Jakavi

RSS

ruxolitinib

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

Overview

Jakavi is a medicine used to treat the following conditions:

  • splenomegaly (enlarged spleen) or other disease-related symptoms such as fever, night sweats, bone pain and weight loss in adults who have myelofibrosis. Myelofibrosis is a disease in which the bone marrow becomes very dense and rigid and produces abnormal, immature blood cells.
  • polycythaemia vera in adults in whom the medicine hydroxycarbamide (also known as hydroxyurea) does not work or causes unacceptable side effects. In polycythaemia vera, too many red blood cells are produced, which can cause reduced blood flow to the organs due to ‘thickening’ of the blood and occasionally the formation of blood clots.
  • acute or chronic graft-versus-host disease (when transplanted cells attack the body) in people aged 12 and older who have had a transplantation and for whom corticosteroids or other systemic therapies (treatments given by mouth or injection) did not work well enough.

Jakavi contains the active substance ruxolitinib.

This EPAR was last updated on 18/05/2022

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
  • Polycythemia Vera
  • Graft vs Host Disease
Anatomical therapeutic chemical (ATC) code
L01EJ01
Publication details
Marketing-authorisation holder
Novartis Europharm Limited
Revision
26
Date of issue of marketing authorisation valid throughout the European Union
23/08/2012
Contact address

Vista Building
Elm Park
Merrion Road
Dublin 4
Ireland

Product information

29/04/2022 Jakavi - EMEA/H/C/002464 - II/0053

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Antineoplastic 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.

Graft versus host disease (GvHD)

Jakavi is indicated for the treatment of patients aged 12 years and older with acute graft versus host disease or chronic graft versus host disease who have inadequate response to corticosteroids or other systemic therapies (see section 5.1).

Assessment history

Changes since initial authorisation of medicine

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