EMEA-001066-PIP01-10 - paediatric investigation plan

aciclovir

Key facts

• Active Substance:
  aciclovir
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/83/2011
• PIP number:
  EMEA-001066-PIP01-10
• Pharmaceutical form(s):
  Muco-adhesive buccal tablet
• Condition(s) / indication(s):
  • Prevention of recurrences of herpes simplex labialis
  • Treatment of recurrent herpes simplex labialis
• Route(s) of administration:
  Gingival use
• Decision type:
  RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
• Decision date:
  06/04/2011

Decision

P/83/2011: EMA decision of 6 April 2011 on the refusal of a product specific waiver for aciclovir (EMEA-001066-PIP01-10)

AdoptedReference Number: EMA/249985/2011