TEVA-EVEROLIMUS TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

EVEROLIMUS

Available from:

TEVA CANADA LIMITED

ATC code:

L04AH02

INN (International Name):

EVEROLIMUS

Dosage:

2.5MG

Pharmaceutical form:

TABLET

Composition:

EVEROLIMUS 2.5MG

Administration route:

ORAL

Units in package:

10

Prescription type:

Prescription

Therapeutic area:

ANTINEOPLASTIC AGENTS

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2019-12-06

Summary of Product characteristics

_TEVA-EVEROLIMUS_
_ _
Page 1 of 102
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
TEVA-EVEROLIMUS
Everolimus Tablets
Tablets, 2.5 mg, 5 mg, 7.5 mg and 10 mg, Oral
Protein Kinase Inhibitor
ATC Code: L01XE10
Teva Canada Limited
30 Novopharm Court
Toronto, ON
M1B 2K9
Canada
www.tevacanada.com
Date of Initial Authorization:
December 06, 2019
Date of Revision:
MAR 06, 2024
Submission Control Number: 275710
_TEVA-EVEROLIMUS_
_ _
Page 2 of 102
RECENT MAJOR LABEL CHANGES
7 Warning and Precautions, Radiation Sensitization and Radiation
Recall
03/2022
1 Indications, 1.1 Pediatrics
03/2022
3 Serious Warnings and Precautions Box
03/2022
4 Dosage and Administration, 4.1 Dosing Considerations
03/2022
4 Dosage and Administration, 4.4 Administration
03/2022
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
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2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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1 INDICATIONS
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4
1.1
Pediatrics
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5
1.2
Geriatrics
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6
2 CONTRAINDICATIONS
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6
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
................................................................. 6
4 DOSAGE AND ADMINISTRATION
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7
4.1 Dosing Considerations
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