EMEA-002242-PIP01-17 - paediatric investigation plan

tucatinib

Key facts

• Active substance:
  tucatinib
• Therapeutic area:
  Oncology
• Decision number:
  P/0036/2018
• PIP number:
  EMEA-002242-PIP01-17
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  Treatment of breast malignant neoplasms
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  31/01/2018
• Compliance check done:
  No

Decision

P/0036/2018: EMA decision of 30 January 2018 on the granting of a product specific waiver for tucatinib (EMEA-002242-PIP01-17)

Reference Number: EMA/848797/2017