ATORVASTATIN TABLET

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

ATORVASTATIN (ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE)

Commercializzato da:

APOTEX INC

Codice ATC:

C10AA05

INN (Nome Internazionale):

ATORVASTATIN

Dosaggio:

80MG

Forma farmaceutica:

TABLET

Composizione:

ATORVASTATIN (ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE) 80MG

Via di somministrazione:

ORAL

Confezione:

250ML

Tipo di ricetta:

Prescription

Area terapeutica:

HMG-COA REDUCTASE INHIBITORS

Dettagli prodotto:

Active ingredient group (AIG) number: 0133055004; AHFS:

Stato dell'autorizzazione:

MARKETED

Data dell'autorizzazione:

2013-01-07

Scheda tecnica

Page 1 of 46
PRODUCT MONOGRAPH
Pr
ATORVASTATIN
(ATORVASTATIN CALCIUM TABLETS)
10 MG, 20 MG, 40 MG AND 80 MG
(ATORVASTATIN AS ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE)
LIPID METABOLISM REGULATOR
APOTEX INC.
DATE OF PREPARATION:
150 SIGNET DRIVE
NOVEMBER 5, 2012
TORONTO, ONTARIO
M9L 1T9
SUBMISSION CONTROL NO: 159558
Page 2 of 46
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
3
SUMMARY PRODUCT INFORMATION
...........................................................................................
3
INDICATIONS AND CLINICAL USE
.................................................................................................
3
CONTRAINDICATIONS
......................................................................................................................
4
WARNINGS AND PRECAUTIONS
.....................................................................................................
5
ADVERSE REACTIONS
......................................................................................................................
9
DRUG INTERACTIONS
.....................................................................................................................
12
DOSAGE AND ADMINISTRATION
.................................................................................................
16
OVERDOSAGE
...................................................................................................................................
17
ACTION AND CLINICAL PHARMACOLOGY
...............................................................................
18
STORAGE AND STABILITY
.............................................................................................................
20
SPECIAL HANDLING INSTRUCTIONS
..........................................................................................
20
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................................ 21
PART II: SCIENTIFIC INFORMATION