Fertavid

Withdrawn

This medicine's authorisation has been withdrawn

follitropin beta

Overview

On 23 January 2020, the European Commission withdrew the marketing authorisation for Fertavid (follitropin beta) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Merck Sharp & Dohme B.V., which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. 

Fertavid was granted marketing authorisation in the EU on 19 March 2009 for treatment of infertility. The marketing authorisation was initially valid for a 5-year period. It was then granted unlimited validity in 2014. Fertavid is an identical product to Puregon, which is authorised in the EU to treat infertility. The marketing authorisation holder will maintain the marketing authorisation for Puregon. 

The European Public Assessment Report (EPAR) for Fertavid is updated to indicate that the marketing authorisation is no longer valid.

Fertavid : EPAR - Summary for the public

Product information

Fertavid : EPAR - Product Information

Fertavid : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Fertavid
• Active substance:
  follitropin beta
• International non-proprietary name (INN) or common name:
  follitropin beta
• Therapeutic area (MeSH):
  • Infertility
  • Hypogonadism
• Anatomical therapeutic chemical (ATC) code:
  G03GA06

Pharmacotherapeutic group

Sex hormones and modulators of the genital system

Therapeutic 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.

Authorisation details

• EMA product number:
  EMEA/H/C/001042
• Marketing authorisation holder:
  Merck Sharp & Dohme B.V.

  Waarderweg 39; 2031 BN Haarlem; The Netherlands

• Marketing authorisation issued:
  19/03/2009
• Revision:
  12

Assessment history

Changes since initial authorisation of medicine

Fertavid : EPAR - Procedural steps taken and scientific information after authorisation

Initial marketing authorisation documents

Fertavid : EPAR - Public assessment report

Committee for medicinal products for human use summary of positive opinion for Fertavid

Reference Number: EMEA/CHMP/16455/2009