ATORVASTATIN TABLET

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

ATORVASTATIN (ATORVASTATIN CALCIUM)

Disponible des:

SIVEM PHARMACEUTICALS ULC

Codi ATC:

C10AA05

Designació comuna internacional (DCI):

ATORVASTATIN

Dosis:

40MG

formulario farmacéutico:

TABLET

Composición:

ATORVASTATIN (ATORVASTATIN CALCIUM) 40MG

Vía de administración:

ORAL

Unidades en paquete:

30/100/500

tipo de receta:

Prescription

Área terapéutica:

HMG-COA REDUCTASE INHIBITORS

Resumen del producto:

Active ingredient group (AIG) number: 0133055003; AHFS:

Estat d'Autorització:

CANCELLED POST MARKET

Data d'autorització:

2018-05-09

Fitxa tècnica

_ATORVASTATIN Product Monograph _
_Page 1 of 49 _
PRODUCT MONOGRAPH
PR
ATORVASTATIN
(atorvastatin calcium tablets)
10 mg, 20 mg, 40 mg and 80 mg atorvastatin
LIPID METABOLISM REGULATOR
Sivem Pharmaceuticals ULC
4705 Dobrin Street
DATE OF REVISION:
September 26, 2017
Saint-Laurent, Quebec
H4R 2P7
Submission Control No.: 209551
_ATORVASTATIN Product Monograph _
_ _
_Page 2 of 49 _
_ _
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
.........................................................................................................
10
DRUG INTERACTIONS
.........................................................................................................
13
DOSAGE AND ADMINISTRATION
....................................................................................
18
OVERDOSAGE
.......................................................................................................................
19
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 20
STORAGE AND STABILITY
................................................................................................
23
SPECIAL HANDLING INSTRUCTIONS
..............................................................................
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 23
PART II: SCIENTIFIC INFORMATION
...............................................................................24
PHARMACEUTICAL INFORMATIO