EMEA-001268-PIP01-12-M05 - paediatric investigation plan

Evolocumab

Key facts

• Invented name:
  • Repatha
  • Repatha
• Active Substance:
  Evolocumab
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0104/2018
• PIP number:
  EMEA-001268-PIP01-12-M05
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  • Treatment of elevated cholesterol
  • Treatment of mixed dyslipidaemia
• Route(s) of administration:
  Subcutaneous use
• Contact for public enquiries:

  Amgen Europe B.V

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

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  11/04/2018
• Compliance procedure number:
  EMEA-C-001268-PIP01-12-M05
• Compliance opinion date:
  24/06/2022
• Compliance outcome:
  Positive

Decision

P/0105/2018: EMA decision of 11 April 2018 on the acceptance of a modification of an agreed paediatric investigation plan for evolocumab (Repatha), (EMEA-001268-PIP01-12-M05)

AdoptedReference Number: EMA/194970/2018