Orgalutran

RSS

ganirelix

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

Overview

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

This EPAR was last updated on 09/11/2018

Authorisation details

Product details
Name
Orgalutran
Agency product number
EMEA/H/C/000274
Active substance
ganirelix
International non-proprietary name (INN) or common name
ganirelix
Therapeutic area (MeSH)
  • Reproductive Techniques, Assisted
  • Ovulation Induction
Anatomical therapeutic chemical (ATC) code
H01CC01
Publication details
Marketing-authorisation holder
Merck Sharp and Dohme B.V
Revision
17
Date of issue of marketing authorisation valid throughout the European Union
16/05/2000
Contact address

Waarderweg 39
2031 BN Haarlem
The Netherlands

Product information

28/09/2018 Orgalutran - EMEA/H/C/000274 - IA/0042

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

The prevention of premature luteinising-hormone surges in women undergoing controlled ovarian hyperstimulation for assisted reproduction techniques.

In clinical studies, Orgalutran was used with recombinant human follicle-stimulating hormone or corifollitropin alfa, the sustained follicle stimulant.

Assessment history

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