ATORVASTATIN-10 TABLET

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

ATORVASTATIN (ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE)

Διαθέσιμο από:

PRO DOC LIMITEE

Φαρμακολογική κατηγορία (ATC):

C10AA05

INN (Διεθνής Όνομα):

ATORVASTATIN

Δοσολογία:

10MG

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

ATORVASTATIN (ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE) 10MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

100/500

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

HMG-COA REDUCTASE INHIBITORS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0133055001; AHFS:

Καθεστώς αδειοδότησης:

CANCELLED POST MARKET

Ημερομηνία της άδειας:

2011-07-27

Αρχείο Π.Χ.Π.

Page 1 of 48
PRODUCT MONOGRAPH
Pr
ATORVASTATIN – 10
Pr
ATORVASTATIN – 20
Pr
ATORVASTATIN – 40
Pr
ATORVASTATIN – 80
(ATORVASTATIN CALCIUM TABLETS)
10 MG, 20 MG, 40 MG AND 80 MG
(ATORVASTATIN AS ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE)
LIPID METABOLISM REGULATOR
PRO DOC LTÉE
DATE OF PREPARATION:
2925, BOUL. INDUSTRIEL
MAY 18, 2010
LAVAL, QUÉBEC
H7L 3W9
SUBMISSION CONTROL NO: 137958
Page 2 of 48
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
.......................................................................................................10
DRUG
INTERACTIONS........................................................................................................11
DOSAGE AND
ADMINISTRATION.......................................................................................15
OVERDOSAGE.....................................................................................................................17
ACTION AND CLINICAL PHARMACOLOGY
.......................................................................17
STORAGE AND STABILITY
.................................................................................................20
SPECIAL HANDLING
INSTRUCTIONS................................................................................20
DOSAGE FORMS, COMPOSITION AND PACKAGING
......................................................20
PART II: SCIENTIFIC
INFORMATION..................................................................................