Aldara
Authorised
imiquimod
Medicine
Human
Authorised
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).
Aldara is a cream containing the active substance imiquimod. It is available as 250-mg sachets, each containing 12.5 mg imiquimod (5%).
Aldara is used in adults to treat the following skin diseases:
The medicine can only be obtained with a prescription.
The number of times Aldara is applied and the duration of treatment depend on the condition being treated.
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.
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.
In all studies, Aldara was compared with placebo (the same cream but without the active substance).
In all studies, Aldara was more effective than placebo.
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.
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.
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.
This medicine’s product information is available in all official EU languages.
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Product information documents contain:
Imiquimod cream is indicated for the topical treatment of :