FINACEA GEL

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

AZELAIC ACID

Предлага се от:

LEO PHARMA INC

АТС код:

D10AX03

INN (Международно Name):

AZELAIC ACID

дозиране:

15%

Лекарствена форма:

GEL

Композиция:

AZELAIC ACID 15%

Начин на приложение:

TOPICAL

Броя в опаковка:

15G/50G

Вид предписание :

Prescription

Терапевтична област:

MISC. SKIN AND MUCOUS MEMBRANE AGENTS

Каталог на резюме:

Active ingredient group (AIG) number: 0126787002; AHFS:

Статус Оторизация:

APPROVED

Дата Оторизация:

2005-09-02

Данни за продукта

_FINACEA Product Monograph, version 1.0_
_Page 1 of 20 _
PRODUCT MONOGRAPH
PR FINACEA
®
Azelaic Acid Gel
15% w/w
Topical
Antirosacea Agent
LEO Pharma Inc.
Thornhill, Ontario
L3T 7W8
www.leo-pharma.ca
Submission Control No.: 229634
Date of Revision:
September 18, 2019
®Registered trademark of LEO Pharma A/S used under license by LEO
Pharma Inc., Thornhill, ON
_FINACEA Product Monograph, version 1.0_
_Page 2 of 20 _
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
....................................................................................................5
DRUG INTERACTIONS
....................................................................................................6
DOSAGE AND ADMINISTRATION
................................................................................7
OVERDOSAGE
..................................................................................................................7
ACTION AND CLINICAL PHARMACOLOGY
..............................................................8
STORAGE AND STABILITY
............................................................................................9
SPECIAL HANDLING INSTRUCTIONS
.........................................................................9
DOSAGE FORMS, COMPOSITION AND PACKAGING
...............................................9
PART II: SCIENTIFIC INFORMATION
...............................................................................10
PHARMACEUTICAL INFORMATION
................................................