Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Zelboraf   
Auth. number : EU/1/12/751
INN : vemurafenib
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L01 - Cytostatics
Pharmacological subgroup: L01X - Other cytostatics
Chemical subgroup: L01XE - Protein kinase inhibitors
Chemical substance: L01XE15 - Vemurafenib
(See WHO ATC Index)
Indication: Vemurafenib is indicated in monotherapy for the treatment of adult patients with BRAF V600 mutation-positive unresectable or metastatic melanoma.
Marketing Authorisation Holder: Roche Registration Limited
6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, 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
21/02/2012 Centralised - Authorisation EMEA/H/C/2409 (2012)1180 of 17/02/2012
02/01/2013 Centralised - Variation EMEA/H/C/2409/II/1, 2, 4 (2012)9944 of 20/12/2012
17/01/2013 Centralised - Variation EMEA/H/C/2409/II/3
Updated with Decision(2013)9734 of 18/12/2013
17/01/2013 Centralised - Variation EMEA/H/C/2409/II/5
Updated with Decision(2013)9734 of 18/12/2013
30/05/2013 Centralised - Variation EMEA/H/C/2409/II/8
Updated with Decision(2013)9734 of 18/12/2013
27/06/2013 Centralised - Variation EMEA/H/C/2409/II/7
Updated with Decision(2013)9734 of 18/12/2013
24/10/2013 Centralised - Variation EMEA/H/C/2409/II/10
Updated with Decision(2013)9734 of 18/12/2013
18/12/2013 Centralised - Variation EMEA/H/C/2409/II/11
23/12/2013 Centralised - Yearly update (2013)9734 of 18/12/2013
20/02/2014 Centralised - Variation EMEA/H/C/2409/II/14
26/06/2014 Centralised - Variation EMEA/H/C/2409/II/15