País: Canadá
Língua: inglês
Origem: Health Canada
LETROZOLE
MINT PHARMACEUTICALS INC
L02BG04
LETROZOLE
2.5MG
TABLET
LETROZOLE 2.5MG
ORAL
15G/50G
Prescription
ANTINEOPLASTIC AGENTS
Active ingredient group (AIG) number: 0132937001; AHFS:
APPROVED
2020-11-20
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 ............................................................................................................... 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 .............................................................. Leia o documento completo