SANDOZ LOVASTATIN TABLET

Држава: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

LOVASTATIN

Доступно од:

SANDOZ CANADA INCORPORATED

АТЦ код:

C10AA02

INN (Међународно име):

LOVASTATIN

Дозирање:

40MG

Фармацеутски облик:

TABLET

Састав:

LOVASTATIN 40MG

Пут администрације:

ORAL

Јединице у пакету:

100

Тип рецептора:

Prescription

Терапеутска област:

HMG-COA REDUCTASE INHIBITORS

Резиме производа:

Active ingredient group (AIG) number: 0120669001; AHFS:

Статус ауторизације:

CANCELLED POST MARKET

Датум одобрења:

2019-08-01

Карактеристике производа

_ _
_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
............................................