РОСЗДРАВНАДЗОР Информационное письмо № 16И-562/13 от 30.05.2013


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 № 16И-562/13 от 30.05.2013

Решение по результатам экспертизы качества лекарственных средств

Mnnncrepcrro gaprBooxPaHeHxf,
Pocculcxoil Oegepaunn

oEAEPAJTbHAfl CJrv2r(EA nO HAA3OPy
B COEPE 3IFanOO)PArrEHAfl
(PoC3.TABHAA3OP)
CrasrHcrar nJr.,.{. 4, crp. l, Mocrna" 109074

rcr.: (495)

o4nrer.fl M opraH r,I3 a \r4irrrpor43BoAr4TeJreft JreKapcTBeHHbx
cpeAcrB
Pyrco

n

698 46 28,698 46 I I

Pyrono4ureJrrM opraHra3arlufi LrMnopTepoB neKapcTBeHHbrx cpeAcTB

Cy6mrarra o6parqeHur
JreKapcTBeHHhrx cpeAcTB
Peruenne no pe3yn6TaraM sKcrreprr{3br
KarrecTBa neKapcTBeHHhrx cpeAcTB

@e4epzurrH€rf, cnyx6a uo HaA3opy B cQepe 3ApaBooxpaHeHlr{ raHQoprr,rupyer, qro
pe3yJrbTaTaM
no
sKcrrepTH3br KaqecTBa JreKapcTBeHHbrx cpeAcTB npr,rHrro peureHr{e o
cooTBeTcTBrrI,I ycTaHoBneHHbIM TpeooBaHr{flM KarrecTBa JreKapcTBeHHbrx cpeAcTB,

nepequcreHHbrx B npl|IJroxelJvkl.

flpuroxeHne:Ha 5

Bpno pyKoBoAr4reJrt

f.B. fanHoqxa
8499s780187

n.e 1 sxg.

M.A. Mypamxo

f Ip aroxeu

cnegennr

ue K r H c b My Pocss

o JreKapcrBe'Eblx cpeAcrBaxr no pe3ynbraraM SKcneprrr3br
KaqecrBa Koropbrx Pocr4pan'aAgopoM

pan u a4 ropu

o,

2 Q/.^Ja/S Nn /f4_,lV //fg

np'rrrro perue'rre o coorBercrBr* ux KaqecrBa

HaHMeHosaH He opraHn3aqr.ut,

Honaep 3a4ar.Hr
Ns 04LI-1304/12

or27.12.2012

npeAcraBr.rBrueft o6pa:qsr
neKapcTBeHHblx cpeAcTB

OOO ''CJIAB'HKA''
(yn.tlnxona, A.26,.nnrep A,
r.Hnxne4eruqr,
HnxHe4enuqrufi p-H,
Bopouexcxar o6aacrs)

JlerapcroeuHoe cpeAcrBo

r'a6lema I 3.5nrr
20ur., ynaKoBKlt rqeftroeue
CeuaAe@

Usilus

3rcneprHar opraHH3aur,tt

ofEy "HMUSyAOCMII"
Pocs4paena.qsopa (Kypc

Cepr.nt

482t02

rr,r E

Qu.rrnan)

sqeftroesle rourypHue (2),

Ns04V-1304/12 OOO ''CJIAB'HKA''
or 27.12.2012
(yn.t{r,rxoua" 4.26, lurep A,

Aqerulca.nnqlrnoBar KucJrora

r.Huxne.qennqx,
HnxHeAesuqxnft p-u,

Llranla JIr4

CrpaHa np-na

KoHTypHBre

Ns04V-1304/12 OOO'CJIAB'HKA''
(yl.tlnxora, A.26, aurep A,
r.HnxHe4ennqr,
Hnxue,qenuqxnft p-n,
Bopouexcras o6-nacrs)

w27.12.2012

flponseogurels

Paunrn4u u-JIexT ra6le.rru

OAO "TrorvreHcrcufi

nlntlo l50ur l0urr., yraKoBKH xo3"

PoccHq

ynaKoBKr,r 6esrrqeft Kosrre
KoHTypHEre

030812

Pocsgpaeua4:opa (Kypcrufi
Sunr,lan)

naq. KapT.

ra6lerru 500ur l0urr.,

ofBy "HMU3yAocMfI"

OAO "Eopncoscrr4fi
3aBOA

Pecnyblura
Eelapycs

uegnpenapaloa"

ofEy "HMU3yAocMn"

7321212

Pocs4panua4ropa (Kypcrcuft

Iurnar)

Bopouexcras o6lacrr)

tft04r4-r304/r2 AY3 BopoHexcxoft o6lacrn
or 27.12.2012

"Bopouexcrcufi o6.nacrsofi

roucylsrar[BHoA[arHocrurlecrnfi qeHTptt
KnHHl,rqecKnft

Jlr,rAoKa[H cnpeft AJrr MecrHoro OAO "(DaprvrcraHAaprnpHMeHeHHr 4osnponanHufi
JIerccpe4crea"

Poccz.fl

ofEy "HMIISyAOCMn;

405t2

PocslpaeHa4ropa (Kypcrnfi

l0%o38r, Qlarcouu c

Snnraan)

Ao3upyroqru ycrpoft crnona

(nn.Jlenr,rua, A.5o, n.BopoHex,

Bopouexcrcar o6lacru)
Ng 04Ll-1304/12

or27.12.2012

AV3 BopoHexcrcofi o6lacru
"Bopouexcrnft o6nacrsofi
KJrr,rHuqecKr,rfi xoucylrrartrBHoAl,rarHocrurlecxnfi IIeHTp "
(nr.JIeHnHa, A.5 n, r.BopoHex,
BopoHexcrcar

o6lacrt)

HosoranH pacrBop AJrt

nHrerrlnfi 5ur/ul5ul,
aMnynrr (10), nav. xap.r.

OAO ".{alrxnusapu"

Poccl.ls

ofEy "ltMuSyAOCMnt
Pocs4panna4sopa (Kypcruft
Qunr.ral)

830610

Ns 0414-1304112 AV3 Boponexcrcofi o6.nacrn

or 27.12.2012

Ng04V-1304/12

or 27.12.2012

HosoranH pacrBop An,

"BopoHexcrnfi o6lacruofi
KJIHHT{qecKHfi xoucylurarlrBHoAuarHocrnqecrafi qeHTp"
(nl.Jleuuua, A.54 r.Bopouex,
Bopouexcrar o6-rracrs)

nurerqafi 20ur/un2un,
aMnyrrrt (10), nav. rapr.

OAO "{alrxnruSapnr"

Poccr.rs

@fEy "I4M(3Veo6yn"

100412

PocgApaeHaAsopa (KypcrcnE

Qurzaa)

AV3 Bopouexcrofi o6lacrn- Aruuuar pacrBop
Anfl
"BopoHexcrnfi o6lacrlrofi
HapyxGoro npHMeHeHH' rd
KnI,tHHrIecKI{ft xoHcylrrarr{BHo- nnrwwlJ.uft,
0un lUyo
AuarHocrprqecrnft r{eHTp"
(QlaroHu TeMHoro crexla)
(nl.JleHnna, A.54 r.BopoHex,

\-,4(J

Poccr.lr

"@apuaqeerHqecKau

qrr

by "r4MIl3yAocMfI"

Pocs4parua4sopa (Kypcr
Sa6pnra"
[r.9e6orcaprr]

26072012

fir.rnnar)

BopoHexcrar o6lacrr)
Np04Id-1304/12
or 27.12.2012

AV3 Boponexcxofi o6lac.ru"Boponexcxr.lft o6lacnroft
KJrlrHnqecKltfr xoncylr.rarllBHoAltarHocr[qecrutfi rIeHTp "
(nn.JlennHa, A. 58, r. Bopouex,
BopoHexcrcar o6lacru)
Np 0414-1304/12 Anrera EV3 BopoHexcrcoft
or 27.12.2012
o6lacru "BopouexcKar .qercKa,
Krr.tHr,rqecKar 6oarHnrra Ns l "

Ns04V-1304/12
or 27.12.2012

Ng 04Ll-1304112

or 27.12.2012

Ne04V-1304/12
or 27.12.2012

(yn.Pnneen 4 p.2\e, r. Bopouex,
BopoHexcrar o6lacrs)
Anrera BV3 BopoHexcrcoft
o6lacrn "BopoHexcKar Aerc Ka.fl
KJrr,tHnqecKar 6oarHurla Nbl "
(yr.Prureer a, p22s, r.Bopouex,
Bopouexcrar o6lacrr)

,)lJropreKcr{AHH p-p AJI'
MecTHOro r{ Hapy)KHOTO npr,rM.,

OY HIIU "EHoreH"

I',occnt

PocsgpanHa4sopa (Kypc

l00un 0.05% (rfu. IIOT c

rablerrn n/nt/ o
Our I Ourr., ynaKoBKr.r
rqeftroeHe roHrypHue (3),

)AO ''ABBA PYC"

I

l'occHC

rablerru n/nt/o
l0ur lOun., ynaKoBKl

ofBy "HMI{3Va9gyn,

OAO "BepoQapur"

Pocct,tq

(DfEy ,nMrl3yAocMil"

rqeftroetle roHrypHue (3),

Pocs4paeua4sopa (Kypcrufi

narr. KapT.

$wnwat)

Anrera EY3 Boponexcrofi
I acTan(&'ra6lerrcu 6urr.,
o6racu "Bopouexcnat AercKa, ynaKoBKH rqefixosule
KnnHr{rrecKar 6olrunqa Nbl "
KoHrypHlre (10), nav. rapr.
(yn.Puneena, p,.222, r.Bopouex,
BopoHexcrcar o6lacrr)
Anrerca EV3 Boponexcrofi
uMe[pa3oJr KancyJrbr K[ru._
o6lacrn "BopoHexcxar Aercrafl pacrB. 20nrr l0rur.,
yn.,q.
KJrr,rHnr{ecKar 6olrHuqa Nl
roHr. (3), raq. Kapr.
"
(yr.Puneeua, p.22t, r. BopoHex,
BopoHexcrar o6.nacrr)

690612
fi

Poc:gparHa4:opa (Kypcrnfr
Qruruar)

nar{. KapT.

wtornlarc@

rcn

Suanal)

pacnururrelena)

vrorouuynr@

lofEy ,HMqeyeoctvtn.

flrusa Kparon,

flolrrua

@apuaqenrnqecrnft
sasoa A.O.

OOO "flpou3BolcrBo
Me1t,txaMeutot"

ofEy "I4MIISyAocMn,
Pocs4panua4sopa (Kypcrnfi
Qunr.ral)

Yoccvtfl

ofEy "I4MII3yAOCM[,
Pocsgpannagsopa (Kypcxufi

Snrnar)

t0tt2

4l0l

I

14055212

1903t2

Ne 04V-1304/12

Anrera BY3 BopoHexcrofi
o6lacrn "BopouexcK:ur AercKa,
KnHHHqecKar dolrunqa Nel "
(yl. Prrneen a, p,.22e, r. Boponex,
Boponexcrcar o6lacrr)
Ns04V-1304/12 Anrera BY3 BopoHexcroft
or 27.12.2012
o6lacrn "BopoHexcKafl AercKa,
KruHr.rqecKar 6oasHnqa J\!l "
or 27.12.2012

[n.

Psnrees a, p.22s, r.Bopouexg

nan-

H HrorH Hosiur KHcJrora-B

pacrBop

4lr nHrerqufi
I Orr,rrlrr,rn I ul, arrlnylsr (I 0),

Cunyn Kcupraur
@apuacrrcruran
Ko.JIra

Knraft

3aBoA

sqefiroerre roHrypHsre (2),

ue4npenaparoe"

OAO "Bopnconcraft

t20302

@unnar)

naqKr,r KapToHHbre

MerpoHuAa3ol ra6lerxu
250ur 1Orur., ynaKoBrcll

@fEy "HMI_lSyAocMtfl
Pocr4panua4ropa (Kypcruft

tsecnybrHKa

@fBy "I4MLI3yAOCMIr

Benapycs

Poct4paoua4sopa (Kypcrnfi

390612

Qr.unzur)

naq. KapT.

Bopouexcrcar o6nacrr)

Jft 04lt-t304/12
or 27.12.2012

Anrera EY3 Boponexcroft
AsalrrnH pacrBop gtrt tls u
o6lacrn "BopouexcKar AercKa, r/rra nnegeuur 500rur/un
2nan.
K:r[Hnr{ecKar 6olsuuqa J\bl "
aMnyJrbr (10), navrcrE
$n.Prueeea, g.22u, n. BopoHex, KapToHHbre

\J\JTJ

Vrpauna

"@apn,taqeeruqecKat
KoMnaHHt "34opoBbe"

ofEy "I4MIISyAoCMII"

1806t2

Pocs4paeHa4sopa (Kypcrnfi

fiurnan)

Bopouexcrcar o6nacrs)

Jft04kt-t304n2 Anreqsoe yqpexAeHr,te
ueHaAeG) raOaerru I 3.5rvrr
or 27.12.2012
OOO "AJIJIA" (yl.farapnH4
20ttt., ynaKoBKtr lqeft rossle
q.66, r.Kypcx, Kypcxar o6lacrs) r(oHTypHHe
Ne04V-1304/12
or 27.12.2012

Anreqnoe yqpexAeHrie
P auuruguu ra6le'rrcn nl nnl o
OOO "AJIJIA" (yl.farapnHa,
I 50nar lOrur., ynaKoBKH
a.66, r.Kypcrc, K5rpcnar o6nacrr) sqeftKosue ronrypnrre (2),

[aq.
Np 04kl-1304/12

or 27.122012

AnreqHoe yqpexAeHrde
OOO "AJIJIA" (yl.3anorrbHarr,

L(nnra JIr4

Hwlws

)ocsqpanua4ropa

Poccnr

ra6lerru 4lr
[ue4orue]

paccacbrBaHnr

fluerxnro
Ne I

NHNW

6, @apuacrrcrHK:trr3

Ns 04Vl-1304/12

Anrequoe frpexAeHue

or 27.12.2012

OOO'AJIJIA" (yr.l-ar
Buuruenar, 4. I 7, n.Kypcr,

Kypcrar o6lac.rs)

lOtur, yn. rq.

KoHT.

l00rrlr
(6), nau.

1039

Sulnan)
ueHrpHt

@fEy "HMUSyAOCMII"

L2t3N04r2

Pocs4panua4sopa (Kypcrufi

Qairual)
VttAwn

(.l,r

by "I4MIISyAOCM|I"

0212010

Pocs4panua4sopa (Kypcrnft
Qralr,rzur)

Kapr.
HoBoKar{H pacrBop AJrt
r.rHrercqnft

@fEy ,HMII3yAOCMII"
Pocslpaoua4sopa (Kypcrrrft

JIra.

AnreqHoe yqpexAeHr.re
KopAaQreKc@ ra6lerru
oAo
OOO "AJIJIA" (np.flo6e4u,
nporroHrr{p. 4eftcrour nlo 20ur "(Dapuaqemuqecrcnfi
.q.48, n.Kypcr, Kypcrcar o6lacrs) 60urr., 6aHx[, [aq. KaDT.
:aao4 3fHC"
Anreqnoe 1n{pexAeHue
l peHTarG) raOlerru floKpbrrbre AseHrrc (Dapl,ra
JIr4
OOO "AJIJIA" (yl.I-ar
Ku[r.-pacrB. m. o6.

Br.ruHenal, 4. 17, r.Kypcr,
Kypcrcar o6lacrr)

t42t0t2

PocrlpaaHa4sopa (Kypcrr.rft

KOHTypHbre, naq. KaDT.

Ns04V-1304/12
or 27.12.2012

ofBy ,uMuSyAOCMIIr
Qnlr.ra.n)

4.41, r.Kypcr, K5rpcrar o6lacrr) ynaKoBKr{ qqeftrosrre
Ns04H-1304/12
or 27.12.2012

22060

(Kypcru.rft

pnlHal)
JIJU (J30H"

KapT.

I paBHcHn

pl by "nMtISyAocMfI"

5ur/un 5ul,

aMnyJlbr (10), na.r. rap.r.

OAO "EnoxHMHK"

PoccHt

ofBy "HMLI3yAocMtt,
Poe4paeua4sopa (Kypcxnfi
r[uraa.n)

2201012

Ns04V-1304/12 Anrequoe yqpex(AeHne
or27.12.2012
OOO "AJIJIA" (ya.,{eft Heru,
g.19, r.Kypcrc, Kypcrar o6nacru)
Ns04V-1304/12 AnreqHoe yttpexAeHne
or 27.12.2012
OOO "AJIJIA" (y1..{eft Hercn,

fac'ral@ ra6lerrn 6rur.,
ynaKoBKrl rqefiroeHe
KoHrypHbre (10), na.r. xapr.
Pu6orccnH ra6n. nlnn/o 200rvrr
25 rul., y[aKoBKH rqeft rosrre
9.19, r.Kypcrc, Kypcraa o6nac.rs) KoHTypHbre (2), naurn

flrusa Kparoe,
Oapnraqeernqecrufi
sasol A.O.

florsura

OOO "Ogou"

Pocclrc

OAO "Arpenanrar, a. lA/l 8, r.Kypcr,
Kypcrar o6lacrr)

Ns04V-1304/12 OAO "OaprucraH.qapror27.12.2012
Jlerccpe4crn a" $r 1.2-at
Arperaruar, l. lA/l 8, r.Kypcr,
Kypcrar o6lacrr)
Ns04V-1304/12 OAO "OapucraHAapror 27.12.2012
Jlercpe4crn a" (y n.2-an
Arperaruar, g. I A/l 8, r.Kypcr,
Kypcrar o6nac'ru)
Np04Id-1304/12
or 27.122012

Np04Ll-1304/12
or 27.12.2012

Ns04V-1304/12

m 27.12.2012

OAO "Oaprr,rcraHAaprJlercpegcua" (yn.Z-ax
Arperaruar, 4. I A/l 8, r.Kypcr,
Kypcrar o6lacrs)
OAO "@aprvrcraHAaprJlercpegcm a" $r tr.2-at
ArperarHar, l. lA/l 8, r.Kypcr,
Kypcrar o6nac'ru)
OAO "@apucraHAaprJlercpegcrn a" (y n.2-an
ArperarHar, 4. lA./l 8, r.Kypcx,
Kypcxar o6nacru)

l{e0414-1304/12
or 27.12.2012

OOO'A.B.C." (yr.flo6e4u,
4.42, r.flnancr, Tylscnar
o6racrr)

Ap6n4on@, KancyJrbr 100 rur
Ne 10,

ynaronrr lqeftxosrre

Qraluan)

ynaxosr[ rqeftroerre

Qranna.n)

OAO "@aprvlcraHAaprJIercpe4craa"

Poccnq

OAO "Oaprr,rcraHAaprJIercpe4croa"

Poccnr

OOO "A.B.C." (yr.flo6egu,

or 27.12.2012

q.42,

r.fltatcrc, Tylrcnar

o6racru)

2641012

ofEy ,I{MLISyAOCMn"

3r0lI12

Pocsgpaoua4sopa (Kypcrcnfi
Quraa.n)

Ap6ngon@, Kancynsr 100 rvrr
ynarosril cqeftrosHe

Nr I 0,

0AO "(DapucraHAapr-

Poccnc

JIercpe4crna"

ofBy "pIMuSyAOCMfI'

09tt12

Pocs4par Ha4:opa (Kypc rr.rfi

KOHrypH6re

Snnr.ral)

KoQnqun-nmoc ra6lerxn N! I 0 OAO "(Daprr,rcraHAaprJIercpe4crna"

Poccur

ynaKoBKH sqeftnogue
KoHrypHbre

D|EY "l,IMUSyAOCMfl"

)ocagpaoHa4ropa (Kypcruft

47ltt2

pulnan)
Ns I 0.

ynaKoBKH nqefixosHe

OAO "@apnacraHAaprJlercpe4crna"

Poccuc

KOHTypHbre

rqefirosue xonrypHrre)
flaHrpearnu ra6lerrn
noKpbrTbre KHu.-pacTB.

o6oro.{roft 25E{ lOrur., yn.
rrr. KoHT. (6), nav. rapr.

421

t2

Qr.rnnan)

Banu4ol c rnorogofi ra6lerru 0AO "(DapucraHAaprnoAbr3rrrtHbre I 0rur., ynaKoBKH Jlexcpe4crna"
xqefiroeHe KoHTypHsre
Aruroxon ra6rerrn noKpbtrbre
o6oroqmofi Ns24 (ynaxorrn

ofBy "tIMII3yAOCMft"
PocrgpaaHa4sopa (Kypc xrafi

OAO
"MocxnuQapMnpenaparbl"

Poccnr

OAO "EuocHHTe3"

ofBy "I4MIISyAOCMII"
Pocs.qpan nagropa

290912

(Kypcrnft

Sznual)
Poccl,r.s

ofBy "HMU3yAOCMII"
Pocs4paeHa4sopa

439tlrl

(Kypcrnfi

Qunnzul)

r.ru.H.A.Ceuarurco
Ns 0414-1304112

ofEy ,HMII3yAOCMn'
Pocs4pannagsopa (Kypcrnft

KoHTypHbre

KoQnqnn-urcc ra6rsrrcu

s209t2

{urua.n)

Ap6n4on@, KancyJrbt 100 nrr
0,

ofEy "I,IMII3yAocMn"
Poct4paoua4ropa (Kypcrcuft

KoHTypHHe

Ne I

t4t697t2

Pocs4panua4ropa (Kypcru.rft

KapToHHbre

Ns04H-1304/12
or 27.12.2012

ofBy .t4MIISyAOCMft"

Poccuq

ofBy "l4MUSyAOCMfl"
Poe4pan ua4sopa (Kypc

Sanual)

rr.r

fi

2t3r0l2

Ns 04U-1304/12

or 27.12.2012
04H-1304/t2
or 27.12.2012
Ns04H-1304/t2
or 27.12.2012

)OO "A.8.C. " (yr.I-lo6e4i1
9.42, r.fltaecrc, Tyarcrar
o6lacra)
uA.B.C."
(yr.flo6egsr,
42, r.flnazcr, Tylrcraa
OOO "A.B.C." (ynJlGeair.
2, r.fllaacr, Tylscrcar

20

ra6lerrcz l3.5rrar
wr., ynaKoBKr.r rqefi rosHe

"HMrI3yAOCtil
PocsApasHaA:opa (Kypocufi
QHnHiur)

KoHrypHbre

flapaqerauoa ra6nerra
lOrur., ynar(oBKr,l

5 00rr,r

r

"HMU3yAOaMt-r,

6egrs.{efi roBbre KoHrypHbre

Pocslpas Ha.qsopa (Kypcrcnfr

Kanronpnl ra6lrernr 2Strr
I Orur., ynaKoBKr.r sqefi
xosue

"14Mr{SyAOdi;

KoHrypHbre (4), navxr.r

foceapan

KapTOHHbre

NsO4V-13O4/|2

27.t2.20t2

OOO "A.B.C. " 1yn.fto6eai,,

r.IllaBcr, Tylrcrar

0414-1304n2
"A.B.C. u (yn.flo6earr,
27.12.2012
a.42, r.IInancr, Tylrcxar

o6lacrr)

HurornHosa" *tncaoru
50ur 50ur.,6auxr.r
rHooKcHH ra6n. n/nt/o 200rvrr
., ynaKoBKH
KoHTypHbre
KapTOHHbre

rqeftrosrre

e),nauxu

VSaBHTA"

uaaropa (Kypcp.rfi

orsy ,HMrl.5iloci\4rr;
f

ocssPaa HaA:opa (Kypcxr.rfi

"14MI{SyAOCMrJ"
Pocr4paeua4sopa (Kypc

qulual)

rcr.rfi

Mnnncrepcrro gaprBooxPaHeHxf, Pocculcxoil Oegepaunn

oEAEPAJTbHAfl CJrv2r(EA nO HAA3OPy B COEPE 3IFanOO)PArrEHAfl Pyrco n o4nrer.fl M opraH r,I3 a \r4ir- (PoC3.TABHAA3OP) rrpor43BoAr4TeJreft JreKapcTBeHHbx
CrasrHcrar nJr.,.{. 4, crp. l, Mocrna" 109074 cpeAcrB rcr.: (495) 698 46 28,698 46 I I Pyrono4ureJrrM opraHra3arlufi - LrMnopTepoB neKapcTBeHHbrx cpeAcTB
Cy6mrarra o6parqeHur JreKapcTBeHHhrx cpeAcTB Peruenne no pe3yn6TaraM sKcrreprr{3br KarrecTBa neKapcTBeHHhrx cpeAcTB

@e4epzurrH€rf, cnyx6a uo HaA3opy B cQepe 3ApaBooxpaHeHlr{ raHQoprr,rupyer, qro no pe3yJrbTaTaM sKcrrepTH3br KaqecTBa JreKapcTBeHHbrx cpeAcTB npr,rHrro peureHr{e o cooTBeTcTBrrI,I ycTaHoBneHHbIM TpeooBaHr{flM KarrecTBa JreKapcTBeHHbrx cpeAcTB, nepequcreHHbrx B npl|IJroxelJvkl.

flpuroxeHne:Ha 5 n.e 1 sxg.

Bpno pyKoBoAr4reJrt M.A. Mypamxo

f.B. fanHoqxa 8499s780187 f Ip aroxeu ue K r H c b My Pocss pan u a4 ropu o, 2 Q/.^Ja/S Nn /f4_,lV //fg cnegennr o JreKapcrBe'Eblx cpeAcrBaxr no pe3ynbraraM SKcneprrr3br KaqecrBa Koropbrx Pocr4pan'aAgopoM np'rrrro perue'rre o coorBercrBr* ux KaqecrBa HaHMeHosaH He opraHn3aqr.ut, Honaep 3a4ar.Hr npeAcraBr.rBrueft o6pa:qsr JlerapcroeuHoe cpeAcrBo flponseogurels CrpaHa np-na 3rcneprHar opraHH3aur,tt neKapcTBeHHblx cpeAcTB Cepr.nt Ns 04LI-1304/12 OOO ''CJIAB'HKA'' CeuaAe@ r'a6lema I 3.5nrr Llranla JIr4 Usilus ofEy "HMUSyAOCMII"
or27.12.2012 (yn.tlnxona, A.26,.nnrep A, 20ur., ynaKoBKlt rqeftroeue 482t02 r.Hnxne4eruqr, Pocs4paena.qsopa (Kypc rr,r E KoHTypHBre HnxHe4enuqrufi p-H, Qu.rrnan) Bopouexcxar o6aacrs) Ns04V-1304/12 OOO'CJIAB'HKA'' Paunrn4u u-JIexT ra6le.rru OAO "TrorvreHcrcufi PoccHq ofBy "HMU3yAocMfI"
w27.12.2012 (yl.tlnxora, A.26, aurep A, nlntlo l50ur l0urr., yraKoBKH xo3" 030812 r.HnxHe4ennqr, Pocsgpaeua4:opa (Kypcrufi sqeftroesle rourypHue (2), Hnxue,qenuqxnft p-n, naq. KapT. Sunr,lan) Bopouexcras o6-nacrs) Ns04V-1304/12 OOO ''CJIAB'HKA'' Aqerulca.nnqlrnoBar KucJrora OAO "Eopncoscrr4fi Pecnyblura ofEy "HMU3yAocMn"
or 27.12.2012 (yn.t{r,rxoua" 4.26, lurep A, ra6lerru 500ur l0urr., 7321212 3aBOA Eelapycs r.Huxne.qennqx, Pocs4panua4ropa (Kypcrcuft ynaKoBKr,r 6esrrqeft Kosrre uegnpenapaloa"
HnxHeAesuqxnft p-u, KoHTypHEre Iurnar) Bopouexcras o6lacrr) tft04r4-r304/r2 AY3 BopoHexcxoft o6lacrn Jlr,rAoKa[H cnpeft AJrr MecrHoro OAO "(DaprvrcraHAapr- or 27.12.2012 "Bopouexcrcufi o6.nacrsofi npHMeHeHHr 4osnponanHufi Poccz.fl ofEy "HMIISyAOCMn; 405t2 JIerccpe4crea" PocslpaeHa4ropa (Kypcrnfi KnHHl,rqecKnft roucylsrar[BHo- l0%o38r, Qlarcouu c A[arHocrurlecrnfi qeHTptt Snnraan) Ao3upyroqru ycrpoft crnona (nn.Jlenr,rua, A.5o, n.BopoHex, Bopouexcrcar o6lacru) Ng 04Ll-1304/12 AV3 BopoHexcrcofi o6lacru HosoranH pacrBop AJrt OAO ".{alrxnusapu" Poccl.ls ofEy "ltMuSyAOCMnt or27.12.2012 "Bopouexcrnft o6nacrsofi nHrerrlnfi 5ur/ul5ul, 830610 KJrr,rHuqecKr,rfi xoucylrrartrBHo- Pocs4panna4sopa (Kypcruft aMnynrr (10), nav. xap.r.
Al,rarHocrurlecxnfi IIeHTp " Qunr.ral) (nr.JIeHnHa, A.5 n, r.BopoHex, BopoHexcrcar o6lacrt) Ns 0414-1304112 AV3 Boponexcrcofi o6.nacrn HosoranH pacrBop An, OAO "{alrxnruSapnr"
or 27.12.2012 "BopoHexcrnfi o6lacruofi nurerqafi 20ur/un2un, Poccr.rs @fEy "I4M(3Veo6yn" 100412 KJIHHT{qecKHfi xoucylurarlrBHo- aMnyrrrt (10), nav. rapr. PocgApaeHaAsopa (KypcrcnE AuarHocrnqecrafi qeHTp" Qurzaa) (nl.Jleuuua, A.54 r.Bopouex, Bopouexcrar o6-rracrs) Ng04V-1304/12 AV3 Bopouexcrofi o6lacrn- Aruuuar pacrBop or 27.12.2012 Anfl \-,4(J Poccr.lr qrr by "r4MIl3yAocMfI"
"BopoHexcrnfi o6lacrlrofi HapyxGoro npHMeHeHH' rd 26072012 "@apuaqeerHqecKau KnI,tHHrIecKI{ft xoHcylrrarr{BHo- nnrwwlJ.uft, Pocs4parua4sopa (Kypcr AuarHocrprqecrnft r{eHTp" (QlaroHu TeMHoro crexla) fir.rnnar) (nl.JleHnna, A.54 r.BopoHex, [r.9e6orcaprr]
BopoHexcrar o6lacrr) Np04Id-1304/12 AV3 Boponexcxofi o6lac.ru- ,)lJropreKcr{AHH p-p or 27.12.2012 AJI' OY HIIU "EHoreH" I',occnt lofEy ,HMqeyeoctvtn.
"Boponexcxr.lft o6lacnroft MecTHOro r{ Hapy)KHOTO npr,rM., 690612 KJrlrHnqecKltfr xoncylr.rarllBHo- l00un 0.05% (rfu. IIOT c PocsgpanHa4sopa (Kypc rcn fi AltarHocr[qecrutfi rIeHTp " pacnururrelena) Suanal) (nn.JlennHa, A. 58, r. Bopouex, BopoHexcrcar o6lacru) Np 0414-1304/12 Anrera EV3 BopoHexcrcoft vrorouuynr@ rablerrn n/nt/ o )AO or 27.12.2012 o6lacru "BopouexcKar .qercKa, I Our I Ourr., ynaKoBKr.r ''ABBA PYC" l'occHC ofBy "HMI{3Va9gyn, t0tt2 Krr.tHr,rqecKar 6oarHnrra Ns l " rqeftroeHe roHrypHue (3), Poc:gparHa4:opa (Kypcrnfr (yn.Pnneen 4 p.2\e, r. Bopouex, nar{. Qruruar) KapT.
BopoHexcrar o6lacrs) Ns04V-1304/12 Anrera BV3 BopoHexcrcoft wtornlarc@ rablerru n/nt/o OAO "BepoQapur"
or 27.12.2012 o6lacrn "BopoHexcKar Aerc Ka.fl l0ur lOun., ynaKoBKl Pocct,tq (DfEy ,nMrl3yAocMil"
4l0l I KJrr,tHnqecKar 6oarHurla Nbl " rqeftroetle roHrypHue (3), Pocs4paeua4sopa (Kypcrufi (yr.Prureer a, p22s, r.Bopouex, narr. KapT. $wnwat) Bopouexcrar o6lacrr) Ng 04Ll-1304112 Anrera EY3 Boponexcrofi I acTan(&'ra6lerrcu 6urr., flrusa Kparon, or 27.12.2012 o6racu "Bopouexcnat AercKa, ynaKoBKH rqefixosule flolrrua ofEy "I4MIISyAocMn, @apuaqenrnqecrnft 14055212 KnnHr{rrecKar 6olrunqa Nbl " KoHrypHlre (10), nav. rapr. Pocs4panua4sopa (Kypcrnfi sasoa A.O.
(yn.Puneena, p,.222, r.Bopouex, Qunr.ral) BopoHexcrcar o6lacrr) Ne04V-1304/12 Anrerca EV3 Boponexcrofi uMe[pa3oJr KancyJrbr K[ru._ OOO "flpou3BolcrBo or 27.12.2012 o6lacrn "BopoHexcxar Aercrafl pacrB. 20nrr l0rur., yn.,q.
Yoccvtfl ofEy "I4MII3yAOCM[, 1903t2 Me1t,txaMeutot"
KJrr,rHnr{ecKar 6olrHuqa Nl " roHr. (3), raq. Kapr. Pocsgpannagsopa (Kypcxufi (yr.Puneeua, p.22t, r. BopoHex, Snrnar) BopoHexcrar o6.nacrr) Ne 04V-1304/12Anrera BY3 BopoHexcrofi H HrorH Hosiur KHcJrora-B nan- Cunyn or 27.12.2012 Kcupraur Knraft @fEy "HMI_lSyAocMtfl o6lacrn "BopouexcK:ur AercKa, pacrBop t20302 4lr nHrerqufi @apuacrrcruran Pocr4panua4ropa (Kypcruft KnHHHqecKar dolrunqa Nel " I Orr,rrlrr,rn I ul, arrlnylsr (I 0), Ko.JIra (yl. Prrneen a, p,.22e, r. Boponex, naqKr,r KapToHHbre @unnar) Boponexcrcar o6lacrr) Ns04V-1304/12 Anrera BY3 BopoHexcroft MerpoHuAa3ol ra6lerxu OAO "Bopnconcraft tsecnybrHKa or 27.12.2012 o6lacrn "BopoHexcKafl AercKa, 250ur 1Orur., ynaKoBrcll @fBy "I4MLI3yAOCMIr 390612 3aBoA Benapycs KruHr.rqecKar 6oasHnqa J\!l " sqefiroerre roHrypHsre (2), Poct4paoua4sopa (Kypcrnfi ue4npenaparoe"
[n. Psnrees a, p.22s, r.Bopouexg naq. KapT. Qr.unzur) Bopouexcrcar o6nacrr) Jft 04lt-t304/12 Anrera EY3 Boponexcroft AsalrrnH pacrBop gtrt tls u \J\JTJ or 27.12.2012 o6lacrn "BopouexcKar AercKa, r/rra nnegeuur 500rur/un Vrpauna ofEy "I4MIISyAoCMII" 1806t2 2nan. "@apn,taqeeruqecKat K:r[Hnr{ecKar 6olsuuqa J\bl " Pocs4paeHa4sopa (Kypcrnfi aMnyJrbr (10), navrcrE KoMnaHHt "34opoBbe"
$n.Prueeea, g.22u, n. BopoHex, KapToHHbre fiurnan) Bopouexcrcar o6nacrs) Jft04kt-t304n2 Anreqsoe yqpexAeHr,te ueHaAeG) raOaerru I 3.5rvrr L(nnra JIr4 Hwlws pl by "nMtISyAocMfI"
or 27.12.2012 OOO "AJIJIA" (yl.farapnH4 20ttt., ynaKoBKtr lqeft rossle 22060 q.66, r.Kypcx, Kypcxar o6lacrs) r(oHTypHHe )ocsqpanua4ropa (Kypcru.rft Ne04V-1304/12 Anreqnoe yqpexAeHrie pnlHal) P auuruguu ra6le'rrcn nl nnl o JIJU (J30H" Poccnr ofBy ,uMuSyAOCMIIr or 27.12.2012 OOO "AJIJIA" (yl.farapnHa, I 50nar lOrur., ynaKoBKH t42t0t2 a.66, r.Kypcrc, K5rpcnar o6nacrr) sqeftKosue ronrypnrre (2), PocrlpaaHa4sopa (Kypcrr.rft [aq. KapT. Qnlr.ra.n) Np 04kl-1304/12 AnreqHoe yqpexAeHrde I paBHcHn ra6lerru 4lr fluerxnro or 27.122012 OOO "AJIJIA" (yl.3anorrbHarr, paccacbrBaHnr [ue4orue] Ne I 6, @apuacrrcrHK:trr3 NHNW @fEy ,HMII3yAOCMII" 1039 4.41, r.Kypcr, K5rpcrar o6lacrr) ynaKoBKr{ qqeftrosrre Pocslpaoua4sopa (Kypcrrrft JIra.
KOHTypHbre, naq. KaDT. Sulnan) Ns04H-1304/12 AnreqHoe yqpexAeHr.re KopAaQreKc@ ra6lerru or 27.12.2012 oAo ueHrpHt @fEy "HMUSyAOCMII"
OOO "AJIJIA" (np.flo6e4u, nporroHrr{p. 4eftcrour nlo 20ur "(Dapuaqemuqecrcnfi L2t3N04r2 .q.48, n.Kypcr, Kypcrcar o6lacrs) 60urr., 6aHx[, [aq. KaDT. Pocs4panua4sopa (Kypcrufi :aao4 3fHC"
Ns04V-1304/12 Anreqnoe 1n{pexAeHue l peHTarG) raOlerru floKpbrrbre AseHrrc (Dapl,ra Qairual) or 27.12.2012 JIr4 VttAwn (.l,r by "I4MIISyAOCM|I"
OOO "AJIJIA" (yl.I-ar Ku[r.-pacrB. m. o6. l00rrlr 0212010 Br.ruHenal, 4. 17, r.Kypcr, Pocs4panua4sopa (Kypcrnft lOtur, yn. rq. KoHT. (6), nau.
Kypcrcar o6lacrr) Kapr. Qralr,rzur) Ns 04Vl-1304/12 Anrequoe frpexAeHue HoBoKar{H pacrBop AJrt OAO "EnoxHMHK"
or 27.12.2012 OOO'AJIJIA" (yr.l-ar r.rHrercqnft 5ur/un 5ul, PoccHt ofBy "HMLI3yAocMtt, 2201012 Buuruenar, 4. I 7, n.Kypcr, Poe4paeua4sopa (Kypcxnfi aMnyJlbr (10), na.r. rap.r.
Kypcrar o6lac.rs) r[uraa.n) Ns04V-1304/12 Anrequoe yqpex(AeHne fac'ral@ ra6lerrn 6rur., flrusa Kparoe, or27.12.2012 OOO "AJIJIA" (ya.,{eft Heru, florsura ofBy .t4MIISyAOCMft" t4t697t2 ynaKoBKrl rqefiroeHe Oapnraqeernqecrufi Pocs4panua4ropa (Kypcru.rft g.19, r.Kypcrc, Kypcrar o6nacru) KoHrypHbre (10), na.r. xapr. sasol A.O.
Qraluan) Ns04V-1304/12 AnreqHoe yttpexAeHne Pu6orccnH ra6n. nlnn/o 200rvrr OOO "Ogou"
or 27.12.2012 OOO "AJIJIA" (y1..{eft Hercn, Pocclrc ofEy "I,IMII3yAocMn" s209t2 25 rul., y[aKoBKH rqeft rosrre Poct4paoua4ropa (Kypcrcuft 9.19, r.Kypcrc, Kypcraa o6nac.rs) KoHTypHbre (2), naurn Qranna.n) KapToHHbre Ns04H-1304/12 OAO " OAO "@aprvlcraHAapr- Poccnq ofEy ,HMII3yAOCMn' 2641012 Ne 10, ynaronrr lqeftxosrre JIercpe4craa" Pocs4pannagsopa (Kypcrnft Arpenanrar, a. lA/l 8, r.Kypcr, KoHTypHHe Kypcrar o6lacrr) {urua.n) Ns04V-1304/12 OAO "OaprucraH.qapr- Ap6n4on@, KancyJrbt 100 nrr or27.12.2012 Jlerccpe4crn a" $r 1.2-at OAO "Oaprr,rcraHAapr- Poccnr ofEy ,I{MLISyAOCMn" 3r0lI12 Ne I 0, ynaxosr[ rqeftroerre JIercpe4croa" Pocsgpaoua4sopa (Kypcrcnfi Arperaruar, l. lA/l 8, r.Kypcr, KoHTypHbre Kypcrar o6lacrr) Quraa.n)
Ns04V-1304/12 OAO "OapucraHAapr- Ap6ngon@, Kancynsr 100 rvrr 0AO "(DapucraHAapr- or 27.12.2012 Jlercpe4crn a" (y n.2-an Poccnc ofBy "pIMuSyAOCMfI' 09tt12 Nr I 0, ynarosril cqeftrosHe JIercpe4crna" Pocs4par Ha4:opa (Kypc rr.rfi Arperaruar, g. I A/l 8, r.Kypcr, KOHrypH6re Kypcrar o6nac'ru) Snnr.ral)
Np04Id-1304/12 OAO "Oaprr,rcraHAapr- KoQnqun-nmoc ra6lerxn N! I 0 OAO "(Daprr,rcraHAapr- Poccur D|EY "l,IMUSyAOCMfl" 47ltt2 or 27.122012 Jlercpegcua" (yn.Z-ax ynaKoBKH sqeftnogue JIercpe4crna" )ocagpaoHa4ropa (Kypcruft Arperaruar, 4. I A/l 8, r.Kypcr, KoHrypHbre pulnan) Kypcrar o6lacrs) Np04Ll-1304/12 OAO "@aprvrcraHAapr- KoQnqnn-urcc ra6rsrrcu Ns I 0. OAO "@apnacraHAapr- or 27.12.2012 Jlercpegcm a" $r tr.2-at Poccuc ofBy "tIMII3yAOCMft" 421 t2 ynaKoBKH nqefixosHe Jlercpe4crna" PocrgpaaHa4sopa (Kypc xrafi ArperarHar, l. lA/l 8, r.Kypcr, KOHTypHbre Qr.rnnan) Kypcrar o6nac'ru) Ns04V-1304/12 OAO "@apucraHAapr- Banu4ol c rnorogofi ra6lerru 0AO "(DapucraHAapr- m 27.12.2012 Poccnr ofBy "I4MIISyAOCMII" 290912 Jlercpegcrn a" (y n.2-an noAbr3rrrtHbre I 0rur., ynaKoBKH Jlexcpe4crna"
Pocs.qpan nagropa (Kypcrnft ArperarHar, 4. lA./l 8, r.Kypcx, xqefiroeHe KoHTypHsre Kypcxar o6nacru) Sznual) l{e0414-1304/12 OOO'A.B.C." (yr.flo6e4u, Aruroxon ra6rerrn noKpbtrbre OAO or 27.12.2012 Poccl,r.s ofBy "HMU3yAOCMII" 439tlrl 4.42, r.flnancr, Tylscnar o6oroqmofi Ns24 (ynaxorrn "MocxnuQapMnpe- Pocs4paeHa4sopa (Kypcrnfi o6racrr) rqefirosue xonrypHrre) naparbl"
Qunnzul) r.ru.H.A.Ceuarurco Ns 0414-1304112 OOO "A.B.C." (yr.flo6egu, flaHrpearnu ra6lerrn OAO "EuocHHTe3" Poccuq ofBy "l4MUSyAOCMfl" 2t3r0l2 or 27.12.2012 q.42, r.fltatcrc, Tylrcnar noKpbrTbre KHu.-pacTB.
Poe4pan ua4sopa (Kypc rr.r fi o6racru) o6oro.{roft 25E{ lOrur., yn.
Sanual) rrr. KoHT. (6), nav. rapr.
Ns 04U-1304/12 )OO "A.8.C. " (yr.I-lo6e4i1 or 27.12.2012 ra6lerrcz l3.5rrar 9.42, r.fltaecrc, Tyarcrar 20 wr., ynaKoBKr.r rqefi rosHe "HMrI3yAOCtil o6lacra) KoHrypHbre PocsApasHaA:opa (Kypocufi 04H-1304/t2 uA.B.C."
(yr.flo6egsr, flapaqerauoa ra6nerra 5 00rr,r r QHnHiur) or 27.12.2012 42, r.flnazcr, Tylrcraa lOrur., ynar(oBKr,l "HMU3yAOaMt-r, 6egrs.{efi roBbre KoHrypHbre Pocslpas Ha.qsopa (Kypcrcnfr Ns04H-1304/t2 OOO "A.B.C." (ynJlGeair.
Kanronpnl ra6lrernr 2Strr or 27.12.2012 2, r.fllaacr, Tylscrcar I Orur., ynaKoBKr.r sqefi xosue "14Mr{SyAOdi;
KoHrypHbre (4), navxr.r uaaropa (Kypcp.rfi foceapan KapTOHHbre NsO4V-13O4/|2 OOO "A.B.C. " 1yn.fto6eai,, HurornHosa" *tncaoru 27.t2.20t2 r.IllaBcr, Tylrcrar 50ur 50ur.,6auxr.r VSaBHTA" orsy ,HMrl.5iloci\4rr;
ocssPaa HaA:opa (Kypcxr.rfi 0414-1304n2 f "A.B.C. u (yn.flo6earr, rHooKcHH ra6n. n/nt/o 200rvrr 27.12.2012 a.42, r.IInancr, Tylrcxar ., ynaKoBKH rqeftrosrre "14MI{SyAOCMrJ"
o6lacrr) KoHTypHbre e),nauxu Pocr4paeua4sopa (Kypc rcr.rfi KapTOHHbre qulual)

Министерство здравоохранения Российской Федерации
ФЕДЕРАЛЬНАЯ СЛУЖБА ПО НАДЗОРУ В СФЕРЕ ЗДРАВООХРАНЕНИЯ (РОСЗДРАВНАДЗОР)
Славянская пл., д. 4, стр. 1, Москва, 109074 тел.: (495) 698 46 28, 698 46 11
0 22-009 № ИБ 56 8 На № от Г |

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 | экз.

Врио руководителя
Г.В. Ганночка 84995780187
Руководителям организаций- производителей лекарственных средств
Руководителям организаций- импортеров лекарственных средств
Субъектам обращения лекарственных средств
М.А. Мурашко

Скачать документ: Письмо 16И-562/13 от 30.05.2013

Информационные письма Росздравнадзора по контролю качества: Лекарственные средства

Информационные письма Росздравнадзора по контролю качества: Медицинские изделия

   

Первая страница документа


image

Статьи