🇪🇺 Ganirelix 0.25 mg. in European Union

EMA authorised Ganirelix 0.25 mg. on 16 May 2000

Marketing authorisation

EMA — authorised 16 May 2000

• Application: EMEA/H/C/000274
• Marketing authorisation holder: Organon N.V.
• Local brand name: Orgalutran
• 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.
• Status: approved

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Frequently asked questions

Is Ganirelix 0.25 mg. approved in European Union?

Yes. EMA authorised it on 16 May 2000.

Who is the marketing authorisation holder for Ganirelix 0.25 mg. in European Union?

Organon N.V. holds the EU marketing authorisation.