Fedratinib (Inrebic®) – Myelofibrosis (MF)

1. Characteristics

Start date 15.03.2021
Resolution 02.09.2021
Limitation date 01.03.2025
INN Fedratinib
Brand name Inrebic®
Company Celgene GmbH
G-BA procedure ID 2021-03-15-D-650
ATC code L01EJ02
ICD-10 codes C94.40Acute myelofibrosis NOS, C94.41Acute panmyelosis with myelofibrosis, in remission, C94.60, C94.61, D47.1Chronic myeloproliferative disease, D47.4Osteomyelofibrosis
Therapeutic area Oncological diseases ORPHAN
Reason for procedure New INN
Specialties Register study

Indication (German)

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 hrombocythaemia myelofibrosis who are Janus Associated Kinase (JAK) inhibitor naïve or have been treated with ruxolitinib.

Subgroup Indication Comparator
a) Erwachsene Patienten mit primärer Myelofibrose, Post-Polycythaemia Vera-Myelofibrose oder Post-Essentielle Thrombozythämie-Myelofibrose, die nicht mit einem Janus-assoziierten Kinase (JAK)-Inhibitor vorbehandelt sind, zur Behandlung krankheitsbedingter Splenomegalie oder Symptome – (Orphan drug)
b) Erwachsene Patienten mit primärer Myelofibrose, Post-Polycythaemia Vera-Myelofibrose oder Post-Essentielle Thrombozythämie-Myelofibrose, die mit Ruxolitinib behandelt wurden, zur Behandlung krankheitsbedingter Splenomegalie oder Symptome – (Orphan drug)

9. Associated procedures

Resolution INN Brand name Indication Additional benefit
Fedratinib Inrebic® Myelofibrosis (MF)


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