SANDOZ PRAVASTATIN TABLET

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

PRAVASTATIN SODIUM

Διαθέσιμο από:

SANDOZ CANADA INCORPORATED

Φαρμακολογική κατηγορία (ATC):

C10AA03

INN (Διεθνής Όνομα):

PRAVASTATIN

Δοσολογία:

10MG

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

PRAVASTATIN SODIUM 10MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

30/100/250/500

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

HMG-COA REDUCTASE INHIBITORS

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

CANCELLED POST MARKET

Ημερομηνία της άδειας:

2017-05-29

Αρχείο Π.Χ.Π.

PRODUCT MONOGRAPH
PR
SANDOZ PRAVASTATIN
Pravastatin Sodium
10 mg, 20 mg and 40 mg tablets
Lipid Metabolism Regulator
Sandoz Canada Inc.
145 Jules-Léger
Date of Revision: February 16, 2017
Boucherville, QC, Canada
J4B 7K8
Control No. 202280
Sandoz Pravastatin
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
..........................................................................................................
15
DOSAGE AND ADMINISTRATION
......................................................................................
17
OVERDOSAGE
........................................................................................................................
18
ACTION AND CLINICAL PHARMACOLOGY
....................................................................
18
STORAGE AND STABILITY
.................................................................................................
20
DOSAGE FORMS, COMPOSITION AND PACKAGING
..................................................... 20
PART II: SCIENTIFIC INFORMATION
...............................................................................
21
PHARMACEUTICAL INFORMATION
.................................................................................
21
CLINICAL TRIALS
............................................................................................................