NIASPAN TABLET (EXTENDED-RELEASE)

Nchi: Kanada

Lugha: Kiingereza

Chanzo: Health Canada

Nunua Sasa

Tabia za bidhaa Tabia za bidhaa (SPC)
23-10-2015

Viambatanisho vya kazi:

NICOTINIC ACID

Inapatikana kutoka:

SUNOVION PHARMACEUTICALS CANADA INC

ATC kanuni:

C10AD02

INN (Jina la Kimataifa):

NICOTINIC ACID

Kipimo:

1000MG

Dawa fomu:

TABLET (EXTENDED-RELEASE)

Tungo:

NICOTINIC ACID 1000MG

Njia ya uendeshaji:

ORAL

Vitengo katika mfuko:

30

Dawa ya aina:

Prescription

Eneo la matibabu:

MISCELLANEOUS ANTILIPEMIC AGENTS

Bidhaa muhtasari:

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

Idhini hali ya:

CANCELLED POST MARKET

Idhini ya tarehe:

2017-06-30

Tabia za bidhaa

                                PRODUCT MONOGRAPH
PR
NIASPAN
®
Extended-Release Niacin
500 mg and 1000 mg Extended-Release Tablets
Lipid Metabolism Regulator
Manufacturer:
DATE OF REVISION:
Sunovion Pharmaceuticals Canada Inc.
October 23, 2015
6790 Century Ave. Suite 100
Mississauga, Ontario
Canada
Submission #: 185768
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
................................................................................
3
INDICATIONS AND CLINICAL
USE......................................................................................
3
CONTRAINDICATIONS
...........................................................................................................
3
WARNINGS AND PRECAUTIONS
.........................................................................................
4
ADVERSE REACTIONS
...........................................................................................................
7
DRUG INTERACTIONS
..........................................................................................................
11
DOSAGE AND ADMINISTRATION
......................................................................................
12
OVERDOSAGE
........................................................................................................................
14
ACTION AND CLINICAL PHARMACOLOGY
....................................................................
14
STORAGE AND STABILITY
.................................................................................................
16
DOSAGE FORMS, COMPOSITION AND PACKAGING
..................................................... 16
PART II: SCIENTIFIC INFORMATION
..............................................................................
17
PHARMACEUTICAL INFORMATION
.................................................................................
17
CLINICAL
TRIALS...............................................................................................
                                
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