EMEA-001867-PIP01-15 - paediatric investigation plan

Humanised IgG4 monoclonal antibody against extracellular tau (BMS-986168)

Key facts

• Active Substance:
  Humanised IgG4 monoclonal antibody against extracellular tau (BMS-986168)
• Therapeutic area:
  Neurology
• Decision number:
  P/0041/2016
• PIP number:
  EMEA-001867-PIP01-15
• Pharmaceutical form(s):
  Solution for infusion
• Condition(s) / indication(s):
  Treatment of progressive supranuclear palsy
• Route(s) of administration:
  Intravenous use
• Contact for public enquiries:

  Biogen Idec Ltd

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

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  19/02/2016

Decision

P/0041/2016: EMA decision of 9 February 2016 on the granting of a product specific waiver for humanised IgG4 monoclonal antibody against extracellular tau (BMS-986168) (EMEA-001867-PIP01-15)

AdoptedReference Number: EMA/103424/2016