Inrebic
fedratinib
Table of contents
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.
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Inrebic : EPAR - Medicine overview (PDF/123.08 KB)
First published: 03/03/2021
EMA/694589/2020 -
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Inrebic : EPAR - Risk-management-plan summary (PDF/148.76 KB)
First published: 03/03/2021
Authorisation details
Product details | |
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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) |
|
Anatomical therapeutic chemical (ATC) code |
L01EJ02
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Additional 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. |
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 | |
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Marketing-authorisation holder |
Bristol Myers Squibb Pharma EEIG
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Revision |
4
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Date of issue of marketing authorisation valid throughout the European Union |
08/02/2021
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Contact address |
Plaza 254 |
Product information
23/02/2023 Inrebic - EMEA/H/C/005026 - II/0010/G
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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.