TEVA-PRAVASTATIN TABLET

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

PRAVASTATIN SODIUM

Διαθέσιμο από:

TEVA CANADA LIMITED

Φαρμακολογική κατηγορία (ATC):

C10AA03

INN (Διεθνής Όνομα):

PRAVASTATIN

Δοσολογία:

20MG

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

PRAVASTATIN SODIUM 20MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

30/100

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

HMG-COA REDUCTASE INHIBITORS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0122563002; AHFS:

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2003-01-08

Αρχείο Π.Χ.Π.

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TEVA-PRAVASTATIN
pravastatin sodium
10 mg, 20 mg and 40 mg
Lipid Metabolism Regulator
Teva Canada Limited
Date of Revision:
30 Novopharm Court
July 14, 2020
Toronto, Ontario
Canada M1B 2K9
SUBMISSION CONTROL NO:
240026
_ _
2
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
...........................................................................................................
19
ACTION AND CLINICAL PHARMACOLOGY
....................................................... 19
STORAGE AND STABILITY
.....................................................................................
21
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................ 21
PART II: SCIENTIFIC INFORMATION
................................................................... 23
PHARMACEUTICAL INFORMATION
.....................................................................
23
CLINICAL TRIALS
.....................................................................................................
24
DETAILED PHARMACOLOGY
................................................................................
30
TOXICOLOGY
.................................................