AURO-FINASTERIDE 1MG TABLET

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

FINASTERIDE

Disponible depuis:

AURO PHARMA INC

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:

2014-10-14

Résumé des caractéristiques du produit

Page 1 of 23
PRODUCT MONOGRAPH
PR
AURO-FINASTERIDE 1 MG
Finasteride tablets BP
1 mg
Type II 5α-reductase inhibitor
AURO PHARMA INC.
Date of Revision:
3700 Steeles Avenue West, Suite # 402
November 6, 2019
Woodbridge, Ontario, L4L 8K8
CANADA.
SUBMISSION CONTROL NO: 232924
Page 2 of 23
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
...............................................................................
11
PHARMACEUTICAL INFORMATION
.....................................