SANDOZ ATORVASTATIN TABLET

দেশ: কানাডা

ভাষা: ইংরেজি

সূত্র: Health Canada

সক্রিয় উপাদান:

ATORVASTATIN (ATORVASTATIN CALCIUM)

থেকে পাওয়া:

SANDOZ CANADA INCORPORATED

এটিসি কোড:

C10AA05

INN (আন্তর্জাতিক নাম):

ATORVASTATIN

ডোজ:

20MG

ফার্মাসিউটিকাল ফর্ম:

TABLET

রচনা:

ATORVASTATIN (ATORVASTATIN CALCIUM) 20MG

প্রশাসন রুট:

ORAL

প্যাকেজ ইউনিট:

100/500

প্রেসক্রিপশন টাইপ:

Prescription

থেরাপিউটিক এলাকা:

HMG-COA REDUCTASE INHIBITORS

পণ্য সারাংশ:

Active ingredient group (AIG) number: 0133055002; AHFS:

অনুমোদন অবস্থা:

APPROVED

অনুমোদন তারিখ:

2010-05-19

পণ্য বৈশিষ্ট্য

_Sandoz Atorvastatin _
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_Page 1 of 63_
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PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
SANDOZ ATORVASTATIN
Atorvastatin Calcium Tablets
Tablets, 10 mg, 20 mg, 40 mg and 80 mg atorvastatin (as atorvastatin
calcium trihydrate), Oral
Manufacturer’s Standard
Lipid Metabolism Regulator
Sandoz Canada Inc.
110 Rue de Lauzon
Boucherville, Québec, Canada
J4B 1E6
Date of Initial Authorization:
May 19, 2010
Date of Revision:
September 11, 2023
Submission Control Number: 274576
_Sandoz Atorvastatin _
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_Page 2 of 63_
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RECENT MAJOR LABEL CHANGES
2 Contraindications
7 Warnings and Precautions, Musculoskeletal
09/2023
7 Warnings and Precautions, Musculoskeletal
09/2023
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
......................................................................................
6
4.1
Dosing Considerations
...............................................................................................
6
4.2
Recommended Dose and Dosage Adjustment
.......................................................... 6
4.4