Pharmaceuticals - Community Register


Community register of veterinary medicinal products


Product information

Invented name: Masivet   
Auth. number : EU/2/08/087
Active substance : masitinib
ATC: Anatomical main group: QL - Antineoplastic and immunomodulating agents
Therapeutic subgroup: QL01 - Antineoplastic Agents
Pharmacological subgroup: QL01X - Other antineoplastic agents
Chemical subgroup: QL01XE - Protein kinase inhibitors
Chemical substance: QL01XE90 - masitinib
(See WHO ATCvet Index)
Indication: Treatment of non-resectable dog mast cell tumours (Grade 2 or 3) with confirmed mutated c-kit tyrosine kinase receptor.
Marketing Authorisation Holder: AB Science S.A.
3 avenue George V, 75008 Paris, France
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
19/11/2008 Centralised - Authorisation EMEA/V/C/128 (2008)7066 of 17/11/2008
17/04/2009 Centralised - Notification EMEA/V/C/128/N/1
Updated with Decision(2010)1768 of 15/03/2010
7/08/2009 Centralised - Variation EMEA/V/C/128/IB/2
Updated with Decision(2010)1768 of 15/03/2010
18/09/2009 Centralised - Variation (no change in Commission Decision) EMEA/V/C/128/II/3
17/03/2010 Centralised - Variation (2010)1768 of 15/03/2010
7/05/2010 Centralised - Variation EMEA/V/C/128/IB/5
Updated with Decision(2010)8898 of 03/12/2010
3/08/2010 Centralised - Variation (no change in Commission Decision) EMEA/V/C/128/IA/7
31/08/2010 Centralised - Variation (rejected) EMEA/V/C/128/II/4 (2010)6019 of 26/08/2010
7/12/2010 Centralised - Variation (2010)8898 of 3/12/2010
21/10/2011 Centralised - Variation EMEA/V/C/128/IA/11
Updated with Decision(2011)9438 of 09/12/2011
13/12/2011 Centralised - Variation (2011)9438 of 9/12/2011
10/02/2012 Centralised - Variation EMEA/V/C/128/IA/13
Updated with Decision(2012)1849 of 15/03/2012
19/03/2012 Centralised - Variation EMEA/V/C/128/II/14 (2012)1849 of 15/03/2012
26/09/2013 Centralised - Renewal EMEA/V/C/128/R/16 (2013)6310 of 24/09/2013