Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Roche Registration GmbH, Emil-Barell-Strasse 1, 79639, Grenzach-Wyhlen, Germany
Erivedge 150 mg hard capsules.
| Pharmaceutical Form |
|---|
|
Hard capsule (capsule). Pink coloured opaque body marked “150 mg” and a grey opaque cap marked “VISMO” with black ink. The size of the capsule is ‘Size 1’ (dimensions 19.0 × 6.6 mm). |
Each hard capsule contains 150 mg of vismodegib.
Excipient with known effect: Each hard capsule contains 71.5 mg lactose monohydrate per capsule.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Vismodegib |
Vismodegib is an orally available small-molecule inhibitor of the Hedgehog pathway. Hedgehog pathway signalling through the Smoothened transmembrane protein (SMO) leads to the activation and nuclear localisation of Glioma-Associated Oncogene (GLI) transcription factors and induction of Hedgehog target genes. Vismodegib binds to and inhibits the SMO protein thereby blocking Hedgehog signal transduction. |
| List of Excipients |
|---|
|
Capsule contents: Microcrystalline cellulose Capsule shell: Iron oxide black (E172) Printing ink: Shellac glaze |
HDPE bottle with a child-resistant closure containing 28 hard capsules. Each pack contains one bottle. The bottle cap material is Polypropylene. The cap liner is aluminum foil-lined waxed pulp board.
Roche Registration GmbH, Emil-Barell-Strasse 1, 79639, Grenzach-Wyhlen, Germany
EU/1/13/848/001
Date of first authorisation: 12 July 2013
Date of latest renewal: 26 May 2016
| Drug | Countries | |
|---|---|---|
| ERIVEDGE | Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Lithuania, Netherlands, New Zealand, Poland, Romania, Turkey, United Kingdom, United States, South Africa |
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