Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Roche Registration GmbH, Emil-Barell-Strasse 1, 79639, Grenzach-Wyhlen, Germany
Zelboraf 240 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet (tablet). Pinkish white to orange white, oval, biconvex film-coated tablets of approximately 19 mm, with ‘VEM’ engraved on one side. |
Each tablet contains 240 mg of vemurafenib (as a co-precipitate of vemurafenib and hypromellose acetate succinate).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Vemurafenib |
Vemurafenib is an inhibitor of BRAF serine-threonine kinase. Mutations in the BRAF gene result in constitutive activation of BRAF proteins, which can cause cell proliferation without associated growth factors. Before taking vemurafenib, patients must have BRAF V600 mutation-positive tumour status confirmed by a validated test. |
| List of Excipients |
|---|
|
Tablet core: Croscarmellose sodium Film-coating: Polyvinyl alcohol |
Aluminium/Aluminium perforated unit dose blisters.
Pack-size: 56 × 1 film-coated tablets (7 blisters of 8 × 1 tablet)
Roche Registration GmbH, Emil-Barell-Strasse 1, 79639, Grenzach-Wyhlen, Germany
EU/1/12/751/001
Date of first authorisation: 17 February 2012
Date of latest renewal: 22 September 2016
| Drug | Countries | |
|---|---|---|
| ZELBORAF | Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa |
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