EMEA-000290-PIP01-08-M04 - paediatric investigation plan

nilotinib

Key facts

• Invented name:
  • Tasigna
  • Tasigna
• Active substance:
  nilotinib
• Therapeutic area:
  Oncology
• Decision number:
  P/0297/2015
• PIP number:
  EMEA-000290-PIP01-08-M04
• Pharmaceutical form(s):
  Capsule, hard
• Condition(s) / indication(s):
  Treatment of chronic myeloid leukaemia
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  21/12/2015
• Compliance check done:
  Sim
• Compliance procedure number:
  EMEA-C-000290-PIP01-08-M04
• Compliance opinion date:
  11/11/2016
• Compliance outcome:
  Positive

Decision

P/0297/2015: EMA decision of 21 December 2015 on the acceptance of a modification of an agreed paediatric investigation plan for nilotinib (Tasigna) (EMEA-000290-PIP01-08-M04)

Adopted Reference Number: EMA/792883/2015