Aldara

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). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach its recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the scientific discussion (also part of the EPAR).

This EPAR was last updated on 13/08/2018

Authorisation details

Product details
Name
Aldara
Agency product number
EMEA/H/C/000179
Active substance
imiquimod
International non-proprietary name (INN) or common name
imiquimod
Therapeutic area (MeSH)
  • Condylomata Acuminata
  • Keratosis
  • Keratosis, Actinic
  • Carcinoma, Basal Cell
Anatomical therapeutic chemical (ATC) code
D06BB10
Publication details
Marketing-authorisation holder
Meda AB
Revision
24
Date of issue of marketing authorisation valid throughout the European Union
18/09/1998
Contact address
Pipers väg 2A
170 73 Solna
Sweden

Product information

29/06/2018 Aldara - EMEA/H/C/000179 - IB/0072

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

Imiquimod cream is indicated for the topical treatment of:

  • external genital and perianal warts (condylomata acuminata) in adults;
  • small superficial basal-cell carcinomas (sBCCs) in adults;
  • clinically typical, non-hyperkeratotic, non-hypertrophic actinic keratoses (AKs) on the face or scalp in immunocompetent adult patients when size or number of lesions limit the efficacy and / or acceptability of cryotherapy and other topical treatment options are contraindicated or less appropriate.

Assessment history

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