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:
Marketed
Current status date:
2009-04-20
Original market date: See footnote 1
2009-04-20
Product name:
OMNITROPE
Description:
CARTRIDGE
DIN:
02325063
Product Monograph/Veterinary Labelling:
Date:
2024-05-23
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):
Solution
Route(s) of administration:
Subcutaneous
Number of active ingredient(s):
1
Schedule(s):
Prescription , Schedule D
Biosimilar Biologic Drug:
Yes
American Hospital Formulary Service (AHFS): See footnote 3
68:28.00
Anatomical Therapeutic Chemical (ATC): See footnote 4
H01AC01 SOMATROPIN
Active ingredient group (AIG) number:See footnote5
0131827010
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| SOMATROPIN | 5 MG / 1.5 ML |