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SPRYCEL (Bristol-Myers Squibb Australia Pty Ltd)
Product name
SPRYCEL
Date registered
Evaluation commenced
Decision date
Approval time
213 working days (255)
Active ingredients
dasatinib
Registration type
EOI
Indication
SPRYCEL (film-coated tablet) is now also indicated for the treatment of paediatric patients with:
- Ph+ CML in the chronic phase.
- newly diagnosed Ph+ ALL in combination with chemotherapy.