🇪🇺 FOLLITROPIN BETA in European Union

EMA authorised FOLLITROPIN BETA on 19 March 2009

Marketing authorisations

EMA — authorised 19 March 2009

  • Application: EMEA/H/C/001042
  • Marketing authorisation holder: Merck Sharp & Dohme B.V.
  • Local brand name: Fertavid
  • Indication: In the female: Fertavid is indicated for the treatment of female infertility in the following clinical situations: Anovulation (including polycystic ovarian disease, PCOD) 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 intra-fallopian transfer (GIFT) and intracytoplasmic sperm injection (ICSI). In the male: Deficient spermatogenesis due to hypogonadotrophic hypogonadism.
  • Status: withdrawn

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EMA

  • Application: EMEA/H/C/000086
  • Local brand name: Puregon
  • Status: approved

FOLLITROPIN BETA 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 FOLLITROPIN BETA approved in European Union?

Yes. EMA authorised it on 19 March 2009; EMA has authorised it.

Who is the marketing authorisation holder for FOLLITROPIN BETA in European Union?

Merck Sharp & Dohme B.V. holds the EU marketing authorisation.