JAMP-SIMVASTATIN TABLET

Land: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

SIMVASTATIN

Fáanlegur frá:

JAMP PHARMA CORPORATION

ATC númer:

C10AA01

INN (Alþjóðlegt nafn):

SIMVASTATIN

Skammtar:

20MG

Lyfjaform:

TABLET

Samsetning:

SIMVASTATIN 20MG

Stjórnsýsluleið:

ORAL

Einingar í pakka:

21/30/100/500/1000

Gerð lyfseðils:

Prescription

Lækningarsvæði:

HMG-COA REDUCTASE INHIBITORS

Vörulýsing:

Active ingredient group (AIG) number: 0122415003; AHFS:

Leyfisstaða:

CANCELLED POST MARKET

Leyfisdagur:

2013-07-08

Vara einkenni

_Jamp-Simvastatin (simvastatin) tablets_
_Page 1 of 47_
PRODUCT MONOGRAPH
PR
JAMP-SIMVASTATIN
Simvastatin Tablets, USP
5 mg, 10 mg, 20 mg, 40 mg and 80 mg
Lipid Metabolism Regulator
JAMP Pharma Corporation
Date of Revision:
1310 rue Nobel
June 14, 2019
Boucherville, Québec,
Canada
J4B 5H3
Submission Control No: 227575
_Jamp-Simvastatin (simvastatin) tablets_
_Page 2 of 47_
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
......................................................................................................
12
DRUG INTERACTIONS
......................................................................................................
15
DOSAGE AND ADMINISTRATION
..................................................................................
19
OVERDOSAGE
.....................................................................................................................
21
ACTION AND CLINICAL PHARMACOLOGY
................................................................ 21
STORAGE AND STABILITY
..............................................................................................
22
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................ 22
PART II: SCIENTIFIC INFORMATION
....................................................................................
23
PHARMACEUTICAL INFORMATION
.............................................................................
23
CLINICAL TRIALS
............................................