EMEA-001740-PIP01-14 - paediatric investigation plan

vaborbactam

Key facts

• Active substance:
  vaborbactam
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0230/2015
• PIP number:
  EMEA-001740-PIP01-14
• Pharmaceutical form(s):
  Powder for solution for infusion
• Condition(s) / indication(s):
  Treatment of Gram-negative bacterial infections
• Route(s) of administration:
  Intravenous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  22/10/2015
• Compliance check done:
  No

Decision

P/0230/2015: EMA decision of 22 October 2015 on the agreement of a paediatric investigation plan and on the granting of a deferral for vaborbactam (in combination with meropenem trihydrate) (EMEA-001740-PIP01-14)

Adopted Reference Number: EMA/624852/2015