EMEA-002268-PIP03-18 - paediatric investigation plan

niraparib

Key facts

• Invented name:
  Zejula
• Active substance:
  niraparib
• Therapeutic area:
  Oncology
• Decision number:
  P/0167/2019
• PIP number:
  EMEA-002268-PIP03-18
• 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:
  15/05/2019
• Compliance check done:
  No

Decision

P/0167/2019: EMA decision of 15 May 2019 on the granting of a product specific waiver for niraparib (Zejula), (EMEA-002268-PIP03-18)

Adopted Reference Number: EMA/227256/2019