EMEA-001430-PIP01-13 - paediatric investigation plan

Anti proprotein convertase subtilisin kexin type 9 humanized monoclonal antibody (PF-04950615)

Key facts

• Active Substance:
  Anti proprotein convertase subtilisin kexin type 9 humanized monoclonal antibody (PF-04950615)
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0080/2014
• PIP number:
  EMEA-001430-PIP01-13
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  • Prevention of cardiovascular events in patients with cardiovascular disease or cardiovascular disease risk equivalent
  • Treatment of mixed dyslipidaemia
  • Treatment of elevated cholesterol
• Route(s) of administration:
  Subcutaneous use
• Contact for public enquiries:

  Pfizer Limited

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

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  02/04/2014

Decision

P/0080/2014: EMA decision of 2 April 2014 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for anti proprotein convertase subtilisin kexin type 9 human...

AdoptedReference Number: EMA/52874/2014