Nazione: Canada
Lingua: inglese
Fonte: Health Canada
ATORVASTATIN (ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE)
SIVEM PHARMACEUTICALS ULC
C10AA05
ATORVASTATIN
10MG
TABLET
ATORVASTATIN (ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE) 10MG
ORAL
90/100/500
Prescription
HMG-COA REDUCTASE INHIBITORS
Active ingredient group (AIG) number: 0133055001; AHFS:
APPROVED
2013-08-29
_Product Monograph - ATORVASTATIN-10, -20, -40, -80 _ _ _ _ _ _ _ _Page 1 of 55 _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR ATORVASTATIN-10 PR ATORVASTATIN-20 PR ATORVASTATIN-40 PR ATORVASTATIN-80 Atorvastatin Calcium Tablets Tablet, 10 mg, 20 mg, 40 mg and 80 mg atorvastatin (as atorvastatin calcium propylene glycol solvate), Oral USP Lipid Metabolism Regulator Sivem Pharmaceuticals ULC Date of Initial Authorization: 4705 Dobrin Street August 29, 2013 Saint-Laurent, Quebec, Canada H4R 2P7 Date of Revision: www.sivem.ca March 14, 2023 Submission Control Number: 268525 _Product Monograph - ATORVASTATIN-10, -20, -40, -80 _ _ _ _ _ _ _ _Page 2 of 55 _ RECENT MAJOR LABEL CHANGES 2 Contraindications 03/2023 7 Warnings and Precautions, Musculoskeletal 03/2023 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 .......................................................................................................... 5 2 CONTRAINDICATIONS ..................................................................................................... 5 4 DOSAGE AND ADMINISTRATION ................................................................................... 5 4.1 Dosing Considerations ....................................................................................... 5 4.2 Recommended Dose and Dosage Adjustment .......................... Leggi il documento completo