Lasix long 30

Informazioni principali

  • Nome commerciale:
  • Lasix long 30 capsule
  • Forma farmaceutica:
  • capsule
  • Composizione:
  • furosemidum, 30 mg, colore.: E 132, excipiens pro il capsula.
  • Utilizzare per:
  • Esseri umani
  • Tipo di medicina:
  • Farmaco biologico

Documenti

  • per i professionisti:
  • Il foglio illustrativo per questo prodotto non è al momento disponibile, é possibile inviare una richiesta al nostro Servizio Clienti ed essere avvisati nel momento in cui è disponibile sulla nostra piattaforma.


    Richiedi il foglio illustrativo per i professionisti.

Localizzazione

  • Disponibile in:
  • Lasix long 30 capsule
    Svizzera
  • Lingua:
  • italiano

Informazioni terapeutiche

  • Gruppo terapeutico:
  • Synthetika
  • Area terapeutica:
  • Diuretico

Altre informazioni

Status

  • Fonte:
  • Swissmedic - Swiss Agency for Therapeutic Products
  • Numero dell'autorizzazione:
  • 42482
  • Data dell'autorizzazione:
  • 11-02-1980
  • Ultimo aggiornamento:
  • 19-10-2018

Foglio illustrativo: composizione, posologia, indicazioni, interazioni, gravidanza, allattamento, effetti indesiderati, controindicazioni

Patienteninformation

Lasix® long 30

Sanofi-Aventis (Suisse) SA

Che cos'è Lasix long 30 e quando si usa?

Lasix long 30 contiene come principio attivo la furosemide. Il prodotto possiede un'azione diuretica

che comincia in generale 2 a 3 ore dopo la presa delle capsule, dura per 12 ore al massimo, e provoca

così una eliminazione progressiva degli edemi e una diminuzione morbida dell'ipertensione.

Lasix long 30 è adatto nel trattamento

·di ritenzione di liquida nei tessuti (edema) in seguito a una malattia del cuore (se necessario, in

combinazione con altri farmaci cardiaci), del fegato o dei reni.

·dell'ipertensione arteriosa leggera o media.

Lasix long 30 può essere usato soltanto su prescrizione e sotto costante controllo medico.

Di che cosa occorre inoltre tener conto durante il trattamento?

La terapia con Lasix long 30 richiede un controllo medico regolare.

Poichè l'uso di Lasix long 30 può portare a un abbassamento del tasso di potassio nel sangue, si

consiglia di seguire una dieta ricca di potassio (carne magra, patate, banane, pomodori, cavolfiore,

spinaci, frutta secca ecc.).

Occasionalmente può essere opportuno sostituire la perdita di potassio con un medicamento.

Quando non si può assumere Lasix long 30?

Lasix long 30 non deve essere assunto in caso di: disfunzione renale senza produzione di urina,

disfunzione epatica accompagnata da disturbi della coscienza, grave carenza di potassio (ad es. in

seguito a vomito prolungato, a diarrea grave o cronica, a disturbi della funzione epatica, ad uso

eccessivo di purganti), grave carenza di sodio, ridotto volume sanguigno, perdita di liquido,

ipotensione, ipersensibilità alla furosemide, ai sulfamidici o a uno degli eccipienti e durante

l'allattamento.

Quando è richiesta prudenza nella somministrazione di Lasix long 30?

Un controllo particolarmente accurato è necessario in casi di:

·pressione sanguigna bassa; soprattutto nei pazienti a rischio a causa di una diminuzione significativa

della pressione arteriosa (ad es. pazienti con restringimento delle arterie circonflesse cardiache o

cerebrali);

·diabete mellito (controlli regolari dalla glicemia);

·gotta (controlli regolari dell'acido urico);

·ostacolo al deflusso dell'urina (ad es. in presenza di un ingrossamento della prostata, di

restringimento dell'uretere, di rene con stasi urinaria) [deve essere garantito il deflusso dell'urina];

·carenza di proteine (adattamento delle dosi con cautela);

·presenza concomitante di cirrosi epatica e riduzione della funzionalità renale;

·prematuri.

Durante un trattamento di lunga durata, devono essere controllati regolarmente determinati valori nel

sangue. Una riduzione del volume ematico, una disidratazione corporea, alterazioni significative

degli elettroliti e disturbi dell'equilibrio acido-basico devono essere compensati. È necessario

sorvegliare con particolare attenzione i pazienti ad alto rischio di disturbi degli elettroliti e se ci sia

un'ulteriore perdita di liquidi con un sudore eccessivo, di diarree o vomiti.

Questo medicamento può ridurre la capacità di reazione, la capacità di condurre un veicolo e la

capacità di utilizzare attrezzi o macchine.

Interazioni

Combinazioni sconsigliate

La combinazione con determinati antibiotici o altre sostanze ototossiche, possa comportare un rischio

di danni all'udito o ai reni.

In rari casi, quando la somministrazione endovenosa di Lasix long 30 avviene entro 24 ore dopo la

somministrazione di cloralidrato, possono comparire sensazioni di calore, sudorazioni improvvise,

agitazione, nausea, aumento della pressione sanguigna e palpitazioni. Pertanto è sconsigliata la

contemporanea somministrazione di furosemide e cloralidrato.

Combinazioni che richiedono particolare prudenza e attenzione

Interazioni possono verificarsi con generi voluttuari come la liquirizia e con medicamenti che

influiscono sull'equilibrio dei sali, ad es. lassativi (soprattutto nei casi di impiego prolungato), altri

diuretici, determinati ormoni, un particolare farmaco contro le ulcere gastriche (carbenoxolone) e

provocare una carenza di potassio.

In caso di carenza di potassio o di magnesio, gli effetti terapeutici e gli effetti collaterali di

determinati farmaci per il cuore (glucosidi cardioattivi ad es. digossina) possono essere potenziati.

La furosemide può potenziare l'azione di altri farmaci antipertensivi. Sono stati osservati forti

abbassamenti di pressione, fino al collasso, specialmente in combinazione con i cosiddetti inibitori

dell'ACE. La somministrazione degli inibitori dell'ACE o degli antagonisti recettoriali

dell'angiotensina II (e un aumento del dosaggio) a pazienti già trattati con Lasix long 30 può portare

a un peggioramento della funzione renale e, in casi isolati, a un blocco renale acuto. Prima di

impiegare un inibitore dell'ACE o un antagonista recettoriale dell'angiotensina II, oppure prima di

aumentarne la posologia, la somministrazione di Lasix long 30 va temporaneamente interrotta o la

sua posologia ridotta per 3 giorni.

Lasix long 30 può potenziare gli effetti collaterali di medicamenti dannosi per i reni. La

somministrazione contemporanea della furosemide e di determinati antibiotici (cefalosporina ad alte

dosi, ad es. cefaloridina, cefalotina) può avere un effetto negativo sulla funzione renale.

Determinati antidolorifici (ad es. l'acido acetilsalicilico e l'indometacina) possono indebolire l'azione

di Lasix long 30 e, in presenza di carenza di volume sanguigno o di liquido corporeo, portare a un

arresto della funzione renale. In caso di uso concomitante di Lasix long 30, la tossicità di dosi elevate

di salicilati può essere aumentata (potenziamento degli effetti collaterali dell'acido acetilsalicilico).

Un medicamento contro la gotta (probenecide), un antiepilettico (fenitoina) nonché il metotressato

possono diminuire l'effetto di Lasix long 30. D'altra parte, Lasix long 30 potenzia l'effetto di

determinati farmaci (ad es. gli analgesici, la teofillina - un medicamento contro l'asma - e certi

rilassanti muscolari) oppure ne diminuisce l'effetto (ad es. farmaci contro il diabete o di

vasocostrittori come l'epinefrina e la norepinefrina).

Poiché il principio attivo furosemide può provocare un aumento dell'acido urico nel sangue e la

ciclosporina (un medicamento usato nei trapianti e che agisce sul sistema immunitario) riduce

l'eliminazione dell'acido urico da parte dal rene, il rischio di un'artrite gottosa è più elevato in caso di

somministrazione contemporanea di furosemide e ciclosporina A.

La somministrazione contemporanea di Lasix long 30 e cisplatino (un mezzo per il trattamento dei

tumori) può avere un effetto negativo sull'udito.

La somministrazione concomitante di Lasix long 30 e di litio provoca un potenziamento degli effetti

nocivi del litio sul cuore e sui nervi. Il livello di litio va controllato attentamente nella combinazione

con furosemide.

L'assorbimento della furosemide può essere pregiudicato da un preparato contro l'ulcera gastrica, il

sucralfato. L'assunzione deve esser effettuata a distanza di 2 ore.

È richiesta prudenza nell'uso concomitante con il risperidone e valutare bene i rischi e i benefici di

un'associazione o di un trattamento simultaneo con la furosemide o con altri diuretici potenti, prima

di prendere la decisione di utilizzarli.

Particolare prudenza occorre nel caso in cui vengano somministrate simultaneamente dosi elevate di

Lasix e di levotiroxina (medicamento impiegato nel trattamento ormonale sostitutivo della tiroide),

per la possibile diminuzione dei tassi ormonali tiroidei. Di conseguenza, se la terapia prevede questa

associazione di medicamenti, occorre controllare i valori tiroidei.

Il suo medico o il suo farmacista sono comunque informati sulle possibili interazioni tra

medicamenti.

Informi il medico o il farmacista se

·soffre di altre malattie,

·è allergico o

·assume o applica esternamente altri medicamenti (anche se acquistati di propria iniziativa!).

Si può assumere Lasix long 30 durante la gravidanza o l'allattamento?

In base alle esperienze fatte finora, non sono noti rischi per il bambino se il medicamento è usato

correttamente. Tuttavia non sono ancora state compiute indagini scientifiche sistematiche. Se è

incinta o se prevede una gravidanza, può assumere Lasix long 30 solo dopo aver consultato il suo

medico.

Il trattamento durante la gravidanza richiede la sorveglianza della crescita fetale.

Il principio attivo di Lasix long 30, la furosemide, raggiunge il latte materno e ne inibisce la

produzione. Lasix long 30 non va assunto o utilizzato durante l'allattamento. Se l'assunzione è

indispensabile, si consiglia di interrompere l'allattamento.

Come usare Lasix long 30?

Adulti: cominciare la terapia degli edemi con 1 capsula la mattina o, nei casi gravi, con 2 capsule al

giorno. Per la terapia a lungo termine, si raccomanda in generale di prescrivere 1 (a 2) capsule al

giorno o ogni due o tre giorni.

In caso di ipertensione, si raccomanda di prescrivere una capsula al giorno; nei casi gravi, si può

cominciare con 2 capsule al giorno.

Le capsule vanno inghiottite, senza masticarle, prima i pasti con molto liquido.

Il medico decide la durata del trattamento, che dipende dal tipo e dalla gravità della malattia.

Non modifichi di sua iniziativa la posologia prescritta. Se ritiene che l'azione del medicamento sia

troppo debole o troppo forte, ne parli al suo medico o al suo farmacista.

Quali effetti collaterali può avere Lasix long 30?

Con l'assunzione o l'uso di Lasix long 30 possono manifestarsi i seguenti effetti collaterali:

Come conseguenza dell'aumento di escrezione di urina e di sali, sono stati spesso osservati disturbi

nell'equilibrio dei liquidi e degli elettroliti.

Una eliminazione elevata di urina, particolarmente nelle persone anziane e nei bambini, può

provocare ipovolemia (carenza di volume sanguigno) e disidratazione con problemi alla circolazione,

che si manifestano per-lo-più con mal di testa, vertigini, debolezza, sonnolenza, disturbi alla vista,

secchezza della bocca, diminuzione della pressione sanguigna e disturbi circolatori al momento di

alzarsi. È stata segnalata inoltre una tendenza alla formazione di trombi essenzialmente nelle persone

anziane.

Un aumento della perdita di sodio attraverso i reni può portare a una carenza di sodio - specialmente

in una dieta povera di sale. Questa si manifesta spesso con i seguenti sintomi: crampi ai polpacci,

inappetenza, debolezza, sonnolenza, apatia, stato confusionale e vomito.

Si possono verificare perdite di potassio specialmente in seguito a dieta povera di potassio come pure

in seguito a vomito o a diarrea cronica. Una carenza di potassio può manifestarsi sotto forma di

debolezza muscolare, eccessivo accumulo di gas nello stomaco e nell'intestino, costopazione,

eccessiva escrezione urinaria, aumentata sensazione di sete con assunzioneesagerata di liquidi, e

disturbi della formazione e della conduzione degli stimoli nel cuore. Forti perdite di potassio possono

provocare una paralisi intestinale o disturbi della coscienza che possono arrivare fino al coma.

Sono state osservate situazioni di carenza di magnesio con la comparsa di crampi o disturbi del ritmo

cardiaco.

La furosemide può abbassare il livello del calcio nel sangue (in casi molto rari sono stati osservati

stati convulsivi).

Nei prematuri possono formarsi calcoli renali contenenti calcio e si può avere un deposito di sali di

calcio nel tessuto renale.

Sintomi di disturbi della minzione (imossibilità o difficoltà a urinare) possono manifestarsi o

peggiorare con l'uso di farmaci diuretici. Una ritenzione urinaria acuta con complicazioni secondarie

può esserne la conseguenza.

Spesso si è osservata un'encefalopatia epatica (disturbo reversibile del sistema nervoso legato a

un'insufficienza epatica) nei pazienti che soffrono di insufficienza epatocellulare (causata ad esempio

da epatite, cirrosi o tumori del fegato), i cui sintomi si manifestano attraverso insonnia, ipersonnia

(sonno eccessivo), disturbi della memoria, confusione, disorientamento, contrazioni muscolari

brusche e brevi, tremori, disturbi della consapevolezza dei gesti e disturbi della coscienza.

Occasionalmente sono stati osservati i seguenti effetti collaterali:

Reazioni allergiche (reazioni della pelle e delle mucose, prurito, orticaria, formazione di vescicole

sulla pelle, arrossamenti della pelle, eczemi, emorragie a livello della pelle e delle mucose) ma anche

stati febbrili e infiammazione dei vasi sanguigni o dei reni.

Sono stati segnalati disturbi dell'udito reversibili e casi di sordità, talvolta irreversibili: nausea,

ipersensibilità o fotosensibilità della pelle.

Effetti collaterali rari:

Disturbi gastro-intestinali (vomito e diarrea).

Cambiamenti del quadro sanguigno. In certi casi questi cambiamenti possono portare a una tendenza

aumentata all'insorgenza di infezioni o di emorragie. Alterazioni della formula ematologica possono

mettere la vita in pericolo. Disturbi della sensibilità o febbre: acufeni (percezione di rumori

inesistenti), molto spesso reversibili. In caso di diabete mellito, l'assunzione di Lasix può

(occasionalmente) aggravare il quadro metabolico o rendere manifesto un diabete latente

(raramente).

Parestesia (prurito, formicolii), vascolarità (infiammazione della parete dei vasi sanguigni).

Effetti collaterali molto rari:

Possono insorgere casi isolati di stasi biliare, pancreatiti acute e un aumento degli enzimi epatici:

eruzioni cutanee sotto forma di macchie, con formazione di papule o altre eruzioni.

Alcuni valori di laboratorio possono alterarsi.

In pazienti gottosi si possono verificare accessi di gotta.

Sono stati riportati casi di vertigini, svenimento o incoscienza e cefalea con l'assunzione di Lasix.

L'assunzione di Lasix può aggravare un lupus preesistente o attivare questa malattia autoimmune.

Molto raramente sono state osservate anche reazioni cutanee gravi (sindrome di Stevens-Johnson,

necrolisi epidermica tossica, sindrome DRESS e reazioni lichenoidi) che si manifestano con

un'eruzione cutanea generalizzata (papule violacee, bolle/vescicole) e/o con interessamento delle

mucose e febbre. Se sviluppa eruzioni cutanée e/o febbre, interrompa immediatamente l'assunzione

di Lasix e si rivolga subito al suo medico. Sono stati segnalati casi isolati di rabdomiolisi (degrado

dei tessuti muscolari che può provocare insufficienza renale) caratterizzati in particolare da dolori

muscolari, debolezza e gonfiore muscolare. Se riscontra sintomi analoghi, contatti immediatamente il

suo medico.

Qualora compaiano gli effetti collaterali menzionati o effetti indesiderati qui non descritti, dovrebbe

informare il suo medico o il suo farmacista.

Di che altro occorre tener conto?

Il medicamento va conservato fuori dalla portata dei bambini.

Conservare Lasix long 30 a temperatura ambiente (15-25 °C) e al riparo dalla luce.

Questo medicamento non dev'essere utilizzato oltre la data indicata con «EXP» sulla confezione. Se

è in possesso di compresse scadute, li riporti in farmacia per l'eliminazione.

Il suo medico o il suo farmacista, che sono in possesso di un informazione professionale dettagliata,

possono darle ulteriori informazioni.

Cosa contiene Lasix long 30?

1 capsula contiene 30 mg di furosemide in una forma galenica che garantisce la liberazione

prolungata del principio attivo.

Colorante: indigotina (E132).

Numero dell’omologazione

42482 (Swissmedic).

Dov'è ottenibile Lasix long 30? Quali confezioni sono disponibili?

In farmacia, dietro presentazione della prescrizione medica.

Confezione da 50 capsule

Titolare dell’omologazione

sanofi-aventis (svizzera) sa, 1214 Vernier/GE.

Questo foglietto illustrativo è stato controllato l’ultima volta nell'marzo 2018 dall’autorità

competente in materia di medicamenti (Swissmedic).

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27-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

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

21-11-2018

Setting of an import tolerance for mandipropamid in cocoa beans

Setting of an import tolerance for mandipropamid in cocoa beans

Published on: Tue, 20 Nov 2018 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Syngenta Agro GmbH submitted a request to the competent national authority in Austria to set a maximum residue level (MRL) for the active substance mandipropamid in cocoa beans imported from Nigeria and Cameroon. The data submitted in support of the request were found to be sufficient to derive a MRL proposal of 0.06 mg/kg. Adequate analytical methods for enforcement are available to control the res...

Europe - EFSA - European Food Safety Authority Publications

20-11-2018

Modification of the existing maximum residue levels for pyraclostrobin in soyabean

Modification of the existing maximum residue levels for pyraclostrobin in soyabean

Published on: Mon, 19 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 France to modify the existing maximum residue level (MRL) for the active substance pyraclostrobin in soyabean. The data submitted in support of the request were found to be sufficient to derive MRL proposals for soyabean. The applicant provided a new validated analytical method to control residues of pyraclostrobin on the commodity u...

Europe - EFSA - European Food Safety Authority Publications

20-11-2018

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

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

15-11-2018

Results from 2018 National Youth Tobacco Survey show dramatic increase in e-cigarette use among youth over past year

Results from 2018 National Youth Tobacco Survey show dramatic increase in e-cigarette use among youth over past year

New findings from the National Youth Tobacco Survey show that more than 3.6 million middle and high school students were current (past 30 day) e-cigarette users in 2018.

FDA - U.S. Food and Drug Administration

14-11-2018

“Vita-X Revitalizing Capsules” for men may pose serious health risks

“Vita-X Revitalizing Capsules” for men may pose serious health risks

Health Canada is advising Canadians that two versions of “Vita-X Revitalizing Capsules” by Lanlay Healthmetic Inc., promoted for “long lasting vital energy for men,” may pose serious health risks. One version contains seven capsules and has “NPN 80053009,” a Natural Product Number (NPN) indicating Health Canada authorization, on the label. The second version contains one capsule, has no NPN on the label and is not authorized by Health Canada.

Health Canada

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

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

7-11-2018

Reactie op berichtgeving over nota Waarborgfonds

Reactie op berichtgeving over nota Waarborgfonds

Op dinsdag 30 oktober heeft minister Bruno Bruins een feitenrelaas rondom het faillissement van de MC Groep naar de Tweede Kamer gestuurd.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

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

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

Peer review of the pesticide risk assessment of the active substance dimethoate

Peer review of the pesticide risk assessment of the active substance dimethoate

Published on: Tue, 30 Oct 2018 00:00:00 +0100 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Italy and co‐rapporteur Member State Bulgaria for the pesticide active substance dimethoate are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of dimetho...

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

Safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos when used as a feed flavouring for all animal species

Safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos when used as a feed flavouring for all animal species

Published on: Tue, 30 Oct 2018 00:00:00 +0100 Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos (hop strobiles) when used as a sensory feed additive for all animal species. The additive is specified to containing 40% beta acids and less than 0.2% alpha acids. Known substances of conce...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Efficacy of Bergazym® P100 (endo‐1,4‐β‐xylanase) as a feed additive for chickens for fattening and weaned piglets

Efficacy of Bergazym® P100 (endo‐1,4‐β‐xylanase) as a feed additive for chickens for fattening and weaned piglets

Published on: Tue, 30 Oct 2018 00:00:00 +0100 The product Bergazym® P100 contains a xylanase which is produced by a non‐genetically modified strain of Trichoderma reesei. The additive is available in a coated granular form and it is intended to be used as a zootechnical additive (functional group: digestibility enhancers) for chickens for fattening, and weaned piglets at the dose of 1,500 EPU/kg feed. The production strain and the additive were fully characterised in a previous assessment of the Panel o...

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

31-10-2018

Peer review of the pesticide risk assessment of the active substance methiocarb

Peer review of the pesticide risk assessment of the active substance methiocarb

Published on: Tue, 30 Oct 2018 00:00:00 +0100 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State the United Kingdom and co‐rapporteur Member State Germany for the pesticide active substance methiocarb are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative use...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Safety and efficacy of Lactobacillus hilgardii CNCM I‐4785 and Lactobacillus buchneri CNCM I‐4323/NCIMB 40788 as a silage additive for all animal species

Safety and efficacy of Lactobacillus hilgardii CNCM I‐4785 and Lactobacillus buchneri CNCM I‐4323/NCIMB 40788 as a silage additive for all animal species

Published on: Tue, 30 Oct 2018 00:00:00 +0100 Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed was asked to deliver a scientific opinion on the safety and efficacy of a strain of Lactobacillus hilgardii and of Lactobacillus buchneri when used as a technological additive intended to improve ensiling at a proposed application rate of 3.0 x 108 colony forming units (CFU)/kg fresh material. The two bacterial species are considered by EFS...

Europe - EFSA - European Food Safety Authority Publications

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

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

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

P. East Trading Corp. Issues Alert on Undeclared Sulfites In Fruits Du Sud Golden Seedless Raisins

P. East Trading Corp. Issues Alert on Undeclared Sulfites In Fruits Du Sud Golden Seedless Raisins

P. EAST TRADING CORP. of Bronx, NY is recalling Fruits Du Sud Golden Seedless Raisins (Lot No. FDS T499/18) 30 lbs Box, because they contain undeclared SULFITES. People who have a severe sensitivity to sulfites run the risk of serious or life-threatening reactions if they consume these products.

FDA - U.S. Food and Drug Administration

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

15-10-2018

Apollo Food International Inc Issues Allergy Alert on Undeclared Eggs In “Mini Roll”

Apollo Food International Inc Issues Allergy Alert on Undeclared Eggs In “Mini Roll”

Apollo Food International Inc. of Long Island City, NY, is recalling its 2.469 ounce packages of “Mini Roll” food treats because they may contain undeclared eggs. Consumers who are allergic to eggs may run the risk of serious or life-threatening allergic reactions if they consume this product.

FDA - U.S. Food and Drug Administration

20-12-2018

.@US_FDA provides an update on new steps to revise #Essure's post-market study to collect long-term safety information following discontinuation of its U.S. sales. Read FDA Commissioner @SGottliebFDA's statement on the new steps here:  https://go.usa.gov/

.@US_FDA provides an update on new steps to revise #Essure's post-market study to collect long-term safety information following discontinuation of its U.S. sales. Read FDA Commissioner @SGottliebFDA's statement on the new steps here: https://go.usa.gov/

. @US_FDA provides an update on new steps to revise #Essure's post-market study to collect long-term safety information following discontinuation of its U.S. sales. Read FDA Commissioner @SGottliebFDA's statement on the new steps here: https://go.usa.gov/xEaNB  #MedicalDevice

FDA - U.S. Food and Drug Administration

19-12-2018

Join us on January 17, 2019 from 1-2:30 PM EST for a webinar to help clarify the Breakthrough Devices Program final guidance for manufacturers. Find out more about the webinar:  https://go.usa.gov/xExHX  #MedicalDevice #FDApic.twitter.com/sHElqFFODy

Join us on January 17, 2019 from 1-2:30 PM EST for a webinar to help clarify the Breakthrough Devices Program final guidance for manufacturers. Find out more about the webinar: https://go.usa.gov/xExHX  #MedicalDevice #FDApic.twitter.com/sHElqFFODy

Join us on January 17, 2019 from 1-2:30 PM EST for a webinar to help clarify the Breakthrough Devices Program final guidance for manufacturers. Find out more about the webinar: https://go.usa.gov/xExHX  #MedicalDevice #FDA pic.twitter.com/sHElqFFODy

FDA - U.S. Food and Drug Administration

18-12-2018


Orphan designation: Mercaptopurine (oral suspension), Treatment of acute lymphoblastic leukaemia, 30/04/2009, Positive

Orphan designation: Mercaptopurine (oral suspension), Treatment of acute lymphoblastic leukaemia, 30/04/2009, Positive

Orphan designation: Mercaptopurine (oral suspension), Treatment of acute lymphoblastic leukaemia, 30/04/2009, Positive

Europe - EMA - European Medicines Agency

18-12-2018


Orphan designation: H-Phe-Ser-Arg-Tyr-Ala-Arg-OH acetate (Alirinetide), Treatment of amyotrophic lateral sclerosis, 30/05/2016, Positive

Orphan designation: H-Phe-Ser-Arg-Tyr-Ala-Arg-OH acetate (Alirinetide), Treatment of amyotrophic lateral sclerosis, 30/05/2016, Positive

Orphan designation: H-Phe-Ser-Arg-Tyr-Ala-Arg-OH acetate (Alirinetide), Treatment of amyotrophic lateral sclerosis, 30/05/2016, Positive

Europe - EMA - European Medicines Agency

14-12-2018

LONGRANGE (Merial)

LONGRANGE (Merial)

LONGRANGE (Active substance: eprinomectin) - Refusal of authorisation - Commission Decision (2018)8905 of Fri, 14 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/4291

Europe -DG Health and Food Safety

30-11-2018

.@US_FDA issues class I recall, the most serious type pf recall: Zimmer  Biomet, Inc. Recalls Spinal Fusion & Long Bone Stimulators Due to Lack  of Adequate Validation and Controls to Ensure Product Cleanliness. Read  more about the recall:  https://go.us

.@US_FDA issues class I recall, the most serious type pf recall: Zimmer Biomet, Inc. Recalls Spinal Fusion & Long Bone Stimulators Due to Lack of Adequate Validation and Controls to Ensure Product Cleanliness. Read more about the recall: https://go.us

. @US_FDA issues class I recall, the most serious type pf recall: Zimmer Biomet, Inc. Recalls Spinal Fusion & Long Bone Stimulators Due to Lack of Adequate Validation and Controls to Ensure Product Cleanliness. Read more about the recall: https://go.usa.gov/xPMEK  #MedicalDevice pic.twitter.com/M55ddC98wW

FDA - U.S. Food and Drug Administration

30-11-2018

Pregabalin Zentiva k.s (Zentiva, k.s.)

Pregabalin Zentiva k.s (Zentiva, k.s.)

Pregabalin Zentiva k.s (Active substance: pregabalin) - Centralised - Yearly update - Commission Decision (2018)8149 of Fri, 30 Nov 2018

Europe -DG Health and Food Safety

30-11-2018

Pioglitazone Teva (Teva B.V.)

Pioglitazone Teva (Teva B.V.)

Pioglitazone Teva (Active substance: pioglitazone) - Centralised - Yearly update - Commission Decision (2018)8159 of Fri, 30 Nov 2018

Europe -DG Health and Food Safety

30-11-2018

Keppra (UCB Pharma S.A.)

Keppra (UCB Pharma S.A.)

Keppra (Active substance: levetiracetam) - Centralised - Yearly update - Commission Decision (2018)8160 of Fri, 30 Nov 2018

Europe -DG Health and Food Safety

30-11-2018

Pioglitazone Teva Pharma (Teva B.V.)

Pioglitazone Teva Pharma (Teva B.V.)

Pioglitazone Teva Pharma (Active substance: pioglitazone) - Centralised - Yearly update - Commission Decision (2018)8158 of Fri, 30 Nov 2018

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

30-10-2018

EU/3/14/1250 (Akcea Therapeutics UK Ltd)

EU/3/14/1250 (Akcea Therapeutics UK Ltd)

EU/3/14/1250 (Active substance: Phosphorothioate oligonucleotide targeted to transthyretin) - Transfer of orphan designation - Commission Decision (2018)7282 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/098/13/T/01

Europe -DG Health and Food Safety

30-10-2018

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

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

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

Europe -DG Health and Food Safety

30-10-2018

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

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

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

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2078 (Sellas Life Sciences Limited)

EU/3/18/2078 (Sellas Life Sciences Limited)

EU/3/18/2078 (Active substance: Peptides YMFPNAPYL, SGQAYMFPNAPYLPSCLES, RSDELVRHHNMHQRNMTKL and PGCNKRYFKLSHLQMHSRKHTG) - Orphan designation - Commission Decision (2018)7279 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/091/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2077 (Worphmed Srl)

EU/3/18/2077 (Worphmed Srl)

EU/3/18/2077 (Active substance: Melatonin) - Orphan designation - Commission Decision (2018)7278 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/077/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2076 (Orphan Europe S.A.R.L.)

EU/3/18/2076 (Orphan Europe S.A.R.L.)

EU/3/18/2076 (Active substance: Glycine, L-alanine, L-arginine, L-aspartic acid, L-cysteine, L-cystine, L-glutamic acid, L-histidine, L-lysine monohydrate, L-methionine, L-phenylalanine, L-proline, L-serine, L-threonine, L-tryptophan, L-tyrosine, taurine) - Orphan designation - Commission Decision (2018)7277 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/100/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2075 (Consorcio Centro de InvestigaciOn BiomEdica en Red M.P.)

EU/3/18/2075 (Consorcio Centro de InvestigaciOn BiomEdica en Red M.P.)

EU/3/18/2075 (Active substance: Gefitinib) - Orphan designation - Commission Decision (2018)7276 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/090/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2074 (PhaRA bvba)

EU/3/18/2074 (PhaRA bvba)

EU/3/18/2074 (Active substance: Avapritinib) - Orphan designation - Commission Decision (2018)7275 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/079/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2073 (Fondazione Telethon)

EU/3/18/2073 (Fondazione Telethon)

EU/3/18/2073 (Active substance: Autologous CD34+ haematopoietic stem and progenitor cells genetically modified with the lentiviral vector IDUA LV, encoding for the alpha-L-iduronidase cDNA) - Orphan designation - Commission Decision (2018)7274 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/113/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2071 (Loxo Oncology Limited)

EU/3/18/2071 (Loxo Oncology Limited)

EU/3/18/2071 (Active substance: 6-(2-hydroxy-2-methylpropoxy)-4-(6-(6-((6-methoxypyridin-3-yl)methyl)-3,6-diazabicyclo[3.1.1]heptan-3-yl)pyridin-3-yl)pyrazolo[1,5-a]pyridine-3-carbonitrile) - Orphan designation - Commission Decision (2018)7272 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/125/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2072 (FGK Representative Service GmbH)

EU/3/18/2072 (FGK Representative Service GmbH)

EU/3/18/2072 (Active substance: 6'-(R)-methyl-5-O-(5-amino-5,6-dideoxy-alpha-L-talofuranosyl)-paromamine sulfate) - Orphan designation - Commission Decision (2018)7273 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/102/18

Europe -DG Health and Food Safety