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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:

2020-12-30

Original market date: See footnote 1

2015-10-28

Product name:

REVESTIVE

Description:

KIT INCLUDES 5MG POWDER IN VIAL & 0.5ML DILUENT IN PREFILLED SYRINGE

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:

02445727

Product Monograph/Veterinary Labelling:

Date: 2020-12-30 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):

Kit,  Powder For Solution

Route(s) of administration:

Subcutaneous

Number of active ingredient(s):

1

Schedule(s):

Prescription,  Schedule D  

Biosimilar Biologic Drug:

No

American Hospital Formulary Service (AHFS): See footnote 3

56:92.00   MISCELLANEOUS GI DRUGS

Anatomical Therapeutic Chemical (ATC): See footnote 4

A16AX08  Teduglutide

Active ingredient group (AIG) number:See footnote 5

0157350001

List of active ingredient(s)
Active ingredient(s) Strength
TEDUGLUTIDE 5 MG / VIAL

Application information

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