ORKAMBI TABLET

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

IVACAFTOR; LUMACAFTOR

Доступна з:

VERTEX PHARMACEUTICALS (CANADA) INCORPORATED

Код атс:

R07AX30

ІПН (Міжнародна Ім'я):

IVACAFTOR AND LUMACAFTOR

Дозування:

125MG; 200MG

Фармацевтична форма:

TABLET

Склад:

IVACAFTOR 125MG; LUMACAFTOR 200MG

Адміністрація маршрут:

ORAL

Одиниць в упаковці:

112

Тип рецепту:

Prescription

Терапевтична области:

Cystic Fibrosis Transmembrane Conductance Regulator Correctors

Огляд продуктів:

Active ingredient group (AIG) number: 0257771001; AHFS:

Статус Авторизація:

APPROVED

Дата Авторизація:

2016-01-26

Характеристики продукта

_Pr_
_ORKAMBI_
®
_ (Lumacaftor/Ivacaftor Tablets and Granules)_
_ _
_Page 1 of 47_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
ORKAMBI
®
Lumacaftor / Ivacaftor Tablets 100 mg / 125 mg, Oral
Lumacaftor / Ivacaftor Tablets 200 mg / 125 mg, Oral
Lumacaftor / Ivacaftor Granules 75 mg / 94 mg, Oral
Lumacaftor / Ivacaftor Granules 100 mg / 125 mg, Oral
Lumacaftor / Ivacaftor Granules 150 mg / 188 mg, Oral
Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Corrector
and Potentiator
ATC R07AX30
Vertex Pharmaceuticals (Canada) Incorporated
20 Bay Street, Suite 1520
Toronto, Ontario
M5J 2N8
Date of Initial Authorization:
January 25, 2016
Date of Revision:
April 6, 2023
Submission Control Number: 264825
_Pr_
_ORKAMBI_
®
_ (Lumacaftor/Ivacaftor Tablets and Granules)_
_ _
_Page 2 of 47_
RECENT MAJOR LABEL CHANGES
1 INDICATIONS 1.1 Pediatrics
04/2023
2 DOSAGE AND ADMINISTRATION 4.1 Dosing Considerations
04/2023
2 DOSAGE AND ADMINISTRATION 4.2 Recommended Dose and
Dosage Adjustment
04/2023
2 DOSAGE AND ADMINISTRATION 4.4 Administration
04/2023
TABLE OF CONTENTS
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