Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Bristol-Myers Squibb Pharma EEIG, Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland
SPRYCEL 20 mg film-coated tablets.
SPRYCEL 50 mg film-coated tablets.
SPRYCEL 70 mg film-coated tablets.
SPRYCEL 80 mg film-coated tablets.
SPRYCEL 100 mg film-coated tablets.
SPRYCEL 140 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet (tablet). SPRYCEL 20 mg film-coated tablets: White to off-white, biconvex, round film-coated tablet with “BMS” debossed on one side and “527” on the other side. SPRYCEL 50 mg film-coated tablets: White to off-white, biconvex, oval film-coated tablet with “BMS” debossed on one side and “528” on the other side. SPRYCEL 70 mg film-coated tablets: White to off-white, biconvex, round film-coated tablet with “BMS” debossed on one side and “524” on the other side. SPRYCEL 80 mg film-coated tablets: White to off-white, biconvex, triangular film-coated tablet with “BMS 80” debossed on one side and “855” on the other side. SPRYCEL 100 mg film-coated tablets: White to off-white, biconvex, oval film-coated tablet with “BMS 100” debossed on one side and “852” on the other side. SPRYCEL 140 mg film-coated tablets: White to off-white, biconvex, round film-coated tablet with “BMS 140” debossed on one side and “857” on the other side. |
Each film-coated tablet contains 20 mg dasatinib (as monohydrate).
Excipient with known effect: Each film-coated tablet contains 27 mg of lactose monohydrate.
Each film-coated tablet contains 50 mg dasatinib (as monohydrate).
Excipient with known effect: Each film-coated tablet contains 67.5 mg of lactose monohydrate.
Each film-coated tablet contains 70 mg dasatinib (as monohydrate).
Excipient with known effect: Each film-coated tablet contains 94.5 mg of lactose monohydrate.
Each film-coated tablet contains 80 mg dasatinib (as monohydrate).
Excipient with known effect: Each film-coated tablet contains 108 mg of lactose monohydrate.
Each film-coated tablet contains 100 mg dasatinib (as monohydrate).
Excipient with known effect: Each film-coated tablet contains 135.0 mg of lactose monohydrate.
Each film-coated tablet contains 140 mg dasatinib (as monohydrate).
Excipient with known effect: Each film-coated tablet contains 189 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Dasatinib |
Dasatinib inhibits the activity of the BCR-ABL kinase and SRC family kinases along with a number of other selected oncogenic kinases including c-KIT, ephrin (EPH) receptor kinases, and PDGFβ receptor. Dasatinib is a potent, subnanomolar inhibitor of the BCR-ABL kinase with potency at concentration of 0.6-0.8 nM. It binds to both the inactive and active conformations of the BCR-ABL enzyme. |
| List of Excipients |
|---|
|
Tablet core: Lactose monohydrate Film-coating: Hypromellose |
SPRYCEL 20 mg, SPRYCEL 50 mg and SPRYCEL 70 mg film-coated tablets:
Alu/Alu blisters (calendar blisters or perforated unit dose blisters).
HDPE bottle with a polypropylene child-resistant closure.
Carton containing 56 film-coated tablets in 4 calendar blisters of 14 film-coated tablets each.
Carton containing 60 × 1 film-coated tablets in perforated unit dose blisters.
Carton containing one bottle with 60 film-coated tablets.
SPRYCEL 80 mg, SPRYCEL 100 mg and SPRYCEL 140 mg film-coated tablets:
Alu/Alu blisters (perforated unit dose blisters).
HDPE bottle with a polypropylene child-resistant closure.
Carton containing 30 × 1 film-coated tablets in perforated unit dose blisters.
Carton containing one bottle with 30 film-coated tablets.
Not all pack sizes may be marketed.
Bristol-Myers Squibb Pharma EEIG, Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland
SPRYCEL 20 mg film-coated tablets:
EU/1/06/363/004
EU/1/06/363/007
EU/1/06/363/001
SPRYCEL 50 mg film-coated tablets:
EU/1/06/363/005
EU/1/06/363/008
EU/1/06/363/002
SPRYCEL 70 mg film-coated tablets:
EU/1/06/363/006
EU/1/06/363/009
EU/1/06/363/003
SPRYCEL 80 mg film-coated tablets:
EU/1/06/363/013
EU/1/06/363/012
SPRYCEL 100 mg film-coated tablets:
EU/1/06/363/011
EU/1/06/363/010
SPRYCEL 140 mg film-coated tablets:
EU/1/06/363/015
EU/1/06/363/014
Date of first authorisation: 20 November 2006
Date of latest renewal: 15 July 2016
| Drug | Countries | |
|---|---|---|
| SPRYCEL | Austria, Australia, Brazil, Canada, Cyprus, 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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