EMEA-002242-PIP02-21 - paediatric investigation plan

tucatinib

Key facts

• Invented name:
  Tukysa
• Active substance:
  tucatinib
• Therapeutic area:
  Oncology
• Decision number:
  P/0077/2022
• PIP number:
  EMEA-002242-PIP02-21
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of solid tumours
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  11/03/2022
• Compliance check done:
  Níl

Decision

EMA decision of 11 March 2022 on the granting of a product specific waiver for tucatinib (Tukysa) (EMEA-002242-PIP02-21)

Adopted Reference Number: EMA/65200/2022