MINT-FINASTERIDE TABLET

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

FINASTERIDE

Mevcut itibaren:

MINT PHARMACEUTICALS INC

ATC kodu:

G04CB01

INN (International Adı):

FINASTERIDE

Doz:

5MG

Farmasötik formu:

TABLET

Kompozisyon:

FINASTERIDE 5MG

Uygulama yolu:

ORAL

Paketteki üniteler:

100/150

Reçete türü:

Prescription

Terapötik alanı:

5 ALFA REDUCTASE INHIBITORS

Ürün özeti:

Active ingredient group (AIG) number: 0124110001; AHFS:

Yetkilendirme durumu:

APPROVED

Yetkilendirme tarihi:

2012-07-25

Ürün özellikleri

_Page 1 of 30_
PRODUCT MONOGRAPH
PR
MINT-FINASTERIDE
Finasteride tablets, USP
Film-coated Tablets 5 mg
Type II 5 alpha-reductase inhibitor
Mint Pharmaceuticals Inc.
6575 Davand Drive
Date of Revision:
Mississauga, Ontario
August 6, 2020
L5T 2M3
SUBMISSION CONTROL NO: 239214
_Page 2 of 30_
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
.............................................................................
10
OVERDOSAGE
................................................................................................................
11
ACTION AND CLINICAL
PHARMACOLOGY............................................................
11
STORAGE AND STABILITY
.........................................................................................
12
SPECIAL HANDLING
INSTRUCTIONS.......................................................................
12
DOSAGE FORMS, COMPOSITION AND
PACKAGING............................................. 12
PART II: SCIENTIFIC INFORMATION
....................................................................
13
PHARMACEUTICAL INFORMATION
.........................................................................
13
CLINICAL TRIALS
.........................................................................................................
13
DET