MYLAN-ESOMEPRAZOLE CAPSULE (DELAYED RELEASE)

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM)

MAH:

MYLAN PHARMACEUTICALS ULC

ATC_code:

A02BC05

INN:

ESOMEPRAZOLE

dosage:

20MG

pharmaceutical_form:

CAPSULE (DELAYED RELEASE)

composition:

ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM) 20MG

administration_route:

ORAL

units_in_package:

100

prescription_type:

Prescription

therapeutic_area:

PROTON-PUMP INHIBITORS

leaflet_short:

Active ingredient group (AIG) number: 0145162001; AHFS:

authorization_status:

CANCELLED PRE MARKET

authorization_date:

2017-01-11

SPC

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
................