EXEN FORT 15 MG 10 TABLET

Genel Bilgiler

  • Ticaret Unvanı:
  • EXEN FORT 15 MG 10 TABLET
  • Reçete türü:
  • Normal
  • İçin kullanmak:
  • İnsanlar
  • İlaç türü:
  • allopatik ilaç

Belgeler

Yerelleştirme

  • Bulunduğu ülkeler::
  • EXEN FORT 15 MG 10 TABLET
    Türkiye
  • Dil:
  • Türkçe

Terapötik bilgiler

  • Terapötik alanı:
  • Celebrex

Diğer bilgiler

Durum

  • Kaynak:
  • TİTCK - TÜRKİYE İLAÇ VE TIBBİ CİHAZ KURUMU - Türkiye
  • Yetkilendirme durumu:
  • Aktif
  • Yetkilendirme numarası:
  • 8699536010373
  • Yetkilendirme tarihi:
  • 29-01-2013
  • Son Güncelleme:
  • 24-05-2018

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

1

KULLANMATALĐMATI

EXENFORT15mgtablet

Ağızdanalınır.

Etkinmadde:Herbirtablet15mgmeloksikamiçerir.

Yardımcımaddeler:Trisodyumsitratdihidrat,laktozmonohidrat,mikrokristalselüloz,

povidon,silikondioksit,krospovidon,magnezyumstearat.

BuilacıkullanmayabaşlamadanöncebuKULLANMATALĐMATINIdikkatlice

okuyunuz,çünküsiziniçinönemlibilgileriçermektedir.

Bukullanmatalimatınısaklayınız.Dahasonratekrarokumayaihtiyaçduyabilirsiniz.

Eğerilavesorularınızolursa,lütfendoktorunuzaveyaeczacınızadanışınız.

Builaçkişiselolaraksiziniçinreçeteedilmiştir,başkalarınavermeyiniz.

Builacınkullanımısırasında,doktoraveyahastaneyegittiğinizdedoktorunuzabuilacı

kullandığınızısöyleyiniz.

Butalimattayazılanlaraaynenuyunuz.Đlaçhakkındasizeönerilendozundışındayüksek

veyadüşükdozkullanmayınız.

BuKullanmaTalimatında:

1.EXENFORTnedirveneiçinkullanılır?

2.EXENFORT’ukullanmadanöncedikkatedilmesigerekenler

3.EXENFORTnasılkullanılır?

4.Olasıyanetkilernelerdir?

5.EXENFORT’unsaklanması

Başlıklarıyeralmaktadır.

1.EXENFORTnedirveneiçinkullanılır?

EXENFORT,herbirtabletteetkinmaddeolarak15mgmeloksikamiçerenhafifsarırenkli,

oblong,ikiyüzüçentiklitabletlerdir.Çentiğinamacıtabletieşitdozlarabölebilmektir.Böylece

tablet7.5mg'lıkeşityarımlarabölünebilir.10adettabletiçerenblisterambalajlardakullanıma

sunulmuştur.10ve30adettabletiçerenblisterambalajlardakullanımasunulmuştur.

Meloksikam,eklemvekaslardakiiltihapveağrıyıazaltmakiçinkullanılansteroidiçermeyen

iltihapgidericiilaçlar(non-steroidalantiinflamatuvarilaçlar-NSAĐĐ)grubunadahildir.

EXENFORT,

Kireçlenme(osteoartrit),eklemlerdeağrıveşekilbozukluğunayolaçansüreğenbirhastalık

olanromatoidartritvesırteklemlerindesertleşmeileseyredenağrılıilerleyicibir

romatizmalhastalıkolanankilozanspondilitinbelirtivebulgularınıntedavisinde,

Eklemlerdekiürikasitbirikiminebağlıolaraközellikleayakvebacaklardakieklemlerdeani

ağrınöbetlerişeklindeseyredenakutgutartriti,akutkasiskeletsistemiağrıları,ameliyat

sonrasıağrıveağrılıadetgörme(dismenore)tedavisindekullanılır.

2

2.EXENFORT’ukullanmadanöncedikkatedilmesigerekenler

EXENFORT’uaşağıdakidurumlardaKULLANMAYINIZ:

Eğer;

Hamileiseniz,hamilekalmayıplanlıyorsanızveyabebeğiniziemziriyorsanız

Meloksikam’aveyailaçtakiherhangibir/birdenfazlayardımcımaddeyekarşıalerjinizvarsa

Koronerartercerrahisi(koronerarterbypassgreft)geçirdiyseniz,ameliyatöncesi,sırasıve

EXENFORT’undadahilolduğubazıilaçgruplarınınkalpkrizi(miyokartinfarktüsü)

vefelçriskiniazdaolsaarttırabilmeriskivardır.Buriskuzunsürelitedaviveyayüksek

dozilaçkullanımındadahaolasıdır.Doktorunuztarafındantavsiyeedilendozvetedavi

süresiniaşmayınız.

Kalprahatsızlıklarınızvarsa,geçmiştefelçgeçirdiysenizyadabudurumlariçinrisk

faktörlerinitaşıyorsanız(örneğintansiyonunuzveyakolesterolünüzyüksekse,şeker

hastalığınızvarsa,sigarakullanıyorsanız)tedaviyebaşlamadanöncelütfendoktorunuza

danışınız.

Kalp-damarsistemindeortayaçıkabilenciddiyanetkilerherhangibiruyarıbelirtisi

vermedenoluşabilir.Bununlabirliktegöğüsağrısı,nefesdarlığı,halsizlikvegeveleyerek

konuşmabelirtileriaçısındantetikteolmalısınız.Herhangibirbelirtiilekarşılaşırsanız

tıbbiyardımistemelisiniz.

EXENFORTmide-barsakrahatsızlıklarınayolaçabilir.Nadirenortayaçıkanülserve

kanamagibiciddiyanetkilerhastanedeyatmayayadaölümesebepolabilir.Mide-

barsakkanalındaciddiülserleşmelervekanama,herhangibiruyarıbelirtisi

vermeksizinortayaçıkabilir;bununlabirliktekarınağrısı,hazımsızlık,kanamayabağlı

katranrenklidışkı,kankusmagibibelirtilerlekarşılaşırsanıztıbbiyardımistemelisiniz.

EXENFORT,derideciddiyanetkilereyolaçabilir.Buyanetkilerherhangibiruyarı

vermeksizinortayaçıkabilir.Bununlabirliktederidedöküntüvekabarcıklar,ateşveya

kaşıntıgibidiğeraşırıduyarlılıkbelirtileriyönündentetikteolmalıveherhangibir

belirtiilekarşılaşırsanıztıbbiyardımistemelisiniz.Döküntügelişirsederhalilacı

kullanmayıbırakınızvehekiminizlegörüşünüz.

Beklenmedikkiloalmayadaödemilekarşılaşırsanızhekiminizileirtibatageçiniz.

Bulantı,yorgunluk,halsizlik,kaşıntı,sarılık,sağüstkadranhassasiyetivegripbenzeri

belirtilerkaraciğerzehirlenmesininuyarıcıişaretleridir.Bunlarlakarşılaşırsanızilacı

kullanmayasonveripderhalhekiminizebaşvurunuz.

DiğerNSAĐilaçlargibi,EXENFORTkullanımındandagebeliğinileridönemlerinde

kaçınılmalıdırçünküduktusarteriosusun(normaldeannekarnındaaçıkolupdoğumu

takibenkapanmasıgereken,kalptençıkanikibüyükatardamararasındakiaçıklık)

erkenkapanmasınayolaçabilir.

Nefesalmadagüçlük,yüzünveyaboğazınşişmesigibianiaşırıduyarlılıktepkisi

belirtileriilekarşılaşırsanızderhalacilyardımalmalısınız.

3

Aspirinveyadiğeriltihapgidericiilaçlarakarşıalerjinizvarsa,builaçlarsizdeastımkrizine

yolaçtıysa

Dahaönceaspirinveyabaşkabiriltihapgidericiilaçaldıktansomahırıltılısolunum,burun

akıntısıilebirliktenazalpolipler(burnuniçindealerjidendolayıoluşanşişlikler),ciltte

şişme,kurdeşengeliştiyse

Mideveyabarsakülserinizvarsaveyadahaöncedenmideveyabarsakülserigeçirdiyseniz

Herhangibirkanamabozukluğunuzvarsaveyadahaöncedengastrointestinalkanama(mide

yadabarsaklakanama)veyaserebrovaskülerkanama(beyindekanama)geçirdiyseniz

Ağırkaraciğerhastalığınızvarsa

Ağırböbrekhastalığınızvarsavediyalizegirmiyorsanız

Ağırkalphastalığınızvarsa

16yaşınaltındakiçocuklarda

EXENFORT’uaşağıdakidurumlardaDĐKKATLĐKULLANINIZ

Eğer;

Yemekborusuiltihabı(özofajit),midemukozasıiltihabı(gastrit)veyaülseratifkolit,Crohn

hastalığı(iltihabibarsakhastalıkları)gibibaşkamide-barsakrahatsızlığıöykünüzvarsa

Astımınızvarsa

Kansızlığınız(anemi)varsa

Kanbasıncınızyüksekse

Đlerlemişyaştaiseniz

Kalp,karaciğerveyaböbrekhastalığınızvarsa

Şekerhastasıiseniz

Ciddikankaybıveyayanık,ameliyatyadayetersizsıvıalımıilegelişebilenhipovoleminiz

(azalmışkanhacmi)varsa

Herhangibirzamandakanpotasyumseviyelerinizinyüksekolduğutanısıkonduysa

Pıhtılaşmasorunlarınızvarsa

EXENFORTdadahilolmaküzeretümNSAĐilaçlarınkullanımıile,eksfolyatifdermatit

denenbirtürderihastalığı,cilttevegözçevresindekanoturması,şişlikvekızarıklıkla

seyredeniltihap(Stevens-Johnsonsendromu)vederideiçisıvıdolukabarcıklarlaseyreden

ciddibirhastalıkolantoksikepidermalnekrolizdahilciddideritepkilerigörülebilir.Butür

reaksiyonlarlakarşılaşırsanızderhaldoktorunuzahaberveriniz.

Buuyarılargeçmiştekiherhangibirdönemdedahiolsa,siziniçingeçerliyselütfendoktorunuza

danışın.

EXENFORT’unyiyecekveiçecekilekullanılması

EXENFORT,suveyafarklısıvılarlaveyemeklerlebirliktealınmalıdır.

Hamilelik:

Đlacıkullanmadanöncedoktorunuzaveyaeczacınızadanışınız.

EXENFORThamileliksüresincekullanılmamalıdır.

Tedavinizsırasındahamileolduğunuzufarkedersenizhemendoktorunuzaveyaeczacınıza

danışınız.

Emzirme:

Đlacıkullanmadanöncedoktorunuzaveyaeczacınızadanışınız.

EXENFORT,emzirmedönemindekullanılmamalıdır.

4

Araçvemakinekullanımı

EXENFORTgörmebozuklukları,uyuşuklukvesersemliğesebepolabilir.Buetkilersizde

mevcutisearaçveyamakinekullanmayınız.

EXENFORT’uniçeriğindebulunanbazıyardımcımaddelerhakkındaönemlibilgiler:

EXENFORTtabletlerlaktozmonohidratiçerir.Eğerdahaöncedendoktorunuztarafındanbazı

şekerlerekarşıdayanıksızlığınızolduğusöylenmişsebutıbbiürünüalmadanöncedoktorunuzla

temasageçiniz.

Butıbbiürünherdozunda1mmol(23mg)’dandahaazsodyumihtivaeder;budozdasodyuma

bağlıherhangibiryanetkibeklenmemektedir.

Diğerilaçlarilebirliktekullanımı:

EXENFORT,diğerilaçlarıetkileyeceğindenveyadiğerilaçlardanetkileneceğinden,lütfen

doktorunuzaveyaeczacınızakullanmaktaolduğunuzyadayakınzamanakadarkullandığınız

tümilaçları(reçetelendirilmemişilaçlardahil)bildiriniz.

Özellikleaşağıdakiilaçlarıkullanıyorsanızyadakullandıysanızdoktorunuzabildiriniz.

Aspirindahildiğeriltihapgidericiilaçlar

Varfaringibikanınpıhtılaşmasınıengelleyenilaçlar

Kanpıhtılarınıparçalayanilaçlar(trombolitikler)

Yüksekkanbasıncınıntedavisindekullanılanilaçlar

Kortikosteroidler

Siklosporin(organnakillerindensonraveciddiderirahatsızlıkları,romatoidartrit,nefrotik

sendromtedavisindesıkçakullanılanbirilaç)

Đdrarsöktürücüler(butürilaçlarıkullanıyorsanızdoktorunuzböbrekfonksiyonlarınızı

izleyebilir)

Lityum(duygudurumbozukluklarınıntedavisindekullanılanbirilaç)

Selektifserotoningerialıminhibitörleriveserotonin/norepinefringerialıminhibitörleri

(depresyontedavisindekullanılanbirtakımilaçgrupları)

Metotreksat(temelolaraktümörlerinveyaciddikontroledilemeyenderirahatsızlıklarıve

romatoidartritintedavisindekullanılanbirilaç)

Kolestiramin(temelolarakkolesterolseviyelerinidüşürmekiçinkullanılanbirilaç)

Rahimiçiaraçkullanıyorsanızdoktorunuzabununhakkındabilgiveriniz.

Alkol,midemukozasınıntahrişiniarttırabileceğindenEXENFORTtedavisisüresince

kullanılmamalıdır.

Çeşitligıdaürünlerivebitkiselürünlerilacınızileetkileşebilir.Bunlararasındaalfalfa(adi

yonca),anason,yabanmersini,fukus(bladderwrack),bromelin,kedipençesi(cat'sclaw),

kereviz,mayıspapatyası,kolyoz,kordisepsmantarı,dongquai(Çinmelekotu/Angelica

sinensis),çuhaçiçeği,çemenotu,gümüşdüğme,sarımsak,zencefil,japoneriği(Ginkgobiloba),

ginseng(Amerikan,Panax,Sibirya),üziimçekirdeği,yeşilçay,guggul,atkestanesitohumu,

bayırturpu,meyankökü,frenkinciri,çayırüçgülü(kırmızıyonca),reishimantarı,SAMe(S-

adenozilmetionin),acemotu(melisa),zerdeçal,aksöğütyeralır.Bütünbuürünlerinilavekan

sulandırıcı(antiplatelet)etkileriolduğundantedavinizsüresincebuürünlerikullanmayınız.

Eğerreçeteliyadareçetesizherhangibirilacısuandakullanıyorsanızveyasonzamanlarda

kullandıysanızlütfendoktorunuzaveyaeczacınızabunlarhakkındabilgiveriniz.

5

3.EXENFORTnasılkullanılır?

Uygunkullanımvedoz/uygulamasıklığıiçintalimatlar:

Hastalığınızabağlıolarakalacağınızdozmiktarınıvetedavisüresinidoktorunuzbelirleyecektir.

Önerilengeneldozlaraşağıdaverilmiştir.

Osteoartritalevlenmelerinde:

Günlükdozgünde1kez7.5mg’dır(birtabletinyarısı).Doktorunuzgerekligördüğündebu

dozugünde1kez15mg'a(birtablet)yükseltebilir.

Romatoidartrittedavisinde:

Günlükdozgünde1kez15mg’dır(birtablet).Doktorunuzgerekligördüğündebudozu

günde1kez7.5mg'a(birtabletinyarısı)düşürebilir.

Ankilozanspondilittedavisinde:

Günlükdozgünde1kez15mg’dır(birtablet).Doktorunuzgerekligördüğündebudozu

günde1kez7.5mg’a(birtabletinyarısı)düşürebilir.

Akutgutartriti,akutkasiskeletsistemiağrıları,ameliyatsonrasıağrıveağrılıadetgörme

(dismenore)tedavisindeönerilendoz7.5mg/gün(biradet15mgtabletinyarısı)olup

istenenetkininsağlanamadığıdurumlardadoz15mg/gün'e(biradet15mgtablet)

yükseltilebilir.

Uygulamayoluvemetodu:

Günlüktoplamdozutekdozolarak,suveyafarklısıvılarlaveyemeklerlebirliktealınız.

TabletinüzerindebulunançentiksayesindeEXENFORTeşitdozlarabölünebilir.15mg

tabletlerikieşitparçayaayrılırveyarımtabletalınarak7.5mg’lıkdozeldeedilir.

Önerilendozutekdozhalinde/birkeredealınız.

Önerilengünlükmaksimumdozolan15mg'ıgeçmeyiniz.

Eğer"EXENFORT’uaşağıdakidurumlardaDĐKKATLĐKULLANINIZ"başlığıaltında

listelenendurumlardanherhangibirisiziniçingeçerliyse,doktorunuzdozunuzugünde1kez7.5

mgilesınırlandırabilir.

Tedavinizikendikendinizekesmeyinizveuzatmayınız.

Değişikyaşgrupları:

Çocuklardakullanımı:

EXENFORT,16yaşınaltındakiçocuklardakullanmamalıdır.

Yaşlılardakullanımı:

Yaşlıhastalardaankilozanspondilitinveromatoidartritinuzun-dönemtedavisiiçintavsiye

edilendoz7.5mg/gün'dür.

Özelkullanımdurumları:

Böbrekyetmezliği:

Ciddiböbrekyetmezliğiolanvediyaliztedavisiuygulananhastalardatavsiyeedilengünlükdoz

maksimum7.5mg’dır.

EXENFORTdiyaliztedavisigörmeyenveciddiböbrekyetmezliğibulunanhastalarda

kullanılmamalıdır.

6

Karaciğeryetmezliği:

Hafif-ortaşiddettekaraciğeryetmezliğiolanhastalardadozunazaltılmasınagerekyoktur.

EXENFORTağırkaraciğeryetmezliğiolanhastalardakullanılmamalıdır.

Diğer

Đstenmeyenetkiriskiyüksekolanhastalardatedaviyegünlük7.5mgdozilebaşlanmalıdır.

EğerEXENFORT’unetkisininçokgüçlüveyazayıfolduğunadairbirizleniminizvarise

doktorunuzveyaeczacınızilekonuşunuz.

KullanmanızgerekendendahafazlaEXENFORTkullandıysanız:

EXENFORT’dankullanmanızgerekendenfazlasınıkullanmışsanızbirdoktorveyaeczacıile

konuşunuz.

Aşırıdozvekazaylailaçalmadurumlarındaderhaldoktorunuzaveyabirhastaneyebaşvurunuz.

Kalantabletlerivebukullanmatalimatınıyanındagötürmeniz,sağlıkpersonelinintamolarakne

kullandığınızıanlamasınısağlayacağıiçinönemlidir.

EXENFORT’ukullanmayıunutursanız:

Unutulandozlarıdengelemekiçinçiftdozalmayınız.

EXENFORT’unormalzamanındaalmayıunutursanız,birsonrakidozunalınmazamanınaçok

yakınolmadığısüreceunutulandozuhatırlarhatırlamazalınız.Unuttuğunuzdozumümkün

olduğukadarçabukalmayaçalışınızvedahasonradoktorunuzuntavsiyeettiğiaralıklarile

ilacınızıalmayadevamediniz.

EXENFORTiletedavisonlandırıldığındakioluşabileceketkiler

Doktorunuzadanışmadantedavinizesonvermeyiniz.Hastalıkbelirtileriyenidenortayaçıkar.

4.Olasıyanetkiler

TümilaçlargibiEXENFORT’uniçeriğindebulunanmaddelereduyarlıolankişilerdeyanetkiler

olabilir.

Aşağıdakilerdenbiriolursa,EXENFORT’ukullanmayıdurdurunuzveDERHAL

doktorunuzabildirinizveyasizeenyakınhastaneninacilbölümünebaşvurunuz:

-Aniaşırıduyarlılıktepkileri(yüzdeödem,dildeşişme,gırtlaktaşişmeilebirliktesoluk

yolununtıkanması,kalpatışındahızlanma,solukalmagüçlüğü,kanbasıncındadüşmegibi

belirtilerlekendinigösterenakuttepkiler)

-Aniaşırıduyarlılıktepkileriharicindekialerjiktepkiler

-Alerjisonucuyüzveboğazdaşişme

-Kurdeşen

-AspirinvediğerNSAĐilaçlaraalerjiksenizgelişebilecekolanastım

Bunlarınhepsiçokciddiyanetkilerdir.

Eğerbunlardanbirisizdemevcutise,sizinEXENFORT’akarşıciddialerjinizvardemektir.

Aciltıbbimüdaheleyeveyahastaneyeyatırılmanızagerekolabilir.

Aşağıdakiyanetkiler,EXENFORTkullanıyorsanızgörülebilirvebunedenlebelirliönlemlere

vetedavilereihtiyaçduyabilirsiniz.

Yanetkileraşağıdakikategorilerdegösterildiğişekildesıralanmıştır:

Çokyaygın: 10hastanınenazbirindegörülebilir

7

Yaygın: 10hastanınbirindenaz,fakat100hastanınbirindenfazlagörülebilir.

Yaygınolmayan:100hastanınbirindenaz,fakat1000hastanınbirindenfazlagörülebilir.

Seyrek: 1.000hastanınbirindenazgörülebilir.

Çokseyrek: 10.000hastanınbirindenazgörülebilir.

Bilinmiyor: Eldekiverilerdenhareketletahminedilemiyor.

Çokyaygınyanetkiler;

Hazımsızlık,bulantı,kusma,karınağrısı,kabızlık,gazabağlımide-barsaktaşişkinlik,ishal

Yaygınyanetkiler;

Başağrısı,ödem

Yaygınolmayanyanetkiler;

Kansızlık,sersemlik,uykululukhali,dengebozukluğundankaynaklananbaşdönmesi,çarpıntı,

kanbasıncınınyükselmesi,albasması,gizliyadagözlegörülebilenmide-barsakkanalında

kanama,ağıziçindeiltihap,midemukozasıiltihabı(gastrit),geğirme,karaciğerişlev

bozuklukları(örn.yüksekbilirubinveyayüksektransaminazdeğerleri),kaşıntı,döküntüsodyum

vesututulması,kanpotasyumdüzeyininnormalinüstüneyükselmesi,serumüreve/veya

kreatininseviyelerindeartışşeklindeböbrekişlevtestiparametrelerindeanormallikler

Seyrekyanetkiler;

Kansayımıanomalileri,akyuvarsayısındaazalma,trombosit(kanpulcuğu)sayısındaazalma,

duygudurumdalgalanmaları,kabuslar,bulanıkgörmegibigörmebozuklukları,konjonktivit(bir

çeşitgöziltihabı),kulakçınlaması,kalınbarsakiltihabı,gastroduodenalülser,yemekborusu

iltihabı,Stevens-Johnsonsendromu(cilttevegözçevresindekanoturması,şişlik,kızarıklıkve

döküntüyleseyredenbirtüralerjiktepki),toksikepidermalnekroliz(derideiçisıvıdolu

kabarcıklarlaseyredenciddibirhastalık)

Çokseyrekyanetkiler;

Mide-barsakkanalındadelinme,karaciğeriltihabı(hepatit),büllözdermatider(birtürderi

hastalığı),eritemamultiforma(geneldekendiliğindengeçen,el,yüzveayaktadantelebenzer

kızarıklıkoluşturan,aşırıduyarlılıkdurumu),özelikleriskfaktörleritaşıyanhastalardaakut

böbrekyetmezliği

Sıklığıbilinmeyenyanetkiler;

Zihinkarışıklığıdurumu,yönelimbozukluğu,ışığaaşırıduyarlılıktepkileri

Ürünleilişkiliolarakgözlenmemişancakaynısınıftakidiğerbileşikleregenelolarakatfedilen

istenmeyenetkiler:Akutböbrekyetmezliğiilesonuçlanabilenyapısalböbrekhasarı.

NSAĐilaçtedavisiileilişkiliolarakkalpyetmezliğibildirilmiştir.

Özellikleyaşlılardamide-barsakkanalındakanama,tilseroluşumuveyadelinmebazenağırve

öldürücüolabilir.

Meloksikamvediğerpotansiyelmiyelotoksiketkili(kemikiliğiiçinzararlı)ilaçlariletedavi

görenhastalardaçokseyrekolarakagranülositoz(beyazkanhücrelerisayısındaazalma)vakası

raporedilmiştir.

Eğerbukullanmatalimatındabahsigeçmeyenherhangibiryanetkiilekarşılaşırsanız

doktorunuzuveyaeczacınızıbilgilendiriniz.

8

Yanetkilerinraporlanması

KullanmaTalimatındayeralanveyaalmayanherhangibiryanetkimeydanagelmesidurumunda

hekiminiz,eczacınızveyahemşirenizilekonuşunuz.Ayrıcakarşılaştığınızyanetkileri

www.titck.gov.trsitesindeyeralan“ĐlaçYanEtkiBildirimi”ikonunatıklayarakyada0800314

0008numaralıyanetkibildirimhattınıarayarakTürkiyeFarmakovijilansMerkezi(TÜFAM)'ne

bildiriniz.Meydanagelenyanetkileribildirerekkullanmaktaolduğunuzilacıngüvenliliği

hakkındadahafazlabilgiedinilmesinekatkısağlamışolacaksınız.

5.EXENFORT’unsaklanması

EXENFORT’uçocuklarıngöremeyeceği,erişemeyeceğiyerlerdeveambalajındasaklayınız.

EXENFORT’u,25°C’ninaltındakiodasıcaklığındasaklayınız.

Sonkullanmatarihiyleuyumluolarakkullanınız.

AmbalajdakisonkullanmatarihindensonraEXENFORT’ukullanmayınız.

Buürünve/veyaambalajıherhangibirbozuklukiçeriyorsakullanılmamalıdır.

Ruhsatsahibi:SanovelĐlaçSan.veTic.A.Ş.

34460Đstinye-Đstanbul

Üretimyeri: SanovelĐlaçSan.veTic.A.Ş.

34580Silivri-Đstanbul

Bukullanmatalimatı………………tarihindeonaylanmıştır.

15-12-2018

Annual Report of the Scientific Network on BSE‐TSE 2018

Annual Report of the Scientific Network on BSE‐TSE 2018

Published on: Fri, 14 Dec 2018 The EFSA Scientific Network on bovine spongiform encephalopathies and other transmissible spongiform encephalopathies (BSE‐TSE) held its 13th meeting on 15‐16 October 2018 in Parma. The meeting served as an opportunity to exchange scientific information on BSE‐TSE related issues among EU Member States, countries from the European Free Trade Association (EFTA), EFSA, the European Commission and ad hocparticipants. In this occasion, ad hoc representation included the World A...

Europe - EFSA - European Food Safety Authority Publications

14-12-2018

Risk to human health related to the presence of perfluorooctane sulfonic acid and perfluorooctanoic acid in food

Risk to human health related to the presence of perfluorooctane sulfonic acid and perfluorooctanoic acid in food

Published on: Thu, 13 Dec 2018 The European Commission asked EFSA for a scientific evaluation on the risks to human health related to the presence of perfluorooctane sulfonic acid (PFOS) and perfluorooctanoic acid (PFOA) in food. Regarding PFOS and PFOA occurrence, the final data set available for dietary exposure assessment contained a total of 20,019 analytical results (PFOS n = 10,191 and PFOA n = 9,828). There were large differences between upper and lower bound exposure due to analytical methods with i...

Europe - EFSA - European Food Safety Authority Publications

12-12-2018

December 10, 2018: Olympus Medical Systems Corporation, Former Senior Executive Plead Guilty to Distributing Endoscopes After Failing to File FDA-Required Adverse Event Reports of Serious Infections

December 10, 2018: Olympus Medical Systems Corporation, Former Senior Executive Plead Guilty to Distributing Endoscopes After Failing to File FDA-Required Adverse Event Reports of Serious Infections

December 10, 2018: Olympus Medical Systems Corporation, Former Senior Executive Plead Guilty to Distributing Endoscopes After Failing to File FDA-Required Adverse Event Reports of Serious Infections

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

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

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

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

Sprout Creek Farm Recalls “Kinkead” Cheese due to Possible Health Risk

Sprout Creek Farm Recalls “Kinkead” Cheese due to Possible Health Risk

Sprout Creek Farm of Poughkeepsie, New York is recalling 4 wheels of “Kinkead” cheese made on 5-10-18, because it has the potential to be contaminated with Listeria monocytogenes. Listeria monocytogenes is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, L...

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

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

24-11-2018

The EFSA‐funded collection of dietary and related data in the general population aged 10‐74 years in Greece

The EFSA‐funded collection of dietary and related data in the general population aged 10‐74 years in Greece

Published on: Fri, 23 Nov 2018 The Hellenic Health Foundation received support from the European Food Safety Authority in order to organise a national nutrition survey according to the methodology described in the EFSA Guidance document and to collect food consumption and related information among 780 adolescents, adults and elderly residing permanently in Greece. The EFSA‐funded data collection was largely based on the protocol of a large scale Greek national nutrition and health survey, called HYDRIA....

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

Fresenius Kabi Issues Voluntary Nationwide Recall of Sodium Chloride Injection, USP, 0.9% Due to Product Labeling Incorrectly Stating Stoppers Do Not Contain Latex

Fresenius Kabi Issues Voluntary Nationwide Recall of Sodium Chloride Injection, USP, 0.9% Due to Product Labeling Incorrectly Stating Stoppers Do Not Contain Latex

Fresenius Kabi USA is voluntarily recalling 163 lots of Sodium Chloride Injection, USP, 0.9%, 10 mL fill in a 10 mL vial and Sodium Chloride Injection, USP, 0.9%, 20 mL fill in a 20 mL vial to the user level. The product insert states that stoppers for both the 10mL and the 20mL vials do not contain natural rubber latex; the tray label for the two vial sizes and the vial label for the 20mL vial also state that the stoppers do not contain latex. The product is being recalled because the stoppers contain n...

FDA - U.S. Food and Drug Administration

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

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

20-11-2018

Mariam, Floris en Mookie beëdigd tot kinderbewindspersonen van VWS

Mariam, Floris en Mookie beëdigd tot kinderbewindspersonen van VWS

Nederland is vandaag op de Internationale Dag van de Rechten van het Kind drie bewindspersonen rijker. Mariam Yousfi (13 jaar) en Floris Vooren (13 jaar) zijn door ministers Hugo de Jonge en Bruno Bruins benoemd tot kinderminister en Mookie Saluna (15 jaar) is door staatssecretaris Paul Blokhuis benoemd tot kinderstaatssecretaris. De kinderbewindspersonen zullen een jaar lang het ministerie van Volksgezondheid, Welzijn en Sport (VWS) met slimme tips en praktische adviezen helpen het beleid beter en kindv...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

16-11-2018

Setting of an import tolerance for pyraclostrobin in rice

Setting of an import tolerance for pyraclostrobin in rice

Published on: Thu, 15 Nov 2018 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted a request to the competent national authority in Germany to set an import tolerance for the active substance pyraclostrobin in rice. The data submitted in support of the request were found to be sufficient to derive a maximum residue level (MRL) proposal for rice. Based on the risk assessment results, EFSA concluded that the short‐term intake of residues resulting from the use of p...

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

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

Kadesh Incorporation Issues Voluntary Nationwide Recall of Puriton Eye Relief Drops Due to Non-Sterile Production Conditions

Kadesh Incorporation Issues Voluntary Nationwide Recall of Puriton Eye Relief Drops Due to Non-Sterile Production Conditions

Kadesh, Inc. of Garden Grove, CA is voluntarily recalling all lots of Puriton Eye Relief Drops, 0.5 oz. (15ml) bottle, UPC 7 36972 1679 0, to the consumer level. During a recent FDA inspection, investigators observed that ophthalmic drugs, which are required to be sterile, are manufactured without necessary production controls and conditions to assure sterility.

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

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

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

30-10-2018

Pest categorisation of Aleurocanthus spp.

Pest categorisation of Aleurocanthus spp.

Published on: Mon, 29 Oct 2018 00:00:00 +0100 The Panel on Plant Health performed a pest categorisation of Aleurocanthus spp., a well‐defined insect genus of the whitefly family Aleyrodidae (Arthropoda: Hemiptera). Difficulties within the taxonomy of the genus give doubt about the ability to accurately identify some members to species level. Nevertheless, the genus is thought to currently include about ninety species mainly reported from tropical and subtropical areas. The genus is listed in Council Dir...

Europe - EFSA - European Food Safety Authority Publications

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

24-10-2018

Vita Health Products Recall (2018-10-24)

Vita Health Products Recall (2018-10-24)

Health Canada

20-10-2018

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Published on: Fri, 19 Oct 2018 00:00:00 +0200 EFSA was requested to deliver a scientific opinion on the implications for human health of the flavouring substance 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide [FL‐no: 16.133], in the Flavouring Group Evaluation 411 (FGE.411), according to Regulation (EC) No 1331/2008 of the European Parliament and of the Council. The substance has not been reported to occur in natural source materials of botanical or animal origin. It is intende...

Europe - EFSA - European Food Safety Authority Publications

18-10-2018

Mom Life Market recalls 10" & 16" Personalized Stuffed Plush Bunnies

Mom Life Market recalls 10" & 16" Personalized Stuffed Plush Bunnies

The recalled products may contain phthalate levels that exceed the allowable levels.

Health Canada

18-10-2018

Scientific Opinion on Flavouring Group Evaluation 201 Revision 2 (FGE.201Rev2): 2‐alkylated, aliphatic, acyclic alpha,beta‐unsaturated aldehydes and precursors, with or without additional double‐bonds, from chemical subgroup 1.1.2 of FGE.19

Scientific Opinion on Flavouring Group Evaluation 201 Revision 2 (FGE.201Rev2): 2‐alkylated, aliphatic, acyclic alpha,beta‐unsaturated aldehydes and precursors, with or without additional double‐bonds, from chemical subgroup 1.1.2 of FGE.19

Published on: Wed, 17 Oct 2018 00:00:00 +0200 The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to consider in this revision 2 of Flavouring Group Evaluation 201, the additional data on genotoxicity submitted by the Industry on two substances, 2‐methylpent‐2‐enal [FL‐no: 05.090] and 2 methylcrotonaldehyde [FL‐no: 05.095], from subgroup 1.1.2 of FGE.19. In FGE.201Rev1, the Panel concluded that further data were required in order to clarify the genotoxic poten...

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Faribault Foods, Inc. Announces Voluntary Recall of a Limited Quantity of S&W Brand White Beans Due to the Presence of Undeclared (Sulfites)

Faribault Foods, Inc. Announces Voluntary Recall of a Limited Quantity of S&W Brand White Beans Due to the Presence of Undeclared (Sulfites)

Faribault Foods, Inc. of Faribault, MN is recalling its 15 ounce S&W White Beans because it contains undeclared sulfites. People who have an allergy or severe sensitivity to sulfites run the risk of serious or life-threatening allergic reaction if they consume this product.

FDA - U.S. Food and Drug Administration

17-10-2018

Enforcement Report for the Week of October 17, 2018

Enforcement Report for the Week of October 17, 2018

Recently Updated Records for the Week of October 17, 2018 Last Modified Date: Monday, October 15, 2018

FDA - U.S. Food and Drug Administration

17-10-2018

Applicability of in silico tools for the prediction of dermal absorption for pesticides

Applicability of in silico tools for the prediction of dermal absorption for pesticides

Published on: Tue, 16 Oct 2018 00:00:00 +0200 Based on the “Human in vitro dermal absorption datasets” published as supporting information to the revised EFSA Guidance on Dermal Absorption, in silico models for prediction of absorption across the skin have been evaluated. For this evaluation, a systematic literature search and review was performed, identifying 288 publications describing mathematical models for prediction of dermal absorption. Eleven models potentially relevant to the regulatory assessm...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

October 15, 2018: Leader of Fraudulent Prescription Conspiracy Sentenced to Six Years in Prison

October 15, 2018: Leader of Fraudulent Prescription Conspiracy Sentenced to Six Years in Prison

October 15, 2018: Leader of Fraudulent Prescription Conspiracy Sentenced to Six Years in Prison

FDA - U.S. Food and Drug Administration

16-10-2018

October 15, 2018: Four Men and Seven Companies Indicted for Billion-Dollar Telemedicine Fraud Conspiracy, Telemedicine Company and CEO Plead Guilty in Two Fraud Schemes

October 15, 2018: Four Men and Seven Companies Indicted for Billion-Dollar Telemedicine Fraud Conspiracy, Telemedicine Company and CEO Plead Guilty in Two Fraud Schemes

October 15, 2018: Four Men and Seven Companies Indicted for Billion-Dollar Telemedicine Fraud Conspiracy, Telemedicine Company and CEO Plead Guilty in Two Fraud Schemes

FDA - U.S. Food and Drug Administration

10-12-2018

Exondys (AVI BioPharma International Ltd)

Exondys (AVI BioPharma International Ltd)

Exondys (Active substance: eteplirsen) - Centralised - Refusal of marketing authorisation - Commission Decision (2018)8620 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4355

Europe -DG Health and Food Safety

10-12-2018

Ivabradine JensonR (JensonR+ Limited)

Ivabradine JensonR (JensonR+ Limited)

Ivabradine JensonR (Active substance: ivabradine) - Centralised - Withdrawal - Commission Decision (2018)8623 of Mon, 10 Dec 2018

Europe -DG Health and Food Safety

4-12-2018

TGA presentation: Advertising therapeutic goods in 2019: The Code basics, 13 and 15 November 2018

TGA presentation: Advertising therapeutic goods in 2019: The Code basics, 13 and 15 November 2018

A detailed walkthrough of the Code with examples to illustrate the application of the key sections.

Therapeutic Goods Administration - Australia

29-11-2018

Inflacam (Chanelle Pharmaceuticals Manufacturing Limited)

Inflacam (Chanelle Pharmaceuticals Manufacturing Limited)

Inflacam (Active substance: Meloxicam) - Centralised - Variation - Commission Decision (2018)8036 of Thu, 29 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2497/X/15

Europe -DG Health and Food Safety

26-11-2018

In the next few months CDRH will make public on its website cleared devices that demonstrated substantial equivalence to older predicate devices. We’re considering focusing on predicates that are >10 years old as a starting point, so the public is aware o

In the next few months CDRH will make public on its website cleared devices that demonstrated substantial equivalence to older predicate devices. We’re considering focusing on predicates that are >10 years old as a starting point, so the public is aware o

In the next few months CDRH will make public on its website cleared devices that demonstrated substantial equivalence to older predicate devices. We’re considering focusing on predicates that are >10 years old as a starting point, so the public is aware of those technologies.

FDA - U.S. Food and Drug Administration

26-11-2018

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health te

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health te

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health technologies.

FDA - U.S. Food and Drug Administration

23-11-2018

Presentations have been posted for the November 15, 2018 Patient Engagement Advisory Committee meeting. #PEAC2018 Read more:  https://go.usa.gov/xPHxf   #FDA #MedicalDevice

Presentations have been posted for the November 15, 2018 Patient Engagement Advisory Committee meeting. #PEAC2018 Read more: https://go.usa.gov/xPHxf  #FDA #MedicalDevice

Presentations have been posted for the November 15, 2018 Patient Engagement Advisory Committee meeting. #PEAC2018 Read more: https://go.usa.gov/xPHxf  #FDA #MedicalDevice

FDA - U.S. Food and Drug Administration

22-11-2018

Emtricitabine/Tenofovir disoproxil Krka (Krka d. d., Novo mesto)

Emtricitabine/Tenofovir disoproxil Krka (Krka d. d., Novo mesto)

Emtricitabine/Tenofovir disoproxil Krka (Active substance: emtricitabine / tenofovir disoproxil) - Centralised - 2-Monthly update - Commission Decision (2018)7884 of Thu, 22 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4215/IB/10G

Europe -DG Health and Food Safety

21-11-2018

Rheumocam (Chanelle Pharmaceuticals Manufacturing Limited)

Rheumocam (Chanelle Pharmaceuticals Manufacturing Limited)

Rheumocam (Active substance: Meloxicam) - Centralised - Variation - Commission Decision (2018)7841 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/121/X/22

Europe -DG Health and Food Safety

21-11-2018

EU/3/15/1567 (TMC Pharma (EU) Limited)

EU/3/15/1567 (TMC Pharma (EU) Limited)

EU/3/15/1567 (Active substance: Recombinant human interleukin-3 truncated diphtheria toxin fusion protein) - Transfer of orphan designation - Commission Decision (2018)7816 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/064/15/T/02

Europe -DG Health and Food Safety

15-11-2018

Flixabi (Samsung Bioepis NL B.V.)

Flixabi (Samsung Bioepis NL B.V.)

Flixabi (Active substance: infliximab) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7549 of Thu, 15 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4020/T/30

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

15-11-2018

Benepali (Samsung Bioepis NL B.V.)

Benepali (Samsung Bioepis NL B.V.)

Benepali (Active substance: etanercept) - Centralised - Yearly update - Commission Decision (2018) 7557 of Thu, 15 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

8-11-2018

There's only 1 week until the 2018 Patient Engagement Advisory Committee meeting. Join the @US_FDA on Nov 15 to discuss patient-generated health data from sources like social media, activity trackers, and patient-driven registries.pic.twitter.com/WkDNnXqm

There's only 1 week until the 2018 Patient Engagement Advisory Committee meeting. Join the @US_FDA on Nov 15 to discuss patient-generated health data from sources like social media, activity trackers, and patient-driven registries.pic.twitter.com/WkDNnXqm

There's only 1 week until the 2018 Patient Engagement Advisory Committee meeting. Join the @US_FDA on Nov 15 to discuss patient-generated health data from sources like social media, activity trackers, and patient-driven registries. pic.twitter.com/WkDNnXqmbw

FDA - U.S. Food and Drug Administration

31-10-2018

Imraldi (Samsung Bioepis NL B.V.)

Imraldi (Samsung Bioepis NL B.V.)

Imraldi (Active substance: adalimumab) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7344 of Wed, 31 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4279/T/15

Europe -DG Health and Food Safety

23-10-2018

EU/3/16/1804 (Eli Lilly Nederland B.V.)

EU/3/16/1804 (Eli Lilly Nederland B.V.)

EU/3/16/1804 (Active substance: Pegylated recombinant human interleukin-10) - Transfer of orphan designation - Commission Decision (2018)6994 of Tue, 23 Oct 2018

Europe -DG Health and Food Safety

22-10-2018

EU/3/16/1640 (Celgene Europe B.V.)

EU/3/16/1640 (Celgene Europe B.V.)

EU/3/16/1640 (Active substance: 2-methyl-1-[(4-[6-(trifluoromethyl)pyridin-2-yl]-6-{[2-(trifluoromethyl)pyridin-4-yl]amino}-1,3,5-triazin-2-yl)amino]propan-2-ol methanesulfonate) - Transfer of orphan designation - Commission Decision (2018)6989 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/253/15/T/01

Europe -DG Health and Food Safety

22-10-2018

EU/3/15/1495 (Ultragenyx Netherlands B.V.)

EU/3/15/1495 (Ultragenyx Netherlands B.V.)

EU/3/15/1495 (Active substance: Triheptanoin) - Transfer of orphan designation - Commission Decision (2018)6992 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/007/15/T/02

Europe -DG Health and Food Safety

22-10-2018

EU/3/15/1532 (Sirius Regulatory Consulting EU Limited)

EU/3/15/1532 (Sirius Regulatory Consulting EU Limited)

EU/3/15/1532 (Active substance: Insulin human) - Transfer of orphan designation - Commission Decision (2018)6985 of Mon, 22 Oct 2018

Europe -DG Health and Food Safety

22-10-2018

EU/3/10/815 (Pfizer Europe MA EEIG)

EU/3/10/815 (Pfizer Europe MA EEIG)

EU/3/10/815 (Active substance: Sildenafil citrate) - Transfer of orphan designation - Commission Decision (2018)6993 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/068/10/T/01

Europe -DG Health and Food Safety

21-10-2018

Fortunately, while women were underrepresented, the trials were large enough w/adequate #’s of women to determine safety and effectiveness. #FDA continues taking steps to encourage greater inclusion of women in trials, including OWH’s Diverse Women in Cli

Fortunately, while women were underrepresented, the trials were large enough w/adequate #’s of women to determine safety and effectiveness. #FDA continues taking steps to encourage greater inclusion of women in trials, including OWH’s Diverse Women in Cli

Fortunately, while women were underrepresented, the trials were large enough w/adequate #’s of women to determine safety and effectiveness. #FDA continues taking steps to encourage greater inclusion of women in trials, including OWH’s Diverse Women in Clinical Trials Initiative. pic.twitter.com/20d9Sg2vqn

FDA - U.S. Food and Drug Administration

19-10-2018

Recocam (Bimeda Animal Health Limited)

Recocam (Bimeda Animal Health Limited)

Recocam (Active substance: Meloxicam) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6954 of Fri, 19 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2247/T/10

Europe -DG Health and Food Safety

18-10-2018

THREAD: #FDA’s forthcoming proposal to update and modernize our mammography oversight is meant to capitalize on a number of important advances, including the need for more uniform, nation-wide breast density reporting:  https://go.usa.gov/xPRAm pic.twitte

THREAD: #FDA’s forthcoming proposal to update and modernize our mammography oversight is meant to capitalize on a number of important advances, including the need for more uniform, nation-wide breast density reporting: https://go.usa.gov/xPRAm pic.twitte

THREAD: #FDA’s forthcoming proposal to update and modernize our mammography oversight is meant to capitalize on a number of important advances, including the need for more uniform, nation-wide breast density reporting: https://go.usa.gov/xPRAm  pic.twitter.com/8cUIqr8l6x

FDA - U.S. Food and Drug Administration

17-10-2018

Interact with experts from CDER, CBER & CDRH to learn what’s important when conducting clinical trials & preparing submissions for FDA review.

Register for FDA #CDERSBIA Clinical Investigator Training Course – November 13-15 in Silver Spring, MD.  https:

Interact with experts from CDER, CBER & CDRH to learn what’s important when conducting clinical trials & preparing submissions for FDA review. Register for FDA #CDERSBIA Clinical Investigator Training Course – November 13-15 in Silver Spring, MD. https:

Interact with experts from CDER, CBER & CDRH to learn what’s important when conducting clinical trials & preparing submissions for FDA review. Register for FDA #CDERSBIA Clinical Investigator Training Course – November 13-15 in Silver Spring, MD. https://go.usa.gov/xPqku  pic.twitter.com/EYNZANlgr9

FDA - U.S. Food and Drug Administration