MYLAN-ESOMEPRAZOLE CAPSULE (DELAYED RELEASE)

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM)

Disponible depuis:

MYLAN PHARMACEUTICALS ULC

Code ATC:

A02BC05

DCI (Dénomination commune internationale):

ESOMEPRAZOLE

Dosage:

20MG

forme pharmaceutique:

CAPSULE (DELAYED RELEASE)

Composition:

ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM) 20MG

Mode d'administration:

ORAL

Unités en paquet:

100

Type d'ordonnance:

Prescription

Domaine thérapeutique:

PROTON-PUMP INHIBITORS

Descriptif du produit:

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

Statut de autorisation:

CANCELLED PRE MARKET

Date de l'autorisation:

2017-01-11

Résumé des caractéristiques du produit

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