Drug information for GONAL-F

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
INJECTABLE; SUBCUTANEOUS 1,050 IU/VIAL Prescription   FOLLITROPIN ALFA/BETA Follicle Stimulating Hormone, Human EMD SERONO 20378
2004-04-14 Review

2004-04-05 Label

2004-03-28 Letter

2003-07-28 Letter

2003-07-28 Letter

2000-05-24 Letter
INJECTABLE; SUBCUTANEOUS 150 IU/VIAL Discontinued   FOLLITROPIN ALFA/BETA Follicle Stimulating Hormone, Human EMD SERONO   "
INJECTABLE; SUBCUTANEOUS 37.5 IU/VIAL Discontinued   FOLLITROPIN ALFA/BETA Follicle Stimulating Hormone, Human EMD SERONO   "
INJECTABLE; SUBCUTANEOUS 450 IU/VIAL Prescription  (Reference Drug) FOLLITROPIN ALFA/BETA Follicle Stimulating Hormone, Human EMD SERONO   "
INJECTABLE; SUBCUTANEOUS 75 IU/VIAL Discontinued   FOLLITROPIN ALFA/BETA Follicle Stimulating Hormone, Human EMD SERONO   "
INJECTABLE; SUBCUTANEOUS 150 IU/VIAL Discontinued   FOLLITROPIN ALFA/BETA Follicle Stimulating Hormone, Human EMD SERONO 21765
2007-07-10 Letter

2007-07-06 Label

2007-04-20 Review

2006-01-19 Letter

2006-01-06 Label

2004-04-05 Label

2004-03-28 Letter
INJECTABLE; SUBCUTANEOUS 37.5 IU/VIAL Discontinued   FOLLITROPIN ALFA/BETA Follicle Stimulating Hormone, Human EMD SERONO   "

Drug Adverse Effects information for GONAL-F

Role code Indications Reaction # Reports
PS AMENORRHOEA ABORTION 3
PS AMENORRHOEA TWIN PREGNANCY 3
PS IN VITRO FERTILISATION ABDOMINAL PAIN LOWER 3
PS IN VITRO FERTILISATION ABORTION INDUCED 13
PS IN VITRO FERTILISATION ABORTION MISSED 2
PS IN VITRO FERTILISATION COMPLICATION OF PREGNANCY 13
PS IN VITRO FERTILISATION CYSTOSARCOMA PHYLLODES 1
PS IN VITRO FERTILISATION DYSPNOEA 2
PS IN VITRO FERTILISATION ECTOPIC PREGNANCY 3
PS IN VITRO FERTILISATION OEDEMA 2
PS IN VITRO FERTILISATION OVARIAN HYPERSTIMULATION SYNDROME 5
PS IN VITRO FERTILISATION URETERIC INJURY 3
PS IN VITRO FERTILISATION VAGINAL HAEMORRHAGE 3
PS INFERTILITY FEMALE ABORTION MISSED 3
PS INFERTILITY FEMALE MATERNAL EXPOSURE BEFORE PREGNANCY 1
PS INFERTILITY FEMALE PREGNANCY 1
PS OVARIAN HYPERSTIMULATION SYNDROME ABORTION MISSED 1
PS OVULATION INDUCTION ASCITES 9
PS OVULATION INDUCTION CYSTOSARCOMA PHYLLODES 4
PS OVULATION INDUCTION CYTOLYTIC HEPATITIS 6
PS OVULATION INDUCTION ECTOPIC PREGNANCY 2
PS OVULATION INDUCTION OVARIAN HYPERSTIMULATION SYNDROME 9
PS OVULATION INDUCTION PELVIC INFECTION 3
PS OVULATION INDUCTION PREGNANCY 6
PS PRODUCT USED FOR UNKNOWN INDICATION ABDOMINAL DISCOMFORT 3
PS PRODUCT USED FOR UNKNOWN INDICATION ABDOMINAL PAIN LOWER 1
PS PRODUCT USED FOR UNKNOWN INDICATION ABORTION INDUCED 3
PS PRODUCT USED FOR UNKNOWN INDICATION ABORTION MISSED 3
PS PRODUCT USED FOR UNKNOWN INDICATION ABORTION SPONTANEOUS 1
PS PRODUCT USED FOR UNKNOWN INDICATION COMPLICATION OF PREGNANCY 3
PS PRODUCT USED FOR UNKNOWN INDICATION ECTOPIC PREGNANCY 7
PS PRODUCT USED FOR UNKNOWN INDICATION FOETAL EXPOSURE DURING PREGNANCY 6
PS PRODUCT USED FOR UNKNOWN INDICATION MATERNAL EXPOSURE BEFORE PREGNANCY 1
PS PRODUCT USED FOR UNKNOWN INDICATION MATERNAL EXPOSURE DURING PREGNANCY 3
PS PRODUCT USED FOR UNKNOWN INDICATION MATERNAL EXPOSURE TIMING UNSPECIFIED 1
PS PRODUCT USED FOR UNKNOWN INDICATION PREGNANCY 4
PS PRODUCT USED FOR UNKNOWN INDICATION VAGINAL HAEMORRHAGE 4
SS HORMONE THERAPY ECTOPIC PREGNANCY 6
SS HORMONE THERAPY MATERNAL EXPOSURE BEFORE PREGNANCY 2
SS IN VITRO FERTILISATION CYSTOSARCOMA PHYLLODES 5
SS IN VITRO FERTILISATION MATERNAL EXPOSURE BEFORE PREGNANCY 5
SS IN VITRO FERTILISATION PREGNANCY 5
SS INFERTILITY DRUG INTERACTION 3
SS INFERTILITY HAEMOGLOBIN DECREASED 3
SS INFERTILITY HYPERTENSION 3
SS INFERTILITY HYPERTRANSAMINASAEMIA 3
SS INFERTILITY OVARIAN HYPERSTIMULATION SYNDROME 3
SS INFERTILITY PLATELET COUNT INCREASED 3
SS INFERTILITY PROTEINURIA 3
SS INFERTILITY TWIN PREGNANCY 3
SS INFERTILITY FEMALE ABORTION MISSED 3
SS INFERTILITY FEMALE MATERNAL EXPOSURE BEFORE PREGNANCY 1
SS INFERTILITY FEMALE PREGNANCY 1
SS OVARIAN HYPERSTIMULATION SYNDROME ECTOPIC PREGNANCY 6
SS OVARIAN HYPERSTIMULATION SYNDROME MATERNAL EXPOSURE BEFORE PREGNANCY 2
SS OVULATION INDUCTION AMAUROSIS 3
SS OVULATION INDUCTION ANTINUCLEAR ANTIBODY POSITIVE 3
SS OVULATION INDUCTION ECTOPIC PREGNANCY 2
SS OVULATION INDUCTION MYDRIASIS 3
SS PRODUCT USED FOR UNKNOWN INDICATION ABDOMINAL DISTENSION 2
SS PRODUCT USED FOR UNKNOWN INDICATION ABORTION MISSED 3
SS PRODUCT USED FOR UNKNOWN INDICATION AMAUROSIS 1
SS PRODUCT USED FOR UNKNOWN INDICATION ANTINUCLEAR ANTIBODY POSITIVE 1
SS PRODUCT USED FOR UNKNOWN INDICATION ECTOPIC PREGNANCY 12
SS PRODUCT USED FOR UNKNOWN INDICATION FATIGUE 2
SS PRODUCT USED FOR UNKNOWN INDICATION FEELING ABNORMAL 2
SS PRODUCT USED FOR UNKNOWN INDICATION HEADACHE 2
SS PRODUCT USED FOR UNKNOWN INDICATION INSOMNIA 2
SS PRODUCT USED FOR UNKNOWN INDICATION MATERNAL EXPOSURE BEFORE PREGNANCY 5
SS PRODUCT USED FOR UNKNOWN INDICATION MOOD SWINGS 2
SS PRODUCT USED FOR UNKNOWN INDICATION MUSCLE SPASMS 2
SS PRODUCT USED FOR UNKNOWN INDICATION MYDRIASIS 1
SS PRODUCT USED FOR UNKNOWN INDICATION PAIN 2
SS PRODUCT USED FOR UNKNOWN INDICATION PREGNANCY 1
SS VITAMIN SUPPLEMENTATION AMAUROSIS 1
SS VITAMIN SUPPLEMENTATION ANTINUCLEAR ANTIBODY POSITIVE 1
SS VITAMIN SUPPLEMENTATION MYDRIASIS 1
C BLOOD FOLLICLE STIMULATING HORMONE OFF LABEL USE 1
C BLOOD FOLLICLE STIMULATING HORMONE SUBCHORIONIC HAEMORRHAGE 1
C BLOOD FOLLICLE STIMULATING HORMONE VITAMIN D DEFICIENCY 1
C BLOOD GONADOTROPHIN ABNORMAL OFF LABEL USE 1
C BLOOD GONADOTROPHIN ABNORMAL SUBCHORIONIC HAEMORRHAGE 1
C BLOOD GONADOTROPHIN ABNORMAL VITAMIN D DEFICIENCY 1
C IN VITRO FERTILISATION OFF LABEL USE 11
C IN VITRO FERTILISATION SUBCHORIONIC HAEMORRHAGE 11
C IN VITRO FERTILISATION VITAMIN D DEFICIENCY 11
C PRODUCT USED FOR UNKNOWN INDICATION ABDOMINAL DISTENSION 3
C PRODUCT USED FOR UNKNOWN INDICATION ANXIETY 5
C PRODUCT USED FOR UNKNOWN INDICATION ARTHRALGIA 3
C PRODUCT USED FOR UNKNOWN INDICATION BACK PAIN 8
C PRODUCT USED FOR UNKNOWN INDICATION BREAST PAIN 5
C PRODUCT USED FOR UNKNOWN INDICATION DIZZINESS 12
C PRODUCT USED FOR UNKNOWN INDICATION DYSPNOEA 5
C PRODUCT USED FOR UNKNOWN INDICATION FATIGUE 10
C PRODUCT USED FOR UNKNOWN INDICATION FEELING ABNORMAL 11
C PRODUCT USED FOR UNKNOWN INDICATION HEADACHE 17
C PRODUCT USED FOR UNKNOWN INDICATION HOT FLUSH 2
C PRODUCT USED FOR UNKNOWN INDICATION ILL-DEFINED DISORDER 4
C PRODUCT USED FOR UNKNOWN INDICATION INCREASED APPETITE 4
C PRODUCT USED FOR UNKNOWN INDICATION INJECTION SITE HAEMATOMA 5
C PRODUCT USED FOR UNKNOWN INDICATION INJECTION SITE PAIN 3
C PRODUCT USED FOR UNKNOWN INDICATION MEMORY IMPAIRMENT 5
C PRODUCT USED FOR UNKNOWN INDICATION MOOD SWINGS 5
C PRODUCT USED FOR UNKNOWN INDICATION MUSCLE SPASMS 3
C PRODUCT USED FOR UNKNOWN INDICATION NAUSEA 14
C PRODUCT USED FOR UNKNOWN INDICATION OFF LABEL USE 6
C PRODUCT USED FOR UNKNOWN INDICATION POOR QUALITY SLEEP 5
C PRODUCT USED FOR UNKNOWN INDICATION SUBCHORIONIC HAEMORRHAGE 6
C PRODUCT USED FOR UNKNOWN INDICATION UTERINE SPASM 5
C PRODUCT USED FOR UNKNOWN INDICATION VITAMIN D DEFICIENCY 6
C PROPHYLAXIS OF ABORTION OFF LABEL USE 1
C PROPHYLAXIS OF ABORTION SUBCHORIONIC HAEMORRHAGE 1
C PROPHYLAXIS OF ABORTION VITAMIN D DEFICIENCY 1
C THYROID DISORDER OFF LABEL USE 1
C THYROID DISORDER SUBCHORIONIC HAEMORRHAGE 1
C THYROID DISORDER VITAMIN D DEFICIENCY 1
C VITAMIN D DEFICIENCY OFF LABEL USE 1
C VITAMIN D DEFICIENCY SUBCHORIONIC HAEMORRHAGE 1
C VITAMIN D DEFICIENCY VITAMIN D DEFICIENCY 1
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