MINT-FINASTERIDE TABLET

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

FINASTERIDE

Commercializzato da:

MINT PHARMACEUTICALS INC

Codice ATC:

D11AX10

INN (Nome Internazionale):

FINASTERIDE

Dosaggio:

1MG

Forma farmaceutica:

TABLET

Composizione:

FINASTERIDE 1MG

Via di somministrazione:

ORAL

Confezione:

100

Tipo di ricetta:

Prescription

Dettagli prodotto:

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

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2023-04-26

Scheda tecnica

_Product-Monograph MINT-FINASTERIDE _
_Page 1 of 23 _
PRODUCT MONOGRAPH
PR
MINT-FINASTERIDE
Finasteride tablets, USP
Film-coated Tablets 1 mg
Type II 5α-reductase inhibitor
Submission Control No.: 263828
Mint Pharmaceuticals Inc.
6575 Davand Drive
Mississauga, Ontario
L5T 2M3
Date of Preparation:
April 24, 2023
_Product-Monograph MINT-FINASTERIDE _
_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
.................................................................10
PHARMACEUTICAL INFORMATION
..........................................................10
CLINICAL TRIALS
...........................................................................................10
DETAILED PHARMACOLOGY
......................................................................12
TOXICOLOGY
....................................