NAT-EVEROLIMUS TABLET

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

EVEROLIMUS

Disponible desde:

NATCO PHARMA (CANADA) INC

Código ATC:

L04AH02

Designación común internacional (DCI):

EVEROLIMUS

Dosis:

2.5MG

formulario farmacéutico:

TABLET

Composición:

EVEROLIMUS 2.5MG

Vía de administración:

ORAL

Unidades en paquete:

15G/50G

tipo de receta:

Prescription

Resumen del producto:

Active ingredient group (AIG) number: 0152682003; AHFS:

Estado de Autorización:

APPROVED

Fecha de autorización:

2022-08-29

Ficha técnica

_ _
_NAT-EVEROLIMUS_
_Product Monograph _
_Page 1 of 93_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
NAT-EVEROLIMUS
Everolimus
Tablets, 2.5 mg, 5 mg, 7.5 mg, and 10 mg, Oral
Protein kinase inhibitors
ATC Code: L01XE10
Natco Pharma (Canada) Inc.
2000 Argentia Road
Plaza 1, Suite 200
Mississauga, Ontario
L5N 1P7
Date of Initial Authorization:
August 22, 2022
Date of Revision:
January 25, 2023
Submission Control Number: 267697
_ _
_NAT-EVEROLIMUS_
_Product Monograph _
_Page 2 of 93_
RECENT MAJOR LABEL CHANGES
Not applicable.
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.................................................................................................................
5
1.2
Geriatrics
.................................................................................................................
6
2
CONTRAINDICATIONS.........................................................................................................
6
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
.......................................................................
7
4
DOSAGE AND ADMINISTRATION
..........................................................................................
8
4.1
Dosing
Considerations...............................................................................................
8
4.2
Recommended Dose and Dosage Adjustment
............................................................... 8
4.3
Reconst