LABELS · 59d39f88-54fb-480a-979b-4d3d2c7c2cd4

Ovidrel

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: 2023-12-26
Captured: 2026-09-09T23:37:47.659725+00:00
Current indication reconciliation: Not reconciled

Indications and usage: exact source text

INDICATIONS AND USAGE Ovidrel ® PreFilled Syringe (choriogonadotropin alfa injection) is indicated for the induction of final follicular maturation and early luteinization in infertile women who have undergone pituitary desensitization and who have been appropriately pretreated with follicle stimulating hormones as part of an Assisted Reproductive Technology (ART) program such as in vitro fertilization and embryo transfer. Ovidrel ® PreFilled Syringe is also indicated for the induction of ovulation (OI) and pregnancy in anovulatory infertile patients in whom the cause of infertility is functional and not due to primary ovarian failure. Selection of Patients Before treatment with gonadotropins is instituted, a thorough gynecologic and endocrinologic evaluation must be performed. This should include an assessment of pelvic anatomy. Patients with tubal obstruction should receive Ovidrel ® PreFilled Syringe only if enrolled in an in vitro fertilization program. Primary ovarian failure should be excluded by the determination of gonadotropin levels. Appropriate evaluation should be performed to exclude pregnancy. Patients in later reproductive life have a greater predisposition to endometrial carcinoma as well as a higher incidence of anovulatory disorders. A thorough diagnostic evaluation should always be performed in patients who demonstrate abnormal uterine bleeding or other signs of endometrial abnormalities before starting FSH and Ovidrel ® PreFilled Syringe therapy. Evaluation of the partner's fertility potential should be included in the initial evaluation.

Full extracted label fields

application numbers

BLA021149

boxed warning exact

brand names

Ovidrel

current indication status

not_reconciled

dailymed set url

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generic names

CHORIOGONADOTROPIN ALFA

59d39f88-54fb-480a-979b-4d3d2c7c2cd4

indications and usage exact

INDICATIONS AND USAGE Ovidrel ® PreFilled Syringe (choriogonadotropin alfa injection) is indicated for the induction of final follicular maturation and early luteinization in infertile women who have undergone pituitary desensitization and who have been appropriately pretreated with follicle stimulating hormones as part of an Assisted Reproductive Technology (ART) program such as in vitro fertilization and embryo transfer. Ovidrel ® PreFilled Syringe is also indicated for the induction of ovulation (OI) and pregnancy in anovulatory infertile patients in whom the cause of infertility is functional and not due to primary ovarian failure. Selection of Patients Before treatment with gonadotropins is instituted, a thorough gynecologic and endocrinologic evaluation must be performed. This should include an assessment of pelvic anatomy. Patients with tubal obstruction should receive Ovidrel ® PreFilled Syringe only if enrolled in an in vitro fertilization program. Primary ovarian failure should be excluded by the determination of gonadotropin levels. Appropriate evaluation should be performed to exclude pregnancy. Patients in later reproductive life have a greater predisposition to endometrial carcinoma as well as a higher incidence of anovulatory disorders. A thorough diagnostic evaluation should always be performed in patients who demonstrate abnormal uterine bleeding or other signs of endometrial abnormalities before starting FSH and Ovidrel ® PreFilled Syringe therapy. Evaluation of the partner's fertility potential should be included in the initial evaluation.

indications and usage tables exact

is original packager

true

manufacturer names

EMD Serono, Inc.

matched search terms

carcinoma

package ndcs

44087-1150-1

product ndcs

44087-1150

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

record type

complete_spl_indications_section_candidate

routes

SUBCUTANEOUS

rxcuis

727505
727507

source batch

file

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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

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exact text: INDICATIONS AND USAGE Ovidrel ® PreFilled Syringe (choriogonadotropin alfa injection) is indicated for the induction of final follicular maturation and early luteinization in infertile women who have undergone pituitary desensitization and who have been appropriately pretreated with follicle stimulating hormones as part of an Assisted Reproductive Technology (ART) program such as in vitro fertilization and embryo transfer. Ovidrel ® PreFilled Syringe is also indicated for the induction of ovulation (OI) and pregnancy in anovulatory infertile patients in whom the cause of infertility is functional and not due to primary
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exact text: INDICATIONS AND USAGE Ovidrel ® PreFilled Syringe (choriogonadotropin alfa injection) is indicated for the induction of final follicular maturation and early luteinization in infertile women who have undergone pituitary desensitization and who have been appropriately pretreated with follicle stimulating hormones as part of an Assisted Reproductive Technology (ART) program such as in vitro fertilization and embryo transfer.
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exact text: tization and who have been appropriately pretreated with follicle stimulating hormones as part of an Assisted Reproductive Technology (ART) program such as in vitro fertilization and embryo transfer. Ovidrel ® PreFilled Syringe is also indicated for the induction of ovulation (OI) and pregnancy in anovulatory infertile patients in whom the cause of infertility is functional and not due to primary ovarian failure. Selection of Patients Before treatment with gonadotropins is instituted, a thorough gynecologic and endocrinologic evaluation must be performed. This should include an assessment of pelvic anatomy. P
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exact text: ed Syringe is also indicated for the induction of ovulation (OI) and pregnancy in anovulatory infertile patients in whom the cause of infertility is functional and not due to primary ovarian failure. Selection of Patients Before treatment with gonadotropins is instituted, a thorough gynecologic and endocrinologic evaluation must be performed. This should include an assessment of pelvic anatomy. Patients with tubal obstruction should receive Ovidrel ® PreFilled Syringe only if enrolled in an in vitro fertilization program. Primary ovarian
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Passage 4 · unclassified context

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exact text: is functional and not due to primary ovarian failure. Selection of Patients Before treatment with gonadotropins is instituted, a thorough gynecologic and endocrinologic evaluation must be performed. This should include an assessment of pelvic anatomy. Patients with tubal obstruction should receive Ovidrel ® PreFilled Syringe only if enrolled in an in vitro fertilization program. Primary ovarian failure should be excluded by the determination of go
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exact text: . Selection of Patients Before treatment with gonadotropins is instituted, a thorough gynecologic and endocrinologic evaluation must be performed. This should include an assessment of pelvic anatomy. Patients with tubal obstruction should receive Ovidrel ® PreFilled Syringe only if enrolled in an in vitro fertilization program. Primary ovarian failure should be excluded by the determination of gonadotropin levels. Appropriate evaluation should be performed to exclude pregnancy. Patients in later reproductive life have a gre
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exact text: st be performed. This should include an assessment of pelvic anatomy. Patients with tubal obstruction should receive Ovidrel ® PreFilled Syringe only if enrolled in an in vitro fertilization program. Primary ovarian failure should be excluded by the determination of gonadotropin levels. Appropriate evaluation should be performed to exclude pregnancy. Patients in later reproductive life have a greater predisposition to endometrial carcinoma as well as a higher incidence of anovulator
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start: 1125

source url

https://api.fda.gov/drug/label.json?search=id%3A%2259d39f88-54fb-480a-979b-4d3d2c7c2cd4%22

spl effective date

2023-12-26

spl set id

a683e58a-63ea-44b8-a326-1a99a537bcf2

spl version

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

BLA021149

brand names

Ovidrel

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 1584
end exclusive: true
exact text: evaluation should be performed to exclude pregnancy. Patients in later reproductive life have a greater predisposition to endometrial carcinoma as well as a higher incidence of anovulatory disorders. A thorough diagnostic evaluation should always be performed in patients who demonstrate abnormal uterine bleeding or other signs of endometrial abnormalities before starting FSH and Ovidrel ® PreFilled Syringe therapy. Evaluation of the partner's fertility potential should be included in the initial evaluation.
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source text sha256: 92ca8dabfafbc6ab0e9af4c4bcded393d8092f5dc124bfba60d5af3aba4da3bd
start: 1072

current approval status

not_reconciled

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dup-42da8cf5440c8b921cda

extraction review status

automated_candidate_pending_source_review

generic names

CHORIOGONADOTROPIN ALFA

ind-span-95375e920d08e00107c0

label id

59d39f88-54fb-480a-979b-4d3d2c7c2cd4

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

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source defined aliases

source span

end: 1490
end exclusive: true
exact text: A thorough diagnostic evaluation should always be performed in patients who demonstrate abnormal uterine bleeding or other signs of endometrial abnormalities before starting FSH and Ovidrel ® PreFilled Syringe therapy.
label id: 59d39f88-54fb-480a-979b-4d3d2c7c2cd4
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 92ca8dabfafbc6ab0e9af4c4bcded393d8092f5dc124bfba60d5af3aba4da3bd
start: 1272

source url

https://api.fda.gov/drug/label.json?search=id%3A%2259d39f88-54fb-480a-979b-4d3d2c7c2cd4%22

spl effective date

2023-12-26

spl set id

a683e58a-63ea-44b8-a326-1a99a537bcf2

spl version

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

BLA021149

brand names

Ovidrel

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 1584
end exclusive: true
exact text: ic evaluation should always be performed in patients who demonstrate abnormal uterine bleeding or other signs of endometrial abnormalities before starting FSH and Ovidrel ® PreFilled Syringe therapy. Evaluation of the partner's fertility potential should be included in the initial evaluation.
label id: 59d39f88-54fb-480a-979b-4d3d2c7c2cd4
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 92ca8dabfafbc6ab0e9af4c4bcded393d8092f5dc124bfba60d5af3aba4da3bd
start: 1291

current approval status

not_reconciled

duplicate text group

dup-327ca5f5d1fe241e5b8d

extraction review status

automated_candidate_pending_source_review

generic names

CHORIOGONADOTROPIN ALFA

ind-span-01aafe9e4ec01d884a79

label id

59d39f88-54fb-480a-979b-4d3d2c7c2cd4

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e

source defined aliases

source span

end: 1584
end exclusive: true
exact text: Evaluation of the partner's fertility potential should be included in the initial evaluation.
label id: 59d39f88-54fb-480a-979b-4d3d2c7c2cd4
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 92ca8dabfafbc6ab0e9af4c4bcded393d8092f5dc124bfba60d5af3aba4da3bd
start: 1491

source url

https://api.fda.gov/drug/label.json?search=id%3A%2259d39f88-54fb-480a-979b-4d3d2c7c2cd4%22

spl effective date

2023-12-26

spl set id

a683e58a-63ea-44b8-a326-1a99a537bcf2

spl version

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

Preserved source evidence · Not medical advice