Χώρα: Καναδάς
Γλώσσα: Αγγλικά
Πηγή: Health Canada
ATORVASTATIN (ATORVASTATIN CALCIUM)
MYLAN PHARMACEUTICALS ULC
C10AA05
ATORVASTATIN
40MG
TABLET
ATORVASTATIN (ATORVASTATIN CALCIUM) 40MG
ORAL
90/500
Prescription
HMG-COA REDUCTASE INHIBITORS
Active ingredient group (AIG) number: 0133055003; AHFS:
APPROVED
2012-10-30
_MYLAN-ATORVASTATIN _ _Atorvastatin (as Atorvastatin Calcium Trihydrate) _ _Page 1 of 55_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR MYLAN-ATORVASTATIN Atorvastatin Calcium Tablets Tablets, 10 mg, 20 mg, 40 mg and 80 mg atorvastatin (as atorvastatin calcium trihydrate), Oral USP Lipid Metabolism Regulator Mylan Pharmaceuticals ULC 85 Advance Road Etobicoke, Ontario M8Z 2S6 Date of Initial Authorization: OCT 30, 2012 Date of Revision: OCT 23, 2023 Submission Control Number: 275378 _MYLAN-ATORVASTATIN _ _Atorvastatin (as Atorvastatin Calcium Trihydrate) _ _Page 2 of 55_ RECENT MAJOR LABEL CHANGES 2 CONTRAINDICATIONS 10/2023 7 WARNINGS AND PRECAUTIONS, Musculoskeletal 10/2023 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 ........................................................ 6 4.4 Administration Διαβάστε το πλήρες έγγραφο