РОСЗДРАВНАДЗОР Информационное письмо № 16И-1067/13 от 10.09.2013


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-1067/13 от 10.09.2013

Решение по результатам экспертизы качества лекарственных средств

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lrb 04H-1304/12 An'reqHoe yqpex.{eHne hl
KaBKa3a"
KaPT'
SlarcoHul r/c'r. Nel, naq.
JI.H. (yr.KPacHat, .q. I 33a,
or 27J2.2012
r.Hosonasroncr, CranPononscruft
roafi)
Eorprturunra uacroft ra 25utr, OAO "tDnopa
Ns04V-1304112 Anreqsoe yqpexAeHue kll I lllesqeHro
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KaPr'
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JI.H. (yr.KP ac*an, l. I 33a,
or27.12.2012
r.Hosonasroecr, CranPononrcrnfi
rpafi)
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N9 0414-1304/12 Anreqsoe yqpexAeHl'le
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JI.H. (yn.KP acuan, t.l33a,
or27.12.2012
JIerccpegcraa"
KOHT.
n.Hononasroscr, CraePononrcrnfi

100413

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"OapucraHgaPrJIercpe4crna"

HuroruHosas KI'IcJIora
ra6ne'mn 5Orvrr lOurr.' Yn. tq'
roHr. (5), natl. KaPr.

"l4MU3yAOCMfl"

(Craepononscruil $unuan)

Acnaprau raoJlerKn luur r.'
ynaKoBKIl rqeilronste
KoHrypHbte (5), nav. raPr.*

(l),

orsy

PocsgpaeHaA3oPa

Jlercpegcraa"

KOHT.

4.9, r.feoPrueBcK, CranPonolscrufi
xnafi)

or27]2.2012

Poccnr

(Cranpononrcrnil $r,lnnar)
PoccHr

orsy "HMII3yAocMn"

351I

12

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(Craeponolscruil i[mnar)

Vugut

orsy

"HMU3yAOCMII"

t82l8l

Pocr4panuagsoPa

(Craaponolrcxnil Qulna'n)
Poccttc

orsy "HMIISyAocMfl"

70313

PocsgpanHa.qsoPa

(Cranpononrcxtlft tlniluar)
PoccttR

orsy "l4MU3yAocMfl"

35ll12

Pocs4paeuagsoPa

(Craspononscruft $nluar)
Poccnq

orsy "l,IMII3yAOCMfl"

70413

Pocsgpasua4roPa

(Craspononscrnfi Qmuar)
PoccHq

orsy

"HMUSyAOCMII"

Pocsgpanua4eoPa

(Craspononrcrcufi

t[nlual)

080413

Ns 04H-1304/12

or 27.12.2012

Hfl llleeqeHro Aualuruu ra6lerru

Anrequoe yqpexAeHne
JI.H. (yn.KP acHan, l. 1 33a,
r.Hosonasroacrc, CranPonolucrufi

rpafi)
Ns 04H-1304/12

or 27.12.2012

Anrequoe yqpexleHHe llll uleBqe
JI.l4. (yr.KP acHar.' l. I 33a,
r.Hosonaeroecr, CraePonolscru ft

rnafi)

500rur

lOurr., ynaKoBKl4

OAO "TtoueHcrcufi

OAO "JlyraHcrcuil
x(D3"

xpafi)

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I

5404

(Cranpononucrufi t[r'uuar)

6egtcqefi roBble KoHTYPHble

A.*p*u" ra6nerxu J\b50
(ynaronxu sqefirosste
roHrypuue)*

brsy "l4Mu3yAocMfl"
Pocs4pauuaA3opa

x(D3"

OAO "nPoHrcKl'lrl
l4l I LilesqeHro @ypauunuH ra6l. dnPuror' PyqpexAeHne
Anrequoe
Ns 04H-1304/12
pa Ant MecTHoro H Hap)D{GOfo xo3"
JI.H. (yn.KPacHan' .q. I 33a,
or 27.12.2012
npI,tMeHeHI4r 20rvr Nel0 (Yn'
r.Hosonagroacr, CrarPonolscrufi
6e$rq. rour.)
roail)
"t unnoKpar
Eotp"truH"rca uacrofi ra 25 ul, OOO
Anrera Hfl TPanesaHoBofr H'M"
J\|9 04H-1304/12
KaPT'
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(yn. Jlenv rn uua, 9.22a,
or 27.12,2012
cr.Cyaopoocral, CrarPonolucruil
ra

Poccnq

YrcpaIaHa

orsy

"l4MUSyAocMfl"

25310t2

Poc:gpaauaA3opa

(Craepononucrnfi rfulr,tar)
Poccur

orsy

"HMUSyAOCMII"

6002 I 3

Pocsgpasua,qsoPa

(Cranpono.nrcruI Quruar)
Pocctts

ilrsy-"nnaugYAocMn"
Pocr4panHa4soPa

(Craspononscxt't il Qnr nar)

l3

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r* -/6t4- 4Q6?1.t5 Pyroao4ureJrsM opraHn3arrufi - Ha Ne r{MnopTepoB neKapcTBeHHbrx cpeAcrB
Cy6rexraM o6par{eHut ["*""te no pe3ynbraraM r*rrr"ottr"rl JIeKapcTBeHHbrx cpeAcTB KaqecTBa neKapcTBeHHbx cpeAcTB

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llpnroxeHr{e: Ha 5 r.s I ers.

Bpr,ro pyKoBoAHTeJIt M.A. Mypaurxo

f.B. fasuoqra 84995780 I 87 llpnaoxeHne K nncbMy PocrlpasuaA3opaorl tJ'
v4IVre'v2I'-!-sa r2
PoeIDrBtra3itpoM npfFro pe[exfc o cooTB€TtcTBlrll Ix *aqccTBt cBala||||f o JIGx|pDCBSBTT cpqaoEax, no pe!yIDTrttM grcneF[lEa *aqegIBr x0rpgl HOBJIEHHbIM
HauMeHosaHHe opraHH3aufi r, CrpaHa Cepnr.r flpourno.qnrens SxcneprHar oPraHH3aqnt Horraep 3aAaHHt npeAcraBH Burefi o6Pa:qsl JI exapcree u Hoe cpeAcrBo np-Ba neKapcTBeHHblx cpeAcTB 4505 | 3 Pesur Apalfie }.l!l00,6auxu ()40 PoccHs orEy "I,|MIISyAOCMfl"
Ns 04H-1304/12 Anrexa OOO "HaryPa Bnta" Pocs4pauHagsoPa (Con neq H rr fi np-A, A.za, r.Jleprtaouron, nonuuepuule* "Map6xotfaPu"
or 27.12.2012 (C'ranpo nonucxu il $nnraar) Craapononucxnil rPafi) Kap6auarenuu ra6nerrn 200mr 3AO "AJICH roccHR of6y 'l,lMu3yAOCMfl" 591212 Ns 04H-1304/12 Anrerca OOO "HaryPa BH.ra"
PocrgpaoHa.qroPa n27.12.2012 $l.JIer r,t Ha, A.25, r.JIePuouroe, l0ur., yn. tq. roHT . (5), nav. Oapua"
(Craepononucrnil Surnar) Craaponolrcrr.r fi rPafi ) KapT.
OOO "O:oH" rocc14t orBy "HMU3yAOCMn" l0l0l2 Ns 04H-1304/12 Anrera OOO "HaryPa Bura" Hn$egunnu ra6rgrrcn n/nn/o lOprr 50urT ., yn. ttl. ronr. (l)'
PocsApaaHa4soPa or 27.12.2012 (yn.Jleu n Ha, A.25, r.JlePuoHror, (Crasponorscrufi Sunuar) Cranponorucrnfi rcPafi) naq. KaDT.
Pocctts orBy "HMLlSvAUUMll" 50r l3 Anroxon rablerrn n/o l0rur., OAO "EttocHHTe3"
Ne 04H-1304/12 Anrera HII Xoloaosofi H.B. PocrgpasHaqsoPa or27.12.2012 (yn.Coaercx an, p,.24a, r.feoprneucr' ynaKoBKlt rqefixoaHe (Crasponoltrcrufi Sulnar) Crarponorscrnft rPafi) KoHryDHble (5), nav. raPr.
Poccun orBy "l4Mq3vAUUM!l" 04lol2 PauurnAnH-JIexT'ra6le'rxu OAO "TrcpreHcxnfi Ns 04H-1304/12 Anrera Hll Xorroaosofi H-B. Pocrgparua4soPa or27.12.2012 (yn.Cosercx an, 9.24a, r-feopnueecr, nlnnlo | 50rrlr 10ru'r-, ynaKoBKl'l xo3"
(Craapononucrufi Qnlnan) Craeponolscxr.rfi rPail) rqefi rosste ronryPusre (2), naq. Kapr.
VsAun orBy "HMU9yAOCMn" 122081 CeHaae@ ra6netrn I 3.5ur llxnna JlrA Ns04V-1304112 Anrera Hll Xonoaosoil H.B. PocsgpanuagsoPa cr 27.12.2012 (yn.Coaercra n, p.24a, r.feoprueacr, 20urr., ynaKoBKH c'leil rcoslle (Cranponolrcxnft t[rnnar) Crarpononrcrufi rPafi) KOHrypHbIe BaruAon c rnrcro:ofi ra6lerxn OA() Poccsr orEy .HMUSyAOCMn" 250912 Ns 04H-1304/12 Anrera Hll Xono,sosoil H.B. Pocsgparua4roPa or27.12.2012 [n.Conercr as, A.24a, r.feoPnnescx, noAtffiHr{Hble l0urr., Yn. tq- "@apucrau,4aPr- JIeKcD€,ncrBa" (Cranponor rcrnfi rDn-rr nan) Ctaaponolscrnil rPafi) KOHT.
270413 Merpouxgasol ra6lsrxH OAO "Eopucoecrufi Pecny6nNra ofEy "HMU3yAOCM|I"
Ne0414-1304112 Anrexa Hfl VnscHqeHro B.A. PocrgparHa4soPa yn. ttt. ronr- (2), 3a8OA Eelapycu or 27.12.2012 (yn.JlennHa, A.l23l yl.flyrurnua, A.35, 250ur l0ru'r., ue,u,npenapatoe"
(Cranpononscrufi 0rn1*) r.l-eoprnescr, Cranpononucrnfi Kpaq nAq KanT- EorpuuHHxa uactofi ra 25un, OAO "@ropa Poccuc or6y "l4MUgyAOCMlI" 70313 Ns 04H-1304/12 Anrexa Hfl YnssHqeHro B.A- Pocs4pauua4soPa or 27.122012 (yn.JIeHnua, a-123| yl.flyrurnna, A.35, $raxouu r/cr. Ngl, naq. KaPr. KaBKa3a" (CraspononrcrHft Qnlna.n) r.feopruencr, Cranponolucrnfi TP",)- l103r3 Kap6arr,rasenux ra6lerrn 200 trl r 3AO "AJICll Poccur orEy "HMq3yAUUMll"
lrb 0414-1304/12 Anrera Hfl YluruqeHxo B.A' PocsqpasHagsoPa or2l.l2.2012 (yn.JIeHnHa, a.l23l y.rr.flyruxn Ha, 4-35, | 0un., yn. f,q- rour. (5), nau- @apua" (Cranponollcrsfi {n-nuar) r.leoprneocr, Craeponolrcru ft tcpaq Kapr.
PfSV "tatvtUSYAOCM[1" l0l0l2 Poccuq *;"0nerKll n/nn/o OOO "O:oH"
Ns 04H-1304112 A"*-" Hfl VnsruqeHro B'A' "
O.a, U 50rur., Yn. flq' ronr' (l)'
"
Poc:gPaeuagsoPa
t.l23 | yr'flyu-munu' a'3 lOrr,tr 'c".n nnonorucrufi tbrannal) or27.12.2012 (yn.Jleur'rna, ?' 60313 f Cranpono'nscrnfi KpryI naq. KaDT. Poccun of6v "HMq3yAocMn"
"- "nn."r".r. OOO "Act[aPua Hfl YnsnsqeHKo B'A' AqerulcaauuuroBafl KLlcJIora PocrgPaeua4soPa N 0414-1304/12 Anrera g'35' ra6rerrut 500rvrr Nsl0, (CranPononscrufi t[unraar) or 27.12.2012 (yn.JleHl*ra, t.123 | yl'flyuxnH a' roerte rcpafi) ynaKoBKlI 6e:lnqefi ..f"op.""""n, Craepononscru'rfi 9303 I 3 KOHTVDHbIE Pocct'ts ofEy "l4MU3yA(JLwrrr oAO Acrop6ranoBafl KI'lcJIora Apaxe Ns 04H-1304/12 Anrera l4fl VnusqeHKo b'A' "Map6noQaPu"
Pocs.qPanHagsoPa 5Orrar 200rur.,6auru rcra Bnonorucrcufi i[ralr'ran) o"r27.12.2012 (yn.JleHuua, 1'123| yn'flyuruHa' A'35 941212 f".rrrrr"""r. Craeponolucruafi rcpaft ) .- NONHMEDHbIE Pocct'ts ofBy "l4MU3yAULvrr r OAO "Tror.aeHcKt'lR Kaltqun rJlloKoHara TaoJIerKI'l Ns 04H-1304/12 Anrera I4n YnrcHqeHKo tt'A' xo3"
PocrgPanHagsoPa 500rrar N010, Ynaronrn (cr.ARnonoJIscrnfi $lrnnal) or27J2.2012 (yn.Jlenuua, n.123| yn'flyrurcuna' 4'35'
roBue KoHTYPHbIe 2831212 "
F".rrr.r"""r. Crasponolscrnft rpafi) 6eqr'nqeft oAo Poccnr .DTEY ''HMUSYAUUMTT Hf[ YlrrHqeHKo tt'A' {Halurus'ra6lerrn )uuMr Pocs.qPanHagsoPa Ns 0414-1304/12 An'rera "Map6uoQaPu"
lOurr., YnaKoBKlr /Crannonorucrnfi t[nnnal) or 27.12.2012 (yn.Jlenraua, 1.123| yl'flyrurunu' a'31 rpafi ) 6egtcqeft xoBble KoHTYPHble 2841212 r- f eonrueBcx. Craspononrcnaft Poccns ofBy "l'lMu3yA(JLvrtr AsalsnuH ra6neffiu )uuMr oAo Anrerca Hfl YlsnsqeHKo tt'A'
PocsgPaeua4soPa J..|b 04H-1304/12 "Map6uoQaPu" (craBoonorlcrnfi $nlual) l0un., YnaKoBKH or27.12.2012 (yn.JlenuHa, 1.123| yn'flyruxraHa' 4'35'
6estqqeft roBble KoHTYPHHe 80213 i-f"oorr"".x, CranPonolrcrnft KPaft I Poccfic ofBy "l4Mu3yAtJulvrrr OOO "Act[aPua Y ronu aKTHBI{PoBaHHsI t'l Anrera I4f[ YnusqeHKo tt'A' PocsgPanHagroPa Ns 0414-1304/12 g'35' ra6lerru 250rvrr Nl0' (CranPononucrufi $ulnar) or27J2.2012 (yn.JlennHa, g.123I yn'flyruruna'
6eglqqeft rosHe ..f Cranpononucruft rpafi) ynaKoBKI'I "opr""""r, 2881212 KOHTYPHbIE cAo JIyraHcrcuR v-p"r* lorsv "I'IMU3YAUUMT I Anrera I'I[I VilsrsqeuKo tt'A'
il.*p*" ta6nerr, Ne5o xo3" I PocsapaeHaA3opa Ns 04H-1304/12 p''35' JnaKoBKl'l rqeflrosrte fi Sullrar) or27.12.2012 (yn.JlenlrHa, n.123I yn'flyumraH a' I lCraePonolscrra ronrvDuste)* 482143 ,.f.op.rr""K, Craxpgnon!'cKl{il Kpaft) V*tAvrs ofEy'l4MLl3yAUUMrr'
Ilranna JIr,q Cenaae@ ra6lerxtl I J'f Mr Ns 04H-1304/12 Anrera Hf[ YruqHqeHKo tt'A' rqefi rosHe PocsgPanHa.{soPa 20ul'r., YnaKoBKI'I rcTaBnonorucrufi $nlual) w27.12.2012 (yn.Jlennna , 1.123| yn'flyumlrn a' A'35 '
080213 i f".rrrrt"".rc. CrarPonolrcrcufi rPafi| KOHTVDHbIE Pocctls ofEy "I'IMU3yAULvrtr OOO "Ogog"
Pn6orcnH ra6l. n/nl/o zuuMr Itb 04I{-1304/12 ffit"* Un [IaPanoea B'B' 25wr.,Yn. tq. roHt' (2), nar{Ku Pocr4PanuagsoPa (C'ranPononucrcufi t[unnan) or27.12.2012 (yn.KooneP utuYuan', g'32, p- KaproHHHe a.Ho"oru""AeHHoe' feoprr'reecruil 090912 ,r /aronnAnrrnrcrufi rnafi) Pocct'ts O|BY "l'IMq3YA(JLwrrr OOO "Ogog"
EncaroAnl ra6lerrn Ns 04H-1304/12 Anrera Hfl [IIaPanoBa u'tt' Pocs.qPanuagsoPa noKpblTble KUIU.-pacTB' (CranPononscrufi Qnlraal) (yr.KooneP ar:uluaq g'32, or27J2.2012 eoprr'rencrnfi p- o6oro'txofi 5ur 30un', Yn' tq'
a. Ho"otut"AeHHoe' f ]- lKoHr. (l), nau. raPr'
u, CraePonolrcrnfi KPaf

I 88121 CAO "JlYrascrufi VrpanHa orsvtrnrrauSYAocMn"
A*.*u Hfl lllaPanosa B'B' n.*p*u" ra6rerru Ns50 PocrgpanHaA3oPa Ns 04H-1304/12 (ynaronru RqefiroeHe xo3"
(yr. KooneP arulua4 9.32, (CrauPononucrnil Qnlnar) or27.12.2012 feoprnercruil p- rouryPHure)* c.HososaseAeHHoe, u crnnnononrcrufi rPaft) 3605 l 3 OO() "acPaPua Poccur ofBy "HMUSyAUUMIl AqernlcaluquJloBat KI'tcJIora Ns 04H-1304/12 Anrera Hfl lllaPanoBa ts'B' PocsgPasuagsoPa ra6nemn 5001'rn Nl0, or27J2.2012 (yn. KooneP urusuar., g'32, (CraaPononucrnfi Qr'rnr'rar) p- ynaKoBKH 6egtrqeEroeste a.Ho"oru""AeHHoe' feoprueecrufi H- Crasoonolrcrnfi rPa[) I(OHTVDHbIE O-fSY-Y't'tt'tUSYAOCMn" t50l2l2 oAO Pocctts B'B' Pesnr Apaxe Nsl00' 6asru Ns 04H-1304/12 Ante*u Hfl lllaPanosa Poct,4PasHa.4:oPa "Map6noQaPu"
or 27J2.2012 (yl.KoonePa'rusHaR, A'32, noruuePuue* (Craapononrcrnfi t!unuar) p- c.Hoeo:aseAeHHoe' feopn'rencruft u C'raRnonolscrnil rpail) lOur' 3AU "MocrcossKot po"*r lornv"I4MUSYAUUMIr 351012
Anrexa I4f[ lllaPanoBa tt'tt' n"Ou"on ra6nerru 20rrr lPocg.qpasHaA3oPa Ng04V-1304112 ynaKoBKH 6earrqefi rosue SapruaqearnqecKafl or 27.12.2012 (yr.KooneP arusua4 g'32, llctu"Ponorucrnfi tlurnar) p- KoHrypHble $a6puxa"
c.HosogaseAeHHoe' feopruercnufi ofEy "HMII3yAUUMII 270413 ' Crnnnononrcrnfi rcPaft) Metpo"t.qarol ra6nerrcu JAU "boPncoeo Pecny6nura tfe 04H-1304/12 Anrexa HII lllaPanoBa B'tt' (2), EelaPYcs Pocr4ParHa4:oPa 250rvrr l0urr., Yn. tq. roHr'
raBoA (yr. KooneP arusua4 P,'32, (CranPononscrufi t[nrlna"n) n 27.12.2012 l*e.qnpenaParon"
p- naq. KapT.
c.HosogaseAeHHoe' f eoprnencru'1fi u Crannonorscxr,rft rPafi) iDTEV ''HMII3YAUUMII 07r2 OAU "l'lpot'IrcKnu Poccl.ts HaroruHosat KI'lcJIora Ns04Id-1304112 Ant"ra Hfl lllaPanosa B'B' Pocs,qPanua.qsoPa (yn.KooneP atwluaq P,.32, ra6le'mn 50ur l0ur.' Yn' tq' x(D3"
(CranPononscrufi tlnnaar) or 27.12.2012 p- ron'r. (5), naq. KaPT.
c.HosoraseAeHHoe' feopnraeucrnft u Crannononrcrufi rcPafi) 3705 I 3 O0() "acqaPua Pocctts ofBy "I4MqSyAUUMIl AqernlcaluqnJloBafl KHcJIora Ns 04H-1304/12 An'rexa I'Ifl MraHocqHlr ts'b' Pocs4PanuagsoPa (yn.Kannnr'r na, A.20 | yn'Tt'ltr'tnprseaa'
ra6lerrcu 500rr'rr Nl0, (Cranpononucrcnfi Snnuait) or27.12.2012 ynaKoBKI'I 6estsqeilrcogue a.9, a.f"optfieBcK' Crarponolrcxt'til rnafi) I(OHTVDHbIE 6-tsy "uvtlrSvAocMrl" 284r2r2 oAo Poccnq AHansrus ra6nerru 500ur Ne04114-1304112 Anrena I'Ifl MltrrocqHlr ts'ts' "Map6uo$aPu"
PocsgPanua4soPa (yr.KanuHlr lela, 1.201 yl'Tnuuprsena'
lOurr., yrIaKoBKH (CraePononucrnfi <[ulual) or 27J2.2012 6egtqqeilroBble KoHTYPHble l.9, r.f "op.ueBcK' CranPononscxuft 351012 rpaft) "MocroacKax Poccuc orEy "HMIISyAUUMIT'
Irb 04H-1304/12 Anrera Hf[ MunocqHlr B'tt' ntO*- *0JIerKH 20r'r lOun'' 3A() Pocr.qpasHaAsopa ynaKoBKll 6egtsqeft rosue $aprrraueernqecKat (CranPononucruft $lrlual) or 27.12.2012 (yn.Kanuuu :aa, 1.20 I yl'Tu rra npreena'
KOHTypHble 1Qa6pura"
g.9, r.feoprueBcK' Cranponolscrnft rpaft)

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I

Министерство здравоохранения Российской Федерации
ФЕДЕРАЛЬНАЯ СЛУЖБА ПО НАДЗОРУ Г.
В СФЕРЕ ЗДРАВООХРАНЕНИЯ |
(РОСЗДРАВНАДЗОР) Руководителям организаций- Славянская: пл. 4. exp: |. Моския, 104 производителей лекарственных Телефон: (495) 698 45 38; 698 15 74 средств Gi - ..
0, 2, LW, 72 № ЧЕи— 106 + fA 4 Руководителям организаций- На № от импортеров лекарственных средств Г. | Субъектам обращения Решение по результатам экспертизы качества лекарственных средств 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 lV ’ М.А. Мурашко y
Г.В. Ганночка 84995780187

Скачать документ: Письмо 16И-1067/13 от 10.09.2013

Информационные письма Росздравнадзора по контролю качества: Лекарственные средства

Информационные письма Росздравнадзора по контролю качества: Медицинские изделия

   

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