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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:

2020-10-27

Original market date: See footnote 1

2020-10-27

Product name:

OSNUVO

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:

02495589

Product Monograph/Veterinary Labelling:

Date: 2020-01-13 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company: 

AVIR PHARMA INC.
660 Boulevard Industriel
Blainville
Quebec
Canada  J7C 3V4

Class: 

Human

Dosage form(s):

Solution

Route(s) of administration:

Subcutaneous

Number of active ingredient(s):

1

Schedule(s):

Schedule D,  Prescription  

Biosimilar Biologic Drug:

Yes

American Hospital Formulary Service (AHFS): See footnote 3

92:22.00   BONE ANABOLIC AGENTS ,  68:24.08   PARATHYROID AGENTS

Anatomical Therapeutic Chemical (ATC): See footnote 4

H05AA02  TERIPARATIDE

Active ingredient group (AIG) number:See footnote 5

0150152001

List of active ingredient(s)
Active ingredient(s) Strength
TERIPARATIDE 250 MCG / ML

Application information

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