Skip to main content

MedPath Trial Home

Organizations News Research

Data Sources:ClinicalTrials.govEU CTRFDAEMANMPATGAHealth CanadaWHO ICTRP

MedPath Trial Home

Search trials. Track pipelines. Understand approvals. With AI-powered intelligence for clinical research.

Product

Clinical Trials
Drug Intelligence
Global Approvals
AI Research
Pricing

Resources

FAQ
Search

Company

News
About
Contact

Legal

Privacy Policy
Terms of Service

Disclaimer: This website provides information retrieval and data analysis services. The content does not constitute medical advice. Eligibility assessments are for reference only and should not replace consultation with qualified healthcare professionals. Data is sourced from public registries and regulatory agencies; MedPath does not guarantee completeness or accuracy. Always verify information with primary sources.

© 2026 MedPath Trial. All rights reserved.

We value your privacy

We use cookies to analyze site traffic and improve your experience. See our Privacy Policy.

KALYDECO - Health Canada Drug Approval Details

Approvals/Health Canada/KALYDECO

Authorized

STANDARD

KALYDECO

Vertex Pharmaceuticals (Canada) Incorporated🇨🇦 Health Canada

Approval Date: Jul 4, 2025
Approval ID: ba6b8d8503dc0cf3
Company: Vertex Pharmaceuticals (Canada) Incorporated
Type: Standard

Approval Details

Approval Id: ba6b8d8503dc0cf3
Drug Approval Canada Name: KALYDECO
Product Name: KALYDECO
Status: Marketed
Status Date: 2021-09-01
Original Market Date: 2021-09-01
Din: 02519364
Drug Class: Human
Dosage Form: Granules
Route Of Administration: Oral
Schedule: Prescription
Ahfs: 48:14.12
Atc Original: R07AX02 IVACAFTOR
Atc Name: r 07 ax 02
Aig Number: 0153450004
Company Name: Vertex Pharmaceuticals (Canada) Incorporated
Company Address: 1520, 20 Bay Street, Toronto, Ontario, Canada, M5J 2N8

Active Ingredients

IVACAFTOR

25 MG / SACHET

Authorized

Quick Info

Agency

Health Canada

Country

🇨🇦

Approval Date

Jul 4, 2025

Approval ID

ba6b8d8503dc0cf3

Type

Standard

Back to Health Canada Approvals