Aldara

imiquimod

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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).

What is Aldara?

Aldara is a cream containing the active substance imiquimod. It is available as 250-mg sachets, each containing 12.5 mg imiquimod (5%).

What is Aldara used for?

Aldara is used in adults to treat the following skin diseases:

  • warts on the genitals and around the anus;
  • small basal-cell carcinomas (slow-growing types of skin cancer);
  • actinic keratoses of the face and scalp (precancerous, abnormal skin growths that develop after too much exposure to sunlight), in patients whose immune system is working normally. It is used when other treatments such as cryotherapy (freezing) cannot be used.

The medicine can only be obtained with a prescription.

How is Aldara used?

The number of times Aldara is applied and the duration of treatment depend on the condition being treated.

  • For genital warts, Aldara is applied three times a week for up to 16 weeks.
  • For small basal cell carcinomas, the cream is applied five times a week for six weeks.
  • For actinic keratoses, it is applied three times a week, for one or two four-week courses, with four weeks between courses.

The cream is applied in a thin layer to the affected areas of skin before sleeping, so that it remains on the skin for a suitable length of time (about eight hours) before being washed off. For further information, see the package leaflet.

How does Aldara work?

The active substance in Aldara cream, imiquimod, is an immune-response modifier. This means that it uses the immune system, the body’s natural defences, to bring about its effect. When imiquimod is applied to the skin, it acts locally on the immune system to trigger the release of cytokines, including interferon. These substances help to kill the viruses that cause warts or the abnormal cells in the skin that develop into skin cancer or keratoses.

How has Aldara been studied?

In all studies, Aldara was compared with placebo (the same cream but without the active substance).

  • Aldara has been studied in 923 patients with genital warts in four main studies lasting 16 weeks. The main measure of effectiveness was the number of patients with total clearance of treated warts.
  • Aldara has also been studied in 724 patients with small basal-cell carcinomas in two studies where patients were treated for six weeks, and used Aldara or placebo either five times a week or every day. The main measure of effectiveness was the number of patients with total clearance of the tumours after 12 weeks.
  • Aldara has also been studied in patients with actinic keratoses in two studies involving a total of 505 patients. The main measure of effectiveness was the number of patients whose keratoses had cleared after one or two four-week courses of treatment.
What benefit has Aldara shown during the studies?

In all studies, Aldara was more effective than placebo.

  • In the treatment of genital warts, the total clearance rate across the four main studies was 15 to 52% in the Aldara-treated patients, compared with 3 to 18% in the placebo-treated patients.
  • When the results of the two studies in basal-cell carcinoma were looked at together, total clearance was seen in 66 to 80% of Aldara-treated patients compared with 0 to 3% in the placebo group. There were no differences between the two dose frequencies.
  • In actinic keratoses, complete clearance after one or two courses of treatment was seen in 54 and 55% of Aldara-treated patients in the two studies, compared with 15 and 2% in the placebo-treated patients.
What is the risk associated with Aldara?

The most common side effect with Aldara (seen in more that 1 patient in 10) is a reaction at the site of application of the cream (pain or itching). For the full list of all side effects reported with Aldara, see the package leaflet.

Aldara should not be used in people who may be hypersensitive (allergic) to imiquimod or any of the other ingredients.

Why has Aldara been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Aldara’s benefits are greater than its risks for the treatment of external genital and perianal warts (condylomata acuminata), small basal-cell carcinomas and non-hyperkeratotic, non-hypertrophic actinic keratoses in immunocompetent adult patients when other topical treatment options are contraindicated or less appropriate. The Committee recommended that Aldara be given marketing authorisation.

Other information about Aldara

The European Commission granted a marketing authorisation valid throughout the European Union for Aldara on 18 September 1998. The marketing authorisation was renewed on 18 September 2003 and on 18 September 2008. The marketing-authorisation holder is Meda AB.

Name Language First published Last updated
Aldara : EPAR - Summary for the public BG = bălgarski 08/10/2008  
Aldara : EPAR - Summary for the public ES = español 08/10/2008  
Aldara : EPAR - Summary for the public CS = čeština 08/10/2008  
Aldara : EPAR - Summary for the public DA = dansk 08/10/2008  
Aldara : EPAR - Summary for the public DE = Deutsch 08/10/2008  
Aldara : EPAR - Summary for the public ET = eesti keel 08/10/2008  
Aldara : EPAR - Summary for the public EL = elliniká 08/10/2008  
Aldara : EPAR - Summary for the public EN = English 08/10/2008  
Aldara : EPAR - Summary for the public FR = français 08/10/2008  
Aldara : EPAR - Summary for the public IT = italiano 08/10/2008  
Aldara : EPAR - Summary for the public LV = latviešu valoda 08/10/2008  
Aldara : EPAR - Summary for the public LT = lietuvių kalba 08/10/2008  
Aldara : EPAR - Summary for the public HU = magyar 08/10/2008  
Aldara : EPAR - Summary for the public MT = Malti 08/10/2008  
Aldara : EPAR - Summary for the public NL = Nederlands 08/10/2008  
Aldara : EPAR - Summary for the public PL = polski 08/10/2008  
Aldara : EPAR - Summary for the public PT = português 08/10/2008  
Aldara : EPAR - Summary for the public RO = română 08/10/2008  
Aldara : EPAR - Summary for the public SK = slovenčina 08/10/2008  
Aldara : EPAR - Summary for the public SL = slovenščina 08/10/2008  
Aldara : EPAR - Summary for the public FI = suomi 08/10/2008  
Aldara : EPAR - Summary for the public SV = svenska 08/10/2008  

This EPAR was last updated on 05/08/2016 .

Authorisation details

Product details

Product details for Aldara
NameAldara
Agency product numberEMEA/H/C/000179
Active substance

imiquimod

International non-proprietary name (INN) or common name

imiquimod

Therapeutic area Carcinoma, Basal CellKeratosis, ActinicCondylomata AcuminataKeratosis
Anatomical therapeutic chemical (ATC) code D06BB10

Publication details

Publication details for Aldara
Marketing-authorisation holder

Meda AB

Revision21
Date of issue of marketing authorisation valid throughout the European Union18/09/1998

Contact address:

Meda AB
Pipers väg 2A
170 73 Solna
Sweden

Product information

Product information

28/06/2016  Aldara -EMEA/H/C/000179 -N/0068

Name Language First published Last updated
Aldara : EPAR - Product Information SV = svenska 14/09/2009 05/08/2016
Aldara : EPAR - Product Information SV = svenska 14/09/2009 05/08/2016
Aldara : EPAR - Product Information SV = svenska 14/09/2009 05/08/2016
Aldara : EPAR - Product Information SV = svenska 14/09/2009 05/08/2016
Aldara : EPAR - Product Information SV = svenska 14/09/2009 05/08/2016
Aldara : EPAR - Product Information SV = svenska 14/09/2009 05/08/2016
Aldara : EPAR - Product Information SV = svenska 14/09/2009 05/08/2016
Aldara : EPAR - Product Information SV = svenska 14/09/2009 05/08/2016
Aldara : EPAR - Product Information SV = svenska 14/09/2009 05/08/2016
Aldara : EPAR - Product Information SV = svenska 14/09/2009 05/08/2016
Aldara : EPAR - Product Information SV = svenska 14/09/2009 05/08/2016
Aldara : EPAR - Product Information SV = svenska 14/09/2009 05/08/2016
Aldara : EPAR - Product Information SV = svenska 14/09/2009 05/08/2016
Aldara : EPAR - Product Information SV = svenska 14/09/2009 05/08/2016
Aldara : EPAR - Product Information SV = svenska 14/09/2009 05/08/2016
Aldara : EPAR - Product Information SV = svenska 14/09/2009 05/08/2016
Aldara : EPAR - Product Information SV = svenska 14/09/2009 05/08/2016
Aldara : EPAR - Product Information SV = svenska 14/09/2009 05/08/2016
Aldara : EPAR - Product Information SV = svenska 14/09/2009 05/08/2016
Aldara : EPAR - Product Information SV = svenska 14/09/2009 05/08/2016
Aldara : EPAR - Product Information SV = svenska 14/09/2009 05/08/2016
Aldara : EPAR - Product Information SV = svenska 14/09/2009 05/08/2016
Aldara : EPAR - Product Information SV = svenska 14/09/2009 05/08/2016
Aldara : EPAR - Product Information SV = svenska 14/09/2009 05/08/2016
Aldara : EPAR - Product Information SV = svenska 14/09/2009 05/08/2016

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.


Name Language First published Last updated
Aldara : EPAR - All Authorised presentations SV = svenska 14/09/2009  
Aldara : EPAR - All Authorised presentations SV = svenska 14/09/2009  
Aldara : EPAR - All Authorised presentations SV = svenska 14/09/2009  
Aldara : EPAR - All Authorised presentations SV = svenska 14/09/2009  
Aldara : EPAR - All Authorised presentations SV = svenska 14/09/2009  
Aldara : EPAR - All Authorised presentations SV = svenska 14/09/2009  
Aldara : EPAR - All Authorised presentations SV = svenska 14/09/2009  
Aldara : EPAR - All Authorised presentations SV = svenska 14/09/2009  
Aldara : EPAR - All Authorised presentations SV = svenska 14/09/2009  
Aldara : EPAR - All Authorised presentations SV = svenska 14/09/2009  
Aldara : EPAR - All Authorised presentations SV = svenska 14/09/2009  
Aldara : EPAR - All Authorised presentations SV = svenska 14/09/2009  
Aldara : EPAR - All Authorised presentations SV = svenska 14/09/2009  
Aldara : EPAR - All Authorised presentations SV = svenska 14/09/2009  
Aldara : EPAR - All Authorised presentations SV = svenska 14/09/2009  
Aldara : EPAR - All Authorised presentations SV = svenska 14/09/2009  
Aldara : EPAR - All Authorised presentations SV = svenska 14/09/2009  
Aldara : EPAR - All Authorised presentations SV = svenska 14/09/2009  
Aldara : EPAR - All Authorised presentations SV = svenska 14/09/2009  
Aldara : EPAR - All Authorised presentations SV = svenska 14/09/2009  
Aldara : EPAR - All Authorised presentations SV = svenska 14/09/2009  
Aldara : EPAR - All Authorised presentations SV = svenska 14/09/2009  
Aldara : EPAR - All Authorised presentations SV = svenska 14/09/2009  

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

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Aldara : EPAR - Procedural steps taken before authorisation SV = svenska 21/07/2006  
Aldara : EPAR - Scientific Discussion SV = svenska 21/07/2006  

Authorised

This medicine is approved for use in the European Union