Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Bayer AG, 51368 Leverkusen, Germany
Stivarga 40 mg film-coated tablets.
| Pharmaceutical Form |
|---|
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Film-coated tablet. Light pink film-coated tablets, oval shaped with a length of 16 mm and a width of 7 mm marked with ‘BAYER’ on one side and ‘40’ on the other side. |
Each film-coated tablet contains 40 mg of regorafenib.
Excipients with known effect: Each daily dose of 160 mg contains 2.427 mmol (or 55.8 mg) of sodium (see section 4.4).
Each daily dose of 160 mg contains 1.68 mg of lecithin (derived from soya) (see section 4.4).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Regorafenib |
Regorafenib is an oral tumour deactivation agent that potently blocks multiple protein kinases, including kinases involved in tumour angiogenesis (VEGFR1, -2, -3, TIE2), oncogenesis (KIT, RET, RAF-1, BRAF, BRAFV600E), metastasis (VEGFR3, PDGFR, FGFR) and tumour immunity (CSF1R). Regorafenib inhibits mutated KIT, a major oncogenic driver in gastrointestinal stromal tumours, and thereby blocks tumour cell proliferation. |
| List of Excipients |
|---|
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Tablet core: Cellulose microcrystalline Film coat: Iron oxide red (E172) |
White opaque HDPE bottle closed with a PP/PP (polypropylene) screw cap with sealing insert and a molecular sieve desiccant.
Each bottle contains 28 film-coated tablets.
Pack sizes:
Pack of 28 film-coated tablets.
Pack of 84 (3 bottles of 28) film-coated tablets.
Not all pack sizes may be marketed.
Bayer AG, 51368 Leverkusen, Germany
EU/1/13/858/001
EU/1/13/858/002
Date of first authorisation: 26 August 2013
Date of latest renewal: 22 May 2018
| Drug | Countries | |
|---|---|---|
| STIVARGA | Austria, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States, South Africa |
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