Zyclara

RSS

imiquimod

Authorised
This medicine is authorised for use in the European Union.

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.

This EPAR was last updated on 06/07/2023

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)
  • Keratosis
  • Keratosis, Actinic
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
Damastown Industrial Park
Mulhuddart
Dublin 15
Dublin
Ireland

Product information

05/07/2023 Zyclara - EMEA/H/C/002387 - IA/0030

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:

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.

Assessment history

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