Fertavid

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follitropin beta

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Fertavid. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Fertavid.

This EPAR was last updated on 15/11/2018

Authorisation details

Product details
Name
Fertavid
Agency product number
EMEA/H/C/001042
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
Publication details
Marketing-authorisation holder
Merck Sharp & Dohme B.V. 
Revision
11
Date of issue of marketing authorisation valid throughout the European Union
19/03/2009
Contact address

Waarderweg 39
2031 BN Haarlem
The Netherlands

Product information

28/09/2018 Fertavid - EMEA/H/C/001042 - IG/0968

Contents

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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.

Assessment history

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