РОСЗДРАВНАДЗОР Информационное письмо № 16И-646/13 от 18.06.2013


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-646/13 от 18.06.2013

Решение по результатам экспертизы качества лекарственных средств

Mr uucrepcrao 3apaBooxpaHetrtrr
Poccsilcroil Oeaepaunn

oEAEPAJTbHAf, CJnDKBA nO HAI3OPy
B COEPE 3.ryABOO)GAHEHIIff
(POc3.ryABHAA3OP)

ren:

/,(
Ha

r

I.

Pyrono4ureJrrM opraHu3arlnfi -

po/^

Jtlb

npou3BoAr,rTeJreft JreKapcTBeHHbrx

cpeAcrB

4, crp. l, MocraU 109074
(495) 698 46 28,698 46 I I

CrascHcrar nn.,

PyrorogureJrrM opraHr,Barlufi -

r{MropTepoB JreKapcTBeHHbrx cpeAcTB

OT

Cy6rexrau o6paulenHr
JreKapcTBeHHbrx cpeAcTB

t-

Peruenue rro pe3yJrbraraM 3Kc[eprr,r3br
KaqecTBa JreKapcTBeHHbrx cpeAcTB

(De4epanrHar cJryx(6a no HaA3opy B cQepe 3ApaBooxpanenufl r,{H0opMr,rpyer, qro
no pe3yJrbTaTaM sKcrrepTu3br KaqecTBa ireKapcTBeHHbrx cpeAcTB npr4HrTO perueHne o
coorBercrBur4 ycraHoBJIeHHbIM Tpe6oBaHI,IsM KarrecrBa neKapcrBeHHbrx cpeAcrB,
[epequcneHHhrx B rrpnnox eHI,III.

flpnnoxeHue:Ha 5

BprEo pyKoBoAr,rreJrfl

f.B. laHHo.tra
84995780t87

n.s I

srs.

M.A. Myparuro

flpuroxeHne
Cnegennr o nercapcrBeH

Horr,rep 3aAaHlar.

Ns04V-1304/12

Ng04LI-1304/12

or 27.12.2012

rlrcbMy Poc:4panuas zopu o,

Hanueuor mHe opfaHn3aur,rH,
npeAcT, lreuefi o6pasqrr

JlerapcraeuHoe cpeAcrBo

flpousno4nreru

Crpaua np-Ba

KOTKYCO 'Py6rencrurft
ncuxoHeBpc roruqecrnfi
nHrepnar" ( ,rrcp.JfrHracono,
4.I4yunuqsr r.Knpoa,
Knpoacxar, 6nac'rs)

PenH'r

fEY3 "ToH :uHcrar I{PE"
(yr.EolrHu uar, g. lA,

.(n6ason pacrBop Ntt sls u sltl OAO ",{anrxnuQapu"

p.n.ToHxr,ru r, HuxenopoAcKat

(aunynu), naq. Kapr.

Ne0414-1304/12

Anrera @l' iy "oIICCX"
MuHs4pasa Poccr.rr.r (r.fleHsa)
(yr.Cracon: 9.6, r.fleu:a,
fleHsencrat o6racrr)
Anrera (Df ;y "oIICCX"

or 27.12.2012

MnHr.qpaea Poco.rr.r (r.flensa)

or 27.12.2012

(yr.Cracoer ,4.6, r.flens4
fleugeHcrar o6nacrr)
Ns04V-1304/12
or 27.12.2012

Anrera

Of ;y "oqccx'

MnH:.qpana Pocclu,r (r.fleHsa)

(yn.Cracorr ,9.6, r.flensa,
fleHseHcrar o6nacrs)
Ns04V-1304/12

Apore Nsl00, 6asrn
noluuepuste*

Srcnepruar opraH[3aqr{t

Ceprau

OAO "Map6no$apu"

PoccHq

ofEy "HMuSyAOCMfl"

360512

Pocs4paoHa1sopa (Kasaucrufi

Qunua:l)

BBeAeHnr,

5ul

Poccus

lOrvrr/rr,ril .I\|bl0

HoeorauH, pacrBop AJrt
nHrerquft 5 run/rr,rn 200run,

OAO "6nocHHTe3"

Poccnq

"Hosocn6xuuSapu"

Jln4orcanH pacrBop Ant

OAO "Euoct{HTe3rr

Poccur

or 27.12.2012

(ruocce Koc {oHaBToB, n.252,
r.flepus, flr pnacrnft rcpaft)

25

orEy 'HMIISyAOCMII"

20612

Pocs4panHa4aopa (Ka:aHcrr.rfi

t[urnar)
Poccnc

nurexqnft 20ur|ul2utr,
aMrryJrbr (10), nav. rapr.

Pn6oxcuu ra6t. slnt/o 200ur

50712

Qn-rrr,ral)

uHrerqnft Z0v.rlut2utr,
aMrynbr (10), nav. rapr.

An'rera OO ) "Apreunga"

ofEy "HMIISyAOCMn"
Pocsgpaen44sopa (KasaHcrnft

oAO

Ne04I"|-1304/12

206r2

$r,rnnaa)

JlngorauH pacrBop AJrt

Acrop6nHoBar KncJrora Apaltce
50ur 200un., 6aHrn

ofBy "I4MI{SyAOCMII"
Pocs4panHa4sopa (Kasancrra ft

6yrsrlra

Anrera OO ) "Apreun4at'
(ruocce Koc roHaBToB, 9.252,
r.flepus, fl pucnnfi rpafi)

or 27.12.2012

?6t
/6A 'e ,6//J

I

o6racts)
Ns 0414-1304/12

//.0€.1h/JNn

cpeAcTBax, IIo pe3ynbTaTaM 3xcnepTH3bt KaqecTBa rcoTopbrx PocrqpannaA3opou nptrHflTo pe[reHrre o coorBercrBrrlr rlx KaqecrBa
ycraHoBJreHHbru roe6onar IIflM

neKapc' BeHHbrx cpeAcTB

or 27.12.2012

K

@fEy "I4MII3yAOCMII"

40212

Pocs4panHaAsopa (Karancru fi

Qnnnal)
OAO "Map6uoQapu"

Poccnr

ofBy 'HMu3yAocMf["

t72lt12

Pocsgparua4sopa (Karancrra ft

noJlr.rMepHble

r[nruan)
OOO "Ogog"

Poccnr

mr., ynaKoBKr,r sqeft xosHe
KoHTypHbre (2), navrn

orEy 'HMIISyAOCMfI"

78ttt2

Poc:qpanua4sopa (Ka:aHcrnft

Snruan)

KapToHHbre

Ne04V-1304112 OOO "Mr.rn rn" (yl.flyunnHa,
HltxornHoean rcnclora-Buan
g.l l, c.,frrr oeo, Fraronapcrnfi pacrBop glr nurercquft
or 27.12.2012
p-n, Pecny( rnra Earurop'roc'raH) l0rrar/run 1rraa, arranylu (10),
naqKu KaproHHbte

Cnuryu Kcnpxaur

(Dapuacsnrnrar
Ko.JIra

Kr.rmfi

ol-Ey "I4MIISyAOCMII"
Pocrgparua1ropa (KaraHu
Qnruar)

t20303
fi

Ns 04H-1304112

or 27.12.2012

(yn. flep

OOO $rapr'aa "OapM-qeHrp"
e orra aircxal, g,.9,

llapaqerauol ra6rerxn
l0urr., ynaKoBKH

r.Meley:, Pecny6lnxa

6e$sqeft

5

00

rr,r

r

3AO "floK

Poccr,r.s

"O6HoBreHl,te"

Poc:4paa Ha4:opa (Karanc

rcoBbte KoHrypH bte

3AO "Baulue4Qaprra"
(yn.Coqr.ranr.rcrHqecKar, a. I 0e,

MeHoBa3HH pacTBop Ant
Hapy)r(Hofo npHMeHeHr4t

4on.r.8, r.BlaroaeuleHcrc,

[cnnproeofi ] 40run, $aaxouu

Pecnydlurca BaurxoprocraH)
Ns 04V-1304/12

or 27.12.2012

HfI Axrr.rerona 3.,{. (ya.Jleuu ua, Pesur Apor(e i\b 100, 6aurn
4. 1 6, r.lroprto;tlt, Pecny6nraxa
noruuepHule*

3AO "3KOna6"

Pocg..ls

OOO "faleH" (yl,Ka-nnanua,

or 27.12.2012

Pesu'r Apa:l
g.222,' n.r.r -Coaercxu fi ,
Pecny6rnrca Mapufi 3n)

no.nurtepHuex

Ns 04H-1304112

fEY PM3 "3eeHhroBcKar [P5" Peeur Apaxe Jt100,

OAO "Map6noQapu"

Poccus

fEY3 PM "Jhu6npcrcaa I{PE"
(yn.Jleunna, 4. | 4A,, c.Jku6ups,
Jknrdupcrcuft p-u, Pecny6lurca

OAO "Map6uoSapu"

Poccr.rs

Ns 04V-1304112

or 27.122012

fEY3 PM "Jlrn6upcrcar I{PE"
(y.n.,rlennna, p.l 4 A, c.Jku6npr,
Jlarra6rlpcrufi p-H, Pec ny6.nuxa

6aHrcr

OAO "Map6no$apu"

Poccr,rs

noluuepHste*

fEY3 PM "Ilnu6npcxar I{P6"
(yn.JIeHuna, g.l 4 A, c.Jlru6npu,
Jkr,a6upcrcnfi p-u, Pecny6lnxa

Mop4osnr)

ofEy "t4MI_l3yAoCMn"

t37

t2t2

$unuar)
ofBy "HMI_l3yAOCMll"

6908 I 2

Poce4pan ua4:opa (KaraHcxnfi

Qnrna.n)

Hosorcanu pacrBop Ant

OAO "EHoxHMr.tK"

Poccl,rs

uutexquil 5rrar/rrll 5ul, aunylu
(10), nav. rapr.

"larrxuv$apu"

Poccl,rs

BBeAeHHr, 5r',ln I0rur/rr,rn J'.lbI0

ofEy 'HMII3yAOCMII"

610t2

Poc:gpaaHa4sopa (Ka:aucxrafi

Kapr.

Suruar)

JIHAOKaHH pacrBop AJI'

PYII

nHtexunft Z}urlun2un,
aMnynbr (10), nav, rapr.

"6ell,,teqnpenaparu"

HHKorHHosar KncJrora pacrBop
Anr HHbeKuuft l0nar/ul lrun,

O

aMnynbr (10), navru.r KaproHHbre

15007t2

Qn;rnan)

.{r.r6ason pacrBop pnx z/n u n/u OAO

(avnylsr), naq.

orEy "hMII3yAOCM[I"
Pocs4par xa4sopa (KasaHcrnfi

Pecny6;ruxa

Eenapycr

ofBy "HMII3yAOCMII"

r56t 012

Pocsgpana a4ropa (Ka:axcxrafi

$urnal)

Mop4onnr)
Np04V-1304112
or 27 .12.2A12

r35l112

Pocr4pae ua4:opa (Ka:arcrcnfi

Mopqonrr)
Ne04V-1304/12 fEY3 PM "Jlru6npcrcar I{PE"
or 27.12.2012
(yl.JIeHrna, .q. | 4,A, c.JInru6nps,
Jlrrr,r6upcrnfi p-H, Pecny6lt ra
Mop4onur)

orEy "HMq3yAocMfl"
Pocr4pao Ha4:opa (KasaHcxufi

[.3senr4roso, Pecny6lnra Mapnfi

or 27.12.2012

2410t2

{r.rnna,r)

3n)
Ne 04V-1304/12

ofBy "HMI{3yAOCM|I"

Qunnan)

Ns 04M-1304/12

(yl.Pocroanl nxota, g.25,

rufi

Pocs4paaHag:opa (Kasaxcxr,rfi

EaruroprocraH)

or 27.12.2012

96t0t2

Qmnan)

EaurxoprocraH)
Ns04V-1304112
or 27.12.2012

ofEy "l,IMuSyAocMfl"

AO ".{zurrx a

rra

Saprr,r

Poccuc

ofBy "HMu3yAocMn"
Poc:gpanx a4sopa (Karau cxr.rfi

Qnnnat)

220612

.h/b

04H-1304n2 fEY3 PM "Crapouraft roBcKat

or 27.12.2012

J{g

04V-1304112

or 27.12.2012

I-{PE" (yr.BorsullvHa.a, 4.60,

Pr.r6oxcnu pacrBop gnt s/a
20u r/rra,r 5ul,

c.Crapoe LLIafiroeo,
Craporuafiroacrcnfi p-H,
Pecny6rnxa Mop4osxr)

aMfiyJrbr (10), nav, xapr.

fEY3 PM "Crapouaft

IJPB" (yr.6orrnnvHa.a, g.60,

Kal sqns rJrrcKoHar ra6lgrrn
500nar I Our., ynaKoBr(H

c.Crapoe lllafiroso,

6ests.refi xoBbre KoHTypHble

roBcK€ul

OAO "EnoxHMHK"

Poccur

BBeAeHr,ttr

(DfEy "t4MI_l3yAOCMfl,'

120611

Poc:gpanua4sopa (KasaHcxufi
Qnnua,r)

JAU

'MeAHcopO

PoccHq

ofBy "HMII3yAOCMII"

014032010

Poc:gpan nag:opa (Ka:aHcrufi
Qnnua.n)

Crapouraftrorcxuft p-H,
Pecny6rnrca Mopgoaar)
Ns 04V-1304112

or 27.12.2012

fEY3 PM "CrapouaftroBcKat
I{PE" (yr.EolrHauuar, g.60,
c.Crapoe [Iaftroao,
Craporuafrroncrcufi p-H,

or27.12.2012

OOO "BMcepnHc" (yn.lOxnrrfi
npo$A, a.224, n.Caruapa,

Cauapcrar

o6.rracr.u)

(Xulofi

Ns04V-1304112

OOO "Ha4exqa"

or27.12.2012

KBapran ATX,9.62,
noc.

"UHHTC3

Poccur

\-rMst tPztsoIr Ka[cyJlbt KHLu._

OOO "tlpon3BoAcrBo

pacrB.20ur 1Ourr., yn. rq.
ronr. (3), naq. Kapr.

Me.[HKaMeHToB"

n r{ KOTHHOBaT Kr,IcJloTa pacTBOp OAO
AJU HHbeKr{r.rfi

|0rrlr/ul

Poccnq

Poccur

Irr,rn,

(yl.JIeHu Ha, l. | 20, r.Eallarono,

Caparoncrar

or 27.12.2012

o6lacrr)

OOO "lJeHrpanbHat
MoNrHHcra.fl anreKa"
(yn.HaronHu una, p,.69, r.Moxra,

Y4r',ryprcxar Pccny6rNrca)

HHbeKqufi

l0ur/ul

1tr_rr,

340812

Poccng

ofFy

"HMUSyAOCMII"

401012

Pocs4paa uagropa (Kasaucr
Sunnan)
PoccHq

ofEy "HMU3yAOCMII"

681012

Pocs4pan ua4sopa (KasaHcxnfi

$r,rnnal)
@aprtlaqenrnqecrcufi

floluua

3aro4 "florb$apnra"
C.A.

HnrottHosac Kncrora pacrBop UUO
/qJr.rr

@fBy "HMU3yAOCMfI"
Qluuan)

xour. (3), naq. Kapr.
raoflerKr.t 25Our
1 0rur., y[aKoBKH Rqefi xonsre
KoHrypHbre (2), nav. rcapr.

68r012

Poce4pan uagsopa (Ka:aHcxrafi

MeAHKaMeHToB"

I pHxononQ9

orBy "HMU3yAOCMII"
Pocs4pan Hag:opa (Kasaucrcr,rfi

flpo6yxgeu ue,

Caparorcraa o6.;racru)
04H-1304112 OAO "An'rexa Nel85"

Ng 0411-1304/12

il

$unuan)

".{alrxnlrQapu"

3H relscc rufi aMnynbr (10), na.rru KaproHHbte
o6lacrr)
Ns04V-1304112 OAO "Anrerca Nsl85"
AxalrruH ra6nerrn 500vr
UAU 'r,IpoHTCKHrz
or 27.12.2012
(yr.JIeHtxa, A.l2O, r.Baraxoso.
Jlo | 0, ynaxosru 6eglgqeft Kosure X(D3"
Caparoncxar o6lacrr)
KoHrypHbre
Ng04V-t304112 OAO "Anrera Ibl85"
Orr.re npason Ka[cyn br Khrx.
OOO "Ilpon3BoAcrBo
or 27.12.2012
(yn,JIeHu Ha, A.120, r.Eararcoeo,
pacrB. 20rur l0urr., yn. rq.

or 27.12.2012

l30l

$nruar)

p-H, Caparoacxas

Ns

ofBy "HMII3yAOCMII"
Pocs4par ua4sopa (Ka:aucrnfr

Mop4onnr)

Pecny6nurca
Ns 04V-1304/12

.{uuoQeHax-AKOC@ pacrBop IJAU
gnn slu nee4eHur, 3ul
25 ur I u n Ne I 0 (arvrnynsr)

"Oapnaqeat.kqecKaq

aM[ynbr (10), nauxn KaproHHbre KoM[aHHt "34opoBle"

@fEy "HMII3yAOCMII"

3t2ll

Poc:4pas ua4aopa (KasaHcrufi
Qunr.ran)

YrpanHa

orEy "HMI{3yAOCM[["
Poc:4panua4ropa (Kaaaucxu fi
Qunuan)

30r t2

l

Ns04V-1304112

or 27.12.2012

OOO "l-{enrpiurbHat
Pesrr Apaxe Ne 1 00, 6aHxu
Moxruncrcaq anreKa"
nonrl,leDuule*
(yl.HarosHrluua, 8 .69, r.MoNra,

OAO "Map6no{rapu"

Poccr,rs

Np04t{-1304112

OOO "IleHrp:ubHat
MoNrugcxat a[TeKa"

(yl.Hal'oauq uaa, 9.69,

Acrop6anoBar xucnora ApiDffe
50ur' 200rur., 6aHrcu
r'.

Qnruan)
OAO "Map6norlapv"

Pocct.rs

Moxra, nonHMepHbre

t69nt2

Qunnar)

OAO "lepnar

Ptt6oxcus ^ra6n. nlnnlo 200vr

$apuaqeerr,r qecKar Supnaa"

25

(np.TpanropocrpoHrelefi,
r.tle6oxcapu, t{yoarucrcar

KoHTypHbre (2), naurra
KapToHHbte

q. I 8,

(DfEy "HMI_I3yAOCMfl"
Poc:4panua4:opa (Ka:aHcxrafi

Vguyprcxar Pecny6nnra)
Ilb 04H-I304n2
or 27.12.2012

136lt12

Pocs4pasHa4sopa (Ka:aucxuil

Y4ruyprcxar Pecny6nurca)

or 27.12.2012

ofBy "HMu3yAocMfl"

OOO "O:os"

Poccnr

wr., ynaKoBKLI sqefi xoesle

ofBy "HMu3yAocMII"

660912

Poce4pan nag:opa (KaaaHcrcnfi

<[unnan)

Pecny6nr.rrca)
Ne 04Vl-1304112

n

27.12.2012

OAO "flepnar
Qapuaqerrr,rqecKar Qupua"
(np.TpamopocrpoHreJrefi , 4. I 8,
r.

AHarsrus ra6.nerxn 500prr
OOO "AcQaprua"
0, ynaxoexfi 6egrs,reilrcosue

Poccnr

No I

ofEy "HMu3yAocMfl"

251012

Poc:qpaur ag:opa (Kasaucxnft

KOHTypHbre

$urua;r)

tle6orcaprr, t{yaaurcxat

Pecny6arara)

Ns04V-1304112
tr 27 .12.2012

OOO "fauua-7" (yn.farapnHaj
4.29, r.9e6oKcapbr, r{ynaurcxaa

Pecny6nura)
Ns

04H-1304112

cr 27.122012

OOO "favua-7" (yn.farapn*a,
4.29, r'.9e6oKcapbr, 9yaaurcxar
Pecny6nr.lr
Huxorunosar Kr4cJrora pacrBop OAO ".{a,rrxnuSapna"
Am HHbeKLlufi lOur/ul Iul,
aMnynbt (10), navrr.r KaproHHbte

Pocqrs

Pu6orcnH ra6l. n/nr/o 200vr

Poccrq

OOO "O3oH"

(DfEy "HMI_l3yAOCMII"

220612

PocsgpanHa4ropa (Kasancruft

Qulna,r)

25wr., ynaKoBKH q.{efi rosrre
KoHTypHbre (2), navnr

ofEy "HMuSyAocMft"

700912

Poc:4paeHa4aopa (KaaaHcxnft

Qnrna.r)

KapToHHbre

Ns04ld-l3A4ll2 OOO "Bracra" (yl.3Hry3HacroB, Asaarrun ra6nerlcu

tr

27

.12.2012

q.3

l,

r.9e6oKcapbt, 9yearucxar

Pecny6m.rrca)

Ns I

500nnr

Ng04V-1304112
or 27 .12.2012

OOO "Blacra" (yl.3Hry3r4acroB, KoQrlqnr-nlrcc ra6lerxn
l, r.9e6oKcapbr, r{ynaurcxar ynaKoBKH .qqefirogrle
KOHrypHbte

ofEy "I4MUSyAOCM|I"

248n12

PocsgpaeHaA3opa (KasaHcrr,rfi

Snrnar)
OAO "Map6noQapu"

Pocu,rg

ofEy "I4MII3yAOCMfl"

401 l3

Poc:4paoHa4sopa (Ka:ancrufi

norHMepHbte

4.3

Pecny6lura)

Poco,rs

KoHTypHbre

Ilb 04H-1304n2 OOO "B:racra" (yl.3Hry3nacroB, Acrcop6aHoBafl KncJrora ApiDKe
or 27 .12.2012
50rr,t r' 200urr.. 6aHru
9.3 l, r.tle6oKcapbr, tlyeaurcra.r
Pecny6nr.rxa)

OAO "Map6noQapu"

0, ynanoexn 6egrr.refi rcosue

tlmuan)
No 10,

OAO "tDapnacraH,qaprJlexcpegcrna"

Poccur

ofBy "HMu3yAocMfI"
Poc:4pao u a4sopa (Ka:aHcxnfr
Qunua:r)

320912

}\fs

0414-r304n2

OOO "B,racra" (y,r. 3 Hry3uacroB, Peear ApDKe }lb 100, 6asrcn

or

27 .12.2012

4.3 l,

r.r{e6oKcapbr,

9yuaucrar

OAO "Map6noQaprrr"

Poccur

nonnnepHue*

Qnrnan)
OAO "Jlyrascxnfi

BY "Kyrecrcrrfi Aercxufi got*,t-

Acnaprcau rabrerrcu

HHTepHaT AnR yMCTBeHHO

(ynaroa rr.r sqeft roerre
roHrypHsre)

xo3"

@onnesar Kncrora ra6lerxx

OAO "EopucoecrcHfi

rrrr l0rur., ynaKoBKH
sqefircossle rcoHrypnrre

3480n

rerefi" M3CP
9yrarunu (yl. fiepsou ailcKafl ,

orcruurbrx

4.14, ropn.

l,

570812

Pocr4paa Hagropa (KasaHcxu fi

Pecny6nnra)

Np04V-1304/t2
cr27.12.2012

of6y "HMu3yAocMfl"

J',1b50

Vrpauna

orBy "HMu3yAocMfI"

1540712

Pocagpasuagsopa (Ka:axcxu il
QurNan)

noc.Kyrecu,

He6orcapcxn fi p-H, t{yeaurcxar
Pecny6nr,rxa)

Ilit 0414-1304112 BY "Pecny6JruKaHcKat Aercr(at
or 27.12.2012
KJIHHllqecKaq 6orrHlrua"

(yn.fnalroea, A.27,
r.tle6orcapsr, 9yuaucrax
Pecny6nurca)

* - no

nporepeHHbrM noKa3areJlflM

I

NAqKH KADTOHHbIE

(5

),

ue4npenaparor"

Pecny6rrara
6erapycs

OI-EY ''hMIISYAOCMII''
Poc:4paeua4:opa (Ka:aucxu fi

Qunnar)

900612

Mr uucrepcrao 3apaBooxpaHetrtrr Poccsilcroil Oeaepaunn

oEAEPAJTbHAf, CJnDKBA nO HAI3OPy B COEPE 3.ryABOO)GAHEHIIff PyrorogureJrrM opraHr,Barlufi - (POc3.ryABHAA3OP) npou3BoAr,rTeJreft JreKapcTBeHHbrx CrascHcrar nn., I. 4, crp. l, MocraU 109074 cpeAcrB ren: (495) 698 46 28,698 46 I I Pyrono4ureJrrM opraHu3arlnfi - /,( r po/^ r{MropTepoB JreKapcTBeHHbrx cpeAcTB
Ha Jtlb OT Cy6rexrau o6paulenHr JreKapcTBeHHbrx cpeAcTB t- Peruenue rro pe3yJrbraraM 3Kc[eprr,r3br KaqecTBa JreKapcTBeHHbrx cpeAcTB

(De4epanrHar cJryx(6a no HaA3opy B cQepe 3ApaBooxpanenufl r,{H0opMr,rpyer, qro no pe3yJrbTaTaM sKcrrepTu3br KaqecTBa ireKapcTBeHHbrx cpeAcTB npr4HrTO perueHne o coorBercrBur4 ycraHoBJIeHHbIM Tpe6oBaHI,IsM KarrecrBa neKapcrBeHHbrx cpeAcrB, [epequcneHHhrx B rrpnnox eHI,III.

flpnnoxeHue:Ha 5 n.s I srs.

BprEo pyKoBoAr,rreJrfl M.A. Myparuro

f.B. laHHo.tra 84995780t87 flpuroxeHne K rlrcbMy Poc:4panuas zopu o, //.0€.1h/JNn /6A 'e ,6//J ?6t Cnegennr o nercapcrBeH cpeAcTBax, IIo pe3ynbTaTaM 3xcnepTH3bt KaqecTBa rcoTopbrx PocrqpannaA3opou nptrHflTo pe[reHrre o coorBercrBrrlr rlx KaqecrBa ycraHoBJreHHbru roe6onar IIflM Hanueuor mHe opfaHn3aur,rH, Horr,rep 3aAaHlar. npeAcT, lreuefi o6pasqrr JlerapcraeuHoe cpeAcrBo flpousno4nreru Crpaua np-Ba Srcnepruar opraH[3aqr{t Ceprau neKapc' BeHHbrx cpeAcTB I

Ns04V-1304/12 KOTKYCO 'Py6rencrurft PenH'r Apore Nsl00, 6asrn OAO "Map6no$apu" PoccHq ofEy "HMuSyAOCMfl" 360512 or 27.12.2012 ncuxoHeBpc roruqecrnfi noluuepuste* Pocs4paoHa1sopa (Kasaucrufi nHrepnar" ( ,rrcp.JfrHracono, Qunua:l) 4.I4yunuqsr r.Knpoa, Knpoacxar, 6nac'rs) Ng04LI-1304/12 fEY3 "ToH :uHcrar I{PE" .(n6ason pacrBop Ntt sls u sltl OAO ",{anrxnuQapu" Poccus ofBy "I4MI{SyAOCMII" 206r2 or 27.12.2012 (yr.EolrHu uar, g. lA, BBeAeHnr, 5ul lOrvrr/rr,ril .I\|bl0 Pocs4panHa4sopa (Kasancrra ft p.n.ToHxr,ru r, HuxenopoAcKat (aunynu), naq. Kapr. $r,rnnaa) o6racts) Ns 0414-1304/12 Anrera @l' iy "oIICCX" HoeorauH, pacrBop AJrt OAO "6nocHHTe3" Poccnq ofEy "HMIISyAOCMn" 50712 or 27.12.2012 MuHs4pasa Poccr.rr.r (r.fleHsa) nHrerquft 5 run/rr,rn 200run, Pocsgpaen44sopa (KasaHcrnft (yr.Cracon: 9.6, r.fleu:a, 6yrsrlra Qn-rrr,ral) fleHsencrat o6racrr) Ne0414-1304/12 Anrera (Df ;y "oIICCX" JlngorauH pacrBop AJrt oAO Poccur orEy 'HMIISyAOCMII" 20612 or 27.12.2012 MnHr.qpaea Poco.rr.r (r.flensa) uHrerqnft Z0v.rlut2utr, "Hosocn6xuuSapu" Pocs4panHa4aopa (Ka:aHcrr.rfi (yr.Cracoer ,4.6, r.flens4 aMrynbr (10), nav. rapr. t[urnar) fleugeHcrar o6nacrr) Ns04V-1304/12 Anrera Of ;y "oqccx' Jln4orcanH pacrBop Ant OAO "Euoct{HTe3rr Poccnc @fEy "I4MII3yAOCMII" 40212 or 27.12.2012 MnH:.qpana Pocclu,r (r.fleHsa) nurexqnft 20ur|ul2utr, Pocs4panHaAsopa (Karancru fi (yn.Cracorr ,9.6, r.flensa, aMrryJrbr (10), nav. rapr. Qnnnal) fleHseHcrar o6nacrs) Ns04V-1304/12 Anrera OO ) "Apreun4at' Acrop6nHoBar KncJrora Apaltce OAO "Map6uoQapu" Poccnr ofBy 'HMu3yAocMf[" t72lt12 or 27.12.2012 (ruocce Koc roHaBToB, 9.252, 50ur 200un., 6aHrn Pocsgparua4sopa (Karancrra ft r.flepus, fl pucnnfi rpafi) noJlr.rMepHble r[nruan) Ne04I"|-1304/12 An'rera OO ) "Apreunga" Pn6oxcuu ra6t. slnt/o 200ur OOO "Ogog" Poccnr orEy 'HMIISyAOCMfI" 78ttt2 or 27.12.2012 (ruocce Koc {oHaBToB, n.252, 25 mr., ynaKoBKr,r sqeft xosHe Poc:qpanua4sopa (Ka:aHcrnft r.flepus, flr pnacrnft rcpaft) KoHTypHbre (2), navrn Snruan) KapToHHbre Ne04V-1304112 OOO "Mr.rn rn" (yl.flyunnHa, HltxornHoean rcnclora-Buan Cnuryu Kcnpxaur Kr.rmfi ol-Ey "I4MIISyAOCMII" t20303 or 27.12.2012 g.l l, c.,frrr oeo, Fraronapcrnfi pacrBop glr nurercquft (Dapuacsnrnrar Pocrgparua1ropa (KaraHuor 27.12.2012 Poccus orEy "HMq3yAocMfl" r35l112 4. 1 6, r.lroprto;tlt, Pecny6nraxa noruuepHule* Pocr4pao Ha4:opa (KasaHcxufi EaruroprocraH) Qunnan) Ns 04M-1304/12 OOO "faleH" (yl,Ka-nnanua, Pesu'r Apa:lor 27.12.2012 (yl.Pocroanl nxota, g.25, Poccr,rs ofBy "HMI_l3yAOCMll" 6908 I 2 noluuepHste* Poce4pan ua4:opa (KaraHcxnfi [.3senr4roso, Pecny6lnra Mapnfi Qnrna.n) 3n) Ne 04V-1304/12 fEY3 PM "Jhu6npcrcaa I{PE" Hosorcanu pacrBop Ant or 27.12.2012 (yn.Jleunna, 4. | 4A,, c.Jku6ups, OAO "EHoxHMr.tK" Poccl,rs orEy "hMII3yAOCM[I" 15007t2 uutexquil 5rrar/rrll 5ul, aunylu Pocs4par xa4sopa (KasaHcrnfi Jknrdupcrcuft p-u, Pecny6lurca (10), nav. rapr.
Qn;rnan) Mopqonrr) Ne04V-1304/12 fEY3 PM "Jlru6npcrcar I{PE" .{r.r6ason pacrBop pnx z/n u n/u OAO "larrxuv$apu"
or 27.12.2012 (yl.JIeHrna, .q. | 4,A, c.JInru6nps, Poccl,rs ofEy 'HMII3yAOCMII" 610t2 BBeAeHHr, 5r',ln I0rur/rr,rn J'.lbI0 Poc:gpaaHa4sopa (Ka:aucxrafi Jlrrr,r6upcrnfi p-H, Pecny6lt ra (avnylsr), naq. Kapr.
Mop4onur) Suruar) Ns 04V-1304112 fEY3 PM "Jlrn6upcrcar I{PE" JIHAOKaHH pacrBop AJI' PYII or 27.122012 (y.n.,rlennna, p.l 4 A, c.Jku6npr, Pecny6;ruxa ofBy "HMII3yAOCMII" r56t 012 nHtexunft Z}urlun2un, "6ell,,teqnpenaparu" Eenapycr Pocsgpana a4ropa (Ka:axcxrafi Jlarra6rlpcrufi p-H, Pec ny6.nuxa aMnynbr (10), nav, rapr.
Mop4onnr) $urnal) Np04V-1304112 fEY3 PM "Ilnu6npcxar I{P6" HHKorHHosar KncJrora pacrBop O AO ".{zurrx a rra Saprr,r or 27 .12.2A12 (yn.JIeHuna, g.l 4 A, c.Jlru6npu, Poccuc ofBy "HMu3yAocMn" 220612 Anr HHbeKuuft l0nar/ul lrun, Poc:gpanx a4sopa (Karau cxr.rfi Jkr,a6upcrcnfi p-u, Pecny6lnxa aMnynbr (10), navru.r KaproHHbre Mop4osnr) Qnnnat) .h/b 04H-1304n2 fEY3 PM "Crapouraft roBcKat Pr.r6oxcnu pacrBop gnt s/a OAO "EnoxHMHK" Poccur (DfEy "t4MI_l3yAOCMfl,'
or 27.12.2012 I-{PE" (yr.BorsullvHa.a, 4.60, 120611 BBeAeHr,ttr 20u r/rra,r 5ul, Poc:gpanua4sopa (KasaHcxufi c.Crapoe LLIafiroeo, aMfiyJrbr (10), nav, xapr.
Craporuafiroacrcnfi p-H, Qnnua,r) Pecny6rnxa Mop4osxr) J{g 04V-1304112 fEY3 PM "Crapouaft roBcK€ul Kal sqns rJrrcKoHar ra6lgrrn JAU 'MeAHcopO or 27.12.2012 IJPB" (yr.6orrnnvHa.a, g.60, 500nar I Our., ynaKoBr(H PoccHq ofBy "HMII3yAOCMII" 014032010 Poc:gpan nag:opa (Ka:aHcrufi c.Crapoe lllafiroso, 6ests.refi xoBbre KoHTypHble Crapouraftrorcxuft p-H, Qnnua.n) Pecny6rnrca Mopgoaar) Ns 04V-1304112 fEY3 PM "CrapouaftroBcKat .{uuoQeHax-AKOC@ pacrBop IJAU "UHHTC3 or 27.12.2012 I{PE" (yr.EolrHauuar, g.60, gnn slu nee4eHur, 3ul Poccur ofBy "HMII3yAOCMII" l30l il l Pocs4par ua4sopa (Ka:aucrnfr c.Crapoe [Iaftroao, 25 ur I u n Ne I 0 (arvrnynsr) Craporuafrroncrcufi p-H, $nruar) Pecny6nurca Mop4onnr) Ns 04V-1304/12 OOO "BMcepnHc" (yn.lOxnrrfi \-rMst tPztsoIr Ka[cyJlbt KHLu._ OOO "tlpon3BoAcrBo Poccnq orBy "HMU3yAOCMII"
or27.12.2012 npo$A, a.224, n.Caruapa, pacrB.20ur 1Ourr., yn. rq. 68r012 Me.[HKaMeHToB" Pocs4pan Hag:opa (Kasaucrcr,rfi Cauapcrar o6.rracr.u) ronr. (3), naq. Kapr.
Ns04V-1304112 OOO "Ha4exqa" (Xulofi $unuan) n r{ KOTHHOBaT Kr,IcJloTa pacTBOp OAO ".{alrxnlrQapu"
Poccur @fBy "HMU3yAOCMfI" 340812 or27.12.2012 KBapran ATX,9.62, AJU HHbeKr{r.rfi |0rrlr/ul Irr,rn, Poce4pan uagsopa (Ka:aHcxrafi noc. flpo6yxgeu ue, 3H relscc rufi aMnynbr (10), na.rru KaproHHbte p-H, Caparoacxas o6lacrr) Qluuan) Ns04V-1304112 OAO "Anrerca Nsl85" AxalrruH ra6nerrn 500vr UAU 'r,IpoHTCKHrz Poccng ofFy "HMUSyAOCMII" 401012 or 27.12.2012 (yr.JIeHtxa, A.l2O, r.Baraxoso. Jlo | 0, ynaxosru 6eglgqeft Kosure X(D3" Pocs4paa uagropa (Kasaucr PoccHq ofEy "HMU3yAOCMII" 681012 MeAHKaMeHToB" Pocs4pan ua4sopa (KasaHcxnfi Caparorcraa o6.;racru) xour. (3), naq. Kapr.
Ns 04H-1304112 $r,rnnal) OAO "An'rexa Nel85" I pHxononQ9 raoflerKr.t 25Our @aprtlaqenrnqecrcufi floluua @fEy "HMII3yAOCMII"
or 27.12.2012 (yl.JIeHu Ha, l. | 20, r.Eallarono, 0rur., y[aKoBKH Rqefi xonsre 3t2ll 1 3aro4 "florb$apnra" Poc:4pas ua4aopa (KasaHcrufi Caparoncrar o6lacrr) KoHrypHbre (2), nav. rcapr. C.A.
Ng 0411-1304/12 Qunr.ran) OOO "lJeHrpanbHat HnrottHosac Kncrora pacrBop UUO or 27.12.2012 MoNrHHcra.fl anreKa"
YrpanHa orEy "HMI{3yAOCM[[" 30r t2 /qJr.rr HHbeKqufi l0ur/ul 1tr_rr, "Oapnaqeat.kqecKaq Poc:4panua4ropa (Kaaaucxu fi (yn.HaronHu una, p,.69, r.Moxra, aM[ynbr (10), nauxn KaproHHbre KoM[aHHt "34opoBle"
Y4r',ryprcxar Pccny6rNrca) Qunuan) Ns04V-1304112 OOO "l-{enrpiurbHat Pesrr Apaxe Ne 1 00, 6aHxu OAO "Map6no{rapu" ofBy "HMu3yAocMfl"
Poccr,rs 136lt12 or 27.12.2012 Moxruncrcaq anreKa" nonrl,leDuule* Pocs4pasHa4sopa (Ka:aucxuil (yl.HarosHrluua, 8 .69, r.MoNra, Qnruan) Y4ruyprcxar Pecny6nurca) Np04t{-1304112 OOO "IleHrp:ubHat Acrop6anoBar xucnora ApiDffe OAO "Map6norlapv" (DfEy "HMI_I3yAOCMfl"
Pocct.rs t69nt2 or 27.12.2012 MoNrugcxat a[TeKa" 50ur' 200rur., 6aHrcu Poc:4panua4:opa (Ka:aHcxrafi (yl.Hal'oauq uaa, 9.69, r'. Moxra, nonHMepHbre Qunnar) Vguyprcxar Pecny6nnra) Ilb 04H-I304n2 OAO "lepnar Ptt6oxcus ^ra6n. nlnnlo 200vr OOO "O:os" Poccnr ofBy "HMu3yAocMII" 660912 or 27.12.2012 $apuaqeerr,r qecKar Supnaa" 25 wr., ynaKoBKLI sqefi xoesle Poce4pan nag:opa (KaaaHcrcnfi (np.TpanropocrpoHrelefi, q. I 8, KoHTypHbre (2), naurra <[unnan) r.tle6oxcapu, t{yoarucrcar KapToHHbte Pecny6nr.rrca)
Ne 04Vl-1304112 OAO "flepnar AHarsrus ra6.nerxn 500prr OOO "AcQaprua" Poccnr ofEy "HMu3yAocMfl" 251012 n 27.12.2012 Qapuaqerrr,rqecKar Qupua" No I 0, ynaxoexfi 6egrs,reilrcosue Poc:qpaur ag:opa (Kasaucxnft (np.TpamopocrpoHreJrefi , 4. I 8, KOHTypHbre $urua;r) r. tle6orcaprr, t{yaaurcxat Pecny6arara) Ns04V-1304112 OOO "fauua-7" (yn.farapnHaj Huxorunosar Kr4cJrora pacrBop OAO ".{a,rrxnuSapna" Pocqrs (DfEy "HMI_l3yAOCMII" 220612 tr 27 .12.2012 4.29, r.9e6oKcapbr, r{ynaurcxaa Am HHbeKLlufi lOur/ul Iul, PocsgpanHa4ropa (Kasancruft Pecny6nura) aMnynbt (10), navrr.r KaproHHbte Qulna,r)
Ns 04H-1304112 OOO "favua-7" (yn.farapn*a, Pu6orcnH ra6l. n/nr/o 200vr OOO "O3oH" Poccrq ofEy "HMuSyAocMft" 700912 cr 27.122012 4.29, r'.9e6oKcapbr, 9yaaurcxar 25wr., ynaKoBKH q.{efi rosrre Poc:4paeHa4aopa (KaaaHcxnft Pecny6nr.lrIlb 04H-1304n2 OOO "B:racra" (yl.3Hry3nacroB, Acrcop6aHoBafl KncJrora ApiDKe OAO "Map6noQapu" ofEy "I4MII3yAOCMfl"
Pocu,rg 401 l3 or 27 .12.2012 9.3 l, r.tle6oKcapbr, tlyeaurcra.r 50rr,t r' 200urr.. 6aHru Poc:4paoHa4sopa (Ka:ancrufi Pecny6nr.rxa) norHMepHbte tlmuan)
Ng04V-1304112 OOO "Blacra" (yl.3Hry3r4acroB, KoQrlqnr-nlrcc ra6lerxn No 10, OAO "tDapnacraH,qapr- Poccur ofBy "HMu3yAocMfI" 320912 or 27 .12.2012 4.3 l, r.9e6oKcapbr, r{ynaurcxar ynaKoBKH .qqefirogrle Jlexcpegcrna" Poc:4pao u a4sopa (Ka:aHcxnfr Pecny6lura) KOHrypHbte Qunua:r) }\fs 0414-r304n2 OOO "B,racra" (y,r. 3 Hry3uacroB, Peear ApDKe }lb 100, 6asrcn OAO "Map6noQaprrr" Poccur of6y "HMu3yAocMfl" 570812 or 27 .12.2012 4.3 l, r.r{e6oKcapbr, 9yuaucrar nonnnepHue* Pocr4paa Hagropa (KasaHcxu fi Pecny6nnra) Qnrnan)
Np04V-1304/t2 BY "Kyrecrcrrfi Aercxufi got*,t- Acnaprcau rabrerrcu J',1b50 OAO "Jlyrascxnfi Vrpauna orBy "HMu3yAocMfI" 1540712 cr27.12.2012 HHTepHaT AnR yMCTBeHHO (ynaroa rr.r sqeft roerre xo3" Pocagpasuagsopa (Ka:axcxu il orcruurbrx rerefi" M3CP roHrypHsre) QurNan) 9yrarunu (yl. fiepsou ailcKafl , 4.14, ropn. l, noc.Kyrecu, He6orcapcxn fi p-H, t{yeaurcxar Pecny6nr,rxa)
Ilit 0414-1304112 BY "Pecny6JruKaHcKat Aercr(at @onnesar Kncrora ra6lerxx OAO "EopucoecrcHfi Pecny6rrara OI-EY ''hMIISYAOCMII'' 900612 or 27.12.2012 KJIHHllqecKaq 6orrHlrua" I rrrr l0rur., ynaKoBKH 3480n 6erapycs Poc:4paeua4:opa (Ka:aucxu fi (yn.fnalroea, A.27, sqefircossle rcoHrypnrre (5 ), ue4npenaparor" Qunnar) r.tle6orcapsr, 9yuaucrax NAqKH KADTOHHbIE Pecny6nurca)
* - no nporepeHHbrM noKa3areJlflM

Министерство здравоохранения Российской Федерации
ФЕДЕРАЛЬНАЯ СЛУЖБА ПО НАДЗОРУ Г |
В СФЕРЕ ЗДРАВООХРАНЕНИЯ Руководителям организаций- (РОСЗДРАВНАДЗОР) _° === прозводителей лекарственных средств
Славянская пл., д. 4, стр. 1, Москва, 109074 тел.: (495) 698 46 28, 698 46 11
Руководителям организаций-
UOC. #079 SE 4-6 4 JVB импортеров лекарственных средств
На № Субъектам обращения Г 7 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 М.А. Мурашко
Г.В. Ганночка 84995780187

Скачать документ: Письмо 16И-646/13 от 18.06.2013

Информационные письма Росздравнадзора по контролю качества: Лекарственные средства

Информационные письма Росздравнадзора по контролю качества: Медицинские изделия

   

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