Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Zyclara   
Auth. number : EU/1/12/783
INN : imiquimod
ATC: Anatomical main group: D - Dermatologicals
Therapeutic subgroup: D06 - Antibiotics and chemotherapeutics for dermatological use
Pharmacological subgroup: D06B - Chemotherapeutics for topical use
Chemical subgroup: D06BB - Antivirals
Chemical substance: 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

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 is available in the Community Register.

 

European Commission proceduresGoto top of the page

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