EMEA-001080-PIP03-18 - paediatric investigation plan

Delafloxacin

Key facts

• Active Substance:
  Delafloxacin
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0125/2019
• PIP number:
  EMEA-001080-PIP03-18
• Pharmaceutical form(s):
  • Powder for concentrate for solution for infusion
  • Tablet
• Condition(s) / indication(s):
  Treatment of community-acquired pneumonia
• Route(s) of administration:
  • Oral use
  • Intravenous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  17/04/2019

Decision

P/0125/2019: EMA decision of 17 April 2019 on the granting of a product specific waiver for delafloxacin (EMEA-001080-PIP03-18)

AdoptedReference Number: EMA/215324/2019