EMEA-002545-PIP01-19-M01 - paediatric investigation plan

atropine sulfate

Key facts

• Active substance:
  atropine sulfate
• Therapeutic area:
  Ophthalmology
• Decision number:
  P/0416/2022
• PIP number:
  EMEA-002545-PIP01-19-M01
• Pharmaceutical form(s):
  Eye drops
• Condition(s) / indication(s):
  Treatment of myopia
• Route(s) of administration:
  Ocular use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  28/10/2022
• Compliance check done:
  No

Decision

P/0416/2022 : EMA decision of 28 October 2022 on the acceptance of a modification of an agreed paediatric investigation plan for atropine (sulphate) (EMEA-002545-PIP01-19-M01)

Adopted Reference Number: EMA/777575/2022