Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Glivec 100 mg film-coated tablets.
Glivec 400 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet. Glivec 100 mg film-coated tablets: Very dark yellow to brownish-orange film-coated tablet, round with “NVR” on one side and “SA” and score on the other side. Glivec 400 mg film-coated tablets: Very dark yellow to brownish-orange, ovaloid, biconvex film-coated tablet with bevelled edges, debossed with “glivec” on one side. |
Glivec 100 mg film-coated tablets: Each film-coated tablet contains 100 mg imatinib (as mesilate).
Glivec 400 mg film-coated tablets: Each film-coated tablet contains 400 mg imatinib (as mesilate).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Imatinib |
Imatinib is a protein-tyrosine kinase inhibitor which potently inhibits the Bcr-Abl tyrosine kinase at the in vitro, cellular and in vivo levels. |
| List of Excipients |
|---|
|
Tablet core: Cellulose microcrystalline Tablet coat: Iron oxide, red (E172) |
Glivec 100 mg film-coated tablets:
PVC/alu blisters: Packs containing 20, 60, 120 or 180 film-coated tablets.
PVDC/alu blisters: Packs containing 60, 120 or 180 film-coated tablets.
Glivec 400 mg film-coated tablets:
PVDC/alu blisters: Packs containing 10, 30 or 90 film-coated tablets.
Not all pack sizes may be marketed.
Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Glivec 100 mg film-coated tablets:
EU/1/01/198/007
EU/1/01/198/008
EU/1/01/198/011
EU/1/01/198/012
EU/1/01/198/014
EU/1/01/198/015
EU/1/01/198/016
Glivec 400 mg film-coated tablets:
EU/1/01/198/009
EU/1/01/198/010
EU/1/01/198/013
Date of first authorisation: 07 November 2001
Date of latest renewal: 07 November 2006
| Drug | Countries | |
|---|---|---|
| GLIVEC | Austria, Australia, Brazil, Cyprus, Germany, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Mexico, Nigeria, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom |
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