PICATO GEL
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
20-02-2020
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:
INGENOL MEBUTATE
Available from:
LEO PHARMA INC
ATC code:
D06BX02
INN (International Name):
INGENOL MEBUTATE
Dosage:
0.015%
Pharmaceutical form:
GEL
Composition:
INGENOL MEBUTATE 0.015%
Administration route:
TOPICAL
Units in package:
0.47G
Prescription type:
Prescription
Therapeutic area:
MISC. SKIN AND MUCOUS MEMBRANE AGENTS
Product summary:
Active ingredient group (AIG) number: 0153650001; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2020-10-14
Summary of Product characteristics
LEO®
_ _
_PICATO® (ingenol mebutate) Product Monograph, version 5.0 _
_Page 1 of 29_
PRODUCT MONOGRAPH
Pr
PICATO®
ingenol mebutate
Topical Gel
0.015% and 0.05%
Chemotherapeutic for topical use (D06BX02)
LEO Pharma Inc.
Thornhill, Ontario
L3T 7W8
www.leo-pharma.com/canada
Date of Revision:
February 20, 2020
Control No.: 233545
® Registered trademark of LEO Pharma A/S used under license by LEO
Pharma Inc., Thornhill, ON
LEO®
_ _
_PICATO® (ingenol mebutate) Product Monograph, version 5.0 _
_Page 2 of 29_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................7
DOSAGE AND ADMINISTRATION
..............................................................................11
OVERDOSAGE
................................................................................................................13
ACTION AND CLINICAL PHARMACOLOGY
............................................................13
STORAGE AND STABILITY
..........................................................................................15
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................15
PART II: SCIENTIFIC INFORMATION
...............................................................................16
PHARMACEUTICAL INFORMATION
..........................................................................16
CLINICAL TRIALS- 15-Nov-20192
...............................................................................
Read the complete document
