EMEA-002375-PIP02-18 - paediatric investigation plan

Dexamethasone (sodium phosphate)

levofloxacin

Key facts

• Active Substance:
  • Dexamethasone (sodium phosphate)
  • levofloxacin
• Therapeutic area:
  Oto-rhino-laryngology
• Decision number:
  P/0242/2019
• PIP number:
  EMEA-002375-PIP02-18
• Pharmaceutical form(s):
  Ear drops, solution
• Condition(s) / indication(s):
  Treatment of acute otitis externa
• Route(s) of administration:
  Auricular use
• Decision type:
  RP: decision refers to a refusal on a proposed Paediatric Investigation Plan
• Decision date:
  17/07/2019

Decision

P/0242/2019: EMA decision of 17 July 2019 on the refusal of a paediatric investigation plan and on the granting of a waiver for dexamethasone (sodium phosphate) / levofloxacin (EMEA-002375-PIP02-18)

AdoptedReference Number: EMA/364992/2019