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The product monograph is developed by a drug sponsor according to guidelines published by Health Canada that provide direction on the content and format. The veterinary labelling is developed by the drug sponsor according to the Food and Drug Regulations. While Health Canada reviews the product monograph or the veterinary labelling as part of the drug review process, it remains the responsibility of the drug sponsor to ensure that the product monograph or the veterinary labelling is complete and accurate.

Current status:

Marketed

Current status date:

2021-01-25

Original market date: See footnote 1

2021-01-25

Product name:

VPI-AMIKACIN

Description:

SINGLE USE VIAL

Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section .

DIN:

02506599

Product Monograph/Veterinary Labelling:

Date: 2020-10-13 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company: 

VPI PHARMACEUTICALS INC
16,667 Boul. Hymus
Kirkland
Quebec
Canada  H9H 4R9

Class: 

Human

Dosage form(s):

Solution

Route(s) of administration:

Intravenous,  Intramuscular

Number of active ingredient(s):

1

Schedule(s):

Prescription  

Biosimilar Biologic Drug:

No

American Hospital Formulary Service (AHFS): See footnote 3

08:12.02   AMINOGLYCOSIDES

Anatomical Therapeutic Chemical (ATC): See footnote 4

J01GB06  AMIKACIN

Active ingredient group (AIG) number:See footnote 5

0111922001

List of active ingredient(s)
Active ingredient(s) Strength
AMIKACIN (AMIKACIN SULFATE) 500 MG / 2 ML

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