EMEA-002268-PIP02-18-M01 - paediatric investigation plan

Niraparib (tosilate monohydrate)

Key facts

• Invented name:
  Zejula
• Active Substance:
  Niraparib (tosilate monohydrate)
• Therapeutic area:
  Oncology
• Decision number:
  P/0184/2021
• PIP number:
  EMEA-002268-PIP02-18-M01
• Pharmaceutical form(s):
  • Film-coated tablet
  • Capsule (hard)
  • Age appropriate oral liquid formulation
• 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
• Contact for public enquiries:

  GlaxoSmithKline (Ireland) Limited

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

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  10/05/2021

Decision

P/0184/2021 : EMA decision of 10 May 2021 on the acceptance of a modification of an agreed paediatric investigation plan for niraparib (tosylate monohydrate), (Zejula), (EMEA-002268-PIP02-18-M01)

AdoptedReference Number: EMA/251320/2021