MYLAN-LOVASTATIN TABLET

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

LOVASTATIN

Dostupno od:

MYLAN PHARMACEUTICALS ULC

ATC koda:

C10AA02

INN (International ime):

LOVASTATIN

Doziranje:

40MG

Farmaceutski oblik:

TABLET

Sastav:

LOVASTATIN 40MG

Administracija rute:

ORAL

Jedinice u paketu:

100

Tip recepta:

Prescription

Područje terapije:

HMG-COA REDUCTASE INHIBITORS

Proizvod sažetak:

Active ingredient group (AIG) number: 0120669001; AHFS:

Status autorizacije:

CANCELLED POST MARKET

Datum autorizacije:

2017-08-02

Svojstava lijeka

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_Product Monograph –Mylan_-_Lovastatin Page 1 of 45_
PRODUCT MONOGRAPH
PR
MYLAN-LOVASTATIN
Lovastatin Tablets, USP
20 mg and 40 mg
LIPID METABOLISM REGULATOR
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Submission Control No.: 172776
Date of Revision: March 26, 2014
_ _
_Product Monograph –Mylan_-_Lovastatin Page 2 of 45 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
4
WARNINGS AND PRECAUTIONS
.................................................................................
5
ADVERSE REACTIONS
.................................................................................................
13
DRUG INTERACTIONS
.................................................................................................
15
DOSAGE AND ADMINISTRATION
.............................................................................
18
OVERDOSAGE
...............................................................................................................
20
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 20
STORAGE AND STABILITY
.........................................................................................
21
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 21
PART II: SCIENTIFIC INFORMATION
...............................................................................
22
PHARMACEUTICAL INFORMATION
.........................................................................
22
CLINICAL TRIALS
.........................................................................................................
23
DETAILED PHARMACOLOGY
....