EMEA-000120-PIP01-07-M05 - paediatric investigation plan

tigecycline

Key facts

• Invented name:
  • Tygacil
  • Tygacil
• Active substance:
  tigecycline
• Therapeutic area:
  Other
• Decision number:
  P/0292/2014
• PIP number:
  EMEA-000120-PIP01-07-M05
• Pharmaceutical form(s):
  Powder for solution for infusion
• Condition(s) / indication(s):
  • Treatment of complicated intra-abdominal infections
  • 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:
  24/10/2014
• Compliance check done:
  Tak
• Compliance procedure number:
  EMEA-C-000120-PIP01-07-M05
• Compliance opinion date:
  12/12/2014
• Compliance outcome:
  Positive

Decision

P/0292/2014: EMA decision of 24 October 2014 on the acceptance of a modification of an agreed paediatric investigation plan for tigecycline (Tygacil), (EMEA-000120-PIP01-07-M05)

Reference Number: EMA/640003/2014