Zyclara
imiquimod
Table of contents
Overview
This is a summary of the European public assessment report (EPAR) for Zyclara. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Zyclara.
For practical information about using Zyclara, patients should read the package leaflet or contact their doctor or pharmacist.
Authorisation details
Product details | |
---|---|
Name |
Zyclara
|
Agency product number |
EMEA/H/C/002387
|
Active substance |
imiquimod
|
International non-proprietary name (INN) or common name |
imiquimod
|
Therapeutic area (MeSH) |
|
Anatomical therapeutic chemical (ATC) code |
D06BB10
|
Publication details | |
---|---|
Marketing-authorisation holder |
Viatris Healthcare Limited
|
Revision |
15
|
Date of issue of marketing authorisation valid throughout the European Union |
23/08/2012
|
Contact address |
Viatris Healthcare Limited |
Product information
05/07/2023 Zyclara - EMEA/H/C/002387 - IA/0030
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.
Pharmacotherapeutic group
Antibiotics and chemotherapeutics for dermatological use
Therapeutic indication
Zyclara is indicated for the topical treatment of clinically typical, non-hyperkeratotic, non-hypertrophic, visible or palpable actinic keratosis of the full face or balding scalp in immunocompetent adults when other topical treatment options are contraindicated or less appropriate.