Zoely

RSS

nomegestrol / estradiol

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

Overview

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

This EPAR was last updated on 12/01/2022

Authorisation details

Product details
Name
Zoely
Agency product number
EMEA/H/C/001213
Active substance
  • Nomegestrol acetate
  • estradiol
International non-proprietary name (INN) or common name
  • nomegestrol
  • estradiol
Therapeutic area (MeSH)
Contraception
Anatomical therapeutic chemical (ATC) code
G03AA14
Publication details
Marketing-authorisation holder
Theramex Ireland Limited
Revision
21
Date of issue of marketing authorisation valid throughout the European Union
26/07/2011
Contact address

3rd Floor, Kilmore House
Park Lane, Spencer Dock
Dublin 1, D01 YE64
Ireland

Product information

16/12/2021 Zoely - EMEA/H/C/001213 - SW/0058

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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

Oral contraception

Assessment history

Changes since initial authorisation of medicine

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