3896
end exclusive: true
exact text: sician [see Warnings and Precautions ( 5 ) ] . 1.8 Hidradenitis Suppurativa HUMIRA is indicated for the treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. 1.9 Uveitis HUMIRA is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older.
label id: 8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 4a691d17c9c295180a2eb7a93f8e84568851de90dc3bf2233da326087f57d6d3
start: 3530

current approval status

not_reconciled

duplicate text group

dup-fe1471f86e79032a1795

extraction review status

automated_candidate_pending_source_review

generic names

ADALIMUMAB

ind-span-6422517533128c8116d2

label id

8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a

positive predicate support span

end: 3761
end exclusive: true
exact text: is indicated
label id: 8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 4a691d17c9c295180a2eb7a93f8e84568851de90dc3bf2233da326087f57d6d3
start: 3749

qualifier mentions

context exact
f non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older.
kind
age
polarity
not_inferred
span
end
3847
end exclusive
true
exact text
adults
label id
8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
4a691d17c9c295180a2eb7a93f8e84568851de90dc3bf2233da326087f57d6d3
start
3841
context exact
tious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older.
kind
age
polarity
not_inferred
span
end
3870
end exclusive
true
exact text
pediatric patients
label id
8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
4a691d17c9c295180a2eb7a93f8e84568851de90dc3bf2233da326087f57d6d3
start
3852
context exact
posterior, and panuveitis in adults and pediatric patients 2 years of age and older.
kind
age
polarity
not_inferred
span
end
3885
end exclusive
true
exact text
2 years of age
label id
8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
4a691d17c9c295180a2eb7a93f8e84568851de90dc3bf2233da326087f57d6d3
start
3871

regulatory links

schema version

0.1.0

source batch sha256

424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3

source defined aliases

source span

end: 3896
end exclusive: true
exact text: 1.9 Uveitis HUMIRA is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older.
label id: 8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 4a691d17c9c295180a2eb7a93f8e84568851de90dc3bf2233da326087f57d6d3
start: 3730

source url

https://api.fda.gov/drug/label.json?search=id%3A%228bf84b15-6763-41cf-bfa4-bcee9ad4ef9a%22

spl effective date

2025-12-23

spl set id

608d4f0d-b19f-46d3-749a-7159aa5f933d

spl version

2154

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

non_oncology_or_unclear_candidate

Preserved source evidence · Not medical advice