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:

6MG/CARTRIDGE

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:

02350122

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

0131827003

List of active ingredient(s)
Active ingredient(s) Strength
SOMATROPIN 5.83 MG / ML

Risk Management Plans See footnote 7

A Risk Management Plan (RMP) for this product was submitted.

Pharmacovigilance/Monitoring Activity
Clinical Trials
Version 4.0.2
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