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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:

Approved

Current status date:

2009-04-20

Product name:

OMNITROPE

Description:

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:

02325055

Product Monograph/Veterinary Labelling:

Date: 2015-05-08 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):

Kit,  Powder For Solution

Route(s) of administration:

Subcutaneous

Number of active ingredient(s):

2

Schedule(s):

Prescription,  Schedule D  

Biosimilar Biologic Drug:

Yes

American Hospital Formulary Service (AHFS): See footnote 3

68:28.00   PITUITARY

Anatomical Therapeutic Chemical (ATC): See footnote 4

H01AC01  SOMATROPIN

Active ingredient group (AIG) number:See footnote 5

0228557006

List of active ingredient(s)
Active ingredient(s) Strength
SOMATROPIN 5.8 MG / VIAL
WATER 1.14 ML / CARTRIDGE

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