EMEA-003554-PIP01-23 - paediatric investigation plan

acetylcysteine amide

Key facts

• Active Substance:
  acetylcysteine amide
• Therapeutic area:
  Vascular disorders
• Decision number:
  P/0139/2024
• PIP number:
  EMEA-003554-PIP01-23
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  Treatment of hereditary cystatin C amyloid angiopathy
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  06/05/2024

Decision

P/0139/2024: EMA decision of 6 May 2024 on the granting of a product specific waiver for acetylcysteine amide, (EMEA-003554-PIP01-23)

Reference Number: EMA/153120/2024