Cetrotide

RSS

cetrorelix

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

Overview

This is a summary of the European public assessment report (EPAR) for Cetrotide. 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 Cetrotide.

This EPAR was last updated on 06/12/2018

Authorisation details

Product details
Name
Cetrotide
Agency product number
EMEA/H/C/000233
Active substance
cetrorelix
International non-proprietary name (INN) or common name
cetrorelix
Therapeutic area (MeSH)
  • Ovulation
  • Ovulation Induction
Anatomical therapeutic chemical (ATC) code
H01CC02
Publication details
Marketing-authorisation holder
Merck Europe B.V.
Revision
24
Date of issue of marketing authorisation valid throughout the European Union
12/04/1999
Contact address

Gustav Mahlerplein 102
1082 MA Amsterdam
The Netherlands

Product information

02/08/2018 Cetrotide - EMEA/H/C/000233 - T/0067

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

PITUITARY AND HYPOTHALAMIC HORMONES AND ANALOGUES

Therapeutic indication

Prevention of premature ovulation in patients undergoing a controlled ovarian stimulation, followed by oocyte-pick-up and assisted-reproductive techniques.

In clinical trials, Cetrotide was used with human menopausal gonadotropin (HMG), however, limited experience with recombinant follicule-stimulating hormone (FSH) suggested similar efficacy.

Assessment history

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