Apo-Letrozole tablets

Страна: Армения

Язык: английский

Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активный ингредиент:

letrozole

Доступна с:

Apotex Inc.

код АТС:

L02BG04

ИНН (Международная Имя):

letrozole

дозировка:

2,5mg

Фармацевтическая форма:

tablets

Штук в упаковке:

(30/3x10/) in blister

Тип рецепта:

Prescription

Статус Авторизация:

Registered

Дата Авторизация:

2017-09-26

Характеристики продукта

The
summarv of
the
product
characteristics
(SmPC)
1)
Name
of
the
Product:
APO-LETROZOLE
Tablets
2.5
mg
(Letrozole
Tablets
2.5 mg
USP)
2l
Qualitative
and
Quantitative
Formula
*
Evaporated
during the coating
process
¡ri,itûvil
ËT
5iil,{tL
J$[
3)
PHARMACEUTICAL
FORM
Tablets
Appendix
1.9
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7
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Component
and
Quality
Standard
(and
Grade, if applicable)
Function
of
Component
2.5 mg
o/owlw
of
tablet
Quantity
per
unit
(mg/tablet)
Core
Letrozole
USP
Active
2.71
2.5
Lactose
Monohydrate
NF
(Type
316)
Diluent
73.70
68.0
Microcrystalline Cellulose NF
M1
02
Diluent/Binder
13.00
12.0
Sodium Starch
Glycolate
NF
Disintegrant
7.6
7.0
Magnesium Stearate
NF
Lubricant
0.54
0.5
Total
Core
Tablet Weight
97.55
90.0
Film-Coating
Hydroxypropyl Methyl Cellulose
2910
USP
E5
Film-Forming
Polymer
0.98
0.9
Hydroxypropyl Cellulose
NF
Type
LF
Film-Forming
Polymer
0.325
0.3
Polyethylene Glycol 8000
NF
Plasticizer
0.65
0.6
Yellow
Ferric Oxide
NF
Colorant
4.21
0.19
Titanium
Dioxide
USP
Opacifier/Pigment
0.293
4.27
Purified
Water
USP*
Solvent
Total
coating
(excluding
water)
2.26
Total
Tablet Weight
(Excluding
Water)
100.0
s2.26
Page
I
of2l
The
ii*iherl¡i;ii:ì
Appendix
1.9
The summarv
of the
product
characteristics
(SmpCì
4l
cLtNtcAL
PARTTCULARS
4.1
Therapeutic
indications
APO-LETROZOLE
(letrozole)
is indicated
for:
a
The
adjuvant
treatment
of
postmenopausal
women
with
hormone
receptor-
positive
invasive
early
breast cancer.
Approval
was
based on
superior Disease-Free
Survival
(DFS)
compared
to
tamoxifen,
at a
median
follow-up
of
26
months.
However,
overall
survival
was
not
significantly
different
between
the
two treatments.
The
extended
adjuvant
treatment
of
hormone
receptor-positive
invasive
early
breasl
cancer
in
postmenopausal
women
who
have
received
approximately
S
years
of
prior
standard
adjuvant tamoxifen
therapy.
Approval
was
based
on
superior
Disease-Free
Survival
(DFS)
compared
to
placebo
in
the
overall study
po