EMEA-000292-PIP01-08-M03 - paediatric investigation plan

alipogene tiparvovec

Key facts

• Invented name:
  • Glybera
  • Glybera
• Active Substance:
  alipogene tiparvovec
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0285/2016
• PIP number:
  EMEA-000292-PIP01-08-M03
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of hyperchylomicronaemia
• Route(s) of administration:
  Intramuscular use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  04/11/2016

Decision

P/0285/2016: EMA decision of 4 November 2016 on the acceptance of a modification of an agreed paediatric investigation plan for alipogene tiparvovec (Glybera), (EMEA-000292-PIP01-08-M03)

Reference Number: EMA/639652/2016