Zoely

nomegestrol / estradiol

Overview
Authorisation details
Product information
Assessment history

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.

: Zoely is a medicine available as 24 white ‘active’ tablets that contain the active substances nomegestrol acetate (2.5 mg) and estradiol (1.5 mg), and four yellow ‘inactive’ (placebo) tablets that do not contain any active substance.

: Zoely is a contraceptive pill. The medicine can only be obtained with a prescription.

: One tablet a day is taken for as long as contraception is required, starting with an active tablet on the first day of the cycle. Zoely comes in blisters containing 28 tablets (24 white tablets followed by 4 yellow tablets), which are taken in sequence using stickers to identify the days of the week for each tablet.

: Zoely is a combined contraceptive pill that contains two active substances, nomegestrol acetate (a progestogen) and estradiol (an oestrogen). Estradiol is the same as a hormone naturally produced by the ovaries during a menstrual cycle. Nomegestrol acetate is derived from the hormone called progesterone which is also produced by the ovaries during a menstrual cycle. Zoely works by changing the body’s hormonal balance to prevent ovulation, by altering the cervical mucus and by thinning the endometrium (the lining of the womb).

: Zoely was investigated in two main studies involving a total of 4,433 women aged 18 to 50 years old. The participants were given either Zoely or another contraceptive pill containing drospirenone and ethinyl estradiol for one year (13 menstrual cycles). The main measure of effectiveness was the number of women aged 18 to 35 who became pregnant during or shortly after treatment, expressed in terms of a pregnancy rate using the ‘Pearl Index’. The Pearl Index is a standard way of measuring the effectiveness of contraceptives, which measures how many unwanted pregnancies occur in 100 women-years (corresponding to 1,300 menstrual cycles). A lower Pearl Index represents a lower chance of getting pregnant.
No clinical study data on Zoely are available in adolescents under 18 years old.

: In women aged 18 to 35, the Pearl Index was around 0.4 with Zoely and 0.8 with the comparator medicine in the first study, and around 1.2 with Zoely and 1.9 with the comparator medicine in the second study.

: The most frequent side effects with Zoely (seen in more than 1 user in 10) are acne and changes to menstrual periods (e.g. absence or irregularity). For the full list of all side effects reported with Zoely, see the package leaflet.
Zoely must not be used when a woman has, or has had, blood clots in the veins or arteries or when a woman has some of the risk factors for blood clots. It should not be used in women who have pancreatitis (inflammation of the pancreas), severe liver problems, liver tumours or a history of liver tumours, certain types of cancer, or abnormal bleeding from the genital area whose cause has not been diagnosed. For the full list of restrictions, see the package leaflet.

: The CHMP decided that the benefits of Zoely are greater than its risks and recommended that it be given marketing authorisation.

: A risk management plan has been developed to ensure that Zoely is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Zoely, including the appropriate precautions to be followed by healthcare professionals and patients.
In addition, the company will perform a study to further investigate the risk of blood clots.

: The European Commission granted a marketing authorisation valid throughout the European Union for Zoely on 27 July 2011.
For more information about treatment with Zoely, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

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Zoely : EPAR - Summary for the public (PDF/77.02 KB)

First published: 06/10/2011
Last updated: 17/05/2016
EMA/243813/2011
- Bulgarian
  (PDF/101.94 KB)
- Croatian
  (PDF/94.84 KB)
- Czech
  (PDF/100.43 KB)
- Danish
  (PDF/75.17 KB)
- Dutch
  (PDF/75.79 KB)
- Estonian
  (PDF/84.19 KB)
- Finnish
  (PDF/74.76 KB)
- French
  (PDF/76.14 KB)
- German
  (PDF/76.68 KB)
- Greek
  (PDF/104.05 KB)
- Hungarian
  (PDF/96.35 KB)
- Italian
  (PDF/75.69 KB)
- Latvian
  (PDF/97.5 KB)
- Lithuanian
  (PDF/99.01 KB)
- Maltese
  (PDF/99.83 KB)
- Polish
  (PDF/101.6 KB)
- Portuguese
  (PDF/76.27 KB)
- Romanian
  (PDF/97.14 KB)
- Slovak
  (PDF/99.62 KB)
- Slovenian
  (PDF/94 KB)
- Spanish
  (PDF/76.07 KB)
- Swedish
  (PDF/75.38 KB)
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Zoely : EPAR - Risk-management-plan summary (PDF/1.23 MB)

First published: 11/02/2020
Last updated: 16/02/2023

This EPAR was last updated on 16/02/2023

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	23
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

28/11/2022 Zoely - EMEA/H/C/001213 - A31/0060

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Zoely : EPAR - Product Information (PDF/692.18 KB)

First published: 06/10/2011
Last updated: 16/12/2022
- Bulgarian
  (PDF/860.1 KB)
- Croatian
  (PDF/674.48 KB)
- Czech
  (PDF/796.63 KB)
- Danish
  (PDF/590.62 KB)
- Dutch
  (PDF/526.13 KB)
- Estonian
  (PDF/681.81 KB)
- Finnish
  (PDF/748.83 KB)
- French
  (PDF/812.41 KB)
- German
  (PDF/646.08 KB)
- Greek
  (PDF/797.54 KB)
- Hungarian
  (PDF/759.42 KB)
- Icelandic
  (PDF/552.61 KB)
- Italian
  (PDF/621.25 KB)
- Latvian
  (PDF/780.18 KB)
- Lithuanian
  (PDF/762.39 KB)
- Maltese
  (PDF/768.56 KB)
- Norwegian
  (PDF/552.36 KB)
- Polish
  (PDF/773.28 KB)
- Portuguese
  (PDF/651.25 KB)
- Romanian
  (PDF/817.84 KB)
- Slovak
  (PDF/743.44 KB)
- Slovenian
  (PDF/871.86 KB)
- Spanish
  (PDF/507 KB)
- Swedish
  (PDF/665.77 KB)

Other EU languages available icon 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.

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Zoely : EPAR - All Authorised presentations (PDF/12.72 KB)

First published: 06/10/2011
Last updated: 06/10/2011
- Bulgarian
  (PDF/45.78 KB)
- Czech
  (PDF/26.75 KB)
- Danish
  (PDF/13.38 KB)
- Dutch
  (PDF/13.19 KB)
- Estonian
  (PDF/13.95 KB)
- Finnish
  (PDF/13.75 KB)
- French
  (PDF/13.71 KB)
- German
  (PDF/13.53 KB)
- Greek
  (PDF/43.72 KB)
- Hungarian
  (PDF/26.86 KB)
- Icelandic
  (PDF/13.7 KB)
- Italian
  (PDF/13.28 KB)
- Latvian
  (PDF/42.94 KB)
- Lithuanian
  (PDF/43.18 KB)
- Maltese
  (PDF/41.49 KB)
- Norwegian
  (PDF/13.41 KB)
- Polish
  (PDF/43.95 KB)
- Portuguese
  (PDF/13.72 KB)
- Romanian
  (PDF/41.72 KB)
- Slovak
  (PDF/27.2 KB)
- Slovenian
  (PDF/13.77 KB)
- Spanish
  (PDF/13.74 KB)
- Swedish
  (PDF/13.69 KB)

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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Zoely : EPAR - Procedural steps taken and scientific information after authorisation (PDF/212.42 KB)

First published: 02/12/2011
Last updated: 16/12/2022
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Zoely-H-A-31-1510-C-1213-60 : EPAR - Divergent positions to CHMP opinion (PDF/74.71 KB)

First published: 16/12/2022
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Zoely-H-A-31-1510-C-1213-60 : EPAR - Assessment report (PDF/656.76 KB)

Adopted

First published: 16/12/2022
EMA/773938/2022
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Zoely-H-C-001213-PSUSA-2182-202101 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/85.77 KB)

First published: 12/01/2022
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Zoely-H-C-001213-SW-0058 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/132.79 KB)

First published: 12/01/2022
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Zoely-H-C-1213-0000 : EPAR - Assessment Report (PDF/381.84 KB)

Adopted

First published: 03/07/2020
EMA/283916/2020
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Zoely-H-C-1213-A31-1356 : EPAR - Assessment Report - Article 31 (PDF/341.6 KB)

Adopted

First published: 08/04/2014
Last updated: 08/04/2014
EMA/739865/2013
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Zoely : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisations, and detailed explanation for the differences from the PRAC recommendation. CHMP members’ divergent positio... (PDF/53.62 KB)

First published: 08/04/2014
Last updated: 08/04/2014
- Bulgarian
  (PDF/76.22 KB)
- Croatian
  (PDF/62.45 KB)
- Czech
  (PDF/72.6 KB)
- Danish
  (PDF/33.73 KB)
- Dutch
  (PDF/34.89 KB)
- Estonian
  (PDF/37.02 KB)
- Finnish
  (PDF/32.48 KB)
- French
  (PDF/34.61 KB)
- German
  (PDF/37.7 KB)
- Greek
  (PDF/73.63 KB)
- Hungarian
  (PDF/62.49 KB)
- Italian
  (PDF/35.77 KB)
- Latvian
  (PDF/64.93 KB)
- Lithuanian
  (PDF/68.02 KB)
- Maltese
  (PDF/70.71 KB)
- Polish
  (PDF/66.13 KB)
- Portuguese
  (PDF/34.24 KB)
- Romanian
  (PDF/68.62 KB)
- Slovak
  (PDF/66.05 KB)
- Slovenian
  (PDF/63.5 KB)
- Spanish
  (PDF/35.4 KB)
- Swedish
  (PDF/35 KB)
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Zoely-H-C-1213-PSU-0005 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation (PDF/73.43 KB)

First published: 21/11/2013
Last updated: 21/11/2013
EMA/721048/2013

Zoely

Table of contents

Overview

Zoely : EPAR - Summary for the public (PDF/77.02 KB)

Zoely : EPAR - Risk-management-plan summary (PDF/1.23 MB)

Authorisation details

Product information

Zoely : EPAR - Product Information (PDF/692.18 KB)

Zoely : EPAR - All Authorised presentations (PDF/12.72 KB)

Pharmacotherapeutic group

Therapeutic indication

Assessment history

Changes since initial authorisation of medicine

Zoely : EPAR - Procedural steps taken and scientific information after authorisation (PDF/212.42 KB)

Zoely-H-A-31-1510-C-1213-60 : EPAR - Divergent positions to CHMP opinion (PDF/74.71 KB)

Zoely-H-A-31-1510-C-1213-60 : EPAR - Assessment report (PDF/656.76 KB)

Zoely-H-C-001213-PSUSA-2182-202101 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/85.77 KB)

Zoely-H-C-001213-SW-0058 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/132.79 KB)

Zoely-H-C-1213-0000 : EPAR - Assessment Report (PDF/381.84 KB)

Zoely-H-C-1213-A31-1356 : EPAR - Assessment Report - Article 31 (PDF/341.6 KB)

Zoely : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisations, and detailed explanation for the differences from the PRAC recommendation. CHMP members’ divergent positio... (PDF/53.62 KB)

Zoely-H-C-1213-PSU-0005 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation (PDF/73.43 KB)

Initial marketing-authorisation documents

Zoely : EPAR - Public assessment report (PDF/623.17 KB)

CHMP summary of positive opinion for Zoely (PDF/69.38 KB)

News

More information on Zoely

Direct healthcare professional communications (DHPC)

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