EMEA-000567-PIP01-09-M05 - paediatric investigation plan

dasatinib

Key facts

• Invented name:
  • Sprycel
  • 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
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  16/02/2018
• Compliance check done:
  Ja
• Compliance procedure number:
  EMEA-C-000567-PIP01-09-M05
• Compliance opinion date:
  23/02/2018
• Compliance outcome:
  Positive

Decision

P/0042/2018: EMA decision of 16 February 2018 on the acceptance of a modification of an agreed paediatric investigation plan for dasatinib (Sprycel) (EMEA-000567-PIP01-09-M05)

Reference Number: EMA/75416/2018