EMEA-000239-PIP01-08-M03 - paediatric investigation plan

telavancin hydrochloride

Key facts

• Invented name:
  • Vibativ
  • Vibativ
• Active substance:
  telavancin hydrochloride
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0354/2017
• PIP number:
  EMEA-000239-PIP01-08-M03
• Pharmaceutical form(s):
  Powder for concentrate for solution for infusion
• Condition(s) / indication(s):
  • Treatment of nosocomial pneumonia
  • Treatment of complicated skin and soft tissue infections (cSSTI)
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  01/12/2017
• Compliance check done:
  No

Decision

P/0354/2017: EMA decision of 1 December 2017 on the acceptance of a modification of an agreed paediatric investigation plan for telavancin (hydrochloride) (Vibativ), (EMEA-000239-PIP01-08-M03)

Adopted Reference Number: EMA/763133/2017