Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: Bristol-Myers Squibb Pharma EEIG, Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland
Inrebic 100 mg hard capsules.
| Pharmaceutical Form |
|---|
|
Hard capsule. Reddish-brown opaque capsules, 21.4-22.0 mm (size 0), printed with “FEDR” on the cap and “100 mg” on the body in white ink. |
Each hard capsule contains fedratinib dihydrochloride monohydrate equivalent to 100 mg fedratinib.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Fedratinib |
Fedratinib is a kinase inhibitor with activity against wild type and mutationally activated Janus Associated Kinase 2 (JAK2) and FMS-like tyrosine kinase 3 (FLT3). Fedratinib reduced JAK2-mediated phosphorylation of signal transducer and activator of transcription (STAT3/5) proteins, inhibited malignant cell proliferation in vitro and in vivo. |
| List of Excipients |
|---|
|
Capsule content: Silicified microcrystalline cellulose (contains microcrystalline cellulose (E460) and silica colloidal anhydrous (E551)). Capsule shell: Gelatin (E441) Printing ink: Shellac (E904) |
High-density polyethylene (HDPE) bottle with polypropylene child resistant cap and heat induction seal.
Each bottle contains 120 hard capsules and is packed in a cardboard carton.
Bristol-Myers Squibb Pharma EEIG, Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland
EU/1/20/1514/001
Date of first authorisation: 8 February 2021
| Drug | Countries | |
|---|---|---|
| INREBIC | Austria, Estonia, Ireland, Israel, Lithuania, Poland, Romania, United Kingdom, United States |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
