EMEA-001394-PIP01-12 - paediatric investigation plan

Clostridium difficile toxin A human monoclonal antibody

Clostridium difficile toxin B human monoclonal antibody

Key facts

• Active Substance:
  • Clostridium difficile toxin A human monoclonal antibody
  • Clostridium difficile toxin B human monoclonal antibody
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0243/2013
• PIP number:
  EMEA-001394-PIP01-12
• Pharmaceutical form(s):
  Concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of Clostridium difficile infection
• Route(s) of administration:
  Intravenous use
• Contact for public enquiries:

  Merck Sharp & Dohme (Europe), Inc.

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

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  21/09/2013

Decision

P/0243/2013: EMA decision of 27 September 2013 on the agreement of a paediatric investigation plan and on the granting of a deferral for Clostridium difficile toxin A human monoclonal antibody / Clostridium difficile tox...

AdoptedReference Number: EMA/582624/2013