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:

2021-08-13

Original market date: See footnote 1

2018-03-06

Product name:

ADYNOVATE

Description:

400 UNITS/ML (5 ML DILUENT) - SINGLE-USE VIAL

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:

02459078

Product Monograph/Veterinary Labelling:

Date: 2023-09-19 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):

Powder For Solution ,  Kit

Route(s) of administration:

Intravenous

Number of active ingredient(s):

1

Schedule(s):

Schedule D

 

American Hospital Formulary Service (AHFS): See footnote 3

20:28.16 

Anatomical Therapeutic Chemical (ATC): See footnote 4

B02BD02 COAGULATION FACTOR VIII

Active ingredient group (AIG) number:See footnote5

0158550004

List of active ingredient(s)
Active ingredient(s) Strength
ANTIHEMOPHILIC FACTOR (RECOMBINANT), PEGYLATED 2000 UNIT / VIAL

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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