LETROZOLE TABLET

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

LETROZOLE

Commercializzato da:

SANIS HEALTH INC

Codice ATC:

L02BG04

INN (Nome Internazionale):

LETROZOLE

Dosaggio:

2.5MG

Forma farmaceutica:

TABLET

Composizione:

LETROZOLE 2.5MG

Via di somministrazione:

ORAL

Confezione:

15G/50G

Tipo di ricetta:

Prescription

Area terapeutica:

ANTINEOPLASTIC AGENTS

Dettagli prodotto:

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

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2020-09-02

Scheda tecnica

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
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2
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
4
1.
INDICATIONS
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4
1.1.
Paediatrics
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4
1.2.
Geriatrics
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4
2.
CONTRAINDICATIONS
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4
3.
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 5
4.
DOSAGE AND ADMINISTRATION
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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
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