EMEA-002634-PIP01-19-M02 - paediatric investigation plan

temozolomide

Key facts

• Active substance:
  temozolomide
• Therapeutic area:
  Oncology
• Decision number:
  002634-PIP01-19
• PIP number:
  EMEA-002634-PIP01-19-M02
• Pharmaceutical form(s):
  Powder for oral suspension
• Condition(s) / indication(s):
  Treatment of malignant glioma
• Route(s) of administration:
  • Gastric use
  • Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  13/04/2023
• Compliance check done:
  No

Decision

P/0131/2023 : EMA decision of 13 April 2023 on the acceptance of a modification of an agreed paediatric investigation plan for temozolomide (EMEA-002634-PIP01-19-M02)

Reference Number: EMA/147170/2023