EMEA-001256-PIP02-12-M02 - paediatric investigation plan

phenylephrine hydrochloride

ketorolac trometamol (OMS302)

Key facts

• Active substance:
  • phenylephrine hydrochloride
  • ketorolac trometamol (OMS302)
• Therapeutic area:
  Ophthalmology
• Decision number:
  P/0362/2018
• PIP number:
  EMEA-001256-PIP02-12-M02
• Pharmaceutical form(s):
  • Concentrate for solution for injection
  • Irrigation solution
• Condition(s) / indication(s):
  Lens therapeutic procedures
• Route(s) of administration:
  • Intraocular use
  • Ocular use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  07/12/2018
• Compliance check done:
  No

Decision

P/0362/2018: EMA decision of 7 December 2018 on the acceptance of a modification of an agreed paediatric investigation plan for phenylephrine hydrochloride / ketorolac trometamol (OMS302) (EMEA-001256-PIP02-12-M02)

Adopted Reference Number: EMA/710628/2018