CAPRELSA Film-coated tablets Ref.[8958] Active ingredients: Vandetanib

Source: European Medicines Agency (EU)  Revision Year: 2020  Publisher: Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam, The Netherlands

Product name and form

Caprelsa 100 mg film-coated tablets.

Caprelsa 300 mg film-coated tablets.

Pharmaceutical Form

Caprelsa 100 mg tablets: The Caprelsa 100 mg tablet is a round, biconvex, white film-coated tablet with ‘Z100’ impressed on one side.

Caprelsa 300 mg tablets: The Caprelsa 300 mg tablet is an oval-shaped, biconvex, white film-coated tablet with ‘Z300’ impressed on one side.

Qualitative and quantitative composition

Caprelsa 100 mg tablets: Each film-coated tablet contains 100 mg of vandetanib.

Caprelsa 300 mg tablets: Each film-coated tablet contains 300 mg of vandetanib.

For a full list of excipients, see section 6.1.

Active Ingredient Description
Vandetanib

Vandetanib is a potent inhibitor of vascular endothelial growth factor receptor-2 (VEGFR-2 also known as kinase insert domain containing receptor [KDR]), epidermal growth factor receptor (EGFR) and RET tyrosine kinases. Vandetanib is also a sub-micromolar inhibitor of vascular endothelial receptor-3 tyrosine kinase. Vandetanib inhibits VEGF-stimulated endothelial cell migration, proliferation, survival and new blood vessel formation in in vitro models of angiogenesis. In addition, vandetanib inhibits epidermal growth factor (EGF)-stimulated EGF receptor tyrosine kinase in tumour cells and endothelial cells.

List of Excipients

Tablet core:

Calcium hydrogen phosphate dihydrate
Microcrystalline cellulose
Crospovidone (type A)
Povidone (K 29-32)
Magnesium stearate

Film-coating:

Hypromellose
Macrogol (300)
Titanium dioxide (E171)

Pack sizes and marketing

PVC/ PVDC/Alu blisters, sealed with aluminium foil, each containing 30 film-coated tablets.

Marketing authorization holder

Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam, The Netherlands

Marketing authorization dates and numbers

EU/1/11/749/001
EU/1/11/749/002

Date of first authorisation: 17 February 2012
Date of latest renewal: 15 January 2019

Drugs

Drug Countries
CAPRELSA Austria, Brazil, Canada, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Ireland, Israel, Japan, Lithuania, Netherlands, Poland, Romania, United Kingdom, United States

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.