Puregon (follitropin beta)
- Region
- 🇪🇺 EU
- Active substance
- follitropin beta
- Company
- Organon N.V.
- Status
- Authorised
- Therapeutic area
- Infertility; Hypogonadism
- CHMP opinion
- Wed 20 Dec 1995
- EU approval
- Thu 02 May 1996
- Application
- EMEA/H/C/000086
- ATC
- G03GA06
- Official record
- www.ema.europa.eu
Indication
In the female: Puregon is indicated for the treatment of female infertility in the following clinical situations: anovulation (including polycystic ovarian syndrome, PCOS) in women who have been unresponsive to treatment with clomifene citrate; controlled ovarian hyperstimulation to induce the development of multiple follicles in medically assisted reproduction programs (e.g. in-vitro fertilisation / embryo transfer (IVF/ET), gamete intrafallopian transfer (GIFT) and intracytoplasmic sperm injection (ICSI)). In the male: Deficient spermatogenesis due to hypogonadotrophic hypogonadism.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Fertavid Withdrawn · Merck Sharp & Dohme B.V.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.