Jakavi

RSS

ruxolitinib

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Jakavi. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Jakavi.

This EPAR was last updated on 08/06/2018

Authorisation details

Product details
Name
Jakavi
Agency product number
EMEA/H/C/002464
Active substance
ruxolitinib (as phosphate)
International non-proprietary name (INN) or common name
ruxolitinib
Therapeutic area (MeSH)
Myeloproliferative Disorders
Anatomical therapeutic chemical (ATC) code
L01XE18
Orphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation

Publication details
Marketing-authorisation holder
Novartis Europharm Limited
Revision
16
Date of issue of marketing authorisation valid throughout the European Union
23/08/2012
Contact address
Elm Park
Merrion Road
Dublin 4
Ireland

Product information

22/05/2018 Jakavi - EMEA/H/C/002464 - T/0035

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Antineplastic agents

Therapeutic 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.

Assessment history

Changes since initial authorisation of medicine

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