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KALYDECO

KALYDECO

Approved
DIN Number

02519364

Drug Class

Human

Market Date

Sep 1, 2021

Company
HC

Vertex Pharmaceuticals (Canada) Incorporated

Product Information

Detailed information about this Health Canada approved drug product, including dosage form, route of administration, and regulatory classification.

Product Details

Health Canada regulatory and product classification information

Regulatory Identifiers
DIN Number02519364
AIG Number0153450004
Classification & Schedule
C
Drug Class
Human
S
Schedule
Prescription
A
ATC Code
R07AX02 IVACAFTOR
Product Specifications
Dosage FormGranules
Route of AdministrationOral
AHFS Classification48:14.12
Health Canada Classification

ACTIVE INGREDIENTS (1)

IVACAFTORActive
Strength: 25 MG / SACHET
Monograph: IVACAFTOR

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