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 28/03/2022

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
G03GA10
Publication details
Marketing-authorisation holder
Ferring Pharmaceuticals A/S
Revision
5
Date of issue of marketing authorisation valid throughout the European Union
12/12/2016
Contact address

Amager Strandvej 405
2770 Kastrup
Denmark

Product information

25/03/2022 Rekovelle - EMEA/H/C/003994 - IAIN/0032

Other EU languages available icon 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:

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

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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