Data from EMA (European Medicines Agency) - Curated by EPG Health - Last updated 07 September 2018

Indication(s)

- 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

SPRYCEL is indicated for the treatment of adult patients with:
• newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukaemia (CML) in the chronic phase.
• chronic, accelerated or blast phase CML with resistance or intolerance to prior therapy including imatinib mesilate.
• Ph+ acute lymphoblastic leukaemia (ALL) and lymphoid blast CML with resistance or intolerance to prior therapy.

SPRYCEL is indicated for the treatment of paediatric patients with:
• newly diagnosed Ph+ CML in chronic phase (Ph+ CML-CP) or Ph+ CML-CP resistant or intolerant to prior therapy including imatinib.



- SPRYCEL 10 mg/mL powder for oral suspension

SPRYCEL is indicated for the treatment of paediatric patients with:
• newly diagnosed Philadelphia chromosome-positive chronic myelogenous leukaemia in chronic phase (Ph+ CML-CP) or Ph+ CML-CP resistant or intolerant to prior therapy including imatinib.

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More information

Category Value
Agency product number EMEA/H/C/000709
Orphan designation No
Date First Approved 20-11-2006
Type Medicinal product subject to restricted medical prescription
Marketing authorisation holder Bristol-Myers Squibb Pharma EEIG