EMEA-002016-PIP03-19-M02 - paediatric investigation plan

alpelisib

Key facts

• Invented name:
  Piqray
• Active substance:
  alpelisib
• Therapeutic area:
  Other
• Decision number:
  P/0412/2022
• PIP number:
  EMEA-002016-PIP03-19-M02
• Pharmaceutical form(s):
  • Film-coated tablet
  • Granules
• Condition(s) / indication(s):
  Treatment of PIK3CA related overgrowth spectrum
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  30/09/2022
• Compliance check done:
  No

Decision

P/0412/2022: EMA decision of 30 September 2022 on the acceptance of a modification of an agreed paediatric investigation plan for alpelisib (Piqray and associated names), (EMEA-002016-PIP03-19-M02)

Reference Number: EMA/776062/2022