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, France, Croatia, Ireland, Israel, Italy, Lithuania, Poland, Romania, United Kingdom, United States |
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