EMEA-001831-PIP01-15 - paediatric investigation plan

Monoclonal IgG1 anti-influenza A antibody

Key facts

• Active Substance:
  Monoclonal IgG1 anti-influenza A antibody
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0300/2016
• PIP number:
  EMEA-001831-PIP01-15
• Pharmaceutical form(s):
  Concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of influenza
• Route(s) of administration:
  Intravenous use
• Contact for public enquiries:

  Roche Products Limited

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

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  04/11/2016

Decision

P/0300/2016: EMA decision of 4 November 2016 on the agreement of a paediatric investigation plan and on the granting of a deferral for monoclonal IgG1 anti-influenza A antibody (EMEA-001831-PIP01-15)

AdoptedReference Number: EMA/639659/2016