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LABELS · 3a716937-c2af-4bf9-976c-c34746b22ff0

Rituxan

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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
2025-01-06
Captured
2026-09-09T23:37:44.904352+00:00
Current indication reconciliation
Not reconciled
Boxed warning in this label
  1. WARNING: FATAL INFUSION-RELATED REACTIONS, SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY WARNING: FATAL INFUSION-RELATED REACTIONS, SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY See full prescribing information for complete boxed warning. Fatal infusion-related reactions within 24 hours of RITUXAN infusion; approximately 80% of fatal reactions occurred with first infusion. Monitor patients and discontinue RITUXAN infusion for severe reactions ( 5.1 ). Severe mucocutaneous reactions, some with fatal outcomes ( 5.2 ). Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death ( 5.3 ). Progressive multifocal leukoencephalopathy (PML) resulting in death ( 5.4 ). Infusion-Related Reactions RITUXAN administration can result in serious, including fatal, infusion-related reactions. Deaths within 24 hours of RITUXAN infusion have occurred. Approximately 80% of fatal infusion reactions occurred in association with the first infusion. Monitor patients closely. Discontinue RITUXAN infusion for severe reactions and provide medical treatment for Grade 3 or 4 infusion-related reactions [see Warnings and Precautions (5.1) , Adverse Reactions (6.1) ]. Severe Mucocutaneous Reactions Severe, including fatal, mucocutaneous reactions can occur in patients receiving RITUXAN [see Warnings and Precautions (5.2) ] . Hepatitis B Virus (HBV) Reactivation HBV reactivation can occur in patients treated with RITUXAN, in some cases resulting in fulminant hepatitis, hepatic failure, and death. Screen all patients for HBV infection before treatment initiation, and monitor patients during and after treatment with RITUXAN. Discontinue RITUXAN and concomitant medications in the event of HBV reactivation [see Warnings and Precautions (5.3) ] . Progressive Multifocal Leukoencephalopathy (PML), including fatal PML, can occur in patients receiving RITUXAN [see Warnings and Precautions (5.4) and Adverse Reactions (6.1) ] .

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE RITUXAN is a CD20-directed cytolytic antibody indicated for the treatment of: Adult patients with Non-Hodgkin's Lymphoma (NHL) ( 1.1 ). Relapsed or refractory, low grade or follicular, CD20-positive B-cell NHL as a single agent. Previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy. Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy. Previously untreated diffuse large B-cell, CD20-positive NHL in combination with (cyclophosphamide, doxorubicin, vincristine, and prednisone) (CHOP) or other anthracycline-based chemotherapy regimens. Pediatric patients aged 6 months and older with mature B-cell NHL and mature B-cell acute leukemia (B-AL) ( 1.1 ) Previously untreated, advanced stage, CD20-positive, diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL), Burkitt-like lymphoma (BLL) or mature B-cell acute leukemia (B-AL) in combination with chemotherapy. Adult patients with Chronic Lymphocytic Leukemia (CLL) ( 1.2 ). Previously untreated and previously treated CD20-positive CLL in combination with fludarabine and cyclophosphamide (FC). Rheumatoid Arthritis (RA) in combination with methotrexate in adult patients with moderately-to severely-active RA who have inadequate response to one or more TNF antagonist therapies ( 1.3 ). Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA) in adult and pediatric patients 2 years of age and older in combination with glucocorticoids ( 1.4 ). Moderate to severe Pemphigus Vulgaris (PV) in adult patients ( 1.5 ). 1.1 Non–Hodgkin's Lymphoma (NHL) RITUXAN is indicated for the treatment of adult patients with: Relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL as a single agent. Previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy. Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy. Previously untreated diffuse large B-cell, CD20-positive NHL in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) or other anthracycline-based chemotherapy regimens. RITUXAN is indicated for the treatment of pediatric patients aged 6 months and older with: Previously untreated, advanced stage, CD20-positive diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL), Burkitt-like lymphoma (BLL) or mature B-cell acute leukemia (B-AL) in combination with chemotherapy. 1.2 Chronic Lymphocytic Leukemia (CLL) RITUXAN, in combination with fludarabine and cyclophosphamide (FC), is indicated for the treatment of adult patients with previously untreated and previously treated CD20-positive CLL. 1.3 Rheumatoid Arthritis (RA) RITUXAN, in combination with methotrexate, is indicated for the treatment of adult patients with moderately- to severely-active rheumatoid arthritis who have had an inadequate response to one or more TNF antagonist therapies. 1.4 Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA) RITUXAN, in combination with glucocorticoids, is indicated for the treatment of adult and pediatric patients 2 years of age and older with Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA). 1.5 Pemphigus Vulgaris (PV) RITUXAN is indicated for the treatment of adult patients with moderate to severe pemphigus vulgaris.
Full extracted label fields
application numbers
  1. BLA103705
boxed warning exact
  1. WARNING: FATAL INFUSION-RELATED REACTIONS, SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY WARNING: FATAL INFUSION-RELATED REACTIONS, SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY See full prescribing information for complete boxed warning. Fatal infusion-related reactions within 24 hours of RITUXAN infusion; approximately 80% of fatal reactions occurred with first infusion. Monitor patients and discontinue RITUXAN infusion for severe reactions ( 5.1 ). Severe mucocutaneous reactions, some with fatal outcomes ( 5.2 ). Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death ( 5.3 ). Progressive multifocal leukoencephalopathy (PML) resulting in death ( 5.4 ). Infusion-Related Reactions RITUXAN administration can result in serious, including fatal, infusion-related reactions. Deaths within 24 hours of RITUXAN infusion have occurred. Approximately 80% of fatal infusion reactions occurred in association with the first infusion. Monitor patients closely. Discontinue RITUXAN infusion for severe reactions and provide medical treatment for Grade 3 or 4 infusion-related reactions [see Warnings and Precautions (5.1) , Adverse Reactions (6.1) ]. Severe Mucocutaneous Reactions Severe, including fatal, mucocutaneous reactions can occur in patients receiving RITUXAN [see Warnings and Precautions (5.2) ] . Hepatitis B Virus (HBV) Reactivation HBV reactivation can occur in patients treated with RITUXAN, in some cases resulting in fulminant hepatitis, hepatic failure, and death. Screen all patients for HBV infection before treatment initiation, and monitor patients during and after treatment with RITUXAN. Discontinue RITUXAN and concomitant medications in the event of HBV reactivation [see Warnings and Precautions (5.3) ] . Progressive Multifocal Leukoencephalopathy (PML), including fatal PML, can occur in patients receiving RITUXAN [see Warnings and Precautions (5.4) and Adverse Reactions (6.1) ] .
brand names
  1. Rituxan
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b172773b-3905-4a1c-ad95-bab4b6126563
generic names
  1. RITUXIMAB
id
3a716937-c2af-4bf9-976c-c34746b22ff0
indications and usage exact
  1. 1 INDICATIONS AND USAGE RITUXAN is a CD20-directed cytolytic antibody indicated for the treatment of: Adult patients with Non-Hodgkin's Lymphoma (NHL) ( 1.1 ). Relapsed or refractory, low grade or follicular, CD20-positive B-cell NHL as a single agent. Previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy. Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy. Previously untreated diffuse large B-cell, CD20-positive NHL in combination with (cyclophosphamide, doxorubicin, vincristine, and prednisone) (CHOP) or other anthracycline-based chemotherapy regimens. Pediatric patients aged 6 months and older with mature B-cell NHL and mature B-cell acute leukemia (B-AL) ( 1.1 ) Previously untreated, advanced stage, CD20-positive, diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL), Burkitt-like lymphoma (BLL) or mature B-cell acute leukemia (B-AL) in combination with chemotherapy. Adult patients with Chronic Lymphocytic Leukemia (CLL) ( 1.2 ). Previously untreated and previously treated CD20-positive CLL in combination with fludarabine and cyclophosphamide (FC). Rheumatoid Arthritis (RA) in combination with methotrexate in adult patients with moderately-to severely-active RA who have inadequate response to one or more TNF antagonist therapies ( 1.3 ). Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA) in adult and pediatric patients 2 years of age and older in combination with glucocorticoids ( 1.4 ). Moderate to severe Pemphigus Vulgaris (PV) in adult patients ( 1.5 ). 1.1 Non–Hodgkin's Lymphoma (NHL) RITUXAN is indicated for the treatment of adult patients with: Relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL as a single agent. Previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy. Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy. Previously untreated diffuse large B-cell, CD20-positive NHL in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) or other anthracycline-based chemotherapy regimens. RITUXAN is indicated for the treatment of pediatric patients aged 6 months and older with: Previously untreated, advanced stage, CD20-positive diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL), Burkitt-like lymphoma (BLL) or mature B-cell acute leukemia (B-AL) in combination with chemotherapy. 1.2 Chronic Lymphocytic Leukemia (CLL) RITUXAN, in combination with fludarabine and cyclophosphamide (FC), is indicated for the treatment of adult patients with previously untreated and previously treated CD20-positive CLL. 1.3 Rheumatoid Arthritis (RA) RITUXAN, in combination with methotrexate, is indicated for the treatment of adult patients with moderately- to severely-active rheumatoid arthritis who have had an inadequate response to one or more TNF antagonist therapies. 1.4 Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA) RITUXAN, in combination with glucocorticoids, is indicated for the treatment of adult and pediatric patients 2 years of age and older with Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA). 1.5 Pemphigus Vulgaris (PV) RITUXAN is indicated for the treatment of adult patients with moderate to severe pemphigus vulgaris.
indications and usage tables exact
    is original packager
    1. true
    manufacturer names
    1. Genentech, Inc.
    matched search terms
    1. lymphoma
    2. leukemia
    package ndcs
    1. 50242-051-21
    2. 50242-051-10
    3. 50242-053-06
    product ndcs
    1. 50242-051
    2. 50242-053
    product types
    1. HUMAN PRESCRIPTION DRUG
    recent major changes exact
    1. Indications and Usage ( 1.1 ) 12/2021 Dosage and Administration, Important Dosing Information ( 2.1 ) 12/2021 Dosage and Administration, NHL ( 2.2 .) 12/2021 Dosage and Administration, Premedication and Prophylactic Medication ( 2.8 ) 12/2021 Dosage and Administration, Administration and Storage ( 2.9 ) 6/2021 Warnings and Precautions, Infusion-Related Reactions ( 5.1 ) 12/2021
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    1. INTRAVENOUS
    rxcuis
    1. 1657862
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    meta
    disclaimer
    Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.
    last updated
    2026-09-09
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    source url
    https://api.fda.gov/drug/label.json?search=id%3A%223a716937-c2af-4bf9-976c-c34746b22ff0%22
    spl effective date
    2025-01-06
    spl effective time
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    spl set id
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    spl version
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    substance names
    1. RITUXIMAB
    uniis
    1. 4F4X42SYQ6
    verification flags
    1. oncology_keyword_candidate_not_clinically_classified
    2. spl_text_not_verified_identical_to_latest_approved_label
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    Drugs@FDA application source records
    1. application number
      BLA103705
      payload
      all indexed label documents
      1. Appl No
        103705
        Application Docs Date
        2006-02-14 00:00:00
        Application Docs ID
        18605
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        5209
        Submission Type
        SUPPL
      2. Appl No
        103705
        Application Docs Date
        2006-03-14 00:00:00
        Application Docs ID
        18606
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
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        Submission Type
        SUPPL
      3. Appl No
        103705
        Application Docs Date
        2006-10-02 00:00:00
        Application Docs ID
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        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        5231
        Submission Type
        SUPPL
      4. Appl No
        103705
        Application Docs Date
        2007-03-07 00:00:00
        Application Docs ID
        18608
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        5247
        Submission Type
        SUPPL
      5. Appl No
        103705
        Application Docs Date
        2007-08-30 00:00:00
        Application Docs ID
        18609
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        5259
        Submission Type
        SUPPL
      6. Appl No
        103705
        Application Docs Date
        2007-10-10 00:00:00
        Application Docs ID
        18610
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        5262
        Submission Type
        SUPPL
      7. Appl No
        103705
        Application Docs Date
        2009-10-22 00:00:00
        Application Docs ID
        18611
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        5299
        Submission Type
        SUPPL
      8. Appl No
        103705
        Application Docs Date
        2010-02-19 00:00:00
        Application Docs ID
        18612
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        5311
        Submission Type
        SUPPL
      9. Appl No
        103705
        Application Docs Date
        2010-02-19 00:00:00
        Application Docs ID
        18613
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        5312
        Submission Type
        SUPPL
      10. Appl No
        103705
        Application Docs Date
        2011-01-31 00:00:00
        Application Docs ID
        18614
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        5332
        Submission Type
        SUPPL
      11. Appl No
        103705
        Application Docs Date
        2011-01-10 00:00:00
        Application Docs ID
        18615
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        5343
        Submission Type
        SUPPL
      12. Appl No
        103705
        Application Docs Date
        2011-04-21 00:00:00
        Application Docs ID
        18616
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        5344
        Submission Type
        SUPPL
      all submission records
      1. Appl No
        103705
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        5467
        Submission Status
        AP
        Submission Status Date
        2021-12-17 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      2. Appl No
        103705
        Review Priority
        PRIORITY
        Submission Class Code ID
        2
        Submission No
        5465
        Submission Status
        AP
        Submission Status Date
        2021-12-02 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      3. Appl No
        103705
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        5464
        Submission Status
        AP
        Submission Status Date
        2021-06-30 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      4. Appl No
        103705
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        5461
        Submission Status
        AP
        Submission Status Date
        2020-01-23 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      5. Appl No
        103705
        Review Priority
        STANDARD
        Submission Class Code ID
        2
        Submission No
        5460
        Submission Status
        AP
        Submission Status Date
        2020-08-28 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      6. Appl No
        103705
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        5459
        Submission Status
        AP
        Submission Status Date
        2019-11-25 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      7. Appl No
        103705
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        5458
        Submission Status
        AP
        Submission Status Date
        2020-03-13 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      8. Appl No
        103705
        Review Priority
        PRIORITY
        Submission Class Code ID
        2
        Submission No
        5457
        Submission Status
        AP
        Submission Status Date
        2019-09-27 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      9. Appl No
        103705
        Review Priority
        STANDARD
        Submission Class Code ID
        2
        Submission No
        5454
        Submission Status
        AP
        Submission Status Date
        2019-01-25 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      10. Appl No
        103705
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        5453
        Submission Status
        AP
        Submission Status Date
        2018-04-03 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      11. Appl No
        103705
        Review Priority
        STANDARD
        Submission Class Code ID
        2
        Submission No
        5451
        Submission Status
        AP
        Submission Status Date
        2018-10-18 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      12. Appl No
        103705
        Review Priority
        PRIORITY
        Submission Class Code ID
        2
        Submission No
        5450
        Submission Status
        AP
        Submission Status Date
        2018-06-07 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      application number
      BLA103705
      approval interpretation
      Application linkage and approved submission are not indication-level current approval verification
      current indication status
      not_reconciled
      has approved submission record
      true
      latest approved submission date
      2021-12-17
      latest label selection rule
      max FDA ApplicationDocsDate, including all ties; posting date is not approval date and latest indexed document may be incomplete
      latest posted label documents
      1. Appl No
        103705
        Application Docs Date
        2021-12-19 00:00:00
        Application Docs ID
        69634
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        5467
        Submission Type
        SUPPL
      official application record
      Appl No
      103705
      Appl Public Notes
      Appl Type
      BLA
      Sponsor Name
      GENENTECH
      openfda application present
      true
      products
      1. Active Ingredient
        RITUXIMAB
        Appl No
        103705
        Drug Name
        RITUXAN
        Form
        SOLUTION;INTRAVENOUS
        Product No
        001
        Reference Drug
        0
        Reference Standard
        Strength
        100MG/10ML (10MG/ML)
        marketing status
        1. Prescription
      2. Active Ingredient
        RITUXIMAB
        Appl No
        103705
        Drug Name
        RITUXAN
        Form
        SOLUTION;INTRAVENOUS
        Product No
        002
        Reference Drug
        0
        Reference Standard
        0
        Strength
        500MG/50ML (10MG/ML)
        marketing status
        1. Prescription

    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
    1. BLA103705
    brand names
    1. Rituxan
    classification reasons
    1. explicit_positive_indication_predicate
    2. tumor_or_malignant_hematology_words_in_positive_statement
    clinical review status
    pending
    content role
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    context span
    end
    359
    end exclusive
    true
    exact text
    1 INDICATIONS AND USAGE RITUXAN is a CD20-directed cytolytic antibody indicated for the treatment of: Adult patients with Non-Hodgkin's Lymphoma (NHL) ( 1.1 ). Relapsed or refractory, low grade or follicular, CD20-positive B-cell NHL as a single agent. Previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and
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              reviously untreated diffuse large B-cell, CD20-positive NHL in combination with (cyclophosphamide, doxorubicin, vincristine, and prednisone) (CHOP) or other anthracycline-based chemotherapy regimens.
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              Passage 6 · unclassified context
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                Pediatric patients aged 6 months and older with mature B-cell NHL and mature B-cell acute leukemia (B-AL) ( 1.1 ) Previously untreated, adv
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              3. context exact
                ukemia (B-AL) ( 1.1 ) Previously untreated, advanced stage, CD20-positive, diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (B
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              4. context exact
                B-cell acute leukemia (B-AL) ( 1.1 ) Previously untreated, advanced stage, CD20-positive, diffuse large B-cell lymphoma (DLBCL), Burk
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              5. context exact
                B-cell NHL and mature B-cell acute leukemia (B-AL) ( 1.1 ) Previously untreated, advanced stage, CD20-positive, diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL), Burkitt-like lymphoma (BLL) or mature B-cell acute leukemia (B-AL) in combination with chemotherapy.
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                Passage 7 · unclassified context
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                  1221
                  source url
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                  Passage 8 · unclassified context
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                    source url
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                    use intent
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                    Passage 9 · unclassified context
                    application numbers
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                            source text sha256
                            0bf127c9965cac2217bebb7d7626b5fb20888dbfd0503e8c92c011cccd151623
                            start
                            1913
                            qualifier mentions
                            1. context exact
                              Previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and
                              kind
                              biomarker
                              polarity
                              not_inferred
                              span
                              end
                              2108
                              end exclusive
                              true
                              exact text
                              CD20-positive
                              label id
                              3a716937-c2af-4bf9-976c-c34746b22ff0
                              offset unit
                              unicode_code_points
                              source array index
                              0
                              source field
                              indications_and_usage_exact
                              source text sha256
                              0bf127c9965cac2217bebb7d7626b5fb20888dbfd0503e8c92c011cccd151623
                              start
                              2095
                            2. context exact
                              Previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent mainte
                              kind
                              prior_therapy_or_line
                              polarity
                              not_inferred
                              span
                              end
                              2242
                              end exclusive
                              true
                              exact text
                              Previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab prod
                              label id
                              3a716937-c2af-4bf9-976c-c34746b22ff0
                              offset unit
                              unicode_code_points
                              source array index
                              0
                              source field
                              indications_and_usage_exact
                              source text sha256
                              0bf127c9965cac2217bebb7d7626b5fb20888dbfd0503e8c92c011cccd151623
                              start
                              2062
                            3. context exact
                              Previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy.
                              kind
                              regimen
                              polarity
                              not_inferred
                              span
                              end
                              2300
                              end exclusive
                              true
                              exact text
                              in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent main
                              label id
                              3a716937-c2af-4bf9-976c-c34746b22ff0
                              offset unit
                              unicode_code_points
                              source array index
                              0
                              source field
                              indications_and_usage_exact
                              source text sha256
                              0bf127c9965cac2217bebb7d7626b5fb20888dbfd0503e8c92c011cccd151623
                              start
                              2121
                            regulatory links
                              schema version
                              0.1.0
                              source batch sha256
                              d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571
                              source defined aliases
                              1. abbreviation
                                DLBCL
                                definition exact
                                diffuse large B-cell lymphoma
                                definition span
                                end
                                1095
                                end exclusive
                                true
                                exact text
                                diffuse large B-cell lymphoma (DLBCL)
                                label id
                                3a716937-c2af-4bf9-976c-c34746b22ff0
                                offset unit
                                unicode_code_points
                                source array index
                                0
                                source field
                                indications_and_usage_exact
                                source text sha256
                                0bf127c9965cac2217bebb7d7626b5fb20888dbfd0503e8c92c011cccd151623
                                start
                                1058
                              source span
                              end
                              2316
                              end exclusive
                              true
                              exact text
                              Previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy.
                              label id
                              3a716937-c2af-4bf9-976c-c34746b22ff0
                              offset unit
                              unicode_code_points
                              source array index
                              0
                              source field
                              indications_and_usage_exact
                              source text sha256
                              0bf127c9965cac2217bebb7d7626b5fb20888dbfd0503e8c92c011cccd151623
                              start
                              2062
                              source url
                              https://api.fda.gov/drug/label.json?search=id%3A%223a716937-c2af-4bf9-976c-c34746b22ff0%22
                              spl effective date
                              2025-01-06
                              spl set id
                              b172773b-3905-4a1c-ad95-bab4b6126563
                              spl version
                              36
                              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 14 · unclassified context
                              application numbers
                              1. BLA103705
                              brand names
                              1. Rituxan
                              classification reasons
                              1. no_unambiguous_positive_indication_predicate
                              clinical review status
                              pending
                              content role
                              unclassified_context
                              context span
                              end
                              2698
                              end exclusive
                              true
                              exact text
                              NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy. Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy. Previously untreated diffuse large B-cell, CD20-positive NHL in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) or other anthracycline-based chemotherapy regimens. RITU
                              label id
                              3a716937-c2af-4bf9-976c-c34746b22ff0
                              offset unit
                              unicode_code_points
                              source array index
                              0
                              source field
                              indications_and_usage_exact
                              source text sha256
                              0bf127c9965cac2217bebb7d7626b5fb20888dbfd0503e8c92c011cccd151623
                              start
                              2117
                              current approval status
                              not_reconciled
                              duplicate text group
                              dup-fb1a7f7ef27d81ff71b2
                              extraction review status
                              automated_candidate_pending_source_review
                              generic names
                              1. RITUXIMAB
                              id
                              ind-span-f7b793cd68437237a7c4
                              label id
                              3a716937-c2af-4bf9-976c-c34746b22ff0
                              positive predicate support span
                              Source null
                              qualifier mentions
                              1. context exact
                                Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophospha
                                kind
                                biomarker
                                polarity
                                not_inferred
                                span
                                end
                                2385
                                end exclusive
                                true
                                exact text
                                CD20-positive
                                label id
                                3a716937-c2af-4bf9-976c-c34746b22ff0
                                offset unit
                                unicode_code_points
                                source array index
                                0
                                source field
                                indications_and_usage_exact
                                source text sha256
                                0bf127c9965cac2217bebb7d7626b5fb20888dbfd0503e8c92c011cccd151623
                                start
                                2372
                              2. context exact
                                ow-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy.
                                kind
                                prior_therapy_or_line
                                polarity
                                not_inferred
                                span
                                end
                                2497
                                end exclusive
                                true
                                exact text
                                first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy
                                label id
                                3a716937-c2af-4bf9-976c-c34746b22ff0
                                offset unit
                                unicode_code_points
                                source array index
                                0
                                source field
                                indications_and_usage_exact
                                source text sha256
                                0bf127c9965cac2217bebb7d7626b5fb20888dbfd0503e8c92c011cccd151623
                                start
                                2422
                              3. context exact
                                uding stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy.
                                kind
                                regimen
                                polarity
                                not_inferred
                                span
                                end
                                2497
                                end exclusive
                                true
                                exact text
                                as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy
                                label id
                                3a716937-c2af-4bf9-976c-c34746b22ff0
                                offset unit
                                unicode_code_points
                                source array index
                                0
                                source field
                                indications_and_usage_exact
                                source text sha256
                                0bf127c9965cac2217bebb7d7626b5fb20888dbfd0503e8c92c011cccd151623
                                start
                                2398
                              regulatory links
                                schema version
                                0.1.0
                                source batch sha256
                                d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571
                                source defined aliases
                                1. abbreviation
                                  DLBCL
                                  definition exact
                                  diffuse large B-cell lymphoma
                                  definition span
                                  end
                                  1095
                                  end exclusive
                                  true
                                  exact text
                                  diffuse large B-cell lymphoma (DLBCL)
                                  label id
                                  3a716937-c2af-4bf9-976c-c34746b22ff0
                                  offset unit
                                  unicode_code_points
                                  source array index
                                  0
                                  source field
                                  indications_and_usage_exact
                                  source text sha256
                                  0bf127c9965cac2217bebb7d7626b5fb20888dbfd0503e8c92c011cccd151623
                                  start
                                  1058
                                source span
                                end
                                2498
                                end exclusive
                                true
                                exact text
                                Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy.
                                label id
                                3a716937-c2af-4bf9-976c-c34746b22ff0
                                offset unit
                                unicode_code_points
                                source array index
                                0
                                source field
                                indications_and_usage_exact
                                source text sha256
                                0bf127c9965cac2217bebb7d7626b5fb20888dbfd0503e8c92c011cccd151623
                                start
                                2317
                                source url
                                https://api.fda.gov/drug/label.json?search=id%3A%223a716937-c2af-4bf9-976c-c34746b22ff0%22
                                spl effective date
                                2025-01-06
                                spl set id
                                b172773b-3905-4a1c-ad95-bab4b6126563
                                spl version
                                36
                                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 15 · positive indication candidate
                                application numbers
                                1. BLA103705
                                brand names
                                1. Rituxan
                                classification reasons
                                1. inherited_predicate_from_same_label_section_requires_review
                                2. no_tumor_directed_keyword_in_positive_statement
                                clinical review status
                                pending
                                content role
                                positive_indication_candidate
                                context span
                                end
                                2893
                                end exclusive
                                true
                                exact text
                                ntenance therapy. Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy. Previously untreated diffuse large B-cell, CD20-positive NHL in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) or other anthracycline-based chemotherapy regimens. RITUXAN is indicated for the treatment of pediatric patients aged 6 months and older with: Previously untreated, advanced stage, CD20-positive diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma
                                label id
                                3a716937-c2af-4bf9-976c-c34746b22ff0
                                offset unit
                                unicode_code_points
                                source array index
                                0
                                source field
                                indications_and_usage_exact
                                source text sha256
                                0bf127c9965cac2217bebb7d7626b5fb20888dbfd0503e8c92c011cccd151623
                                start
                                2299
                                current approval status
                                not_reconciled
                                duplicate text group
                                dup-198129a43f2d4067cd34
                                extraction review status
                                automated_candidate_pending_source_review
                                generic names
                                1. RITUXIMAB
                                id
                                ind-span-8751a0da32729f5f0ba3
                                label id
                                3a716937-c2af-4bf9-976c-c34746b22ff0
                                positive predicate support span
                                end
                                1925
                                end exclusive
                                true
                                exact text
                                is indicated
                                label id
                                3a716937-c2af-4bf9-976c-c34746b22ff0
                                offset unit
                                unicode_code_points
                                source array index
                                0
                                source field
                                indications_and_usage_exact
                                source text sha256
                                0bf127c9965cac2217bebb7d7626b5fb20888dbfd0503e8c92c011cccd151623
                                start
                                1913
                                qualifier mentions
                                1. context exact
                                  Previously untreated diffuse large B-cell, CD20-positive NHL in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) or o
                                  kind
                                  biomarker
                                  polarity
                                  not_inferred
                                  span
                                  end
                                  2586
                                  end exclusive
                                  true
                                  exact text
                                  CD20-positive NHL in combination with cyclop
                                  label id
                                  3a716937-c2af-4bf9-976c-c34746b22ff0
                                  offset unit
                                  unicode_code_points
                                  source array index
                                  0
                                  source field
                                  indications_and_usage_exact
                                  source text sha256
                                  0bf127c9965cac2217bebb7d7626b5fb20888dbfd0503e8c92c011cccd151623
                                  start
                                  2542
                                2. context exact
                                  Previously untreated diffuse large B-cell, CD20-positive NHL in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) or other anthracycline-based chemotherapy regimens.
                                  kind
                                  prior_therapy_or_line
                                  polarity
                                  not_inferred
                                  span
                                  end
                                  2679
                                  end exclusive
                                  true
                                  exact text
                                  Previously untreated diffuse large B-cell, CD20-positive NHL in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) or other anthracycline-based chemothe
                                  label id
                                  3a716937-c2af-4bf9-976c-c34746b22ff0
                                  offset unit
                                  unicode_code_points
                                  source array index
                                  0
                                  source field
                                  indications_and_usage_exact
                                  source text sha256
                                  0bf127c9965cac2217bebb7d7626b5fb20888dbfd0503e8c92c011cccd151623
                                  start
                                  2499
                                3. context exact
                                  reviously untreated diffuse large B-cell, CD20-positive NHL in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) or other anthracycline-based chemotherapy regimens.
                                  kind
                                  regimen
                                  polarity
                                  not_inferred
                                  span
                                  end
                                  2692
                                  end exclusive
                                  true
                                  exact text
                                  in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) or other anthracycline-based chemotherapy regimens
                                  label id
                                  3a716937-c2af-4bf9-976c-c34746b22ff0
                                  offset unit
                                  unicode_code_points
                                  source array index
                                  0
                                  source field
                                  indications_and_usage_exact
                                  source text sha256
                                  0bf127c9965cac2217bebb7d7626b5fb20888dbfd0503e8c92c011cccd151623
                                  start
                                  2560
                                regulatory links
                                  schema version
                                  0.1.0
                                  source batch sha256
                                  d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571
                                  source defined aliases
                                  1. abbreviation
                                    DLBCL
                                    definition exact
                                    diffuse large B-cell lymphoma
                                    definition span
                                    end
                                    1095
                                    end exclusive
                                    true
                                    exact text
                                    diffuse large B-cell lymphoma (DLBCL)
                                    label id
                                    3a716937-c2af-4bf9-976c-c34746b22ff0
                                    offset unit
                                    unicode_code_points
                                    source array index
                                    0
                                    source field
                                    indications_and_usage_exact
                                    source text sha256
                                    0bf127c9965cac2217bebb7d7626b5fb20888dbfd0503e8c92c011cccd151623
                                    start
                                    1058
                                  source span
                                  end
                                  2693
                                  end exclusive
                                  true
                                  exact text
                                  Previously untreated diffuse large B-cell, CD20-positive NHL in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) or other anthracycline-based chemotherapy regimens.
                                  label id
                                  3a716937-c2af-4bf9-976c-c34746b22ff0
                                  offset unit
                                  unicode_code_points
                                  source array index
                                  0
                                  source field
                                  indications_and_usage_exact
                                  source text sha256
                                  0bf127c9965cac2217bebb7d7626b5fb20888dbfd0503e8c92c011cccd151623
                                  start
                                  2499
                                  source url
                                  https://api.fda.gov/drug/label.json?search=id%3A%223a716937-c2af-4bf9-976c-c34746b22ff0%22
                                  spl effective date
                                  2025-01-06
                                  spl set id
                                  b172773b-3905-4a1c-ad95-bab4b6126563
                                  spl version
                                  36
                                  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 16 · positive indication candidate
                                  application numbers
                                  1. BLA103705
                                  brand names
                                  1. Rituxan
                                  classification reasons
                                  1. explicit_positive_indication_predicate
                                  2. tumor_or_malignant_hematology_words_in_positive_statement
                                  clinical review status
                                  pending
                                  content role
                                  positive_indication_candidate
                                  context span
                                  end
                                  3199
                                  end exclusive
                                  true
                                  exact text
                                  apy. Previously untreated diffuse large B-cell, CD20-positive NHL in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) or other anthracycline-based chemotherapy regimens. RITUXAN is indicated for the treatment of pediatric patients aged 6 months and older with: Previously untreated, advanced stage, CD20-positive diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL), Burkitt-like lymphoma (BLL) or mature B-cell acute leukemia (B-AL) in combination with chemotherapy. 1.2 Chronic Lymphocytic Leukemia (CLL) RITUXAN, in combination with fludarabine and cyclophosphamide (FC), is indicated for the treatment of adult patients with previously untreated and previously tr
                                  label id
                                  3a716937-c2af-4bf9-976c-c34746b22ff0
                                  offset unit
                                  unicode_code_points
                                  source array index
                                  0
                                  source field
                                  indications_and_usage_exact
                                  source text sha256
                                  0bf127c9965cac2217bebb7d7626b5fb20888dbfd0503e8c92c011cccd151623
                                  start
                                  2494
                                  current approval status
                                  not_reconciled
                                  duplicate text group
                                  dup-bde0bf644bfbd9244393
                                  extraction review status
                                  automated_candidate_pending_source_review
                                  generic names
                                  1. RITUXIMAB
                                  id
                                  ind-span-ffb7285a0b8985d3d87f
                                  label id
                                  3a716937-c2af-4bf9-976c-c34746b22ff0
                                  positive predicate support span
                                  end
                                  2714
                                  end exclusive
                                  true
                                  exact text
                                  is indicated
                                  label id
                                  3a716937-c2af-4bf9-976c-c34746b22ff0
                                  offset unit
                                  unicode_code_points
                                  source array index
                                  0
                                  source field
                                  indications_and_usage_exact
                                  source text sha256
                                  0bf127c9965cac2217bebb7d7626b5fb20888dbfd0503e8c92c011cccd151623
                                  start
                                  2702
                                  qualifier mentions
                                  1. context exact
                                    RITUXAN is indicated for the treatment of pediatric patients aged 6 months and older with: Previously untreated, advance
                                    kind
                                    age
                                    polarity
                                    not_inferred
                                    span
                                    end
                                    2754
                                    end exclusive
                                    true
                                    exact text
                                    pediatric patients
                                    label id
                                    3a716937-c2af-4bf9-976c-c34746b22ff0
                                    offset unit
                                    unicode_code_points
                                    source array index
                                    0
                                    source field
                                    indications_and_usage_exact
                                    source text sha256
                                    0bf127c9965cac2217bebb7d7626b5fb20888dbfd0503e8c92c011cccd151623
                                    start
                                    2736
                                  2. context exact
                                    ITUXAN is indicated for the treatment of pediatric patients aged 6 months and older with: Previously untreated, advanced stage, CD20-positive diffuse large B-cell lymphom
                                    kind
                                    age
                                    polarity
                                    not_inferred
                                    span
                                    end
                                    2805
                                    end exclusive
                                    true
                                    exact text
                                    aged 6 months and older with: Previously untreated
                                    label id
                                    3a716937-c2af-4bf9-976c-c34746b22ff0
                                    offset unit
                                    unicode_code_points
                                    source array index
                                    0
                                    source field
                                    indications_and_usage_exact
                                    source text sha256
                                    0bf127c9965cac2217bebb7d7626b5fb20888dbfd0503e8c92c011cccd151623
                                    start
                                    2755
                                  3. context exact
                                    onths and older with: Previously untreated, advanced stage, CD20-positive diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL), Burkitt-like lymphoma (BLL)
                                    kind
                                    biomarker
                                    polarity
                                    not_inferred
                                    span
                                    end
                                    2867
                                    end exclusive
                                    true
                                    exact text
                                    CD20-positive diffuse large B-cell lymphoma
                                    label id
                                    3a716937-c2af-4bf9-976c-c34746b22ff0
                                    offset unit
                                    unicode_code_points
                                    source array index
                                    0
                                    source field
                                    indications_and_usage_exact
                                    source text sha256
                                    0bf127c9965cac2217bebb7d7626b5fb20888dbfd0503e8c92c011cccd151623
                                    start
                                    2823
                                  4. context exact
                                    atients aged 6 months and older with: Previously untreated, advanced stage, CD20-positive diffuse large B-cell lymphoma (DLBCL), Burki
                                    kind
                                    stage_or_setting
                                    polarity
                                    not_inferred
                                    span
                                    end
                                    2821
                                    end exclusive
                                    true
                                    exact text
                                    advanced stage
                                    label id
                                    3a716937-c2af-4bf9-976c-c34746b22ff0
                                    offset unit
                                    unicode_code_points
                                    source array index
                                    0
                                    source field
                                    indications_and_usage_exact
                                    source text sha256
                                    0bf127c9965cac2217bebb7d7626b5fb20888dbfd0503e8c92c011cccd151623
                                    start
                                    2807
                                  5. context exact
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                                    RITUXAN is indicated for the treatment of pediatric patients aged 6 months and older with: Previously untreated, advanced stage, CD20-positive diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL), Burkitt-like lymphoma (BLL) or mature B-cell acute leukemia (B-AL) in combination with chemotherapy.
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                                    Source null
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                                    Source null
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                                    Source null
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                                    Source null
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                                    Source null
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                                    application numbers
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                                    eated, advanced stage, CD20-positive diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL), Burkitt-like lymphoma (BLL) or mature B-cell acute leukemia (B-AL) in combination with chemotherapy. 1.2 Chronic Lymphocytic Leukemia (CLL) RITUXAN, in combination with fludarabine and cyclophosphamide (FC), is indicated for the treatment of adult patients with previously untreated and previously treated CD20-positive CLL. 1.3 Rheumatoid Arthritis (RA) RITUXAN, in combination with methotrexate, is indicated for the treatment of adult patients with moderately- to severely-active rheumatoid arthritis who have had an inad
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                                    qualifier mentions
                                    1. context exact
                                      nd cyclophosphamide (FC), is indicated for the treatment of adult patients with previously untreated and previously treated CD20-posit
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                                    2. context exact
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                                      (FC), is indicated for the treatment of adult patients with previously untreated and previously treated CD20-positive CLL.
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                                      3161
                                    4. context exact
                                      1.2 Chronic Lymphocytic Leukemia (CLL) RITUXAN, in combination with fludarabine and cyclophosphamide (FC), is indicated for the treatment of adult patients with previously untreated and previously treated CD20-positive CLL.
                                      kind
                                      regimen
                                      polarity
                                      not_inferred
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                                      exact text
                                      in combination with fludarabine and cyclophosphamide (FC), is indicated for the treatment of adult patients with previously untreated and previously treated CD20-positive CLL
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                                    regulatory links
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                                      source defined aliases
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                                        diffuse large B-cell lymphoma
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                                        true
                                        exact text
                                        diffuse large B-cell lymphoma (DLBCL)
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                                      exact text
                                      1.2 Chronic Lymphocytic Leukemia (CLL) RITUXAN, in combination with fludarabine and cyclophosphamide (FC), is indicated for the treatment of adult patients with previously untreated and previously treated CD20-positive CLL.
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                                      source url
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                                      regimen
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                                      brand names
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                                      exact text
                                      Leukemia (CLL) RITUXAN, in combination with fludarabine and cyclophosphamide (FC), is indicated for the treatment of adult patients with previously untreated and previously treated CD20-positive CLL. 1.3 Rheumatoid Arthritis (RA) RITUXAN, in combination with methotrexate, is indicated for the treatment of adult patients with moderately- to severely-active rheumatoid arthritis who have had an inadequate response to one or more TNF antagonist therapies. 1.4 Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA) RITUXAN, in combination with glucocorticoids, is indicated for the treatment of adult and pedi
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                                      is indicated
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                                      qualifier mentions
                                      1. context exact
                                        nation with methotrexate, is indicated for the treatment of adult patients with moderately- to severely-active rheumatoid arthritis wh
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                                        polarity
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                                      2. context exact
                                        1.3 Rheumatoid Arthritis (RA) RITUXAN, in combination with methotrexate, is indicated for the treatment of adult patients with mode
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                                        3295
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                                      3. context exact
                                        1.3 Rheumatoid Arthritis (RA) RITUXAN, in combination with methotrexate, is indicated for the treatment of adult patients with moderately- to severely-active rheumatoid arthritis who have had an inadequate response to one or more TNF antagonist therapies.
                                        kind
                                        regimen
                                        polarity
                                        not_inferred
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                                        3442
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                                        true
                                        exact text
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                                      regulatory links
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                                          diffuse large B-cell lymphoma
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                                          1095
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                                          true
                                          exact text
                                          diffuse large B-cell lymphoma (DLBCL)
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                                        3479
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                                        true
                                        exact text
                                        1.3 Rheumatoid Arthritis (RA) RITUXAN, in combination with methotrexate, is indicated for the treatment of adult patients with moderately- to severely-active rheumatoid arthritis who have had an inadequate response to one or more TNF antagonist therapies.
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                                        3224
                                        source url
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                                        spl effective date
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                                        Source null
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                                        Source null
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                                        Source null
                                        disease stage
                                        Source null
                                        limitations
                                        Source null
                                        line
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                                        Source null
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                                        Source null
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                                        Source null
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                                        application numbers
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                                        brand names
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                                        3954
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                                        true
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                                        th methotrexate, is indicated for the treatment of adult patients with moderately- to severely-active rheumatoid arthritis who have had an inadequate response to one or more TNF antagonist therapies. 1.4 Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA) RITUXAN, in combination with glucocorticoids, is indicated for the treatment of adult and pediatric patients 2 years of age and older with Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA). 1.5 Pemphigus Vulgaris (PV) RITUXAN is indicated for the treatment of adult patients with moderate to severe pemphigus vulgaris.
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                                        3a716937-c2af-4bf9-976c-c34746b22ff0
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                                        current approval status
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                                        qualifier mentions
                                        1. context exact
                                          ion with glucocorticoids, is indicated for the treatment of adult and pediatric patients 2 years of age and older with Granul
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                                          polarity
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                                          3670
                                          end exclusive
                                          true
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                                          3665
                                        2. context exact
                                          lucocorticoids, is indicated for the treatment of adult and pediatric patients 2 years of age and older with Granulomatosis with Polyangii
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                                          age
                                          polarity
                                          not_inferred
                                          span
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                                          3693
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                                        3. context exact
                                          indicated for the treatment of adult and pediatric patients 2 years of age and older with Granulomatosis with Polyangiitis (GPA) (Wege
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                                          age
                                          polarity
                                          not_inferred
                                          span
                                          end
                                          3708
                                          end exclusive
                                          true
                                          exact text
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                                          label id
                                          3a716937-c2af-4bf9-976c-c34746b22ff0
                                          offset unit
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                                          start
                                          3694
                                        4. context exact
                                          Granulomatosis) and Microscopic Polyangiitis (MPA) RITUXAN, in combination with glucocorticoids, is indicated for the treatment of adult and pediatric patients 2 years of age and older with Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA).
                                          kind
                                          regimen
                                          polarity
                                          not_inferred
                                          span
                                          end
                                          3773
                                          end exclusive
                                          true
                                          exact text
                                          in combination with glucocorticoids, is indicated for the treatment of adult and pediatric patients 2 years of age and older with Granulomatosis with Polyangiitis (GPA) (Wegener's
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                                            diffuse large B-cell lymphoma (DLBCL)
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                                          1.4 Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA) RITUXAN, in combination with glucocorticoids, is indicated for the treatment of adult and pediatric patients 2 years of age and older with Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA).
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                                          Source null
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                                          Source null
                                          line
                                          Source null
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                                          Source null
                                          regimen
                                          Source null
                                          tumor histology
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                                          use intent
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                                          1. BLA103705
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                                          1. Rituxan
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                                          ids, is indicated for the treatment of adult and pediatric patients 2 years of age and older with Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA). 1.5 Pemphigus Vulgaris (PV) RITUXAN is indicated for the treatment of adult patients with moderate to severe pemphigus vulgaris.
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                                            gus Vulgaris (PV) RITUXAN is indicated for the treatment of adult patients with moderate to severe pemphigus vulgaris.
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                                            1.5 Pemphigus Vulgaris (PV) RITUXAN is indicated for the treatment of adult patients with moderate to severe pemphigus vulgaris.
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                                            Source null
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                                            Source null
                                            limitations
                                            Source null
                                            line
                                            Source null
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                                            regimen
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                                            Preserved source evidence · Not medical advice