MYLAN-ESOMEPRAZOLE CAPSULE (DELAYED RELEASE)
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
28-01-2017
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Active ingredient:
ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM)
Available from:
MYLAN PHARMACEUTICALS ULC
ATC code:
A02BC05
INN (International Name):
ESOMEPRAZOLE
Dosage:
40MG
Pharmaceutical form:
CAPSULE (DELAYED RELEASE)
Composition:
ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM) 40MG
Administration route:
ORAL
Units in package:
100
Prescription type:
Prescription
Therapeutic area:
PROTON-PUMP INHIBITORS
Product summary:
Active ingredient group (AIG) number: 0145162002; AHFS:
Authorization status:
CANCELLED PRE MARKET
Authorization date:
2017-01-11
Summary of Product characteristics
1
PRODUCT MONOGRAPH
PR
MYLAN-ESOMEPRAZOLE
esomeprazole delayed release capsules
20 and 40 mg esomeprazole (as esomeprazole magnesium)
H
+
, K
+
-ATPase Inhibitor
Mylan Pharmaceuticals ULC
85 Advance Rd.
Etobicoke, Ontario
M8Z 2S6
Control Number: 194955
Submission Control No.
Date of Revision:
June 03, 2016
2
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..................................................... 3
SUMMARY PRODUCT INFORMATION
..........................................................................
3
INDICATIONS AND CLINICAL USE
................................................................................
3
CONTRAINDICATIONS
.....................................................................................................
4
WARNINGS AND PRECAUTIONS
....................................................................................
4
ADVERSE REACTIONS
......................................................................................................
8
DRUG INTERACTIONS
....................................................................................................
14
DOSAGE AND ADMINISTRATION
................................................................................
17
OVERDOSAGE
..................................................................................................................
19
ACTION AND CLINICAL PHARMACOLOGY
.............................................................. 19
STORAGE AND STABILITY
............................................................................................
22
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................... 22
PART II: SCIENTIFIC INFORMATION
............................................................................
24
PHARMACEUTICAL INFORMATION
........................................................................
24
CLINICAL TRIALS
............................................................................................................
25
DETAILED PHARMACOLOGY
................
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