Source: European Medicines Agency (EU) Revision Year: 2018 Publisher: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Zykadia 150 mg hard capsules.
| Pharmaceutical Form |
|---|
|
Hard capsule. Capsule with white opaque body and blue opaque cap, with “LDK 150MG” imprinted on the cap and “NVR” on the body, containing white to almost white powder. |
Each hard capsule contains 150 mg ceritinib.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Ceritinib |
Ceritinib is an orally highly selective and potent ALK inhibitor. Ceritinib inhibits autophosphorylation of ALK, ALK-mediated phosphorylation of downstream signalling proteins and proliferation of ALK-dependent cancer cells both in vitro and in vivo. |
| List of Excipients |
|---|
|
Capsule content: Microcrystalline cellulose Capsule shell: Gelatin Printing ink: Shellac (bleached, de-waxed) glaze 45% |
PVC/polychlorotrifluoroethylene (PCTFE) – Alu blisters containing 10 hard capsules.
Packs containing 40, 90 or 150 (3 packs of 50) hard capsules.
Not all pack sizes may be marketed.
Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
EU/1/15/999/001-003
Date of first authorisation: 06 May 2015
Date of latest renewal: 22 March 2017
| Drug | Countries | |
|---|---|---|
| ZYKADIA | Austria, Australia, Canada, Estonia, Spain, France, Hong Kong, Ireland, Japan, Lithuania, Netherlands, Poland, Romania, Singapore, Turkey, United Kingdom, United States |
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