ARLEC 12,5 MG 28 TABLET

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  • Ticaret Unvanı:
  • ARLEC 12,5 MG 28 TABLET
  • Reçete türü:
  • Normal
  • İçin kullanmak:
  • İnsanlar
  • İlaç türü:
  • allopatik ilaç

Belgeler

Yerelleştirme

  • Bulunduğu ülkeler::
  • ARLEC 12,5 MG 28 TABLET
    Türkiye
  • Dil:
  • Türkçe

Terapötik bilgiler

  • Terapötik alanı:
  • Allegra

Diğer bilgiler

Durum

  • Kaynak:
  • TİTCK - TÜRKİYE İLAÇ VE TIBBİ CİHAZ KURUMU - Türkiye
  • Yetkilendirme durumu:
  • Aktif
  • Yetkilendirme numarası:
  • 8699543010649
  • Yetkilendirme tarihi:
  • 29-01-2013
  • Son Güncelleme:
  • 25-05-2018

Hasta Bilgi broşürü: Ürün Özellikleri Özeti - kompozisyon, endikasyonlar, yan etkiler, dozaj, etkileşimleri, advers reaksiyonlar, gebelik, laktasyon

Sayfa1|8

KULLANMATALİMATI

ARLEC ®

12.5mgtablet

Ağızyoluileuygulamaiçindir.

Etkinmadde:

Karvedilol 12.5mg

Yardımcımadde(ler):

Laktozanhidröz,prejelatinizenişasta,kroskarmellozsodyum,sodyumlaurilsülfat,aerosil

200,kırmızı demir oksit(E172),magnezyum stearat.

BuilacıkullanmayabaşlamadanöncebuKULLANMATALİMATINIdikkatlice

okuyunuz,çünküsiziniçinönemlibilgileriçermektedir.

Bukullanmatalimatınısaklayınız.Dahasonratekrarokumayaihtiyaçduyabilirsiniz.

Eğerilavesorularınızolursa,lütfendoktorunuzaveyaeczacınızadanışınız.

Builaçkişiselolaraksiziniçinreçeteedilmiştir,başkalarınavermeyiniz.

Builacınkullanımısırasında,doktoraveyahastaneyegittiğinizdedoktorunuzabuilacı

kullandığınızı söyleyiniz.

Butalimattayazılanlaraaynenuyunuz.İlaçhakkındasizeönerilendozundışındayüksek

veyadüşükdozkullanmayınız.

BuKullanmaTalimatında:

1.ARLEC ®

nedirveneiçinkullanılır?

2.ARLEC ® ’ikullanmadanöncedikkatedilmesigerekenler

3.ARLEC ®

nasılkullanılır?

4.Olasıyanetkilernelerdir?

5.ARLEC ®

'insaklanması

Başlıklarıyeralmaktadır.

1.ARLEC ®

nedirveneiçinkullanılır?

ARLEC ®

,karvediloladıverilenbiretkinmaddeiçerir.Bu,“beta-blokerler”adıverilenbir

grubadahildir.ARLEC ®

aşağıdakidurumlarıntedavisindekullanılır:

Yüksekkanbasıncı(hipertansiyon)

Anjina(kalbinizyeterinceoksijenalmadığızamanoluşangöğüsağrısıveya

rahatsızlık)

Kronikkalpyetmezliği

DoktorunuzARLEC ®

dışındadurumunuzutedavietmekiçinbaşkailaçlardaverebilir.

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2.ARLEC ®

'ikullanmadanöncedikkatedilmesigerekenler

ARLEC ® ’i aşağıdakidurumlardaKULLANMAYINIZ

Eğer:

KarvedilolveyaARLEC ® ’iniçindekilerdenherhangibirinealerjinizvarsa

Astımveyabaşkaakciğerhastalıklarısebebiylegöğsünüzdehırıltıyaşadıysanız.

Damardanverilenilaçlar(intravenöz)iletedaviedilen,ciddisıvıtutulumu

yaşıyorsanız(ellerin,bileklerinveayaklarınşişmesi).

Karaciğerrahatsızlığınızvarsa.

Kalbinizdesorunvarsa(örneğin‘kalpbloğu’veyakalpatışınınyavaşlaması).

ARLEC ®

bellitürdekalpsorunuolankişileriçindahaazuygundur.

Kanbasıncınızdüşükse.

Metabolikasidoz(kanınızınasitdeğeriyüksekse)

Böbreküstübezlerinizdebüyümevarsa(feokromositoma)

ARLEC ®

'i aşağıdakidurumlardaDİKKATLİKULLANINIZ

Eğer:

Böbreklerinizderahatsızlığınızvarsa.

Diyabetinizvarsa(kanşekerininyüksekolması).

Kontaktlenskullanıyorsanız.

Geçmiştetiroidileilgilirahatsızlıkgeçirdiyseniz.

Ciddialerjikreaksiyongeçirdiyseniz(örneğin,vücudunanidenşişmesivebunun

sonucuolaraknefesalmadaveyutkunmadagüçlük,ellerin,ayaklarınvebileklerin

şişmesi,şiddetlidöküntü).

Alerjinizvarsavesiziduyarlıhalegetirecektedavialıyorsanız.

Elveayakparmaklarınızdakikandolaşımınızdasorunlarvarsa(Raynaudfenomeni)

Betablokergrubundanilaçlaraldıktansonra,‘sedef’adıverilenderihastalığı

geçirdiyseniz.

Steven-Johnsonsendromu(cildinsoyulması,şişmesi,kabarcıklarveateşileseyreden

ciddihastalık)vetoksikepidermalnekroliz(deriiçisıvıdolukabarcıklarladeri

soyulmalarıvedokukaybıileseyredenciddihastalık)gibiciddiderireaksiyonları

gelişmesi halinde.

Buuyarılar,geçmiştekiherhangibirdönemdedahiolsasiziniçingeçerliyselütfen

doktorunuzadanışınız.

ARLEC ®

'inyiyecekveiçecekilekullanılması

ARLEC ®

suilealınmalıdır.KronikkalpyetmezliğihastalarındaARLEC ®

yiyecekle

birlikteverilmelidir.

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Hamilelik

İlacıkullanmadanöncedoktorunuzaveyaeczacınızadanışınız.

ARLEC ® ’inhamilelerdekullanımınailişkinyeterliveriyoktur.ARLEC ®

gerekliolmadıkça

hamileliktekullanılmamalıdır.

Tedavinizsırasındahamileolduğunuzufarkedersenizhemendoktorunuzaveyaeczacınıza

danışınız.

Emzirme

İlacıkullanmadanöncedoktorunuzaveyaeczacınızadanışınız.

ARLEC ® ’ininsandasütegeçipgeçmediğibilinmemektedir.Emzirmeninyada

ARLEC ®

tedavisininkesilipkesilmeyeceğikararı,emzirmeninçocukiçinyararıile

ARLEC ®

tedavisininkadıniçinyararıdikkatealınarakverilmelidir.

Araçvemakinekullanımı

ARLEC ®

kullanırken,başdönmesiyaşayabilirsiniz.Bunun,tedaviyebaşladığınızdaveya

tedavinizdedeğişiklikyapıldığındavealkoltükettiğinizdegörülmeihtimalidaha

yüksektir.Eğerbaşdönmesiyaşıyorsanız,araçveyaherhangibiraletveyamakine

kullanmayınız.ARLEC ®

alırken,arabakullanmanızı,aletveyamakinekullanmanızı

etkileyebilecekherhangibirsorunyaşarsanız,doktorunuzadanışınız.

ARLEC ®

'iniçeriğindebulunanbazıyardımcımaddelerhakkındaönemlibilgiler

Builaçlaktoziçermektedir.Eğerdahaöncedendoktorunuztarafındanbazışekerlerekarşı

intoleransınız(duyarlılığınız)olduğusöylenmişsebutıbbiürünüalmadanöncedoktorunuzla

temasageçiniz.

Builaç,sodyumiçermektedir.Kontrollüsodyumdiyetindeolanhastalariçingözönünde

bulundurulmalıdır.

Diğerilaçlarilebirliktekullanımı

Özellikle,aşağıdakiilaçlarıkullanıyorsanızdoktorunuzaveyaeczacınızabunlarhakkında

bilgiveriniz.

İdrarsöktürücüler(diüretikler),kalsiyumkanalıblokerleri(örneğindiltiazemveya

verapamil)dahilolmaküzerekalbinizvekanbasıncınızıntedavisindekullandığınızdiğer

ilaçlar

İzokarboksitvefenelzingibimonoaminoksidazinhibitörleri(MAOI)(depresyon

tedavisindekullanılır).

İnsülinvemetformingibidiyabetiçinkullanılanilaçlar

Klonidin(yüksekkanbasıncını,migrenvemenapozsırasındakiateşbasmalarınıtedavi

etmekiçinkullanılır).

Rifampisin(enfeksiyonlarıntedavisiiçinkullanılır)

Simetidin(sindirimgüçlüğü,mideyanmasıvemideülserlerinitedavietmekiçin

kullanılır)

Siklosporin(organnaklisonrasındakullanılır)

Fluoksetin(depresyontedavisiiçinkullanılır)

Nonsteroidalantiinflamatuvarilaçlar(aspirin,indometazinveibuprofengibi)

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Betaagonistbronkodilatörler(göğüstesıkışmahissi,astımabağlıhırıltıveyadiğergöğüsile

ilgilirahatsızlıklarıntedavisindekullanılansalbutamolveterbutalinsülfatgibiilaçlar)

Eğerreçeteliyadareçetesizherhangibirilacışuandakullanıyorsanızveyasonzamanlarda

kullandınıziselütfendoktorunuzaveyaeczacınızabunlarhakkındabilgiveriniz.

3.ARLEC ®

nasılkullanılır?

Uygunkullanımvedoz/uygulamasıklığıiçintalimatlar:

ARLEC ® ’iherzaman,tamolarakdoktorunuzunsöylediğişekildealınız.Emin

olmadığınızzamandoktorunuzaveyaeczacınızadanışınız.

Kronikkalpyetmezliği

Kalpyetmezliğiiçinkullanıldığında,ARLEC ®

iletedavininuzmandoktortarafından

başlatılmasıgereklidir.

Tabletleri,yemekilebirliktealmalısınız.

Normalbaşlangıç,ikihaftaboyuncagündeikidefa3.125mg’dır.

Doktorunuzbundansonra,dozuyavaşyavaşhaftalarayayarakgündeikidefa25mg’akadar

yükseltecektir.Eğerkilonuz85kg’dan(187lb)fazlaise,dozgündeikidefa50mg’akadar

arttırılabilir.

İkihaftadandahafazlasüreboyuncaARLEC ®

almayıbıraktıysanız,doktorunuzile

konuşmalısınız. Başlangıçdozunageridönmekgerekecektir.

Yüksekkanbasıncı:

Normalbaşlangıçdozu,ikigünboyuncagündebirdefa12.5mg’dır.İkigünsonra,doz,

genelliklegündebirdefa25mg’dır.

Eğerkanbasıncınızkontrolaltınaalınmamışsa,doktorunuzdozuhaftalarayayılacakşekilde

yavaşyavaş50mg’yekadaryükseltebilir.

Eğeryaşlıysanız,kanbasıncınızınkontroledilmesiiçingündebirdefa12.5mg'dandahafazla

ilacaihtiyaçduymayabilirsiniz.

Angina:

Başlangıçdozu,ikigünsüreilegündeikikez12.5mg

İkigündensonra,gündeikikez25mg’dır.

Uygulamayoluvemetodu:

Hertabletibirbardaksıvıileyutunuz.

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Değişikyaşgrupları:

Çocuklardakullanımı:

ARLEC ®

18yaşınaltındakiçocuklardakullanımiçinuygundeğildir.

Yaşlılardakullanımı:

Doktorunuzbaşlangıçdozunuzaveuzunsüreliolarakalmanızgerekeneniyidozakarar

verecektir.Normalmaksimumdozdahaküçükdozlardaalınarak(dozlarbölünerek)günde

birdefa50mg’dır.

Özelkullanımdurumları:

Böbrekyetmezliği:

Değişikderecelerdeböbrekyetmezliğiolanhastalarlailgilimevcutverileregöre,ortaveağır

şiddetteböbrekyetmezliğiolanhastalardakarvediloldozşemasındadeğişiklikönerilmez.

Karaciğeryetmezliği:

Karvedilolkaraciğeryetmezliğiklinikolarakbelirginolanhastalardakullanılmamalıdır.

Doktorunuzhastalığınızabağlıolarakilacınızındozunubelirleyecekvesizeuygulayacaktır.

EğerARLEC ® ’inetkisininçokgüçlüveyazayıfolduğunadairbirizleniminizvarise

doktorunuzveyaeczacınızilekonuşunuz.

KullanmanızgerekendendahafazlaARLEC ®

kullandıysanız:

EğerkullanmanızgerekendendahafazlaARLEC ®

aldıysanızveyabaşkabirisizin

ARLEC ®

tabletlerinizialdıysadoktorunuzadanışınızveyahemenhastaneyegidiniz.İlaç

paketinideyanınızaalınız.

Almanızgerekendenfazlatabletaldıysanızaşağıdakietkileroluşabilir:

kalpatışınınyavaşlaması

başdönmesivesersemlikhissi

nefessizkalmak

aşırıyorgunluk.

ARLEC ® ’denkullanmanızgerekendenfazlasınıkullanmışsanızbirdoktorveyaeczacıile

konuşunuz.

ARLEC ®

'ikullanmayıunutursanız

Birdozalmayıunutursanız,hatırladıktansonraenkısasüredealınız.Bununlabirlikte,bir

sonrakidozualmazamanınayakınsa,kaçırılandozuatlayınız.

Unutulandozlarıdengelemekiçinçift dozalmayınız.

Sayfa6|8

ARLEC ®

iletedavisonlandırıldığındakioluşabileceketkiler

Doktorunuzilekonuşmadanöncebuilacıkullanmayıkesmeyiniz.Doktorunuz,bırakılacağı

zamanARLEC ®

almayıanideğil1ila2haftaiçindeyavaşyavaşbırakmanızıönerecektir.Bu

ilacınkullanımınadairdahabaşkasorularınızolursa,doktorunuzayadaeczacınızadanışınız.

4.Olasıyanetkilernelerdir?

Tümilaçlargibi,ARLEC ® ’iniçeriğindebulunanmaddelereduyarlıolankişilerdeyanetkiler

olabilir.

Yanetkilerşuşekildesınıflandırılır:

Çokyaygın:10hastanınenaz1’indegörülebilir.

Yaygın:10hastanınbirindenaz,fakat100hastanınbirindenfazlagörülebilir.

Yaygınolmayan:100hastanınbirindenaz,fakat1.000hastanınbirindenfazlagörülebilir.

Seyrek:1.000 hastanınbirindenaz,fakat10.000hastanınbirindenfazlagörülebilir.

Çokseyrek:10.000hastanınbirindenazgörülebilir.

Bilinmiyor:eldekiverilerdentahminedilemiyor.

Çokyaygın:

Başdönmesihissi

Başağrısı(bugenelliklehafifdüzeydedirvetedavinizinbaşındagörülür)

Zayıflıkveyorgunlukhissi

Kalpileilgilirahatsızlıklar.Belirtilerarasında,göğüsağrısı,yorgunluk,nefessizkalma

vekollarvebacaklardaşişkinlikbulunmaktadır.

Düşükkanbasıncı.Belirtilerarasında,özellikleayağakalkıncabaşdönmesive

sersemlikhissibulunmaktadır.

Yaygın:

Bronşiltihabı,akciğeriltihabı,burunveboğazdailtihaplanmaşeklindegörülen

solunumyollarıiltihaplanması.Belirtilerarasında,hırıltılıve/veyakesikkesiknefes

alma,göğüssıkışmasıveboğazdaağrıbulunmaktadır.

Boşaltımsistemindeiltihaplanma(suatılımındaproblemoluşturabilir)

Kırmızıkanhücrelerindeazalma(kansızlık).Belirtilerarasında,yorgunhissetme,

solukciltrengi,çarpıntıhissivenefesalmadagüçlükbulunmaktadır.

Kiloartışı

Kolesteroldüzeylerindeyükselme(kantestiilegösterilir)

Diyabeti olankişilerdekanşekerkontrolününbozulması

Depresifhissetme

Kalpatışınınyavaşlamasıveayağakalkıncabaşdönmesiveyasersemlikhissi(Bu

etkilergenellikletedavinizinbaşındagörülür)

Sıvıtutulumu.Belirtilerarasındaörneğinel,ayakvebacaklardaşişkinlikve

vücudunuzdaki kanmiktarınınartmasıbulunmaktadır.

Kollarvebacaklardakandolaşımıileilişkilirahatsızlıklar.Belirtilerarasında,elve

ayaklardasoğuma,cildinbeyazlaşması,parmaklarınızdakarıncalanmaveağrıve

yürümekistediğinizdekötüleşenbacakağrısıbulunmaktadır.

Nefesalmaproblemleri

Kendinihastahissetmevehastaolmak.

İshal

Görmeileilgilisorunlar

Gözyaşınınazalmasısebebiyle,gözlerdekurulukhissi

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Başdönmesi,yorgunlukvebaşağrısı(buetkilergenelliklehafifdüzeydedirve

tedavinizin başındagörülür)

Mideağrısı.Belirtilerarasındakendinihastahissetme,mideağrısıveishal

bulunmaktadır.

Elveayaklardaağrı

Böbrekproblemleri(tuvaletegitmesıklığındadeğişikliğinideiçermektedir)

Yaygınolmayan:

Bayılma

Uykudüzensizlikleri

Elveyaayaklardahiskaybıveyakarıncalanma

Kabızlık

Terlemeartışı

Ciltileilişkilisorunlar,tümvücudunuzukaplayanderidöküntüleri,pütürlüdöküntü

(ürtiker),kaşınmahissivecildinkuruyarakparçaparçaolması

Ereksiyonyaşamadagüçlük(erektilfonksiyonbozukluğu)

Saçdökülmesi

Seyrek:

Kanınızdakitrombositsayısınındüşükolması.Belirtilerarasında,cildinkolay

morarmasıveburunkanamasıbulunmaktadır.

Buruntıkanıklığı,nefessizkalma,soğukalgınlığıbenzeribelirtiler

Ağızkuruluğu

Çokseyrek:

Beyazkanhücresisayısınındüşükolması.Belirtilerarasındaağız,dişeti,boyunve

akciğerenfeksiyonlarıbulunmaktadır.

Kantestiilegösterilenböbrekileilgilisorunlar.

Bazıkadınlar,mesanekontrolünüsağlamaktazorlanabilirler(ürinerinkontinans).Bu

durum,normaldetedavidurdurulduğundadahaiyiyedönecektir.

Akutciddialerjikreaksiyonlar.Belirtilerarasında,boğazınveyayüzünanidenşişmesive

bununsonucuolaraknefesalmadaveyutkunmadagüçlük,ellerin,ayaklarınve

bileklerinşişmesi bulunmaktadır.

Steven-Johnsonsendromu(cildinsoyulması,şişmesi,kabarcıklarveateşileseyreden

ciddihastalık)vetoksikepidermalnekroliz(deriiçisıvıdolukabarcıklarladeri

soyulmaları vedoku kaybı ile seyredenciddihastalık) gibiciddideri reaksiyonları.

ARLEC ®

,“gizlidiyabet”adıverilendiyabetinhafifformunasahipkişilerdediyabet

belirtilerinin ortayaçıkmasınadanedenolur.

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Yan etkilerin raporlanması

KullanmaTalimatındayeralanveyaalmayanherhangibiryanetkimeydanagelmesi

durumundahekiminiz,eczacınızveyahemşirenizilekonuşunuz.Ayrıcakarşılaştığınızyan

etkileriwww.titck.gov.trsitesindeyeralan“İlaçYanEtkiBildirimi”ikonunatıklayarakyada0

8003140008numaralıyanetkibildirimhattınıarayarakTürkiyeFarmakovijilansMerkezi

(TÜFAM)’nebildiriniz.Meydanagelenyanetkileribildirerekkullanmaktaolduğunuzilacın

güvenliliği hakkındadahafazla bilgi edinilmesinekatkısağlamışolacaksınız.

Eğerbukullanmatalimatındabahsigeçmeyenherhangibiryanetkiilekarşılaşırsanız

doktorunuzuveyaeczacınızıbilgilendiriniz.

5.ARLEC ®

'inSaklanması

ARLEC ®

'içocuklarıngöremeyeceği,erişemeyeceğiyerlerdeveambalajındasaklayınız.

25°C’ninaltındakiodasıcaklığında,ışıktanvenemdenkoruyaraksaklayınız.

Sonkullanmatarihiyleuyumluolarakkullanınız.

AmbalajdakisonkullanmatarihindensonraARLEC ® ’ikullanmayınız.

Eğerüründeve/veyaambalajındabozukluklarfarkedersenizARLEC ® ’ikullanmayınız.

Ruhsatsahibi:

ALİRAİFİLAÇ SANAYİA.Ş.

YeşilceMahallesi DoğaSokak No:4

34418 Kağıthane/İstanbul

Üretimyeri:

ALİRAİFİLAÇ SANAYİA.Ş.

İkitelli OSBMah. 10.CaddeNo:3/1A

34306 Başakşehir/İstanbul

Bukullanmatalimatı…………..onaylanmıştır.

Sayfa9|8

13-12-2018

Evaluation of the safety and efficacy of the organic acids lactic and acetic acids to reduce microbiological surface contamination on pork carcasses and pork cuts

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Published on: Wed, 12 Dec 2018 Studies evaluating the safety and efficacy of lactic and acetic acids to reduce microbiological surface contamination on pork carcasses pre‐chill and pork meat cuts post‐chill were assessed. Lactic acid treatments consisted of 2–5% solutions at temperatures of up to 80°C applied to carcasses by spraying or up to 55°C applied on cuts by spraying or dipping. Acetic acid treatments consisted of 2–4% solutions at temperatures of up to 40°C applied on carcasses by spraying or o...

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Pest categorisation of Septoria malagutii

Pest categorisation of Septoria malagutii

Published on: Wed, 12 Dec 2018 The Panel on Plant Health performed a pest categorisation of Septoria malagutii, the causal agent of annular leaf spot of potato, for the EU. The pest is a well‐defined fungal species and reliable methods exist for its detection and identification. S. malagutii is present in Bolivia, Ecuador, Peru and Venezuela. The pest is not known to occur in the EU and is listed as Septoria lycopersici var. malagutii in Annex IAI of Directive 2000/29/EC, meaning its introduction into t...

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The European Union summary report on trends and sources of zoonoses, zoonotic agents and food-borne outbreaks in 2017

The European Union summary report on trends and sources of zoonoses, zoonotic agents and food-borne outbreaks in 2017

Published on: Wed, 12 Dec 2018 This report of the European Food Safety Authority and the European Centre for Disease Prevention and Control presents the results of zoonoses monitoring activities carried out in 2017 in 37 European countries (28 Member States (MS) and nine non-MS). Campylobacteriosis was the commonest reported zoonosis and its EU trend for confirmed human cases increasing since 2008 stabilised during 2013–2017. The decreasing EU trend for confirmed human salmonellosis cases since 2008 end...

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Enforcement Report for the Week of December 12, 2018

Enforcement Report for the Week of December 12, 2018

Recently Updated Records for the Week of December 12, 2018 Last Modified Date: Wednesday, December 12, 2018

FDA - U.S. Food and Drug Administration

11-12-2018

THAN YOU tablets

THAN YOU tablets

THAN YOU tablets pose a serious risk to your health and should not be taken.

Therapeutic Goods Administration - Australia

8-12-2018

Annual assessment of Echinococcus multilocularis surveillance reports submitted in 2018 in the context of Commission Regulation (EU) No 1152/2011

Annual assessment of Echinococcus multilocularis surveillance reports submitted in 2018 in the context of Commission Regulation (EU) No 1152/2011

Published on: Fri, 07 Dec 2018 This report is part of the `Echinococcus multilocularis surveillance’ scientific reports which are presented annually by EFSA to the European Commission and are intended to assess the sampling strategy, data collection and detection methods used by Finland, Ireland, Malta, the United Kingdom (UK) and Norway in their respective surveillance programmes. The surveillance programmes of these five countries were evaluated by checking the information submitted by each of them an...

Europe - EFSA - European Food Safety Authority Publications

7-12-2018

Fine Land Corp Issues Allergy Alert on Undeclared Milk Allergens in “Meiqili Durian Candy”

Fine Land Corp Issues Allergy Alert on Undeclared Milk Allergens in “Meiqili Durian Candy”

Fine Land Corp is recalling it’s 12 ounce (340 g) Meiqili Durian Candy in plastic bag with clear window because it contains undeclared milk allergens. Consumers who are allergic to milk allergens may run the risk of serious or life – threatening allergic reactions if they consume this product.

FDA - U.S. Food and Drug Administration

7-12-2018

Magnesium citrate malate as a source of magnesium added for nutritional purposes to food supplements

Magnesium citrate malate as a source of magnesium added for nutritional purposes to food supplements

Published on: Thu, 06 Dec 2018 The present scientific opinion deals with the assessment of the bioavailability of magnesium, from the proposed nutrient source, magnesium citrate malate (MgCM), when added for nutritional purposes to food supplements. MgCM is a mixed salt consisting of magnesium cations and citrate and malate anions, and with a magnesium content of 12–15%. MgCM is proposed to be used in food supplements that are intended to provide up to 300–540 mg/day magnesium. The data provided demonst...

Europe - EFSA - European Food Safety Authority Publications

6-12-2018

Country Flavor Inc Issues Alert on Undeclared Sulfites In "Best Taste Brand Dried Bamboo Shoot"

Country Flavor Inc Issues Alert on Undeclared Sulfites In "Best Taste Brand Dried Bamboo Shoot"

Country Favor Inc. of Maspeth, New York is recalling its 12 ounce packages of "Best Taste Brand DRIED BAMBOO SHOOT" food treats because they contained undeclared sulfites. Consumers who have severe sensitivity to sulfites run the risk of serious or life-threatening allergic reactions if they consume this product.

FDA - U.S. Food and Drug Administration

4-12-2018

Mylan Expands Its Voluntary Nationwide Recall of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, to all Lots Within Expiry Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylam

Mylan Expands Its Voluntary Nationwide Recall of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, to all Lots Within Expiry Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylam

– Mylan N.V. (NASDAQ: MYL) today announced that its U.S. based Mylan Pharmaceuticals business is expanding its consumer-level voluntary nationwide recall to include all lots of Valsartan-containing products within expiry. The 104 additional lots include 26 lots of Amlodipine and Valsartan Tablets, USP (including the 5mg/160mg, 10mg/160mg, 5mg/320mg and 10mg/320mg strengths), 51 lots of Valsartan Tablets, USP (including 40 mg, 80 mg, 160 mg and 320 mg strengths), and 27 lots of Valsartan and Hydrochloroth...

FDA - U.S. Food and Drug Administration

4-12-2018

FDA Approves Pexion for Treating Noise Aversion in Dogs

FDA Approves Pexion for Treating Noise Aversion in Dogs

The U.S. Food and Drug Administration announced today that its Center for Veterinary Medicine has approved Pexion (imepitoin tablets) to treat noise aversion in dogs. Dogs with noise aversion are sensitive to loud noises such as fireworks, street/traffic noises, and gun shots.

FDA - U.S. Food and Drug Administration

3-12-2018

November 28, 2018: Former Vice President of Insys Pharmaceuticals Pleads Guilty to Racketeering Scheme

November 28, 2018: Former Vice President of Insys Pharmaceuticals Pleads Guilty to Racketeering Scheme

November 28, 2018: Former Vice President of Insys Pharmaceuticals Pleads Guilty to Racketeering Scheme

FDA - U.S. Food and Drug Administration

3-12-2018

PMS-Amoxicillin (2018-12-03)

PMS-Amoxicillin (2018-12-03)

Health Canada

30-11-2018

The European Union summary report on surveillance for the presence of transmissible spongiform encephalopathies (TSEs) in 2017

The European Union summary report on surveillance for the presence of transmissible spongiform encephalopathies (TSEs) in 2017

Published on: Thu, 29 Nov 2018 This report presents the results of surveillance on transmissible spongiform encephalopathies (TSEs) in bovine animals, sheep, goats, cervids and other animal species, as well as genotyping in sheep, carried out in 2017 in the European Union (EU) according to Regulation (EC) 999/2001, and in Iceland, Norway and Switzerland. In total, 1,312,714 cattle were tested by the 28 EU Member States (MSs) which is a decrease of 3% compared with 2016; 18,526 were tested by the three n...

Europe - EFSA - European Food Safety Authority Publications

29-11-2018

FDA approves first treatment for Lambert-Eaton myasthenic syndrome, a rare autoimmune disorder

FDA approves first treatment for Lambert-Eaton myasthenic syndrome, a rare autoimmune disorder

FDA approved Firdapse (amifampridine) tablets for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults. LEMS is a rare autoimmune disorder. This is the first FDA approval of a treatment for LEMS.

FDA - U.S. Food and Drug Administration

28-11-2018

FDA approves treatment for adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a certain genetic mutation

FDA approves treatment for adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a certain genetic mutation

The FDA approved Xospata (gilteritinib) tablets for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test.

FDA - U.S. Food and Drug Administration

28-11-2018

Enforcement Report for the Week of November 28, 2018

Enforcement Report for the Week of November 28, 2018

Recently Updated Records for the Week of November 28, 2018 Last Modified Date: Tuesday, November 27, 2018

FDA - U.S. Food and Drug Administration

28-11-2018

Information Update - Mylan-Valsartan medications voluntarily recalled as a precaution due to an impurity

Information Update - Mylan-Valsartan medications voluntarily recalled as a precaution due to an impurity

Mylan Pharmaceuticals ULC is voluntarily recalling four lots of Mylan-Valsartan tablets (40 mg, 80 mg, 160 mg and 320 mg strength) after testing found low levels of an impurity, N-nitrosodiethylamine (NDEA).

Health Canada

27-11-2018

Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall of All Amlodipine/Valsartan Combination Tablets and Amlodipine/Valsartan/Hydrochlorothiazide Combination Tablets That Are Within Expiry

Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall of All Amlodipine/Valsartan Combination Tablets and Amlodipine/Valsartan/Hydrochlorothiazide Combination Tablets That Are Within Expiry

Teva Pharmaceuticals has initiated a voluntary recall in the United States, to the patient level, of all lots of Amlodipine / Valsartan combination tablets and Amlodipine / Valsartan / Hydrochlorothiazide combination tablets (see table below) due to an impurity detected above specification limits in an active pharmaceutical ingredient (API) manufactured by Mylan India. The impurity found in Mylan’s valsartan API is known as N-nitroso-diethylamine (NDEA), which has been classified as a probable human carc...

FDA - U.S. Food and Drug Administration

27-11-2018

Risk assessment of new sequencing information for genetically modified soybean A2704‐12

Risk assessment of new sequencing information for genetically modified soybean A2704‐12

Published on: Mon, 26 Nov 2018 The GMO Panel has previously assessed genetically modified (GM) soybean A2704‐12. This soybean was found to be as safe and nutritious as its conventional counterpart with respect to potential effects on human and animal health and the environment in the context of its intended uses. On 5 June 2018, the European Commission requested EFSA to analyse new nucleic acid sequencing data and updated bioinformatics data for GM soybean A2704‐12 and to indicate whether the previous c...

Europe - EFSA - European Food Safety Authority Publications

23-11-2018

ACT-Candesartan 4mg tablets (2018-11-23)

ACT-Candesartan 4mg tablets (2018-11-23)

Health Canada

22-11-2018

Foreign Product Alert: Black Ant King tablets, Gold Viagra 9800mg capsules, LIPRO Dietary capsules, Stree Overlord Strong tablets (pills), Vegetal Vigra capsules, ViaGro 500mg Male Enhancement capsules

Foreign Product Alert: Black Ant King tablets, Gold Viagra 9800mg capsules, LIPRO Dietary capsules, Stree Overlord Strong tablets (pills), Vegetal Vigra capsules, ViaGro 500mg Male Enhancement capsules

These foreign health products have been found by regulators in other countries to contain undeclared drug ingredients.

Health Canada

21-11-2018

FDA approves new treatment for patients with acute myeloid leukemia

FDA approves new treatment for patients with acute myeloid leukemia

The FDA approved Daurismo (glasdegib) tablets to be used in combination with low-dose cytarabine (LDAC), a type of chemotherapy, for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults who are 75 years of age or older or who have other chronic health conditions or diseases (comorbidities) that may preclude the use of intensive chemotherapy.

FDA - U.S. Food and Drug Administration

21-11-2018

Mylan Initiates Voluntary Nationwide Recall of 15 Lots of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Fou

Mylan Initiates Voluntary Nationwide Recall of 15 Lots of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Fou

Mylan N.V. (NASDAQ: MYL) today announced that its U.S. based Mylan Pharmaceuticals business is conducting a voluntary nationwide recall to the consumer level of select lots of Valsartan-containing products, including six lots of Amlodipine and Valsartan Tablets, USP (including the 5mg/160mg, 10mg/160mg, and 10mg/320mg strengths), seven lots of Valsartan Tablets, USP (including 40 mg, 80 mg, 160 mg, and 320 mg strengths), and two lots of Valsartan and Hydrochlorothiazide Tablets, USP 320mg/25mg strength. ...

FDA - U.S. Food and Drug Administration

17-11-2018

Review of the existing maximum residue levels for tau‐fluvalinate according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for tau‐fluvalinate according to Article 12 of Regulation (EC) No 396/2005

Published on: Fri, 16 Nov 2018 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance tau‐fluvalinate. To assess the occurrence of tau‐fluvalinate residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008 as well as the European authorisations reported by Member St...

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

Peer review of the pesticide risk assessment of the active substance napropamide‐M

Peer review of the pesticide risk assessment of the active substance napropamide‐M

Published on: Mon, 12 Nov 2018 00:00:00 +0100 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State the United Kingdom for the pesticide active substance napropamide‐M are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative uses of napropamid...

Europe - EFSA - European Food Safety Authority Publications

13-11-2018

Setting of import tolerances for teflubenzuron in grapefruits, mandarins and broccoli

Setting of import tolerances for teflubenzuron in grapefruits, mandarins and broccoli

Published on: Mon, 12 Nov 2018 00:00:00 +0100 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF Agro BV submitted a request to the competent national authority in the United Kingdom to set import tolerances for the active substance teflubenzuron in grapefruits and mandarins imported from Brazil and for broccoli imported from Paraguay. The data submitted were found to be sufficient to derive maximum residue level (MRL) proposals for grapefruits and broccoli. The MRL derived ...

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

9-11-2018

Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Losartan Potassium and Hydrochlorothiazide Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)

Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Losartan Potassium and Hydrochlorothiazide Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)

Sandoz Inc. is voluntarily recalling one lot of Losartan Potassium Hydrochlorothiazide Tablets, USP 100mg/25mg to the consumer level. This product is being recalled due to the trace amount of an impurity, N-nitrosodiethylamine (NDEA) contained in the API Losartan, USP manufactured by Zhejiang Huahai Pharmaceutical Co. Ltd. Sandoz Inc. Losartan Potassium Hydrochlorothiazide product is manufactured by Lek Pharmaceuticals dd, Ljubljana, Slovenia. This impurity, which is a substance that occurs naturally in ...

FDA - U.S. Food and Drug Administration

7-11-2018

Several store-brand pain or sinus relief tablets recalled because consumers may be unable to access important safety information

Several store-brand pain or sinus relief tablets recalled because consumers may be unable to access important safety information

Vita Health Products is voluntarily recalling several store-brand (Care, Exact, Life, and Pharmasave) over-the-counter drugs used for pain or sinus relief because of a labelling issue. Consumers may be unable to peel open the wrap-around label on the bottle to access the warning statements, or the label may not peel off completely, which may make it difficult to read some of the important safety information.

Health Canada

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

6-11-2018

Setting of import tolerances for haloxyfop‐P in linseed and rapeseed

Setting of import tolerances for haloxyfop‐P in linseed and rapeseed

Published on: Fri, 02 Nov 2018 00:00:00 +0100 In accordance with Article 6 of Regulation (EC) No 396/2005, the Australian Government Department of Agriculture and Water Resources submitted two requests to the competent national authority in Denmark to set import tolerances for the active substance haloxyfop‐P in linseed and rapeseed. The data submitted in support of the request were found to be sufficient to derive maximum residue level (MRL) proposals for linseed and rapeseed. Adequate analytical metho...

Europe - EFSA - European Food Safety Authority Publications

3-11-2018

Janssen Issues Voluntary Nationwide Recall for one lot of ORTHO-NOVUM 1/35 and two lots of ORTHO-NOVUM 7/7/7 Due to Incorrect Veridate Dispenser Instructions

Janssen Issues Voluntary Nationwide Recall for one lot of ORTHO-NOVUM 1/35 and two lots of ORTHO-NOVUM 7/7/7 Due to Incorrect Veridate Dispenser Instructions

Janssen Pharmaceuticals, Inc. has initiated a voluntary recall of one lot of ORTHO-NOVUM 1/35 (norethindrone / ethinyl estradiol) Tablets and two lots of ORTHO-NOVUM 7/7/7 (norethindrone / ethinyl estradiol) Tablets to the pharmacy level. The patient information provided inside affected packages of ORTHO-NOVUM does not include the appropriate instructions for the Veridate dispenser.

FDA - U.S. Food and Drug Administration

31-10-2018

Outcome of a public consultation on the draft guidance on the scientific requirements for health claims related to muscle function and physical performance

Outcome of a public consultation on the draft guidance on the scientific requirements for health claims related to muscle function and physical performance

Published on: Tue, 30 Oct 2018 00:00:00 +0100 The European Food Safety Authority (EFSA) carried out a public consultation to receive input from the scientific community and all interested parties on a draft guidance on the scientific requirements for health claims related to muscle function and physical performance, prepared by the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA), supported by the Working Group on Claims. The draft guidance was endorsed by the Panel for public consultation ...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Updated review of the existing maximum residue levels for imazalil according to Article 12 of Regulation (EC) No 396/2005 following new toxicological information

Updated review of the existing maximum residue levels for imazalil according to Article 12 of Regulation (EC) No 396/2005 following new toxicological information

Published on: Tue, 30 Oct 2018 00:00:00 +0100 In compliance with Article 43 of Regulation (EC) No 396/2005, EFSA received a mandate from the European Commission to provide an update of the reasoned opinion on the review of existing maximum residue levels (MRLs) for imazalil published on 5 September 2017, taking into account the additional information provided on the toxicity of the metabolites R014821, FK‐772 and FK‐284. EFSA did not derive MRL proposals from the post‐harvest uses reported on citrus fru...

Europe - EFSA - European Food Safety Authority Publications

30-10-2018

Sciegen Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Irbesartan Tablets, USP  75 Mg, 150 Mg, and 300 Mg Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in The Active Pharmaceutical Ingredient (API)

Sciegen Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Irbesartan Tablets, USP 75 Mg, 150 Mg, and 300 Mg Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in The Active Pharmaceutical Ingredient (API)

ScieGen Pharmaceuticals, Inc. is voluntarily recalling listed lots, within expiry, of Irbesartan Tablets, USP 75 mg, 150 mg, and 300 mg dosage forms to the consumer level. These products are being recalled due to the presence of an impurity, N-nitrosodiethylamine (NDEA) contained in the API Irbesartan, USP manufactured by Aurobindo Pharma Limited. This impurity, which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, has been classified as a...

FDA - U.S. Food and Drug Administration

29-10-2018

Big Penis U.S.A tablets

Big Penis U.S.A tablets

Big Penis U.S.A tablets pose a serious risk to your health and should not be taken

Therapeutic Goods Administration - Australia

26-10-2018

Multi-country outbreak of Listeria monocytogenes sequence type 8 infections linked to consumption of salmon products

Multi-country outbreak of Listeria monocytogenes sequence type 8 infections linked to consumption of salmon products

Published on: Thu, 25 Oct 2018 00:00:00 +0200 A multi-country outbreak of 12 listeriosis cases caused by Listeria monocytogenes sequence type (ST) 8 has been identified through whole genome sequencing (WGS) analysis in three EU/EEA countries: Denmark (6 cases), Germany (5) and France (1). Four of these cases have died due to or with the disease. It is likely that the extent of this outbreak has been underestimated since the outbreak was identified through sequencing and only a subset of the EU/EEA count...

Europe - EFSA - European Food Safety Authority Publications

24-10-2018

FDA approves new drug to treat influenza

FDA approves new drug to treat influenza

FDA approved Xofluza (baloxavir marboxil) to treat acute uncomplicated flu in patients 12 years old and older who have been symptomatic for less than 48 hours.

FDA - U.S. Food and Drug Administration

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

13-12-2018

voriconazole

voriconazole

voriconazole (Active substance: voriconazole) - Centralised - Art 28 - (PSUR - Commission Decision (2018)8915 of Thu, 13 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/3127/201802

Europe -DG Health and Food Safety

11-12-2018

Webinar recording: Medicine shortages reporting reforms, 28 November 2018

Webinar recording: Medicine shortages reporting reforms, 28 November 2018

An overview of mandatory medicine shortages reporting obligations for sponsors to be implemented on 1 January 2019

Therapeutic Goods Administration - Australia

28-11-2018

Docetaxel Zentiva (Zentiva k.s.)

Docetaxel Zentiva (Zentiva k.s.)

Docetaxel Zentiva (Active substance: Docetaxel) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8039 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/808/T/56

Europe -DG Health and Food Safety

28-11-2018

Econor (Elanco GmbH)

Econor (Elanco GmbH)

Econor (Active substance: Valnemulin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8038 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/42/T/54

Europe -DG Health and Food Safety

28-11-2018

Zeffix (GlaxoSmithKline (Ireland) Limited)

Zeffix (GlaxoSmithKline (Ireland) Limited)

Zeffix (Active substance: Lamivudine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8044 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/242/T/73

Europe -DG Health and Food Safety

28-11-2018

Orkambi (Vertex Pharmaceuticals (Ireland) Limited)

Orkambi (Vertex Pharmaceuticals (Ireland) Limited)

Orkambi (Active substance: Lumacaftor/Ivacaftor) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8042 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3954/T/39

Europe -DG Health and Food Safety

28-11-2018

Leflunomide ratiopharm (ratiopharm GmbH)

Leflunomide ratiopharm (ratiopharm GmbH)

Leflunomide ratiopharm (Active substance: leflunomide) - Centralised - Yearly update - Commission Decision (2018)8045 of Wed, 28 Nov 2018

Europe -DG Health and Food Safety

28-11-2018

PHEBURANE (Eurocept International BV)

PHEBURANE (Eurocept International BV)

PHEBURANE (Active substance: Sodium Phenylbutyrate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8043 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2500/T/20

Europe -DG Health and Food Safety

28-11-2018

Darunavir Krka d.d. (Krka d. d., Novo mesto)

Darunavir Krka d.d. (Krka d. d., Novo mesto)

Darunavir Krka d.d. (Active substance: darunavir) - Centralised - 2-Monthly update - Commission Decision (2018)8046 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4891/IB/2/G

Europe -DG Health and Food Safety

28-11-2018

GILENYA (Novartis Europharm Limited)

GILENYA (Novartis Europharm Limited)

GILENYA (Active substance: Fingolimod) - Centralised - Variation - Commission Decision (2018)7969 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2202/X/44

Europe -DG Health and Food Safety

28-11-2018

Anoro Ellipta (Glaxo Group Ltd)

Anoro Ellipta (Glaxo Group Ltd)

Anoro Ellipta (Active substance: umeclidinium bromide / vilanterol trifenatate) - Centralised - Yearly update - Commission Decision (2018)8049 of Wed, 28 Nov 2018

Europe -DG Health and Food Safety

28-11-2018

Kalydeco (Vertex Pharmaceuticals (Ireland) Limited)

Kalydeco (Vertex Pharmaceuticals (Ireland) Limited)

Kalydeco (Active substance: ivacaftor) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8047 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2494/T/71

Europe -DG Health and Food Safety

15-11-2018

alitretinoin

alitretinoin

alitretinoin (Active substance: alitretinoin) - Centralised - Art 28 - (PSUR - Commission Decision (2018)7675 of Thu, 15 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/90/201801

Europe -DG Health and Food Safety

12-11-2018

Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva (Zentiva, k.s.)

Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva (Zentiva, k.s.)

Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva (Active substance: efavirenz / emtricitabine / tenofovir disoproxil) - Centralised - Yearly update - Commission Decision (2018)7547 of Mon, 12 Nov 2018

Europe -DG Health and Food Safety

12-11-2018

Ruconest (Pharming Group N.V.)

Ruconest (Pharming Group N.V.)

Ruconest (Active substance: Conestat alfa) - Centralised - Yearly update - Commission Decision (2018)7548 of Mon, 12 Nov 2018

Europe -DG Health and Food Safety

12-11-2018

Spinraza (Biogen Netherlands B.V.)

Spinraza (Biogen Netherlands B.V.)

Spinraza (Active substance: nusinersen) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7550 of Mon, 12 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4312/T/10

Europe -DG Health and Food Safety

12-11-2018

Irbesartan HCT Zentiva (Zentiva k.s.)

Irbesartan HCT Zentiva (Zentiva k.s.)

Irbesartan HCT Zentiva (Active substance: irbesartan / hydrochlorothiazide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7555 of Mon, 12 Nov 2018

Europe -DG Health and Food Safety

12-11-2018

Xeljanz (Pfizer Europe MA EEIG)

Xeljanz (Pfizer Europe MA EEIG)

Xeljanz (Active substance: Tofacitinib) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7554 of Mon, 12 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/004214/T/0015

Europe -DG Health and Food Safety

12-11-2018

Tracleer (Janssen-Cilag International NV)

Tracleer (Janssen-Cilag International NV)

Tracleer (Active substance: bosentan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7556 of Mon, 12 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/000401/T/0088

Europe -DG Health and Food Safety

12-11-2018

Neupro (UCB Pharma S.A.)

Neupro (UCB Pharma S.A.)

Neupro (Active substance: Rotigotine) - Centralised - Yearly update - Commission Decision (2018)7551 of Mon, 12 Nov 2018

Europe -DG Health and Food Safety