COFACT

Genel Bilgiler

  • Ticaret Unvanı:
  • COFACT 20 ML IV ENJ. ICIN COZ. ICEREN FLAKON
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  • Turuncu
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Yerelleştirme

  • Bulunduğu ülkeler::
  • COFACT 20 ML IV ENJ. ICIN COZ. ICEREN FLAKON
    Türkiye
  • Dil:
  • Türkçe

Terapötik bilgiler

  • Terapötik alanı:
  • pıhtılaşma faktörü IX, II, birlikte VII ve x

Diğer bilgiler

Durum

  • Kaynak:
  • TİTCK - TÜRKİYE İLAÇ VE TIBBİ CİHAZ KURUMU - Türkiye
  • Yetkilendirme durumu:
  • Aktif
  • Yetkilendirme numarası:
  • 8699823980112
  • Yetkilendirme tarihi:
  • 29-01-2013
  • Son Güncelleme:
  • 25-05-2018

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KULLANMATALİMATI

COFACT250IU/10mLIVEnjeksiyonİçinTozİçerenFlakon

Etkinmadde:İnsanProtrombinKompleksi(=FaktörII/VII/IX/X)

Yardımcımaddeler:Trisodyumsitratdihidrat,sodyumklorürveantitrombinIII

Çözücü:Enjeksiyonluksu

Bukullanmatalimatında:

1. COFACT

nedirveneiçinkullanılır?

2. COFACT’ıkullanmadanöncedikkatedilmesigerekenler

3. COFACTnasılkullanılır?

4. Olasıyanetkilernelerdir?

5. COFACT’ınsaklanması

Başlıklarıyeralmaktadır.

1. COFACTnedirveneiçinkullanılır?

COFACT,enjeksiyonlukçözeltiiçintozveçözücüsü(10mLflakon)ilebiradettransfer

iğnesivedezenfeksiyonmendiliiçerir.EnjeksiyoniçinCOFACTtozmavimsibirtozdur.

Enjeksiyonahazırçözeltimavimsirenkalır.

Etkinmaddeler,koagülasyon(pıhtılaşma)faktörleriII,VII,IXveX’dur.Bufaktörlerinsan

kanınınnormalbileşenleridir.Bufaktörlerdenbirveyabirkaçınıneksikliğindekanınızda

pıhtılaşmaproblemleriortayaçıkacaktır.Bununsonucundakanamameydanagelebilir.

COFACT kullanılarakbueksikliğingiderilmesiyoluylakanamanıntedavisiveyaönlenmesi

amaçlanır.

COFACTaşağıdabelirtilenendikasyonlardakullanılabilir:

Aşağıdakidurumlarınsonucundaortayaçıkabilenkanamalarıntedavisiveyaoperasyon

sırasındakikanamalarınönlenmesinde:

Protrombinkompleksikoagülasyon(pıhtılaşma)faktörlerininedinilmiş(kazanılmış)

yetmezlikleri.ÖrneğinVitaminKantagonistleriiletedaviveyaVitaminK

antagonistlerininaşırıdozdauygulanmasıilemeydanagelenyetmezliklerde,bu

BuilacıkullanmayabaşlamadanöncebuKULLANMATALİMATINIdikkatlice

okuyunuz,çünküsiziniçinönemlibilgileriçermektedir.

Bukullanmatalimatınısaklayınız.Dahasonratekrarokumayaihtiyaçduyabilirsiniz.

Eğerilavesorularınızolursa,lütfendoktorunuzaveyaeczacınızadanışınız.

Builaçkişiselolaraksiziniçinreçeteedilmiştir,başkalarınavermeyiniz.

Builacınkullanımısırasında,doktoraveyahastaneyegittiğinizdebuilacıkullandığınızı

doktorunuzasöyleyiniz.

Butalimattayazılanlaraaynenuyunuz.İlaçhakkındasizeönerilendozundışında

yüksekveyadüşükdozkullanmayınız.

Kvitamininebağımlıkoagülasyon(pıhtılaşma)faktörlerininKonjenital(doğumsal)

olarakeksikliğinde.(Saflaştırılmışvespesifikkoagülasyon(pıhtılaşma)faktörü

ürünlerininbulunmadığıdurumlarda)

2. COFACT’ıkullanmadanöncedikkatedilmesigerekenler

COFACTinsankanınınsıvıolankısmından(plazmasından)eldeedilir.Bunedenlepekçok

insanınkanıtoplanmaktavebukanlarınplazmasındanyararlanılmaktadır.İlaçlarinsankanı

yadaplazmasındanüretildiğinde,hastalarageçebilecekhastalıknedenleriniönlemekve

etkenleriningeçişiniengellemekiçinbirdiziönlemleralınır.Bunlar,hastalıktaşımariskiolan

kanvericilerinisaptamakvedışarıdabırakıldıklarındaneminolmakiçin,kanveplazma

vericilerinindikkatlibirşekildeseçiminiveherbirkanbağışınınveplazmahavuzlarının,

virüs/enfeksiyonbelirtileriaçısındantestedilmesiniiçerir.Buürünlerinüreticileriayrıca,

kanınveplazmanınişlenmesisürecinevirüsleriarındıracakyadaetkisizhalegetirecek

basamaklarıdadahilederler.

COFACT’ınüretimiiçinalınanönlemler,İnsanİmmünYetmezlikVirüsü(HIV),hepatitB

virüsü,hepatitCvirüsügibizarflıvirüsleriçinvehepatitAvirüsügibizarfsızvirüsleriçin

etkiliolarakdeğerlendirilmektedir.AlınanönlemlerParvovirüsB19gibidiğerzarfsız

virüslerekarşıkısıtlıolabilmektedir.ParvovirüsB19enfeksiyonu,hamilekadınlar(cenin

enfeksiyonu),bağışıklıksistemibaskılanmışbireyleryadadiğertipteanemihastaları

(örneğinorakhücreanemisiyadahemolitikanemi)içinciddiolabilir.

Buürüninsankanındaneldeedildiğinden,virüslergibienfeksiyözajanlarınveteorikolarak

Creutzfeldt-Jacob(CJD)hastalığıajanlarınınbulaşmariskinitaşıyabilir.Hekimbuürününrisklerive

yararlarıhakkındahastayabilgivermelidir.

Tümbuönlemlererağmeninsanplazmasındanyadakanındaneldeedilenürünlerenfeksiyon

bulaştırmariskitaşıyabilmektedir.Bunedenleilerideoluşabilecekbirhastalıklakullanılmış

ürünarasındakibağlantıyıkurabilmekiçin,kullandığınızürününadıveserinumarasını

kaydederekbukayıtlarısaklayınız.

COFACTtekkullanımlıktır.Aynıflakonuikincikezkullanmayınızveyabaşkabirhastaya

kullandırmayınız.

Buuyarılargeçmiştekiherhangibirdönemdedahiolsa,siziniçingeçerliyselütfen

doktorunuzadanışınız.

COFACT’ıaşağıdakidurumlardaKULLANMAYINIZ

EğerCOFACTiçeriğindekietkinmaddeyeveyaherhangibirbileşeneaşırı

duyarlıysanız(alerjikseniz)

COFACT’ıaşağıdakidurumlardaDİKKATLİKULLANINIZ:

Eğerdahaöncekanürünükullanımlarınızsırasındaaşırıduyarlıolduğunuzortaya

çıkmışisedikkatliolmalısınız.COFACTancakbaşkabirseçenekolmadığı

durumlardakullanılmalıdır(hayatitehlikegibidurumlarda).Tedavimutlakahastanede

veyabirdoktorunkontrolüaltındayapılmalıdır.

COFACT,kumarintürevlerinin(kanınpıhtılaşmasınıönleyenilaçlardır,bunedenle

antikoagülanlarolarakadlandırılırlar)etkilerineaksitesiryapar.EğerCOFACT

kumarintürevlerininaşırıdozdaalınmışolmasınedeniyleuygulanıyorsa,sizetedavi

ilebirlikteK1vitaminideverilecektir.

Doktorunuz,COFACTkullanımınınsiziniçintrombozriski(kandamarlarıiçinde

kanpıhtısıoluşumu,Bkz.“olasıyanetkiler”)oluşturupoluşturmayacağınıkontrol

edecektir.Aşağıdakibireylerintrombozgeliştirmeolasılığıyüksektir:

Kalpkrizigeçirenler

Diğerkoronerarterhastalıklarıgeçirmiş(veyahalengeçiren)bireyler

Karaciğerhastalığıolanlar

Yenidoğanlar

Yenicerrahioperasyongeçirmişolanlar.

Buuyarılargeçmiştekiherhangibirdönemdedahiolsa,siziniçingeçerliyselütfen

doktorunuzadanışınız.

COFACT’ınyiyecekveiçecekilekullanılması

Yiyecekveiçeceklerilebilinenbiretkisiyoktur.

Hamilelik

lacıkullanmadanöncedoktorunuzaveyaeczacınızadanışınız.

HamilekadınlardaCOFACTkullanımıaraştırılmamıştır.COFACTinsankanındanüretildiği

içinhayvanlarüzerindearaştırmamümkündeğildir.Hamileysenizveyahamilekalmak

istiyorsanızdoktorunuzadanışınız.

Tedavinizsırasındahamileolduğunuzufarkedersenizhemendoktorunuzaveeczacınıza

danışınız.

Emzirme

lacıkullanmadanöncedoktorunuzaveyaeczacınızadanışınız.

Emziriyorsanızbudurumudoktorunuzabildiriniz.COFACTemzirmedönemindegerektiği

takdirdekullanılabilir.

Araçvemakinekullanımı

COFACT’ınaraçveyamakinekullanmayeteneğiüzerineherhangibiretkisi

beklenmemektedir.

COFACT’ıniçeriğindebulunanbazıyardımcımaddelerhakkındaönemlibilgi

Butıbbiürünherdoziçin125-195mmol/Lsodyumiçerir.Budurum,kontrollüsodyum

diyetindeolanhastalariçingözönündebulundurulmalıdır.

Diğerilaçlarilebirliktekullanım

COFACT’ınantikoagülanlarhariçdiğerilaçlarlaolasıetkileşiminedairherhangibirbilgi

bulunmamaktadır.

Eğerreçeteliyadareçetesizherhangibirilacışuandakullanıyorsanızveyasonzamanlarda

kullandınızsalütfendoktorunuzaveyaeczacınızabunlarhakkındabilgiveriniz.

3. COFACTnasılkullanılır?

Uygunkullanımvedoz/uygulamasıklığıiçintalimatlar:

Doktorunuz,antikoagülankullanımısonucundaveyavitaminK’yabağımlıkoagülasyon

(pıhtılaşma)faktörlerindenbirininkonjenital(doğumsal)olarakeksikliğisonucundaortaya

çıkankanamalarıntedavisiveyaönlenmesiiçingerekenCOFACTmiktarınakararverecektir.

Kesindozşudurumlarabağlıdır:

Durumunuzunşiddeti

Kilonuz

İhtiyacınızolanpıhtılaşmafaktörleri

Bufaktörlerinkanınızdakimiktarı(kandakidüzeyi)

Konjenital(doğumsal)koagülasyon(pıhtılaşma)faktörüyetmezliklerinde,koagülasyon

(pıhtılaşma)faktörlerininkandakidüzeylerinindüzenliolarakizlenmesiönemlidir.

Pıhtılaşmayıönleyiciilaç(antikoagülan)kullanımısonucundaortayaçıkankanamaların

tedavisiveönlenmesiiçinUluslararasıNormalizeEdilmişOran(INR)değerinintespiti:

Pıhtılaşmayıönleyiciilaçkullanımısonucundakanınızınpıhtılaşmasıuzunsürecektir.Bu

durumkanamaolasılığınıarttırır.Pıhtılaşmanınçözülmesitedavisisırasındaistenen

pıhtılaşmayıönleyiciilaçaktivitesininderecesinintespitiiçinkanpıhtısıtesti(trombotesti,

TT)kullanılır.SonuçUluslararasıNormalizeEdilmişOran(INR)olarakifadeedilir.Kanama

durumundaveyakanamanınönlenmesiiçinINRdeğerinizinbellidüzeyegetirilmesi

önemlidir.

stenenINRdüzeyinisağlamakiçinşunlaryapılmalıdır:

Pıhtılaşmayıönleyiciilaçuygulamasıdurdurulmalıdır.

MutlakaKvitaminiuygulanmalıdır.Aşırıderecedeşiddetlikankaybı(şok)

durumundaVitaminKdamariçineuygulanmalıdır(intravenözolarak).

COFACTistenenINRdüzeyineulaşılıncayakadarkullanılmalıdır.Doktorunuz

doztayiniiçinözeltablolarkullanacaktır.

COFACTkullanımınıtakibenvebundansonrakibellibirsüreINRdeğerinizin

düzenliolarakölçülmesiönemlidir.

Uygulamayoluvemetodu:

ntravenözyollauygulanır.

Toz,beraberindekienjeksiyonluksudaçözülmelidir.Kullanmadanönceflakonlarınher

ikisinindeodasıcaklığına(15-25°C)getirilmesigerekir.Çözmeböylecedahakolay

olacaktır.Ayrıca,kullanımsırasındaçözeltiçoksoğukolmamalıdır.

1.Toziçerenflakonunveenjeksiyonluksuyuiçerenflakonunplastikkoruyucukapakları

kaldırılır.

2.Herikiflakonunlastikkapaklarıdezenfeksiyonmendiliveyaalkolle(%70)ıslatılmış

gazlıbezledezenfekteedilir.

3.Transferiğnesinintakılıpçıkarılabilenbölümündenkoruyucukılıfçıkarılırvetransfer

iğnesininkılıfolmayankısmıenjeksiyonluksuiçerenflakonabatırılır.Dahasonra

transferiğnesinindiğerucundakikoruyucukaldırılır.

4.Transferiğnesiniiçindebulunduğuflakonbaşaşağıçevirilirveiğnetoziçerenflakona

sokulur.Sukendiliğindentoziçerenflakonageçer.Suyunflakonunduvarlarından

akmasınısağlamakiçintoziçerenflakonhafifçeeğiktutulmaldır.Sukarşıtarafageçer

geçmezboşflakonvetransferiğnesitekbirhareketleçıkarılır.

Hafifçedöndürerek(çalkalamadan)tozçözülür.Toz,10dakikaiçindeçözünerek

neredeysetamamenberrakmavirenklibirçözeltioluşturur.Çözeltibulanıkolmamalıve

tortuiçermemelidir.Birkezçözündüktensonraürünodasıcaklığında(15-25 0 C)3saat

saklanabilir.

Uygulama:Çözeltiderhal,enfazla3saatiçerisindekullanılmalıdır.Kullanmadanönce

ürününberraklığıveiçerisindetortuolupolmadığıkontroledilmelidir.

Çözülmüşürünflakondanenjektörkullanılarakçekilir.

COFACTdamariçine(intravenözolarak)uygulanmalıdır.

Çözülmüşürünyavaşçauygulanır(yaklaşıkolarakdakikada2mL)

Değişikyaşgrupları:

Çocuklardakullanım:

COFACTdozunveinfüzyonhızınındikkatlibirşekildeayarlanmasıdurumundaçocuklarda

güvenlekullanılabilir.

Yaşlılardakullanım:

65yaşınınüzerindekihastalarda;doktortarafındandozayarlamasıyapılarakvedahayavaş

birinfüzyonhızındaverilir.

Özelkullanımdurumları:

Böbrek/karaciğeryetmezliği:

Böbrekvekaraciğerfonksiyonbozukluğunuzbulunuyorsa,builacıkullanmadanönce

doktorunuzasöyleyinizvedoktorunuzuntalimatlarınauyunuz.Böbrekve/veyakaraciğer

yetmezliğiolanhastalardaCOFACT,doktorunbelirleyeceğiçokdüşükkonsantrasyonlardave

pratikolarakmümkünolabilecekenyavaşinfüzyonhızındaverilir.Böbrekfonksiyontestleri

dedüzenliolarakyapılmalıdır.

DoktorunuzCOFACTiletedavinizinnekadarsüreceğinisizebildirecektir.Tedaviyi

kesinlikleerkenkesmeyinizçünküistenensonucualamayabilirsiniz.

EğerCOFACT’ınetkisininçokgüçlüveyazayıfolduğunadairbirizleniminizvarise

doktorunuzveyaeczacınızlakonuşunuz.

KullanmanızgerekendendahafazlaCOFACTkullandıysanız:

KullanmanızgerekendendahafazlaCOFACTkullandıysanız,kandamarlarındapıhtı

oluşmasınedeniyletrombojeniketkilergörülebilir

COFACT’tankullanmanızgerekendenfazlasınıkullanmışsanızbirdoktorveyaeczacıile

konuşunuz.

COFACT’ıkullanmayıunutursanız:

Unutulandozlarıdengelemekiçinçiftdozalmayınız.

COFACTiletedavisonlandırıldığındaoluşabileceketkiler

Bulunmamaktadır.

4. Olasıyanetkilernelerdir?

Tümilaçlargibi,COFACTyanetkilerenedenolabilir,ancakherkullanandabuetkiler

görülmez.

YüksekdozlardaCOFACT’ınkullanılması,damarlardakanpıhtılaşmasınanedenolan

trombozayolaçabilir.

II,VII,IXyadaXpıhtılaşmafaktörlerindenbirinineksikolduğuhastalardaCOFACT

kullanımısonucundabufaktörlerekarşıantikorgelişebilir.Bugibibirdurumda,ürünün

etkinliğienuygundüzeydeolmayacaktır.

Teorikolarakalerji(aşırıduyarlılık)oluşabilmektedir.Budurumdauygulamaderhal

durdurulmalıdır.

Eğeryanetkilerdenherhangibiriciddileşirsedoktorunuzaveyaeczacınızıbilgilendiriniz.

Eğerbukullanmatalimatındabahsigeçmeyenherhangibiryanetkiilekarşılaşırsanız,

doktorunuzuveyaeczacınızıbilgilendiriniz.

5. COFACT’ınsaklanması

COFACT’ıçocuklarıngöremeyeceği,erişemeyeceğiyerlerdeveambalajındasaklayınız.

COFACT’ı2°C-8°C(buzdolabında)saklayınız.

Işıktankorumakiçinflakonudışkartonuiçindesaklayınız.

Dondurmayınız.Donmuşürünüçözüpkullanmayınız.

Sonkullanmatarihiyleuyumluolarakkullanınız.

AmbalajlardabelirtilensonkullanmatarihindensonraCOFACT’ıkullanmayınız.

ÇevreyikorumakamacıylakullanmadığınızCOFACT’ışehirsuyunaveyaçöpeatmayınız.Bu

konudaeczacınızadanışınız.

RuhsatSahibi

CenturionPharmaİlaçSanayiveTicaretLtdŞti.

BalmumcuHoşsohbetSok.No:6

34349İstanbul

Telefon:02122750708

Faks:02122746149

Üretici:

SanquinBloedvoorziening

Plesmanlaan1251066CXAmsterdam–HOLLANDA

Bukullanmatalimatı03.02.2012tarihindeonaylanmıştır.



AŞAĞIDAKİBİLGİLERBUİLACIUYGULAYACAKSAĞLIKPERSONELİ

ÇİNDİR.

Pozoloji:

Tedavikoagülasyonhastalıklarınıntedavisindeuzmanbirhekimingözetimialtında

başlatılmalıdır.Yerinekoymatedavisinindozajıvesüresi,hastalığınşiddetine,kanamanın

yerivebüyüklüğünevehastanınklinikdurumunabağlıdır.

Uygulamayöntemi:

Ürünaşağıdabelirtildiğigibiçözündürülür.COFACTintravenözolarakuygulanmalıdır.

Sulandırılarakhazırlananürünündakikadayaklaşık2mlhızındauygulanmasıtavsiye

edilmektedir.

Çözündürme

Kurutulmuşproteinfraksiyonubelirtilenhacimdeenjeksiyonluksuylasulandırılmalıdır.Ürün2-

8°C’desaklandıise,COFACTveenjeksiyonluksuflakonlarınınçözündürülmedenönceoda

sıcaklığına(15-25°C)getirilmesigereklidir.

Transferiğnesininkullanmaprosedürü

1.Hemürünüiçerenflakonununhemdeenjeksiyonluksuiçerenflakonunplastikkoruyucu

kapaklarıkaldırılır.

2.Herikiflakonunkauçuktıpaları,dezenfeksiyonmendiliyadaalkolle(%70)ıslatılangazlı

bezledezenfekteedilir.

3.Transferiğnesininbirucundakikoruyucukapakçıkarılırveenjeksiyonluksuiçeren

flakonunkapağınabatırılır.Dahasonratransferiğnesinindiğerucundakikoruyucuçıkartılır.

Transferiğnesiniiçerenflakonbaşaşağıçevrilirveucuhalenboşolaniğnehementozürünü

içerenflakonabatırılır.

4.Ürününbulunduğuflakondakidüşükbasınç,enjeksiyonluksuyunflakonageçişini

sağlayacaktır.Öneri:Enjeksiyonluksutransferedilirkentozürünüiçerenflakonyanadoğru

eğilerek,çözücününürünflakonununyanlarınıyıkamasısağlanır.Buürünündahahızlı

çözünmesineyardımcıolmaktadır.Tümsutransferitamamlandıktansonraboşflakonve

transferiğnesitekbirhareketleçıkartılmalıdır.

Çözünmeyihızlandırmakiçinflakonhafifçekendietrafındadöndürülebilirveeğergerekirse,

30°C’yekadarısıtılabilir.Flakonaslaçalkalanmamalıveyaflakonunsıcaklığının37°C’yi

aşmasınamüsadeedilmemelidir.Eğerflakonsubanyosundaısıtılırsa,koruyucukapağın

ve/veyakauçuktıpanınsuylatemasetmemesinedikkatedilmelidir.

Kuralolarak,mavirenklibirçözeltioluşmasıiçinkurutulmuşmadde10dk.içerisindetam

olarakçözündürülmelidir;mavirenkplazmaproteiniseruloplazmininvarlığıilemeydana

gelmektedir.

Çözeltiberrakyadaçokhafifopakolmalıdır.Bulanıkyadaçökeltiiçerençözeltiler

kullanılmamalıdır.

Sulandırılarakhazırlananürünuygulamaöncesindepartikülmaddeverenkdeğişimi

açısındangörselolarakincelenmelidir.

Cofactherhangibirürünlekarıştırılmamalıdır.

Kullanılmamışolanürünleryadaatıkmateryaller“TıbbiAtıklarınKontroluYönetmeliği”ve

“AmbalajAtıklarınınKontroluYönetmeliği’neuygunolarakimhaedilmelidir.

14-12-2018

Analysis of hunting statistics collection frameworks for wild boar across Europe and proposals for improving the harmonisation of data collection

Analysis of hunting statistics collection frameworks for wild boar across Europe and proposals for improving the harmonisation of data collection

Published on: Thu, 13 Dec 2018 Heterogeneities in the wild boar data collection frameworks across Europe were analysed using questionnaires to explore comparability of hunting data in the short term and propose a common framework for future collection. Fifty‐seven respondents representing 32 countries covering more than 95% of European territory participated to the questionnaire. The most frequently recorded information in the official statistics included the quantity of animals shot per hunting ground ...

Europe - EFSA - European Food Safety Authority Publications

11-12-2018

FDA warns API manufacturer involved in valsartan recall, provides information for patients taking these medications

FDA warns API manufacturer involved in valsartan recall, provides information for patients taking these medications

FDA update on the ongoing investigation into angiotensin II receptor blocker impurities, recalls and current findings.

FDA - U.S. Food and Drug Administration

30-11-2018

Epidemiological analyses of African swine fever in the European Union (November 2017 until November 2018)

Epidemiological analyses of African swine fever in the European Union (November 2017 until November 2018)

Published on: Thu, 29 Nov 2018 This update on the African swine fever (ASF) outbreaks in the EU demonstrated that out of all tested wild boar found dead, the proportion of positive samples peaked in winter and summer. For domestic pigs only, a summer peak was evident. Despite the existence of several plausible factors that could result in the observed seasonality, there is no evidence to prove causality. Wild boar density was the most influential risk factor for the occurrence of ASF in wild boar. In th...

Europe - EFSA - European Food Safety Authority Publications

28-11-2018

EFSA Scientific Colloquium 24 – 'omics in risk assessment: state of the art and next steps

EFSA Scientific Colloquium 24 – 'omics in risk assessment: state of the art and next steps

Published on: Tue, 27 Nov 2018 In recent years, the development of innovative tools in genomics, transcriptomics, proteomics and metabolomics (designated collectively as 'omics technologies) has opened up new possibilities for applications in scientific research and led to the availability of vast amounts of analytical data. The interpretation and integration of 'omics data can provide valuable information on the functional status of an organism and on the effect of external factors such as stressors. T...

Europe - EFSA - European Food Safety Authority Publications

27-11-2018

Database of processing techniques and processing factors compatible with the EFSA food classification and description system FoodEx 2 Objective 1: Compendium of Representative Processing Techniques investigated in regulatory studies for pesticides

Database of processing techniques and processing factors compatible with the EFSA food classification and description system FoodEx 2 Objective 1: Compendium of Representative Processing Techniques investigated in regulatory studies for pesticides

Published on: Mon, 26 Nov 2018 EFSA is conducting pan‐European dietary exposure and risk assessments related to actual levels of pesticide residues in food commodities. These assessments use the pesticide occurrence data generated under the official monitoring programs of Member States, the consumption data from EFSA's comprehensive food consumption database and pesticide‐specific information such as processing factors. Currently no harmonised list of processing factors is available within Europe and wo...

Europe - EFSA - European Food Safety Authority Publications

27-11-2018

Database of processing techniques and processing factors compatible with the EFSA food classification and description system FoodEx 2 Objective 3: European database of processing factors for pesticides in food

Database of processing techniques and processing factors compatible with the EFSA food classification and description system FoodEx 2 Objective 3: European database of processing factors for pesticides in food

Published on: Mon, 26 Nov 2018 EFSA is conducting pan‐European dietary exposure and risk assessments related to actual levels of pesticide residues in food commodities. These assessments use the pesticide occurrence data generated under the official monitoring programs of Member States, the consumption data from EFSA's comprehensive food consumption database and pesticide‐specific information such as processing factors. Currently no harmonised list of processing factors is available within Europe and wo...

Europe - EFSA - European Food Safety Authority Publications

27-11-2018

Database of processing techniques and processing factors compatible with the EFSA food classification and description system FoodEx2 related to pesticide residues Objective 2: Linking the processing techniques investigated in regulatory studies with the E

Database of processing techniques and processing factors compatible with the EFSA food classification and description system FoodEx2 related to pesticide residues Objective 2: Linking the processing techniques investigated in regulatory studies with the E

Published on: Mon, 26 Nov 2018 In the framework of the project ‘Database of processing techniques and processing factors compatible with the EFSA food classification and description system FoodEx2’ a compendium of representative processing techniques was prepared as a result of Objective 1. In Objective 2 the food / feed items and processes as described in the compendium of Objective 1 were coded using the FoodEx2 coding system. The coding covers the raw agricultural commodities and the food / feed item...

Europe - EFSA - European Food Safety Authority Publications

23-11-2018

FDA Classifies Field Action Related to Fc 500™ And Epics® As Class 1 Recall Beckman Coulter Life Sciences Committed to Helping Customers Take Prompt, Appropriate Actions

FDA Classifies Field Action Related to Fc 500™ And Epics® As Class 1 Recall Beckman Coulter Life Sciences Committed to Helping Customers Take Prompt, Appropriate Actions

Beckman Coulter Life Sciences today announced the previously communicated global voluntary recall launched in January 2018 related to the FC 500™ Series Flow Cytometers (FC 500), COULTER® EPICS® XL™ and COULTER® EPICS® XL-MCL™ Flow Cytometer with System II Software (together referred to as the EPICS) has been classified as Class 1 by the U.S. Food and Drug Administration (FDA).

FDA - U.S. Food and Drug Administration

21-11-2018

Safety and efficacy of Monteban® G100 (narasin) for chickens for fattening

Safety and efficacy of Monteban® G100 (narasin) for chickens for fattening

Published on: Tue, 20 Nov 2018 The feed additive Monteban® G100, containing the active substance narasin, an ionophore anticoccidial, is intended to control coccidiosis in chickens for fattening at a dose of 60–70 mg/kg complete feed. Narasin is produced by fermentation. Limited data on the taxonomic identification of the production strain did not allow the proper identification of strain NRRL 8092 as Streptomyces aureofaciens. The FEEDAP Panel cannot conclude on the absence of genetic determinants for ...

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

Risk for animal and human health related to the presence of dioxins and dioxin-like PCBs in feed and food

Risk for animal and human health related to the presence of dioxins and dioxin-like PCBs in feed and food

Published on: Tue, 20 Nov 2018 The European Commission asked EFSA for a scientific opinion on the risks for animal and human health related to the presence of dioxins (PCDD/Fs) and DL‐PCBs in feed and food. The data from experimental animal and epidemiological studies were reviewed and it was decided to base the human risk assessment on effects observed in humans and to use animal data as supportive evidence. The critical effect was on semen quality, following pre‐ and postnatal exposure. The critical s...

Europe - EFSA - European Food Safety Authority Publications

17-11-2018

Evaluation of confirmatory data following the Article 12 MRL review for picolinafen

Evaluation of confirmatory data following the Article 12 MRL review for picolinafen

Published on: Fri, 16 Nov 2018 The applicant BASF Agro B.V. submitted a request to the competent national authority in Germany to evaluate the confirmatory data that were identified for picolinafen in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, a new validated analytical method for enforcement of the residue in dry/high starch‐, high water content‐, high acid content‐ and high oil content commodities ...

Europe - EFSA - European Food Safety Authority Publications

16-11-2018

Evaluation of confirmatory data following the Article 12 MRL review for pyraclostrobin

Evaluation of confirmatory data following the Article 12 MRL review for pyraclostrobin

Published on: Thu, 15 Nov 2018 The applicant BASF SE submitted a request to the competent national authority in Germany to evaluate the confirmatory data that were identified for pyraclostrobin in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, residues trials supporting the existing use of pyraclostrobin on table grapes authorised in southern EU Member States and an analytical method for analysing residues of pyraclostrobin in ...

Europe - EFSA - European Food Safety Authority Publications

14-11-2018

Evaluation of confirmatory data following the Article 12 MRL review for cyazofamid

Evaluation of confirmatory data following the Article 12 MRL review for cyazofamid

Published on: Tue, 13 Nov 2018 The applicant ISK Biosciences Europe N.V. submitted a request to the competent national authority in France to evaluate the confirmatory data that were identified in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005 as not available. The data gap which was related to information on freezer storage conditions for the residue trials reported on potatoes, tomatoes and cucurbits with edible and inedible peel was considered satisfactorily addressed...

Europe - EFSA - European Food Safety Authority Publications

13-11-2018

The importance of vector abundance and seasonality

The importance of vector abundance and seasonality

Published on: Mon, 12 Nov 2018 00:00:00 +0100 This joint ECDC‐EFSA report assesses whether vector count data (abundance) and the way these change throughout the year (seasonality) can provide useful information about vector‐borne diseases epidemiological processes of interest, and therefore, whether resources should be devoted to collecting such data. The document also summarises what measures of abundance and seasonality can be collected for each vector group (mosquitoes, sandflies, midges and ticks), ...

Europe - EFSA - European Food Safety Authority Publications

8-11-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to strengthen FDA’s expanded access program

Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to strengthen FDA’s expanded access program

The FDA is committed to the expanded access program which provides a pathway for patients to gain access to investigational drugs, biologics and medical devices for serious diseases and life-threatening conditions outside of clinical trials when no comparable or satisfactory approved alternative therapy options are available.

FDA - U.S. Food and Drug Administration

6-11-2018

Evaluation of confirmatory data following the Article 12 MRL review for kresoxim‐methyl

Evaluation of confirmatory data following the Article 12 MRL review for kresoxim‐methyl

Published on: Fri, 02 Nov 2018 00:00:00 +0100 The applicant BASF SE submitted a request to the competent national authority in Belgium to evaluate the confirmatory data that were identified for kresoxim‐methyl in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the confirmatory data requirement, a new study on the storage stability of kresoxim‐methyl residues in animal matrices was submitted. The data gap was considered ...

Europe - EFSA - European Food Safety Authority Publications

30-10-2018

Training courses on “Steering an Expert Knowledge Elicitation” and “Use of the Expert Knowledge Elicitation Guidance in Risk Assessments for EFSA Management” and “Conduct of the Sheffield protocol for an Expert Knowledge Elicitation”

Training courses on “Steering an Expert Knowledge Elicitation” and “Use of the Expert Knowledge Elicitation Guidance in Risk Assessments for EFSA Management” and “Conduct of the Sheffield protocol for an Expert Knowledge Elicitation”

Published on: Mon, 29 Oct 2018 00:00:00 +0100 This report presents the results from an exploratory study in 2016 on clear communication of scientific assessment results. It had a specific focus on the communication of scientific uncertainties in EFSA scientific opinions. Qualitative methods were applied to the design and communication of an opinion summary and uncertainty statements related to that opinion, and to collect evidence on how different stakeholder groups responded to them. The study tested t...

Europe - EFSA - European Food Safety Authority Publications

23-10-2018

Evaluation of confirmatory data following the Article 12 MRL review for pendimethalin

Evaluation of confirmatory data following the Article 12 MRL review for pendimethalin

Published on: Mon, 22 Oct 2018 00:00:00 +0200 The applicant BASF Agro BV submitted a request to the competent national authority in the Netherlands to evaluate the confirmatory data that were identified in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, residue trials on strawberries, onions, garlic, tomatoes, peppers, cucumbers, artichokes, leeks and rape seeds were submitted. The data gaps are considere...

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

Evaluation of confirmatory data following the Article 12 MRL review for dimethomorph

Evaluation of confirmatory data following the Article 12 MRL review for dimethomorph

Published on: Fri, 19 Oct 2018 00:00:00 +0200 The applicant BASF SE submitted a request to the competent national authority in Germany to evaluate the confirmatory data that were identified for dimethomorph in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. The submitted residue data on raspberries were satisfactorily addressing the data gaps on raspberries and blackberries. Considering the new information provided, it is appropri...

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

Evaluation of confirmatory data following the Article 12 MRL review for pyraflufen‐ethyl

Evaluation of confirmatory data following the Article 12 MRL review for pyraflufen‐ethyl

Published on: Fri, 19 Oct 2018 00:00:00 +0200 The applicant, Nichino Europe Co. Ltd., submitted application request to the competent national authority in the Netherlands to evaluate confirmatory data that were identified for pyraflufen‐ethyl in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. The submitted data were sufficient to confirm the MRLs for citrus fruits, tree nuts, pome fruits, stone fruits, table and wine grapes, curra...

Europe - EFSA - European Food Safety Authority Publications

18-10-2018

Flushmate recalls Flushmate II 501-B Pressure-Assisted Flushing Systems

Flushmate recalls Flushmate II 501-B Pressure-Assisted Flushing Systems

The Flushmate II 501-B system can burst at or near the vessel weld seam releasing stored pressure. This pressure can lift the tank lid and shatter the tank, posing impact and laceration hazards to consumers and property damage.

Health Canada

17-10-2018

Lumpy skin disease: scientific and technical assistance on control and surveillance activities

Lumpy skin disease: scientific and technical assistance on control and surveillance activities

Published on: Tue, 16 Oct 2018 00:00:00 +0200 The duration of the vaccination campaign sufficient to eliminate lumpy skin disease (LSD) mainly depends on the vaccination effectiveness and coverage achieved. By using a spread epidemiological model, assuming a vaccination effectiveness of 65%, with 50% and 90% coverage, 3 and 4 years campaigns, respectively, are needed to eliminate LSD. When vaccination effectiveness is 80% to 95%, 2 years of vaccination at coverage of 90% is sufficient to eliminate LSD vir...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Evaluation of confirmatory data following the Article 12 MRL review for teflubenzuron

Evaluation of confirmatory data following the Article 12 MRL review for teflubenzuron

Published on: Mon, 15 Oct 2018 00:00:00 +0200 The applicant BASF Agro BV submitted a request to the competent national authority in United Kingdom to evaluate the confirmatory data that were identified for teflubenzuron in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, a new metabolism study on leafy crops, a study investigating the nature of residues under standard hydrolytic conditions and a validated ...

Europe - EFSA - European Food Safety Authority Publications

27-9-2018

Outcome of the consultation on confirmatory data used in risk assessment for the active substance  copper (I), copper (II) variants

Outcome of the consultation on confirmatory data used in risk assessment for the active substance copper (I), copper (II) variants

Published on: Wed, 26 Sep 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the risk assessment for an active substance in light of confirmatory data requested following the first approval in accordance with Article 6(1) of Directive 91/414/EEC and Article 6(f) of Regulation (EC) No 1107/2009. In this context EFSA's scientific views on the specific points raised during the commenting phase conducted with Me...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Identification and evaluation of potentially mutagenic and carcinogenic food contaminants

Identification and evaluation of potentially mutagenic and carcinogenic food contaminants

Published on: Mon, 27 Aug 2018 00:00:00 +0200 Heat processing of food gives rise to a plethora of chemical compounds whose toxicological effects are largely unknown. Due to a general lack of experimental toxicological data, assessing the risks associated with the consumption of these substances remains a challenge. Computer models that allow for an in silico prediction of physicochemical and toxicological characteristics, may be able to fill current data gaps and facilitate the risk assessment of toxico...

Europe - EFSA - European Food Safety Authority Publications

7-9-2018

Orphan designation:  Recombinant human beta-glucuronidase (vestronidase alfa),  for the: Treatment of mucopolysaccharidosis type VII (Sly syndrome)

Orphan designation: Recombinant human beta-glucuronidase (vestronidase alfa), for the: Treatment of mucopolysaccharidosis type VII (Sly syndrome)

On 21 March 2012, orphan designation (EU/3/12/973) was granted by the European Commission to NDA Regulatory Science Ltd, United Kingdom, for recombinant human beta-glucuronidase for the treatment of mucopolysaccharidosis type VII (Sly syndrome).

Europe - EMA - European Medicines Agency

1-9-2018

Spodoptera frugiperda partial risk assessment

Spodoptera frugiperda partial risk assessment

Published on: Fri, 31 Aug 2018 00:00:00 +0200 EFSA was asked for a partial risk assessment of Spodoptera frugiperda for the territory of the EU focussing on the main pathways for entry, factors affecting establishment, risk reduction options and pest management. As a polyphagous pest, five commodity pathways were examined in detail. Aggregating across these and other pathways, we estimate that tens of thousands to over a million individual larvae could enter the EU annually on host commodities. Instigat...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Scientific Opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) effect models for regulatory risk assessment of pesticides for aquatic organisms

Scientific Opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) effect models for regulatory risk assessment of pesticides for aquatic organisms

Published on: Thu, 23 Aug 2018 00:00:00 +0200 Following a request from EFSA, the Panel on Plant Protection Products and their Residues (PPR) developed an opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) models and their use in prospective environmental risk assessment (ERA) for pesticides and aquatic organisms. TKTD models are species‐ and compound‐specific and can be used to predict (sub)lethal effects of pesticides under untested (time‐variable) exposure conditions. Three differen...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Joint EFSA and ECDC 2018 workshop on preparedness for a multi‐national food safety/public health incident

Joint EFSA and ECDC 2018 workshop on preparedness for a multi‐national food safety/public health incident

Published on: Tue, 21 Aug 2018 00:00:00 +0200 Abstract In May 2018, EFSA and ECDC co‐facilitated a workshop on preparedness for a multi‐national food safety/public health incident. The workshop, hosted at AGES in Vienna, was conceived to closely align with EFSA's Strategy 2020 commitment to prepare for future risk assessment challenges. EFSA, ECDC, AGES and BfR worked together closely to develop a workshop and associated training materials to be delivered over a 2.5‐day agenda. The workshop was attended...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Explanatory note on the determination of newly expressed protein levels in the context of genetically modified plant applications for EU market authorisation

Explanatory note on the determination of newly expressed protein levels in the context of genetically modified plant applications for EU market authorisation

Published on: Mon, 20 Aug 2018 00:00:00 +0200 Genetically modified organisms are subject to a risk assessment and regulatory approval before entering the European market. According to legislation (Directive 2001/18/EC, Regulation (EC) No 1829/2003 and Regulation (EU) No 503/2013) and the EFSA guidance documents on the risk assessment of food and feed from genetically modified (GM) plants and on the environmental risk assessment of GM plants, applicants need to perform a molecular characterisation of any...

Europe - EFSA - European Food Safety Authority Publications

11-12-2018

Ziagen (ViiV Healthcare BV)

Ziagen (ViiV Healthcare BV)

Ziagen (Active substance: abacavir sulfate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8685 of Tue, 11 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/252/T/104

Europe -DG Health and Food Safety

26-11-2018

Atripla (Bristol-Myers Squibb and Gilead Sciences Limited)

Atripla (Bristol-Myers Squibb and Gilead Sciences Limited)

Atripla (Active substance: efavirenz / emtricitabine / tenofovir disoproxil fumarate) - Centralised - 2-Monthly update - Commission Decision (2018)7982 of Mon, 26 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/797/II/130

Europe -DG Health and Food Safety

22-11-2018

NovoSeven (Novo Nordisk A/S)

NovoSeven (Novo Nordisk A/S)

NovoSeven (Active substance: Eptacog alfa (activated)) - Centralised - 2-Monthly update - Commission Decision (2018)7877 of Thu, 22 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/000074/II/0104

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2085 (Rigenerand S.r.l.)

EU/3/18/2085 (Rigenerand S.r.l.)

EU/3/18/2085 (Active substance: Autologous human adipose perivascular stromal cells genetically modified to secrete soluble tumour necrosis factor-related apoptosis-inducing ligand) - Orphan designation - Commission Decision (2018)7794 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/110/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2080 (Freeline Therapeutics Ltd)

EU/3/18/2080 (Freeline Therapeutics Ltd)

EU/3/18/2080 (Active substance: Recombinant adeno-associated viral vector serotype S3 containing codon-optimised expression cassette encoding human coagulation factor IX variant) - Orphan designation - Commission Decision (2018)7281 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/127/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2079 (Spark Therapeutics Ireland Ltd)

EU/3/18/2079 (Spark Therapeutics Ireland Ltd)

EU/3/18/2079 (Active substance: Recombinant adeno-associated viral vector containing a bioengineered capsid and a codon-optimised expression cassette to drive the expression of the SQ form of a B-domain deleted human coagulation factor VIII) - Orphan designation - Commission Decision (2018)7280 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/104/18

Europe -DG Health and Food Safety

29-10-2018

Sustiva (Bristol-Myers Squibb Pharma EEIG)

Sustiva (Bristol-Myers Squibb Pharma EEIG)

Sustiva (Active substance: efavirenz) - Centralised - 2-Monthly update - Commission Decision (2018)7252 of Mon, 29 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/249/II/145/G

Europe -DG Health and Food Safety

25-10-2018

Xtandi (Astellas Pharma Europe B.V.)

Xtandi (Astellas Pharma Europe B.V.)

Xtandi (Active substance: enzalutamide) - Centralised - 2-Monthly update - Commission Decision (2018)7132 of Thu, 25 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2639/II/39G

Europe -DG Health and Food Safety

18-10-2018

Kivexa (ViiV Healthcare BV)

Kivexa (ViiV Healthcare BV)

Kivexa (Active substance: abacavir / Lamivudine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6924 of Thu, 18 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/000581/T/0076

Europe -DG Health and Food Safety

2-10-2018

Trizivir (ViiV Healthcare BV)

Trizivir (ViiV Healthcare BV)

Trizivir (Active substance: abacavir, lamivudine, zidovudine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6483 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/338/T/108

Europe -DG Health and Food Safety

2-10-2018

Telzir (ViiV Healthcare BV)

Telzir (ViiV Healthcare BV)

Telzir (Active substance: Fosamprenavir) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6468 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/534/T/93

Europe -DG Health and Food Safety

2-10-2018

Celsentri (ViiV Healthcare BV)

Celsentri (ViiV Healthcare BV)

Celsentri (Active substance: maraviroc) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6467 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/811/T/56

Europe -DG Health and Food Safety

14-9-2018

#FDA MQSA: Mammography Facility Adverse Event and Action Report - September 13, 2018: Lakes Radiology II, Inc. Read the report here:  http://go.usa.gov/xPgTB  #MedicalDevice

#FDA MQSA: Mammography Facility Adverse Event and Action Report - September 13, 2018: Lakes Radiology II, Inc. Read the report here: http://go.usa.gov/xPgTB  #MedicalDevice

#FDA MQSA: Mammography Facility Adverse Event and Action Report - September 13, 2018: Lakes Radiology II, Inc. Read the report here: http://go.usa.gov/xPgTB  #MedicalDevice

FDA - U.S. Food and Drug Administration

7-9-2018

 2018 Annual workshop of the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA), European Medicines Agency, London, UK, From: 07-Jun-2018, To: 07-Jun-2018

2018 Annual workshop of the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA), European Medicines Agency, London, UK, From: 07-Jun-2018, To: 07-Jun-2018

Enpr-EMA will hold its tenth annual workshop on 7-8 June 2018 at EMA. The workshop brings relevant stakeholders together to discuss requirements, barriers and opportunities for the conduct of high-quality clinical studies in children. The overall theme of this year’s workshop will be a ‘holistic approach to paediatric research’. Highlights of this year’s workshop include: i) short perspectives of the various stakeholders involved in paediatric research (patient/young people advisory groups, research netw...

Europe - EMA - European Medicines Agency

4-9-2018

Epoetin alfa Hexal (Hexal AG)

Epoetin alfa Hexal (Hexal AG)

Epoetin alfa Hexal (Active substance: epoetin alfa) - Centralised - 2-Monthly update - Commission Decision (2018)5857 of Tue, 04 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/726/II/WS/1406

Europe -DG Health and Food Safety

4-9-2018

Binocrit (Sandoz GmbH)

Binocrit (Sandoz GmbH)

Binocrit (Active substance: epoetin alfa) - Centralised - 2-Monthly update - Commission Decision (2018)5856 of Tue, 04 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/725/II/WS/1406

Europe -DG Health and Food Safety

4-9-2018

Spinraza (Biogen Idec Limited)

Spinraza (Biogen Idec Limited)

Spinraza (Active substance: nusinersen) - Centralised - 2-Monthly update - Commission Decision (2018)5862 of Tue, 04 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4312/II/4

Europe -DG Health and Food Safety

30-8-2018

Fluenz Tetra (AstraZeneca AB)

Fluenz Tetra (AstraZeneca AB)

Fluenz Tetra (Active substance: influenza vaccine (live attenuated, nasal)) - Centralised - Variation - Commission Decision (2018)5815 of Thu, 30 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2617/II/82

Europe -DG Health and Food Safety

29-8-2018

Coagadex (Bio Products Laboratory Ltd)

Coagadex (Bio Products Laboratory Ltd)

Coagadex (Active substance: human coagulation factor X) - Centralised - 2-Monthly update - Commission Decision (2018)5772 of Wed, 29 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3855/II/07

Europe -DG Health and Food Safety

29-8-2018

Nucala (GlaxoSmithKline Trading Services Limited)

Nucala (GlaxoSmithKline Trading Services Limited)

Nucala (Active substance: mepolizumab) - Centralised - 2-Monthly update - Commission Decision (2018)5770 of Wed, 29 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3860/II/13/G

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2061 (Pharma Gateway AB)

EU/3/18/2061 (Pharma Gateway AB)

EU/3/18/2061 (Active substance: Autologous glioma tumour cells treated with antisense molecule directed against the insulin-like growth factor type 1 receptor) - Orphan designation - Commission Decision (2018)5739 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/049/18

Europe -DG Health and Food Safety

27-8-2018

Mepsevii (Ultragenyx Germany GmbH)

Mepsevii (Ultragenyx Germany GmbH)

Mepsevii (Active substance: vestronidase alfa) - Centralised - Authorisation - Commission Decision (2018)5714 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4438

Europe -DG Health and Food Safety

27-8-2018

Beromun (BELPHARMA s.a.)

Beromun (BELPHARMA s.a.)

Beromun (Active substance: Tasonermin (Tumor Necrosis Factor alfa-1a)) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5699 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/206/T/40

Europe -DG Health and Food Safety

27-8-2018

RoActemra (Roche Registration GmbH)

RoActemra (Roche Registration GmbH)

RoActemra (Active substance: tocilizumab) - Centralised - 2-Monthly update - Commission Decision (2018)5687 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/955/II/78

Europe -DG Health and Food Safety

23-8-2018

EU/3/18/1979 (Bayer AG)

EU/3/18/1979 (Bayer AG)

EU/3/18/1979 (Active substance: Human monoclonal IgG2 antibody against tissue factor pathway inhibitor) - Corrigendum - Commission Decision (2018)1246 of Thu, 23 Aug 2018

Europe -DG Health and Food Safety

22-8-2018

Lenvima (Eisai Europe Limited)

Lenvima (Eisai Europe Limited)

Lenvima (Active substance: lenvatinib) - Centralised - 2-Monthly update - Commission Decision (2018)5627 of Wed, 22 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3727/II/11/G

Europe -DG Health and Food Safety

22-8-2018

BTVPUR (Merial)

BTVPUR (Merial)

BTVPUR (Active substance: Bluetongue virus vaccine (inactivated) (multistrain: 1-2 strains out of a set of 4)) - Centralised - 2-Monthly update - Commission Decision (2018)5630 of Wed, 22 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2231/II/10

Europe -DG Health and Food Safety