FINASTERIDE TABLET

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

FINASTERIDE

Disponible depuis:

SIVEM PHARMACEUTICALS ULC

Code ATC:

D11AX10

DCI (Dénomination commune internationale):

FINASTERIDE

Dosage:

1MG

forme pharmaceutique:

TABLET

Composition:

FINASTERIDE 1MG

Mode d'administration:

ORAL

Unités en paquet:

28/30/100/1000

Type d'ordonnance:

Prescription

Domaine thérapeutique:

5 ALFA REDUCTASE INHIBITORS

Descriptif du produit:

Active ingredient group (AIG) number: 0124110002; AHFS:

Statut de autorisation:

APPROVED

Date de l'autorisation:

2015-10-21

Résumé des caractéristiques du produit

_Product Monograph FINASTERIDE 1 mg _
_Page 1 of 22_
_ _
PRODUCT MONOGRAPH
PR
FINASTERIDE
Finasteride tablets, BP
1 mg
Type II 5α-reductase inhibitor
Sivem Pharmaceuticals ULC
4705 Dobrin Street
Saint-Laurent, Quebec
H4R 2P7
www.sivem.ca
DATE OF REVISION:
June 9, 2020 SUBMISSION CONTROL NO: 239438
_Product Monograph FINASTERIDE 1 mg _
_Page 2 of 22_
_ _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
...................................................................................
3
INDICATIONS AND CLINICAL USE
.........................................................................................
3
CONTRAINDICATIONS
..............................................................................................................
3
WARNINGS AND PRECAUTIONS
.............................................................................................
4
ADVERSE REACTIONS
...............................................................................................................
5
DRUG INTERACTIONS
...............................................................................................................
7
DOSAGE AND ADMINISTRATION
...........................................................................................
7
OVERDOSAGE
.............................................................................................................................
8
ACTION AND CLINICAL PHARMACOLOGY
.........................................................................
8
STORAGE AND STABILITY
.......................................................................................................
9
SPECIAL HANDLING INSTRUCTIONS
....................................................................................
9
DOSAGE FORMS, COMPOSITION AND PACKAGING
.......................................................... 9
PART II: SCIENTIFIC INFORMATION
............................................................................