NIASPAN FCT TABLET (EXTENDED-RELEASE)

देश: कनाडा

भाषा: अंग्रेज़ी

स्रोत: Health Canada

इसे खरीदें

सक्रिय संघटक:

NICOTINIC ACID

थमां उपलब्ध:

SUNOVION PHARMACEUTICALS CANADA INC

ए.टी.सी कोड:

C10AD02

INN (इंटरनेशनल नाम):

NICOTINIC ACID

डोज़:

1000MG

फार्मास्यूटिकल फॉर्म:

TABLET (EXTENDED-RELEASE)

रचना:

NICOTINIC ACID 1000MG

प्रशासन का मार्ग:

ORAL

पैकेज में यूनिट:

90

प्रिस्क्रिप्शन प्रकार:

Prescription

चिकित्सीय क्षेत्र:

MISCELLANEOUS ANTILIPEMIC AGENTS

उत्पाद समीक्षा:

Active ingredient group (AIG) number: 0108396010; AHFS:

प्राधिकरण का दर्जा:

CANCELLED POST MARKET

प्राधिकरण की तारीख:

2019-07-22

उत्पाद विशेषताएं

                                PRODUCT MONOGRAPH
PR
NIASPAN FCT
®
Extended-Release Niacin
500 mg and 1000 mg Extended-Release Film Coated Tablets
Lipid Metabolism Regulator
Manufacturer:
Sunovion Pharmaceuticals Canada Inc.
6790 Century Ave., Suite 100
Mississauga, Ontario
Canada
DATE OF REVISION:
October 18, 2017
SUBMISSION CONTROL NUMBER:
208538
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
...........................................................................................................
7
DRUG INTERACTIONS
..........................................................................................................
11
DOSAGE AND ADMINISTRATION
......................................................................................
12
OVERDOSAGE
........................................................................................................................
14
ACTION AND CLINICAL PHARMACOLOGY
....................................................................
15
STORAGE AND STABILITY
.................................................................................................
17
DOSAGE FORMS, COMPOSITION AND PACKAGING
..................................................... 17
PART II: SCIENTIFIC INFORMATION
..............................................................................
18
PHARMACEUTICAL INFORMATION
.................................................................................
18
CLINICAL
TRIALS.................................................................
                                
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