EMEA-000726-PIP01-09-M02 - paediatric investigation plan

valganciclovir

Key facts

• Invented name:
  Valcyte and associated names
• Active substance:
  valganciclovir
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0220/2013
• PIP number:
  EMEA-000726-PIP01-09-M02
• Pharmaceutical form(s):
  • Film-coated tablet
  • Powder for oral solution
• Condition(s) / indication(s):
  • Prevention of infection due to cytomegalovirus in solid-organ-transplant recipients
  • Treatment of infection due to cytomegalovirus in immunocompromised patients
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  06/09/2013
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-000726-PIP01-09-M02
• Compliance opinion date:
  11/10/2013
• Compliance outcome:
  Positive

Decision

P/0220/2013: EMA decision of 6 September 2013 on the acceptance of a modification of an agreed paediatric investigation plan for valganciclovir (Valcyte and associated names), (EMEA-000726-PIP01-09-M02)

Adopted Reference Number: EMA/496855/2013