PRAVASTATIN TABLET

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

PRAVASTATIN SODIUM

Commercializzato da:

SANIS HEALTH INC

Codice ATC:

C10AA03

INN (Nome Internazionale):

PRAVASTATIN

Dosaggio:

20MG

Forma farmaceutica:

TABLET

Composizione:

PRAVASTATIN SODIUM 20MG

Via di somministrazione:

ORAL

Confezione:

30/100

Tipo di ricetta:

Prescription

Area terapeutica:

HMG-COA REDUCTASE INHIBITORS

Dettagli prodotto:

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

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2010-11-03

Scheda tecnica

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PRAVASTATIN
Pravastatin Sodium Tablets
10 mg, 20 mg and 40 mg
Manufacturer’s Standard
Lipid Metabolism Regulator
Sanis Health Inc.
Date of Revision:
1 President’s Choice Circle
November 9, 2020
Brampton, Ontario
L6Y 5S5
SUBMISSION CONTROL NO.: 244865
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2
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
................................................................... 23
PHARMACEUTICAL INFORMATION
.....................................................................
23
CLINICAL TRIALS
.....................................................................................................
24
DETAILED PHARMACOLOGY
................................................................................
30
TOXICOLOGY
.............