Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Jakavi   
Auth. number : EU/1/12/773
INN : ruxolitinib
Orphan status based on designation EU/3/08/572 added on 28/08/2012
Orphan status based on designation EU/3/09/620 added on 28/08/2012
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: L01XE18 - Ruxolitinib
(See WHO ATC Index)
Indication: 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.
Marketing Authorisation Holder: Novartis Europharm Limited
Wimblehurst Road, Horsham, West Sussex RH12 5AB, 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 Centralised - 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
20/11/2014 Centralised - Variation EMEA/H/C/2464/II/18