PRAVASTATIN-10 TABLET

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

PRAVASTATIN SODIUM

Commercializzato da:

PRO DOC LIMITEE

Codice ATC:

C10AA03

INN (Nome Internazionale):

PRAVASTATIN

Dosaggio:

10MG

Forma farmaceutica:

TABLET

Composizione:

PRAVASTATIN SODIUM 10MG

Via di somministrazione:

ORAL

Confezione:

100

Tipo di ricetta:

Prescription

Area terapeutica:

HMG-COA REDUCTASE INHIBITORS

Dettagli prodotto:

Active ingredient group (AIG) number: 0122563001; AHFS:

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2001-06-13

Scheda tecnica

Page 1 of 41
PRODUCT MONOGRAPH
Pr
PRAVASTATIN
– 10
Pr
PRAVASTATIN
– 20
Pr
PRAVASTATIN
– 40
PRAVASTATIN SODIUM TABLETS USP
10 MG, 20 MG AND 40 MG
LIPID METABOLISM REGULATOR
PRO DOC LTÉE
DATE OF REVISION:
2925, boul. Industriel
March 2, 2021
Laval, Quebec
H7L 3W9
CONTROL NUMBER: 249000
Page 2 of 41
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
.......................................................................................................16
DOSAGE AND ADMINISTRATION
......................................................................................18
OVERDOSAGE
....................................................................................................................19
ACTION AND CLINICAL PHARMACOLOGY
......................................................................19
STORAGE AND STABILITY
................................................................................................22
DOSAGE FORMS, COMPOSITION AND PACKAGING
.........................................................22
PART II: SCIENTIFIC INFORMATION .................................................................................23
PHARMACEUTICAL INFORMATION
..................................................................................23
CLINICAL TRIALS
.........................................................................................