NAT-EVEROLIMUS TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

EVEROLIMUS

Available from:

NATCO PHARMA (CANADA) INC

ATC code:

L04AH02

INN (International Name):

EVEROLIMUS

Dosage:

5MG

Pharmaceutical form:

TABLET

Composition:

EVEROLIMUS 5MG

Administration route:

ORAL

Units in package:

15G/50G

Prescription type:

Prescription

Product summary:

Active ingredient group (AIG) number: 0152682001; AHFS:

Authorization status:

APPROVED

Authorization date:

2022-08-29

Summary of Product characteristics

_ _
_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