NTP-ACYCLOVIR TABLET

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

ACYCLOVIR

Предлага се от:

TEVA CANADA LIMITED

АТС код:

J05AB01

INN (Международно Name):

ACYCLOVIR

дозиране:

200MG

Лекарствена форма:

TABLET

Композиция:

ACYCLOVIR 200MG

Начин на приложение:

ORAL

Броя в опаковка:

100

Вид предписание :

Prescription

Терапевтична област:

NUCLEOSIDES AND NUCLEOTIDES

Каталог на резюме:

Active ingredient group (AIG) number: 0115506002; AHFS:

Статус Оторизация:

CANCELLED PRE MARKET

Дата Оторизация:

2015-08-06

Данни за продукта

_ _
_ _
PRODUCT MONOGRAPH
PR
NTP-ACYCLOVIR
Acyclovir Tablets, USP
200 mg, 400 mg and 800 mg
(Acyclovir, as Acyclovir Hydrate)
ANTIVIRAL AGENT
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada, M1B 2K9
Date of Preparation:
June 20, 2013
Submission Control No: 165696
_ _
_ _
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
...................................................................................................
6
DRUG INTERACTIONS
...................................................................................................
8
DOSAGE AND ADMINISTRATION
...............................................................................
9
OVERDOSAGE
...............................................................................................................
10
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 11
STORAGE AND STABILITY
.........................................................................................
13
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 13
PART II: SCIENTIFIC INFORMATION
..............................................................................
14
PHARMACEUTICAL INFORMATION
.........................................................................
14
CLINICAL TRIALS
.........................................................................................................
15
DETAILED PHARMACOLOGY
...................................................................