EMEA-001548-PIP01-13 - paediatric investigation plan

valaciclovir (hydrochloride)

Key facts

• Active substance:
  valaciclovir (hydrochloride)
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0207/2014
• PIP number:
  EMEA-001548-PIP01-13
• Pharmaceutical form(s):
  Powder for oral suspension
• Condition(s) / indication(s):
  • Treatment and prevention of Herpes simplex virus disease
  • Treatment and prevention of Varicella Zoster virus disease
• Route(s) of administration:
  Oral use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  08/08/2014
• Compliance check done:
  No

Decision

P/0207/2014: EMA decision of 8 August 2014 on the agreement of a paediatric investigation plan and on the granting of a waiver for valaciclovir (hydrochloride) (EMEA-001548-PIP01-13)

Adopted Reference Number: EMA/433934/2014