JAMP-FINASTERIDE TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

FINASTERIDE

Available from:

JAMP PHARMA CORPORATION

ATC code:

G04CB01

INN (International Name):

FINASTERIDE

Dosage:

5MG

Pharmaceutical form:

TABLET

Composition:

FINASTERIDE 5MG

Administration route:

ORAL

Units in package:

30

Prescription type:

Prescription

Therapeutic area:

5 ALFA REDUCTASE INHIBITORS

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2014-10-10

Summary of Product characteristics

_JAMP-Finasteride_
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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) _
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_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
..........................................................................