Q-SIMVASTATIN TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

SIMVASTATIN

Available from:

QD PHARMACEUTICALS ULC

ATC code:

C10AA01

INN (International Name):

SIMVASTATIN

Dosage:

5MG

Pharmaceutical form:

TABLET

Composition:

SIMVASTATIN 5MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

HMG-COA REDUCTASE INHIBITORS

Product summary:

Active ingredient group (AIG) number: 0122415001; AHFS:

Authorization status:

CANCELLED PRE MARKET

Authorization date:

2015-08-21

Summary of Product characteristics

_ _
_Product Monograph –Q-Simvastatin _
_Page 1 _
PRODUCT MONOGRAPH
PR
Q-SIMVASTATIN
(Simvastatin Tablets)
5 mg, 10 mg, 20 mg, 40 mg and 80 mg
USP
Lipid Metabolism Regulator
QD Pharmaceuticals ULC
DATE OF REVISION:
85 Advance Road
May 04, 2015
Etobicoke, ON
Canada
M8Z 2S6
Control No.: 183639
_ _
_Product Monograph –Q-Simvastatin _
_Page 2 of 50 _
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
.................................................................................................
16
DOSAGE AND ADMINISTRATION
.............................................................................
20
OVERDOSAGE
...............................................................................................................
21
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 22
STORAGE AND STABILITY
.........................................................................................
22
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 22
PART II: SCIENTIFIC INFORMATION
...............................................................................
24
PHARMACEUTICAL INFORMATION
.........................................................................
24
CLINICAL TRIALS
.........................................................................................................
26
DETAILED PHARMACOLOGY
...