MHRA-100130-PIP01-21-M01 (update)

Key Facts

Active Substance
Active Substance:
  • BUPIVACAINE
Invented Name
  • EXPAREL liposomal
  • EXPAREL
  • EXPAREL
  • EXPAREL
  • EXPAREL
  • EXPAREL
  • EXPAREL
PIP Number MHRA-100130-PIP01-21-M01 (update)
Pharmaceutical form(s)
  • Prolonged release dispersion for injection
  • Suspension for injection
Therapeutic area
Therapeutic area:
  • Pain
Conditions / Indications
Conditions / Indications:
  • Postsurgical analgesia
Route(s) of administration
  • Infiltration use
  • Perineural use
PIP applicant
Decision Type
Decision Type
PM: decision on the application for modification of an agreed paediatric investigation plan.
Compliance Check
Compliance Check
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):BUPIVACAINE.pdf
Published Date 29/07/2022