MYLAN-LOVASTATIN TABLET
Land: Canada
Sprog: engelsk
Kilde: Health Canada
Produktets egenskaber
(SPC)
26-03-2014
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Aktiv bestanddel:
LOVASTATIN
Tilgængelig fra:
MYLAN PHARMACEUTICALS ULC
ATC-kode:
C10AA02
INN (International Name):
LOVASTATIN
Dosering:
40MG
Lægemiddelform:
TABLET
Sammensætning:
LOVASTATIN 40MG
Indgivelsesvej:
ORAL
Enheder i pakken:
100
Recept type:
Prescription
Terapeutisk område:
HMG-COA REDUCTASE INHIBITORS
Produkt oversigt:
Active ingredient group (AIG) number: 0120669001; AHFS:
Autorisation status:
CANCELLED POST MARKET
Autorisation dato:
2017-08-02
Produktets egenskaber
_ _
_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
....
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