EMEA-000016-PIP01-07-M09 - paediatric investigation plan

dalbavancin hydrochloride

Key facts

• Invented name:
  Xydalba
• Active substance:
  dalbavancin hydrochloride
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0467/2023
• PIP number:
  EMEA-000016-PIP01-07-M09
• Pharmaceutical form(s):
  Powder for concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of acute bacterial skin and skin structure infections
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  01/12/2023
• Compliance check done:
  Igen
• Compliance procedure number:
  EMEA-C-000016-PIP01-07-M09
• Compliance opinion date:
  06/09/2024
• Compliance outcome:
  Positive

Decision

P/0467/2023 : EMA decision of 1 December 2023 on the acceptance of a modification of an agreed paediatric investigation plan for dalbavancin hydrochloride (Xydalba), (EMEA-000016-PIP01-07-M09)

Adopted Reference Number: EMA/512491/2023