Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Mekinist   
Auth. number : EU/1/14/931
Active substance : trametinib
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L01 - Antineoplastic agents
Pharmacological subgroup: L01X - Other antineoplastic agents
Chemical subgroup: L01XE - Protein kinase inhibitors
Chemical substance: L01XE25 - Trametinib
(See WHO ATC Index)
Indication: Trametinib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.
Trametinib has not demonstrated clinical activity in patients who have progressed on a prior BRAF inhibitor therapy
Marketing Authorisation Holder: Novartis Europharm Limited
Frimley Business Park, Camberley GU16 7SR, United Kingdom
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
02/07/2014 Centralised - Authorisation EMEA/H/C/2643 (2014)4586 of 30/06/2014
20/11/2014 Centralised - Variation EMEA/H/C/2643/II/1/G
Updated with Decision(2015)2740 of 20/04/2015
22/04/2015 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/2643/T/5 (2015)2740 of 20/04/2015
21/05/2015 Centralised - Variation EMEA/H/C/2643/II/3
Updated with Decision(2015)6038 of 25/08/2015
13/07/2015 Centralised - Variation EMEA/H/C/2643/IAin/9/G
Updated with Decision(2015)6038 of 25/08/2015
23/07/2015 Centralised - Variation EMEA/H/C/2643/II/2/G
Updated with Decision(2015)6038 of 25/08/2015
27/08/2015 Centralised - 2-Monthly update EMEA/H/C/2643/WS/736 (2015)6038 of 25/08/2015
24/09/2015 Centralised - Variation EMEA/H/C/2643/II/6/G
Updated with Decision(2016)1907 of 22/03/2016
24/09/2015 Centralised - Variation EMEA/H/C/2643/II/7
Updated with Decision(2016)1907 of 22/03/2016
03/12/2015 Centralised - Variation EMEA/H/C/2643/IB/12
Updated with Decision(2016)1907 of 22/03/2016
25/02/2016 Centralised - Variation EMEA/H/C/2643/II/13
Updated with Decision(2016)5401 of 16/08/2016
29/03/2016 PSUSA - Modification EMEA/H/C/PSUSA/10262/201505 (2016)1907 of 22/03/2016
18/08/2016 PSUSA - Modification EMEA/H/C/PSUSA/10262/201511 (2016)5401 of 16/08/2016