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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:

2019-10-31

Original market date: See footnote 1

2000-04-25

Product name:

CYTOGAM

Description:

ALSO KNOWN AS CYTOMEGALOVIRUS 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:

02231962

Product Monograph/Veterinary Labelling:

Date: 2019-10-30 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company: 

SAOL THERAPEUTICS RESEARCH LIMITED
Peter Street, Unit G04, Adelaide Chambers
Dublin 8
--
Ireland

Class: 

Human

Dosage form(s):

Solution

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

J06BB09  CYTOMEGALOVIRUS IMMUNOGLOBULIN

Active ingredient group (AIG) number:See footnote 5

0132826001

List of active ingredient(s)
Active ingredient(s) Strength
CYTOMEGALOVIRUS IMMUNOGLOBULIN (HUMAN) 50 MG / ML

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