Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium
XALKORI 200 mg hard capsules.
XALKORI 250 mg hard capsules.
| Pharmaceutical Form |
|---|
|
Hard capsule. XALKORI 200 mg hard capsules: White opaque and pink opaque hard capsule, with “Pfizer” imprinted on the cap and “CRZ 200” on the body. XALKORI 250 mg hard capsules: Pink opaque hard capsule, with “Pfizer” imprinted on the cap and “CRZ 250” on the body. |
XALKORI 200 mg hard capsules: Each hard capsule contains 200 mg of crizotinib.
XALKORI 250 mg hard capsules: Each hard capsule contains 250 mg of crizotinib.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Crizotinib |
Crizotinib is a selective small-molecule inhibitor of the ALK receptor tyrosine kinase (RTK) and its oncogenic variants (i.e. ALK fusion events and selected ALK mutations). Crizotinib is also an inhibitor of the Hepatocyte Growth Factor Receptor (HGFR, c-Met) RTK, ROS1 (c-ros) and Recepteur d’Origine Nantais (RON) RTK. |
| List of Excipients |
|---|
|
Capsule content: Colloidal anhydrous silica Capsule shell: Gelatin Printing ink: Shellac |
XALKORI 200 mg hard capsules:
HDPE bottles with a polypropylene closure containing 60 hard capsules.
PVC-foil blisters containing 10 hard capsules.
Each carton contains 60 hard capsules.
XALKORI 250 mg hard capsules:
HDPE bottles with a polypropylene closure containing 60 hard capsules.
PVC-foil blisters containing 10 hard capsules.
Each carton contains 60 hard capsules.
Not all pack sizes may be marketed.
Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium
XALKORI 200 mg hard capsules:
EU/1/12/793/001
EU/1/12/793/002
XALKORI 250 mg hard capsules:
EU/1/12/793/003
EU/1/12/793/004
Date of first authorisation: 23 October 2012
Date of latest renewal: 29 July 2016
| Drug | Countries | |
|---|---|---|
| XALKORI | Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Ireland, Israel, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa |
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