TEVA-EVEROLIMUS TABLET

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

EVEROLIMUS

MAH:

TEVA CANADA LIMITED

ATC_code:

L04AH02

INN:

EVEROLIMUS

dosage:

5MG

pharmaceutical_form:

TABLET

composition:

EVEROLIMUS 5MG

administration_route:

ORAL

units_in_package:

15G/50G

prescription_type:

Prescription

therapeutic_area:

ANTINEOPLASTIC AGENTS

leaflet_short:

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

authorization_status:

APPROVED

authorization_date:

2019-12-06

SPC

_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
........................................................................................
2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................. 4
1 INDICATIONS
....................................................................................................................
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
.......................................