🇪🇺 follicle stimulating hormone in European Union

EMA authorised follicle stimulating hormone on 20 October 1995

Marketing authorisation

EMA — authorised 20 October 1995

  • Application: EMEA/H/C/000071
  • Marketing authorisation holder: Merck Europe B.V.
  • Local brand name: GONAL-f
  • Indication: Anovulation (including polycystic ovarian disease, PCOD) in women who have been unresponsive to treatment with clomiphene citrate. Stimulation of multifollicular development in patients undergoing superovulation for assisted reproductive technologies (ART) such as in-vitro fertilisation (IVF), gamete intra-fallopian transfer (GIFT) and zygote intra-fallopian transfer (ZIFT). GONAL-f in association with a luteinising hormone (LH) preparation is recommended for the stimulation of follicular development in women with severe LH and FSH deficiency. In clinical trials these patients were defined by
  • Status: approved

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follicle stimulating hormone in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is follicle stimulating hormone approved in European Union?

Yes. EMA authorised it on 20 October 1995.

Who is the marketing authorisation holder for follicle stimulating hormone in European Union?

Merck Europe B.V. holds the EU marketing authorisation.