LUPIN-CELECOXIB CAPSULE

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

CELECOXIB

Disponible depuis:

LUPIN PHARMA CANADA LIMITED

Code ATC:

M01AH01

DCI (Dénomination commune internationale):

CELECOXIB

Dosage:

100MG

forme pharmaceutique:

CAPSULE

Composition:

CELECOXIB 100MG

Mode d'administration:

ORAL

Unités en paquet:

100/500

Type d'ordonnance:

Prescription

Domaine thérapeutique:

CYCLOOXYGENASE-2 (COX-2) INHIBITORS

Descriptif du produit:

Active ingredient group (AIG) number: 0137043001; AHFS:

Statut de autorisation:

APPROVED

Date de l'autorisation:

2014-11-17

Résumé des caractéristiques du produit

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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