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 08/03/2018

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
Meda AB
Revision
7
Date of issue of marketing authorisation valid throughout the European Union
23/08/2012
Contact address
Pipers väg 2A
SE-170 09 Solna
Sweden

Product information

16/02/2018 Zyclara - EMEA/H/C/002387 - IB/0016

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

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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