ANDROCUR

Genel Bilgiler

  • Ticaret Unvanı:
  • ANDROCUR 50 MG 50 TABLET
  • Reçete türü:
  • Normal
  • İçin kullanmak:
  • İnsanlar
  • İlaç türü:
  • allopatik ilaç

Belgeler

Yerelleştirme

  • Bulunduğu ülkeler::
  • ANDROCUR 50 MG 50 TABLET
    Türkiye
  • Dil:
  • Türkçe

Terapötik bilgiler

  • Terapötik alanı:
  • siproteron

Diğer bilgiler

Durum

  • Kaynak:
  • TİTCK - TÜRKİYE İLAÇ VE TIBBİ CİHAZ KURUMU - Türkiye
  • Yetkilendirme durumu:
  • Aktif
  • Yetkilendirme numarası:
  • 8699546011667
  • Yetkilendirme tarihi:
  • 29-01-2013
  • Son Güncelleme:
  • 25-05-2018

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

KULLANMATALĐMATI

ANDROCUR ®

100mgtablet

Ağızyoluilealınır.

Etkinmadde:Herbirtablet100mgsiproteronasetatiçerir.

Yardımcımaddeler:Laktozmonohidrat,mısırnişastası,povidon25,magnezyumstearat.

BuilacıkullanmayabaşlamadanöncebuKULLANMATALĐMATINIdikkatlice

okuyunuz,çünküsiziniçinönemlibilgileriçermektedir.

Bukullanmatalimatınısaklayınız.Dahasonratekrarokumayaihtiyaçduyabilirsiniz.

Eğerilavesorularınızolursa,lütfendoktorunuzaveyaeczacınızadanışınız.

Builaçkişiselolaraksiziniçinreçeteedilmiştir,başkalarınavermeyiniz.

Builacınkullanımısırasında,doktoraveyahastaneyegittiğinizdebuilacı

kullandığınızıdoktorunuzasöyleyiniz.

Butalimattayazılanlaraaynenuyunuz.Đlaçhakkındasizeönerilendozundışında

yüksekveyadüşükdozkullanmayınız.

BuKullanmaTalimatında:

1.ANDROCUR ®

nedirveneiçinkullanılır?

2.ANDROCUR ® ’ukullanmadanöncedikkatedilmesigerekenler

3.ANDROCUR ®

nasılkullanılır?

4.Olasıyanetkilernelerdir?

5.ANDROCUR ® ’unsaklanması

Başlıklarıyeralmaktadır.

1.ANDROCUR ®

nedirveneiçinkullanılır?

ANDROCUR ®

,erkeksekshormonlarına(androjenler)karşıetkigösterenbirhormon

preperatıdır.Androjenlerin,prostatkanserininbüyümesinekatkıdabulunduğuhastalarda

ANDROCUR ® ,buetkiyiazaltır.

Herambalajda30adetANDROCUR ®

tabletbulunmaktadır.

Herbirtablette100mgsiproteronasetatvardır.

ANDROCUR ®

ayrıca50mgsiproteronasetatiçeren,50tabletlikambalajdada

sunulmaktadır.

ANDROCUR ® ameliyatedilemeyecekprostatkanserindekullanılır.

2.ANDROCUR ®

ukullanmadanöncedikkatedilmesigerekenler

ANDROCUR ®

uaşağıdakidurumlardaKULLANMAYINIZ:

Eğer;

Karaciğerhastalığınızvarsa,

DubinJohnsonsendromu(sarılığanedenolangenetikbirhastalık),Rotorsendromu(sarılığa

nedenolangenetikbirhastalık)

Öncedengeçirilmişyadahalihazırdakaraciğertümörünüzvarsa,

Đyihuylubeyintümörünüz(meninjiyom)varsaveyadahaönceolduysa,

Zayıflamayanedenolan(prostatkanseridışında)birhastalığınızvarsa,

Ciddikronikdepresyonunuzvarsa,

Pıhtılaşmabozukluğunuzvarsa,

Đlacıniçindekimaddelerdenbirinekarşıalerjinizvarsa,

ANDROCUR ®

’uaşağıdakidurumlardaDĐKKATLĐKULLANINIZ:

Eğer;

Sarılık,hepatitvekaraciğeryetmezliğinizvarsa,

Şekerhastalığınızvarsa,

Aneminiz(kansızlık)varsa,

Bacaktadamartıkanıklığıvarsa,

Dahaöncebacaktadamartıkanıklığı,akciğerdepıhtı(pulmonerembolizm),kalpkrizi

(miyokardinfarktüsü)veinme(serebrovaskülerolay)gibiarteryelveyavenözkanpıhtısı

sorunuylakarşılaştıysanız,

Nefesdarlığınızvarsa,

Beyinhasarıöykünüzvarsa,

Kandolaşımbozukluğunuzvarsa,

Orakhücrelianeminiz(birtürkansızlık),

Damardeğişikliğinenedenolanilerişekerhastalığınızvarsa.

Karaciğerveböbreküstübezifonksiyonlarıdüzenlitakipedilmelidir.

Đyihuylubeyintümörünüz(meninjiyom)varsadoktorunuzANDROCUR ®

tedavisini

durduracaktır.

18yaşvealtındakiçocuklarda(kızveerkek)veergenlerdekullanımıönerilmemektedir.

Buuyarılar,geçmiştekiherhangibirdönemdedahiolsasiziniçingeçerliyselütfendoktorunuza

danışınız.

ANDROCUR ®

’unyiyecekveiçecekilekullanılması

Tabletler,yemeklerdensonrayeterlimiktardasuilealınmalıdır.

Araçvemakinekullanımı

ANDROCUR ® ,yorgunlukvekonsantrasyonbozukluğunanedenolabilir,zindeliğiazaltabilir.

ANDROCUR ®

’uniçeriğindebulunanbazıyardımcımaddelerhakkındaönemlibilgiler

ANDROCUR ® , laktoziçermektedir.Eğerdahaöncedendoktorunuztarafındanbazışeker

çeşitlerinekarşıtahammülsüzlüğünüz(toleransınızınolmadığı)olduğusöylenmişse,builacı

kullanmadanöncedoktorunuzadanışınız.

Diğerilaçlarilebirliktekullanımı

AşağıdakiilaçlarıANDROCUR ®

ilebirliktekullanırkendikkatliolunuz:

Mantarhastalıklarınıntedavisindekullanılanketokonazol,itrakonazol,klotrimazol,

ViralbirenfeksiyonolanHIV’nintedavisindekullanılanritonavir,

Tüberküloztedavisindekullanılanrifampisin,

Sarahastalığınıntedavisindekullanılanfenitoin,

Sarıkantoronotu,

Kolesteroldüşürmekamacıylakullanılanstatingrubuilaçlar.

YüksekdozANDROCUR ® (100mg,günde3kez),alınandiğerilacınetkigöstermesinisağlayan

bazıkaraciğerenzimlerininetkisiniyavaşlatabilir.

Eğerreçeteliyadareçetesizherhangibirilacışuandakullanıyorsanızveyasonzamanlarda

kullandınıziselütfendoktorunuzaveyaeczacınızabunlarhakkındabilgiveriniz.

3.ANDROCUR ®

nasılkullanılır?

Uygunkullanımvedoz/uygulamasıklığıiçintalimatlar:

Günde2-3kez,1tabletANDROCUR ®

100mg(=200-300mg).Günlükmaksimumdoz300

mg.

Biriyileşmehissettiğinizdedoktorunuzunuyguladığıtedaviveyadozajıdeğiştirmeyinveya

kullanımaaravermeyin.

GnRH-agonistleriilekombinetedavide,başlangıçtayükselenandrojendüzeylerinekarşı:

Önerilendozşudur:Başlangıçta5-7günsüreilegünde2keztekbaşına1tablet(=200mg)

ANDROCUR ®

-100mg,dahasonra3-4haftasüreilegünde2kez1tabletANDROCUR ®

-100

mg(=200mg)ruhsatsahibitarafındanönerilendozdabirGnRH-agonistiilebirlikte(GnRH

agonistiürünbilgilerinebakınız).

TestislericerrahiolarakçıkartılmışveGnRHgrubuilaçlarlatedaviedilenhastalardasıcak

basmalarınıtedavietmekiçin:

Günde½-1½tabletANDROCUR ® -100(50-150mg),şayetgerekliisedoztedricengünde3

defa1tablet’ekadar(300mg)arttırılabilir.

Uygulamayoluvemetodu:

ANDROCUR ® yeterlimiktardasuileyutulmalıdır.

Değişikyaşgrupları:

Çocuklardakullanımı:Güvenlilikveetkililiğinedairyeterliveribulunmadığıiçin,erkek

çocuklardave18yaşaltındakierkeklerdekullanımıönerilmez.

Yaşlılardakullanımı:Yaşlılarda,dozayarlamasıgerektiğinidestekleyenveribulunmamaktadır.

Özelkullanımdurumları:

Böbrekyetmezliği:Böbrekyetmezliğiolanhastalarda,dozayarlamasınagerekolduğunu

destekleyenveribulunmamaktadır.

Karaciğeryetmezliği:ANDROCUR ® ,karaciğeryetmezliğibulunanhastalardakaraciğer

fonksiyondeğerlerinormaledönmedikçekullanılmamalıdır.

EğerANDROCUR ®

’unetkisininçokgüçlüveyazayıfolduğunadairbirizleniminizvarise

doktorunuzveyaeczacınızilekonuşunuz.

KullanmanızgerekendendahafazlaANDROCUR ®

kullandıysanız:

ANDROCUR ® ’dankullanmanızgerekendenfazlasınıkullanmışsanızbirdoktorveyaeczacıile

konuşunuz.

ANDROCUR ®

’ukullanmayıunutursanız

Unutulandozlarıdengelemekiçinçiftdozalmayınız.

Tabletlerinizinormalzamanındaalmayadevamediniz.

ANDROCUR ®

iletedavisonlandırıldığındaoluşabileceketkiler

DoktorunuzunsizeANDROCUR ®

reçetelemesinigerektirenbaşlangıçşikayetlerikötüleşebilir.

Doktorunuzsöylemediğisürece,tabletlerikullanmayadevamediniz.ANDROCUR ®

‘u

sonlandırmakistiyorsanız,öncedoktorunuzlakonuşunuz.

Builacınkullanımıylailgilibaşkasorularınızolursa,doktorunuzasorunuz.

4. Olasıyanetkilernelerdir?

Tümilaçlargibi,ANDROCUR ®

‘uniçeriğindebulunanmaddelereduyarlıolankişilerdeyan

etkilerolabilir.

Aşağıdakilerdenbiriolursa,ANDROCUR ®

’ukullanmayıdurdurunuzveDERHAL

doktorunuzabildirinizveyasizeenyakınhastaneninacilbölümünebaşvurunuz:

Alerjikreaksiyonlar,

Döküntü,

Karıniçikanama

Bunlarınhepsiçokciddiyanetkilerdir.Eğerbunlardanbirisizdemevcutise,sizin

ANDROCUR ®

’akarşıciddialerjinizvardemektir.Aciltıbbimüdahaleyeveyahastaneye

yatırılmanızagerekolabilir.

Aşağıdakilerdenherhangibirinifarkederseniz,hemendoktorunuzabildirinizveyasizeen

yakınhastaneninacilbölümünebaşvurunuz:

Kemikerimesi,

Beyintümörleri(meninjiyom),

Đyivekötühuylukaraciğertümörleri,

Pıhtılaşmayaeğilimartışı

Sarılık,karaciğeriltihabı,karaciğeryetmezliğidahilolmaküzerekaraciğerüzerinetoksik

etki.

Bunlarınhepsiciddiyanetkilerdir.Aciltıbbimüdahalegerekebilir.

Aşağıdakilerdenherhangibirinifarkederseniz,doktorunuzasöyleyiniz:

Kiloartışı,

Kiloazalması,

Cinselistekazalması,

Sertleşmebozukluğu,

Depresifdurum,

Huzursuzluk,

Spermoluşmaması,

Memehassasiyeti,

Memebüyümesi,

Yorgunluk,

Sıcakbasması,

Terleme,

Anemi

BunlarANDROCUR ®

’unhafifyanetkileridir.

Olasıyanetkiler,görülmesıklıklarınagöredeaşağıdayeralmaktadır.

AşağıdabelirtilenyanetkilerinsıklığıÇokyaygın(≥1/10);yaygın(≥1/100ila<1/10);yaygın

olmayan(≥1/1000ila<1/100);seyrek(≥1/10.000ila<1/1000);çokseyrek(<1/10.000),klinik

çalışmalardaeldeedilenverileredayanmaktadır.

Đyi,kötüvebelirlenmemiştümörler

Çokseyrek:Đyivekötühuylukaraciğertümörleri

Bilinmiyor:Beyintümörleri

Kanvelenfsistemihastalıkları

Bilinmiyor:Anemi(kansızlık)

Bağışıklıksistemihastalıkları

Seyrek:Aşırıduyarlılıkreaksiyonu

Metabolizmavebeslenmehastalıkları

Yaygın:Kilodaartışveyaazalma

Psikiyatrikrahatsızlıklar

Çokyaygın:Cinselistekteazalma,sertleşmebozuklukları

Yaygın:Depreseduygudurum,huzursuzluk(geçici)

Vaskülerhastalıklar

Bilinmiyor:Pıhtılaşmayaeğilimartışı

Solunum,göğüsbozukluklarıvemediastinalhastalıklar

Yaygın:Nefesdarlığı

Gastrointestinalhastalıklar

Bilinmiyor:Karıniçikanama

Hepato-bilierhastalıklar

Yaygın:Sarılık,karaciğeriltihabı,karaciğeryetmezliğidahilolmaküzerekaraciğerüzerine

toksiketki

Derivederialtıdokuhastalıkları

Yaygınolmayan:Döküntü

Kas-iskeletbozukluklar,bağdokuvekemikhastalıkları

Bilinmiyor:Osteoporoz(kemikerimesi)

Üremesistemivememehastalıkları

Çokyaygın:Spermüretiminingeridönüşümlüinhibisyonu

Yaygın:Erkeklerdememelerdebüyüme

Genelbozukluklarveuygulamabölgesineilişkinhastalıklar

Yaygın:Yorgunluk,sıcakbasması,terleme

Eğerbukullanmatalimatındabahsigeçmeyenherhangibiryanetkiilekarşılaşırsanız

doktorunuzuveyaeczacınızıbilgilendiriniz.

5. ANDROCUR ®

’unsaklanması

ANDROCUR ®’ uçocuklarıngöremeyeceği,erişemeyeceğiyerlerdeveambalajındasaklayınız.

30ºC’ninaltında,odasıcaklığındasaklayınız.

Sonkullanmatarihiyleuyumluolarakkullanınız

AmbalajdakisonkullanmatarihindensonraANDROCUR ®’

ukullanmayınız.

Eğerüründeve/veyaambalajındabozukluklarfarkedersenizANDROCUR ®

’ukullanmayınız.

Ruhsatsahibi:

BayerScheringPharmaAGAlmanyalisansıile,

BayerTürkKimyaSan.Ltd.Şti.

ÇakmakMah.BalkanCad.No:53

34770Ümraniye–Đstanbul

Üretimyeri:

DellpharmLilleS.A.S,Lys-Lez-Lannoy/Fransa

Bukullanmatalimatı.30/11/2010tarihindeonaylanmıştır.

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Modification of the existing maximum residue levels and setting of import tolerances for pyraclostrobin in various crops

Modification of the existing maximum residue levels and setting of import tolerances for pyraclostrobin in various crops

Published on: Mon, 19 Nov 2018 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted two requests to the competent national authority in Germany. The first one, to modify the existing maximum residue levels (MRL) for the active substance pyraclostrobin in various crops and to set import tolerances for sugar canes and American persimmons; the second one to set import tolerances for pineapples and passion fruits/maracujas. The data submitted in support of the request...

Europe - EFSA - European Food Safety Authority Publications

20-11-2018

Dioxins and related PCBs: tolerable intake level updated

Dioxins and related PCBs: tolerable intake level updated

Dioxins and related PCBs: tolerable intake level updated

Europe - EFSA - European Food Safety Authority Press Releases & News Stories

17-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

16-11-2018

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

13-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

10-11-2018

Pest categorisation of Popillia japonica

Pest categorisation of Popillia japonica

Published on: Thu, 08 Nov 2018 00:00:00 +0100 The Panel on Plant Health performed a pest categorisation of Popillia japonica(Coleoptera: Scarabaeidae) for the EU. P. japonica is a distinguishable species listed in Annex IAII of Council Directive 2000/29/EC. It is native to Japan but established in the USA in the early 20th century. It spreads from New Jersey to most US states east of the Mississippi, some to the west and north into Canada. P. japonica feeds on over 700 plant species. Adults attack folia...

Europe - EFSA - European Food Safety Authority Publications

9-11-2018

Safety assessment of the substance Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials

Safety assessment of the substance Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials

Published on: Wed, 07 Nov 2018 00:00:00 +0100 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP Panel) assessed the safety of the additive Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials. It is a family of mixtures combining the four lanthanides lanthanum (La), europium (Eu), gadolinium (Gd) and/or terbium (Tb) in different proportions as their 1,4‐benzene dicarboxylate complexes, used as a taggant in plastics for authentication and ...

Europe - EFSA - European Food Safety Authority Publications

6-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Chapter Plus+ By Backslim Capsules

Chapter Plus+ By Backslim Capsules

Chapter Plus+ By Backslim Capsules pose a serious risk to your health and should not be taken

Therapeutic Goods Administration - Australia

31-10-2018

Li Da Weight Loss Capsules

Li Da Weight Loss Capsules

Li Da Weight Loss Capsules pose a serious risk to your health and should not be taken

Therapeutic Goods Administration - Australia

31-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Guidance on the scientific requirements for health claims related to muscle function and physical performance

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 EFSA has asked the Panel on Nutrition, Novel Foods and Food Allergens (NDA) to update the guidance on the scientific requirements for health claims related to physical performance published in 2012. The update takes into account the experience gained by the NDA Panel with the evaluation of additional health claim applications, changes introduced to the general scientific guidance for stakeholders for health claims applications and information collected from ...

Europe - EFSA - European Food Safety Authority Publications

30-10-2018

FDA takes action to stop the use of lead acetate in hair dyes

FDA takes action to stop the use of lead acetate in hair dyes

FDA takes action to stop the use of lead acetate in hair dyes. FDA will no longer allow lead acetate to be used in certain hair coloring products based on data that demonstrate that there is no longer a reasonable certainty of no harm from the use of this color additive.

FDA - U.S. Food and Drug Administration

30-10-2018

Small increased risk of certain types of skin cancer associated with the use of hydrochlorothiazide

Small increased risk of certain types of skin cancer associated with the use of hydrochlorothiazide

There is a small increased risk of developing basal cell carcinoma and squamous cell carcinoma in long-term use of blood pressure medicine containing hydrochlorothiazide. This follows from a review of new studies and available data undertaken by the European Medicines Agency, EMA.

Danish Medicines Agency

30-10-2018

Sherb Detox capsules

Sherb Detox capsules

Sherb Detox capsules pose a serious risk to your health and should not be taken

Therapeutic Goods Administration - Australia

30-10-2018

You Slim&#039;xs capsules

You Slim&#039;xs capsules

You Slim'xs capsules pose a serious risk to your health and should not be taken

Therapeutic Goods Administration - Australia

30-10-2018

Pest categorisation of Sternochetus mangiferae

Pest categorisation of Sternochetus mangiferae

Published on: Mon, 29 Oct 2018 00:00:00 +0100 The European Commission requested EFSA to conduct a pest categorisation of Sternochetus mangiferae (Coleoptera: Curculionidae), a monophagous pest weevil whose larvae exclusively feed on mango seeds, whereas adults feed on mango foliage. S. mangiferae is a species with reliable methods available for identification. It is regulated in the EU by Council Directive 2000/29/EC where it is listed in Annex IIB as a harmful organism whose introduction into EU Protec...

Europe - EFSA - European Food Safety Authority Publications

30-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

29-10-2018

Mutant YK-11 Capsules

Mutant YK-11 Capsules

Mutant YK-11 Capsules pose a serious risk to your health and should not be taken

Therapeutic Goods Administration - Australia

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

29-10-2018

BFB Be Fast Block Capsules

BFB Be Fast Block Capsules

BFB Be Fast Block Capsules pose a serious risk to your health and should not be taken

Therapeutic Goods Administration - Australia

29-10-2018

Lanky Genuine capsules

Lanky Genuine capsules

Lanky Genuine capsules pose a serious risk to your health and should not be taken

Therapeutic Goods Administration - Australia

26-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

23-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

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

11-10-2018

Re‐evaluation of oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (E 479b) as a food additive

Re‐evaluation of oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (E 479b) as a food additive

Published on: Wed, 10 Oct 2018 00:00:00 +0200 The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion re‐evaluating the safety of thermally oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (TOSOM) (E 479b) when used as a food additive. The Scientific Committee on Food (SCF) and the Joint FAO/WHO Expert Committee on Food Additives (JECFA) derived an acceptable daily intake (ADI) of 25 and 30 mg/kg body weight (bw) per day, respectively. There was n...

Europe - EFSA - European Food Safety Authority Publications

10-10-2018

Tanning booths: ANSES issues a reminder of the proven risk of skin cancer

Tanning booths: ANSES issues a reminder of the proven risk of skin cancer

The health risks associated with exposure to artificial UV radiation from tanning booths have been well established for many years now. ANSES points out that recent data on the subject support previous assessments: there is a proven cancer risk associated with UV radiation from artificial tanning equipment. The Agency therefore recommends that the public authorities take the necessary steps to prevent people from being exposed to artificial UV radiation from tanning booths used for cosmetic purposes.

France - Agence Nationale du Médicament Vétérinaire

6-10-2018

Modification of the existing maximum residue level for epoxiconazole in beetroots

Modification of the existing maximum residue level for epoxiconazole in beetroots

Published on: Fri, 05 Oct 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Agriculture & Horticulture Development Board submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue level (MRL) for the active substance epoxiconazole in beetroots. The data submitted in support of the request were found to be sufficient to derive a MRL proposal for beetroots. Adequate analytical methods for enforcement are...

Europe - EFSA - European Food Safety Authority Publications

26-9-2018

Modification of the existing maximum residue level for flonicamid in various crops

Modification of the existing maximum residue level for flonicamid in various crops

Published on: Tue, 25 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Dienstleistungszentrum Ländlicher Raum submitted a request to the competent national authority in Germany to modify the existing maximum residue level (MRL) for the active substance flonicamid in radishes. Furthermore, in accordance with Article 6 of Regulation (EC) No 396/2005, the applicant ISK Biosciences Europe N.V. submitted a request to the competent national authority in the Ne...

Europe - EFSA - European Food Safety Authority Publications

26-9-2018

Technical Report on the notification of syrup from Sorghum bicolor (L.) Moench as a traditional food from a third country pursuant to Article 14 of Regulation (EU) 2015/2283

Technical Report on the notification of syrup from Sorghum bicolor (L.) Moench as a traditional food from a third country pursuant to Article 14 of Regulation (EU) 2015/2283

Published on: Tue, 25 Sep 2018 00:00:00 +0200 Abstract Following a notification from Sorghum Zrt., submitted to the European Commission under Article 14 of Regulation (EU) 2015/2283 to place on the market syrup from Sorghum bicolor (L.) Moench as a traditional food from a third country (TF), and in line with Article 15(2) of that Regulation, EFSA was asked by the European Commission whether there are duly reasoned safety objections to the placing on the market of the TF within the European Union. The ap...

Europe - EFSA - European Food Safety Authority Publications

30-11-2018

#FDA In Brief: @US_FDA takes steps to advance the safety and accuracy of  blood glucose monitors to empower patients with diabetes with reliable  tools to manage their health. Read more:  https://go.usa.gov/xPMyA   #MedicalDevice

#FDA In Brief: @US_FDA takes steps to advance the safety and accuracy of blood glucose monitors to empower patients with diabetes with reliable tools to manage their health. Read more: https://go.usa.gov/xPMyA  #MedicalDevice

#FDA In Brief: @US_FDA takes steps to advance the safety and accuracy of blood glucose monitors to empower patients with diabetes with reliable tools to manage their health. Read more: https://go.usa.gov/xPMyA  #MedicalDevice

FDA - U.S. Food and Drug Administration

26-11-2018

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009.  https

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009. https

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009. https://go.usa.gov/xPHdn 

FDA - U.S. Food and Drug Administration

26-11-2018

Alunbrig (Takeda Pharma A/S)

Alunbrig (Takeda Pharma A/S)

Alunbrig (Active substance: brigatinib) - Centralised - Authorisation - Commission Decision (2018)7976 of Mon, 26 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4248/

Europe -DG Health and Food Safety

23-11-2018

Management and communication of medicine shortages and discontinuations in Australia

Management and communication of medicine shortages and discontinuations in Australia

Guidance for sponsors and other stakeholder bodies

Therapeutic Goods Administration - Australia

22-11-2018

Further public consultation on appropriate access and safety controls (Poisons Standard schedule) for alkyl nitrites

Further public consultation on appropriate access and safety controls (Poisons Standard schedule) for alkyl nitrites

There will not be a decision announced on scheduling of alkyl nitrites on 29 November 2018. Further public consultation will be undertaken.

Therapeutic Goods Administration - Australia

21-11-2018

Osurnia (Elanco GmbH)

Osurnia (Elanco GmbH)

Osurnia (Active substance: terbinafine / florfenicol / betamethasone acetate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7842 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/003753/T/0010

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2086 (Santhera Pharmaceuticals (Deutschland) GmbH)

EU/3/18/2086 (Santhera Pharmaceuticals (Deutschland) GmbH)

EU/3/18/2086 (Active substance: Cyclo[L-alanyl-L-seryl-L-isoleucyl-L-prolyl-L-prolyl-L-glutaminyl-L-lysyl-L-tyrosyl-D-prolyl-L-prolyl-(2S)-2-aminodecanoyl-L-alpha-glutamyl-L-threonyl]acetate) - Orphan designation - Commission Decision (2018)7795 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/106/18

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2082 (Takeda Pharma A/S)

EU/3/18/2082 (Takeda Pharma A/S)

EU/3/18/2082 (Active substance: 5-{(1R,2R)-2-[(cyclopropylmethyl)amino]cyclopropyl}-N-(tetrahydro-2H-pyran-4-yl)thiophene-3-carboxamide monohydrochloride) - Orphan designation - Commission Decision (2018)7791 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/040/18

Europe -DG Health and Food Safety

20-11-2018

Are you traveling with some yummy food for #Thanksgiving this year? Take a few minutes to learn some #foodsafety tips to make sure you & your family don’t get sick.  http://go.usa.gov/xPXzH pic.twitter.com/tTpNUmwzcm

Are you traveling with some yummy food for #Thanksgiving this year? Take a few minutes to learn some #foodsafety tips to make sure you & your family don’t get sick. http://go.usa.gov/xPXzH pic.twitter.com/tTpNUmwzcm

Are you traveling with some yummy food for #Thanksgiving this year? Take a few minutes to learn some #foodsafety tips to make sure you & your family don’t get sick. http://go.usa.gov/xPXzH  pic.twitter.com/tTpNUmwzcm

FDA - U.S. Food and Drug Administration

6-11-2018

Communication to stakeholders: Autologous human cells and tissues (HCT) products

Communication to stakeholders: Autologous human cells and tissues (HCT) products

Important information about potential impact of regulation changes that came in force on 1 July 2018

Therapeutic Goods Administration - Australia

31-10-2018

Therapeutic goods advertising: Update 31 October 2018

Therapeutic goods advertising: Update 31 October 2018

The 2018 Code No.2 made today replaces the code that was made on 29 June 2018, and will take effect on 1 January 2019

Therapeutic Goods Administration - Australia

10-10-2018

#HurricaneMichael continues to move inland and remains a major hurricane. An extreme wind warning is in effect for portions of the Ern FL Panhandle & extreme SW GA for winds >115 MPH valid until 345 PM CT. If you are in the EWW, TAKE SHELTER NOW!!!pic.twi

#HurricaneMichael continues to move inland and remains a major hurricane. An extreme wind warning is in effect for portions of the Ern FL Panhandle & extreme SW GA for winds >115 MPH valid until 345 PM CT. If you are in the EWW, TAKE SHELTER NOW!!!pic.twi

#HurricaneMichael continues to move inland and remains a major hurricane. An extreme wind warning is in effect for portions of the Ern FL Panhandle & extreme SW GA for winds >115 MPH valid until 345 PM CT. If you are in the EWW, TAKE SHELTER NOW!!! pic.twitter.com/Mhx4LNoJCr

FDA - U.S. Food and Drug Administration

10-10-2018

As Hurricane #Michael nears land, take shelter & stay safe.

Follow weather updates on your phone or radio.

 In a tornado WARNING, go to an interior, windowless room.

 If water comes in, go to the highest floor that’s not flooded but do NOT enter a clos

As Hurricane #Michael nears land, take shelter & stay safe. Follow weather updates on your phone or radio. In a tornado WARNING, go to an interior, windowless room. If water comes in, go to the highest floor that’s not flooded but do NOT enter a clos

As Hurricane #Michael nears land, take shelter & stay safe. Follow weather updates on your phone or radio. In a tornado WARNING, go to an interior, windowless room. If water comes in, go to the highest floor that’s not flooded but do NOT enter a closed attic. pic.twitter.com/KD5WZ7gamP

FDA - U.S. Food and Drug Administration

1-10-2018

EU/3/03/133 (Shire Orphan Therapies GmbH)

EU/3/03/133 (Shire Orphan Therapies GmbH)

EU/3/03/133 (Active substance: Icatibant acetate) - Transfer of orphan designation - Commission Decision (2018)6432 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/054/02/T/01

Europe -DG Health and Food Safety

25-9-2018

We hope this extra time will allow stakeholders to continue to provide  input on the ideas shared during the two-day Pediatric Device  Development public meeting held last month. #devices4kids https://go.usa.gov/xPjwd 

We hope this extra time will allow stakeholders to continue to provide input on the ideas shared during the two-day Pediatric Device Development public meeting held last month. #devices4kids https://go.usa.gov/xPjwd 

We hope this extra time will allow stakeholders to continue to provide input on the ideas shared during the two-day Pediatric Device Development public meeting held last month. #devices4kids https://go.usa.gov/xPjwd 

FDA - U.S. Food and Drug Administration