Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Zyclara   
Auth. number : EU/1/12/783
Active substance : 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, 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
26/09/2013 Centralised - Notification EMEA/H/C/2387/N/5
Updated with Decision(2015)8810 of 02/12/2015
16/12/2014 Centralised - Variation EMEA/H/C/2387/IB/8
Updated with Decision(2015)8810 of 02/12/2015
04/09/2015 Centralised - Notification EMEA/H/C/2387/N/10
Updated with Decision(2015)8810 of 02/12/2015
04/12/2015 Centralised - Yearly update (2015)8810 of 02/12/2015
27/06/2016 Centralised - Notification EMEA/H/C/2387/N/11
Updated with Decision(2017)2049 of 22/03/2017
24/03/2017 Centralised - Renewal EMEA/H/C/2387/R/12 (2017)2049 of 22/03/2017
13/12/2017 Centralised - 2-Monthly update EMEA/H/C/2387/II/13 (2017)8702 of 11/12/2017
16/02/2018 Centralised - Variation EMEA/H/C/2387/IB/16