INREBIC Hard capsule Ref.[27855] Active ingredients: Fedratinib

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

Product name and form

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.

Qualitative and quantitative composition

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)).
Sodium stearyl fumarate

Capsule shell:

Gelatin (E441)
Titanium dioxide (E171)
Red iron oxide (E172)

Printing ink:

Shellac (E904)
Titanium dioxide (E171)
Propylene glycol (E1520)

Pack sizes and marketing

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.

Marketing authorization holder

Bristol-Myers Squibb Pharma EEIG, Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland

Marketing authorization dates and numbers

EU/1/20/1514/001

Date of first authorisation: 8 February 2021

Drugs

Drug Countries
INREBIC Austria, Estonia, France, Croatia, Ireland, Israel, Italy, Lithuania, Poland, Romania, United Kingdom, United States

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