Skinoren gel for external use

Država: Armenija

Jezik: angleščina

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktivna sestavina:

azelaic acid

Dostopno od:

Bayer Healthcare Manufacturing S.r.l.

Koda artikla:

D10AX03

INN (mednarodno ime):

azelaic acid

Odmerek:

150mg/g

Farmacevtska oblika:

gel for external use

Enote v paketu:

5g and 30g aluminium tube

Tip zastaranja:

OTC

Status dovoljenje:

Registered

Datum dovoljenje:

2016-02-04

Lastnosti izdelka

I
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tlrcare
Summary
o
f
Produc
t
Char
acteri
stics
Skinoren
Gel.
Azelaic
Acid
15
%
gel
*
This
medicinal
product
is
fegisterecl
/
marketed
undel
the
followilrg
trade
namgs:
skinof€n,
Finacea,
Azelainsaeure
Schering,
Azclan'
Finel'in,
Zelaika
7"r'f
,o<-
l,
2.
TABLE
OF
CONTENTS
NAME
OF
THE
MEDICINAL
PRODUCT
""""""""""""""""""""
"""""""""
4
OUALITATIVE
AND
QUANTITATIVE
COMPOSITION
IN TERMS
OF
irlii
,rCiivp
iussrANcBts)
..
"""""""
4
PHARMACEUTICAL
FORM........'
""""""""""""""""""""'
4
CLINICAL
PARTICULARS
'.".......'.
""""""""""""
"""""""
4
Indication(si
......'.
Dosase
and
method
of
administration
Contraindications
""""""""""""""""""""
4
Special
warnings
and
precautions
fot'
use""""""'--"
""""""'
4
Interaction
with
other
medicinal
products
and
other
forms
of
interaction
""""'
5
Pregnancy
and
lactation..".',.'
Undesirable
effects.."..'....'.-""'-----
3.
4,
4.1
4.2
4.3
4,4
4.6
4.6.1
4.6.2
4.7
4.8
4.9
5.
5,1
.
Pharmacodynamic
properties"
5.2
Pharmacoklnetic
Properties""
"""
""""""'
/
-1
5,3
Preclinicalsafetydata.....""'-"-""'--'
6,
PHARMACEUTICALPARTICULARS..
6.1
6.2
6.3
6.4
6.5
6.6
7.
List
of
excipients
Incompatlbilities
Shelf
life
Special
precautions
for
storage
Nature
and
contents
ofcontainer
Instl.uctions
for
use
/
handling
OWNER
OFTHE
PRODUCT
ffi
1.
NA]VIE
OF
THE
MEDICINAL
PRODUCT
Skinoren
15
%
gel
2.
QUALITATIVE
AND
QUANTITATIVE
COMPOSITION
TI{D
ACTIVE
SUBSTANCE(S)
I
g
Skinoren
gel
contains
150
mg
(15
%)
azelaic
actd'
For
a
full
List
ofexcipients,
see
section
6
l
3.
PHARMACEUTICAL
FORM
Gel
(white
to
yellowish-whrte
opaque
gerJ
IN
TERMS
OF
4.1
Indications
Acne:
rnild
ancl
moderale
case
of
papulopttstular
acne
on
facial
skin'
papulopustular
Iosac€a
4,2
Dosage
and
method
of
administration
For
extemal
use.
Adults
and
children
above
12
years
of
age:.gel
'should
be
applied
to
tbe
,ir"*o
"ti"*itr.tn
twice
aday
(momine
ancl
evening)
and
mbbed
in€enlYskinor"n
g"t
i.
;;;;;t
r.icm
of
get
is
sufficieni
for
the
entire
facial
area
!
"Tji"i,'i*
tir"
,rro.,to
u"it'oro'gt'lv
cleaned
with
plain
water
or
mild