NIASPAN FCT TABLET (EXTENDED-RELEASE)
Država: Kanada
Jezik: angleščina
Source: Health Canada
Lastnosti izdelka
(SPC)
18-10-2017
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Aktivna sestavina:
NICOTINIC ACID
Dostopno od:
SUNOVION PHARMACEUTICALS CANADA INC
Koda artikla:
C10AD02
INN (mednarodno ime):
NICOTINIC ACID
Odmerek:
500MG
Farmacevtska oblika:
TABLET (EXTENDED-RELEASE)
Sestava:
NICOTINIC ACID 500MG
Pot uporabe:
ORAL
Enote v paketu:
3/90
Tip zastaranja:
Prescription
Terapevtsko območje:
MISCELLANEOUS ANTILIPEMIC AGENTS
Povzetek izdelek:
Active ingredient group (AIG) number: 0108396003; AHFS:
Status dovoljenje:
CANCELLED POST MARKET
Datum dovoljenje:
2019-07-22
Lastnosti izdelka
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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