NRA-LETROZOLE TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
16-09-2021
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Active ingredient:
LETROZOLE
Available from:
NORA 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:
15G/50G
Prescription type:
Prescription
Therapeutic area:
ANTINEOPLASTIC AGENTS
Product summary:
Active ingredient group (AIG) number: 0132937001; AHFS:
Authorization status:
APPROVED
Authorization date:
2021-09-23
Summary of Product characteristics
PRODUCT MONOGRAPH
PR NRA-LETROZOLE
(letrozole tablets USP)
2.5 mg
Non-steroidal aromatase inhibitor;
inhibitor of estrogen biosynthesis;
anti-tumour agent
Nora Pharma Inc.
40 rue Prince-Arthur, suite 310
St. Lambert, Quebec
J4P 1X2
DATE OF PREPARATION: SEPTEMBER 16, 2021
SUBMISSION CONTROL NO.: 256092
_NRA-LETROZOLE Product Monograph _
_ _
_Page 2 of 60 _
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
......................................................................................................................
26
DOSAGE AND ADMINISTRATION
..................................................................................................
27
OVERDOSAGE
.....................................................................................................................................
28
ACTION AND CLINICAL PHARMACOLOGY
..............................................................................
29
STORAGE AND
STABILITY..............................................................................................................
31
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................................. 31
PART II: SCIENTIFIC INFORMATION
............................................................................................
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