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ORKAMBI - Health Canada Drug Approval Details

Approvals/Health Canada/ORKAMBI

Authorized

STANDARD

ORKAMBI

Vertex Pharmaceuticals (Canada) Incorporated🇨🇦 Health Canada

Approval Date: Jul 4, 2025
Approval ID: 1e0fac78e7b55a3e
Company: Vertex Pharmaceuticals (Canada) Incorporated
Type: Standard

Approval Details

Approval Id: 1e0fac78e7b55a3e
Drug Approval Canada Name: ORKAMBI
Product Name: ORKAMBI
Status: Marketed
Status Date: 2018-12-14
Original Market Date: 2018-12-14
Din: 02483858
Drug Class: Human
Dosage Form: Granules
Route Of Administration: Oral
Schedule: Prescription
Ahfs: 48:14.04
Atc Original: R07AX30 IVACAFTOR AND LUMACAFTOR
Atc Name: r 07 ax 30
Aig Number: 0257771003
Company Name: Vertex Pharmaceuticals (Canada) Incorporated
Company Address: 1520, 20 Bay Street, Toronto, Ontario, Canada, M5J 2N8

Active Ingredients

LUMACAFTOR

150 MG / SACHET

IVACAFTOR

188 MG / SACHET

Authorized

Quick Info

Agency

Health Canada

Country

🇨🇦

Approval Date

Jul 4, 2025

Approval ID

1e0fac78e7b55a3e

Type

Standard

Back to Health Canada Approvals