MYLAN-SIMVASTATIN TABLET

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

SIMVASTATIN

Pieejams no:

MYLAN PHARMACEUTICALS ULC

ATĶ kods:

C10AA01

SNN (starptautisko nepatentēto nosaukumu):

SIMVASTATIN

Deva:

20MG

Zāļu forma:

TABLET

Kompozīcija:

SIMVASTATIN 20MG

Ievadīšanas:

ORAL

Vienības iepakojumā:

30/100

Receptes veids:

Prescription

Ārstniecības joma:

HMG-COA REDUCTASE INHIBITORS

Produktu pārskats:

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

Autorizācija statuss:

CANCELLED POST MARKET

Autorizācija datums:

2019-09-17

Produkta apraksts

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
...................................