Land: Kanada
Sprache: Englisch
Quelle: Health Canada
SIMVASTATIN
TEVA CANADA LIMITED
C10AA01
SIMVASTATIN
10MG
TABLET
SIMVASTATIN 10MG
ORAL
100/500
Prescription
HMG-COA REDUCTASE INHIBITORS
Active ingredient group (AIG) number: 0122415004; AHFS:
APPROVED
2004-03-19
_TEVA-SIMVASTATIN Page 1 of 60 _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION Pr TEVA-SIMVASTATIN Simvastatin Tablets Tablets, 5 mg, 10 mg, 20 mg, 40 mg and 80 mg, Oral USP Lipid Metabolism Regulator Teva Canada Limited Date of Initial Authorization: 30 Novopharm Court April 30, 2010 Toronto, ON M1B 2K9 Date of Revision: Canada February 20, 2024 www.tevacanada.com Submission Control Number: 279407 _TEVA-SIMVASTATIN Page 2 of 60 _ RECENT MAJOR LABEL CHANGES 7 Warnings and Precautions, Musculoskeletal 02/2024 TABLE OF CONTENTS SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF AUTHORIZATION ARE NOT LISTED. 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 ................................................................................... Lesen Sie das vollständige Dokument