SANDOZ LOVASTATIN TABLET

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

LOVASTATIN

זמין מ:

SANDOZ CANADA INCORPORATED

קוד ATC:

C10AA02

INN (שם בינלאומי):

LOVASTATIN

כמות:

20MG

טופס פרצבטיות:

TABLET

הרכב:

LOVASTATIN 20MG

מסלול נתינה (של תרופות):

ORAL

יחידות באריזה:

100/500

סוג מרשם:

Prescription

איזור תרפויטי:

HMG-COA REDUCTASE INHIBITORS

leaflet_short:

Active ingredient group (AIG) number: 0120669002; AHFS:

מצב אישור:

CANCELLED POST MARKET

תאריך אישור:

2019-08-01

מאפייני מוצר

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_Sandoz Lovastatin _
_Page 1 of 43_
PRODUCT MONOGRAPH
PR SANDOZ LOVASTATIN
Lovastatin Tablets USP
20 mg and 40 mg
Lipid Metabolism Regulator
Sandoz Canada Inc.
145 Jules-Léger
Boucherville, QC
J4B 7K8
Date of Revision: March 20, 2014
Submission Control Number: 172518
_ _
_Sandoz Lovastatin _
_Page 2 of 43_
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
..................................................................................................12
DRUG INTERACTIONS
..................................................................................................15
DOSAGE AND ADMINISTRATION
..............................................................................17
OVERDOSAGE
................................................................................................................19
ACTION AND CLINICAL PHARMACOLOGY
............................................................19
STORAGE AND STABILITY
..........................................................................................20
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................20
PART II: SCIENTIFIC INFORMATION
...............................................................................21
PHARMACEUTICAL INFORMATION
..........................................................................21
CLINICAL TRIALS
..........................................................................................................22
DETAILED PHARMACOLOGY
............................................