SANDOZ ROSUVASTATIN TABLET

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

ROSUVASTATIN (ROSUVASTATIN CALCIUM)

제공처:

SANDOZ CANADA INCORPORATED

ATC 코드:

C10AA07

INN (국제 이름):

ROSUVASTATIN

복용량:

10MG

약제 형태:

TABLET

구성:

ROSUVASTATIN (ROSUVASTATIN CALCIUM) 10MG

관리 경로:

ORAL

패키지 단위:

30/100/500

처방전 유형:

Prescription

치료 영역:

HMG-COA REDUCTASE INHIBITORS

제품 요약:

Active ingredient group (AIG) number: 0148963001; AHFS:

승인 상태:

APPROVED

승인 날짜:

2012-03-15

제품 특성 요약

_Sandoz Rosuvastatin (rosuvastatin calcium) Product Monograph _
_Page 1 of 57_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
SANDOZ ROSUVASTATIN
Rosuvastatin Calcium Tablets
Tablets, 5, 10, 20 and 40 mg rosuvastatin (as rosuvastatin calcium),
Oral
Manufacturer’s Standard
Lipid Metabolism Regulator
Sandoz Canada Inc.
110 Rue de Lauzon
Boucherville, (Québec), Canada
J4B 1K6
Date of Initial Authorization:
SEP 29, 2020
Date of Revision:
December 13, 2023
Submission Control Number: 278851
_Sandoz Rosuvastatin (rosuvastatin calcium) Product Monograph _
_Page 2 of 57_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Musculoskeletal
02/2023
7 WARNINGS AND PRECAUTIONS, Musculoskeletal
12/2023
4.2 Recommended Dose and Dosage Adjustment
12/2023
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
..........................................................................................................................
4
2
CONTRAINDICATIONS
.............................................................................................................
5
4
DOSAGE AND ADMINISTRATION
.............................................................................................
5
4.1
Dosing Considerations
..............................................................................