TEVA-FLURBIPROFEN TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
14-07-2015
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Active ingredient:
FLURBIPROFEN
Available from:
TEVA CANADA LIMITED
ATC code:
M01AE09
INN (International Name):
FLURBIPROFEN
Dosage:
50MG
Pharmaceutical form:
TABLET
Composition:
FLURBIPROFEN 50MG
Administration route:
ORAL
Units in package:
100/500
Prescription type:
Prescription
Therapeutic area:
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Product summary:
Active ingredient group (AIG) number: 0115998002; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2019-08-08
Summary of Product characteristics
PRODUCT MONOGRAPH
PR
TEVA-FLURBIPROFEN
(Flurbiprofen tablets BP)
50 mg and 100 mg Tablets
Nonsteroidal anti-inflammatory drug (NSAID)
Teva Canada Limited
Date of Revision:
30 Novopharm Court
July 14, 2015
Toronto, Ontario
M1B 2K9
www.tevacanada.com
Control No.: 184835
2
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
INDICATIONS AND CLINICAL USE
..........................................................................
3
CONTRAINDICATIONS
................................................................................................
4
WARNINGS AND PRECAUTIONS
..............................................................................
5
ADVERSE REACTIONS
...............................................................................................
16
DRUG INTERACTIONS
...............................................................................................
19
DOSAGE AND ADMINISTRATION
..........................................................................
22
OVERDOSAGE
..............................................................................................................
23
ACTION AND CLINICAL PHARMACOLOGY
....................................................... 23
STORAGE AND
STABILITY.......................................................................................
25
DOSAGE FORMS, COMPOSITION AND PACKAGING
....................................... 25
PART II: SCIENTIFIC INFORMATION
..............................................................................
27
PHARMACEUTICAL INFORMATION
.....................................................................
27
CLINICAL TRIALS
.......................................................................................................
28
DETAILED PHARMACOLOGY
.................................................................................
30
TOXICOLOGY
..............................................................................................................
30
REFERENCES
.
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