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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:

2021-06-22

Original market date: See footnote 1

2021-06-22

Product name:

TRIKAFTA

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:

02517140

Product Monograph/Veterinary Labelling:

Date: 2021-06-17 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company: 

VERTEX PHARMACEUTICALS (CANADA) INCORPORATED
1520  20 Bay Street
Toronto
Ontario
Canada  M5J 2N8

Class: 

Human

Dosage form(s):

Tablet

Route(s) of administration:

Oral

Number of active ingredient(s):

4

Schedule(s):

Prescription  

American Hospital Formulary Service (AHFS): See footnote 3

48:14.04   Cystic Fibrosis Transmembrane Conductance Regulator Correctors ,  48:14.12   Cystic Fibrosis Transmembrane Conductance Regulator Potentiators

Anatomical Therapeutic Chemical (ATC): See footnote 4

R07AX32  IVACAFTOR, TEZACAFTOR AND ELEXACAFTOR

Active ingredient group (AIG) number:See footnote 5

0462989001

List of active ingredient(s)
Active ingredient(s) Strength
ELEXACAFTOR 100 MG
IVACAFTOR 150 MG
IVACAFTOR 75 MG
TEZACAFTOR 50 MG

Risk Management Plans See footnote 7

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

Pharmacovigilance/Monitoring Activity
Drug Utilisation Study (DUS)
Observational Studies

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