FINACEA GEL
Country: Kanada
Tungumál: enska
Heimild: Health Canada
Vara einkenni
(SPC)
18-09-2019
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Senda beiðni.
Senda beiðni.
Virkt innihaldsefni:
AZELAIC ACID
Fáanlegur frá:
LEO PHARMA INC
ATC númer:
D10AX03
INN (Alþjóðlegt nafn):
AZELAIC ACID
Skammtar:
15%
Lyfjaform:
GEL
Samsetning:
AZELAIC ACID 15%
Stjórnsýsluleið:
TOPICAL
Einingar í pakka:
15G/50G
Gerð lyfseðils:
Prescription
Lækningarsvæði:
MISC. SKIN AND MUCOUS MEMBRANE AGENTS
Vörulýsing:
Active ingredient group (AIG) number: 0126787002; AHFS:
Leyfisstaða:
APPROVED
Leyfisdagur:
2005-09-02
Vara einkenni
_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
................................................
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