FINACEA GEL
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
18-09-2019
Some documents for this product are not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain them.
Send request.
Send request.
Active ingredient:
AZELAIC ACID
Available from:
LEO PHARMA INC
ATC code:
D10AX03
INN (International Name):
AZELAIC ACID
Dosage:
15%
Pharmaceutical form:
GEL
Composition:
AZELAIC ACID 15%
Administration route:
TOPICAL
Units in package:
15G/50G
Prescription type:
Prescription
Therapeutic area:
MISC. SKIN AND MUCOUS MEMBRANE AGENTS
Product summary:
Active ingredient group (AIG) number: 0126787002; AHFS:
Authorization status:
APPROVED
Authorization date:
2005-09-02
Summary of Product characteristics
_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
................................................
Read the complete document
