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:
2010-12-02
Original market date: See footnote 1
2010-12-02
Product name:
SAIZEN
Description:
12MG/CARTRIDGE
DIN:
02350130
Product Monograph/Veterinary Labelling:
Date:
2020-06-08
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
EMD SERONO, A DIVISION OF EMD INC., CANADA
2695 North Sheridan Way, Suite 200
Mississauga
Ontario
Canada
L5K 2N6
Class:
Human
Dosage form(s):
Solution
Route(s) of administration:
Subcutaneous
Number of active ingredient(s):
1
Schedule(s):
Schedule D , Prescription
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
0131827013
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| SOMATROPIN | 8 MG / ML |
Risk Management Plans See footnote 7
A Risk Management Plan (RMP) for this product was submitted.
| Pharmacovigilance/Monitoring Activity |
|---|
| Clinical Trials |