Fertavid

Withdrawn

This medicine's authorisation has been withdrawn

follitropin beta

Overview

The marketing authorisation for Fertavid has been withdrawn at the request of the marketing-authorisation holder.

Fertavid : EPAR - Summary for the public

Product information

Fertavid : EPAR - Product Information

Latest procedure affecting product information: WS/1702

20/01/2020

This medicine’s product information is available in all official EU languages.
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Product information documents contain:

• summary of product characteristics (annex I);
• manufacturing authorisation holder responsible for batch release (annex IIA);
• conditions of the marketing authorisation (annex IIB);
• labelling (annex IIIA);
• package leaflet (annex IIIB).

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