Rekovelle
follitropin delta
Table of contents
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.
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 |
Product information
25/03/2022 Rekovelle - EMEA/H/C/003994 - IAIN/0032
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
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.