Country: Canada
Language: English
Source: Health Canada
FLURBIPROFEN
PFIZER CANADA ULC
M01AE09
FLURBIPROFEN
50MG
TABLET
FLURBIPROFEN 50MG
ORAL
100
Prescription
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Active ingredient group (AIG) number: 0115998002; AHFS:
CANCELLED POST MARKET
2013-07-25
_ _ PRODUCT MONOGRAPH ANSAID* Flurbiprofen tablets USP 50 mg and 100 mg Tablets Nonsteroidal anti-inflammatory drug (NSAID) Pfizer Canada Inc 17,300 Trans-Canada Highway Kirkland, Quebec H9J 2M5 www.pfizer.ca DATE OF REVISION: FEBRUARY 3, 2010 SUBMISSION CONTROL NO: 133863 * TM Pharmacia & Upjohn Company LLC Pfizer Canada Inc, Licensee © Pfizer Canada Inc 2010 _ _ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION......................................................3 SUMMARY PRODUCT INFORMATION ........................................................................3 INDICATIONS AND CLINICAL USE..............................................................................3 CONTRAINDICATIONS ...................................................................................................4 WARNINGS AND PRECAUTIONS..................................................................................5 ADVERSE REACTIONS..................................................................................................14 DRUG INTERACTIONS ..................................................................................................17 DOSAGE AND ADMINISTRATION..............................................................................20 OVERDOSAGE ................................................................................................................21 ACTION AND CLINICAL PHARMACOLOGY ............................................................21 STORAGE AND STABILITY..........................................................................................24 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................24 PART II: SCIENTIFIC INFORMATION..............................................................................25 PHARMACEUTICAL INFORMATION..........................................................................25 CLINICAL TRIALS..........................................................................................................25 DETAILED PHARMACOLOGY... Read the complete document