MYL-ESOMEPRAZOLE TABLET (DELAYED-RELEASE)

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM TRIHYDRATE)

Available from:

MYLAN PHARMACEUTICALS ULC

ATC code:

A02BC05

INN (International Name):

ESOMEPRAZOLE

Dosage:

40MG

Pharmaceutical form:

TABLET (DELAYED-RELEASE)

Composition:

ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM TRIHYDRATE) 40MG

Administration route:

ORAL

Units in package:

100/500

Prescription type:

Prescription

Therapeutic area:

PROTON-PUMP INHIBITORS

Product summary:

Active ingredient group (AIG) number: 0145162002; AHFS:

Authorization status:

APPROVED

Authorization date:

2018-07-26

Summary of Product characteristics

_MYL-ESOMEPRAZOLE (esomeprazole) _
_Page 1 of 58_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR MYL-ESOMEPRAZOLE
Esomeprazole Delayed Release Tablets
Delayed release tablets, 20 mg and 40 mg esomeprazole (as esomeprazole
magnesium
trihydrate), Oral
H
+
, K
+
-ATPase Inhibitor
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, Ontario
M8Z 2S6
Date of Initial Authorization:
JUL 26, 2018
Date of Revision:
JUN 22, 2023
Submission Control Number: 271970
_MYL-ESOMEPRAZOLE (esomeprazole) _
_Page 2 of 58_
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
06/2023
7 WARNINGS AND PRECAUTIONS, General
06/2023
7 WARNINGS AND PRECAUTIONS, Carcinogenesis and
Mutagenesis
06/2023
7 WARNINGS AND PRECAUTIONS, Gastrointestinal
06/2023
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women
06/2023
7 WARNINGS AND PRECAUTIONS, 7.1.2 Breast-feeding
06/2023
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
.....................................................................
5
1
INDICATIONS
..............................................................................................................
5
1.1
Pediatrics
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5
2
CONTRAINDICATIONS
.................................................................................................
6
4
DOSAGE AND ADMINISTRATION
.................................................................................
6
4.1
Dosing Considerations
..............................................................................................
6
4.2
Recommended Dose and Dosage Adjustment
......................................................... 6
4.