EMEA-001080-PIP01-10 - paediatric investigation plan

Delafloxacin

Key facts

• Active Substance:
  Delafloxacin
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0148/2018
• PIP number:
  EMEA-001080-PIP01-10
• Pharmaceutical form(s):
  • Powder for solution for infusion
  • Capsule (hard)
  • Tablet
• Condition(s) / indication(s):
  Treatment of local infections of skin and subcutaneous tissues
• Route(s) of administration:
  • Intravenous use
  • Oral use
• Contact for public enquiries:

  A.Menarini - IndustrieFarmaceutiche Riunite - s.r.I.

  E-mail: [e-mail]; Tel. [phone]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  18/05/2018

Decision

P/0148/2018: EMA decision of 18 May 2018 on the review of a granted waiver for delafloxacin (EMEA-001080-PIP01-10)

AdoptedReference Number: EMA/267331/2018