Basic Information
Gonal-f 300 iu/0.5 ml (22 mcg/0.5 ml) Solution for Injection in a pre-filled pen
INJECTION, SOLUTION
Regulatory Information
SIN13023P
August 18, 2004
Prescription Only
Therapeutic
SUBCUTANEOUS
August 10, 2023
June 3, 2025
XG03GA05
Company Information
Active Ingredients
Strength: 22.23 mcg
Detailed Information
Contraindications
**4.3 Contraindications** - hypersensitivity to the active substance follitropin alfa, FSH or to any of the excipients - tumours of the hypothalamus or pituitary gland - ovarian enlargement or ovarian cyst not due to polycystic ovarian syndrome - gynaecological haemorrhages of unknown aetiology - ovarian, uterine or mammary carcinoma GONAL-f must not be used when an effective response cannot be obtained, such as: - primary ovarian failure - malformations of sexual organs incompatible with pregnancy - fibroid tumours of the uterus incompatible with pregnancy
Indication Information
**4.1 Therapeutic indications** In adult women - Anovulation (including polycystic ovarian syndrome) in women who have been unresponsive to treatment with clomiphene citrate. - Stimulation of multifollicular development in women undergoing superovulation for assisted reproductive technologies (ART) such as in vitro fertilisation (IVF), gamete intra-fallopian transfer and zygote intra-fallopian transfer.