Is Follitropin delta authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Follitropin delta: Rekovelle.

Active substance

Follitropin delta

EMA 1
Health Canada 3

EMA European Union — centrally authorised medicines

Rekovelle Ferring Pharmaceuticals A/S · Authorised · authorised 12 Dec 2016 · ATC G03GA10

Therapeutic indication (EMA)

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.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
REKOVELLE	02487462	12 MCG / 0.36 ML	SOLUTION · SUBCUTANEOUS	FERRING INC
REKOVELLE	02487470	36 MCG / 1.08 ML	SOLUTION · SUBCUTANEOUS	FERRING INC
REKOVELLE	02487489	72 MCG / 2.16 ML	SOLUTION · SUBCUTANEOUS	FERRING INC

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.