Inrebic

RSS

fedratinib

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

Overview

Inrebic is a medicine used to treat adults with myelofibrosis (a rare form of blood cancer) who have enlarged spleen or other symptoms related to the disease.

Inrebic can be used in three types of the disease: primary myelofibrosis (also known as chronic idiopathic myelofibrosis, where the cause is unknown), post-polycythaemia vera myelofibrosis (where the disease is linked to an overproduction of red blood cells) and post-essential thrombocythaemia myelofibrosis (where the disease is linked to an overproduction of platelets, components that help the blood to clot).

Inrebic is used both in patients who have not been treated with medicines known as Janus kinase (JAK) inhibitors before and in those who have been treated with the JAK inhibitor ruxolitinib.

These diseases are rare, and Inrebic was designated an ‘orphan medicine’ (a medicine used in rare diseases). Further information on the orphan designations can be found on the European Medicines Agency’s website (primary myelofibrosis: 1 October 2010; post-polycythaemia vera myelofibrosis: 26 November 2010; post-essential thrombocythaemia myelofibrosis: 26 November 2010).

Inrebic contains the active substance fedratinib.

This EPAR was last updated on 08/12/2021

Authorisation details

Product details
Name
Inrebic
Agency product number
EMEA/H/C/005026
Active substance
fedratinib dihydrochloride monohydrate
International non-proprietary name (INN) or common name
fedratinib
Therapeutic area (MeSH)
  • Myeloproliferative Disorders
  • Primary Myelofibrosis
Anatomical therapeutic chemical (ATC) code
L01EJ02
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

OrphanOrphan

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
Bristol Myers Squibb Pharma EEIG
Revision
3
Date of issue of marketing authorisation valid throughout the European Union
08/02/2021
Contact address

Plaza 254
Blanchardstown Corporate Park 2
Dublin 15
D15 T867
Ireland

Product information

07/12/2021 Inrebic - EMEA/H/C/005026 - IAIN/0009

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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

Inrebic is indicated for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis who are Janus Associated Kinase (JAK) inhibitor naïve or have been treated with ruxolitinib.

Assessment history

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