MYLAN-LOVASTATIN TABLET

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

LOVASTATIN

Boleh didapati daripada:

MYLAN PHARMACEUTICALS ULC

Kod ATC:

C10AA02

INN (Nama Antarabangsa):

LOVASTATIN

Dos:

40MG

Borang farmaseutikal:

TABLET

Komposisi:

LOVASTATIN 40MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

100

Jenis preskripsi:

Prescription

Kawasan terapeutik:

HMG-COA REDUCTASE INHIBITORS

Ringkasan produk:

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

Status kebenaran:

CANCELLED POST MARKET

Tarikh kebenaran:

2017-08-02

Ciri produk

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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
....