EMEA-001147-PIP01-11-M07 - paediatric investigation plan

dabrafenib mesilate

Key facts

• Invented name:
  Tafinlar
• Active substance:
  dabrafenib mesilate
• Therapeutic area:
  Oncology
• Decision number:
  P/0410/2020
• PIP number:
  EMEA-001147-PIP01-11-M07
• Pharmaceutical form(s):
  • Capsule, hard
  • Dispersible tablet
• Condition(s) / indication(s):
  • Treatment of melanoma
  • Treatment of solid malignant tumours (excluding melanoma)
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  23/10/2020
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-001147-PIP01-11-M07
• Compliance opinion date:
  11/11/2022
• Compliance outcome:
  Positive

Decision

P/0410/2020: EMA decision of 23 October 2020 on the acceptance of a modification of an agreed paediatric investigation plan for dabrafenib (mesilate) (Tafinlar), (EMEA-001147-PIP01-11-M07)

Adopted Reference Number: EMA/494516/2020