MYLAN-LOVASTATIN TABLET

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

LOVASTATIN

Dostopno od:

MYLAN PHARMACEUTICALS ULC

Koda artikla:

C10AA02

INN (mednarodno ime):

LOVASTATIN

Odmerek:

40MG

Farmacevtska oblika:

TABLET

Sestava:

LOVASTATIN 40MG

Pot uporabe:

ORAL

Enote v paketu:

100

Tip zastaranja:

Prescription

Terapevtsko območje:

HMG-COA REDUCTASE INHIBITORS

Povzetek izdelek:

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

Status dovoljenje:

CANCELLED POST MARKET

Datum dovoljenje:

2017-08-02

Lastnosti izdelka

_ _
_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
....