LETROZOLE TABLET
Land: Kanada
Tungumál: enska
Heimild: Health Canada
Vara einkenni
(SPC)
05-02-2013
Sum skjöl fyrir þessa vöru eru ekki tiltæk eins og er, þú getur sent beiðni til þjónustu við viðskiptavini okkar og við munum láta þig vita um leið og við getum fengið þau.
Senda beiðni.
Senda beiðni.
Virkt innihaldsefni:
LETROZOLE
Fáanlegur frá:
MELIAPHARM INC
ATC númer:
L02BG04
INN (Alþjóðlegt nafn):
LETROZOLE
Skammtar:
2.5MG
Lyfjaform:
TABLET
Samsetning:
LETROZOLE 2.5MG
Stjórnsýsluleið:
ORAL
Einingar í pakka:
30
Gerð lyfseðils:
Prescription
Lækningarsvæði:
ANTINEOPLASTIC AGENTS
Vörulýsing:
Active ingredient group (AIG) number: 0132937001; AHFS:
Leyfisstaða:
CANCELLED POST MARKET
Leyfisdagur:
2014-06-25
Vara einkenni
PRODUCT MONOGRAPH
PR
LETROZOLE
Letrozole Tablets, USP
2.5 mg
Non-steroidal aromatase inhibitor; inhibitor of estrogen biosynthesis;
anti-tumour agent
MELIAPHARM INC.
DATE OF REVISION
6111 Royalmount Ave., Suite 100
February 5, 2013
Montréal, Québec
H4P 2T4
SUBMISSION CONTROL NO: 161698
_ _
_LETROZOLE Product Monograph _
_ _
_ _
_ _
_ _
_ _
_Page 2 of 54_
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
.................................................................................................
22
DOSAGE AND ADMINISTRATION
.............................................................................
23
OVERDOSAGE
................................................................................................................
24
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 24
STORAGE AND STABILITY
.........................................................................................
26
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 26
PART II: SCIENTIFIC INFORMATION
..............................................................................
27
PHARMACEUTICAL INFORMATION
.........................................................................
27
CLINICAL TRIALS
.........................................................................................................
28
DETAILED PHAR
Lestu allt skjalið
