MYLAN-SIMVASTATIN TABLET

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

SIMVASTATIN

Boleh didapati daripada:

MYLAN PHARMACEUTICALS ULC

Kod ATC:

C10AA01

INN (Nama Antarabangsa):

SIMVASTATIN

Dos:

10MG

Borang farmaseutikal:

TABLET

Komposisi:

SIMVASTATIN 10MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

30/100

Jenis preskripsi:

Prescription

Kawasan terapeutik:

HMG-COA REDUCTASE INHIBITORS

Ringkasan produk:

Active ingredient group (AIG) number: 0122415004; AHFS:

Status kebenaran:

CANCELLED POST MARKET

Tarikh kebenaran:

2019-09-17

Ciri produk

PRODUCT MONOGRAPH
PR
MYLAN-SIMVASTATIN
(Simvastatin Tablets)
5 mg, 10 mg, 20 mg, 40 mg and 80 mg
USP
Lipid Metabolism Regulator
Mylan Pharmaceuticals ULC
DATE OF REVISION: July 31, 2019
85 Advance Road
Etobicoke, ON
Canada
M8Z 2S6
Submission Number: 230095
_ _
_Product Monograph –Mylan_-_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
.................................................................................................
13
DRUG INTERACTIONS
.................................................................................................
16
DOSAGE AND ADMINISTRATION
.............................................................................
20
OVERDOSAGE
...............................................................................................................
22
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 22
STORAGE AND STABILITY
.........................................................................................
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 23
PART II: SCIENTIFIC INFORMATION
...............................................................................
25
PHARMACEUTICAL INFORMATION
.........................................................................
25
CLINICAL TRIALS
.........................................................................................................
27
DETAILED PHARMACOLOGY
...................................