EMEA-001134-PIP01-11 - paediatric investigation plan

chimeric monoclonal anti-Shiga toxin antibodies cαStx1 and cαStx2

Key facts

• Active substance:
  chimeric monoclonal anti-Shiga toxin antibodies cαStx1 and cαStx2
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/308/2011
• PIP number:
  EMEA-001134-PIP01-11
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Prevention of Shiga toxin-mediated complications
• Route(s) of administration:
  Intravenous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  20/12/2011
• Compliance check done:
  Nej

Decision

P/308/2011: EMA decision of 20 December 2011 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the refusal of a waiver for chimeric monoclonal anti-Shiga toxin (Stx) antibodies ...

Adopted Reference Number: EMA/954001/2011