РОСЗДРАВНАДЗОР Информационное письмо № 04И-215/13 от 05.03.2013


ФЕДЕРАЛЬНАЯ СЛУЖБА ПО НАДЗОРУ В СФЕРЕ ЗДРАВООХРАНЕНИЯ (РОСЗДРАВНАДЗОР)

109012, Москва, Славянская пл. 4, стр. 1, Телефон: 8(495)698-45-38; 8(495)698-15-74 https://roszdravnadzor.gov.ru

Информационное письмо № 04И-215/13 от 05.03.2013

Решение по результатам экспертизы качества лекарственных средств

llln nl|cr-epcrao 3ApaBooxpaHer|n,
Pocclf,cxoft Oeaepaunn

oEAEPAnbHAff CJIyIKEA rIO HAA3OPy
B COf,PE 3IPABOO)CAHEHT.Ifl
(POC3FABHAA3OP)

Pyrouo4llreJrrM opraHr{3aru4fi rrpor43BoAr{TeJrefi neKapcTBeHHbrx

cpeAcrB

CiaerHcrar nn.,.u. 4, crp. l. MocKBA 109074
re,r.: (495) 698 46 28.698 46 l I

C5 C'./C/JNN

/3

Ha Ns

Pyxono4ureJrsM opraHr,r3arlufi r{MnopTepoB neKapcTBeHHbrx cpeAcTB

Cy6rexraM o6paqeHr,rt
neKapcTBeHHbrx cpeAcTB

t-

Peureuue tro pe3ynbraraM sKcleprlr3br
KaqecTBa neKapcTBeHHbrX CpeAcTB

tDe4epalrHat cnyx6a no HaA3opy B c$epe 3ApaBooxpaHeHr.rr
HHOopMHpyer, qro
IIo pe3yJlbraraM 3KC[eprI{3bI KaqecrBa JreKapcrBeHHbrx cpeAcrB npHHrro perueHHe
o
coorBercrBr4u ycraHoBJIeHHbIM rpe6onanzrna KaqecrBa neKapcrBeHHbrx
cpeAcrB,
lepequcneHHbrx B rrpHJrox eHuLr.

flpznoxeHr.re:Ha 5

Bpno pyKoBoAnreJrt

f.B. fausoqra
84995780 I 87

n.e I

exs.

E.A.TenrHoBa

llpnroxeune

K

nrcbMy poc:gpaeua4zopa or C,j- Cj.

* /*s o?u-sl />

Cne4eHnn o JrerapcrBeHnbtx cpeAcrBax, no pe3ynbraraM rKcflepr[3bl
KaqecrBa Koropblx Pocr4panHaA3opoM npilHnro peuenrre
o coorBercrBrrrr Hx KaqecTBa
HaHMeHosaHHe opraHrl3auuH,

Houep 3aAaHr.tt

rpeAcraBl,tBrueft o6pa:qur

JlerapcraeuHoe cpeAcrBo

flponseo4nrelr

CrpaHa np-ea

OAO "@aprucraHAaprY$aBHTA"

Poccnr

JreKapcTBeHHbtx cpeAcTB

Ns 04H-l13/12

OOO "OnroBafl KoMnaHHt

or 22.02.2012:
Ns 04W-52lll2

Acrop6nnoBaq Kl,tcJrora c

''BHTA IIJIIOC''
(yl.6elrescKal, g.6,

mrcrolofi ra6lerrn

or

r.Open6ypr, OpeH6yprcrar
o6nacrs)

nonHMepHbre

Ns04V-ll3ll2

Anrerca MY3 "IIPB

or 22.02.2012;

OpeH6yprcroro paftona"
(Hexnucrcoe uocce, 4.4, .nnrep
E 12, r.OpeH6ypr, OpeH6yprcKat

flapauerauol 4ercrnft cycn.
4/nH. npueua l20rr,tr/5rvrl 100r,
$r. reuH. cr., Mepnafl Jro)KKa,

19.06.2012

Ns 0414-52ll12

or

19.06.2012

I

3rccneprHar opraHH3aqHt

ofBy "I4MU3yAOCMII"

Cepnn

9105t2

Poc:4paauag:opa

00rvr+8 77rr,rr 40urr., 6aH xn

(KasaHcrnfi Snrnan)

OAO "tDaprracraHAapr

Poccl.rc

JIercpe4crea"

ofEy "tIMU3yAOCMI"

r0820t

PocsApaaHaAsopa

(Kasancrnfi $lrrlHar)

naq. KapT.

o6lacrs)
Ns

04V-l 13/12

or 22.02.2012:
Ns04V-52lll2

or

19.06.2012

AnreKa My3 "t{Pb
OpeH6yprcroro pafioua"
(HexaHcxoe uocce, g.4, lurep
E 12, r.OpeH6ypr, OpeH6ypfcKat

,{n rrlo$eHar-Arpr.r@ perapA

ra6l. npoloHrnp.

crnun
nlnn/o l00rvrr lOrur., yn. rq.

rcoHr.

4eft

OAO ''XOK
ttAKpHxHH"

PoccHq

DI-Ey "l,lMII3yAOCMn"

I t07

12

Poc:4paaHa4:opa

'KasaHcrHft

(2), naq. Kapr.

$nnnal)

o6racru)
Ns

04V-l13/12

or 22.02.2012;
Ns 0414-52ll12

or

19.06.2012

04V-l l3l12
or 22.02.2012;
Ns04A-521/12
Ns

or

19.06.2012

Anrera MY3 "IIPB

Kerorr.l$eH ra6lerrn I ur lOrur.,
Opeu6ypncroro pafioHa"
ynaKoBKH sqeft rosue KoHTypHbre
(HexrHcrcoe ulocce, g.4, lnrep
(3), navrcn KaproHHbre
E l2, r.OpeH6ypr, OpeH6yprcKafl

o6lacrr)
Anrera MY3 "IIPE

Acrop6uuoBar KncJrora c
Open6yprcroro pafioHa"
mrcrorofi ra6.nerrn
(Hexuucrcoe trtocce, A.4, nwrep |00nar+877nrr I0urr., yn.
6earrv.
E I 2, r.Open6ypr, Open6yprcKa, KOHT.

UA{J "l4p6nrcrnil

Poccrs

xo3"

oI-By "I4MII3yAOCMI-1"

70312

Poc:4panua4sopa

(Ka:aHcrr.rfi Sulran)

0AO

"
craHAapr-

Poccnr

YSaBHTA"

of6y

',HMI_{3yAocMn,

t770812

Poc14panuag:opa

(Ka:aHcrnI Qunuaa)

o6.nacrs)
Ns 0414-l 13/12

OOO "OnroBafl KoMnaHHt

or 22.02.2012:

''BHTA I-IJIIOC''

Np04L1-52ll12

(yn.EenrencKar, g.6,

or

r.OpeH6ypr, Opeu6yprcrar
o6nacru)

19.06.2012

[nrpalrou fI ra6lerrn l0rur.,

UAO "
ynaKoBKH cqefi rossre KoHrypHbre

JIerccpe4craa"

Pocclrs

ofBy "HML{3yAocMfI"
Poc:4paeHa4:opa
(Ka.:aucrcnfi $unna:)

t7l03t2

I

l3l12
or 22.02.2012,
Ns 04V-521/12
Ng 0414-l

or

19.06.2012

Anrera MY3 "l_lPE
Opeu6yprcroro paftoHa"
(HexrHcroe uocce, 4.4, larep
E 12,

l-lnrpauoH [I

ra6rerru l0urr..

ynaKoBKH 6errcqeft xoaHe

3AO "n@K

Poccur

"06HoBreHHe"

ofBy "HMuSyAOCMfl"

5806 l 2

Poc:4paeHaA3opa

KoHrypHbre

(Ka:aHcrr.rfi QNnuan)

r.OpeH6ypr, OpeH6yprcKat

o6lacrs)
Ns04V-113/12

Anrera MY3 "UPE

or22.02.2012;

OpeH6yprcrcoro pafioHa"
KHlx.-pacrB. o6oro.troft 25iur
(HexnHcroe trtocce, g.4, lnrep
lOrur., yn. rq. roHr. (3), nav.
E I 2, r.OpeH6ypr, Opeu6yprcKat Kapr.

Ns 04Vl-521/12

or 19.06.2012

OproQeu

ra6lerrn

noKpbtrbre

oAo

Poccur

ofBy "HMu3yAOCMfl"

"TarxnruSapMnpetta-

Pocr4paauag:opa

parbl"

(Ka:aHcxuft Qunuar)

870512

o6nacrs)
Ns04H-113/12

OOO "OnroBar KoMnaHHt

I{r.rrparuoH

or 22.02.2012:

''BHTA NJIIOC'

Ng 04V-521/12

(yr.BelnencKafl, g.6,
r.Open6ypr, Opeu6yprcran

ynaKoBKH 6esrrqefi rossre
KOHrypHbre

or

19.06.2012

fl ra6lerxu 6nr.,

OAO "tDaprracraHAaprToucrxurrlSapn,t "

Poccnr

ofBy

"HMI_I3yAOCMn"

l20l l il

Poc:gpaaHa4aopa

(Kasancrnft Sraluar)

o6racru)

Ns04V-ll3l12
or 22.02.2012:
Ns 04H-52ll12

or

19.06.2012

04I,I-l l3lt 2
or 22.02.2012;'
.t\lb

Ns

04V-52lll2

or 19.06.2012

Anrera MY3 "UPE
OpeH6yprcroro pailona"

OeHasenarrl@
I

ra6nerxn I ur

0ur., y[aKoBKH qqeilrosHe

(Hexnucroe flrocce, 4.4, nxrep
r(oHTypHbte (5), na.rrc.r KaproHHbre
E I 2, r.OpeH6ypr, Opeu6yprcKat
o6lacrs)

Anrera MY3 "UPB
Opeu6yprcroro pafioHa"
(Hexuucroe uocce, g.4, nnrep
El

2, r.Opeu6ypr, OpeH6yprcKat

OAO "Baleura
Oapuaqeatnxa"

OAO "Hp6nrcrcnfi

Arr

xo3"

npnMeHeHH s 20ur
6esrc.t. rour.)

J\b I

orBy "HMUSyAOCMI"

t903t2

Poc:4panna4aopa

(KaraHcrHft Snnnal)

MecTHoro n HapyxHoro

Poccnr

Pocclrs

(DfBy "l4Mu3yAOCMfI"

t8307t2

Pocs4panHa4sopa

0 (yn.

(Ka:aHcrnfi Srruar)

o6racrr)

Ns04H-ll3l12
or 22.02.2012;
Ns 04V-521/12

or

19.06.2012

Ns04V-l13/12
or 22.02.2012;
Ns

04V-52lll2

or

19.O6.2O12

Anrexa MY3 "UPE
Opeu6yprcroro pailoHa"
(Hexnucroe uocce, 4.4, lurep
E 12, r.Opeu6ypr, OpeH6yprcKat
o6racrs)

A uernlcal nqhnoBar KncJrora
OAO "Map6noQaprr,l"
ra6nerru 500ur l0rur., yraKoBKH

Anrera MY3 "UPE

JInHrac@ JIop nacrHlxl.r
[urrHrre] No l6 (ynaroexr.l

OpeH6yprcroro pafioua"

ofFy "HMuSyAoCMfl"

5108r2

Poc:4paoua4sopa

6e:rsqefi roBHe KoHrypHbre

(Hexrucroe trrocce, g.4, nwrep qqefiroeue rcoHrypnure)
E | 2, r.Opex6ypr, Oper-r6yprcKat
o6nacrs)

Poccas

(KarancrHfi Snruaa)

Xep6roH llarcucrau
l-lpafieer JInuureA

flarucrau

ofBy "HMu3yAOCMfl"
Poc:tpaaHa4ropa
(Kaeaucrnfi Qnnual)

281 1068

04H- ll3l12
or 22.02.2012;

J\e

Anrera MY3 "UPE

Ns 0414-521/12

OpeH6yprcroro pailoua"
(HexuHcrcoe [Iocce, 4.4, nnrep
E | 2, r.Opeu6ypr, OpeH6yprcKat

or 19.06.2012

6opuar Kucrora nop. n/Hapyx.
npfiM., l0r (narerul ur
xou6uHnp. repMocBap.
uarepnaaa)r

OOO "Tyrscxar

Poccac

ofBy "HMu?yAOCMft"

SapnraqeurHr{ecKat

Poc:4paaua4:opa

$a6pnra"

(KaraHcruft Surnan)

505t2

o6racrs)

04H-l13/12
or 22.02.2012:'
Ns 04Vl-521/12
or 19.06.2012

OOO "foaoBaJtoB"

04H-ll3/12

OOO "foaoBaroB"

Ns

qroro, 4.39,
r.l-lepuu, Ileprucrnft rpaft )
(yr.B.XnrenrH

u

.{nxno$eHaK pacrBop Ars s/rr,l
BBeAeHilfl 25nar/un 3rul ananylu

OAO "Eopr.lcoacxnft

(10), navrr KaproHHbte

rr,le4npenaparos"

3aBOA

Pecny6nnxa
Ee.napycs

ofBy "HMu3yAocMlI"
(KasaHcrrft Snlaal)

(yl.E.XueluHnqroro, 4.39,
r. flepuu, fleprvrcrr.rft rcpaft )

Karsqnr xnopuA pacrBop Alts/s

oryn

BBeAeHnr | OOrr,r/rran 5nal arunylsl
(10), navrcn KaproHHbre

"AprrrannpcxaR

Pocs4paaHa4ropa

6HororHqecxac

(Ka:aucxufi SHlna.n)

Ns04V-l13/12
or 22.02.2012:

OOO "Bce gln lgopontr"
(yl.BauroprocraH, 4. I 0, noru.2,

Ns 0414-521/12

r.Yva.nul, Pecny6lura

or 19.06.2012

Acrop6nHoBar Kr,rcnora c
mrorogofi ra6lerru
| 00rur+877un I 0ul'r., yn. 6errnv.

6auxoprocrau)

KOHT.

04V-l13/12
or 22.02.2012:
Np 04k1-52lll2

(nrparvloH

ynaKoBKH 6egtsqefi

OproQen

Ns

or 22.02.2012:
Np

04V-52ll12

or 19.06.2012

or

19.06.2012

OOO "Bce 4ll 34opoasr"
(yl.BaruxoprocraH, 4. | 0, norra.2,
r.Yva:rsl, Pecny6lura
EaurroprocraH)

Ns

04H-l l3112

OOO "Afi,[oc"

Np

fl ra6lerru l0rur.,
roeue

Poccl.rc

Poccnr

Ma3b AJu

Happrcor-o

04V-l 13/12
or 22.02.2012:
Ns 04V-521/12
or 19.06.2012

3AO "@apureHg"
(yr. EypeaecrHr,tKa, a. I 2, r.Y$a,

Arsra-npnru@ ra6.nemn

3AO "nOK

Poccnr

"06HoBreHHett

Pecny6lrra EauroprocraH)

3AO "Beprercc"

Pocq.rs

5906t2

3AO "@aprrareH4"

Bnranpocr@ @opre cynn.

or 22.02.2012;
Ns04H-521/12
or 19.06.2012

OAO "Hnxdapu"

(yn.EypenecrHfi Ka, 4. I 2, r.V$a,
Pecny6.nnra Eauxoprocrau)

Pocq.rs

peKrarbHbte

Ns 0414-l 13/12

3AO "
or 22.02.2012;

(yr.EypenecrHnKa, g. 12, r.Y$a,

04V-52lll2
or 19.06.2012

AqerulcaluunjroBat Kncrora
3AO "nOK
ra6lerru 500ur lOur'., ynaKoBKtl "06HogreHnet'

Pecny6rnra EaurroprocraH)

6ertsqefi xoBbte KoHrypHbte

0 (ynarconrn

| OOrrar Ns

060612

(Ka:aHcrnfi fir,rnnal)

u, Pecny6lnxa Eaurroprocrau)
J\e |

ofEy "HMu3yAOCMfl"
Poc:gpanHa4sopa

6ertr.tefi ronue rourypuue)

Ns

ofBy "HMu3yAOCMn"
Pocs4paaua4:opa

flolsura

04H-l l3112

1360812

(KasancrHfi $nluan)

Oapuaqeeru.lecrufi
:ano4 "floluSapua"
AO

Ns

(DfEy "HMU3yAOCMII"

030712

(Ka:aHcrcnfi Snlna.n)

(yl.Ilepnouaficrar, g. I l,
nprMeHeHil n 2o/o 30r ry6at
c.Kapan4els, Kapan4elrcxxfi p- aJItoM., naqKH KapTOHHbte

urHnyr{ne

or6y "HMI{3yAOCMn"

Pocr4paeua4:opa

KoHrypHble

or 22.02-2012:.
Ne 04V-521/12
or 19.06.2012
Np

$a6pnra"
OAO "
4807 t2

Pocs4paaHaA3opa

of6y

"l4MI{3yAOCMn"

70212

Poc:4panua4ropa
(KaraHcru.rfi $unuar)

l0

ofBy "HMu3yAOCMn"

20n2

Poc:4paaua4ropa

(ynaxonrH RqefirosHe
rourypHsre)

(Ka:aHcrnfi $urraar)
PoccHq

orEy "HMu3yAOCMfl"
Pocs4panHa4:opa

(Ka:aucrnfi Sunual)

130312

lle 0414- ll3l12
or 22.02.2012;
Np 0414-52ll12

OOO "Afiaoc"

or

19.06.2012

l-rnxo:a pacrBop 4rr rH$y:rfi
(yr.Ilepeouaficrar, 4. I l,
5oh 200u1, 6yrsllxrl Arq KpoBH,
c.Kapar4elu, Kapan4enrcrnfi p- rpauc$y:r.loHHbtx H
u, Pecny6lnra Eaurxoprocrau)
r.rH$y:nonHbtx rperaparoB

Ns

04V-ll3/12

fEY PM3 "Pecny6lnrascxnfi

AunHorcanpoHoBar KucJrora p-p

oHKororxqecrufi 4ncnaucep"
(yn. Ocn neH rco, p,.22, r.fr oru rapOra, Pecny6lura Mapr.rfi 3l)

Nuv'6.
6yrrrrxr.r
Anr KpoBH rpaHc$y:uoHublx H
nnSyrnoHHbtx npenaparoB

OOO "Acrpyu " (yl.farapuHa,
89/5 5, r.Ka3aHt, Pecny6lnra

y[aKoBKH cqefi rcosHe KoHTypHbte

or 22.02.2012;
Ns 04V-521112

or

19.06.2012

04H-l l3112
or 22.02.2012;

A.

Ns 04H-521/12

Tarapcrau)

J\e

or

OAO "MocQap""

Poccur

I

Orur.,

04H-l l3112
or 22.02.2012;
Ns 0414-52ll12

or

19.06.2012

.hrb

04H-l t3112

OOO "Acrpyu" (yl.farapHHa,
A.89 / 5 5, r.Ka3aH s, Pecny6rnxa
TarapcraH)

Poccl,rs

Auernlcalr

ra6lerrr

unJroBas KncJrora
500rvrr lOrur., ynaKoBKH

04H-l l3/12
or 22.02.2012;

fKY3 "O6lacrnofi
rllnHnqecrcnfi

fl ra6lerru | Ourr.,
ynaKoBKH 6egrsqeft rosHe

Ns 0414-52ll12

npotneory6epryle:uslfi

KOHTypHbte

or

4ucnaHcep" (yn.Kr.rpos a, A.4,

Ns

19.06.2012

00708t

(KasaHcrrft Snruar)
OAO "@aprracraHAapr-

PoccHq

JIercpe4c'raa"

orBy "HMuSyAOCM[I"

1230612

Poc14paoua4:opa

3AO "flOK
"06HoBreHlte"

Poccl.rs

nuterqnfi 20nar/nrl 2ul

50712

Poc:4panua4ropa

(KasaHcxnfi $r.llnan)

Pytl
an,tnylsr

ofBy "HMuSyAOCMn"

"Berue4npenaparsl"

Pecny6lnrca

Eelapycu

( I 0), navrcr.r KaproHHbre

orEy "l4MuSyAOCM["

l37r

il

Poc:4panHagaopa

(KamHcrnft $nlna.n)

I-[n'rparr,rou

OAO "BnocHHTe3"

Poccnr

ofBy "HMu3yAOCMfl"

2505 I I

Poc14paeHa4sopa

(Ka:aHcrcuft Snnr.ra.n)

r.Yrscr{oscr, Vltruoncrar
o6racru)
irb 04H-t

l3lt2

fKY3 "O6lactsofi

or 22.02.2012:
Np04[-52ll12

nporanory6epryne:Hufi

or

19.06.2012

4ncnaHcep" (yl.Kr,rpon a,

Ns

04H-ll3ll2

fKY3 "O6lacrsoft

or 22.02.2012;
Np04I4-52ll12

or

19.06.2012

r.nnuuqecrnfi

Aualrrns pacrBop lls sls u s/u
BBeAeHHT 500rrar/rru 2nal,

OAO "EnocrHTe3"

Poccl.rs

aunynu

(10), navxu KaproHHbte

nporueory6epryrmnufi
gncnaHcep" (yl.Krpoea, A.4,
r.YrusHoscr. VlstHoncrar
o6racrs)

f.nrcrora pacrBop anr nH$yrnfi
5o/o200un, SlaroHu 4lr
KpoBe3aMeHnre.nefi

ofBy "HMII3yAOCMII"

30212

Pocs4paaHa4sopa

(Ka:aHcxufi $nru.rar)

I.4,
r.YrtsHoecr, Vrrtnoscras
o6lacrs)
x.nnHnqecrnfi

I

Pocs4panua4sopa

6egrcqeft roBue KoHrypHbre

JlnAoranH pacrBop Anfl

19.06.2012

ofBy "l4Mu3yAOCMfl"

(Ka:ancrufi Snlnar)

MY3 "BolrcKar aercKat
6olsHuqa" (yl. KorrlcorraoJrbcKar,
A. I 90, r.Bolucr, Caparoncrar
o6racrr)

or 22.02.2012;
Ns 04W-52lll2

02t0412

(KasaHcxuft $n"rrua.n)

SOrvrr/rvrn | 00r'ar,

Acro$en-fl ra6lerrcn

ol-Ey "HMu3yAOCMfl"
Poc:4paaHag:opa

19.06.2012

-lls

or

OAO "Moc$ap""

OAO "EnocHHTe3"

Poccur

ofEy "HMIISyAOCMn"
Pocr4paeHagtopa

(Ka:ancruft $rruar)

490412

r

Ns04W-ll3ll2
or 22.02.2012',
Ns04V-52ll12
or 19.06.2012
Ns04V-ll3l12
or 22.02.2012;
Ns04V-521/12

or

OAO "Vpan6not[apm"
(np.Tparropocrpoxrenefi , a. | 0 l,
r.9e6orcapsl, t{yearucraR
Pecny6rnxa)
3AO "UPA }lb43" (yr.JIeHnxa,
4. l, c.Kaapeuro, Opeu6yprcKat
o6lacrs)

OAO "Vpan6uoQapr*4"

fleHra$nyuuH@ rpauyr sl

Poccl,rs

or6y "HMI{?yAOCMn"

A/npHror. p-pa Anfl nPHeMa
BHyrpb 5 r, nareruxH (10), naqKn
KapToHHble

Keropon@ pacrBop 4lr e/rrt
BBeAeHnt, lrvrn 3Orun/rr.rn

ltl0

,{-p PegAn'c

Vuhwn

ofEy "HMu3yAOCMn"
(KaraHcrnfi Srarnal)

(aunylur reMHoFo crexla)*

19.06.2012

l0urr., 3AO "Beprexc"

PoccHc

ofEy "HMq3yAOCMil"

OOO "OnroBafl KoMnaHhfl

Keroponar ra6lerxn

or 22.02.2012;
Ng04V-52ll12

''BHTA NJIFOC"

ynaKoBKH tqefi rosrte KoHTYPHbIe

Pocr4paeHag:opa

(yr.EenneacKafl, 4.6,
r.OpeH6ypr, OpeH6yprcran

(2), naurcu KaproHHbte

(Ka:aHcrnil Sunrar)

19.06.2012

| Orvrr

o6racru)

04H-l l3l12
or22.02.2012:
Ne.04V-52lll2
Ns

or

19.06.2012

Anrera fEY3 "flesleucrcnfi

Keropon@ pacrBop g.nr n/u

ropo4cxofi poAnTenbcKnfi Aot't " BBeAeHHt, lun 30rvrr/nrn Jtbl0
flapanaouona O.K. (yl.[lYurnua, (arvrnyrur reMHoro crexla)*
.q.

,{-p Peaan'c

VnAus

l3l12

or 22.02.2012'.
Ns04V-52lll2

orEy "HMu3yAOCMfl"

020512

42162

Poce4panHa4:opa

Jla6oparopr.rc JIrg

(KasaHcrufi $unHar)

56, r.fleula, fleuleHcxar

o6racrs)
}.lb 0414-l

A2125

Pocrgpanua4:opa

Jla6oparopnc JIr4

Jle 0414-l l3112

or

t60812

Pocr4panuaA30pa
(KaraHcr
OOO "foaoBaroB"
(yr.E.Xr*,tenssnuroro, A.39,
r.flepnas, fieprr,tcruail rPafi )

or 19.06.2012
* - no nponepeHHbrM noKa3arerflM

Pesarrnlr ra6rempr Ns20
(ynaxonrn 6ettR'tefi rosHe
xourypHue)*

lllper JIafiS
CaileHcua ner. JIra

l4y.Ans

orEy "HMuSyAOCMfl"
Poc:4paaHa4:opa

(KaraHcrrafi $nnHar)

c9667

llln nl|cr-epcrao 3ApaBooxpaHer|n, Pocclf,cxoft Oeaepaunn

oEAEPAnbHAff CJIyIKEA rIO HAA3OPy B COf,PE 3IPABOO)CAHEHT.Ifl (POC3FABHAA3OP) Pyrouo4llreJrrM opraHr{3aru4fi - rrpor43BoAr{TeJrefi neKapcTBeHHbrx CiaerHcrar nn.,.u. 4, crp. l. MocKBA 109074 cpeAcrB re,r.: (495) 698 46 28.698 46 l I
Pyxono4ureJrsM opraHr,r3arlufi - C5 C'./C/JNN /3 r{MnopTepoB neKapcTBeHHbrx cpeAcTB
Ha Ns Cy6rexraM o6paqeHr,rt t- neKapcTBeHHbrx cpeAcTB Peureuue tro pe3ynbraraM sKcleprlr3br KaqecTBa neKapcTBeHHbrX CpeAcTB

tDe4epalrHat cnyx6a no HaA3opy B c$epe 3ApaBooxpaHeHr.rr HHOopMHpyer, qro IIo pe3yJlbraraM 3KC[eprI{3bI KaqecrBa JreKapcrBeHHbrx cpeAcrB npHHrro perueHHe o coorBercrBr4u ycraHoBJIeHHbIM rpe6onanzrna KaqecrBa neKapcrBeHHbrx cpeAcrB, lepequcneHHbrx B rrpHJrox eHuLr.

flpznoxeHr.re:Ha 5 n.e I exs.

Bpno pyKoBoAnreJrt E.A.TenrHoBa

f.B. fausoqra 84995780 I 87 llpnroxeune K nrcbMy poc:gpaeua4zopa or C,j- Cj. * /*s o?u-sl />
Cne4eHnn o JrerapcrBeHnbtx cpeAcrBax, no pe3ynbraraM rKcflepr[3bl KaqecrBa Koropblx Pocr4panHaA3opoM npilHnro peuenrre o coorBercrBrrrr Hx KaqecTBa
HaHMeHosaHHe opraHrl3auuH, Houep 3aAaHr.tt rpeAcraBl,tBrueft o6pa:qur JlerapcraeuHoe cpeAcrBo flponseo4nrelr CrpaHa np-ea 3rccneprHar opraHH3aqHt JreKapcTBeHHbtx cpeAcTB Cepnn
Ns 04H-l13/12 OOO "OnroBafl KoMnaHHt Acrop6nnoBaq Kl,tcJrora c OAO "@aprucraHAapr- Poccnr ofBy "I4MU3yAOCMII"
or 22.02.2012: ''BHTA IIJIIOC'' 9105t2 mrcrolofi ra6lerrn Y$aBHTA"
Ns 04W-52lll2 Poc:4paauag:opa (yl.6elrescKal, g.6, I 00rvr+8 77rr,rr 40urr., 6aH xn (KasaHcrnfi Snrnan) or 19.06.2012 r.Open6ypr, OpeH6yprcrar nonHMepHbre o6nacrs) Ns04V-ll3ll2 Anrerca MY3 "IIPB flapauerauol 4ercrnft cycn. OAO "tDaprracraHAapr or 22.02.2012; OpeH6yprcroro paftona"
Poccl.rc ofEy "tIMU3yAOCMI" r0820t I 4/nH. npueua l20rr,tr/5rvrl 100r, JIercpe4crea"
Ns 0414-52ll12 PocsApaaHaAsopa (Hexnucrcoe uocce, 4.4, .nnrep $r. reuH. cr., Mepnafl Jro)KKa, (Kasancrnfi $lrrlHar) or 19.06.2012 E 12, r.OpeH6ypr, OpeH6yprcKat naq. KapT.
o6lacrs) Ns 04V-l 13/12 AnreKa My3 "t{Pb ,{n rrlo$eHar-Arpr.r@ perapA OAO ''XOK PoccHq DI-Ey "l,lMII3yAOCMn"
or 22.02.2012: OpeH6yprcroro pafioua" I t07 12 ra6l. npoloHrnp. 4eft crnun ttAKpHxHH"
Ns04V-52lll2 Poc:4paaHa4:opa (HexaHcxoe uocce, g.4, lurep nlnn/o l00rvrr lOrur., yn. rq. 'KasaHcrHft or 19.06.2012 E 12, r.OpeH6ypr, OpeH6ypfcKat rcoHr. (2), naq. Kapr.
$nnnal) o6racru) Ns 04V-l13/12 Anrera MY3 "IIPB Kerorr.l$eH ra6lerrn I ur lOrur., UA{J "l4p6nrcrnil Poccrs oI-By "I4MII3yAOCMI-1"
or 22.02.2012; Opeu6ypncroro pafioHa" ynaKoBKH sqeft rosue KoHTypHbre 70312 xo3" Poc:4panua4sopa Ns 0414-52ll12 (HexrHcrcoe ulocce, g.4, lnrep (3), navrcn KaproHHbre or 19.06.2012 (Ka:aHcrr.rfi Sulran) E l2, r.OpeH6ypr, OpeH6yprcKafl o6lacrr) Ns 04V-l l3l12 Anrera MY3 "IIPE Acrop6uuoBar KncJrora c 0AO " 6earrv. (Ka:aHcrnI Qunuaa) or 19.06.2012 E I 2, r.Open6ypr, Open6yprcKa, KOHT.
o6.nacrs) Ns 0414-l 13/12 OOO "OnroBafl KoMnaHHt [nrpalrou fI ra6lerrn l0rur., UAO "or 22.02.2012: ''BHTA I-IJIIOC'' ynaKoBKH cqefi rossre KoHrypHbre t7l03t2 JIerccpe4craa" Poc:4paeHa4:opa Np04L1-52ll12 (yn.EenrencKar, g.6, or 19.06.2012 (Ka.:aucrcnfi $unna:) r.OpeH6ypr, Opeu6yprcrar o6nacru) Ng 0414-l l3l12 Anrera MY3 "l_lPE l-lnrpauoH [I ra6rerru l0urr.. 3AO "n@K Poccur ofBy "HMuSyAOCMfl" 5806 l 2 or 22.02.2012, Opeu6yprcroro paftoHa" ynaKoBKH 6errcqeft xoaHe "06HoBreHHe" Poc:4paeHaA3opa Ns 04V-521/12 (HexrHcroe uocce, 4.4, larep KoHrypHbre (Ka:aHcrr.rfi QNnuan) or 19.06.2012 E 12, r.OpeH6ypr, OpeH6yprcKat o6lacrs) Ns04V-113/12 Anrera MY3 "UPE OproQeu ra6lerrn noKpbtrbre oAo Poccur ofBy "HMu3yAOCMfl" 870512 or22.02.2012; OpeH6yprcrcoro pafioHa" KHlx.-pacrB. o6oro.troft 25iur "TarxnruSapMnpetta- Pocr4paauag:opa Ns 04Vl-521/12 (HexnHcroe trtocce, g.4, lnrep lOrur., yn. rq. roHr. (3), nav. parbl" (Ka:aHcxuft Qunuar) or 19.06.2012 E I 2, r.OpeH6ypr, Opeu6yprcKat Kapr.
o6nacrs) Ns04H-113/12 OOO "OnroBar KoMnaHHt I{r.rrparuoH fl ra6lerxu 6nr., OAO "tDaprracraHAapr- Poccnr ofBy "HMI_I3yAOCMn" l20l l il or 22.02.2012: ''BHTA NJIIOC' ynaKoBKH 6esrrqefi rossre ToucrxurrlSapn,t " Poc:gpaaHa4aopa Ng 04V-521/12 (yr.BelnencKafl, g.6, KOHrypHbre (Kasancrnft Sraluar) or 19.06.2012 r.Open6ypr, Opeu6yprcran o6racru) Ns04V-ll3l12 Anrera MY3 "UPE ra6nerxn I ur OeHasenarrl@ OAO "Baleura Poccnr orBy "HMUSyAOCMI" t903t2 or 22.02.2012: OpeH6yprcroro pailona" I 0ur., y[aKoBKH qqeilrosHe Oapuaqeatnxa" Poc:4panna4aopa Ns 04H-52ll12 (Hexnucroe flrocce, 4.4, nxrep r(oHTypHbte (5), na.rrc.r KaproHHbre (KaraHcrHft Snnnal) or 19.06.2012 E I 2, r.OpeH6ypr, Opeu6yprcKat o6lacrs) .t\lb 04I,I-l l3lt 2 Anrera MY3 "UPB or 22.02.2012;' t8307t2 Opeu6yprcroro pafioHa" Arr MecTHoro n HapyxHoro xo3" Pocs4panHa4sopa Ns 04V-52lll2 (Hexuucroe uocce, g.4, nnrep npnMeHeHH s 20ur J\b I 0 (yn. (Ka:aHcrnfi Srruar) or 19.06.2012 E l 2, r.Opeu6ypr, OpeH6yprcKat 6esrc.t. rour.) o6racrr) Ns04H-ll3l12 Anrexa MY3 "UPE A uernlcal nqhnoBar KncJrora OAO "Map6noQaprr,l" Poccas ofFy "HMuSyAoCMfl" 5108r2 or 22.02.2012; Opeu6yprcroro pailoHa" ra6nerru 500ur l0rur., yraKoBKH Poc:4paoua4sopa Ns 04V-521/12 (Hexnucroe uocce, 4.4, lurep 6e:rsqefi roBHe KoHrypHbre (KarancrHfi Snruaa) or 19.06.2012 E 12, r.Opeu6ypr, OpeH6yprcKat o6racrs) Ns04V-l13/12 Anrera MY3 "UPE JInHrac@ JIop nacrHlxl.r Xep6roH llarcucrau flarucrau ofBy "HMu3yAOCMfl" 281 1068 or 22.02.2012; OpeH6yprcroro pafioua" [urrHrre] No l6 (ynaroexr.l l-lpafieer JInuureA Poc:tpaaHa4ropa Ns 04V-52lll2 (Hexrucroe trrocce, g.4, nwrep qqefiroeue rcoHrypnure) (Kaeaucrnfi Qnnual) or 19.O6.2O12 E | 2, r.Opex6ypr, Oper-r6yprcKat o6nacrs) J\e 04H- ll3l12 Anrera MY3 "UPE 6opuar Kucrora nop. n/Hapyx. OOO "Tyrscxar Poccac ofBy "HMu?yAOCMft" 505t2 or 22.02.2012; OpeH6yprcroro pailoua" npfiM., l0r (narerul ur SapnraqeurHr{ecKat Poc:4paaua4:opa Ns 0414-521/12 (HexuHcrcoe [Iocce, 4.4, nnrep xou6uHnp. repMocBap. $a6pnra" (KaraHcruft Surnan) or 19.06.2012 E | 2, r.Opeu6ypr, OpeH6yprcKat uarepnaaa)r o6racrs) Ns 04H-l13/12 OOO "foaoBaJtoB" .{nxno$eHaK pacrBop Ars s/rr,l OAO "Eopr.lcoacxnft Pecny6nnxa ofBy "HMu3yAocMlI" 4807 t2 or 22.02.2012:' (yr.B.XnrenrH u qroro, 4.39, BBeAeHilfl 25nar/un 3rul ananylu 3aBOA Ee.napycs Pocs4paaHaA3opa Ns 04Vl-521/12 r.l-lepuu, Ileprucrnft rpaft ) (10), navrr KaproHHbte rr,le4npenaparos" (KasaHcrrft Snlaal) or 19.06.2012 Ns 04H-ll3/12 OOO "foaoBaroB" Karsqnr xnopuA pacrBop Alts/s oryn Poccl.rc or6y "HMI{3yAOCMn" 030712 or 22.02.2012: (yl.E.XueluHnqroro, 4.39, BBeAeHnr | OOrr,r/rran 5nal arunylsl "AprrrannpcxaR Pocs4paaHa4ropa Np 04V-52ll12 r. flepuu, fleprvrcrr.rft rcpaft ) (10), navrcn KaproHHbre 6HororHqecxac (Ka:aucxufi SHlna.n) or 19.06.2012 $a6pnra"
Ns04V-l13/12 OOO "Bce gln lgopontr" Acrop6nHoBar Kr,rcnora c OAO "Np 04V-l13/12 OOO "Bce 4ll 34opoasr" (nrparvloH fl ra6lerru l0rur., 3AO "nOK Poccnr ofBy "HMu3yAOCMn" 5906t2 or 22.02.2012: (yl.BaruxoprocraH, 4. | 0, norra.2, ynaKoBKH 6egtsqefi roeue "06HoBreHHett Pocs4paaua4:opa Np 04k1-52lll2 r.Yva:rsl, Pecny6lura KoHrypHble (Ka:aHcrcnfi Snlna.n) or 19.06.2012 EaurroprocraH) Ns 04H-l l3112 OOO "Afi,[oc" OproQen Ma3b AJu Happrcor-o 3AO "Beprercc" Pocq.rs ofEy "HMu3yAOCMfl" 060612 or 22.02-2012:. (yl.Ilepnouaficrar, g. I l, nprMeHeHil n 2o/o 30r ry6at Poc:gpanHa4sopa Ne 04V-521/12 c.Kapan4els, Kapan4elrcxxfi p- aJItoM., naqKH KapTOHHbte (Ka:aHcrnfi fir,rnnal) or 19.06.2012 u, Pecny6lnxa Eaurroprocrau) Np 04V-l 13/12 3AO "@apureHg" Arsra-npnru@ ra6.nemn Oapuaqeeru.lecrufi flolsura of6y "l4MI{3yAOCMn" 70212 or 22.02.2012: (yr. EypeaecrHr,tKa, a. I 2, r.Y$a, urHnyr{ne J\e | 0 (ynarconrn :ano4 "floluSapua" Poc:4panua4ropa Ns 04V-521/12 Pecny6lrra EauroprocraH) 6ertr.tefi ronue rourypuue) AO (KaraHcru.rfi $unuar) or 19.06.2012 Ns 04H-l l3112 3AO "@aprrareH4" Bnranpocr@ @opre cynn. OAO "Hnxdapu" Pocq.rs ofBy "HMu3yAOCMn" 20n2 or 22.02.2012; (yn.EypenecrHfi Ka, 4. I 2, r.V$a, peKrarbHbte | OOrrar Ns l0 Poc:4paaua4ropa Ns04H-521/12 Pecny6.nnra Eauxoprocrau) (ynaxonrH RqefirosHe (Ka:aHcrnfi $urraar) or 19.06.2012 rourypHsre) Ns 0414-l 13/12 3AO "Ns04V-ll3l12 3AO "UPA }lb43" (yr.JIeHnxa, Keropon@ pacrBop 4lr e/rrt ,{-p PegAn'c Vuhwn ofEy "HMu3yAOCMn" A2125
or 22.02.2012; 4. l, c.Kaapeuro, Opeu6yprcKat BBeAeHnt, lrvrn 3Orun/rr.rn ltl0 Jla6oparopnc JIr4 Pocrgpanua4:opa (aunylur reMHoFo crexla)* (KaraHcrnfi Srarnal) Ns04V-521/12 o6lacrs) or 19.06.2012 Jle 0414-l l3112 OOO "OnroBafl KoMnaHhfl Keroponar ra6lerxn | Orvrr l0urr., 3AO "Beprexc" PoccHc ofEy "HMq3yAOCMil" 020512 ynaKoBKH tqefi rosrte KoHTYPHbIe Pocr4paeHag:opa or 22.02.2012; ''BHTA NJIFOC"
(yr.EenneacKafl, 4.6, (2), naurcu KaproHHbte (Ka:aHcrnil Sunrar) Ng04V-52ll12 or 19.06.2012 r.OpeH6ypr, OpeH6yprcran o6racru) Ns 04H-l l3l12 Anrera fEY3 "flesleucrcnfi Keropon@ pacrBop g.nr n/u ,{-p Peaan'c VnAus orEy "HMu3yAOCMfl" 42162 Jla6oparopr.rc JIrg Poce4panHa4:opa or22.02.2012: ropo4cxofi poAnTenbcKnfi Aot't " BBeAeHHt, lun 30rvrr/nrn Jtbl0 (KasaHcrufi $unHar) Ne.04V-52lll2 flapanaouona O.K. (yl.[lYurnua, (arvrnyrur reMHoro crexla)* or 19.06.2012 r.fleula, fleuleHcxar .q. 56,
o6racrs) }.lb 0414-l l3l12 OOO "foaoBaroB" Pesarrnlr ra6rempr Ns20 lllper JIafiS l4y.Ans orEy "HMuSyAOCMfl" c9667 (yr.E.Xr*,tenssnuroro, A.39, (ynaxonrn 6ettR'tefi rosHe CaileHcua ner. JIra Poc:4paaHa4:opa or 22.02.2012'.
xourypHue)* (KaraHcrrafi $nnHar) Ns04V-52lll2 r.flepnas, fieprr,tcruail rPafi ) or 19.06.2012
* - no nponepeHHbrM noKa3arerflM

Министерство здравоохранения Российской Федерации
ФЕДЕРАЛЬНАЯ СЛУЖБА ПО НАДЗОРУ Г |
В СФЕРЕ ЗДРАВООХРАНЕНИЯ Руководителям организаций- (РОСЗДРАВНАДЗОР) .
производителей лекарственных Славянская пл., д. 4, стр. 1. Москва, 109074 средств
Tes: (495) 698 46 28, 698 46 1 Руководителям организаций-
22-23203» _C YU - 915/73 импортеров лекарственных средств
На № от Субъектам обращения
Г ] лекарственных средств
Решение по результатам экспертизы качества лекарственных средств
Федеральная служба по надзору в сфере здравоохранения информирует, что по результатам экспертизы качества лекарственных средств принято решение о
соответствии установленным требованиям качества лекарственных средств, перечисленных в приложении.

Приложение: на 5 л.в 1 экз.

Врио руководителя Е.А.Тельнова
Г.В. Ганночка 84995780187

Скачать документ: Письмо 04И-215/13 от 05.03.2013

Информационные письма Росздравнадзора по контролю качества: Лекарственные средства

Информационные письма Росздравнадзора по контролю качества: Медицинские изделия

   

Первая страница документа


image

Статьи