JAMP-FINASTERIDE TABLET

Land: Canada

Språk: engelsk

Kilde: Health Canada

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Last ned Preparatomtale (SPC)
05-04-2023

Aktiv ingrediens:

FINASTERIDE

Tilgjengelig fra:

JAMP PHARMA CORPORATION

ATC-kode:

G04CB01

INN (International Name):

FINASTERIDE

Dosering :

5MG

Legemiddelform:

TABLET

Sammensetning:

FINASTERIDE 5MG

Administreringsrute:

ORAL

Enheter i pakken:

30

Resept typen:

Prescription

Terapeutisk område:

5 ALFA REDUCTASE INHIBITORS

Produkt oppsummering:

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

Autorisasjon status:

APPROVED

Autorisasjon dato:

2014-10-10

Preparatomtale

                                _JAMP-Finasteride_
_(finasteride) _
_ _
_ _
_ _
_Page 1 of 31_
PRODUCT MONOGRAPH
PR
JAMP-FINASTERIDE
Finasteride Tablets, USP
Film-coated Tablets 5 mg
Type II 5α-reductase inhibitor
JAMP PHARMA CORPORATION
1310 rue Nobel
Boucherville, Quebec
J4B 5H3, Canada
DATE OF REVISION:
April 5, 2023 SUBMISSION CONTROL NO.: 268915
_JAMP-Finasteride_
_(finasteride) _
_ _
_ _
_ _
_Page 2 of 31_
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
................................................................................................................
12
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 12
STORAGE AND STABILITY
..........................................................................................
13
SPECIAL HANDLING INSTRUCTIONS
.......................................................................
13
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 13
PART II: SCIENTIFIC INFORMATION
................................................................................
14
PHARMACEUTICAL INFORMATION
..........................................................................
                                
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