Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Tafinlar   
Auth. number : EU/1/13/865
Active substance : DABRAFENIB
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: L01XE23 - dabrafenib
(See WHO ATC Index)
Indication: Melanoma
Dabrafenib as monotherapy or in combination with trametinib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation (see sections 4.4 and 5.1).
Adjuvant treatment of melanoma
Dabrafenib in combination with trametinib is indicated for the adjuvant treatment of adult patients with Stage III melanoma with a BRAF V600 mutation, following complete resection.
Non small cell lung cancer (NSCLC)
Dabrafenib in combination with trametinib is indicated for the treatment of adult patients with advanced non small cell lung cancer with a BRAF V600 mutation.
Marketing Authorisation Holder: Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
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
29/08/2013 Centralised - Authorisation EMEA/H/C/2604 (2013)5604 of 26/08/2013
20/02/2014 Centralised - Variation EMEA/H/C/2604/II/2/G
Updated with Decision(2014)9043 of 21/11/2014
5/06/2014 Centralised - Variation EMEA/H/C/2604/IG/442
Updated with Decision(2014)9043 of 21/11/2014
24/07/2014 Centralised - Variation EMEA/H/C/2604/II/1/G
Updated with Decision(2014)9043 of 21/11/2014
25/11/2014 PSUSA - Modification EMEA/H/C/2604/PSUV/5 (2014)9043 of 21/11/2014
22/01/2015 Centralised - Variation EMEA/H/C/2604/II/6
Updated with Decision(2015)3220 of 06/05/2015
8/05/2015 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/2604/T/10 (2015)3220 of 6/05/2015
11/06/2015 Centralised - Variation EMEA/H/C/2604/II/8
Updated with Decision(2015)6046 of 25/08/2015
13/07/2015 Centralised - Variation EMEA/H/C/2604/IAIN/14/G
Updated with Decision(2015)6046 of 25/08/2015
27/08/2015 Centralised - 2-Monthly update EMEA/H/C/2604/WS/736 (2015)6046 of 25/08/2015
24/09/2015 Centralised - Variation EMEA/H/C/2604/II/9
Updated with Decision(2016)2825 of 02/05/2016
8/10/2015 Centralised - Variation EMEA/H/C/2604/II/15/G
Updated with Decision(2016)2825 of 02/05/2016
4/05/2016 Centralised - 2-Monthly update EMEA/H/C/2604/II/18 (2016)2825 of 2/05/2016
12/05/2016 Centralised - Variation EMEA/H/C/2604/II/19
Updated with Decision(2017)2217 of 29/03/2017
31/03/2017 Centralised - 2-Monthly update EMEA/H/C/2604/WS/996 (2017)2217 of 29/03/2017
30/05/2017 PSUSA - Modification EMEA/H/C/PSUSA/10084/201608 (2017)3752 of 24/05/2017
6/07/2017 Centralised - Variation EMEA/H/C/2604/II/24
Updated with Decision(2018)3010 of 08/05/2018
5/10/2017 Centralised - Variation EMEA/H/C/2604/II/25
Updated with Decision(2018)3010 of 08/05/2018
18/01/2018 Centralised - Variation EMEA/H/C/2604/II/29
Updated with Decision(2018)3010 of 08/05/2018
25/01/2018 Centralised - Variation EMEA/H/C/2604/WS/1210/G
Updated with Decision(2018)3010 of 08/05/2018
15/05/2018 Centralised - Renewal EMEA/H/C/2604/R/30 (2018)3010 of 8/05/2018
10/07/2018 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/2604/T/32 (2018)4475 of 6/07/2018
29/08/2018 Centralised - 2-Monthly update EMEA/H/C/2604/WS/1274 (2018)5775 of 27/08/2018