EMEA-002789-PIP01-20 - paediatric investigation plan

Niraparib (tosilate monohydrate)

abiraterone acetate

Key facts

• Active Substance:
  • Niraparib (tosilate monohydrate)
  • abiraterone acetate
• Therapeutic area:
  Oncology
• Decision number:
  P/0244/2020
• PIP number:
  EMEA-002789-PIP01-20
• Pharmaceutical form(s):
  Film-coated tablet
• 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:
  15/07/2021

Decision

P/0244/2020: EMA decision of 15 July 2020 on the granting of a product specific waiver for niraparib (tosylate monohydrate) / abiraterone (acetate) (EMEA-002789-PIP01-20)

AdoptedReference Number: EMEA-002789-PIP01-20