Nazione: Canada
Lingua: inglese
Fonte: Health Canada
SIMVASTATIN
MINT PHARMACEUTICALS INC
C10AA01
SIMVASTATIN
10MG
TABLET
SIMVASTATIN 10MG
ORAL
30/100/1000
Prescription
HMG-COA REDUCTASE INHIBITORS
Active ingredient group (AIG) number: 0122415004; AHFS:
APPROVED
2011-08-29
_MINT-SIMVASTATIN_ _ _ _(simvastatin) _ Page 1 of 60 _ _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR MINT-SIMVASTATIN Simvastatin Tablets Tablets, 5 mg, 10 mg, 20 mg, 40 mg and 80 mg, Oral USP Lipid Metabolism Regulator Mint Pharmaceuticals Inc. 6575 Davand Drive Mississauga, Ontario L5T 2M3 Date of Initial Authorization: AUG 29, 2011 Date of Revision: JAN 24, 2024 Submission Control Number: 278911 _MINT-SIMVASTATIN_ _ _ _(simvastatin) _ Page 2 of 60 _ _ RECENT MAJOR LABEL CHANGES 7 Warnings and Precautions, Musculoskeletal 01/2024 TABLE OF CONTENTS SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF AUTHORIZATION ARE NOT LISTED. TABLE OF CONTENTS RECENT MAJOR LABEL CHANGES ........................................................................................... 2 TABLE OF CONTENTS ............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION ..................................................................... 4 1 INDICATIONS ............................................................................................................... 4 1.1 Pediatrics ............................................................................................................. 4 1.2 Geriatrics ............................................................................................................. 4 2 CONTRAINDICATIONS .................................................................................................. 5 4 DOSAGE AND ADMINISTRATION .................................................................................. 5 4.1 Dosing Considerations ......................................................................................... 5 4.2 Recommended Dose and Dosage Adjustment ...................................................... 6 4.4 Administration ..................................................................................................... 8 4.5 Missed Dose ........................... Leggi il documento completo