EMEA-001880-PIP02-19-M03

Table of contents

Key facts

Invented name
Byfavo
Active substance
Remimazolam (as besilate)
Therapeutic area
Anaesthesiology
Decision number
P/0427/2021
PIP number
EMEA-001880-PIP02-19-M03
Pharmaceutical form(s)
  • Powder for solution for injection or infusion
  • Orodispersible film
  • Age-appropriate formulation
Condition(s) / indication(s)
  • General anaesthesia
  • Sedation
Route(s) of administration
  • Intravenous use
  • Buccal use
Contact for public enquiries
PAION Deutschland GmbH

E-mail: info@paion.com
Tel: +49 2414453128

Decision type
PM: decision on the application for modification of an agreed PIP

Decision

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