EMEA-002506-PIP03-21 - paediatric investigation plan

human monoclonal antibody targeting Staphylococcus aureus alpha-toxin (tosatoxumab)

Key facts

• Active Substance:
  human monoclonal antibody targeting Staphylococcus aureus alpha-toxin (tosatoxumab)
• Therapeutic area:
  • Infectious diseases
  • Pneumology-allergology
• Decision number:
  P/0563/2021
• PIP number:
  EMEA-002506-PIP03-21
• Pharmaceutical form(s):
  Solution for infusion
• Condition(s) / indication(s):
  Treatment of Staphylococcus aureus pneumonia
• 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:
  31/12/2021

Decision

P/0563/2021 : EMA decision of 31 December 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral for tosatoxumab (EMEA-002506-PIP03-21)

AdoptedReference Number: EMA/705997/2021