EMEA-002760-PIP01-19 - paediatric investigation plan

rucaparib camsylate

Key facts

• Invented name:
  Rubraca
• Active substance:
  rucaparib camsylate
• Therapeutic area:
  Oncology
• Decision number:
  P/0242/2020
• PIP number:
  EMEA-002760-PIP01-19
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  • Treatment of fallopian tube cancer
  • Treatment of ovarian cancer
  • Treatment of primary peritoneal cancer
  • 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:
  22/06/2020
• Compliance check done:
  Non

Decision

P/0242/2020: EMA decision of 22 June 2020 on the granting of a product specific waiver for rucaparib (camsylate), (EMEA-002760-PIP01-19)

Adopted Reference Number: EMA/324759/2020