🇪🇺 r-FSH (Gonal-f) in European Union

EMA authorised r-FSH (Gonal-f) on 2 May 1996

Marketing authorisation

EMA — authorised 2 May 1996

  • Application: EMEA/H/C/000086
  • Marketing authorisation holder: Organon N.V.
  • Local brand name: Puregon
  • 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.
  • Status: approved

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Other Reproductive Medicine / Fertility approved in European Union

Frequently asked questions

Is r-FSH (Gonal-f) approved in European Union?

Yes. EMA authorised it on 2 May 1996.

Who is the marketing authorisation holder for r-FSH (Gonal-f) in European Union?

Organon N.V. holds the EU marketing authorisation.