РОСЗДРАВНАДЗОР Информационное письмо № 16И-244/13 от 13.03.2013


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 № 16И-244/13 от 13.03.2013

Решение по результатам экспертизы качества лекарственных средств

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lrb 0414-1401/11 Anrera OOO "I{ennrell-Oapu" r{nrPaMoH rt TaoJIeTKH lUIIIT., OAO "Ypal6no$apu" Poccl,rx ofEy "HMLISyAOCMII"
or 30.12.2011; (yn.flpoernr an, 4.2r', r..{ep6eHr, 910412 )maKoBKx 6egrsqefi rosue Pocs4paruagsopa Ng04VI-221/12 Pecny6luxa.{arecmn) xonr5pnue* or29.03.2012 (fy4eprvreccrnfi Qunual) llb 0414-1401/l I Arr uuu "Jleqe6Ho- Au4unal ra6nerxu J\blO OOO "Ac$apua" Poccra.r otEy "pIMuSyAOCMrI'
or 30.12.2011; Al,rarHocrnrrecrnfi u (ynaxonxr,r 6esrrqeft xoeHe 210312 Ns04VI-22ll12 PocsgpaaHaAgopa o3AopoBr{TeJrsHrrfi qenrp" roHrypnue)* or29.03.2012 (yn.Maxauranr{HcKoe n., p.29 (fy4epueccrcnft Snnr.ran) 4 r. Xacanrcpr, Pecny6lnra
[arecran) Ns04V-1401/l AfI OOO "JIeqe6Ho- r{IrlpaMoH Il TaonsrKx l0rnr., OAO "Vpal6r.lo$apu" PoccH.s oI-Ey "I,1MII3yAOCM[I"
cr 30.12.2011: AnarHocrltrtecxufi u 910412 )rnaroBKn 6egtcqefi rorHe Pocs4paruaAsopa Ne04V-22U12 o3AopoBnTenrHuft qeHrp" roHr5pnue* n29.03.2012 (yl.Maxa.rraJrr,rHcKoe ru., a.Z9a, [fy4eprraeccror 30.12.2011: nnr.P.flAcxepxauoBa" (ynaroaru 6egrrqefi rosHe 370412 Ns04V-221/12 (yr.Anr.rena" 4.2 l, r.XacaBropr, Poce4parHa4sopa roHrypHue)* or29.03.2012 Pecny6luxa {arecrau) (fyaeprtaeccrcnfi Qunzan)

Irb 0414-1401/l I fEY3 P{ "fyHH6cKar IIPE, Keropol@ pacrBop 1trt r,lu or 30.12.201l; .{-p PegAn'c Vl/,tus (DfEy ,I,IMII3yAOCMII' A1660 (c.fynn6, fyHu6crr.rft p-n, BBeAeHnr, Ina.n 30rrrr/rr,rn NsI0 Jla6oparopnc JIr4 Pocs4parnagsopa Ns04h-22lll2 Pecrry6marca ,{arecrau) (alanynu reMHoro creKra)* w29.03.2012 (fy4epueccxuia Qwman) 0414-1401/ll OOO "Ac-npecrr4x" Augnnal ra6rerxr.r Ne I 0 OOO "AcQapua" Pocclrs ofBy "l4MqSyAocMfI"
30.r2.20n; (np.l{.IIIala utn, p,.5 4, 92r010 (ynaronxn 6egrsqefi KosHe Poccgpanna4sopa 04u-221/12 r. Maxaqra.na, Pecrry6lnra rcoHrypuue)* (fygepil{eccru fi Qram.ran) 29.03.2012 {arecraH) Ils 0414-1401/l l Anrexa lIfI Ogaoesa M.B. I{rarpauon fI radnerKn lOur., 3AO "nOK PoccH.fl ofEy "I4MUSyAOCMII' 670712 or 30.12.2011; (yl.Mynanu eea, 6/ u, r.Haspanr, JmaKoBKn 6esrx.{eft xosrre "O6HosreHuett PocsgpaaHa4ropa Ns04V-221/12 Pecny6nuxa l4uryruerur) rcoHqipHue* (fygeprvrecc rcnfi Qunuaa) or29.03.2012 Ns 04H-l40Ul I Anrexa HfI llnuesa X.X. I{nrpauou fI ra6lerrN 6mr., OAO "@apnrcraHlapr- PoccHs ofEy "I4MIISyAOCMII" 40112 or 30.12.2011; (yl.flanea4 4.1, r.HalpaHr, ynaKoBKr.r 6esrrqefi xosHe ToucmrnuQapu" Pocs4panua4sopa Np04U-221/12 Pecrry6nr.rrca Hnryruernr) rourypnue* (fy4epnreccrcnfi Srannan) or29.03.2012 Ns 04H-1401/l I HfI Aupnena M.X. tlr,rrpaMoH ll raOnerxr,r l0rur., 3AO "nOK Pocct.rs ofEy "HMII3yAOCMI" 7107t2 or 30.12.2011; (yn.Bucanrova,6/u, y[aKoBKH 6eslrqeft ronHe ttO6HoBreHHe"
Pocs4panHa4sopa Ns 04LI-221/12 cr.Op4xoHuKrq3eBcKar, rourypHue* or 29.03.2012 Cyuxeucrnfi p-u, Pecny6ru.rra ify4epueccrnft $unuan) llnryrue'rur) Ne 04H-l40Ul I Anrerca I,I[I Apvarosa 3.M. AH4nnal ra6nerrul .Jtlb I 0 OOO "AcQapnaa" Poccl,rs ofEy "I4MII3yAOCMII"
or 30.12.2011; (yr.tDa6pn.r rran, g.l, r.Haspanr, 15021 I ynaKoBKH 6esrqqefi KosHe Ns04H-221/12 PocsgparHa4sopa Pecny6nnxa l4Hryurernr) courypnue)* (fyaeprtreccxr.rfi {nnaa:r) or 29.03.2012 Ns 04n-1401/l I MY3 "Aqxofi -Map.rauorcxar JlraHrouuqnH pacrBop plrr-v/s u OAO "Eopucoscruft Pecny6lura (DfBy "I4MIISyAOCMII" 9l l0l I or 30.12.201I: I{PE" (yn.Ilaulora, 4. I 8, r/nr nnegennr, lul 300nr/nan 3aBoA Beaapycr PocsgparHagsopa Ns 04Vl-221/12 c.Aqxofi -Maprau, tleveHcxa.r Nel0 (arranynu)* nae4npenaparot" (fy4epueccxnft Qunr.ran) or29.03.2012 Pecny6nr.rxa) Ns 04l,t-1401l11 OOO ".{ena -62" $r n.Jlu6rHexra, Au4nnan ra6nerrfi NsIO OOO "Ac$apva Poccnr (DfEy "LIMIISyAOCMn' 30212 or 30.12.2011; 9.5, r.fposHsrfi, geveucrar (ynarorrcu 6esrrqefi rosHe Ng04V-221/12 Pocs4parHa4aopa Pecny6lrara) rourypHue)* or29.03.2012 (fy4eprvreccxuft Surllral)
Ns04Id-1401/ll fEV "Pecny6lnrascnnft JluHxounqnH pacrBop psltr als OAO "tiopucoscrllft Pecrry6nnra ofBy "HMUSyAOCMII" 103101 I or 30.12.2011; KrrdHr,rqecKr.rfi qeurp oxpaHbr r/u enegennr, lul 300ur/un 3aBOA Ee-rrapycr Pocs4paeua4sopa Ns 04pl-221/12 3AopoBbr Marepn u pe6eura Nol0 (arranynsr)* ue4npenaparon"
or 29.03.2012 (fygepueccrcnft Qunr.ral) nu.A.Ka4upoooft " r.fposHoro (yl.Jlopcanota, 4. l, r.fposHuft, t{eqeucrcar Pecny6lr.rra)
Ile 04H-1401/11 OOO "Me4r:exSapu" -bpoMreKcHH Hnroueg pacrBop or 30.12.2011; (yr.Trepcrar, A.24, r.fpoeHnfi , Anr npneMa BHyrpb, l50rr,rn Hnrorraeg,{aunr AnC [auut ofEy "l4Mu3yAocMfl" 106715r9 t{eqescrar Pecny6nr.rrca) Pocsgpaauagsopa NsO4II-22U12 0.8rvr/un No I (Saaxourr (fygepueccrcnfi Sr.rnnan) m29.03.2012 TeMHoro crerua)* Ns 04H-1401/l I OOO "MelrexQapu,' 3S{epanran cnporr [gnr gereft] upncrol-Mafiepc or 30.l2.20ll; (yr.Tnepcrcar, A.24, r.fposuufi @pauqur @fEy "HMUSyAOCMII" M3823 , 30rvrr/rr,rn 90u1, $1. nlacr. a Crcsr,166 Ns 04V-221/12 rleqeucrar Pecny6nrara) Poe4panHagsopa KoMrur. c noxrofi uepuofi, nav.
or 29.03.2012 (fy4eprr,reccrufi Qrlm.ran) rapr.* Ns 04H-1401/t I OOO "MeArex$apna" AHAH[aJr ra6rerru Nsl0 OOO "AcSapMa"
or 30.12.2011; (yn.Teepcrax, A.24, r.lposHuft , (ynarorxu 6egrc.refinoaHe Poccl,rc ofEy "I4MUSyAOCMII" 60212 Ng 04V-221/12 9eqencras Pecny6anrca) Pocs4parua4sopa rourypHue)* or 29.03.2012 (fy4epueccnrEfi Snnual) Ns 04H-1401/11 (Juu "MeATexeapu', Eucrpylarels@ rels 4lr or 30.12.2011;
oAo.x@K Poccnr (DfEy "I4MIISyAOCMII" 970511 (yr.Tnepcrar, A.24, r.fposuuft , Hapy)KHoro npr.rMeHeHn s 2.5yo "AKpHxaH" Pocs4panna4sopa Ns04l4-22llt2 9eqencxar Pecrry6nnxa) 50r ry6rr aJrK)MlrHHeBbre. narrKn or 29.03.2012 (fy4epueccrnft Qnnr.ran) xaproHHue* Ne 0414-1401/11 w\^J 'MeATeXQapM" fpnnno(Dlrc@ or npocry4u n OAO "Map6uoQapu" Poccar oI-By "HMU3yAOCMII"
or 30.12.2011:' (yn.Tnepcrar, A.24, r.fposnufi , rpanna nop. A/npuror. p-pa AJrt 60nll Ns04V-221/12 tleqencrar Pecny6nrEra) PocsgparHaAsopa rpueMa Bnyrpb [n,ta.nnHoruft]
or 29.03.2012 (fy4eprueccrr.lfi {nnraan) l3r, nar. ns rou6nnnp.
!{arepnaJra (10), nau. xapr.t Ns 04kI-1401/tl r-rt,l\_r 'vreATeXQapM" (rarcnoSenar ra6l. noKpbrrbre OOO "OgoH" Pocclrs ofEy "I4MUSyAOCMII"
n 30.12.2011; [yr.Tnepcrar, A.24, r.fposuuft , uu.-pacrB. o6oloqrofi 50ur 04r210 Yp 04kI-221/12 {eqencnar Pecny6nnra) PocsgparHa4sopa [Ourr., yn. r.r. xoHr. (2), nav.
>r29.03.2012 (fyaeprtleccrnft $nnuan) cap'r.* Xe 04lI-1401/l I )OO "Me4rex$apu" flapaqerauol 4ercruafi cycn. 0AO "(DapucraHAapr- or 30.12.2011; yr.Teepcrcar, A.24, r.fpoauuft Poccnq ofEy "I{MIISyAOCMII" 7062011 , 4/nn. npraeua l20rvrr/5rral 100r, Jfercpe4cma"
Ns 04L1-221/12 {eqescxa.g Pecny6lura) PoegpanHa4:opa Ql. reun. cr., MepHalr JrolrcKa, (fylepueccrnft Sunuar) or 29.03.2012 nav. rapr.* Ns 04H-l40Ul I OOO "Me4rexQapu"' l,royeeH@ cycn. 4/np. Bnyrpb MegaHa (Daprvra or 30.12.2011: (yn.Teepcrar, A.24, r.lposHuft flolrrua orEy "nMu3yAocMft" 14081 l , (ane.rrrcunonar) I 00nar/5un ArqnoHepuoe Ns04H-221/12 {eqencxar Pecny6lr.rra) Pocr4panHagsopa 100r, rrJracr. B KoMnn. co Qn. 06ulecrao or29.03.2012 (fy4epnreccnnfi t[nnnan) [rnp.-Ao3ar.. naq. KaDr. * N9 04H-1401/l I OOO "Me4'rex$apu" JroMr.rJraHqp cyc[. A/np. BnyrpL JIen.q.l.
o'r 30.l2.20ll; (yr.Tnepcr an, g.24, r.fporuufi CroseHr,rr oI-Ey "HMII3yAOCMII" BRl29l , 5nrr/5rraa l20u\ {n. r/cr. u Ns04V-221/12 r{eqescrar Pecny6nnra) PocsgpanHa4ropa KoMrur. c loxxofi Ao3r,rp., naq.
or29.03.2012 (fyleprrr eccrr.rft Qr.rnr.ran) rapr.* Is 04I4-l40Ul I OOO "MeArexQapu" r eKcopaJr I aoc TaoJIeTKIT ,rIJIt 3olrgau Xortlr,turr fepnaannr (DfBy "IIMII3yAOCMII'
or 30,12.2011; (yr.Trepcr an, g.24, r.fpornufi paccacbrBaHnr J\b20 (ynarconrr,r 1050093 , Eos6oucneuuuil.t- Pocsgpaaua4sopa Ns04l/-22ll12 t{eqeHcxac Pecny6nn rca) qqeftrosHe rcoHrypnue)* rereH fM6X (fy4epueccxnft Qr.lnr.ran) or 29.03.2012 Ng 04kI-1401/ll fBY "Pecny6turcascxan Keropoa@ pacrBop grrrns/u or 30.12.2011; 6olrHnqa cropoft ue4nqnucrofi BBeAeHnfl, lrran 3Our/ul Nsl0 A-p Peaan'c Vlg^aun ofEy "HMUSyAOCMII" Al08s Jla6oparoprlc JIrl Poc:gpaaHa4ropa Ns04V-221/12 rroMorrlH" (ya.Tacyera, 4.8, (aunynu reMHoro crexla)* (fygepueccruft Qranna.n) or29.03.2012 r.fporHuft, t{eqencraq Pecny6nura) Ne 0414-1401/l I fEY "Pecny6illrcancraq JluuxounquH pacrBop p.l:ll-r,/s u OAO "Eopncoscrprfi or 30.12.2011; 6oruHuqa cropoE ueAnqnHcrcoft n/u rnegenul, lruJr 30Orvrr/nal Pecny6rnxa of6y "I4MU3yAOCM[I" l03l0l I 3aBOA Eenapycr Pocs4paena4sopa Ns04LI-221/12 noMo[1u" (yl.Tacyena, 4.8, J\bl0 (aurrynu)* ure4npenaparoa" (fygep nreccrcnfi Qnirnal) or29.03.2012 r.fposuuft, t{eqencrcar Pecny6nr.rra) llb 0414-1401/l I MBV "Ypyc-Mapranorcrar JlnnxounquH pacrBop pn th u OAO "BopncoscKr.rft or 30.12.2011; I{PE' (yr.JIeHnH4 s.30, r.Vpyc- n/u nee4exu4 lul 300ur/un Pecny6mrxa of6y "HMII3yAOCMI" 0l l0l I 3aBO.U Eenapycr Pocsgpaeuagsopa Ns04Vl-221/12 MapraH, 9eqeHcxac Nel0 (arvrnynrr)* ue4npenaparon" (f y4ep rr.r ecc nn fi Qr.rnr.la.n) or29.03.2012 Pecny6nuxa) Ns 04H-l40Ul1 fEY "Pecny6r[raHcKac AercKat JlnHrcouuqtH pacrBop gtlu t/s u OAO "Eopnconcruft Pecny6lnra ofEy "IdMIISyAOCMII"
or 30.12.2011; KJIHHItqecKaf, 6oltHnuatt 031011 n/na nne4eunl, lMl 30Orr,rrlnrn ]ABO.II Eenapycr Pocs4parna4eopa Ng04Id-221/12 (yr.Konrqora, g.l0l, Nol0 (arvrnynu)* wegnpenaparon" (fy4epureccrnfi SrEnr,ran) or29.03.2012 r.fposuuft, 9eqeHcrat Pecny6nnxa) Ns 04H-1401/l I I-EY "Pecrry6rnrancras AercKat SQSepalraH cr,rpon [am aErefi] Epncrol-Maftepc or 30.12.2011;
OpaHqu-n @fEy "I4MII3yAOCM[[" M4780 KJIHHlIqecKal 6orbHnuat' 3O*rrlrul 9Orral, Ql. uacr. r CrsH66 Poc:4panua4sopa Np0414-221/12 (yn.Konrqosa, A.I0l, KoMnJr. c.noxxoft raeplrofi, nav.
(fygeprvreccxnft {rurr.ran) or29.03.2012 r.fpolnuft, 9e.reHcrat rapr.* Pecrry6nnxa) Ns 0414-1401/l I f EY "Pecrry6rurxancxar lercKat Klapncenc@ cnpofl I nar/rrln OA0 "(DapucraHAapr- or 30.12.2011; KJIITHI{qecKat 6oltHuuatt Poccur ofEy "HMIISyAOCMII" r0720ll l00nal, Ql. reuuoro creKJra, Jlexcpe4crna" Pocsgpanuagsopa Ns04kI-221/12 (yr.Kolsqona, g.l0l, MepHat JIoxerIKa, na.r. rapr.* (fygepn{ecc rcnft Quruar) or29.03.2012 r.fposHuft, 9eqencKac Pecny6nura) Ns 04H-l40Ull fEY "@apuue4rexcua6" M3 tIP Epouxopyc@ cuporr 100un OAO "CnHreg" PoccH.f, ofBy "I4MLISyAOCMII"
or 30.12.201l; (CraponporvrbrcJroBcKoe ur., A.84 3ur/ul Ne l (SnaxoHbr reMHoro 80312 Pocs4parnaAgopa Ns04l-|.-221/12 r.fposHufi, 9eqeHcraq creua)* (fy4ep*reccrcnft tfunual) or29.03.2012 Pecny6nnra) Ns 04tl-l40UlI fEY "Oaprvruegrexcua6" M3 qp Ml,lt G) 400 ra6l. r/o 400rvrr Eeprnn-Xeuu Af / fepuaunr ofBy "I,IMUSyAOCMII"
or 30.12.2011; (Cmponporr,rbrcJroBcKoe 21002 ru., g. 8a, 1 0urr., yrraKoBKH nqeftrosrre Meuapnnu fpynn Pocsgpanua4:opa Ns04K-22lll2 r.fposuufi, 9e.{eHcxat KOHTypHbre, flaqrcr,r raptoHuue* (fygeprrleccrn ft Qunnan) or29.03.2012 Pecny6nnxa)
* - no npoBepeHHbrM noKa3areJlf,M

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
LG. OZ LOR No JE LL IGG 3
Ha No г
Р ешение по результатам экспертизы качества лекарственных средств
OT
|

ным треб перечисленных в приложении.

Приложение: на 6 Л.В 1 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-244/13 от 13.03.2013

Информационные письма Росздравнадзора по контролю качества: Лекарственные средства

Информационные письма Росздравнадзора по контролю качества: Медицинские изделия

   

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