EMEA-002444-PIP02-18 - paediatric investigation plan

Equine immunoglobulin F(ab')2 fragments targeting Shiga toxin

Key facts

• Active substance:
  Equine immunoglobulin F(ab')2 fragments targeting Shiga toxin
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0304/2019
• PIP number:
  EMEA-002444-PIP02-18
• Pharmaceutical form(s):
  Solution for infusion
• Condition(s) / indication(s):
  Prevention of haemolytic uraemic syndrome
• 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:
  10/09/2020
• Compliance check done:
  No

Decision

P/0304/2019: EMA decision of 10 September 2019 on the agreement of a paediatric investigation plan and on the granting of a deferral for equine Immunoglobulin F(ab')2 fragments targeting Shiga toxin (NEAST) (EMEA-002444-PIP02-18)

Adopted Reference Number: EMA/467522/2019