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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