Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Jakavi   
Auth. number : EU/1/12/773
Active substance : ruxolitinib
Orphan market exclusivity for "Treatment of chronic idiopathic myelofibrosis" (based on designation EU/3/08/572) started on 28/08/2012
   10 years of market exclusivity
   This orphan market exclusivity has ended on 20/02/2015
Orphan market exclusivity for "Treatment of myelofibrosis secondary to polycythemia vera or essential thrombocythemia" (based on designation EU/3/09/620) started on 28/08/2012
   10 years of market exclusivity
   This orphan market exclusivity has ended on 20/02/2015
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: L01XE18 - Ruxolitinib
(See WHO ATC Index)
Indication: Myelofibrosis (MF)
Jakavi is indicated for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis.

Polycythaemia vera (PV)
Jakavi is indicated for the treatment of adult patients with polycythaemia vera who are resistant to or intolerant of hydroxyurea.
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
28/08/2012 Centralised - Authorisation EMEA/H/C/2464 (2012)6018 of 23/08/2012
20/02/2013 Centralised - Variation EMEA/H/C/2464/IB/2/G
Updated with Decision(2013)8063 of 13/11/2013
28/06/2013 Centralised - Variation EMEA/H/C/2464/II/6
Updated with Decision(2013)8063 of 13/11/2013
08/10/2013 Centralised - Variation EMEA/H/C/2464/IB/8
Updated with Decision(2014)7363 of 03/10/2014
15/11/2013 PSUSA - Modification EMEA/H/C/2464/II/5, EMEA/H/C/2464/PSUV/9 (2013)8063 of 13/11/2013
24/07/2014 Centralised - Variation EMEA/H/C/2464/II/10
Updated with Decision(2014)7363 of 03/10/2014
07/10/2014 Centralised - Variation EMEA/H/C/2464/X/13 (2014)7363 of 03/10/2014
20/11/2014 Centralised - Variation EMEA/H/C/2464/II/17/G
Updated with Decision(2015)1740 of 11/03/2015
20/11/2014 Centralised - Variation EMEA/H/C/2464/II/18
Updated with Decision(2015)1740 of 11/03/2015
20/02/2015 Centralised - (orphan status)
13/03/2015 Centralised - 2-Monthly update EMEA/H/C/2464/II/16 (2015)1740 of 11/03/2015
23/04/2015 Centralised - Variation EMEA/H/C/2464/IAin/21
Updated with Decision(2016)2273 of 13/04/2016
22/10/2015 Centralised - Variation EMEA/H/C/2464/II/24
Updated with Decision(2016)2273 of 13/04/2016
26/11/2015 Centralised - Variation EMEA/H/C/2464/IB/27
Updated with Decision(2016)2273 of 13/04/2016
23/02/2016 Centralised - Variation EMEA/H/C/2464/IB/28/G
Updated with Decision(2016)2273 of 13/04/2016
15/04/2016 Centralised - Yearly update (2016)2273 of 13/04/2016
02/08/2016 Centralised - 2-Monthly update EMEA/H/C/2464/II/25 (2016)5080 of 29/07/2016
22/11/2016 PSUSA - Modification EMEA/H/C/2464/PSUSA /10015/201602 (2016)7599 of 18/11/2016
15/12/2016 Centralised - Variation EMEA/H/C/2464/II/31
Updated with Decision(2017)2850 of 24/04/2017
26/04/2017 Centralised - Renewal EMEA/H/C/2464/R/32 (2017)2850 of 24/04/2017