Product information

From Health Canada

New search

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:

2021-04-09

Original market date: See footnote 1

1997-08-22

Product name:

GAMMAGARD S/D

Description:

MEDICINAL INGREDIENT ALSO KNOW AS IMMUNE GLOBULIN (HUMAN)

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:

02231471

Product Monograph/Veterinary Labelling:

Date: 2021-04-09 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company: 

TAKEDA CANADA INC
3800  22 Adelaide Street West
Toronto
Ontario
Canada  M5H 4E3

Class: 

Human

Dosage form(s):

Solution,  Powder For Solution,  Kit

Route(s) of administration:

Intravenous

Number of active ingredient(s):

1

Schedule(s):

Schedule D  

Biosimilar Biologic Drug:

No

American Hospital Formulary Service (AHFS): See footnote 3

80:04.00   SERUMS

Anatomical Therapeutic Chemical (ATC): See footnote 4

J06BA02  IMMUNOGLOBULINS, NORMAL HUMAN, FOR INTRAVASC. ADM.

Active ingredient group (AIG) number:See footnote 5

0106267017

List of active ingredient(s)
Active ingredient(s) Strength
IMMUNOGLOBULIN (HUMAN) 10 G / VIAL

Application information

Related information

Contact us

Version 3.9.0
Date modified: