MYLAN-AMLODIPINE/ATORVASTATIN TABLET

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

AMLODIPINE (AMLODIPINE BESYLATE); ATORVASTATIN (ATORVASTATIN CALCIUM)

Tilgængelig fra:

MYLAN PHARMACEUTICALS ULC

ATC-kode:

C10BX03

INN (International Name):

ATORVASTATIN AND AMLODIPINE

Dosering:

10MG; 80MG

Lægemiddelform:

TABLET

Sammensætning:

AMLODIPINE (AMLODIPINE BESYLATE) 10MG; ATORVASTATIN (ATORVASTATIN CALCIUM) 80MG

Indgivelsesvej:

ORAL

Enheder i pakken:

90

Recept type:

Prescription

Terapeutisk område:

HMG-COA REDUCTASE INHIBITORS

Produkt oversigt:

Active ingredient group (AIG) number: 0251555008; AHFS:

Autorisation status:

CANCELLED PRE MARKET

Autorisation dato:

2016-11-02

Produktets egenskaber

_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