Држава: Канада
Језик: Енглески
Извор: Health Canada
AMLODIPINE (AMLODIPINE BESYLATE); ATORVASTATIN (ATORVASTATIN CALCIUM)
MYLAN PHARMACEUTICALS ULC
C10BX03
ATORVASTATIN AND AMLODIPINE
10MG; 40MG
TABLET
AMLODIPINE (AMLODIPINE BESYLATE) 10MG; ATORVASTATIN (ATORVASTATIN CALCIUM) 40MG
ORAL
90/500
Prescription
HMG-COA REDUCTASE INHIBITORS
Active ingredient group (AIG) number: 0251555007; AHFS:
CANCELLED PRE MARKET
2016-11-02
_MYLAN-AMLODIPINE/ATORVASTATIN (amlodipine besylate and atorvastatin calcium) – Product _ _Monograph _ _Page 1 of 67_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR MYLAN-AMLODIPINE/ATORVASTATIN amlodipine besylate and atorvastatin calcium tablets tablets 5/10 mg, 5/20 mg, 5/40 mg, 5/80 mg and 10/10 mg, 10/20 mg, 10/40 mg, 10/80 mg amlodipine (as amlodipine besylate) and atorvastatin (as atorvastatin calcium), Oral Anti-hypertensive/Anti-anginal Agent and Lipid Metabolism Regulator Mylan Pharmaceuticals ULC 85 Advance Road Etobicoke, Ontario M8Z 2S6 Date of Initial Authorization: NOV 27, 2023 Submission Control No.: 280422 © 2023 Mylan Pharmaceuticals ULC, a Viatris company. _MYLAN-AMLODIPINE/ATORVASTATIN (amlodipine besylate and atorvastatin calcium) – Product _ _Monograph _ _Page 2 of 67_ RECENT MAJOR LABEL CHANGES 2 Contraindications 04/2021 7 Warnings and Precautions, Musculoskeletal 04/2022 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 1 INDICATIONS .............................................................................................................. 4 1.1 Pediatrics ................................................................................................................... 4 1.2 Geriatrics ................................................................................................................... 4 2 CONTRAINDICATIONS ................................................................................................. 4 4 DOSAGE AND ADMINISTRATION ................................................................................. 4 4.1 Dosing Considerations .............................................................................................. 4 4.2 Recom Прочитајте комплетан документ