EMEA-000727-PIP01-09-M07 - paediatric investigation plan

Bosutinib

Key facts

• Invented name:
  • Bosulif
  • Bosulif
• Active Substance:
  Bosutinib
• Therapeutic area:
  Oncology
• Decision number:
  P/0336/2023
• PIP number:
  EMEA-000727-PIP01-09-M07
• Pharmaceutical form(s):
  • Capsule, hard
  • Film-coated tablet
• Condition(s) / indication(s):
  Treatment of chronic myeloid leukaemia (CML)
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Pfizer Europe MA EEIG

  Tel. [phone]; E-mail: [e-mail]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  07/08/2023
• Compliance procedure number:
  EMEA-C-000727-PIP01-09-M07
• Compliance opinion date:
  15/12/2023
• Compliance outcome:
  Positive

Decision

P/0336/2023 : EMA decision of 7 August 2023 on the acceptance of a modification of an agreed paediatric investigation plan for bosutinib (Bosulif), (EMEA-000727-PIP01-09-M07)

Reference Number: EMA/351976/2023