EMEA-003607-PIP01-24 - paediatric investigation plan

buparlisib

Key facts

• Active substance:
  buparlisib
• Therapeutic area:
  Neoplasms benign, malignant and unspecified (incl cysts and polyps)
• Decision number:
  P/0274/2024
• PIP number:
  EMEA-003607-PIP01-24
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of head and neck epithelial 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:
  14/08/2024
• Compliance check done:
  No

Decision

P/0274/2024: EMA decision of 14 August 2024 on the granting of a product specific waiver for buparlisib (EMEA-003607-PIP01-24)

Adopted Reference Number: EMA/307578/2024