PMSC-ESOMEPRAZOLE DR TABLET (DELAYED-RELEASE)
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
28-06-2022
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Active ingredient:
ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM DIHYDRATE)
Available from:
PHARMASCIENCE INC
ATC code:
A02BC05
INN (International Name):
ESOMEPRAZOLE
Dosage:
20MG
Pharmaceutical form:
TABLET (DELAYED-RELEASE)
Composition:
ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM DIHYDRATE) 20MG
Administration route:
ORAL
Units in package:
15G/50G
Prescription type:
Prescription
Product summary:
Active ingredient group (AIG) number: 0145162001; AHFS:
Authorization status:
APPROVED
Authorization date:
2022-06-28
Summary of Product characteristics
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PMSC-ESOMEPRAZOLE DR
Esomeprazole Delayed Release Tablets
Delayed release tablets, 20 mg, 40 mg, Oral use
H
+
, K
+
-ATPase Inhibitor
Submission Control No.: 254119
PHARMASCIENCE INC
6111 Royalmount Ave., Suite 100
Montréal,
Quebec
Canada
H4P 2T4
Date
of
Initial
Authorization:
June 28, 2022
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, General
06-2022
7 WARNINGS AND PRECAUTIONS, Gastrointestinal
06-2022
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women
06-2022
TABLE OF CONTENTS
Sections or subsections that are not applicable at the time of
authorization are not listed.
RECENT MAJOR LABEL CHANGES
.............................................................................................
2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................................
4
1
INDICATIONS
........................................................................................................................
4
1.1
Pediatrics
................................................................................................................................
4
2
CONTRAINDICATIONS
...........................................................................................................
4
4
DOSAGE AND ADMINISTRATION
...........................................................................................
4
4.1
Dosing Considerations
...........................................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
......................................................................
5
4.4
Administration
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6
4.5
Missed Dose
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