MDK-NITISINONE CAPSULE

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

NITISINONE

Предлага се от:

MENDELIKABS INC

АТС код:

A16AX04

INN (Международно Name):

NITISINONE

дозиране:

5MG

Лекарствена форма:

CAPSULE

Композиция:

NITISINONE 5MG

Начин на приложение:

ORAL

Броя в опаковка:

60

Вид предписание :

Prescription

Терапевтична област:

OTHER MISCELLANEOUS THERAPEUTIC AGENTS

Каталог на резюме:

Active ingredient group (AIG) number: 0158450002; AHFS:

Статус Оторизация:

APPROVED

Дата Оторизация:

2016-09-20

Данни за продукта

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_Page 1 of 21_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
MDK-NITISINONE
Nitisinone capsules
Capsules, 2 mg, 5 mg, 10 mg and 20 mg
ATC CODE: A16AX04
Various alimentary tract and metabolism products
MendeliKABS Inc
4601, rue de Tonnancour
Saint-Hubert (Quebec)
Canada, J3Y 9J3
Date of Revision:
November 29, 2017
Submission Control No: 202740
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_Page 2 of 21_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................3
ADVERSE REACTIONS
....................................................................................................6
DRUG INTERACTIONS
....................................................................................................8
DOSAGE AND ADMINISTRATION
................................................................................9
OVERDOSAGE
................................................................................................................10
ACTION AND CLINICAL PHARMACOLOGY
............................................................10
STORAGE AND STABILITY
..........................................................................................13
SPECIAL HANDLING INSTRUCTIONS
.......................................................................13
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................13
PART II: SCIENTIFIC INFORMATION
...............................................................................15
PHARMACEUTICAL INFORMATION
..........................................................................15
CLINICAL