TEVA-EXEMESTANE TABLET

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

EXEMESTANE

Dostupné z:

TEVA CANADA LIMITED

ATC kód:

L02BG06

INN (Medzinárodný Name):

EXEMESTANE

Dávkovanie:

25MG

Forma lieku:

TABLET

Zloženie:

EXEMESTANE 25MG

Spôsob podávania:

ORAL

Počet v balení:

30

Typ predpisu:

Prescription

Terapeutické oblasti:

ANTINEOPLASTIC AGENTS

Prehľad produktov:

Active ingredient group (AIG) number: 0141702001; AHFS:

Stav Autorizácia:

APPROVED

Dátum Autorizácia:

2013-10-01

Súhrn charakteristických

_TEVA-EXEMESTANE _Page 1 of 54
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TEVA-EXEMESTANE
Exemestane Tablets
Tablets, 25 mg, Oral
Aromatase Inhibitor
Teva Canada Limited
Date of Initial Authorization:
30 Novopharm Court
FEB 26, 2015
Toronto, ON
M1B 2K9 Date of Revision:
Canada MAY 10, 2023
www.tevacanada.com
Submission Control Number: 273755
_TEVA-EXEMESTANE Page 2 of 54 _
_ _
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Musculoskeletal
05/2023
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
...........................................................................................................................
4
1.2
Geriatrics
............................................................................................................................
4
2
CONTRAINDICATIONS
.....................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
................................................................. 4
4
DOSAGE AND ADMINISTRATION
.....................................................................................
5
4.1
Dosing Considerations
.......................................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
.................................................................. 5
4.4
Administration
.....................................................................