SPRYCEL Film-coated tablet Ref.[8962] Active ingredients: Dasatinib

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

Product name and form

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.

Qualitative and quantitative composition

SPRYCEL 20 mg film-coated tablets

Each film-coated tablet contains 20 mg dasatinib (as monohydrate).

Excipient with known effect: Each film-coated tablet contains 27 mg of lactose monohydrate.

SPRYCEL 50 mg film-coated tablets

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.

SPRYCEL 70 mg film-coated tablets

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.

SPRYCEL 80 mg film-coated tablets

Each film-coated tablet contains 80 mg dasatinib (as monohydrate).

Excipient with known effect: Each film-coated tablet contains 108 mg of lactose monohydrate.

SPRYCEL 100 mg film-coated tablets

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.

SPRYCEL 140 mg film-coated tablets

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
Microcrystalline cellulose
Croscarmellose sodium
Hydroxypropylcellulose
Magnesium stearate

Film-coating:

Hypromellose
Titanium dioxide (E171)
Macrogol 400

Pack sizes and marketing

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.

Marketing authorization holder

Bristol-Myers Squibb Pharma EEIG, Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland

Marketing authorization dates and numbers

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

Drugs

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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