EMEA-000015-PIP01-07-M04 - paediatric investigation plan

Doripenem monohydrate

Key facts

• Invented name:
  • Doribax
  • Doribax
• Active Substance:
  Doripenem monohydrate
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0071/2012
• PIP number:
  EMEA-000015-PIP01-07-M04
• Pharmaceutical form(s):
  Intravenous use
• Condition(s) / indication(s):
  Treatment of bacterial infections
• Route(s) of administration:
  Intravenous use
• Contact for public enquiries:

  Shionogi Limited

  E-mail: [e-mail]; Tel. [phone]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  21/04/2012

Decision

P/0071/2012: EMA decision of 24 April 2012 on the acceptance of a modification of an agreed paediatric investigation plan for doripenem (monohydrate) (Doribax), (EMEA-000015-PIP01-07-M04)

AdoptedReference Number: EMA/202883/2012