MHRA-100553-PIP01-22-M01 (update)

Key Facts

Active Substance
Active Substance:
  • REMIMAZOLAM BESYLATE
Invented Name
  • Byfavo 20mg
  • Anerem
  • Byfavo
  • Byfavo
  • Byfavo
PIP Number MHRA-100553-PIP01-22-M01 (update)
Pharmaceutical form(s)
  • Orodispersible film
  • Powder for solution for injection/infusion
  • Age-appropriate formulation
Therapeutic area
Therapeutic area:
  • Anaesthesiology
Conditions / Indications
  • Sedation
  • General Anaesthesia
Route(s) of administration
  • Buccal use
  • INTRAVENOUS USE
PIP applicant
  • PAION UK LIMITED
  • Country Germany
  • Tel +4924144530
  • Email info@paion.com
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
04/04/2023
Compliance Check Procedure Number
Compliance procedure number
MHRA-100553-PIP01-22-M01-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):REMIMAZOLAM BESYLATE.pdf
Published Date 30/06/2023