Ovitrelle

RSS

choriogonadotropin alfa

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

Overview

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

This EPAR was last updated on 09/01/2019

Authorisation details

Product details
Name
Ovitrelle
Agency product number
EMEA/H/C/000320
Active substance
choriogonadotropin alfa
International non-proprietary name (INN) or common name
choriogonadotropin alfa
Therapeutic area (MeSH)
  • Anovulation
  • Reproductive Techniques, Assisted
  • Infertility, Female
Anatomical therapeutic chemical (ATC) code
G03GA08
Publication details
Marketing-authorisation holder
Merck Europe B.V.
Revision
18
Date of issue of marketing authorisation valid throughout the European Union
02/02/2001
Contact address

Gustav Mahlerplein 102
1082 MA Amsterdam
The Netherlands

Product information

20/09/2018 Ovitrelle - EMEA/H/C/000320 - T/0075

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

Sex hormones and modulators of the genital system

Therapeutic indication

Ovitrelle is indicated in the treatment of:

  • women undergoing superovulation prior to assisted reproductive techniques such as in vitro fertilisation (IVF): Ovitrelle is administered to trigger final follicular maturation and luteinisation after stimulation of follicular growth;
  • anovulatory or oligo-ovulatory women: Ovitrelle is administered to trigger ovulation and luteinisation in anovulatory or oligo-ovulatory patients after stimulation of follicular growth.

Assessment history

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