MHRA-100262-PIP01-21-M01 (update)

Key Facts

PIPS Key Facts
Active Substance
Active Substance:
Invented Name
  • Xydalba
  • Xydalba
  • Dalvance
  • Xydalba
PIP Number MHRA-100262-PIP01-21-M01 (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
  • Allergan Pharmaceuticals International Limited
  • Country Ireland
  • Tel 01628644174
  • Email
Decision Type
Decision Type
PM: decision on the application for modification of an agreed paediatric investigation plan.
Compliance Check
Compliance Check
Compliance Check Decision Date
Compliance opinion date
Compliance Check Procedure Number
Compliance procedure number

Decision Document

PIPS Decision Documents
Decision Document Decision Document on a Paediatric Investigation Plan (PIP):DALBAVANCIN HYDROCHLORIDE.pdf
Published Date 17/05/2022