MYLAN-LETROZOLE TABLET
Land: Canada
Taal: Engels
Bron: Health Canada
Productkenmerken
(SPC)
19-12-2014
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Werkstoffen:
LETROZOLE
Beschikbaar vanaf:
MYLAN PHARMACEUTICALS ULC
ATC-code:
L02BG04
INN (Algemene Internationale Benaming):
LETROZOLE
Dosering:
2.5MG
farmaceutische vorm:
TABLET
Samenstelling:
LETROZOLE 2.5MG
Toedieningsweg:
ORAL
Eenheden in pakket:
30/100
Prescription-type:
Prescription
Therapeutisch gebied:
ANTINEOPLASTIC AGENTS
Product samenvatting:
Active ingredient group (AIG) number: 0132937001; AHFS:
Autorisatie-status:
CANCELLED PRE MARKET
Autorisatie datum:
2016-11-02
Productkenmerken
Page 1 of 63 PRODUCT MONOGRAPH
PR
MYLAN-LETROZOLE
letrozole tablets
2.5 mg
USP
Non-steroidal aromatase inhibitor; inhibitor of estrogen biosynthesis;
anti-tumour agent
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Date of Revision:
December 16, 2014
Submission Control No.: 179644
Page 2 of 63
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
...................................................................................................................
10
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 ........................................................................................
33
PHARMACEUTICAL INFORMATION
............................................................
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