Ruxolitinib Zentiva

Opinion

EMA has issued an opinion on this medicine

ruxolitinib

Overview

On 17 September 2026, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Ruxolitinib Zentiva, intended for the treatment of myelofibrosis, polycythaemia vera and graft-versus-host disease.

The applicant for this medicinal product is Zentiva k.s.

Ruxolitinib Zentiva will be available as 5 mg, 10 mg, 15 mg and 20 mg tablets. The active substance of Ruxolitinib Zentiva is ruxolitinib, a protein kinase inhibitor (ATC code: L01EJ01). The antineoplastic activity of ruxolitinib is linked to the selective inhibition of the Janus-associated kinases (JAKs), which are involved in the signalling pathways of several cytokines and growth factors important for haematopoiesis and immune function.

Ruxolitinib Zentiva is a generic of Jakavi, which has been authorised in the EU since 23 August 2012. Studies have demonstrated the satisfactory quality of Ruxolitinib Zentiva, and its bioequivalence to the reference product Jakavi. 

The full indication is:

Myelofibrosis (MF)

Ruxolitinib Zentiva 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)

Ruxolitinib Zentiva is indicated for the treatment of adult patients with polycythaemia vera who are resistant to or intolerant of hydroxyurea.

Graft versus host disease (GvHD)

Acute GvHD

Ruxolitinib Zentiva is indicated for the treatment of adults and paediatric patients aged 28 days and older with acute graft-versus-host disease who have inadequate response to corticosteroids or other systemic therapies (see section 5.1).

Chronic GvHD

Ruxolitinib Zentiva is indicated for the treatment of adults and paediatric patients aged 6 months and older with chronic graft-versus-host disease who have inadequate response to corticosteroids or other systemic therapies (see section 5.1).

Ruxolitinib Zentiva treatment should only be initiated by a physician experienced in the administration of anticancer medicinal products. 

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after the marketing authorisation has been granted by the European Commission.

CHMP summary of positive opinion for Ruxolitinib Zentiva

Adopted Reference Number: EMADOC-1829012207-68711

Product details

• Name of medicine:
  Ruxolitinib Zentiva
• Active substance:
  ruxolitinib hemifumarate
• International non-proprietary name (INN) or common name:
  ruxolitinib
• Therapeutic area (MeSH):
  • Primary Myelofibrosis
  • Polycythemia Vera
  • Graft vs Host Disease
• Anatomical therapeutic chemical (ATC) code:
  L01EJ01
• EMA product number:
  EMEA/H/C/006791
• Generic:

  This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

• Marketing authorisation applicant:
  Zentiva k.s.
• Opinion adopted:
  17/09/2026
• Opinion status:
  Positive