ESOMEPRAZOLE TABLET (DELAYED-RELEASE)
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
17-11-2022
Some documents for this product are not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain them.
Send request.
Send request.
Active ingredient:
ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM)
Available from:
SIVEM PHARMACEUTICALS ULC
ATC code:
A02BC05
INN (International Name):
ESOMEPRAZOLE
Dosage:
40MG
Pharmaceutical form:
TABLET (DELAYED-RELEASE)
Composition:
ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM) 40MG
Administration route:
ORAL
Units in package:
30/100/500
Prescription type:
Prescription
Therapeutic area:
PROTON-PUMP INHIBITORS
Product summary:
Active ingredient group (AIG) number: 0145162002; AHFS:
Authorization status:
APPROVED
Authorization date:
2021-06-14
Summary of Product characteristics
_Pr_
_ESOMEPRAZOLE (Esomeprazole Magnesium Delayed Release Tablets) Product
Monograph _
_Page 1 of 47_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
ESOMEPRAZOLE
Esomeprazole Magnesium Delayed Release Tablets
Delayed release tablets, 20 mg and 40 mg esomeprazole (as esomeprazole
magnesium amorphous)
, Oral use
H
+
, K
+
-ATPase Inhibitor
Sivem Pharmaceuticals ULC
4705 Dobrin Street
Saint-Laurent, Quebec
Canada H4R 2P7
www.sivem.ca
Date of Initial Authorization:
JUL 21, 2015
Date of Revision:
NOV 17, 2022
Submission Control No. 269390
_Pr_
_ESOMEPRAZOLE (Esomeprazole Magnesium Delayed Release Tablets) Product
Monograph _
_Page 2 of 47_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, General
11-2022
7 WARNINGS AND PRECAUTIONS, Gastrointestinal
11-2022
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women
11-2022
TABLE OF CONTENTS
Sections or subsections that are not applicable at the time of
authorization are not listed.
RECENT MAJOR LABEL
CHANGES………………………..………………………………………………………………….…………
2
PART I: HEALTH PROFESSIONAL INFORMATION
...........................................................................................
4
1 INDICATIONS
..............................................................................................................................................
4
1.1
Pediatrics............................................................................................................................................
4
2 CONTRAINDICATIONS
................................................................................................................................
4
4 DOSAGE AND
ADMINISTRATION................................................................................................................
5
4.1 Dosing Considerations
.......................................................................................................................
5
4.2 Recommended Dose and Dosage Adjustment
.................
Read the complete document
