EMEA-000567-PIP01-09-M05

Key facts

Invented name
Sprycel
Active substance
dasatinib
Therapeutic area
Oncology
Decision number
P/0042/2018
PIP number
EMEA-000567-PIP01-09-M05
Pharmaceutical form(s)
  • Film-coated tablet
  • Age-appropriate oral formulation
Condition(s) / indication(s)
  • Treatment of Philadelphia-chromosome (BCR-ABL translocation)-positive acute lymphoblastic leukaemia
  • Treatment of Philadelphia-chromosome (BCR-ABL translocation)-positive chronic myeloid leukaemia
Route(s) of administration
Oral use
Contact for public enquiries
Bristol-Myers Squibb Pharma EEIG
Tel. +44 (0)1895 523740
E-mail: medical.information@bms.com
Decision type
PM: decision on the application for modification of an agreed PIP
Compliance procedure number
EMEA-C-000567-PIP01-09-M05
Compliance opinion date
23/02/2018
Compliance outcome
positive

Decision

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