EMEA-001311-PIP01-12-M01 - paediatric investigation plan

vancomycin

Key facts

• Active substance:
  vancomycin
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0026/2016
• PIP number:
  EMEA-001311-PIP01-12-M01
• Pharmaceutical form(s):
  Powder for concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of bacterial sepsis
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  26/01/2016
• Compliance check done:
  No

Decision

P/0026/2016: EMA decision of 29 January 2016 on the acceptance of a modification of an agreed paediatric investigation plan for vancomycin (EMEA-001311-PIP01-12-01-M01)

Adopted Reference Number: EMA/3765/2016 corr