EMEA-001569-PIP01-13 - paediatric investigation plan

Raxibacumab

Key facts

• Active Substance:
  Raxibacumab
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0196/2015
• PIP number:
  EMEA-001569-PIP01-13
• Pharmaceutical form(s):
  Concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of bacillary infection
• Route(s) of administration:
  Intravenous use
• Contact for public enquiries:

  GlaxoSmithKline Trading Services Limited

  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:
  04/09/2015

Decision

P/0196/2015: EMA decision of 4 September 2015 on the agreement of a paediatric investigation plan and on the granting of a deferral for raxibacumab (EMEA-001569-PIP01-13)

AdoptedReference Number: EMA/571294/2015