ORKAMBI TABLET

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

IVACAFTOR; LUMACAFTOR

Disponibil de la:

VERTEX PHARMACEUTICALS (CANADA) INCORPORATED

Codul ATC:

R07AX30

INN (nume internaţional):

IVACAFTOR AND LUMACAFTOR

Dozare:

125MG; 200MG

Forma farmaceutică:

TABLET

Compoziție:

IVACAFTOR 125MG; LUMACAFTOR 200MG

Calea de administrare:

ORAL

Unități în pachet:

112

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

Cystic Fibrosis Transmembrane Conductance Regulator Correctors

Rezumat produs:

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

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2016-01-26

Caracteristicilor produsului

_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