TEVA-METHYLPHENIDATE ER-C TABLET (EXTENDED-RELEASE)

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

METHYLPHENIDATE HYDROCHLORIDE

Предлага се от:

TEVA CANADA LIMITED

АТС код:

N06BA04

INN (Международно Name):

METHYLPHENIDATE

дозиране:

36MG

Лекарствена форма:

TABLET (EXTENDED-RELEASE)

Композиция:

METHYLPHENIDATE HYDROCHLORIDE 36MG

Начин на приложение:

ORAL

Броя в опаковка:

100/500

Вид предписание :

Schedule G (CDSA III)

Терапевтична област:

Respiratory and CNS Stimulants

Каталог на резюме:

Active ingredient group (AIG) number: 0107548005; AHFS:

Статус Оторизация:

CANCELLED POST MARKET

Дата Оторизация:

2023-03-21

Данни за продукта

_ _
PRODUCT MONOGRAPH
TEVA-METHYLPHENIDATE ER-C
(Methylphenidate Hydrochloride)
Extended-release Tablets 18 mg, 27 mg, 36 mg, and 54 mg
Teva Standard
CNS Stimulant
Teva Canada Limited
Date of Revision:
30 Novopharm Court
December 19, 2019
Toronto, Ontario
M1B 2K9
www.tevacanada.com
Submission Control No: 233639
C
_Teva-Methylphenidate ER-C_
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TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION...............................................................
3
SUMMARY PRODUCT INFORMATION
...............................................................................
3
INDICATIONS AND CLINICAL USE
.....................................................................................
3
CONTRAINDICATIONS
..........................................................................................................
5
WARNINGS AND PRECAUTIONS
.........................................................................................
5
ADVERSE REACTIONS
.........................................................................................................
11
DRUG INTERACTIONS
.........................................................................................................
19
DOSAGE AND ADMINISTRATION
.....................................................................................
20
OVERDOSAGE
.......................................................................................................................
23
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 23
STORAGE AND STABILITY
.................................................................................................
28
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 28
PART II: SCIENTIFIC INFORMATION
....................................................................................
30
PHARMACEUTICAL INFORMATION
.................................................................................
30
CLINICAL TRIALS
.....................