EMEA-002268-PIP01-17 - paediatric investigation plan

niraparib

Key facts

• Active substance:
  niraparib
• Therapeutic area:
  Oncology
• Decision number:
  P/0088/2018
• PIP number:
  EMEA-002268-PIP01-17
• Pharmaceutical form(s):
  Capsule, hard
• Condition(s) / indication(s):
  Treatment of prostate 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:
  16/03/2018
• Compliance check done:
  No

Decision

P/0088/2018: EMA decision of 16 March 2018 on the granting of a product- specific waiver for niraparib (EMEA-002268-PIP01-17)

Adopted Reference Number: EMA/105604/2018