MYLAN-MELOXICAM TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
09-01-2015
Some documents for this product are not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain them.
Send request.
Send request.
Active ingredient:
MELOXICAM
Available from:
MYLAN PHARMACEUTICALS ULC
ATC code:
M01AC06
INN (International Name):
MELOXICAM
Dosage:
7.5MG
Pharmaceutical form:
TABLET
Composition:
MELOXICAM 7.5MG
Administration route:
ORAL
Units in package:
100
Prescription type:
Prescription
Therapeutic area:
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Product summary:
Active ingredient group (AIG) number: 0131676003; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2018-06-15
Summary of Product characteristics
_ _
_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
Read the complete document
