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:

2012-10-09

Original market date: See footnote 1

2006-05-24

Product name:

IGIVNEX

Description:

ALSO KNOW AS IMMUNE GLOBULIN (HUMAN)

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DIN:

02277921

Product Monograph/Veterinary Labelling:

Date: 2017-07-12 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company:

GRIFOLS THERAPEUTICS LLC
8368 Us 70 Business Hwy. West
Clayton
North Carolina
United States 27520-9464

Class:

Human

Dosage form(s):

Solution

Route(s) of administration:

Subcutaneous ,  Intravenous

Number of active ingredient(s):

1

Schedule(s):

Schedule D

 

American Hospital Formulary Service (AHFS): See footnote 3

80:04.00 

Anatomical Therapeutic Chemical (ATC): See footnote 4

J06BA02 IMMUNOGLOBULINS, NORMAL HUMAN, FOR INTRAVASC. ADM.

Active ingredient group (AIG) number:See footnote5

0106267015

List of active ingredient(s)
Active ingredient(s) Strength
IMMUNOGLOBULIN (HUMAN) 10 G / 100 ML

Risk Management Plans See footnote 7

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

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