LUPIN-CELECOXIB CAPSULE
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
18-11-2014
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Active ingredient:
CELECOXIB
Available from:
LUPIN PHARMA CANADA LIMITED
ATC code:
M01AH01
INN (International Name):
CELECOXIB
Dosage:
100MG
Pharmaceutical form:
CAPSULE
Composition:
CELECOXIB 100MG
Administration route:
ORAL
Units in package:
100/500
Prescription type:
Prescription
Therapeutic area:
CYCLOOXYGENASE-2 (COX-2) INHIBITORS
Product summary:
Active ingredient group (AIG) number: 0137043001; AHFS:
Authorization status:
APPROVED
Authorization date:
2014-11-17
Summary of Product characteristics
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PRODUCT MONOGRAPH
PR
LUPIN-CELECOXIB
(celecoxib)
Capsules, 100 mg and 200 mg
Non-steroidal anti-inflammatory drug (NSAID)
Lupin Pharma Canada Limited
DATE OF PREPARATION:
1155, René-Lévesque West Blvd., Suite 2500 25 July 2014
Montreal QC,
H3B 2K4
SUBMISSION CONTROL NO: 154401, 175860
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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................................................................................................22
DOSAGE AND
ADMINISTRATION...........................................................................25
OVERDOSAGE...............................................................................................................27
ACTION AND CLINICAL
PHARMACOLOGY........................................................27
STORAGE AND
STABILITY.......................................................................................29
DOSAGE FORMS, COMPOSITION AND PACKAGING
.......................................30
PART II: SCIENTIFIC INFORMATION
...............................................................................31
PHARMACEUTICAL
INFORMATION.....................................................................31
CLINICAL
TRIALS.......................................................................................................32
DETAILED
PHARMACOLOGY.................................................................................40
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