MINT-CELECOXIB CAPSULE

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

CELECOXIB

Commercializzato da:

MINT PHARMACEUTICALS INC

Codice ATC:

M01AH01

INN (Nome Internazionale):

CELECOXIB

Dosaggio:

100MG

Forma farmaceutica:

CAPSULE

Composizione:

CELECOXIB 100MG

Via di somministrazione:

ORAL

Confezione:

30/1000

Tipo di ricetta:

Prescription

Area terapeutica:

CYCLOOXYGENASE-2 (COX-2) INHIBITORS

Dettagli prodotto:

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

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2014-11-17

Scheda tecnica

_MINT-CELECOXIB (celecoxib) _
_Page 1 of 57 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
MINT-CELECOXIB
Celecoxib Capsules
Capsules, 100 mg and 200 mg, for oral use
Non-steroidal Anti-Inflammatory Drug (NSAID)
Mint Pharmaceuticals Inc.
6575 Davand Drive
Mississauga, Ontario
L5T 2M3
Date of Initial Authorization:
November 17, 2014
Date of Revision:
September 23, 2022
Submission Control No: 263511
_MINT-CELECOXIB (celecoxib) _
_Page 2 of 57 _
RECENT MAJOR LABEL CHANGES
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
09/2022
7 WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests, Pregnancy
09/2022
7 WARNINGS AND PRECAUTIONS, Skin, _Serious skin reactions_
09/2022
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant women
09/2022
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED .
RECENT MAJOR LABEL CHANGES
......................................................................................................2
TABLE OF CONTENTS
........................................................................................................................2
PART I: HEALTH PROFESSIONAL INFORMATION
................................................................................4
1
INDICATIONS
........................................................................................................................4
1.1
Pediatrics
.....................................................................................................................4
1.2
Geriatrics
.....................................................................................................................4
2
CONTRAINDICATIONS
...........................................................................................................5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
......................................................................6
4
DOSAGE AND ADMINISTRATION
...........................................................................................7
4.1
Dosing Considerations
...........