🇪🇺 Biosimilar recombinant FSH in European Union

EMA authorised Biosimilar recombinant FSH on 26 March 2014

Marketing authorisation

EMA — authorised 26 March 2014

  • Application: EMEA/H/C/002615
  • Marketing authorisation holder: Gedeon Richter Plc.
  • Local brand name: Bemfola
  • Indication: In adult women: 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); follitropin alfa 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
  • Pathway: biosimilar
  • Status: approved

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Other Reproductive Medicine / Fertility approved in European Union

Frequently asked questions

Is Biosimilar recombinant FSH approved in European Union?

Yes. EMA authorised it on 26 March 2014.

Who is the marketing authorisation holder for Biosimilar recombinant FSH in European Union?

Gedeon Richter Plc. holds the EU marketing authorisation.