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/1.73 MB)
First published: 11/02/2020
Last updated: 03/07/2020
|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
09/06/2020 Zoely - EMEA/H/C/001213 - II/0050
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
Sex hormones and modulators of the genital system