Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Sanofi B.V., Paasheuvelweg 25, 1105 BP Amsterdam, The Netherlands
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. |
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. |
| List of Excipients |
|---|
|
Tablet core: Calcium hydrogen phosphate dihydrate Film-coating: Hypromellose |
PVC/PVDC/Alu blisters, sealed with aluminium foil, each containing 30 film-coated tablets.
Sanofi B.V., Paasheuvelweg 25, 1105 BP Amsterdam, The Netherlands
EU/1/11/749/001
EU/1/11/749/002
Date of first authorisation: 17 February 2012
Date of latest renewal: 15 November 2022
| Drug | Countries | |
|---|---|---|
| CAPRELSA | Austria, Brazil, Canada, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Japan, Lithuania, Netherlands, Poland, Romania, United Kingdom, United States |
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