MYLAN-REPAGLINIDE TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
25-09-2015
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Active ingredient:
REPAGLINIDE
Available from:
MYLAN PHARMACEUTICALS ULC
ATC code:
A10BX02
INN (International Name):
REPAGLINIDE
Dosage:
1MG
Pharmaceutical form:
TABLET
Composition:
REPAGLINIDE 1MG
Administration route:
ORAL
Units in package:
100
Prescription type:
Prescription
Therapeutic area:
MEGLITINIDES
Product summary:
Active ingredient group (AIG) number: 0137035002; AHFS:
Authorization status:
CANCELLED PRE MARKET
Authorization date:
2016-11-02
Summary of Product characteristics
1
PRODUCT MONOGRAPH
PR
MYLAN-REPAGLINIDE
Repaglinide Tablets, USP
0.5 mg, 1 mg and 2 mg
Oral Antidiabetic Agent
MYLAN PHARMACEUTICALS ULC DATE OF REVISION:
85 Advance Road September 17, 2015
Etobicoke, Ontario
M8Z 2S6
CONTROL NO. 186886
2
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION .........................................................................
3
INDICATIONS
AND
CLINICAL
USE
..........................................................................................................
3
CONTRAINDICATIONS
...............................................................................................................................
4
WARNINGS
AND
PRECAUTIONS
..............................................................................................................
4
ADVERSE
REACTIONS
...............................................................................................................................
7
DRUG
INTERACTIONS
..............................................................................................................................
10
DOSAGE
AND
ADMINISTRATION
..........................................................................................................
15
OVERDOSAGE
............................................................................................................................................
16
ACTION
AND
CLINICAL
PHARMACOLOGY
........................................................................................
17
STORAGE
AND
STABILITY......................................................................................................................
19
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING
.........................................................................
20
PART II: SCIENTIFIC INFORMATION ................................................................................................
21
PHARMACEUTICAL
INFORMATION
.....................................................................................................
21
CLINICAL
TRIALS
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