NOVO-URSODIOL TABLET

Land: Canada

Taal: Engels

Bron: Health Canada

Werkstoffen:

URSODIOL

Beschikbaar vanaf:

NOVOPHARM LIMITED

ATC-code:

A05AA02

INN (Algemene Internationale Benaming):

URSODEOXYCHOLIC ACID

Dosering:

500MG

farmaceutische vorm:

TABLET

Samenstelling:

URSODIOL 500MG

Toedieningsweg:

ORAL

Eenheden in pakket:

10/100/500

Prescription-type:

Prescription

Therapeutisch gebied:

CHOLELITHOLYTIC AGENTS

Product samenvatting:

Active ingredient group (AIG) number: 0122789002; AHFS:

Autorisatie-status:

CANCELLED PRE MARKET

Autorisatie datum:

2018-07-24

Productkenmerken

Page 1
PRODUCT MONOGRAPH
PR
NOVO-URSODIOL
250 mg and 500 mg Ursodiol tablets
(Ursodiol USP)
Novopharm standard
Cholestatic Liver Diseases
Novopharm Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Submission Control Number: 146780
Date of Preparation:
October 9, 2008
Date of Revision:
June 23, 2011
Page 2
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION............................................ 3
SUMMARY PRODUCT INFORMATION
................................................................... 3
INDICATIONS AND CLINICAL
USE.........................................................................
3
CONTRAINDICATIONS
..............................................................................................
4
WARNINGS AND
PRECAUTIONS.............................................................................
4
ADVERSE
REACTIONS...............................................................................................
5
DRUG INTERACTIONS
.............................................................................................
10
DOSAGE AND
ADMINISTRATION.........................................................................
11
OVERDOSAGE
...........................................................................................................
12
ACTION AND CLINICAL PHARMACOLOGY
....................................................... 12
STORAGE AND
STABILITY.....................................................................................
14
SPECIAL HANDLING INSTRUCTIONS
.................................................................. 14
DOSAGE FORMS, COMPOSITION
AND.................................................................
14
PART II: SCIENTIFIC INFORMATION
................................................................... 15
PHARMACEUTICAL
INFORMATION.....................................................................
15
CLINICAL
TRIALS.....................................................................................................
16
DETAILED
PHARMACOLOGY................