EMEA-001518-PIP03-19 - paediatric investigation plan

eflornithine hydrochloride

sulindac

Key facts

• Active substance:
  • eflornithine hydrochloride
  • sulindac
• Therapeutic area:
  Oncology
• Decision number:
  P/0419/2019
• PIP number:
  EMEA-001518-PIP03-19
• Pharmaceutical form(s):
  Coated tablet
• Condition(s) / indication(s):
  Treatment of Familial Adenomatous Polyposis
• Route(s) of administration:
  Oral use
• Decision type:
  RP: decision refers to a refusal on a proposed Paediatric Investigation Plan
• Decision date:
  06/12/2019
• Compliance check done:
  No

Decision

P/0419/2019: EMA decision of 6 December 2019 on the refusal of a paediatric investigation plan and on the refusal of a deferral and on the granting of a waiver for eflornithine (hydrochloride monohydrate) / sulindac (EMEA-001518-PIP03-19)

Adopted Reference Number: EMA/631881/2019