AURO-LETROZOLE TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
08-05-2013
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Active ingredient:
LETROZOLE
Available from:
AURO PHARMA INC
ATC code:
L02BG04
INN (International Name):
LETROZOLE
Dosage:
2.5MG
Pharmaceutical form:
TABLET
Composition:
LETROZOLE 2.5MG
Administration route:
ORAL
Units in package:
30
Prescription type:
Prescription
Therapeutic area:
ANTINEOPLASTIC AGENTS
Product summary:
Active ingredient group (AIG) number: 0132937001; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2015-04-24
Summary of Product characteristics
PRODUCT MONOGRAPH
PR
AURO-LETROZOLE
(letrozole)
LETROZOLE TABLETS, USP
2.5 mg
Non-steroidal aromatase inhibitor; inhibitor of estrogen biosynthesis;
anti-tumour agent
AURO PHARMA INC.
3700 Steeles Avenue West, Suite # 402 DATE OF PREPARATION:
Woodbridge, ON, L4L 8K8, May 08, 2013
CANADA
Submission Control No: 163255
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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
.......................................................................................................8
DRUG INTERACTIONS
........................................................................................................24
DOSAGE AND ADMINISTRATION
....................................................................................24
OVERDOSAGE
.....................................................................................................................25
ACTION AND CLINICAL PHARMACOLOGY
.................................................................26
STORAGE AND STABILITY
...............................................................................................28
DOSAGE FORMS, COMPOSITION AND PACKAGING
..................................................28
PART II: SCIENTIFIC INFORMATION
....................................................................................29
PHARMACEUTICAL INFORMATION
...............................................................................29
CLINICAL TRIALS
.............................................................................................
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