PMS-PRAVASTATIN TABLET

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

PRAVASTATIN SODIUM

Dostopno od:

PHARMASCIENCE INC

Koda artikla:

C10AA03

INN (mednarodno ime):

PRAVASTATIN

Odmerek:

20MG

Farmacevtska oblika:

TABLET

Sestava:

PRAVASTATIN SODIUM 20MG

Pot uporabe:

ORAL

Enote v paketu:

10/100/500

Tip zastaranja:

Prescription

Terapevtsko območje:

HMG-COA REDUCTASE INHIBITORS

Povzetek izdelek:

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

Status dovoljenje:

APPROVED

Datum dovoljenje:

2003-07-21

Lastnosti izdelka

PRODUCT MONOGRAPH
PR
PMS-PRAVASTATIN
Pravastatin Sodium Tablets, USP
10 mg, 20 mg and 40 mg
LIPID METABOLISM REGULATOR
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Québec
H4P 2T4
www.pharmascience.com
DATE OF REVISION:
July 6, 2020
SUBMISSION CONTROL NO: 239593
_pms-PRAVASTATIN Product Monograph _
_Page 2 of 38_
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
............................................................19
STORAGE AND STABILITY
..........................................................................................21
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................21
PART II: SCIENTIFIC INFORMATION
...............................................................................22
PHARMACEUTICAL INFORMATION
..........................................................................22
CLINICAL TRIALS
..........................................................................................................23
DETAILED PHARMACOLOGY
.........................