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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:

2021-01-05

Original market date: See footnote 1

2020-02-10

Product name:

ERTAPENEM FOR INJECTION

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:

02490773

Product Monograph/Veterinary Labelling:

Date: 2020-05-06 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company: 

JUNO PHARMACEUTICALS CORP.
402  2233 Argentia Road
Mississauga
Ontario
Canada  L5N 2X7

Class: 

Human

Dosage form(s):

Powder For 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

08:12.07.08   CARBAPENEMS

Anatomical Therapeutic Chemical (ATC): See footnote 4

J01DH03  ERTAPENEM

Active ingredient group (AIG) number:See footnote 5

0149104002

List of active ingredient(s)
Active ingredient(s) Strength
ERTAPENEM (ERTAPENEM SODIUM) 1 G / VIAL

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