RIVA-LOVASTATIN TABLET
Država: Kanada
Jezik: angleščina
Source: Health Canada
Lastnosti izdelka
(SPC)
17-01-2018
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Aktivna sestavina:
LOVASTATIN
Dostopno od:
LABORATOIRE RIVA INC.
Koda artikla:
C10AA02
INN (mednarodno ime):
LOVASTATIN
Odmerek:
20MG
Farmacevtska oblika:
TABLET
Sestava:
LOVASTATIN 20MG
Pot uporabe:
ORAL
Enote v paketu:
100
Tip zastaranja:
Prescription
Terapevtsko območje:
HMG-COA REDUCTASE INHIBITORS
Povzetek izdelek:
Active ingredient group (AIG) number: 0120669002; AHFS:
Status dovoljenje:
CANCELLED POST MARKET
Datum dovoljenje:
2018-09-11
Lastnosti izdelka
_RIVA-LOVASTATIN – Product Monograph _
_Page 1 of 43_
PRODUCT MONOGRAPH
PR
RIVA-LOVASTATIN
Lovastatin
20 mg and 40 mg Tablets
USP
Lipid Metabolism Regulator
LABORATOIRE RIVA INC.
660 Boul. Industriel
Blainville, Québec
J7C 3V4
www.labriva.com
Submission Control No.: 212413
Date of revision:
January 17, 2018
_RIVA-LOVASTATIN – Product Monograph _
_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
..................................................................................................
14
DOSAGE AND ADMINISTRATION
..............................................................................
17
OVERDOSAGE
.................................................................................................................
18
ACTION AND CLINICAL PHARMACOLOGY
............................................................. 19
STORAGE AND STABILITY
..........................................................................................
19
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................. 19
PART II: SCIENTIFIC INFORMATION
................................................................................
21
PHARMACEUTICAL INFORMATION
..........................................................................
21
CLINICAL TRIALS
...................................................................................................
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