EMEA-002040-PIP01-16 - paediatric investigation plan

Apolipoprotein A-1

Key facts

• Active Substance:
  Apolipoprotein A-1
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0040/2017
• PIP number:
  EMEA-002040-PIP01-16
• Pharmaceutical form(s):
  Powder for solution for infusion
• Condition(s) / indication(s):
  Treatment of acute myocardial infarction
• Route(s) of administration:
  Intravenous use
• Contact for public enquiries:

  CSL Behring GmbH

  Germany; Tel. [phone]; Fax [phone]; E-mail: [e-mail]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  31/01/2017

Decision

P/0040/2017: European Medicines Agency decision of 31 January 2017 on the granting of a product specific waiver for apolipoprotein A-1 (EMEA-002040-PIP01-16)

AdoptedReference Number: EMA/38346/2017