Land: Kanada
Språk: engelska
Källa: Health Canada
NICOTINIC ACID
SUNOVION PHARMACEUTICALS CANADA INC
C10AD02
NICOTINIC ACID
1000MG
TABLET (EXTENDED-RELEASE)
NICOTINIC ACID 1000MG
ORAL
30
Prescription
MISCELLANEOUS ANTILIPEMIC AGENTS
Active ingredient group (AIG) number: 0108396010; AHFS:
CANCELLED POST MARKET
2017-06-30
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............................................................................................... Läs hela dokumentet