EMEA-002180-PIP02-19 - paediatric investigation plan

pritelivir (mesylate monohydrate)

Key facts

• Active substance:
  pritelivir (mesylate monohydrate)
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0458/2021
• PIP number:
  EMEA-002180-PIP02-19
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment and prevention of Herpes simplex virus disease
• Route(s) of administration:
  • Gastric use
  • Oral use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  29/10/2021
• Compliance check done:
  Nie

Decision

P/0458/2021 : EMA decision of 29 October 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for pritelivir (mesylate monohydrate), (EMEA-002180-PIP02-19)

Adopted Reference Number: EMA/533747/2021