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Community Register of medicinal products
Community register of medicinal products for human use |
AUTHORISED |
Product information |
| Invented name: | Zyclara
|
| Auth. number : | EU/1/12/783 |
| INN : | imiquimod |
| ATC: | D - Dermatologicals D06 - Antibiotics and chemotherapeutics for dermatological use D06B - Chemotherapeutics for topical use D06BB - Antivirals D06BB10 - Imiquimod (See WHO ATC Index) |
| Indication: | Zyclara is indicated for the topical treatment of clinically typical, nonhyperkeratotic, nonhypertrophic, visible or palpable actinic keratosis (AK) of the full face or balding scalp in immunocompetent adults when other topical treatment options are contraindicated or less appropriate. |
| Marketing Authorisation Holder: | Meda AB
Pipers väg 2A, SE-170 73 Solna, Sverige |
EPAR and active package presentations
Package presentations
|
The section of the Community Register "Package presentations" will no longer be updated as from 2 November 2012.
Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information". Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which continues to be available in the Community Register. |
European Commission procedures
| Close date procedure | Procedure type | EMEA number | Decision | summary publ | decision docs | annex |
| 27/08/2012 | Centralised - Authorisation | EMEA/H/C/2387 | (2012)6017 of 23/08/2012 |