Orgalutran (ganirelix)
- Region
- 🇪🇺 EU
- Active substance
- ganirelix
- Company
- Organon N.V.
- Status
- Authorised
- Therapeutic area
- Reproductive Techniques, Assisted; Ovulation Induction; Infertility, Female
- CHMP opinion
- Wed 17 May 2000
- EU approval
- Tue 16 May 2000
- Application
- EMEA/H/C/000274
- ATC
- H01CC01
- Official record
- www.ema.europa.eu
Indication
The prevention of premature luteinising-hormone surges in women undergoing controlled ovarian hyperstimulation for assisted reproduction techniques. In clinical studies, Orgalutran was used with recombinant human follicle-stimulating hormone or corifollitropin alfa, the sustained follicle stimulant.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Ganirelix Gedeon Richter Authorised · Chemical Works of Gedeon Richter Plc. (Gedeon Richter Plc.)
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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.