ACT FINASTERIDE Comprimé

Land: Canada

Taal: Frans

Bron: Health Canada

Werkstoffen:

Finastéride

Beschikbaar vanaf:

ACTAVIS PHARMA COMPANY

ATC-code:

G04CB01

INN (Algemene Internationale Benaming):

FINASTERIDE

Dosering:

5MG

farmaceutische vorm:

Comprimé

Samenstelling:

Finastéride 5MG

Toedieningsweg:

Orale

Eenheden in pakket:

30

Prescription-type:

Prescription

Therapeutisch gebied:

5 ALFA REDUCTASE INHIBITORS

Product samenvatting:

Numéro de groupe d'ingrédients actifs (GIA) :0124110001; AHFS:

Autorisatie-status:

ANNULÉ APRÈS COMMERCIALISATION

Autorisatie datum:

2019-07-08

Productkenmerken

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_ACT FINASTERIDE _
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PRODUCT MONOGRAPH
PR ACT FINASTERIDE
Finasteride Tablets USP
Film-Coated Tablets 5mg
Type II 5α-reductase inhibitor
Actavis Pharma Company
6733 Mississauga Road, Suite 400
Mississauga, Ontario
Canada, L5N 6J5
Date of Revision:
November 13, 2014
Submission Control No: 179759
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_ACT FINASTERIDE _
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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
...................................................................................................
6
DRUG INTERACTIONS
...................................................................................................
9
DOSAGE AND ADMINISTRATION
...............................................................................
9
OVERDOSAGE
.................................................................................................................
8
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 10
STORAGE AND STABILITY
.........................................................................................
11
SPECIAL HANDLING INSTRUCTIONS
......................................................................
11
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 12
PART II: SCIENTIFIC INFORMATION
..............................................................................
13
PHARMACEUTICAL INFORMATION
.........................................................................
13
CLINICAL TRIALS
............................