MYLAN-FINASTERIDE HG TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
24-07-2014
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Active ingredient:
FINASTERIDE
Available from:
MYLAN PHARMACEUTICALS ULC
ATC code:
D11AX10
INN (International Name):
FINASTERIDE
Dosage:
1MG
Pharmaceutical form:
TABLET
Composition:
FINASTERIDE 1MG
Administration route:
ORAL
Units in package:
30/100
Prescription type:
Prescription
Therapeutic area:
MISC. SKIN AND MUCOUS MEMBRANE AGENTS
Product summary:
Active ingredient group (AIG) number: 0124110002; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2017-01-09
Summary of Product characteristics
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MYLAN-FINASTERIDE HG
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PRODUCT MONOGRAPH
PR
MYLAN-FINASTERIDE HG
Finasteride Tablets, USP
Film-coated Tablets 1 mg
Type II 5α-reductase inhibitor
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, Ontario
M8Z 2S6
Date of Revision: July 11, 2014
SUBMISSION CONTROL NO: 175549
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MYLAN-FINASTERIDE HG
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_Page 2 of 24 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
............................................................. 3
SUMMARY PRODUCT INFORMATION
..................................................................................
3
INDICATIONS AND CLINICAL USE
........................................................................................
3
CONTRAINDICATIONS
...........................................................................................................
3
WARNINGS AND PRECAUTIONS
............................................................................................
3
ADVERSE REACTIONS
..............................................................................................................
5
DRUG INTERACTIONS
..............................................................................................................
6
DOSAGE AND ADMINISTRATION
..........................................................................................
7
OVERDOSAGE
.............................................................................................................................
7
ACTION AND CLINICAL PHARMACOLOGY
.........................................................................
8
STORAGE AND STABILITY
......................................................................................................
9
SPECIAL HANDLING INSTRUCTIONS
....................................................................................
9
DOSAGE FORMS, COMPOSITION AND PACKAGING
......................................................... 9
PART II: SCIENTIFIC INFORMATION
....................................................................................
10
PHARMACEU
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