Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium
XALKORI 200 mg hard capsules.
XALKORI 250 mg hard capsules.
XALKORI 20 mg granules in capsules for opening.
XALKORI 50 mg granules in capsules for opening.
XALKORI 150 mg granules in capsules for opening.
| Pharmaceutical Form |
|---|
Hard capsuleXALKORI 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. Granules in capsule for opening.The granules are white to off-white and contained in an opaque hard capsule. XALKORI 20 mg granules in capsules for opening: Light blue cap printed with “Pfizer” in black ink and a white body printed with “CRZ 20” in black ink 3 XALKORI 50 mg granules in capsules for opening: Gray cap printed with “Pfizer” in black ink and a light gray body printed with “CRZ 50” in black ink. XALKORI 150 mg granules in capsules for opening: Light blue cap printed with “Pfizer” in black ink and a light blue body printed with “CRZ 150” in black ink. |
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.
XALKORI 20 mg granules in capsules for opening: Each capsule contains 20 mg crizotinib.
Excipient with known effect: Each capsule for opening contains 6 mg sucrose.
XALKORI 50 mg granules in capsules for opening: Each capsule contains 50 mg crizotinib.
Excipient with known effect: Each capsule for opening contains 14 mg sucrose.
XALKORI 150 mg granules in capsules for opening: Each capsule contains 150 mg crizotinib.
Excipient with known effect: Each capsule for opening contains 43 mg sucrose.
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 |
|---|
XALKORI 200 mg and 250 mg hard capsulesCapsule content: Colloidal anhydrous silica Capsule shell: Gelatin Printing ink: Shellac (E904) XALKORI 20 mg, 50 mg and 150 mg granules in capsules for openingGranules content: Stearyl alcohol Capsule shell: Gelatin Printing ink: Shellac (E904) |
XALKORI 200 mg and 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.
XALKORI 20 mg, 50 mg and 150 mg granules in capsules for opening:
XALKORI granules are supplied in high density polyethylene (HDPE) bottles with a polypropylene child-resistant (CR) closure and an aluminum foil/polyethylene heat induction seal containing 60 capsules for opening.
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
XALKORI 20 mg granules in capsules for opening:
EU/1/12/793/005
XALKORI 50 mg granules in capsules for opening:
EU/1/12/793/006
XALKORI 150 mg granules in capsules for opening:
EU/1/12/793/007
Date of first authorisation: 23 October 2012
Date of latest renewal: 16 July 2021
| Drug | Countries | |
|---|---|---|
| XALKORI | Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa |
© 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.
