PICATO GEL

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

INGENOL MEBUTATE

Dostupné s:

LEO PHARMA INC

ATC kód:

D06BX02

INN (Mezinárodní Name):

INGENOL MEBUTATE

Dávkování:

0.015%

Léková forma:

GEL

Složení:

INGENOL MEBUTATE 0.015%

Podání:

TOPICAL

Jednotky v balení:

0.47G

Druh předpisu:

Prescription

Terapeutické oblasti:

MISC. SKIN AND MUCOUS MEMBRANE AGENTS

Přehled produktů:

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

Stav Autorizace:

CANCELLED POST MARKET

Datum autorizace:

2020-10-14

Charakteristika produktu

LEO®
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_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
...............................................................................