MINT-FINASTERIDE TABLET

Nchi: Kanada

Lugha: Kiingereza

Chanzo: Health Canada

Nunua Sasa

Shusha Tabia za bidhaa (SPC)
24-04-2023

Viambatanisho vya kazi:

FINASTERIDE

Inapatikana kutoka:

MINT PHARMACEUTICALS INC

ATC kanuni:

D11AX10

INN (Jina la Kimataifa):

FINASTERIDE

Kipimo:

1MG

Dawa fomu:

TABLET

Tungo:

FINASTERIDE 1MG

Njia ya uendeshaji:

ORAL

Vitengo katika mfuko:

100

Dawa ya aina:

Prescription

Bidhaa muhtasari:

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

Idhini hali ya:

APPROVED

Idhini ya tarehe:

2023-04-26

Tabia za bidhaa

                                _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
....................................
                                
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