РОСЗДРАВНАДЗОР Информационное письмо № 02И-899/13 от 08.08.2013


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 № 02И-899/13 от 08.08.2013

Решение по результатам экспертизы качества лекарственных средств

MnnncrepcrBo sApaBooxpaxeHufl
Poccnficrofi Oegepaqnn

OEAEPA.IIbHAI CJIY}I(EA NO HA.43OPY
B COEPE 3.(PABOOXPAHEHI{g

Pyrono4ureJltM opraHI,I3aIII4fi -

(POC3APABHA,TI3OP)
GransucKar

m. 4, crp. l, Mocraa,

Tene(poH: (495) 698 45

[por,r3BoAI,ITeJIeft JIeKapCTBeHHbIX

109074

cpeAcrB

38;698 15 74

Pyroao4urenff M opraHI,I3aIIHfi r,rMrroprepoB JIeKapcrBeHHbIx cpeAcrB
'Peruesue uo p$yJlbraraM gKcIreprLI3bI
KaqecrBa neKapcrBeHHbD( cpeAcrB

I
I

Cy6remaM o6paIrIeHLIt
JreKapcrBeHHhrx cpeAcrB

rro pe3yJrbraTaM 9Kcneprrr3br KaqecrBa neKapcTBeHHbrx cpeAcrB rrpr4HrTo perueHue o
cooTBeTcTBuu ycTaHoBJIeHHhIM Tpe6oBaHr,rrM KaqecTBa neKapcTBeHHbrx cpeAcTB,

[epequcreHHbx

B npr{Jro)KeHHr,r.

flpnnoxeHrle:Ha 3

Bpzo pyroBoAr,IreJrfl

f.B. fauuoqxa
849957801 87

n.s

1 srg.

[.B. IIapxoMeHKo

flpuroxeuue

cBer€Ens o noraspcme[gLll clr€rcrBaxr to per:tnlTrra

3rnqhxtfr

rncbMy Poc:4panHa4 sopa oro3. 08,

lA6 Nn 4Nq 89poqnpmnqqropou
nqacrBr KompHr
nprErm pcEesre o c]oorBcrcrBr[ rx KtqecrBr
K

HOBJIE|lHbIM
HaHMeHosaHHe opfaHr,r3aur{H,

Houep sa4aHilfl

npeAcraB[Burefi o6pa3qbr

Jlerapcraeu Hoe cpe.qcrBo

flpousaogurelr

Crpana np-Ba

JreKapcTBeHHbrx cpeAcTB

Np04V-1304112 KO|EY3 "Knponcruft

or 27.12.2012

po4nlrHufi Aol,t Nsl"
(yn.SHrenrc a, g.24, r. Knpon,
Kr.rposcrar o6nacrs)

Np04V-1304/12

or 27.12.2012

An'rera MEY3 "A6gylllucrar
I{PB" (yl.CoBercKar, 4. I 83,
r.A64ylnuo, Opeu6yprcrcar
o6racrr)

Acrop6r.rHoBaff Kr.tcJrora .4parxe

OA0 "Map6noQapu"

Poccr,rx

50ur 200nrr.,6aHKu

@ypaqr.rrun ra6t. g/npuror. p- OAO "Hp6r.rrcxnfi

PoccHq

x(D3,

Poccur

OAO "Map6uoQaprr,r"

fEY PM3 "Crauqul cropofi
MeAr,rqnHcKofi nonaoruu

r.iiorurap-Ona"
(yl.O.Tnxouupoeofi , g.58,

r03t2

Qnnrnal)

Poccnr

ofEy "I4MIISyAOCMII'

601l3

Poca4paaHag:opa (Kasaucxr.r ft
Sn-rrnal)

Poccnr

aI'Ey "HMIISyAOCMII"

r0l r0l2

Pocs4parHa4sopa (Ka:aHcxr.rfi

n.Megre4eno, Pecrryr6lura
Mapnfi 3.rr)

or27.12.2012

ofEy "I,iMUSyAOCMn"
Pocsgpan uagsopa (KasaHcrnfi

6esrsq. rcoHr.)

Ns 04kI-1304/12

2271012

Sr,mr,rar)

Anrera MAy3 "fB Ns3"
AreHolol ra6lerru 50un
3A0 "(DapunpoeKT"
I 0rur., ynaKoBKr,r cqefi Komre
fin.Horoo.l6npcrar,,q. I I 9,
n.Opcr, Open6yprcxar o6lacrr) KoHTypHbre (3), nav. rapr.
Ns04V-1304112 OOO "CeneHa" (l-uft Eofinufi
@ypaqnnnn ra6n. glnpuror. p- 0AO "l4p6r,rrcrnfi
or 27.12.2012
nep., 9.9, r.[epur, flepucxnfi
pa Mfl MeCTHOTO H HapyxGoro x(D3"
Kpafi)
rrpr{MeHeHn s 20ur No I 0 (yn.
OKY I,IK-3 yOCIIH Poccr,rn no Pesn'r Apare Nsl00, 6aHrul
PM3 (yl.Me4ae4eaa, g. l,
noruuepHue*

ofBy "IIMIISyAOCMII"
Poc:4paoHagsopa (KasaHcrnfi

6esrcq. xoHr.)

Ng04H-1304/12

Ns0414-1304112

260312

Qnru.ral)

or27.12.2012

w27.12.2012

(DfEy "HMU3yAOCMII"

Ceprar.r

PocsgpaaHa4sopa (Kamucrufi

nonHMepHbre

pa AJrr MecTHOTO H Hapy)KHoro
npuMeHeHr.rc 20lrr Nol0 (yn.

Sncnepruar opraHH3auHt

Qnnr,ral)

OryfI

MarHuq cynr$ar pacrBop Ant
n/r ane4euus 25Onrr/nrn l0un,

"Apuannpcxar
6uorornqecras

aMnyJrbr (10), nav. r
Qa6pnra"

Poccuq

ofBy "HMII3yAOCMII"

39ttt2

Poc:4panHa4aopa (Ka:aHcrr.rft
tlr.rnr.ral)

fi ournap-O.na, Pecrry6lnrca
Maprafi 3n)
r.

Ns04V-1304/12

or27.12.2012

I-EY3 PM "Kovryponcxar L{PE" AHalrruu pacrBop plt t/s n
(yl.Jlecuar, 4. l, c.Kovrypono,
n/u rne4eHu n, 2ut 500ur/un,
Pecnyblurca Mop4orr.rx)
aMnyJrrr (10), na.r. rcapr.

OAO "Eopr.rcoscrnft
3aBOA

ue4npenaparon"

Pecny6nuxa
Eenapycr

ofBy ,HMIISyAOCMII"
Pocs4parHa4sopa (KaraHcrcr.rft
Qr.rnuar)

2340812

Ns04W-1304/12

Anrera I,III Ceperana f.A.

or27.12.2012

(yr.Kpacnoapueft crcar,
r.Cauapa, Cauapcraa o6nacrs)

l.l2l,

Yrolr

aKrnBr.rpoBanuufi -YE@

OAO "Vpal6uoQaprra"

Poccnr

'ra6rerxn 250Mr Nsl0,

ofBy "HMIISyAOCM|I"

1920812

Pocsqpan uagsopa (Kasancrnfi

ynaKoBKr.r 6esrsqefi rcosHe

Snnual)

KOHTypHbre

or27.12.2012

OOO "BMcepBrc" (yn.IOxnrrfi
rpoe3A, 9.224, r.Cauapa,
Carraapcrar o6nacru)

Megarou pacrBop AJrf,
nurercqnft l0ur/ul lrul,
aMrynbr (10), nav. xapr.

Ns04V-1304/12

AII OOO "Apreu-555"

@ypaquuH ra6n. g/npuror. p- OAO "Hp6r.rrcrcnft

or27.12.2012

(yr. urra.rlanaena B.I4., 1,.99 / 109,
r.Caparon, Caparoncrar

pa AJrr MecTHOTO H Hapy)rGoro

Ns04V-1304/12

o6nacrr)
Ns04V-1304/12

or 27.122012

t 20vr
6egrrq. ronr.)
npr.rMeHeHrd

No

1

OOO "OnurHsrft

Poccur

0 (yn.

rcr.r

I

t0l l3

fi

@paHqr,rr

orBy "HMIISyAOCMII"

vl\

I164

Pocsgpanua4sopa (Kasancrnft
Qnrua.n)

Np04V-1304112 OOO "AEEar M"

XoSr,rron

6rncrepu (2), nav. rcapr.

ra6lerrn n/o 30nrr., Jla6oparopnu Po:a-

@paHqur

Or.rrcQapnaa

(DfEy "HMIISyAOCMII"

\-rN I150

Pocr4panHagropa (KasaHcrnft

r.Caparon, Caparoecxar

Qnnuan)

o6rac'rr)
Ns04V-1304/12

OOO'AEEar M"

fexcopal ra6c ra6lerKu Ant

3on bAAH

or 27.12.2012

(yr.Ac'rpaxaHcKun, a. I 40,

paccacbrBaHnr

Xol1uun*Eos6oscne

r.Caparor, CaparoBcxat
o6nacrr)

tqeftronue KoHTypHbre, naq.

ry3 CO "ArrapcrcaR I{P6"

Maruur cynrQar oacrBop Ant

(yr.Banu Marceesofi, 4.23,
r.Arxapcr, Caparoocrar
o6racrr)

n/n nre4eHur 250nrr/nrn I0rr,rn,
aMnynbr (10), nau. xapr.

MEY3 "Capanynrcrar
ropoAcKar nH$erqnoHnax
6olrHnqa" (yn. I -aa [atnan,
4. I 3, r.Capanyl, Y4uyprcxar

Aqecolr pacrBop 4nr
400ur,6yrurlrcn

Ns04H-1304/12

"HMq3yAOCM[I"

Qnrna.n)

naq. KapT.

or 27.122012

or 27.12.2012

(DI-By

Pocs4par Ha4:opa (Ka:aHc

o6rac'm)

Ns04V-1304112
or 27.12.2012

50712

Pocs4paaxagropa (Karaxcrcufi

xo3"

Xo$nron rablerrn n/o | 80rur., Jla6oparopnr Posa(yn.r.rnr.tlanaera B.H., t.99 I 109, ry6u nolunponHrreHoBbre (l ), Ouro$apnaa

(yn.AcrpaxaHcKaq, p,.l 40,

@fEy "I4MIISyAOCMII"
Sl,rrInan)

AII OOO "Apreu-555"

r.Capa'ron, Caparoncrcar

Vxpanua

rarog "fHLpIC"

J,,1b20,

ynaKoBKn

qnanr,rrereH

fepnrauur

ofBy "I,IMII9yAOCMII"

2t00164

Poc4panHagropa (Ka":aucruft

fu6X

Sriruair)

Kapr.

OAO "Mocxnrr,tQapnanpenaparu"
nru.H.A.Ceuaruro

r.rnSysraft OAO

HIIK "3cKoM"

Poccur

ofBy "I4MIISyAOCMI'

tt8r2t2

Pocs4paruagsopa (Karancrnft
Srairnan)

Poccnr

ofEy "HMII3yAOCMII"

0301l2

Pocrgpanna4sopa (KaraHcxnft

$r.uuar)

Pecrry6nr.ma)

Ns04Vl-1304/12

or 27.12.2012

MBY3 "Capanylrcrar
ropoAcKafl uuQerquouuar
6orbHnqa" (yl. 1 -ar,{auHar,
g. I 3, r.Capanyr, Y4ruyprcrar
Pecny6rnra)

Oypaqnrnu ra6n. l/npnnor. p- OAO "I4p6n'rcrufi
pa Arr MecTHofo r,r HapyxHofo xo3"
npl,rMeHenr,rr 20nar J',lel0 (yn.
6esrrq. r
Poccnq

orBy 'HMu3yAocMfI'
Pocs4panHag:opa (Kasaucrufi
$r.lnnan)

254tl12

Np 04LI-1304112

MEY3 "I,ftolrcKar yqacrKoBat

or 27.12.2012

6orunr.rqa" (nep.AnrevHsrfi
9.21, c.Vrc nbcKoe,

,

Borruscrnfi

MarHHc cyrs$ar pacrBop 4rlt
a/e nnegeHnr 250ur/nal 5ul,

OAO ",{amxnuSapu"

PoccHr

or 27.12.2012

MEY3 "l,ftorscKar yqacrKoBat
6oruunqa" (nep.Anrevuuft ,
9.21, c.Vn nbcKoe, Borrnucxr,rft

aMnyrrbr (10), nav. rap'r.
@ypa:onr.r4ou

ra6lerxn 50ur

lOrur., ynaKoBKr.l

571012

Poc:gpanHagsopa (Karancxr.rft

$r.rruar)

p-u, Y4ruyprcraa Pecny6ar.ma)
Ns 0414-1304112

ofBy "HMu3yAocMfI"

OAO "llp6r.rrcrnft

PoccHq

xo3"

ofEy "HMIISyAOCMn"

40612

Pocrgpae Ha4sopa (KasaHcxr,l fi
t[nrr.rzur)

6egrqqeft xoBbre KoHTypHbre

p-H, V4rvryprcrcar Pecny6nurca)

Ns04V-1304/12
or 27.12.2012
Ns04V-1304/12
or 27.12.2012

fV3 "AnrexaNsl59"

Pesnr Apaxe J\!100, 6anxu

(yn. Haroer,rubrHa, A. 84, r.Moxr4
V4ruyprcrar Pecny6nr.rrca)

nolnuepHue*

I-V3 "Maftscrar [PE"
(yr.3eneHar, g. l, nrr.MafiHa,
Mafi ncruft p-H, YlsaHoBcKat
o6racrs)

Keroporax pacrBop Nn sls u
n/u rnegeHul, llur 3Orr,rrlrul
Nel0, arrrrrylH, [aq. Kapr.

* - no npoBepeHHbrM

noKa3areJrrM

OAO "Map6uo$apu"

Poccnr

ofBy "l,IMuSyAocMtI,

t40l2r2

Poc:4pan ua4:opa (Kasancrcnfi

Qurnan)

OAO "Cnnreg"

Poccaq

ofBy "HMI{SyAOCMII"
Poc:4pan nagsopa (KasaHucnfi

Qnruaa)

4703t2

MnnncrepcrBo sApaBooxpaxeHufl Poccnficrofi Oegepaqnn OEAEPA.IIbHAI CJIY}I(EA NO HA.43OPY B COEPE 3.(PABOOXPAHEHI{g (POC3APABHA,TI3OP) Pyrono4ureJltM opraHI,I3aIII4fi - [por,r3BoAI,ITeJIeft JIeKapCTBeHHbIX GransucKar m. 4, crp. l, Mocraa, 109074 Tene(poH: (495) 698 45 38;698 15 74 cpeAcrB
Pyroao4urenff M opraHI,I3aIIHfi - r,rMrroprepoB JIeKapcrBeHHbIx cpeAcrB
I Cy6remaM o6paIrIeHLIt 'Peruesue uo p$yJlbraraM gKcIreprLI3bI I
JreKapcrBeHHhrx cpeAcrB KaqecrBa neKapcrBeHHbD( cpeAcrB


flpnnoxeHrle:Ha 3 n.s 1 srg.

Bpzo pyroBoAr,IreJrfl [.B. IIapxoMeHKo

f.B. fauuoqxa 849957801 87 flpuroxeuue K rncbMy Poc:4panHa4 sopa oro3. 08, lA6 Nn 4Nq 89- cBer€Ens o noraspcme[gLll clr€rcrBaxr to per:tnlTrra 3rnqhxtfr nqacrBr KompHr poqnpmnqqropou nprErm pcEesre o c]oorBcrcrBr[ rx KtqecrBr HOBJIE|lHbIM HaHMeHosaHHe opfaHr,r3aur{H, Houep sa4aHilfl npeAcraB[Burefi o6pa3qbr Jlerapcraeu Hoe cpe.qcrBo flpousaogurelr Crpana np-Ba Sncnepruar opraHH3auHt Ceprar.r JreKapcTBeHHbrx cpeAcTB Np04V-1304112 KO|EY3 "Knponcruft Acrop6r.rHoBaff Kr.tcJrora .4parxe OA0 "Map6noQapu" Poccr,rx (DfEy "HMU3yAOCMII" 260312 or 27.12.2012 po4nlrHufi Aol,t Nsl" 50ur 200nrr.,6aHKu PocsgpaaHa4sopa (Kamucrufi (yn.SHrenrc a, g.24, r. Knpon, nonHMepHbre Qnru.ral) Kr.rposcrar o6nacrs) Np04V-1304/12 An'rera MEY3 "A6gylllucrar @ypaqr.rrun ra6t. g/npuror. p- OAO "Hp6r.rrcxnfi or 27.12.2012 PoccHq ofBy "IIMIISyAOCMII" 2271012 I{PB" (yl.CoBercKar, 4. I 83, pa AJrr MecTHOTO H Hapy)KHoro x(D3, Poc:4paoHagsopa (KasaHcrnfi r.A64ylnuo, Opeu6yprcrcar npuMeHeHr.rc 20lrr Nol0 (yn.
Sr,mr,rar) o6racrr) 6esrcq. xoHr.) Ng04H-1304/12 Anrera MAy3 "fB Ns3" AreHolol ra6lerru 50un 3A0 "(DapunpoeKT"
or27.12.2012 Poccur ofEy "I,iMUSyAOCMn" r03t2 fin.Horoo.l6npcrar,,q. I I 9, I 0rur., ynaKoBKr,r cqefi Komre Pocsgpan uagsopa (KasaHcrnfi n.Opcr, Open6yprcxar o6lacrr) KoHTypHbre (3), nav. rapr.
Qnnrnal) Ns04V-1304112 OOO "CeneHa" (l-uft Eofinufi @ypaqnnnn ra6n. glnpuror. p- 0AO "l4p6r,rrcrnfi or 27.12.2012 Poccnr ofEy "I4MIISyAOCMII' 601l3 nep., 9.9, r.[epur, flepucxnfi pa Mfl MeCTHOTO H HapyxGoro x(D3"
Poca4paaHag:opa (Kasaucxr.r ft Kpafi) rrpr{MeHeHn s 20ur No I 0 (yn.
Sn-rrnal) 6esrsq. rcoHr.) Ns0414-1304112 OKY I,IK-3 yOCIIH Poccr,rn no Pesn'r Apare Nsl00, 6aHrul OAO "Map6uoQaprr,r"
w27.12.2012 Poccnr aI'Ey "HMIISyAOCMII" r0l r0l2 PM3 (yl.Me4ae4eaa, g. l, noruuepHue* Pocs4parHa4sopa (Ka:aHcxr.rfi n.Megre4eno, Pecrryr6lura Qnnr,ral) Mapnfi 3.rr) Ns 04kI-1304/12 fEY PM3 "Crauqul cropofi MarHuq cynr$ar pacrBop Ant OryfI "Apuannpcxar or27.12.2012 Poccuq ofBy "HMII3yAOCMII" 39ttt2 MeAr,rqnHcKofi nonaoruu n/r ane4euus 25Onrr/nrn l0un, 6uorornqecras Poc:4panHa4aopa (Ka:aHcrr.rft r.iiorurap-Ona" aMnyJrbr (10), nav. r Qa6pnra" tlr.rnr.ral) (yl.O.Tnxouupoeofi , g.58, r. fi ournap-O.na, Pecrry6lnrca Maprafi 3n) Ns04V-1304/12 I-EY3 PM "Kovryponcxar L{PE" AHalrruu pacrBop plt t/s n or27.12.2012 (yl.Jlecuar, 4. l, c.Kovrypono, OAO "Eopr.rcoscrnft Pecny6nuxa ofBy ,HMIISyAOCMII" 2340812 n/u rne4eHu n, 2ut 500ur/un, 3aBOA Eenapycr Pocs4parHa4sopa (KaraHcrcr.rft Pecnyblurca Mop4orr.rx) aMnyJrrr (10), na.r. rcapr. ue4npenaparon"
Qr.rnuar) Ns04W-1304/12 Anrera I,III Ceperana f.A. Yrolr aKrnBr.rpoBanuufi -YE@ OAO "Vpal6uoQaprra" Poccnr ofBy "HMIISyAOCM|I" 1920812 or27.12.2012 (yr.Kpacnoapueft crcar, l.l2l, 'ra6rerxn 250Mr Nsl0, Pocsqpan uagsopa (Kasancrnfi r.Cauapa, Cauapcraa o6nacrs) ynaKoBKr.r 6esrsqefi rcosHe Snnual) KOHTypHbre Ns04V-1304/12 OOO "BMcepBrc" (yn.IOxnrrfi Megarou pacrBop AJrf, OOO "OnurHsrft Vxpanua @fEy "I4MIISyAOCMII" 50712 or27.12.2012 rpoe3A, 9.224, r.Cauapa, nurercqnft l0ur/ul lrul, rarog "fHLpIC" Pocs4paaxagropa (Karaxcrcufi Carraapcrar o6nacru) aMrynbr (10), nav. xapr.
Sl,rrInan) Ns04V-1304/12 AII OOO "Apreu-555" @ypaquuH ra6n. g/npuror. p- OAO "Hp6r.rrcrcnft Poccur (DI-By "HMq3yAOCM[I" I t0l l3 or27.12.2012 (yr. urra.rlanaena B.I4., 1,.99 / 109, pa AJrr MecTHOTO H Hapy)rGoro xo3" Pocs4par Ha4:opa (Ka:aHc rcr.r fi r.Caparon, Caparoncrar t 20vr No 1 0 (yn.
npr.rMeHeHrd Qnrna.n) o6nacrr) 6egrrq. ronr.) Ns04V-1304/12 AII OOO "Apreu-555" Xo$nron rablerrn n/o | 80rur., Jla6oparopnr Posa- @paHqr,rr orBy "HMIISyAOCMII" vl\ I164 or 27.122012 (yn.r.rnr.tlanaera B.H., t.99 I 109, ry6u nolunponHrreHoBbre (l ), Ouro$apnaa Pocsgpanua4sopa (Kasancrnft r.Capa'ron, Caparoncrcar naq. KapT.
Qnrua.n) o6rac'm) Np04V-1304112 OOO "AEEar M" XoSr,rron ra6lerrn n/o 30nrr., Jla6oparopnu Po:a- @paHqur (DfEy "HMIISyAOCMII" \-rN I150 or 27.122012 (yn.AcrpaxaHcKaq, p,.l 40, 6rncrepu (2), nav. rcapr. Or.rrcQapnaa Pocr4panHagropa (KasaHcrnft r.Caparon, Caparoecxar Qnnuan) o6rac'rr) Ns04V-1304/12 OOO'AEEar M" fexcopal ra6c ra6lerKu Ant 3on bAAH fepnrauur ofBy "I,IMII9yAOCMII" 2t00164 or 27.12.2012 (yr.Ac'rpaxaHcKun, a. I 40, paccacbrBaHnr J,,1b20, ynaKoBKn Xol1uun*Eos6oscne Poc4panHagropa (Ka":aucruft r.Caparor, CaparoBcxat tqeftronue KoHTypHbre, naq. qnanr,rrereH fu6X Sriruair) o6nacrr) Kapr.
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Министерство здравоохранения Российской Федерации
ФЕДЕРАЛЬНАЯ СЛУЖБА ПО НАДЗОРУ В СФЕРЕ ЗДРАВООХРАНЕНИЯ (РОСЗДРАВНАДЗОР)
Славянская пл. 4, стр. 1, Москва, 109074 Телефон: (495) 698 45 38; 698 15 74
Od. £073 № Og tt -é 99/3
На №

Решение по результатам экспертизы |
качества лекарственных средств


Руководителям организаций- производителей лекарственных средств
Руководителям организаций- импортеров лекарственных средств
Субъектам обращения 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 3 л.в 1 экз.

Врио руководителя
Г.В. Ганночка 84995780187
Д.В. Пархоменко

Скачать документ: Письмо 02И-899/13 от 08.08.2013

Информационные письма Росздравнадзора по контролю качества: Лекарственные средства

Информационные письма Росздравнадзора по контролю качества: Медицинские изделия

   

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