LETROZOLE TABLET

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

LETROZOLE

Disponible depuis:

SANIS HEALTH INC

Code ATC:

L02BG04

DCI (Dénomination commune internationale):

LETROZOLE

Dosage:

2.5MG

forme pharmaceutique:

TABLET

Composition:

LETROZOLE 2.5MG

Mode d'administration:

ORAL

Unités en paquet:

15G/50G

Type d'ordonnance:

Prescription

Domaine thérapeutique:

ANTINEOPLASTIC AGENTS

Descriptif du produit:

Active ingredient group (AIG) number: 0132937001; AHFS:

Statut de autorisation:

APPROVED

Date de l'autorisation:

2020-09-02

Résumé des caractéristiques du produit

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
LETROZOLE
letrozole tablets
Tablets, 2.5 mg, for oral use
USP
Aromatase inhibitor
Sanis Health Inc.
1 President's Choice Circle
Brampton, Ontario
L6Y 5S5
Submission Control Number:
278227
Date of Initial Authorization:
SEP
02, 2020
Date of Revision:
SEP 01, 2023
LETROZOLE
_(letrozole)_ Tablets
Page 2 of 58
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, MUSCULOSKELETAL
TABLE OF CONTENTS
RECENT MAJOR LABEL CHANGES
...........................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
4
1.
INDICATIONS
..............................................................................................................
4
1.1.
Paediatrics
.........................................................................................................................
4
1.2.
Geriatrics
...........................................................................................................................
4
2.
CONTRAINDICATIONS
.................................................................................................
4
3.
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 5
4.
DOSAGE AND ADMINISTRATION
.................................................................................
5
4.1.
Dosing Considerations
......................................................................................................
5
4.2.
Recommended Dose and Dosage Adjustment
................................................................. 5
4.4.
Administration
..................................................................................................................
6
4.5.
Missed Dose
......................................................................................................................
6
5.
OVERDOSAGE
...........................................................................