nomegestrol / estradiol
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.
Zoely : EPAR - Summary for the public (PDF/77.02 KB)
First published: 06/10/2011
Last updated: 17/05/2016
Zoely : EPAR - Risk-management-plan summary (PDF/1.23 MB)
First published: 11/02/2020
Last updated: 16/02/2023
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Theramex Ireland Limited
|Date of issue of marketing authorisation valid throughout the European Union||
3rd Floor, Kilmore House
28/11/2022 Zoely - EMEA/H/C/001213 - A31/0060
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.
Sex hormones and modulators of the genital system
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