NOVO-GLIMEPIRIDE TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
23-11-2005
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Active ingredient:
GLIMEPIRIDE
Available from:
NOVOPHARM LIMITED
ATC code:
A10BB12
INN (International Name):
GLIMEPIRIDE
Dosage:
1MG
Pharmaceutical form:
TABLET
Composition:
GLIMEPIRIDE 1MG
Administration route:
ORAL
Units in package:
100
Prescription type:
Prescription
Therapeutic area:
SULFONYLUREAS
Product summary:
Active ingredient group (AIG) number: 0146247001; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2015-10-26
Summary of Product characteristics
PRODUCT MONOGRAPH
Pr
NOVO-GLIMEPIRIDE
(glimepiride)
Tablets 1 mg, 2 mg and 4 mg
Oral Hypoglycemic (Sulfonylurea)
Novopharm Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Submission Control No: 091409
Date of Preparation:
November 22, 2005
2
Table of Contents
PART I: HEALTH PROFESSIONAL
INFORMATION......................................................... 3
SUMMARY PRODUCT INFORMATION
........................................................................
3
INDICATIONS AND CLINICAL
USE..............................................................................
3
CONTRAINDICATIONS
...................................................................................................
3
WARNINGS AND
PRECAUTIONS..................................................................................
4
ADVERSE
REACTIONS....................................................................................................
7
DRUG INTERACTIONS
....................................................................................................
9
DOSAGE AND
ADMINISTRATION..............................................................................
12
OVERDOSAGE
................................................................................................................
14
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 14
STORAGE AND
STABILITY..........................................................................................
18
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 18
PART II: SCIENTIFIC INFORMATION
...............................................................................
19
PHARMACEUTICAL
INFORMATION..........................................................................
19
CLINICAL
TRIALS..........................................................................................................
19
DETAILED
PHARMACOLOGY.....................................................................................
24
TOXICOLOGY
...
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