EMEA-002016-PIP02-16 - paediatric investigation plan

alpelisib

Key facts

• Active substance:
  alpelisib
• Therapeutic area:
  Oncology
• Decision number:
  P/0079/2017
• PIP number:
  EMEA-002016-PIP02-16
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of breast cancer
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  16/03/2017
• Compliance check done:
  No

Decision

P/0079/2017: EMA decision of 17 March 2017 on the granting of a product specific waiver for alpelisib (EMEA-002016-PIP02-16)

Adopted Reference Number: EMA/104983/2017