XENICAL CAPSULE

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

ORLISTAT

Mevcut itibaren:

CHEPLAPHARM ARZNEIMITTEL GMBH

ATC kodu:

A08AB01

INN (International Adı):

ORLISTAT

Doz:

120MG

Farmasötik formu:

CAPSULE

Kompozisyon:

ORLISTAT 120MG

Uygulama yolu:

ORAL

Paketteki üniteler:

21/84

Reçete türü:

Prescription

Terapötik alanı:

MISCELLANEOUS GI DRUGS

Ürün özeti:

Active ingredient group (AIG) number: 0137562001; AHFS:

Yetkilendirme durumu:

APPROVED

Yetkilendirme tarihi:

1999-06-03

Ürün özellikleri

_Product Monograph _
_Template Date: September 2020 _
_XENICAL, orlistat _
_Page 1 of 48_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
XENICAL®
orlistat
Capsules, 120 mg, for oral administration
Pharmaceutical Standard: Professed
Anti-Obesity Agent/Gastrointestinal Lipase Inhibitor
MANUFACTURER:
CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 24
17489 Greifswald
Germany
IMPORTER / DISTRIBUTOR:
Xediton Pharmaceuticals Inc
2020 Winston Park Drive, Suite 402
Oakville, Ontario L6H 6X7
Tel: 1-888-XEDITON (933-4866)
DATE OF INITIAL AUTHORIZATION:
JUN 03, 1999
DATE OF REVISION:
JUL 05, 2023
Submission Control Number: 271974
XENICAL
®
is a registered trademark of CHEPLAPHARM Arzneimittel GmbH.
© Copyright 1999 – 2023 CHEPLAPHARM Arzneimittel GmbH.
_ _
_Product Monograph _
_Template Date: September 2020 _
_XENICAL, orlistat _
_Page 2 of 48_
RECENT MAJOR LABEL CHANGES
2 Contraindications
06/2023
7 Warnings and Precautions, 7.1.1 Pregnant Women
06/2023
7 Warnings and Precautions, 7.1.2 Breast-feeding
06/2023
TABLE OF CONTENTS
RECENT MAJOR LABEL CHANGES
............................................................................................
2
TABLE OF CONTENTS
..............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................................
4
1
INDICATIONS
...............................................................................................................
4
1.1
Pediatrics
................................................................................................................
4
1.2
Geriatrics
................................................................................................................
4
2
CONTRAINDICATIONS
.................................................................................................
4
4
DOSAGE AND ADMINISTRATION
.................................................................................
5
4.1
Dosing Consid