NTP-FENOFIBRATE-S TABLET

Riik: Kanada

keel: inglise

Allikas: Health Canada

Toimeaine:

FENOFIBRATE

Saadav alates:

TEVA CANADA LIMITED

ATC kood:

C10AB05

INN (Rahvusvaheline Nimetus):

FENOFIBRATE

Annus:

160MG

Ravimvorm:

TABLET

Koostis:

FENOFIBRATE 160MG

Manustamisviis:

ORAL

Ühikuid pakis:

100/500

Retsepti tüüp:

Prescription

Terapeutiline ala:

FRIBIC ACID DERIVATIVES

Toote kokkuvõte:

Active ingredient group (AIG) number: 0118895004; AHFS:

Volitamisolek:

CANCELLED PRE MARKET

Loa andmise kuupäev:

2015-08-06

Toote omadused

PRODUCT MONOGRAPH
Pr
NTP-FENOFIBRATE-S
Fenofibrate
Micronized Formulation
Film-Coated Tablets
100mg and 160mg
Lipid Metabolism Regulator
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Submission Control No: 167234
Date of Preparation:
28 August 2013
_Page 2 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
.........................................................................
3
INDICATIONS AND CLINICAL USE
..............................................................................
3
CONTRAINDICATIONS
....................................................................................................
4
WARNINGS AND PRECAUTIONS
..................................................................................
4
ADVERSE REACTIONS
....................................................................................................
6
DRUG INTERACTIONS
....................................................................................................
9
DOSAGE AND ADMINISTRATION
................................................................................
9
OVERDOSAGE
.................................................................................................................
10
ACTION AND CLINICAL PHARMACOLOGY
............................................................. 10
STORAGE AND STABILITY
..........................................................................................
11
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................. 12
PART II: SCIENTIFIC INFORMATION
...............................................................................
13
PHARMACEUTICAL INFORMATION
..........................................................................
13
CLINICAL TRIALS
..........................................................................................................
14
DETAILED PHARMACOLOGY
.........................................................