Ganirelix Gedeon Richter (ganirelix)
Generic
- Region
- 🇪🇺 EU
- Active substance
- ganirelix
- Company
- Chemical Works of Gedeon Richter Plc. (Gedeon Richter Plc.)
- Status
- Authorised
- Therapeutic area
- Reproductive Techniques, Assisted; Ovulation Induction; Infertility, Female
- CHMP opinion
- Thu 19 May 2022
- EU approval
- Fri 15 Jul 2022
- Designations
- Generic
- Application
- EMEA/H/C/005641
- ATC
- H01CC01
- Official record
- www.ema.europa.eu
Indication
Prevention of premature luteinising hormone (LH) surges in women undergoing controlled ovarian hyperstimulation (COH) for assisted reproduction techniques (ART).
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Orgalutran Authorised · Organon N.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.