EMEA-002811-PIP01-20 - paediatric investigation plan

alpha-R-lipoic acid choline ester tosilate

Key facts

• Active Substance:
  alpha-R-lipoic acid choline ester tosilate
• Therapeutic area:
  Ophthalmology
• Decision number:
  P/0413/2020
• PIP number:
  EMEA-002811-PIP01-20
• Pharmaceutical form(s):
  Eye drops
• Condition(s) / indication(s):
  Treatment of presbyopia
• Route(s) of administration:
  Ocular use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  23/10/2020

Decision

P/0413/2020 : EMA decision of 23 October on the granting of a product specific waiver for alpha-R-lipoic acid choline ester tosilate (EMEA-002811-PIP01-20)

AdoptedReference Number: EMA/539383/2020