EPARs for authorised medicinal products for human use

H-C-179

Aldara

European Public Assessment Report

Revision 15 - Published 14/09/09

Procedural steps taken and scientific information after authorisation

List of major and/or minor changes and summaries after the authorisation

Detailed Summaries

Detailed summaries are available in case of a major change to the use of the medicinal product e.g. a new indication. These summaries reflect the Scientific Discussion and conclusion by the EMEA scientific committee (CHMP) on a major change to a product after its initial marketing authorisation.

Aldara-H-179-II-26 Scientific Discussion

Aldara-H-179-II-20 Scientific Discussion

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Product Overview

Name of the Medicinal Product

Aldara

Marketing Authorisation Holder

Meda AB
Pipers väg 2A
170 73 Solna
Sweden

Active Substance

Imiquimod

International Nonproprietary Name or Common Name

Imiquimod

Pharmaco-therapeutic Group

Pharmacotherapeutic group: Chemotherapeutics for topical use, antivirals

ATC Code

D06BB10

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, nonhyperkeratotic, nonhypertrophic 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.

Date of issue of Marketing Authorisation valid throughout the European Union

18 September 1998

Orphan medicinal product designation date

Not applicable