ORYVA 15 MG 28 TABLET

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  • ORYVA 15 MG 28 TABLET
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Durum

  • Kaynak:
  • TİTCK - TÜRKİYE İLAÇ VE TIBBİ CİHAZ KURUMU - Türkiye
  • Yetkilendirme durumu:
  • Aktif
  • Yetkilendirme numarası:
  • 8699541015301
  • Yetkilendirme tarihi:
  • 05-04-2016
  • Son Güncelleme:
  • 24-05-2018

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

1/7

KULLANMA TAL İMATI

ORYVA15mg tablet

A ğızdanalınır.

Etkinmadde:Herbirtablet15mgaripiprazol içerir.

Yardımcımaddeler:Laktozmonohidrat,mısırnişastası,mikrokristalinselüloz,

hidroksipropilselüloz, magnezyumstearat, kırmızıdemiroksit.

BuilacıkullanmayabaşlamadanöncebuKULLANMATALİMATINIdikkatlice

okuyunuz,çünkü sizin için önemlibilgileriçermektedir.

Bu kullanma talimatınısaklayınız. Daha sonra tekrarokumaya ihtiyaçduyabilirsiniz.

Eğerilavesorularınızolursa, lütfen doktorunuza veyaeczacınıza danışınız.

Bu ilaçkişiselolaraksizin için reçeteedilmiştir, başkalarına vermeyiniz.

Builacınkullanımısırasında,doktoraveyahastaneyegittiğinizdedoktorunuzabu

ilacıkullandığınızısöyleyiniz.

Butalimattayazılanlaraaynenuyunuz.İlaçhakkındasizeönerilendozundışında

yüksek veya düşükdozkullanmayınız.

BuKullanma Talimatında:

1.ORYVA nedirveneiçinkullanılır?

2.ORYVA’ yıkullanmadanöncedikkatedilmesigerekenler

3.ORYVA nasılkullanılır?

4. Olasıyanetkilernelerdir?

5.ORYVA’ nınsaklanması

Ba şlıklarıyeralmaktadır.

1.ORYVA nedirveneiçinkullanılır?

ORYVA antipsikotiklerolarak adlandırılan birilaçgrubunadahildir.

ORYVA ,açıkpemberenkli,yuvarlak,bikonvekstabletlerşeklindedirve28tabletlikformları

ileblisterambalajlardakullanımasunulmaktadır.

ORYVA ,yetişkinveergenlerde(13-17yaş),olmayanşeyleriduyma,görmeveyahissetme,

şüphecilik,yanlışdüşünceler,tutarsızkonuşmalar,davranışlarveduygusaldurumda

durgunlukgibibelirtilerilekarakterizebirhastalığıntedavisiiçinkullanılır.Budurumdaki

hastalaraynızamandaruhsalçökkünlükiçindeolabilirveyakendilerinisuçlu,endişeliyada

gerginhissedebilirler.

ORYVA ,olağandışıvesürekli,taşkınyadasinirlibirdöneminolması,aşırıderecede

enerjininolması,herzamankindendahaazuykuyaihtiyaçduyulması,düşünceiçeriğinde

hızlanmailebirliktevebazenaşırıderecedetepkiselbirşekildeçokhızlıkonuşma

rumundakiyetişkinlerintedavisindevebudurumuntekrarlamasınınengellenmesinde

kullanılır.

2/7

2.ORYVA’ yıkullanmadan öncedikkatedilmesigerekenler

ORYVA ’yıaşağıdakidurumlardaKULLANMAYINIZ

AripiprazoleveyaORYVATablet’in içerdiklerinden herhangi birinekarşıalerjiniz(aşırı

duyarlılık)varisekullanmayınız.

ORYVA ’yıaşağıdakidurumlarda DİKKATLİKULLANINIZ:

Aşağıdakilerden birisizin için geçerliiseORYVAtedavisinden öncedoktorunuzasöyleyiniz.

Eğer,

Kan şekerinizyüksekseveyaailenizdeşekerhastalığıvarsa,

Nöbetgeçirdiyseniz,

Özellikleyüzdeistemsizvetekrarlayankashareketlerinizvarsa,

Sizde veya ailenizde kalp- damarhastalığı,felç,mini-felç,anormalkanbasıncı

hikayesivarsa,

Antipsikotikkullanımıkanpıhtıoluşumuileilişkilendirildiğinden,sizdeveya

ailenizde kan pıhtılaşmasıdurumu varsa,

Kiloaldığınızıfarkediyorsanız,yutmadaherhangibirgüçlüğünyadaalerjikbelirtilerin

olmasıdurumundalütfen doktorunuzasöyleyiniz.

Bunaması(hafızayadadiğermentalbecerilerdekayıp)olanyaşlıbirhastaiseniz,sizya da

sizebakankişi/akrabanızgeçmişteherhangibirfelçyadamini-felçgeçiripgeçirmediğinizi

doktorunuzasöylemelidir.

Kendinizezararvermedüşünceleriyadahislerinizvarsaderhaldoktorunuzasöyleyiniz.

ripiprazoltedavisiesnasındaintihardüşüncelerivedavranışlarıbildirilmiştir.

Kaslarınızdasertlikyadayüksekateşlebirliktekatılıkdurumu,terleme,mentaldurumda

değişiklikveyaçokhızlıyadadüzensizkalpatışıdurumuvarsaderhaldoktorunuza

söyleyiniz.

Buuyarılargeçmiştekiherhangibirdönemdedahiolsa,siziniçingeçerliyselütfen

doktorunuzadanışınız.

ORYVA’ nınyiyecekveiçecekilekullanılması

ORYVA’ yıyemeklerdenbağımsızolarakalabilirsiniz.

ORYVA kullanırken alkolalmayınız.

Hamilelik

İlacıkullanmadan öncedoktorunuza veyaeczacınıza danışınız.

ORYVA ,gerekliolmadıkçahamilelikdönemindekullanılmamalıdır.

Hamileysenizyadahamileolmaihtimalinizolduğunudüşünüyorsanızdoktorunuzaderhal

söylediğinizden emin olunuz.

Hamileliğinsonüçayındaantipsikotikilaçlaramaruzkalanyenidoğanlar,doğumutakiben

şiddetideğişebilen,anormalkashareketlerive/veyailaçkesilmebelirtileriaçısındanrisk

altındadırlar. Bu belirtilerhakkındadetaylıbilgiiçin doktorunuzadanışınız.

Tedavinizsırasında hamileolduğunuzu farkedersenizhemen doktorunuzaveyaeczacınıza

danışınız.

3/7

Emzirme

İlacıkullanmadan öncedoktorunuza veyaeczacınıza danışınız.

EmzirmenindurdurulupdurdurulmayacağınayadaORYVAtedavisinin durdurulup

durdurulmayacağınailişkinkararverilirken,emzirmeninçocukaçısındanfaydasıveORYVA

tedavisinin emziren anneaçısından faydasıdikkatealınmalıdır.

Araçvemakinekullanımı

ORYVA’ nınsiziolumsuzetkilemediğindeneminolanakadarmotorluaraçlardadahil

tehlikelimakinalarıkullanmayınız.

ORYVA ’nıniçeriğindebulunanbazıyardımcımaddelerhakkında önemlibilgiler

İçeriğindebulunanlaktoznedeniyle,eğerdahaöncedendoktorunuztarafındanbazışekerlere

karşıdayanıksızlığınızolduğusöylenmişse,ORYVA’yıalmadan öncedoktorunuzlatemasa

geçiniz.

Diğerilaçlarilebirliktekullanımı:

Eğer,

Tansiyonunuzudüşürenilaçlaralıyorsanız:ORYVAtansiyondüşürücüilaçlarınetkisini

artırabilir.Tansiyonunuzunkontrolaltındatutulmasıiçin,ilaçaldığınızıdoktorunuza

söyleyiniz.

ORYVA’ nınbazıilaçlarlabirliktekullanımıORYVAdozunuzundeğiştirilmesineneden

olabilir. Doktorunuzaözellikleaşağıdakiilaçlarıbelirtmenizoldukçaönemlidir:

Kalpatışınızıdüzenleyenilaçlar

Ruhsalçökkünlük hali(depresyon)yadaendişe(anksiyete)tedavisiiçindepresyona

karşıetkiliilaçyadabitkiseltedaviler

Mantarilaçları

HIVenfeksiyonu tedavisindekullanılan bazıilaçlar

Sara(epilepsi)tedavisindekullanılan antikonvülsan ilaçlar

Eğerreçeteliyada reçetesizherhangibirilacışu anda kullanıyorsanızveya son zamanlarda

kullandıysanızlütfen doktorunuza veya eczacınıza bunlarhakkında bilgiveriniz.

3.ORYVA nasılkullanılır?

Uygunkullanımvedoz/uygulama sıklığıiçintalimatlar:

ORYVA’ yıherzamandoktorunuzunsöylediğişekildekullanınız.Eğeremindeğilseniz

doktorunuzaveyaeczacınızamuhakkak danışmalısınız.

ORYVA’ nınyetişkinleriçinolannormaldozugündebirkez15mg’dır.Ancak

doktorunuzsize, gündeenyüksek30mgolacakşekildedahadüşükyadayüksekbirdoz

verebilir. Diğerduygudurumbelirtileriiçin sizeek birtedavireçeteedilebilir.

ORYVA, 13- 17yaşlarıarasındakiergenlerde,oralsolüsyon(likid)dozajformuiledüşükbir

dozda başlanabilir.Doz,yetişkinlerdeki10mg/günlükolağandozakademeliolarak

artırılabilir.Ancakdoktorunuzsizegündeenyüksek30mgolacakşekildedahadüşükyada

yüksek birdozverebilir.

İlacınızıhergünaynızamanda almaya özengösteriniz.

Uygulamayoluvemetodu:

Tabletleriyeterlimiktarda(örneğinbirbardak)suilealınız.

ORYVAtabletleriyemeklerdenönceveyasonraalabilirsiniz.

4/7

Kendinizi dahaiyihissetsenizbile, öncelikledoktorunuzadanışmadanORYVAgünlük

dozunu değiştirmeyinizyadakesmeyiniz.

Değişikyaşgrupları

Çocuklardakullanım:

ORYVA’ nın13yaşaltındakiçocuklarda,güvenliliğiveetkililiğibelirlenmediğinden

kullanılmasıönerilmemektedir.ORYVAkullanmadan öncedoktorveyaeczacınızadanışınız.

Yaşlılarda kullanım:

ORYVA 65yaşınüzerindekihastalardakullanılırkendozayarlanmasıgerekmez.Ancakbu

yaşgrubundaaripiprazolkullanımınayönelikkısıtlıdeneyimmevcuttur.Buhastagrubunun

hassasiyetindendolayı,klinikolarakuygunolduğuzamandahadüşükbirbaşlangıçdozu

düşünülmelidir.

Özelkullanımdurumları

Özelkullanımdurumuyoktur.

EğerORYVA’nınetkisininçokgüçlüveyazayıfolduğunadairbirizleniminizvarise

doktorunuzveyaeczacınızilekonuşunuz.

KullanmanızgerekendendahafazlaORYVAkullandıysanız:

ORYVA ’dankullanmanızgerekendenfazlasınıkullanmışsanızbirdoktorveyaeczacıile

konuşunuz.

Doktorunuzaulaşamazsanızilacınızın kutusu ilebirliktesizeenyakın hastaneyegidiniz.

ORYVA’ yıkullanmayıunutursanız

ORYVA’yıkullanmayıunutursanız, hatırladığınızandatabletinizialınız.

Unutulan dozlarıdengelemekiçin çiftdozalmayınız.

ORYVA iletedavisonlandığında oluşabileceketkiler

Tedavisonlandırıldığındaoluşabileceketkilerbilinmemektedir.

4. Olasıyanetkilernelerdir?

Tüm ilaçlargibi,ORYVA ’nıniçeriğindebulunanmaddelereduyarlıolankişilerdeyanetkiler

olabilir.

AşağıdakilerdenbiriolursaORYVA’yıkullanmayıdurdurunuzveDERHAL

doktorunuza bildirinizveya sizeenyakınhastaneninacilbölümünebaşvurunuz:

Alerjik reaksiyonlar(ağız, dil,yüzveboğazın şişmesi, kaşıntı, döküntü)

Kalp krizi

İntihardüşüncesi

İntihargirişimiveintihar

Ketoasidoz(kanveidrardaketonbulunması)(ketoasidozdurumunda;bulantı,kusma,

karınağrısı,halsizlik/yorgunluk,hızlıvederinnefesalma,nefesdarlığı,iştahsızlık,

ağızkuruluğu, çok su içme, sık idraraçıkmagibibelirtilergörülür.)veyakoma

Nöbet

Ateş,kassertliği,hızlınefesalma,terleme,azalmışbilinçvekanbasıncındavekalp

atımındaanideğişikliklerinbiraradagörülmesi

Yüksek kan basıncı

5/7

Vücudunherhangibiryerindekikanpıhtısınınbirkandamarınıtıkaması(venlerdeki

kanpıhtıları-özellikleayaklardaşişme,ağrıvekırmızılıksemptomlarınıiçeren

ayaklardakipıhtılar-damarlarvasıtasıylaakciğereulaşarak,göğüsağrısınavenefes

almadazorluğaneden olabilir.)

Gırtlak çevresindekikasların spazmı

Zatürreriski ilebirliktelikgösterebilen,kazayla yiyeceklerin soluklaiçerialınması

Bunlarınhepsiçokciddiyanetkilerdir.Eğerbunlardanbirisizdemevcutise,sizin

ORYVA’y akarşıciddialerjinizvardemektir.Aciltıbbimüdahaleyeveyahastaneye

yatırılmanızagerekolabilir.

Bu çok ciddiyanetkilerin hepsioldukçaseyrekgörülür.

Aşağıdakilerdenherhangibirinifarkedersenizhemendoktorunuzabildirinizveyasize

enyakınhastaneninacilbölümünebaşvurunuz:

Göğüsağrısı

Olağan dışıkalp atımı

Yüksek kan şekeri

Şekerhastalığının (diyabetin)oluşmasıyadakötüleşmesi

Pankreasilt ihabı

Karaciğeriltihabı

El, bilekyadabileklerinşişmesi

İdraryapmadazorluk

Uzamışyadaağrılıereksiyon(sertleşme)

Vücutısısının kontrolündezorlukyadafazlaısınma

Gözlerin ak bölümünün vecildin sararması

Anormalkaraciğertestdeğerleri

Bazıkan hücreseviyelerindedeğişiklikler

Konuşmabozukluğu

Deridöküntüsü veışığaduyarlılık

Bunların hepsiciddiyanetkilerdir. Aciltıbbimüdahalegerekebilir.

Ciddiyanetkilerçokseyrek görülür.

Aşağıdakilerdenherhangibirinifarkedersenizdoktorunuza söyleyiniz:

Kontroledilemeyen tikyadaseğirmehareketleri

Başağrısı

Halsizlik, yorgunluk

Bulantı, kusma

Hazımsızlık

Kabızlık

Tükürük artışı

Sersemlik

Uyku zorluğuyadauykuhali

Huzursuzluk

Titreme

Bulanıkgörme

Otururyadayatarpozisyon dan kalkarken başdönmesihissetmeyadahızlıkalp atımı

Ruhsalçökkünlük hali

Karın vemiderahatsızlığı

İshal

6/7

Olağandışısaçdökülmesiveincelmesi

Aşırıterleme

Sertlikya da kramplar

Kasağrısı

İstemdışıidrarkaçırma

Kandadüşük sodyumseviyesi

Kilo artışıyadaazalması

Anoreksi

Sinirlilik,ajitasyon

Endişelihissetme

Bayılma

Yutmazorluğu

BunlarORYVA’ nınhafifyanetkileridir.

Bunamasıolanyaşlıhastalardaaripiprazolkullanımıesnasındadahafazlaölümcülvaka

bildirilmiştir.Ekolarak,felçyadamini-felçvakalarıdabildirilmiştir.

17yaşlarıarasındakiergenlerde,tipvesıklıkolarakyetişkinlerdekinebenzeryanetkiler

görülmüştür.Uykuhali,kontroledilemeyentikveseğirmehareketleriiseçokyaygın(10

hastanın1’indenfazla)olarakgörülmüşveağızkuruluğu,iştahtaartış,özellikleotururyada

yatarpozisyondan sonraayağakalkıncahissedilenbaşdönmesiyaygın orandagörülmüştür.

Eğerbukullanmatalimatındabahsigeçmeyenherhangibiryanetkiilekarşılaşırsanız

doktorunuzu veya eczacınızıbilgilendiriniz.

Yan etkilerin raporlanması

KullanmaTalimatındayeralanveyaalmayanherhangibiryanetkimeydanagelmesi

durumundahekiminiz,eczacınızveyahemşirenizilekonuşunuz.Ayrıcakarşılaştığınızyan

etkileri www.titck.gov.tr sitesindeyeralan“İlaçYanEtkiBildirimi”ikonunatıklayarakyada

08003140008numaralıyanetkibildirimhattınıarayarakTürkiyeFarmakovijilansMerkezi

(TÜFAM)’nebildiriniz.Meydanagelenyanetkileribildirerekkullanmaktaolduğunuzilacın

güve nliliğihakkındadahafazlabilgiedinilmesinekatkısağlamışolacaksınız.

5.ORYVA’ nınsaklanması

ORYVA’ yıçocukların göremeyeceği,erişemeyeceğiyerlerdeveambalajında saklayınız.

ORYVA’ yı30°C’nin altındakiodasıcaklığındaveambalajındasaklayınız.

Sonkullanma tarihiyleuyumluolarakkullanınız.

Blistervekartondakisonkullanma tarihinden sonraORYVA’ yıkullanmayınız.

“Son KullanmaTarihi”belirtilen ayın songünüdür.

Çevreyikorumakamacıyla,kullanmadığınızORYVA’yışehirsuyunaveyaçöpeatmayınız.Bu

konuda eczacınıza danışınız.

Eğerüründeve/veyaambalajındabozukluklarfark ederseniz,ORYVA’yıkullanmayınız.

7/7

Ruhsat sahibi:

MustafaNevzatİlaçSanayiiA.Ş.

PakİşMerkezi

Prof. Dr. BülentTarcanSok. No:5/1

34349 Gayrettepe– İstanbul

ÜretimYeri:

MustafaNevzatİlaçSanayiiA.Ş.

SanayiCad.No:13

34196 Yenibosna– İstanbul

Bu kullanma talimatı14/08/2015tarihindeonaylanmıştır.

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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

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

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

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

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

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

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

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

16-10-2018

Pest categorisation of Cronartium harknessii, Cronartium kurilense and Cronartium sahoanum

Pest categorisation of Cronartium harknessii, Cronartium kurilense and Cronartium sahoanum

Published on: Mon, 15 Oct 2018 00:00:00 +0200 Following a request from the European Commission, the EFSA Panel on Plant Health performed a pest categorisation of Cronartium harknessii, Cronartium kurilense and Cronartium sahoanum, which are well‐defined and distinguishable tree fungal pathogens of the family Cronartiaceae. In 2018, these species were moved from the genus Endocronartium to the genus Cronartium. These pathogens are not known to be present in the EU and are regulated in Council Directive 2...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Modification of the existing maximum residue levels for mepiquat in cotton seeds and animal commodities

Modification of the existing maximum residue levels for mepiquat in cotton seeds and animal commodities

Published on: Mon, 15 Oct 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant, BASF SE, submitted an application to the competent national authority in Greece to modify the existing maximum residue level (MRL) for the active substance mepiquat in cotton seeds. The data submitted in support of the application were found to be sufficient to derive a MRL proposal for cotton seeds and the previously derived MRL proposals for animal commodities were found to be stil...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Assessment of low pathogenic avian influenza virus transmission via raw poultry meat and raw table eggs

Assessment of low pathogenic avian influenza virus transmission via raw poultry meat and raw table eggs

Published on: Mon, 15 Oct 2018 00:00:00 +0200 A rapid qualitative assessment has been done by performing a theoretical analysis on the transmission of low pathogenic avian influenza (LPAI) via fresh meat from poultry reared or kept in captivity for the production of meat (raw poultry meat) or raw table eggs. A predetermined transmission pathway followed a number of steps from a commercial or non‐commercial poultry establishment within the EU exposed to LPAI virus (LPAIV) to the onward virus transmission...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Pest categorisation of Melampsora farlowii

Pest categorisation of Melampsora farlowii

Published on: Mon, 15 Oct 2018 00:00:00 +0200 Following a request from the European Commission, the EFSA Panel on Plant Health performed a pest categorisation of Melampsora farlowii, a well‐defined and distinguishable fungus of the family Melampsoraceae. M. farlowii is the causal agent of a leaf and twig rust of hemlocks (Tsuga spp.) in eastern North America. The pathogen is regulated in Council Directive 2000/29/EC (Annex IAI) as a harmful organism whose introduction into the EU is banned. M. farlowii ...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

8-10-2018

Glyceryl trinitrate tablets (Anginine and Lycinate)

Glyceryl trinitrate tablets (Anginine and Lycinate)

Update 3 - continuing medicine shortage

Therapeutic Goods Administration - Australia

5-10-2018

Consumer Alert: Sprout Creek Farm “Margie” Cheese Batch Recalled

Consumer Alert: Sprout Creek Farm “Margie” Cheese Batch Recalled

Today the New York State Department of Agriculture and Markets alerted consumers to a pasteurization problem with one of Sprout Creek Farm's pasteurized cow's milk cheeses, "Margie," made on 8/28/2018. Sprout Creek Farm is located in Poughkeepsie, NY. The reason for the recall is the air temperature at the start and end of the pasteurization process is required to be above 150deg F per the Grade "A" Pasteurized Milk Ordinance; the batch in question did not meet that standard. The recall pertains only to...

FDA - U.S. Food and Drug Administration

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

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

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

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

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

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

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

18-10-2018

ABILIFY MAINTENA (Otsuka Pharmaceutical Netherlands B.V.)

ABILIFY MAINTENA (Otsuka Pharmaceutical Netherlands B.V.)

ABILIFY MAINTENA (Active substance: Aripiprazole) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6925 of Thu, 18 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/002755/T/0026

Europe -DG Health and Food Safety

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

15-10-2018

Riximyo (Sandoz GmbH)

Riximyo (Sandoz GmbH)

Riximyo (Active substance: rituximab) - Centralised - Yearly update - Commission Decision (2018)6811 of Mon, 15 Oct 2018

Europe -DG Health and Food Safety