TEVA-ROSIGLITAZONE TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ROSIGLITAZONE (ROSIGLITAZONE MALEATE)

Available from:

TEVA CANADA LIMITED

ATC code:

A10BG02

INN (International Name):

ROSIGLITAZONE

Dosage:

8MG

Pharmaceutical form:

TABLET

Composition:

ROSIGLITAZONE (ROSIGLITAZONE MALEATE) 8MG

Administration route:

ORAL

Units in package:

30/100/500

Prescription type:

Prescription

Therapeutic area:

THIAZOLIDINEDIONES

Product summary:

Active ingredient group (AIG) number: 0138802004; AHFS:

Authorization status:

CANCELLED PRE MARKET

Authorization date:

2015-10-16

Summary of Product characteristics

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_TEVA-ROSIGLITAZONE Tablets 2 mg, 4 mg and 8 mg _
_Page 1 of 53_
PRODUCT MONOGRAPH
PR
TEVA-ROSIGLITAZONE
rosiglitazone (as rosiglitazone maleate)
2 mg, 4 mg and 8 mg Tablets
Professed Standard
Antidiabetic Agent
Teva Canada Limited.
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Date of Revision
May 10, 2011
Submission Control No: 146250
_ _
_TEVA-ROSIGLITAZONE Tablets 2 mg, 4 mg and 8 mg _
_Page 2 of 53_
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...................................................................................................
9
DRUG INTERACTIONS
.................................................................................................
14
DOSAGE AND
ADMINISTRATION.............................................................................
16
OVERDOSAGE
...............................................................................................................
17
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 18
STORAGE AND
STABILITY.........................................................................................
24
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 24
PART II: SCIENTIFIC INFORMATION
..............................................................................
25
PHARMACEUTICAL
INFORMATION.........................................................................
25
CLINICAL
TRIALS.....................................................................................