GLN-URSODIOL TABLET

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

URSODIOL

Tilgjengelig fra:

GLENMARK PHARMACEUTICALS CANADA INC.

ATC-kode:

A05AA02

INN (International Name):

URSODEOXYCHOLIC ACID

Dosering :

250MG

Legemiddelform:

TABLET

Sammensetning:

URSODIOL 250MG

Administreringsrute:

ORAL

Enheter i pakken:

15G/50G

Resept typen:

Prescription

Terapeutisk område:

CHOLELITHOLYTIC AGENTS

Produkt oppsummering:

Active ingredient group (AIG) number: 0122789001; AHFS:

Autorisasjon status:

APPROVED

Autorisasjon dato:

2015-10-05

Preparatomtale

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_GLN-Ursodiol (Ursodiol Tablets USP, 250 mg and 500 mg) _
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PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
GLN-URSODIOL
Ursodiol Tablets
Tablets, 250 mg and 500 mg, Oral
USP
Bile Acid Preparation
Glenmark Pharmaceuticals Canada Inc.
1600 Steeles Ave. West,
Suite 407, Concord, ON
L4K 4M2
Date of Initial Authorization:
July 07, 2014
Date of Revision:
September 21, 2023
Submission Control Number: 274562
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_GLN-Ursodiol (Ursodiol Tablets USP, 250 mg and 500 mg)_
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_Page 2 of 28_
RECENT MAJOR LABEL CHANGES
7 Warnings and Precautions, Gastrointestinal
09/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
_ _
RECENT MAJOR LABEL CHANGES
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2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1 INDICATIONS
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4
1.1 Pediatrics
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4
1.2 Geriatrics
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4
2 CONTRAINDICATIONS
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4
4 DOSAGE AND ADMINISTRATION
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4
4.1 Dosing Considerations
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4
4.2 Recommended Dose and Dosage Adjustment
................................................................. 5
4.3 Administration
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