EMEA-002268-PIP02-18-M02 - paediatric investigation plan

niraparib (tosilate monohydrate)

Key facts

• Invented name:
  Zejula
• Active substance:
  niraparib (tosilate monohydrate)
• Therapeutic area:
  Neoplasms benign, malignant and unspecified (incl cysts and polyps)
• Decision number:
  P/0229/2024
• PIP number:
  EMEA-002268-PIP02-18-M02
• Pharmaceutical form(s):
  • Capsule, hard
  • Tablet for oral suspension
  • Tablet
• Condition(s) / indication(s):
  Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic and lymphoid tissue neoplasms)
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  19/07/2024
• Compliance check done:
  No

Decision

P/0229/2024: EMA decision of 19 July 2024 on the acceptance of a modification of an agreed paediatric investigation plan for niraparib (tosylate monohydrate) (Zejula), (EMEA-002268-PIP02-18-M02)

Adopted Reference Number: EMA/291561/2024