Cetrotide
cetrorelix
Table of contents
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.
Authorisation details
Product details | |
---|---|
Name |
Cetrotide
|
Agency product number |
EMEA/H/C/000233
|
Active substance |
cetrorelix (as acetate)
|
International non-proprietary name (INN) or common name |
cetrorelix
|
Therapeutic area (MeSH) |
|
Anatomical therapeutic chemical (ATC) code |
H01CC02
|
Publication details | |
---|---|
Marketing-authorisation holder |
Merck Europe B.V.
|
Revision |
27
|
Date of issue of marketing authorisation valid throughout the European Union |
12/04/1999
|
Contact address |
Gustav Mahlerplein 102 |
Product information
12/04/2023 Cetrotide - EMEA/H/C/000233 - IAIN/0089
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
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).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
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.