LIPIDIL EZ TABLET

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

FENOFIBRATE

Disponibil de la:

BGP PHARMA ULC

Codul ATC:

C10AB05

INN (nume internaţional):

FENOFIBRATE

Dozare:

48MG

Forma farmaceutică:

TABLET

Compoziție:

FENOFIBRATE 48MG

Calea de administrare:

ORAL

Unități în pachet:

30

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

FRIBIC ACID DERIVATIVES

Rezumat produs:

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

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2015-01-15

Caracteristicilor produsului

_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