MINT-ANASTROZOLE TABLET

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

ANASTROZOLE

Disponible depuis:

MINT PHARMACEUTICALS INC

Code ATC:

L02BG03

DCI (Dénomination commune internationale):

ANASTROZOLE

Dosage:

1MG

forme pharmaceutique:

TABLET

Composition:

ANASTROZOLE 1MG

Mode d'administration:

ORAL

Unités en paquet:

30

Type d'ordonnance:

Prescription

Domaine thérapeutique:

ANTINEOPLASTIC AGENTS

Descriptif du produit:

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

Statut de autorisation:

APPROVED

Date de l'autorisation:

2013-11-25

Résumé des caractéristiques du produit

_MINT-ANASTROZOLE_
_® _
_Product Monograph _
_Page 1 of 55_
_ _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
MINT-ANASTROZOLE
Anastrozole tablets
Tablet 1 mg, Oral use
USP
Non-Steroidal Aromatase Inhibitor
Mint Pharmaceuticals Inc.
6575 Davand Drive
Mississauga, Ontario
L5T 2M3
Date of Initial Authorization:
NOV 22, 2013
Date of Revision:
AUG 1, 2023
Submission Control Number: 275056
_MINT-ANASTROZOLE_
_® _
_Product Monograph _
_Page 2 of 55_
_ _
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Musculoskeletal
08/2023
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
.................................................................................
4
4.2
Recommended Dose and Dosage Adjustment
....................................................... 4
4.4
Administration
........................................................................................................
5
4.5
Missed Dose
..................................................................