EMEA-000322-PIP01-08-M06 - paediatric investigation plan

cysteamine hydrochloride

Key facts

• Invented name:
  • Cystadrops
  • Cystadrops
• Active substance:
  cysteamine hydrochloride
• Therapeutic area:
  Ophthalmology
• Decision number:
  P/0019/2022
• PIP number:
  EMEA-000322-PIP01-08-M06
• Pharmaceutical form(s):
  Eye drops, solution
• Condition(s) / indication(s):
  Treatment of corneal cystine crystal deposits in cystinosis
• Route(s) of administration:
  Ocular use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  03/02/2022
• Compliance check done:
  Da
• Compliance procedure number:
  EMEA-C-000322-PIP01-08-M06
• Compliance opinion date:
  08/09/2023
• Compliance outcome:
  Positive

Decision

P/0019/2022 : EMA decision of 3 February 2022 on the acceptance of a modification of an agreed paediatric investigation plan for cysteamine (hydrochloride) (Cystadrops), (EMEA-000322-PIP01-08-M06)

Adopted Reference Number: EMA/782279/2021