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a 26.10.2010 konan\'e9ho na MZ SR
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\par }{\rtlch\fcs1 \af0 \ltrch\fcs0 \b\ul\lang1051\langfe1029\langfenp1029\insrsid5773059\charrsid12849006 Za Ministerstvo zdravotn\'edctva SR
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gie
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\par }{\rtlch\fcs1 \af0 \ltrch\fcs0 \b\ul\lang1051\langfe1029\langfenp1029\insrsid5773059\charrsid12849006 Za GlaxoSmithKline, s.r.o.
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\ltrch\fcs0 \lang1051\langfe1029\langfenp1029\insrsid5773059\charrsid228593 ,  produktov\'fd mana\'9e\'e9r}{\rtlch\fcs1 \af0 \ltrch\fcs0 \lang1051\langfe1029\langfenp1029\insrsid5773059 , }{\rtlch\fcs1 \af0 \ltrch\fcs0 
\lang1051\langfe1029\langfenp1029\insrsid5773059\charrsid228593 GlaxoSmithKline, s.r.o.
\par }\pard \ltrpar\qj \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid8870960 {\rtlch\fcs1 \af0 \ltrch\fcs0 \lang1051\langfe1029\langfenp1029\insrsid5773059 
\par }{\rtlch\fcs1 \af0 \ltrch\fcs0 \b\ul\lang1051\langfe1029\langfenp1029\insrsid5773059\charrsid12849006 Za Pfizer Luxembourg SARL, o.z.
\par }{\rtlch\fcs1 \af0 \ltrch\fcs0 \b\lang1051\langfe1029\langfenp1029\insrsid5773059\charrsid10703372 MUDr. Branislav Budke}{\rtlch\fcs1 \af0 \ltrch\fcs0 \lang1051\langfe1029\langfenp1029\insrsid5773059\charrsid228593 , gener\'e1lny riadite\'be
, Pfizer Luxembourg SARL, o.z.
\par }\pard \ltrpar\qj \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid11623652 {\rtlch\fcs1 \af0 \ltrch\fcs0 \b\lang1051\langfe1029\langfenp1029\insrsid5773059\charrsid10703372 Mgr. Martin Bucko}{\rtlch\fcs1 \af0 
\ltrch\fcs0 \lang1051\langfe1029\langfenp1029\insrsid5773059\charrsid228593 , produktov\'fd mana\'9e\'e9r, Pfizer Luxembourg SARL, o.z.
\par }\pard \ltrpar\qj \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid8870960 {\rtlch\fcs1 \af0 \ltrch\fcs0 \i\lang1051\langfe1029\langfenp1029\insrsid5773059\charrsid228593 
\par }{\rtlch\fcs1 \af0 \ltrch\fcs0 \lang1051\langfe1029\langfenp1029\insrsid5773059\charrsid4422085 
\par }{\rtlch\fcs1 \af0\afs28 \ltrch\fcs0 \b\fs28\lang1051\langfe1029\langfenp1029\insrsid5773059\charrsid6047869 Program: 
\par }{\rtlch\fcs1 \af0 \ltrch\fcs0 \b\lang1051\langfe1029\langfenp1029\insrsid5773059\charrsid6047869 Povinn\'e9 o\'e8kovanie proti pneumokokov\'fdm invaz\'edvnym ochoreniam
\par }{\rtlch\fcs1 \af0 \ltrch\fcs0 \lang1051\langfe1029\langfenp1029\insrsid5773059\charrsid4422085 
\par }{\rtlch\fcs1 \af0 \ltrch\fcs0 \lang1051\langfe1029\langfenp1029\insrsid5773059 
\par \tab Pracovn\'e9 stretnutie otvoril minister zdravotn\'edctva, ktor\'fd pozdravil pr\'edtomn\'fdch a hne\'ef v\~\'favode vyzdvihol potrebu zv\'e1\'9eenia v\'9aetk\'fdch aspektov pri rie\'9aen\'ed problematiky povinn\'e9ho o\'e8kovania, a\~to predov\'9aetk
\'fdm aspektov medic\'ednskych a n\'e1sledne finan\'e8n\'fdch. Minister \'efalej odovzdal slovo Mgr. Michaele Gajdo\'9aovej, gener\'e1lnej riadite\'beke Sekcie farm\'e1cie a\~liekovej politiky.
\par 
\par \tab Mgr. Gajdo\'9aov\'e1 v\~\'favode po\'9eiadala z\'e1stupcov spolo\'e8nost\'ed GlaxoSmithKline Slovakia}{\rtlch\fcs1 \af0 \ltrch\fcs0 \lang1051\langfe1029\langfenp1029\insrsid15954935 ,\~}{\rtlch\fcs1 \af0 \ltrch\fcs0 
\lang1051\langfe1029\langfenp1029\insrsid5773059 s.r.o. a\~Pfizer Luxembourg SARL, o.z. o\~kr\'e1tku prezent\'e1ciu odborn\'fdch faktov t\'fdkaj\'facich sa povinn\'e9ho o\'e8kovania proti pneumokokov\'fdm invaz\'edvnym ochoreniam vakc\'ednami SYNFLORIX a
\~PREVENAR. Nasledovala prezent\'e1cia odborn\'e9ho stanoviska PSPI a\~diskusia \'fa\'e8astn\'edkov pracovn\'e9ho stretnutia. V\'9aetky z\'fa\'e8astnen\'e9 strany disponovali vopred predlo\'9een\'fdmi odborn\'fdmi podkladmi, ktor\'e9 k\~obozn\'e1
meniu sa dolo\'9eili spolo\'e8nosti GlaxoSmithKline Slovakia, s.r.o. a Pfizer Luxembourg SARL, o.z.
\par 
\par \tab Z\'e1stupcovia oboch farmaceutick\'fdch spolo\'e8nost\'ed prezentovali odborn\'e9 fakty, pri\'e8om s\'fa\'e8asne uviedli svoje n\'e1vrhy o\'e8kovacej sch\'e9my a z\~toho vypl\'fdvaj\'face zaradenie pr\'edslu\'9an\'fdch vakc\'edn\~v zozname liekov. 

\par 
\par }\pard \ltrpar\qj \fi708\li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid1405321 {\rtlch\fcs1 \af0 \ltrch\fcs0 \lang1051\langfe1029\langfenp1029\insrsid5773059 Spolo\'e8nos\'9d
 GlaxoSmithKline Slovakia, s.r.o. navrhla zaradi\'9d vakc\'ednu SYNFLORIX do povinn\'e9ho o\'e8kovania v\~sch\'e9me 2+1 spolu s\~vakc\'ednou PREVENAR {\*\xmlopen\xmlns2{\factoidname metricconverter}{\xmlattr\xmlattrns0{\xmlattrname ProductID}
{\xmlattrvalue 13 a}}}13 a{\*\xmlclose} pri stanoven\'ed v\'fd\'9aky \'fahrady za \'9atandardn\'fa d\'e1vku lie\'e8iva pova\'9eova\'9d vakc\'ednu SYNFLORIX za referen\'e8n\'fd liek. Spolo\'e8nos\'9d uviedla, \'9ee vakc\'edna Synflorix sp\'e5\'f2a v\'9a
etky z\'e1konom stanoven\'e9 podmienky potrebn\'e9 na jej zaradenie do povinn\'e9ho o\'e8kovania proti invaz\'edvnym pneumokokov\'fdm ochoreniam v\~sch\'e9me 2+1 ako n\'e1kladovo najefekt\'edvnej\'9aia alternat\'edva (podmienky definovan\'e9 v\~z\'e1kone 
\'e8.}{\rtlch\fcs1 \af0 \ltrch\fcs0 \lang1051\langfe1029\langfenp1029\insrsid4815335 \~}{\rtlch\fcs1 \af0 \ltrch\fcs0 \lang1051\langfe1029\langfenp1029\insrsid5773059 577/2004 Z.z.,}{\rtlch\fcs1 \af0 \ltrch\fcs0 
\lang1051\langfe1029\langfenp1029\insrsid4815335  v z\'e1kone \'e8.\~}{\rtlch\fcs1 \af0 \ltrch\fcs0 \lang1051\langfe1029\langfenp1029\insrsid5773059 355/2007 Z.z.}{\rtlch\fcs1 \af0 \ltrch\fcs0 \lang1051\langfe1029\langfenp1029\insrsid4815335 , vo}{
\rtlch\fcs1 \af0 \ltrch\fcs0 \lang1051\langfe1029\langfenp1029\insrsid5773059 \~vyhl\'e1\'9ak}{\rtlch\fcs1 \af0 \ltrch\fcs0 \lang1051\langfe1029\langfenp1029\insrsid4815335 e}{\rtlch\fcs1 \af0 \ltrch\fcs0 \lang1051\langfe1029\langfenp1029\insrsid5773059 
 MZ SR \'e8. 723/2004 Z.z.}{\rtlch\fcs1 \af0 \ltrch\fcs0 \lang1051\langfe1029\langfenp1029\insrsid4815335  a\~}{\rtlch\fcs1 \af0 \ltrch\fcs0 \lang1051\langfe1029\langfenp1029\insrsid5773059 vo vyhl\'e1\'9ake\~\'e8.}{\rtlch\fcs1 \af0 \ltrch\fcs0 
\lang1051\langfe1029\langfenp1029\insrsid4815335 \~}{\rtlch\fcs1 \af0 \ltrch\fcs0 \lang1051\langfe1029\langfenp1029\insrsid5773059 585/2008 Z.z.)}{\rtlch\fcs1 \af0 \ltrch\fcs0 \lang1051\langfe1029\langfenp1029\insrsid3878905 .}{\rtlch\fcs1 \af0 
\ltrch\fcs0 \lang1051\langfe1029\langfenp1029\insrsid5773059  Spolo\'e8nos\'9d s\'fa\'e8asne kvantifikovala odhadovan\'fa n\'e1kladov\'fa efektivitu tak\'e9hoto opatrenia. Ako \'efal\'9aiu z alternat\'edv prezentovala spolo\'e8nos\'9d mo\'9enos\'9d zaradi
\'9d do povinn\'e9ho o\'e8kovania v\'fdhradne vakc\'ednu SYNFLORIX v\~sch\'e9me 2+1. S\'fa\'e8asne spolo\'e8nos\'9d GlaxoSmithKline Slovakia, s.r.o. uviedla, \'9ee v\~\'9eiadnej krajine sa }{\rtlch\fcs1 \af0 \ltrch\fcs0 
\lang1051\langfe1029\langfenp1029\insrsid2228616 v\~r\'e1mci plo\'9an\'e9ho o\'e8kovania }{\rtlch\fcs1 \af0 \ltrch\fcs0 \lang1051\langfe1029\langfenp1029\insrsid5773059 s\'fa\'e8asne nepou\'9e\'edvaj\'fa odli\'9an\'e9 z\'e1kladn\'e9 o\'e8kovacie sch\'e9
my pr}{\rtlch\fcs1 \af0 \ltrch\fcs0 \lang1051\langfe1029\langfenp1029\insrsid2228616 e vakc\'edny SYNFLORIX a\~PREVENAR.}{\rtlch\fcs1 \af0 \ltrch\fcs0 \lang1051\langfe1029\langfenp1029\insrsid5773059 
\par }\pard \ltrpar\qj \fi708\li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid14568786 {\rtlch\fcs1 \af0 \ltrch\fcs0 \lang1051\langfe1029\langfenp1029\insrsid5773059 
\par }\pard \ltrpar\qj \fi708\li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid9964710 {\rtlch\fcs1 \af0 \ltrch\fcs0 \lang1051\langfe1029\langfenp1029\insrsid5773059  Spolo\'e8nos\'9d
 Pfizer Luxembourg SARL, o.z. navrhla ponecha\'9d v\~povinnom o\'e8kovan\'ed len vakc\'ednu PREVENAR 13 v\~o\'e8kovacej sch\'e9me 2+1, tak ako je moment\'e1lne uveden\'e9 v\~aktu\'e1lne platnom o\'e8kovacom kalend\'e1ri pre povinn\'e9  pravideln\'e9 o\'e8
kovanie os\'f4b, ktor\'e9 dosiahli ur\'e8en\'fd vek a\~n\'e1sledne premietnut\'e9 v\~zozname liekov. Spolo\'e8nos\'9d argumentovala, \'9ee}{\rtlch\fcs1 \af0 \ltrch\fcs0 \lang1051\langfe1029\langfenp1029\insrsid8660816  v\~ofici\'e1lnych dokumentoch Eur
\'f3pskej liekovej agent\'fary pre produkt SYNFLORIX (SPC a\~EPAR) nie s\'fa uv\'e1dzan\'e9 odpor\'fa\'e8ania na pou\'9eitie vakc\'edny v\~sch\'e9me 2+1. Spolo\'e8nos\'9d \'efalej argumentovala, \'9ee}{\rtlch\fcs1 \af0 \ltrch\fcs0 
\lang1051\langfe1029\langfenp1029\insrsid5773059  odpor\'fa\'e8anie \'daVZ na aplik\'e1ciu skr\'e1tenej sch\'e9my 2+1 bolo vystaven\'e9 na z\'e1klade materi\'e1lov predlo\'9een\'fdch k\~vakc\'edne PREVENAR (PCV-7), vz\'9dahuje sa v\'fdhradne na t\'fa
to vakc\'ednu a\~nie je mo\'9en\'e9 pova\'9eova\'9d ho za univerz\'e1lne odpor\'fa\'e8anie o\~\'faprave o\'e8kovacej sch\'e9my v\'9aetk\'fdch na trhu dostupn\'fdch pneumokokov\'fdch vakc\'edn, napr. SYNFLORIX-u.
\par 
\par }\pard \ltrpar\qj \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid16412007 {\rtlch\fcs1 \af0 \ltrch\fcs0 \lang1051\langfe1029\langfenp1029\insrsid5773059 \tab K\~}{\rtlch\fcs1 \af0 \ltrch\fcs0 
\lang1051\langfe1029\langfenp1029\insrsid11829164 uveden\'e9mu }{\rtlch\fcs1 \af0 \ltrch\fcs0 \lang1051\langfe1029\langfenp1029\insrsid5773059 probl\'e9mu sa vyjadrili i\~z\'e1stupcovia PSPI \'daradu verejn\'e9ho zdravotn\'ed
ctva Slovenskej republiky, ktor\'ed navrhli ponecha\'9d z\'e1kladn\'fa o\'e8kovaciu sch\'e9mu v\~d\'e1vkach 2+1 a\~pre povinn\'e9 o\'e8kovanie ponecha\'9d iba jednu vakc\'ednu, a\~to PREVENAR 13, tak ako je uveden\'e9 v aktu\'e1lne platnom o\'e8
kovacom kalend\'e1ri. Z\'e1stupcovia PSPI prezentovali negat\'edvne stanovisko k pr\'edpadn\'e9mu s\'fa\'e8asn\'e9mu zaradeniu dvoch pneumokokov\'fdch vakc\'edn do povinn\'e9ho o\'e8kovania.
\par 
\par }\pard \ltrpar\qj \fi708\li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid8929971 {\rtlch\fcs1 \af0 \ltrch\fcs0 \lang1051\langfe1029\langfenp1029\insrsid5773059 V\'9aetky z\'fa\'e8astnen\'e9
 strany sa zhodli na skuto\'e8nosti, \'9ee v\~\'9eiadnom pr\'edpade nie je vhodn\'e9 pou\'9e\'edva\'9d v\~r\'e1mci povinn\'e9ho o\'e8kovania dve r\'f4zne sch\'e9my, t.j. sch\'e9mu 2+1 pre jednu vakc\'ednu a\~sch\'e9mu 3+1 pre druh\'fa vakc\'ednu. S\'fa
\'e8asne sa v\'9aetky z\'fa\'e8astnen\'e9 strany zhodli na potrebe vytvorenia }{\rtlch\fcs1 \af0 \ltrch\fcs0 \lang1051\langfe1029\langfenp1029\insrsid1050494 n\'e1rodn\'e9ho }{\rtlch\fcs1 \af0 \ltrch\fcs0 \lang1051\langfe1029\langfenp1029\insrsid5773059 
referen\'e8n\'e9ho centra pre pneumokokov\'e9 infekcie.
\par }\pard \ltrpar\qj \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid8870960 {\rtlch\fcs1 \af0 \ltrch\fcs0 \lang1051\langfe1029\langfenp1029\insrsid5773059 
\par \tab V\~z\'e1vere stretnutia Mgr. Gajdo\'9aov\'e1 zhrnula n\'e1vrhy spolo\'e8nosti GlaxoSmithKline, s.r.o. a Pfizer Luxembourg SARL, o.z.  na zaradenie vakc\'edn SYNFLORIX a\~PREVENAR. \'cfalej v\~tejto s\'favislosti uviedla, \'9ee Ministerstvo zdravotn
\'edctva Slovenskej republiky v\~zmysle predch\'e1dzaj\'facich stretnut\'ed a\~v\~zmysle dne\'9an\'e9ho stretnutia vyzve z\'e1stupcov oboch spolo\'e8nost\'ed na predlo\'9eenie \'9eiadost\'ed o\~zmenu \'faradne ur\'e8enej ceny lieku pre obe vakc\'edny. 

\par }\pard \ltrpar\qj \fi708\li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid3492256 {\rtlch\fcs1 \af0 \ltrch\fcs0 \lang1051\langfe1029\langfenp1029\insrsid2427970 
\par }{\rtlch\fcs1 \af0 \ltrch\fcs0 \lang1051\langfe1029\langfenp1029\insrsid5773059 Mgr. Gajdo\'9aov\'e1 s\'fa\'e8asne poznamenala, \'9ee v\'fdsledn\'e9 rozhodnutie o zaraden\'ed oboch vakc\'edn priprav\'ed Ministerstvo zdravotn\'edctva SR za z\'e1
klade predlo\'9een\'fdch \'9eiadost\'ed o\~zmenu \'faradne ur\'e8enej ceny liekov a\~zhodnotenia prezentovan\'fdch stanov\'edsk v\'9aetk\'fdch subjektov, ktor\'e9 sa z\'fa\'e8astnili dne\'9an\'e9ho stretnutia. 
\par }{\rtlch\fcs1 \af0 \ltrch\fcs0 \lang1051\langfe1029\langfenp1029\insrsid2427970 
\par }{\rtlch\fcs1 \af0 \ltrch\fcs0 \lang1051\langfe1029\langfenp1029\insrsid5773059 Rozhodnutie ministerstva sa premietne do n\'e1vrhu opatrenia, ktor\'fdm sa vyd\'e1va Zoznam lie\'e8iv a\~liekov s\~predpokladanou \'fa\'e8innos\'9dou od 1.1.2011.
\par }\pard \ltrpar\qj \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid8870960 {\rtlch\fcs1 \af0 \ltrch\fcs0 \lang1051\langfe1029\langfenp1029\insrsid5773059 \tab 
\par }{\rtlch\fcs1 \af0 \ltrch\fcs0 \lang1051\langfe1029\langfenp1029\insrsid5319719 
\par }{\rtlch\fcs1 \af0 \ltrch\fcs0 \lang1051\langfe1029\langfenp1029\insrsid5773059\charrsid3540993 Zap\'edsal}{\rtlch\fcs1 \af0 \ltrch\fcs0 \lang1051\langfe1029\langfenp1029\insrsid5773059 a}{\rtlch\fcs1 \af0 \ltrch\fcs0 
\lang1051\langfe1029\langfenp1029\insrsid5773059\charrsid3540993 :}{\rtlch\fcs1 \af0 \ltrch\fcs0 \lang1051\langfe1029\langfenp1029\insrsid5773059  PharmDr. \'bcubom\'edra Kniezov\'e1, CSc.}{\rtlch\fcs1 \af0 \ltrch\fcs0 
\lang1051\langfe1029\langfenp1029\insrsid5773059\charrsid3540993 
\par }{\rtlch\fcs1 \af0 \ltrch\fcs0 \lang1051\langfe1029\langfenp1029\insrsid5773059 
\par }{\rtlch\fcs1 \af0 \ltrch\fcs0 \lang1051\langfe1029\langfenp1029\insrsid5773059\charrsid3540993 Schv\'e1lil}{\rtlch\fcs1 \af0 \ltrch\fcs0 \lang1051\langfe1029\langfenp1029\insrsid5773059 :}{\rtlch\fcs1 \af0 \ltrch\fcs0 
\lang1051\langfe1029\langfenp1029\insrsid15954935   }{\rtlch\fcs1 \af0 \ltrch\fcs0 \lang1051\langfe1029\langfenp1029\insrsid5773059 Mgr. Michaela Gajdo\'9aov\'e1,}{\rtlch\fcs1 \af0 \ltrch\fcs0 \lang1051\langfe1029\langfenp1029\insrsid5319719  MPH}{
\rtlch\fcs1 \af0 \ltrch\fcs0 \lang1051\langfe1029\langfenp1029\insrsid5773059  gener\'e1lna riadite\'beka Sekcie farm\'e1cie a\~liekovej politiky}{\rtlch\fcs1 \af0 \ltrch\fcs0 \lang1051\langfe1029\langfenp1029\insrsid15954935  - zastupuj\'faca}{
\rtlch\fcs1 \af0 \ltrch\fcs0 \lang1051\langfe1029\langfenp1029\insrsid5773059 
\par \tab     Mgr. Mat\'fa\'9a Teke\'be, riadite\'be odboru kategoriz\'e1cie, cenotvorby a\~liekovej politiky}{\rtlch\fcs1 \af0 \ltrch\fcs0 \lang1051\langfe1029\langfenp1029\insrsid15954935  - zastupuj\'faci}{\rtlch\fcs1 \af0 \ltrch\fcs0 
\lang1051\langfe1029\langfenp1029\insrsid5773059 
\par 
\par 
\par V\~Bratislave, d\'f2a  26.10.2010}{\rtlch\fcs1 \af0 \ltrch\fcs0 \cf1\lang1029\langfe1029\langnp1029\langfenp1029\insrsid5773059 
\par }}