ERIVEDGE Hard capsule Ref.[9090] Active ingredients: Vismodegib

Source: European Medicines Agency (EU)  Revision Year: 2019  Publisher: Roche Registration GmbH, Emil-Barell-Strasse 1, 79639, Grenzach-Wyhlen, Germany

Product name and form

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).

Qualitative and quantitative composition

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
Lactose monohydrate
Sodium lauril sulfate
Povidone (K29/32)
Sodium starch glycolate (Type A)
Talc
Magnesium stearate

Capsule shell:

Iron oxide black (E172)
Iron oxide red (E172)
Titanium dioxide (E171)
Gelatine

Printing ink:

Shellac glaze
Iron oxide black (E172)

Pack sizes and marketing

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.

Marketing authorization holder

Roche Registration GmbH, Emil-Barell-Strasse 1, 79639, Grenzach-Wyhlen, Germany

Marketing authorization dates and numbers

EU/1/13/848/001

Date of first authorisation: 12 July 2013
Date of latest renewal: 26 May 2016

Drugs

Drug Countries
ERIVEDGE Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Ireland, Israel, Lithuania, Netherlands, New Zealand, Poland, Romania, Turkey, United Kingdom, United States, South Africa

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