MINT-LETROZOLE TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

LETROZOLE

Tersedia dari:

MINT PHARMACEUTICALS INC

Kode ATC:

L02BG04

INN (Nama Internasional):

LETROZOLE

Dosis:

2.5MG

Bentuk farmasi:

TABLET

Komposisi:

LETROZOLE 2.5MG

Rute administrasi :

ORAL

Unit dalam paket:

15G/50G

Jenis Resep:

Prescription

Area terapi:

ANTINEOPLASTIC AGENTS

Ringkasan produk:

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

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2020-11-20

Karakteristik produk

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
MINT-LETROZOLE
letrozole tablets
Tablets, 2.5 mg, for oral use
USP
Aromatase inhibitor
Mint Pharmaceuticals Inc.
6575 Davand Drive
Mississauga, ON, L5T 2M3
Canada
Date of Initial Authorization:
NOV 20, 2020
Date of Revision:
MAR 07, 2024
Submission Control Number: 279174
Mint-Letrozole _(letrozole)_ Tablets
Page 2 of 58
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, MUSCULOSKELETAL
03/2024
TABLE OF CONTENTS
RECENT MAJOR LABEL CHANGES
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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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
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6
4.5.
Missed Dose
....................................................................................................................
6
5.
OVERDOSAGE
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