LIPIDIL EZ TABLET
Land: Kanada
Språk: engelska
Källa: Health Canada
Produktens egenskaper
(SPC)
17-02-2021
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Aktiva substanser:
FENOFIBRATE
Tillgänglig från:
BGP PHARMA ULC
ATC-kod:
C10AB05
INN (International namn):
FENOFIBRATE
Dos:
48MG
Läkemedelsform:
TABLET
Sammansättning:
FENOFIBRATE 48MG
Administreringssätt:
ORAL
Enheter i paketet:
30
Receptbelagda typ:
Prescription
Terapiområde:
FRIBIC ACID DERIVATIVES
Produktsammanfattning:
Active ingredient group (AIG) number: 0118895005; AHFS:
Bemyndigande status:
APPROVED
Tillstånd datum:
2015-01-15
Produktens egenskaper
_Lipidil EZ_
®
_ Product Monograph _
_ Page 1 of 45 _
_Date of Revision: February 17, 2021 and Control No. 243888 _
PRODUCT MONOGRAPH
PR
LIPIDIL EZ
®
fenofibrate, NanoCrystal
®
Formulation
film-coated tablets (48 mg and 145 mg)
Manufacturer’s Standard
LIPID METABOLISM REGULATOR
Submission Control No: 243888
® Lipidil EZ: Registered Trademark BGP Product Operations GmbH;
Licenced use by BGP Pharma ULC,
a Mylan company.
® NanoCrystal: Registered Trademark Elan Pharma International
Limited.; Licensed use by BGP Pharma ULC, Etobicoke, Ontario, M8Z 2S6
BGP Pharma ULC
85 Advance Road
Etobicoke, Ontario
M8Z 2S6
_ _
Date of Revision :
February 17, 2021
_Lipidil EZ_
®
_ Product Monograph _
_ Page 2 of 45 _
_Date of Revision: February 17, 2021 and Control No. 243888 _
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
.................................................................................................
10
DRUG INTERACTIONS
.................................................................................................
15
DOSAGE AND ADMINISTRATION
.............................................................................
19
OVERDOSAGE
...............................................................................................................
20
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 20
STORAGE AND STABILITY
.........................................................................................
23
DOSAGE FORMS, COMPOSITION AND PA
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