REMINYL ER CAPSULE (EXTENDED RELEASE)

Држава: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

GALANTAMINE (GALANTAMINE HYDROBROMIDE)

Доступно од:

JANSSEN INC

АТЦ код:

N06DA04

INN (Међународно име):

GALANTAMINE

Дозирање:

16MG

Фармацеутски облик:

CAPSULE (EXTENDED RELEASE)

Састав:

GALANTAMINE (GALANTAMINE HYDROBROMIDE) 16MG

Пут администрације:

ORAL

Јединице у пакету:

30

Тип рецептора:

Prescription

Терапеутска област:

PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS

Резиме производа:

Active ingredient group (AIG) number: 0144660004; AHFS:

Статус ауторизације:

CANCELLED POST MARKET

Датум одобрења:

2017-03-31

Карактеристике производа

_200217 - REMINYL ER - APM.doc _
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_Page 1 of 51 _
PRODUCT MONOGRAPH
PR
REMINYL
® ER
galantamine hydrobromide extended release capsules, House Std.
8 mg, 16 mg, 24 mg galantamine base
Cholinesterase Inhibitor
Janssen Inc.
19 Green Belt Drive
Toronto, Ontario
M3C 1L9
www.janssen.com/canada
Date of Revision:
January 11, 2017
Submission Control No: 200217
All trademarks used under license.
© 2016 Janssen Inc.
_200217 - REMINYL ER - APM.doc _
_ _
_Page 2 of 51 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
...............................................................................
3
INDICATIONS AND CLINICAL USE
.....................................................................................
3
WARNINGS AND PRECAUTIONS
.........................................................................................
4
ADVERSE REACTIONS
...........................................................................................................
7
DRUG INTERACTIONS
.........................................................................................................
14
DOSAGE AND ADMINISTRATION
.....................................................................................
16
OVERDOSAGE
.......................................................................................................................
17
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 18
STORAGE AND STABILITY
.................................................................................................
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 23
PART II: SCIENTIFIC INFORMATION
..............................................................................
24
PHARMACEUTICAL INFORMATION
.................................................................................
24
CLINICAL TRIALS
..................................................