EMEA-000444-PIP01-08 - paediatric investigation plan

dexamethasone

ciprofloxacin hydrochloride

Key facts

• Active Substance:
  • dexamethasone
  • ciprofloxacin hydrochloride
• Therapeutic area:
  Oto-rhino-laryngology
• Decision number:
  P/112/2009
• PIP number:
  EMEA-000444-PIP01-08
• Pharmaceutical form(s):
  Ear drops, suspension
• Condition(s) / indication(s):
  • Other infective otitis externa
  • Otitis media, unspecified
• Route(s) of administration:
  Auricular use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  15/06/2009

Decision

P/112/2009: European Medicines Agency decision of 15 June 2009 on the agreement of a Paediatric Investigation Plan and on the granting of a waiver for dexamethasone/ciprofloxacin hydrochloride (EMEA-000444-PIP01-08) in a...

AdoptedReference Number: EMEA/347310/2009