EMEA-000769-PIP01-09-M08 - paediatric investigation plan

ceftaroline fosamil

Key facts

• Invented name:
  • Zinforo
  • Zinforo
• Active substance:
  ceftaroline fosamil
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0176/2018
• PIP number:
  EMEA-000769-PIP01-09-M08
• Pharmaceutical form(s):
  Powder for concentrate for solution for infusion
• Condition(s) / indication(s):
  • Treatment of community-acquired pneumonia
  • Treatment of complicated skin and soft-tissue infections
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  15/06/2018
• Compliance check done:
  Igen
• Compliance procedure number:
  EMEA-C-000769-PIP01-09-M08
• Compliance opinion date:
  19/10/2018
• Compliance outcome:
  Positive

Decision

P/0176/2018: EMA decision of 15 June 2018 on the acceptance of a modification of an agreed paediatric investigation plan for ceftaroline fosamil (Zinforo), (EMEA-000769-PIP01-09-M08)

Adopted Reference Number: EMA/381903/2018