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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:

2015-09-14

Original market date: See footnote 1

2015-09-14

Product name:

KALYDECO

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:

02442620

Product Monograph/Veterinary Labelling:

Date: 2021-08-24 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):

Granules

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

48:14.12   Cystic Fibrosis Transmembrane Conductance Regulator Potentiators

Anatomical Therapeutic Chemical (ATC): See footnote 4

R07AX02  IVACAFTOR

Active ingredient group (AIG) number:See footnote 5

0153450003

List of active ingredient(s)
Active ingredient(s) Strength
IVACAFTOR 75 MG / SACHET

Risk Management Plans See footnote 7

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

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