MINT-PRAVASTATIN TABLET

국가: 캐나다

언어: 영어

출처: Health Canada

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제품 특성 요약 제품 특성 요약 (SPC)
08-03-2024

유효 성분:

PRAVASTATIN SODIUM

제공처:

MINT PHARMACEUTICALS INC

ATC 코드:

C10AA03

INN (International Name):

PRAVASTATIN

복용량:

20MG

약제 형태:

TABLET

구성:

PRAVASTATIN SODIUM 20MG

관리 경로:

ORAL

패키지 단위:

30/100/500

처방전 유형:

Prescription

치료 영역:

HMG-COA REDUCTASE INHIBITORS

제품 요약:

Active ingredient group (AIG) number: 0122563002; AHFS:

승인 상태:

APPROVED

승인 날짜:

2021-02-09

제품 특성 요약

                                Page 1 of 39
PRODUCT MONOGRAPH
Pr
MINT-PRAVASTATIN
Pravastatin Sodium Tablets, USP
10 mg, 20 mg and 40 mg
Lipid Metabolism Regulator
Mint Pharmaceuticals Inc.,
6575 Davand Drive
Mississauga, ON
L5T 2M3
Date of Preparation:
MAR 08, 2024
Control# 283801
Page 2 of 39
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..............................................................................
3
SUMMARY PRODUCT INFORMATION
...............................................................................................
3
INDICATIONS AND CLINICAL USE
....................................................................................................
3
CONTRAINDICATIONS
..........................................................................................................................
5
WARNINGS AND PRECAUTIONS
........................................................................................................
5
ADVERSE REACTIONS
........................................................................................................................
11
DRUG INTERACTIONS
........................................................................................................................
15
DOSAGE AND ADMINISTRATION
....................................................................................................
17
OVERDOSAGE
.......................................................................................................................................
18
ACTION AND CLINICAL PHARMACOLOGY
...................................................................................
19
STORAGE AND STABILITY
................................................................................................................
21
DOSAGE FORMS, COMPOSITION AND PACKAGING
....................................................................
21
PART II: SCIENTIFIC INFORMATION
...................................................................................................
22
PHARMACEUTICAL INFORMATION
...............
                                
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