Product information

From Health Canada

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:

Cancelled Post Market

Current status date:

2021-04-16

Original market date: See footnote 1

2003-04-10

Lot number: See footnote 2

BY8309

Expiry date: See footnote 2

2013-10-31

Product name:

METHYLPREDNISOLONE ACETATE INJECTABLE SUSPENSION USP -(80MG/ML WITH PRESERVATIVE)

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:

02245408

Product Monograph/Veterinary Labelling:

Date: 2017-06-12 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company:

SANDOZ CANADA INCORPORATED
110 Rue De Lauzon
Boucherville
Quebec
Canada J4B 1E6

Class:

Human

Dosage form(s):

Suspension

Route(s) of administration:

Intramuscular ,  Soft Tissue Injection ,  Intrasynovial ,  Intra-Articular

Number of active ingredient(s):

1

Schedule(s):

Prescription

 

American Hospital Formulary Service (AHFS): See footnote 3

68:04.00 

Anatomical Therapeutic Chemical (ATC): See footnote 4

H02AB04 METHYLPREDNISOLONE

Active ingredient group (AIG) number:See footnote5

0106292004

List of active ingredient(s)
Active ingredient(s) See footnote8 Strength
METHYLPREDNISOLONE ACETATE 80 MG / ML
Version 4.0.3

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