EMEA-001211-PIP01-11-M02 - paediatric investigation plan

Levofloxacin hemihydrate

Key facts

• Active substance:
  Levofloxacin hemihydrate
• Therapeutic area:
  Pneumology-allergology
• Decision number:
  P/0511/2020
• PIP number:
  EMEA-001211-PIP01-11-M02
• Pharmaceutical form(s):
  Nebuliser suspension
• Condition(s) / indication(s):
  Treatment of cystic fibrosis
• Route(s) of administration:
  Inhalation use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  22/12/2020
• Compliance check done:
  No

Decision

P/0511/2020 : EMA decision of 22 December 2020 on the acceptance of a modification of an agreed paediatric investigation plan for levofloxacin (hemihydrate) (EMEA-001211-PIP01-11-M02)

Adopted Reference Number: EMA/654063/2020