Aldara (imiquimod)
- Region
- 🇪🇺 EU
- Active substance
- imiquimod
- Company
- Viatris Healthcare Limited
- Status
- Authorised
- Therapeutic area
- Condylomata Acuminata; Keratosis; Keratosis, Actinic; Carcinoma, Basal Cell
- CHMP opinion
- Wed 27 May 1998
- EU approval
- Fri 18 Sep 1998
- Application
- EMEA/H/C/000179
- ATC
- D06BB10
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Zyclara Authorised · Viatris Healthcare Limited
- 🇪🇺 Zartra Withdrawn · Laboratoires 3M Santé
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.