Rekovelle

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follitropin delta

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

Overview

This is a summary of the European public assessment report (EPAR) for Rekovelle. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Rekovelle.

For practical information about using Rekovelle, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 29/06/2017

Authorisation details

Product details
Name
Rekovelle
Agency product number
EMEA/H/C/003994
Active substance
follitropin delta
International non-proprietary name (INN) or common name
follitropin delta
Therapeutic area (MeSH)
Anovulation
Anatomical therapeutic chemical (ATC) code
G03GA
Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
Ferring Pharmaceuticals A/S
Revision
1
Date of issue of marketing authorisation valid throughout the European Union
12/12/2016
Contact address
Kay Fiskers Plads 11
2300 Copenhagen
Denmark

Product information

18/05/2017 Rekovelle - EMEA/H/C/003994 - II/0003/G

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

Controlled ovarian stimulation for the development of multiple follicles in women undergoing assisted reproductive technologies (ART) such as an in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) cycle.

Assessment history

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