EMEA-001226-PIP01-11-M01 - paediatric investigation plan

surotomycin

Key facts

• Active substance:
  surotomycin
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0019/2015
• PIP number:
  EMEA-001226-PIP01-11-M01
• Pharmaceutical form(s):
  • Tablet
  • Age appropriate oral solid dosage form
• Condition(s) / indication(s):
  Treatment of clostridia infections
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  30/01/2015
• Compliance check done:
  No

Decision

P/0019/2015: EMA decision of 30 January 2015 on the acceptance of a modification of an agreed paediatric investigation plan for surotomycin (EMEA-001226-PIP01-11-M01)

Adopted Reference Number: EMA/779669/2014