TEVA-ANASTROZOLE TABLET

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

ANASTROZOLE

Tilgjengelig fra:

TEVA CANADA LIMITED

ATC-kode:

L02BG03

INN (International Name):

ANASTROZOLE

Dosering :

1MG

Legemiddelform:

TABLET

Sammensetning:

ANASTROZOLE 1MG

Administreringsrute:

ORAL

Enheter i pakken:

30

Resept typen:

Prescription

Terapeutisk område:

ANTINEOPLASTIC AGENTS

Produkt oppsummering:

Active ingredient group (AIG) number: 0128681001; AHFS:

Autorisasjon status:

APPROVED

Autorisasjon dato:

2014-12-01

Preparatomtale

TEVA-ANASTROZOLE
Page 1 of 68
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TEVA-ANASTROZOLE
Anastrozole Tablets
Tablet, 1 mg, Oral
Teva Standard
Non-Steroidal Aromatase Inhibitor (L02BG03)
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Canada
www.tevacanada.com
Date of Initial Authorization:
October 25, 2012
Date of Revision:
March 16, 2023
Submission Control Number: 271296
TEVA-ANASTROZOLE
Page 2 of 68
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Musculoskeletal
03/2023
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………………………………………………………………………5
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
4.2
Recommended Dose and Dosage Adjustment
.......................................................... 5
4.4
Administration
............................................................................................................
5
4.5
Missed Dose
..............................................................