APO-PRAVASTATIN TABLET

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

PRAVASTATIN SODIUM

Commercializzato da:

APOTEX INC

Codice ATC:

C10AA03

INN (Nome Internazionale):

PRAVASTATIN

Dosaggio:

40MG

Forma farmaceutica:

TABLET

Composizione:

PRAVASTATIN SODIUM 40MG

Via di somministrazione:

ORAL

Confezione:

30/100

Tipo di ricetta:

Prescription

Area terapeutica:

HMG-COA REDUCTASE INHIBITORS

Dettagli prodotto:

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

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2001-02-27

Scheda tecnica

Page 1 of 40
PRODUCT MONOGRAPH
Pr
APO-PRAVASTATIN
PRAVASTATIN SODIUM TABLETS USP
10 MG, 20 MG AND 40 MG
LIPID METABOLISM REGULATOR
APOTEX INC.
DATE OF REVISION:
150 SIGNET DRIVE
JULY 17, 2020
TORONTO, ONTARIO
M9L 1T9
CONTROL NUMBER: 240816
Page 2 of 40
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
..............................................................................................................24
DETAILED PHARMACOLOGY
......