PRIVA-LETROZOLE TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
26-08-2020
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Active ingredient:
LETROZOLE
Available from:
PHARMAPAR INC
ATC code:
L02BG04
INN (International Name):
LETROZOLE
Dosage:
2.5MG
Pharmaceutical form:
TABLET
Composition:
LETROZOLE 2.5MG
Administration route:
ORAL
Units in package:
100
Prescription type:
Prescription
Therapeutic area:
ANTINEOPLASTIC AGENTS
Product summary:
Active ingredient group (AIG) number: 0132937001; AHFS:
Authorization status:
CANCELLED PRE MARKET
Authorization date:
2022-07-29
Summary of Product characteristics
Page 1 of 64
PRODUCT MONOGRAPH
PR
PRIVA-LETROZOLE
Letrozole Tablets, USP
2.5 mg Tablets
Non-steroidal aromatase inhibitor;
inhibitor of estrogen biosynthesis;
anti-tumour agent
PHARMAPAR INC.
1565 boul. Lionel-Boulet,
Varennes, Quebec
J3X 1P7
Date of Revision:
August 26, 2020
CONTROL # 240412
Page 2 of 64
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
....................................................................................................................................
25
DOSAGE AND ADMINISTRATION
................................................................................................................
27
OVERDOSAGE
..................................................................................................................................................
28
ACTION AND CLINICAL PHARMACOLOGY
..............................................................................................
28
STORAGE AND STABILITY
...........................................................................................................................
30
DOSAGE FORMS, COMPOSITION AND PACKAGING
...............................................................................
30
PART II:
Read the complete document
