TARO-PRAVASTATIN TABLET

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Cumpara asta acum

Ingredient activ:

PRAVASTATIN SODIUM

Disponibil de la:

SUN PHARMA CANADA INC

Codul ATC:

C10AA03

INN (nume internaţional):

PRAVASTATIN

Dozare:

40MG

Forma farmaceutică:

TABLET

Compoziție:

PRAVASTATIN SODIUM 40MG

Calea de administrare:

ORAL

Unități în pachet:

30/100

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

HMG-COA REDUCTASE INHIBITORS

Rezumat produs:

Active ingredient group (AIG) number: 0122563003; AHFS:

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2022-12-09

Caracteristicilor produsului

                                _Pr_
_TARO-PRAVASTATIN Product Monograph_ Page 1 of 39
PRODUCT MONOGRAPH
Pr
TARO-PRAVASTATIN
Pravastatin Sodium Tablets, USP
10 mg, 20 mg and 40 mg
Lipid Metabolism Regulator
Sun Pharma Canada Inc.
126
East Drive
Brampton, Ontario
L6T 1C1
Control#
269572
Date of Preparation:
AUG 14, 2020
Date of Revision:
DEC
08, 2022
_Pr_
_TARO-PRAVASTATIN Product Monograph_ 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
...................................................................................
18
STORAGE AND STABILITY
................................................................................................................
20
DOSAGE FORMS, COMPOSITION AND PACKAGING
....................................................................
20
PART II: SCIENTIFIC INFORMATION
...................................
                                
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