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 30/11/2018

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
Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
Teva B.V.
Revision
16
Date of issue of marketing authorisation valid throughout the European Union
26/07/2011
Contact address
Swensweg
2031GA Haarlem
The Netherlands

Product information

24/10/2018 Zoely - EMEA/H/C/001213 - N/0046

Contents

  • 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.

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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