STASON-LETROZOLE TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
09-10-2014
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Active ingredient:
LETROZOLE
Available from:
VPI PHARMACEUTICALS INC
ATC code:
L02BG04
INN (International Name):
LETROZOLE
Dosage:
2.5MG
Pharmaceutical form:
TABLET
Composition:
LETROZOLE 2.5MG
Administration route:
ORAL
Units in package:
15/30/100
Prescription type:
Prescription
Therapeutic area:
ANTINEOPLASTIC AGENTS
Product summary:
Active ingredient group (AIG) number: 0132937001; AHFS:
Authorization status:
CANCELLED PRE MARKET
Authorization date:
2018-06-27
Summary of Product characteristics
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_STASON-LETROZOLE _
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PRODUCT MONOGRAPH
Pr
STASON-LETROZOLE
Letrozole Tablets, USP
2.5 mg
Non-steroidal aromatase inhibitor; inhibitor of estrogen biosynthesis;
anti-tumour agent
VPI Pharmaceuticals Inc.
16667 boul. Hymus
Kirkland, Québec
H9H 4R9
Date of Preparation:
September 11, 2014
Submission Control No: 177451
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_STASON-LETROZOLE _
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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
...................................................................................................
9
DRUG INTERACTIONS
.................................................................................................
24
DOSAGE AND ADMINISTRATION
.............................................................................
25
OVERDOSAGE
...............................................................................................................
26
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 26
STORAGE AND STABILITY
.........................................................................................
29
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 29
PART II: SCIENTIFIC INFORMATION
..............................................................................
30
PHARMACEUTICAL INFORMATION
.........................................................................
30
CLINICAL TRIALS
.........................................................................................................
30
DETA
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