MYLAN-MELOXICAM TABLET

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

MELOXICAM

Tilgjengelig fra:

MYLAN PHARMACEUTICALS ULC

ATC-kode:

M01AC06

INN (International Name):

MELOXICAM

Dosering :

7.5MG

Legemiddelform:

TABLET

Sammensetning:

MELOXICAM 7.5MG

Administreringsrute:

ORAL

Enheter i pakken:

100

Resept typen:

Prescription

Terapeutisk område:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Produkt oppsummering:

Active ingredient group (AIG) number: 0131676003; AHFS:

Autorisasjon status:

CANCELLED POST MARKET

Autorisasjon dato:

2018-06-15

Preparatomtale

_ _
_Product Monograph – Mylan-Meloxicam _
_Page 1 of 46 _
PRODUCT MONOGRAPH
PR
MYLAN-MELOXICAM
Meloxicam
7.5 mg and 15 mg Tablets
Professed Standard
Non-Steroidal Anti-Inflammatory Drug (NSAID)
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
Canada
M8Z 2S6
Control No.: 180981
DATE OF REVISION:
January 6, 2015
_ _
_Product Monograph – Mylan-Meloxicam Page 2 of 46_
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
.................................................................................................
15
DRUG INTERACTIONS
.................................................................................................
22
DOSAGE AND ADMINISTRATION
.............................................................................
26
OVERDOSAGE
...............................................................................................................
28
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 28
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 33
PART II: SCIENTIFIC INFORMATION
...............................................................................
34
PHARMACEUTICAL INFORMATION
.........................................................................
34
CLINICAL TRIALS
.........................................................................................................
35
DETAILED PHARMACOLOGY
....................................................................................
37
TOXI