РОСЗДРАВНАДЗОР Информационное письмо № 16И-838/13 от 30.07.2013
РОСЗДРАВНАДЗОР Информационное письмо № 16И-838/13 от 30.07.2013
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-838/13 от 30.07.2013
Решение по результатам экспертизы качества лекарственных средств
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4. I 9,
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OAO "l,Ip6ntcxnil
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ofEy "pIMIISyAOCMII"
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o6nacrs)
Np04Id-1304112 Anrera OOO "Spectra-A"
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or 27.12.2012
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3AO "Me.qucop6"
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or 27.12.2012
MY|I
CyaucJraBcKoro pafi oHa
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ofBy "l4Mu3yAocMf["
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or 27.12.2012
MYn
CygrdcJraBcKoro pafi oHa
"AnreKa N913"
(yr.Korvrcorvrolrcrar,
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c.Pox,qec'rseHcKoe,
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ra6rerru
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ofEy "pIMIISyAOCMII"
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rrr. KoHT. (6), na.r. rapr.
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o6nacrs)
Np04Id-1304112 Anrera OOO "Spectra-A"
or27.12.2012
Ns04V-1304/12
or 27.12.2012
(yr.Bono4apcroro, A.39,
r.Illagpr,rHcr, Kypraucrar
o6nacm)
Anrexa OOO "Spectra-A"
(yn.Bono4apcroro, 4.39,
r.[Iagpuucr, Kypraucraa
o6racrr)
Aqernrcaruql,IJloBat KI,IcJIora
MC ra6rerxra 500ur l0rur.,
3AO "Me.qucop6"
PoccHq
ofEy "HMuSyAOCMII"
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Pocs4panua4sopa (SnnrEan
ropoAa Erarepr.ru6ypra)
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Vp'Ann
ofEy "I,IMUSyAOCMII"
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rcpoAa Erarepr.ru6ypna)
8202335
Ng04V-1304/12
or 27.12.2012
Anrera OOO "Spectra-A"
$r.Boloaapcrcoro, 4.39,
r.
[Ila4pr.rHcr, KyPraHcrcar
HurporcoruH ra6lerrn n/o
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sqefirosrle rouryPnue)
)AO "Hp6urcrufi
fru4ua6@ Mtt raon. c
OAO ''XOK
PoccnR
or27.12.2012
Anrerca OOO "KanaeHcKat
anreKa" (yl.Alrorr,ruHneraR,
.q.
1
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Anrerca
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lOur., yn. tq. roHr. (6), nav.
MVII "Anrera Nsl58
ropoAa ErarepraH6YPra)
6ur',
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MO r.Karvreucr-VPalrcruil"
(yr.CnHapcKat, 9.5, r.KaueHcx- KoHTypHbIe (10), nau. raP'r.
Vpa:rscru.I fi , C repglorcrcar
o6racrr)
Eucarcoaul ra6lerru
Ns04V-1304112 Anrexa MYII "Anrera Nsl58
noKpblTble KltIX.-pacrBMO r.KarraeHcx-VPalrcrufi "
or 27.12.2012
o6oro.{roft 5ur 30urr., yn. sq.
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r.Karvrencr5,
(yn.Cr.IHapcKal,
or 27.12.2012
Vparucrnft , CnePgloncrar
Poccus
"AKpHxnH"
or 27.12.2012
Anrerca MYII "AilreKa Ns158
MO r.Karr,reucr-YPalrcnaft "
flrusa Kparoa,
florsrua
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04H-1304/12
gasoa A.O.
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or 27.12.2012
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ft
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KOHT., nar{. KapT'
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"Hosocld6xnuQaPu"
Poccuq
ofBy "I4MIISyAOCMn'
Pocs.qpauHa4sopa
73ll12
($uldan
ropoAa ExareprlH6YPra)
Maruur cynrt[ar PacrBoP Anq
OryfI
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ofEy "lIMuSyAocMfI"
300412
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ropoAa Erarepr.r u6YPra)
Poccnr
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320812
(t[r'rlnal
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Qa6purca"
, CneP4loncrar
o6nac'rr)
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ofBy "I4MII3yAOCMil"
PocrgpanHagsoPa (r[ralnan
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H[rornHosat KI,IcJIora PacrBoP OAO "MocxuuQaPuAn'rera MYII "AnteKa Nsl58
npenapatrt"
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MO r.Karvreucx-YPalrcrnfi "
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MO r.Karvreucr-VPalrcrufi "
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ofEy "I4MUSyAOCMII"
Pocs4panHa4:opa (Qulnan
KapT.
facran@ ra6lemu
341212
Pocs4pae Ha4ropa ($lrn r'Ian
KO3"
o6nacru)
Ns0414-1304/12
ofEy "l4MUSyAOCMfl"
OOO "Mex6oJIbHlIr{Hat anreKa" Auorccuqullus ra6lerrcrl
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(yr.flenyrarc rcas, A.129 | 9,
qqefirosrte rcoHryPHue (2),
r.TronaeHr. TrcrrleHcxas o6nacrr)
naq. Kapr.
OAO "EuoxlIMI,IK'
PoccHq
ofEy "I,IMqSyAocMn'
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(t[nluan
ropoAa ErarePun6YPra)
210313
lle 04H-1304/12
or27]2.2012
ra6lerrn n/o
OOO (HI4KA-OAPM)
(yr.Eaxoea, A.77, r. CYPryr'
HnrporconuH
Xasru-Mascuftcrnfi
rqefiroeue roHryPusle)
50rrrr Ns50 (ynarourn
Poccnq
CAO "I4p6r.lrcrufi
or 27.12.2012
OOO (HI4KA-OAPM)
(yn.Eaxoea, A.17, r. CYPTYT'
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OAO "EttocLIHTe3rr
or 27.12.2012
OOO (HI4KA-OAPM)
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aMryJIbI (10), nau. raPr.
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or27.12.2012
4.4, r.Cypryr, XaursI-
Ns0414-1304/12
or27.12.2012
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3AO "flOK
nHrexquft I 00ur/nan 2n'r4
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IlnAorcann pacrBop Ant
OAO "EuocI'IHTe3"
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orPYr
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OOO "AorycruHa"
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(yn.flpn norcsalruar, .4.4B,
r.Cypryr, Xanru-Mascuft crufi aMnyJrbl (10), nau. raPr.
Ne04V-1304/12
OOO "Arrycrl'lHa"
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or 21.12.2012
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r.Cypryr, Xas'ru-MaHcnft crnil
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10rur., yn. tq. ron'r. (5), nav.
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(Qnlnal
ofBy "I4MUSyAOCMII"
681212
PocrgpanuagroPa (Quluan
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orEy "I4MIISyAOCMII"
Pocsgpanua4soPa
"O6HoBreHue"
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ropoAa ErarepuH6YPra)
OAO "Vpa.n6uoSaPu"
PoccHq
ofBy "I4MIISyAOCMII"
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aMnynbl (10), uau. raPr.
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ropoAa ErarePr'rH6YPra)
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ofEy "l,lMII3yAOCMil"
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"
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(yr.Aspot[notcxafl, 4.5,
or 27.12.2012
rarepr'tr6YPra)
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OAO "OapnacraHAaprVrfaBHTA"
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Pocs4panuaq:oPa (Qranraan
aBroHoMHbIft orPYr-tOrPa)
Ns0411.-1304/12
33ltlz
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xo3'
aBroHoMHbIft orPYr-tOrPa)
Ns 04H-1304/12
orBy "l4MII3yAOCMfl"
3AO "Me4ncoP6"
Poccfiq
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PocsApasHaAsoPa (Qmnan
ropoAa ErarepnH6YPra)
0707201r
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coorBercrBvrv ycraHoBJreHHbIM Tpe6oBaHutM KaqecrBa neKapcrBeHHblx nepequcJleHHblx B npuno)KeHI'IU.
flpuroxeHl4e:Ha 3 n.s 1 erg.
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f.B. laHHo.{ra 84995780187 flpuroxeHne K rncbMy Pocsspanuas zopa or 30 - O/.J0/3'$ /6a - {3 f,r',
CBelerfm o nerrpcrEeE||fIl qrelcrra& ||o paoynLTsrtir ntqgcrBt Fompur PoctIptEftAtopoM npttaro paueE e o ooortercrafn xt klqecraN '|acteprtLtHOBJIEHHbIM HaulreHosaHne opraHu3aunn, Horvrep 3a4aHlz.n [peAcraB r,rB ureft o6par qsr JlercapcreeHHoe cpeAcrBo flpousro,4nrenu Crpaua np-Ba 3xcnepruar opraHI,I3aIInt Cepr.rr.r
JIEKADCTBCHHbIX CDEACTB Ne04Id-1304112 MYfI Cy.qncJlaBcKoro pafi oua AHanrrnu ra6rerrn 500ur OAO "Hp6r.rrcruil Poccnq ofEy "HMIISyAOCMfI" 301l3 or 27.12.2012 "AnreKa Nsl3" J'{!10, ynaronnn xo3" Poc:gpannagropa (Quluan (yn. Korvrcorr,rorrcrar, 4. I 9, 6e:rrqeft roBue KoHTypHbte ropoAa Erarepr.rHdypra) n.Cy4uclaur, Kocrpoucrar o6nacru) Np04V-1304/12 MY|I CyaucJraBcKoro pafi oHa Aesur Ka[cyJrbr I Ourr., OOO "Jltotul.t" Poccnr ofBy "l4Mu3yAocMf[" 34tl12 or 27.12.2012 "AnreKa Nsl3" y[aKoBKn rqeftrcoeHe PocsAparHaAsopa ($nluan (yn.Korvrcorvrorscrar, g. I 9, KoHTypHbre ropoAa Erarepun6ypra) n.CyAuclaus, Koctpoucxar o6mcrs) Ns04A-1304/12 MYn CygrdcJraBcKoro pafi oHa BarnAor c rruorcogofi ra6rerrn OAO "(DapucraHAapr- Poccnr ofBy "I,IMII3yAOCMII" 270912 or 27.12.2012 "AnreKa N913" noAbr3brqHsle lOrur., yn. tq. JIercpe4crna" Pocsgpanuagsopa ({ulnal (yr.Korvrcorvrolrcrar, 4. I 9, KOHT. ropoAa ErarepnH6ypra) n.Cygnclaers, Kocrpoucrar o6racrs) Ns04Id-1304112 O|EY3 "Por(AecrseHcKac flaHrcpearuu ra6rerru OAO "l,Ip6ntcxnil PoccHq ofEy "pIMIISyAOCMII" r29l2t2 or27.12.2012 flacrKoBat 6orsHlrqa" noKpbrTble KHIII.-paCTB. xo3" PocsgpanHagropa (Qnruar (yr.Coeercrcaa, 9.8, o6oroqxoft 25E,{ lOurr., yn. ropoAa ErarepNn6ypra) c.Pox,qec'rseHcKoe, rrr. KoHT. (6), na.r. rapr.
lllapsraHcrufi p-u, Kocrpoucnar o6nacrs) Np04Id-1304112 Anrera OOO "Spectra-A" Aqernrcaruql,IJloBat KI,IcJIora 3AO "Me.qucop6" PoccHq ofEy "HMuSyAOCMII" 006012013 or27.12.2012 (yr.Bono4apcroro, A.39, MC ra6rerxra 500ur l0rur., Pocs4panua4sopa (SnnrEan r.Illagpr,rHcr, Kypraucrar y[aKoBKr{ 6egrrqeft xosste ropoAa Erarepr.ru6ypra) o6nacm) KOHTypHbIe Ns04V-1304/12 Anrexa OOO "Spectra-A" Keropon@ ra6n. n/n/o l0ltr {-p Pe.q,(r'c Vp'Ann ofEy "I,IMUSyAOCMII" 8202335 or 27.12.2012 (yn.Bono4apcroro, 4.39, 10rur.o yil. rq. roHr. (2), [ar{K}l Ila6oparopnc JIr4 Poe4paena.qropa ($r.uuan r.[Iagpuucr, Kypraucraa KapToHHhre rcpoAa Erarepr.ru6ypna) o6racrr) HurporcoruH ra6lerrn n/o )AO "Hp6urcrufi PoccnR ofEy "l4MUSyAOCMfl" 341212 Ng04V-1304/12 Anrera OOO "Spectra-A"
KO3" Pocs4pae Ha4ropa ($lrn r'Ian 50rrrr Ns50 (ynaroern or 27.12.2012 $r.Boloaapcrcoro, 4.39, ropoAa ErarepraH6YPra) r. [Ila4pr.rHcr, KyPraHcrcar sqefirosrle rouryPnue) o6nacru) OAO ''XOK Poccus ofEy "I4MUSyAOCMII" l0l l3 Ns0414-1304/12 Anrerca OOO "KanaeHcKat fru4ua6@ Mtt raon. c sstcso6. 3 0M r "AKpHxnH" Pocs4panHa4:opa (Qulnan or27.12.2012 anreKa" (yl.Alrorr,ruHneraR, .q. 1 3' r'ao4nor.rqr.rp.
ropoAa Erarepr,rH6YPra) r.Kauescx-Vpaltcruft, lOur., yn. tq. roHr. (6), nav.
CnepAroecrar o6lacrr) KapT.
facran@ ra6lemu 6ur', flrusa Kparoa, florsrua ofEy "I4MII3yAOCM[[' 14169712 Irb 04H-1304/12 Anrerca MVII "Anrera Nsl58 (Dapruaqenru'Iecrnfi Pocs.qpan ua4sopa (rf ral nal or 27.12.2012 MO r.Karvreucr-VPalrcruil" ynaKoBKlr rqeilKosrle gasoa A.O. ropoAa Erarepr.r H6YPra) (yr.CnHapcKat, 9.5, r.KaueHcx- KoHTypHbIe (10), nau. raP'r.
Vpa:rscru.I fi , C repglorcrcar o6racrr) borrapl,Ifl ofBy "I4MII3yAOCMil" 2248rr Ns04V-1304112 Anrexa MYII "Anrera Nsl58 Eucarcoaul ra6lerru EanrcaHQapua- PocrgpanHagsoPa (r[ralnan or 27.12.2012 MO r.KarraeHcx-VPalrcrufi " noKpblTble KltIX.-pacrB- flynHr,rqa A[
ropoAa ErcarePnn6YPra) (yn.Cr.IHapcKal, g. 5, r.Karvrencr- o6oro.{roft 5ur 30urr., yn. sq.
Vparucrnft , CnePgloncrar KOHT., nar{. KapT'
o6nacrr) oAo Poccuq ofBy "I4MIISyAOCMn' 73ll12 Ns 04H-1304/12 Anrerca MYII "AilreKa Ns158 JlugorauH pacrBop AJlfl Pocs.qpauHa4sopa ($uldan or 27.12.2012 MO r.Karr,reucr-YPalrcnaft " nsrexltnft 20urlut2un, "Hosocld6xnuQaPu"
ropoAa ExareprlH6YPra) (yr.CuxapcKat, 4.5, r.Kaueucx- aMryJIbI (10), nav. raPr.
Ypanrcrrafi , CreP4lorcxar o6nac'rs) H[rornHosat KI,IcJIora PacrBoP OAO "MocxuuQaPu- Poccnr ofEy "lIMuSyAocMfI" 300412 Np0414-1304/12 An'rera MYII "AnteKa Nsl58 Pocs,qparHa,q:oPa (<[rmnal or27.12.2012 MO r.Karvreucx-YPalrcrnfi " Am lIHbeKIInft lOur/ul lrul, npenapatrt"
uu.H.A.Ceuaumo ropoAa Erarepr.r u6YPra) (yn.CnuapcKat, A. 5, r.Kaueucx- aMnynbl (10), nauxn Ypamcxnfi , CreP4noncrar KapToHHbIe o6rac'ru) Maruur cynrt[ar PacrBoP Anq OryfI "AptuarnPcrcar Poccnr ofEy "I4MUSyAOCMf[" 320812 J\b 04H-1304/12 Anrera MYII "Anrera Nsl58 6nororuqecrcar PocsgpaoHagsoPa (t[r'rlnal or 27.12.2012 MO r.Karvreucr-VPalrcrufi " s/s sseAeHur 25Orrar/rr'u I Orr'rn, ropoAa Erarepr.ln6YPra) (yn.Cr,rHapcxat, A.5, n.Kauencr- aMryJIbI (10), nau. raPr. Qa6purca"
Ypamcrcu ft , CneP4loncrar o6nac'rr) OAO "EuoxlIMI,IK' PoccHq ofEy "I,IMqSyAocMn' 210313 J\e 04H-1304/12 OOO "Mex6oJIbHlIr{Hat anreKa" Auorccuqullus ra6lerrcrl Pocs4panuageopa (t[nluan ot27.12.2012 (yr.flenyrarc rcas, A.129 | 9, 500l,rr 10rur., YnaKoBKn qqefirosrte rcoHryPHue (2), ropoAa ErarePun6YPra) r.TronaeHr. TrcrrleHcxas o6nacrr) naq. Kapr.
CAO "I4p6r.lrcrufi Poccnq orBy "l4MII3yAOCMfl" 33ltlz lle 04H-1304/12 OOO (HI4KA-OAPM) HnrporconuH ra6lerrn n/o xo3' Pocs4panuagsoPa (Qr'rnuan or27]2.2012 (yr.Eaxoea, A.77, r. CYPryr' 50rrrr Ns50 (ynarourn ropoAa E rarepr'tr6YPra) Xasru-Mascuftcrnfi rqefiroeue roHryPusle) aBroHoMHbIft orPYr-tOrPa) Poccur ofEy "l4MIISyAOCMtl', 68r2r2 Jh.rAorcaus pacrBop Anfl OAO "EttocLIHTe3rr Ns 04H-1304/12 OOO (HI4KA-OAPM) Pocs4panuaq:oPa (Qranraan or 27.12.2012 (yn.Eaxoea, A.17, r. CYPTYT' uHterquft 20t'lr/ul 2u;t, ropoAa Exarepnn6YPra) Xanru-Mancnficrnfi aMryJIbI (10), nau. raPr.
aBroHoMHbIft orPYr-tOrPa) Acropyruu ra6lerra 5utrr.' OAO "OapnacraHAapr- Poccuc ofEy "l,lMII3yAOCMil" 761212 Ns0411.-1304/12 OOO (HI4KA-OAPM) Pocs4paeHaAsoPa ($rallran (yn.Baxoea, A.17, r. CYPryr, 6aunil noiII{MePHble VrfaBHTA"
or 27.12.2012 ropoAa Erarepran6YPra) XaHru-MaHcnftcrnfi aBroHoMHbtfi orPYr-IOrPa) JlnAorans 6yQYc PacrBoP Ant 3AO "flOK Poccnr ofEy "I4MUSyAOCM[[" 10113 Ng04V-1304112 OOO <.{orrop> Pocs.qpas Ha,4soPa (Qnlnal (yr.Aspot[notcxafl, 4.5, nHrexquft I 00ur/nan 2n'r4 "O6HoBreHne"
or 27.12.2012 ropoAa ErarePr'rH6YPra) r.Cypryr, Xarnu-Maucufi crnfi aMnynbl (10), nau. raPr.
aBroHoMHbIfi orPYr-tOrPa) IlnAorcann pacrBop Ant OAO "EuocI'IHTe3" Pocclrq ofBy "I4MUSyAOCMII" 681212 Ns04V-1304112 OOO <[orroP> (Yn.fY6rcuHa, PocrgpanuagroPa (Quluan or27.12.2012 4.4, r.Cypryr, XaursI- nntexuufi 20nar/ul2ul, rcpoAa Erareplr n6YPra) MaHcufi crnft asroHollHufi orPYr aMryJIbI (10), nau. raPr.
IOrpa) JluAorauu 6y0yc PacrBoP Anfl 3AO "ftOK t'occut orEy "I4MIISyAOCMII" 70912 Ns0414-1304/12 OOO "AorycruHa"
"O6HoBreHue" Pocsgpanua4soPa (Smnal or27.12.2012 (yn.flpn norcsalruar, .4.4B, unterunfi I O0trlr/ul 2rvr.n, ropoAa ErarepuH6YPra) r.Cypryr, Xanru-Mascuft crufi aMnyJrbl (10), nau. raPr.
aBroHoMHbIil orcPYr-IOrPa) OAO "Vpa.n6uoSaPu" PoccHq ofBy "I4MIISyAOCMII" 74tl12 Ne04V-1304/12 OOO "Arrycrl'lHa" IleHrai[nyuu n@ rPaHYlrt PocgApasHaAsoPa ( aBroHoMHbIil orcPYr-IOrPa) N'TTK'I KANTOHHbIC oAo Poccrq ofEy "HMIISyAOCMII" 78ll12 Ns04V-1304112 OOO "Anrycruna" JlnAoxauu pacrBop Ant " PocsgpanHagsoPa (t[unnal or 21.12.2012 $n.Ilpr,rror: a:lrsuax, P,.48, unrerunfi 2Our/un 2ul, " Hosoc u6xu tr,l SaP rvr ropoAa ExarePnn6YPra) r.Cypryr, Xas'ru-MaHcnft crnil aMnynbl (10), uau. raPr.
aBroHoMHbtft orcPYr-[OrPa) AuanpulI,IH rablerru 40tur 3AO "Me4ncoP6" Poccfiq ofBy "LIMqSyAocMfI' 0707201r Ns 04H-1304/12 OOO "PraSapu-M"
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or 27.12.2012 ropoAa Erarepran6YPra) XaHru-MaHcnftcrnfi aBroHoMHbtfi orPYr-IOrPa) JlnAorans 6yQYc PacrBoP Ant 3AO "flOK Poccnr ofEy "I4MUSyAOCM[[" 10113 Ng04V-1304112 OOO <.{orrop> Pocs.qpas Ha,4soPa (Qnlnal (yr.Aspot[notcxafl, 4.5, nHrexquft I 00ur/nan 2n'r4 "O6HoBreHne"
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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
30.07. £018 № 6-538 [3
Ha No OT
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 7
Г.В. Ганночка 84995780187
М.А. Мурашко
ФЕДЕРАЛЬНАЯ СЛУЖБА ПО НАДЗОРУ В СФЕРЕ ЗДРАВООХРАНЕНИЯ (РОСЗДРАВНАДЗОР)
Славянская пл. 4, стр. 1, Москва, 109074 Телефон: (495) 698 45 38; 698 15 74
30.07. £018 № 6-538 [3
Ha No OT
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 7
Г.В. Ганночка 84995780187
М.А. Мурашко
Скачать документ: Письмо 16И-838/13 от 30.07.2013
Информационные письма Росздравнадзора по контролю качества: Лекарственные средства
Информационные письма Росздравнадзора по контролю качества: Медицинские изделия
