MINT-LETROZOLE TABLET
Land: Kanada
Språk: engelska
Källa: Health Canada
Produktens egenskaper
(SPC)
07-03-2024
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Aktiva substanser:
LETROZOLE
Tillgänglig från:
MINT PHARMACEUTICALS INC
ATC-kod:
L02BG04
INN (International namn):
LETROZOLE
Dos:
2.5MG
Läkemedelsform:
TABLET
Sammansättning:
LETROZOLE 2.5MG
Administreringssätt:
ORAL
Enheter i paketet:
15G/50G
Receptbelagda typ:
Prescription
Terapiområde:
ANTINEOPLASTIC AGENTS
Produktsammanfattning:
Active ingredient group (AIG) number: 0132937001; AHFS:
Bemyndigande status:
APPROVED
Tillstånd datum:
2020-11-20
Produktens egenskaper
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
............................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................................
4
1.
INDICATIONS
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4
1.1.
Paediatrics
.......................................................................................................................
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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