PICATO GEL

Ország: Kanada

Nyelv: angol

Forrás: Health Canada

Aktív összetevők:

INGENOL MEBUTATE

Beszerezhető a:

LEO PHARMA INC

ATC-kód:

D06BX02

INN (nemzetközi neve):

INGENOL MEBUTATE

Adagolás:

0.015%

Gyógyszerészeti forma:

GEL

Összetétel:

INGENOL MEBUTATE 0.015%

Az alkalmazás módja:

TOPICAL

db csomag:

0.47G

Recept típusa:

Prescription

Terápiás terület:

MISC. SKIN AND MUCOUS MEMBRANE AGENTS

Termék összefoglaló:

Active ingredient group (AIG) number: 0153650001; AHFS:

Engedélyezési státusz:

CANCELLED POST MARKET

Engedély dátuma:

2020-10-14

Termékjellemzők

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
...............................................................................