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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:

2014-10-28

Original market date: See footnote 1

2014-10-28

Product name:

TRINTELLIX

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:

02432943

Product Monograph/Veterinary Labelling:

Date: 2021-03-11 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company: 

LUNDBECK CANADA INC
2600 Alfred-Nobel, Suite 400
St-Laurent
Quebec
Canada  H4S 0A9

Class: 

Human

Dosage form(s):

Tablet

Route(s) of administration:

Oral

Number of active ingredient(s):

1

Schedule(s):

Prescription  

Biosimilar Biologic Drug:

No

American Hospital Formulary Service (AHFS): See footnote 3

28:16.04.24   SEROTONIN MODULATORS

Anatomical Therapeutic Chemical (ATC): See footnote 4

N06AX26  Vortioxetine

Active ingredient group (AIG) number:See footnote 5

0156170004

List of active ingredient(s)
Active ingredient(s) Strength
VORTIOXETINE (VORTIOXETINE HYDROBROMIDE) 20 MG

Risk Management Plans See footnote 7

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

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