MYLAN-ESOMEPRAZOLE CAPSULE (DELAYED RELEASE)

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM)

Dostępny od:

MYLAN PHARMACEUTICALS ULC

Kod ATC:

A02BC05

INN (International Nazwa):

ESOMEPRAZOLE

Dawkowanie:

20MG

Forma farmaceutyczna:

CAPSULE (DELAYED RELEASE)

Skład:

ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM) 20MG

Droga podania:

ORAL

Sztuk w opakowaniu:

100

Typ recepty:

Prescription

Dziedzina terapeutyczna:

PROTON-PUMP INHIBITORS

Podsumowanie produktu:

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

Status autoryzacji:

CANCELLED PRE MARKET

Data autoryzacji:

2017-01-11

Charakterystyka produktu

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