দেশ: কানাডা
ভাষা: ইংরেজি
সূত্র: Health Canada
NICOTINIC ACID
SUNOVION PHARMACEUTICALS CANADA INC
C10AD02
NICOTINIC ACID
750MG
TABLET (EXTENDED-RELEASE)
NICOTINIC ACID 750MG
ORAL
30
Prescription
MISCELLANEOUS ANTILIPEMIC AGENTS
Active ingredient group (AIG) number: 0108396016; AHFS:
CANCELLED POST MARKET
2012-08-02
PRODUCT MONOGRAPH PR NIASPAN ® Extended-Release Niacin 500 mg, 750 mg, 1000 mg Extended-Release Tablets Lipid Metabolism Regulator Manufacturer: DATE OF PREPARATION: Sunovion Pharmaceuticals Canada Inc. October 11, 2011 6790 Century Ave. Suite 100 Mississauga, Ontario Canada Submission #: 149932 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.......................................................................................................... 10 DOSAGE AND ADMINISTRATION...................................................................................... 12 OVERDOSAGE ........................................................................................................................ 15 ACTION AND CLINICAL PHARMACOLOGY.................................................................... 15 STORAGE AND STABILITY ................................................................................................. 17 DOSAGE FORMS, COMPOSITION AND PACKAGING..................................................... 17 PART II: SCIENTIFIC INFORMATION .............................................................................. 19 PHARMACEUTICAL INFORMATION ................................................................................. 19 CLINICAL TRIALS.............................................................................................. সম্পূর্ণ নথি পড়ুন