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
• Contact for public enquiries:

  Janssen Research & Development

  Tel. [phone]; E-mail: [e-mail]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  15/05/2019

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)

AdoptedReference Number: EMA/227256/2019