MHRA-100262-PIP01-21-M02 (update)

Key Facts

Active Substance
Active Substance:
  • DALBAVANCIN HYDROCHLORIDE
Invented Name
  • Xydalba
  • Xydalba
  • Xydalba
PIP Number MHRA-100262-PIP01-21-M02 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Powder for concentrate for solution for infusion
Therapeutic area
Therapeutic area:
  • Infectious diseases
Conditions / Indications
Conditions / Indications:
  • Treatment of acute bacterial skin and skin structure infections (ABSSSI)
Route(s) of administration
Route(s) of administration:
  • Intravenous use
PIP applicant
Decision Type
Decision Type
PM: decision on the application for modification of an agreed paediatric investigation plan.
Compliance Check
Compliance Check
Yes
Compliance Check Decision Date
Compliance opinion date
05/12/2024
Compliance Check Procedure Number
Compliance procedure number
MHRA-100262-PIP01-21-M02 -C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):DALBAVANCIN HYDROCHLORIDE.pdf
Published Date 14/04/2026