EMEA-002375-PIP01-18 - paediatric investigation plan

levofloxacin

dexamethasone

Key facts

• Active Substance:
  • levofloxacin
  • dexamethasone
• Therapeutic area:
  Ophthalmology
• Decision number:
  P/0277/2018
• PIP number:
  EMEA-002375-PIP01-18
• Pharmaceutical form(s):
  Eye drops, solution in single-dose container
• Condition(s) / indication(s):
  Prevention and treatment of inflammation and prevention of infection associated with cataract surgery
• Route(s) of administration:
  Ocular use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  12/09/2018

Decision

P/0277/2018: EMA decision of 12 September 2018 on the granting of a product specific waiver for levofloxacin / dexamethasone (EMEA-002375-PIP01-18)

Reference Number: EMA/517237/2018 Corr.