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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:

2020-10-21

Original market date: See footnote 1

2020-10-21

Product name:

TORPHADINE

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:

02496402

Product Monograph/Veterinary Labelling:

Date: 2020-02-25 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company: 

DECHRA REGULATORY BV
Handelsweg 25
Bladel
--
Netherlands  5531 AE

Class: 

Veterinary

Species:

Horses

Dosage form(s):

Solution

Route(s) of administration:

Intravenous

Number of active ingredient(s):

1

Schedule(s):

Schedule G (CDSA IV)  

Biosimilar Biologic Drug:

No

American Hospital Formulary Service (AHFS): See footnote 3

Not Applicable

Anatomical Therapeutic Chemical (ATC): See footnote 4

Not Applicable

Active ingredient group (AIG) number:See footnote 5

0131407001

List of active ingredient(s)
Active ingredient(s) Strength
BUTORPHANOL (BUTORPHANOL TARTRATE) 10 MG / ML

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