EMEA-003031-PIP01-21 - paediatric investigation plan

Dexamethasone (sodium phosphate)

ofloxacin

Key facts

• Active substance:
  • Dexamethasone (sodium phosphate)
  • ofloxacin
• Therapeutic area:
  Ophthalmology
• Decision number:
  P/0448/2021
• PIP number:
  EMEA-003031-PIP01-21
• Pharmaceutical form(s):
  Eye drops, solution
• Condition(s) / indication(s):
  Prevention and treatment of ocular infections, inflammations and associated manifestations
• Route(s) of administration:
  Ocular use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  29/10/2021
• Compliance check done:
  No

Decision

P/0448/2021 : EMA decision of 29 October 2021 on the granting of a product specific waiver for dexamethasone (sodium phosphate) / ofloxacin (EMEA-003031-PIP01-21)

Adopted Reference Number: EMA/522267/2021