EMEA-001324-PIP01-12-M01 - paediatric investigation plan

glibenclamide

Key facts

• Active Substance:
  glibenclamide
• Therapeutic area:
  Other
• Decision number:
  P/0072/2015
• PIP number:
  EMEA-001324-PIP01-12-M01
• Pharmaceutical form(s):
  Oral suspension
• Condition(s) / indication(s):
  Treatment of neonatal diabetes mellitus
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  01/04/2015

Decision

P/0072/2015: EMA decision of 1 April 2015 on the acceptance of a modification of an agreed paediatric investigation plan for glibenclamide (EMEA-001324-PIP01-12-M01)

AdoptedReference Number: EMA/137572/2015