Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Bayer AG, 51368, Leverkusen, Germany
Nexavar 200 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet (tablet). Red, round, biconvex film-coated tablets, debossed with Bayer cross on one side and “200” on the other side. |
Each film-coated tablet contains 200 mg of sorafenib (as tosylate).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Sorafenib |
Sorafenib is a multikinase inhibitor which has demonstrated both anti-proliferative and anti-angiogenic properties in vitro and in vivo. Sorafenib inhibits the activity of targets present in the tumour cell (CRAF, BRAF, V600E BRAF, c-KIT, and FLT-3) and in the tumour vasculature (CRAF, VEGFR-2, VEGFR-3, and PDGFR-β). |
| List of Excipients |
|---|
|
Tablet core: Croscarmellose sodium Tablet coating: Hypromellose |
112 film-coated tablets (4 × 28) in transparent (PP/Aluminium) blister packs.
Bayer AG, 51368, Leverkusen, Germany
EU/1/06/342/001
Date of first authorisation: 19 July 2006
Date of latest renewal: 21 July 2011
| Drug | Countries | |
|---|---|---|
| NEXAVAR | Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States, South Africa |
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