LIPIDIL EZ TABLET

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

FENOFIBRATE

Verfügbar ab:

BGP PHARMA ULC

ATC-Code:

C10AB05

INN (Internationale Bezeichnung):

FENOFIBRATE

Dosierung:

48MG

Darreichungsform:

TABLET

Zusammensetzung:

FENOFIBRATE 48MG

Verabreichungsweg:

ORAL

Einheiten im Paket:

30

Verschreibungstyp:

Prescription

Therapiebereich:

FRIBIC ACID DERIVATIVES

Produktbesonderheiten:

Active ingredient group (AIG) number: 0118895005; AHFS:

Berechtigungsstatus:

APPROVED

Berechtigungsdatum:

2015-01-15

Fachinformation

_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