EMEA-000560-PIP03-15-M01 - paediatric investigation plan

omadacycline

Key facts

• Active substance:
  omadacycline
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0269/2018
• PIP number:
  EMEA-000560-PIP03-15-M01
• Pharmaceutical form(s):
  • Powder for concentrate for solution for infusion
  • Film-coated tablet
  • Granules
• Condition(s) / indication(s):
  Treatment of bacterial pneumonia
• Route(s) of administration:
  • Intravenous use
  • Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  16/08/2018
• Compliance check done:
  No

Decision

P/0269/2018: EMA decision of 16 August 2018 on the acceptance of a modification of an agreed paediatric investigation plan for omadacycline (EMEA-000560-PIP03-15-M01)

Adopted Reference Number: EMA/514764/2018