MYLAN-AMLODIPINE/ATORVASTATIN TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

AMLODIPINE (AMLODIPINE BESYLATE); ATORVASTATIN (ATORVASTATIN CALCIUM)

Available from:

MYLAN PHARMACEUTICALS ULC

ATC code:

C10BX03

INN (International Name):

ATORVASTATIN AND AMLODIPINE

Dosage:

5MG; 80MG

Pharmaceutical form:

TABLET

Composition:

AMLODIPINE (AMLODIPINE BESYLATE) 5MG; ATORVASTATIN (ATORVASTATIN CALCIUM) 80MG

Administration route:

ORAL

Units in package:

15G/50G

Prescription type:

Prescription

Therapeutic area:

HMG-COA REDUCTASE INHIBITORS

Product summary:

Active ingredient group (AIG) number: 0251555004; AHFS:

Authorization status:

APPROVED

Authorization date:

2020-05-06

Summary of Product characteristics

_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
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2
1
INDICATIONS
..............................................................................................................
4
1.1
Pediatrics
...................................................................................................................
4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
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4
4
DOSAGE AND ADMINISTRATION
.................................................................................
4
4.1
Dosing Considerations
..............................................................................................
4
4.2
Recom