SANDOZ EVEROLIMUS TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

EVEROLIMUS

Available from:

SANDOZ CANADA INCORPORATED

ATC code:

L04AH02

INN (International Name):

EVEROLIMUS

Dosage:

2.5MG

Pharmaceutical form:

TABLET

Composition:

EVEROLIMUS 2.5MG

Administration route:

ORAL

Units in package:

15G/50G

Prescription type:

Prescription

Therapeutic area:

ANTINEOPLASTIC AGENTS

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2019-10-04

Summary of Product characteristics

_Sandoz Everolimus Product Monograph _
_Page _1_ of 95_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
SANDOZ EVEROLIMUS
Everolimus
Tablets, 2.5 mg, 5 mg, and 10 mg, Oral
Protein kinase inhibitors
ATC Code: L01XE10
Sandoz Canada Inc.
110 Rue de Lauzon
Boucherville, Quebec
J4B 1E6
Date of Initial Authorization:
January 27, 2020
Date of revision:
July 04, 2022
Submission Control Number: 261603
_Sandoz Everolimus Product Monograph _
_Page _2_ of 95_
RECENT MAJOR LABEL CHANGES
7 Warnings and Precautions, Radiation Sensitization and
Radiation Recall
07/2022
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............................................................................................................
5
2
CONTRAINDICATIONS
...............................................................................................
6
3
SERIOUS WARNINGS AND PRECAUTIONS
BOX...................................................... 6
4
DOSAGE AND ADMINISTRATION
..............................................................................
7
4.1
Dosing Considerations
........................................................................................
7
4.2
Recommended Dose and Dosage Adjustment
.................................................... 8
4.3
Reconstitution.....................................................................................