FINACEA GEL

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

AZELAIC ACID

Tersedia dari:

LEO PHARMA INC

Kode ATC:

D10AX03

INN (Nama Internasional):

AZELAIC ACID

Dosis:

15%

Bentuk farmasi:

GEL

Komposisi:

AZELAIC ACID 15%

Rute administrasi :

TOPICAL

Unit dalam paket:

15G/50G

Jenis Resep:

Prescription

Area terapi:

MISC. SKIN AND MUCOUS MEMBRANE AGENTS

Ringkasan produk:

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

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2005-09-02

Karakteristik produk

_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
................................................