PMS-EVEROLIMUS TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

EVEROLIMUS

Available from:

PHARMASCIENCE 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

Therapeutic area:

ANTINEOPLASTIC AGENTS

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2020-09-04

Summary of Product characteristics

_pms-EVEROLIMUS (everolimus)_
_Page 1 of 91_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
PMS-EVEROLIMUS
Everolimus Tablets
Tablets, 2.5 mg, 5 mg and 10 mg, Oral
Protein Kinase inhibitors
ATC Code: L01XE10
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Québec
H4P 2T4
www.pharmascience.com
Submission Control Number: 256066
Date of Initial Authorization
4 SEP 2020
Date of Revision:
27 JAN 2022
_pms-EVEROLIMUS (everolimus)_
_Page 2 of 91_ RECENT MAJOR LABEL CHANGES
1.1 Pediatrics
01/2022
4.1 Dosing Considerations
01/2022
4.4 Administration, Switching Dosage Forms
01/2022
7 WARNINGS AND PRECAUTIONS, Radiation Sensitization and Radiation
Recall
01/2022
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..