MYLAN-SIMVASTATIN TABLET

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

SIMVASTATIN

Dostopno od:

MYLAN PHARMACEUTICALS ULC

Koda artikla:

C10AA01

INN (mednarodno ime):

SIMVASTATIN

Odmerek:

5MG

Farmacevtska oblika:

TABLET

Sestava:

SIMVASTATIN 5MG

Pot uporabe:

ORAL

Enote v paketu:

100

Tip zastaranja:

Prescription

Terapevtsko območje:

HMG-COA REDUCTASE INHIBITORS

Povzetek izdelek:

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

Status dovoljenje:

CANCELLED POST MARKET

Datum dovoljenje:

2019-09-17

Lastnosti izdelka

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