XENICAL CAPSULE
Land: Kanada
Språk: engelska
Källa: Health Canada
Produktens egenskaper
(SPC)
05-07-2023
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Aktiva substanser:
ORLISTAT
Tillgänglig från:
CHEPLAPHARM ARZNEIMITTEL GMBH
ATC-kod:
A08AB01
INN (International namn):
ORLISTAT
Dos:
120MG
Läkemedelsform:
CAPSULE
Sammansättning:
ORLISTAT 120MG
Administreringssätt:
ORAL
Enheter i paketet:
21/84
Receptbelagda typ:
Prescription
Terapiområde:
MISCELLANEOUS GI DRUGS
Produktsammanfattning:
Active ingredient group (AIG) number: 0137562001; AHFS:
Bemyndigande status:
APPROVED
Tillstånd datum:
1999-06-03
Produktens egenskaper
_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
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