EMEA-003561-PIP01-23 - paediatric investigation plan

carbachol

brimonidine tartrate

Key facts

• Active substance:
  • carbachol
  • brimonidine tartrate
• Therapeutic area:
  Eye disorders
• Decision number:
  P/0160/2024
• PIP number:
  EMEA-003561-PIP01-23
• Pharmaceutical form(s):
  Eye drops, solution
• Condition(s) / indication(s):
  Treatment of presbyopia
• Route(s) of administration:
  Ophthalmic use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  06/05/2024
• Compliance check done:
  No

Decision

P/0160/2024: EMA decision of 6 May 2024 on the granting of a product specific waiver for carbachol / brimonidine tartrate (EMEA-003561-PIP01- 23)

Adopted Reference Number: EMA/176533/2024