Drug information for BRAVELLE

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
INJECTABLE; INTRAMUSCULAR, SUBCUTANEOUS 75 IU/VIAL Prescription  (Reference Drug) UROFOLLITROPIN Urofollitropin FERRING 21289
2002-05-06 Review

2002-05-06 Letter

2002-05-06 Label
Injectable; Subcutaneous 0.9% Prescription   UROFOLLITROPIN Urofollitropin FERRING 21484
2004-05-28 Letter

2003-05-08 Review

2003-04-09 Label

Drug Adverse Effects information for BRAVELLE

Role code Indications Reaction # Reports
PS IN VITRO FERTILISATION ABORTION SPONTANEOUS 2
PS IN VITRO FERTILISATION MATERNAL EXPOSURE DURING PREGNANCY 2
C PRODUCT USED FOR UNKNOWN INDICATION ABDOMINAL DISTENSION 8
C PRODUCT USED FOR UNKNOWN INDICATION ABDOMINAL PAIN 8
C PRODUCT USED FOR UNKNOWN INDICATION GESTATIONAL DIABETES 8
C PRODUCT USED FOR UNKNOWN INDICATION HAEMORRHAGE 8
C PRODUCT USED FOR UNKNOWN INDICATION HEADACHE 8
C PRODUCT USED FOR UNKNOWN INDICATION MUSCLE SPASMS 8
C PRODUCT USED FOR UNKNOWN INDICATION OVULATION DISORDER 8
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