KALYDECO TABLET

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

IVACAFTOR

Disponibil de la:

VERTEX PHARMACEUTICALS (CANADA) INCORPORATED

Codul ATC:

R07AX02

INN (nume internaţional):

IVACAFTOR

Dozare:

150MG

Forma farmaceutică:

TABLET

Compoziție:

IVACAFTOR 150MG

Calea de administrare:

ORAL

Unități în pachet:

56/60

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

Cystic Fibrosis Transmembrane Conductance Regulator Potentiators

Rezumat produs:

Active ingredient group (AIG) number: 0153450001; AHFS:

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2012-11-26

Caracteristicilor produsului

_ _
_Pr_
_KALYDECO_
_®_
_ (ivacaftor) Tablets and Granules _
_Page 1 of 43_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
KALYDECO
®
Ivacaftor Tablets
Tablets: 150 mg, Oral
Ivacaftor Granules
Granules: 13.4 mg per packet, 25 mg per packet, 50 mg per packet, and
75 mg per packet,
Oral
Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Potentiator
ATC R07AX02
Vertex Pharmaceuticals (Canada) Incorporated
20 Bay Street, Suite 1520
Toronto, Ontario
M5J 2N8
Date of Initial Authorization:
Nov 26, 2012
Date of Revision:
Nov 27, 2023
Submission Control Number: 273575
_ _
_KALYDECO (ivacaftor) Tablets and Granules _
_Page 2 of 43_
RECENT MAJOR LABEL CHANGES
1 Indications
11/2023
1 Indications, 1.1 Pediatrics
11/2023
4 Dosage and Administration
11/2023
7 Warnings and Precautions
11/2023
7 Warnings and Precautions, 7.1.3 Pediatrics
11/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT
LISTED.
RECENT MAJOR LABEL CHANGES
...........................................................................
2
TABLE OF CONTENTS
.................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
................................................... 4
1
INDICATIONS
.....................................................................................................
4
1.1
Pediatrics
....................................................................................................
4
1.2
Geriatrics
....................................................................................................
4
2
CONTRAINDICATIONS
......................................................................................
4
4
DOSAGE AND ADMINISTRATION
.................................................................... 4
4.1
Dosing
Considerations................................................................................
4
4.2
Recommended Dose and Dosage Adjustment
.........................................