ENTECAVIR ACCORD

Informazioni principali

  • Nome commerciale:
  • ENTECAVIR ACCORD
  • Utilizzare per:
  • Esseri umani
  • Tipo di medicina:
  • Farmaco allopatico

Documenti

Localizzazione

  • Disponibile in:
  • ENTECAVIR ACCORD
    Italia
  • Lingua:
  • italiano

Informazioni terapeutiche

  • Area terapeutica:
  • ENTECAVIR
  • Dettagli prodotto:
  • 045675028 - 0,5 MG- COMPRESSA RIVESTITA CON FILM- USO ORALE- BLISTER (ALU/ALU)- 30 X 1 COMPRESSE (DOSE UNITARIA) - autorizzato; 045675030 - 0,5 MG- COMPRESSA RIVESTITA CON FILM- USO ORALE- BLISTER (ALU/ALU)- 90 X 1 COMPRESSE (DOSE UNITARIA) - autorizzato; 045675016 - 0,5 MG- COMPRESSA RIVESTITA CON FILM- USO ORALE- FLACONE (HDPE)- 30 COMPRESSE - autorizzato; 045675055 - 1 MG- COMPRESSA RIVESTITA CON FILM- USO ORALE- BLISTER (ALU/ALU)- 30 X 1 COMPRESSE (DOSE UNITARIA) - autorizzato; 045675067 - 1 MG- COMPRESSA RIVESTITA CON FILM- USO ORALE- BLISTER (ALU/ALU)- 90 X 1 COMPRESSE (DOSE UNITARIA) - autorizzato; 045675042 - 1 MG- COMPRESSA RIVESTITA CON FILM- USO ORALE- FLACONE (HDPE)- 30 COMPRESSE - autorizzato

Altre informazioni

Status

  • Fonte:
  • AIFA - Agenzia Italiana del Farmaco
  • Numero dell'autorizzazione:
  • 045675
  • Ultimo aggiornamento:
  • 26-03-2018

Foglio illustrativo

B. FOGLIO ILLUSTRATIVO

Documento reso disponibile da AIFA il 20/10/2017

Esula dalla competenza dell’AIFA ogni eventuale disputa concernente i diritti di proprietà industriale e la tutela brevettuale dei dati relativi all’AIC dei

medicinali e, pertanto, l’Agenzia non può essere ritenuta responsabile in alcun modo di eventuali violazioni da parte del titolare dell'autorizzazione

all'immissione in commercio (o titolare AIC).

Foglio illustrativo: informazioni per l'utilizzatore

Entecavir Accord 0,5 mg compresse rivestite con film

Entecavir Accord 1 mg compresse rivestite con film

entecavir

Legga attentamente questo foglio prima di prendere questo medicinale perchè contiene

importanti informazioni per lei.

Conservi questo foglio. Potrebbe aver bisogno di leggerlo di nuovo.

Se ha qualsiasi dubbio, si rivolga al medico o al farmacista.

Questo medicinale è stato prescritto soltanto per lei. Non lo dia ad altre persone, anche se i

sintomi della malattia sono uguali ai suoi, perché potrebbe essere pericoloso.

Se si manifesta un qualsiasi effetto indesiderato, compresi quelli non elencati in questo foglio, si

rivolga al medico o al farmacista. Vedere paragrafo 4.

Contenuto di questo foglio:

Che cos'è Entecavir Accord e a che cosa serve

Cosa deve sapere prima di prendere Entecavir Accord

Come prendere Entecavir Accord

Possibili effetti indesiderati

Come conservare Entecavir Accord

Contenuto della confezione e altre informazioni

1.

Che cos'è Entecavir Accord e a che cosa serve

Entecavir Accord compresse è un medicinale antivirale, utilizzato negli adulti per il trattamento

dell'infezione cronica (a lungo termine) da virus dell'epatite B.

Entecavir Accord può essere usato

in persone il cui fegato è danneggiato ma funziona ancora correttamente (malattia epatica compensata)

ed in persone il cui fegato è danneggiato e non funziona correttamente (malattia epatica scompensata).

Entecavir Accord compresse è anche utilizzato per il trattamento dell'infezione cronica (a lungo

termine) da virus dell'epatite B nei bambini e adolescenti da 2 anni in su e al di sotto dei 18 anni

di età.

Entecavir Accord può essere utilizzato in bambini il cui fegato è danneggiato ma funziona

ancora correttamente (malattia epatica compensata).

L'infezione da virus dell'epatite B può causare danni al fegato. Entecavir Accord riduce la quantità di

virus nel corpo e migliora la condizione del fegato.

2.

Cosa deve sapere prima di prendere Entecavir Accord

Non prenda Entecavir Accord

se è allergico (ipersensibile)

all'entecavir o ad uno qualsiasi degli altri componenti di questo

medicinale (elencati al paragrafo 6).

Avvertenze e precauzioni

Si rivolga al medico o al farmacista prima di prendere

Entecavir Accord

se ha avuto problemi renali

, informi il medico. Questo è importante perché Entecavir Accord è

eliminato dal corpo attraverso i reni e potrebbe aver bisogno di un aggiustamento del dosaggio o

dello schema posologico.

non smetta di prendere Entecavir Accord senza consiglio del medico

in quanto l'epatite, a

seguito dell'interruzione del trattamento, può peggiorare. Nel caso il trattamento con Entecavir

Accord venga interrotto, il medico continuerà a controllarla e a farle eseguire gli esami del

sangue per diversi mesi.

Documento reso disponibile da AIFA il 20/10/2017

Esula dalla competenza dell’AIFA ogni eventuale disputa concernente i diritti di proprietà industriale e la tutela brevettuale dei dati relativi all’AIC dei

medicinali e, pertanto, l’Agenzia non può essere ritenuta responsabile in alcun modo di eventuali violazioni da parte del titolare dell'autorizzazione

all'immissione in commercio (o titolare AIC).

discuta con il medico se il fegato funziona correttamente

e, in caso contrario, quali possono

essere gli effetti sul suo trattamento con Entecavir Accord.

se è infettato anche dal virus dell'HIV

(virus dell'immunodeficienza umana) informi il

medico. Non deve prendere Entecavir Accord per trattare l'infezione da epatite B a meno che

non stia già prendendo medicinali per l'HIV, in quanto l'efficacia di un futuro trattamento per

l'HIV può essere ridotta. Entecavir Accord non controllerà la sua infezione da virus dell'HIV.

prendere Entecavir Accord non le impedirà di infettare altre persone con il virus

dell'epatite B (HBV)

attraverso i rapporti sessuali o i fluidi corporei (inclusa la contaminazione

con il sangue). Per questo motivo è importante prendere precauzioni per evitare che altri

vengano infettati dal virus dell'epatite B (HBV). È disponibile un vaccino per proteggere coloro

che sono a rischio di contrarre l'infezione da virus dell'epatite B (HBV).

Entecavir Accord appartiene ad una classe di medicinali che possono causare acidosi

lattica

(eccesso di acido lattico nel sangue) ed ingrossamento del fegato. Sintomi come nausea,

vomito e dolore allo stomaco possono indicare lo sviluppo di acidosi lattica. Questo raro ma

grave effetto indesiderato occasionalmente è stato fatale. L'acidosi lattica è più frequente nelle

donne, soprattutto se molto in sovrappeso. Il medico, durante il trattamento con Entecavir

Accord, la controllerà regolarmente.

se ha precedentemente ricevuto un trattamento per l'epatite B cronica

, informi il medico.

Bambini e adolescenti

Entecavir Accord non deve essere somministrato a bambini di età inferiore ai 2 anni o che pesano

meno di 10 kg.

Altri medicinali e Entecavir Accord

Informi il medico o il farmacista se sta assumendo, ha recentemente assunto o potrebbe assumere

qualsiasi altro medicinale.

Entecavir Accord con cibi e bevande

Nella maggior parte dei casi può prendere Entecavir Accord con o senza cibo. Tuttavia, se è stato

precedentemente trattato con un medicinale contenente il principio attivo lamivudina dovrà

considerare quanto segue. Se è stato passato al trattamento con Entecavir Accord perché la terapia con

lamivudina non ha avuto successo, dovrà prendere Entecavir Accord una volta al giorno a stomaco

vuoto. Se lo stato della malattia epatica è molto avanzato, il medico le prescriverà di prendere

Entecavir Accord a stomaco vuoto. Per stomaco vuoto si intende almeno 2 ore dopo un pasto e almeno

2 ore prima del successivo pasto.

Bambini e adolescenti (da 2 anni in su e al di sotto dei 18 anni di età) possono prendere Entecavir

Accord con o senza cibo.

Gravidanza, allattamento e fertilità

Informi il medico se è in corso una gravidanza o se sta pianificando una gravidanza. Non è stato

dimostrato che l'uso di Entecavir Accord in gravidanza è sicuro. Se non specificatamente stabilito dal

medico, Entecavir Accord non deve essere usato durante la gravidanza. È importante che le donne in

età fertile, durante il trattamento con Entecavir Accord, usino un metodo efficace di contraccezione

per evitare la gravidanza.

Non deve allattare al seno durante la terapia con Entecavir Accord. Informi il medico se sta allattando

al seno. Non è noto se entecavir, il principio attivo di Entecavir Accord, è escreto nel latte materno

umano.

Guida di veicoli e utilizzo di macchinari

Capogiro, affaticamento e sonnolenza sono effetti indesiderati comuni che possono compromettere la

sua capacità di guidare veicoli ed usare macchinari. Per qualsiasi chiarimento consulti il medico.

Documento reso disponibile da AIFA il 20/10/2017

Esula dalla competenza dell’AIFA ogni eventuale disputa concernente i diritti di proprietà industriale e la tutela brevettuale dei dati relativi all’AIC dei

medicinali e, pertanto, l’Agenzia non può essere ritenuta responsabile in alcun modo di eventuali violazioni da parte del titolare dell'autorizzazione

all'immissione in commercio (o titolare AIC).

Entecavir Accord polisaccaride di soia

Questo medicinale contiene polisaccardie di soia. Se è allergico alla soia, non assuma questo

medicinale.

3.

Come prendere Entecavir Accord

Non tutti i pazienti hanno necessità di prendere lo stesso dosaggio di Entecavir Accord.

Prenda questo medicinale seguendo sempre esattamente le istruzioni del medico. Se ha dubbi consulti

il medico o il farmacista.

Per gli adulti

la dose raccomandata è 0,5 mg o 1 mg, una volta al giorno per via orale (per bocca).

La sua dose dipenderà da:

se ha già ricevuto un trattamento per l'infezione da virus dell'epatite B (HBV), e con quale

medicinale è stato trattato.

se ha problemi renali. Il medico potrà prescriverle un dosaggio più basso o indicarle di

prenderlo meno di una volta al giorno.

la condizione del suo fegato.

Per bambini e adolescenti

(da 2 anni in su e al di sotto dei 18 anni di età) è disponibile Entecavir

Accord 0,5 mg compresse oppure può essere disponibile una soluzione orale di entecavir.

Il medico di suo figlio deciderà la giusta dose in base al peso di suo figlio. Bambini che pesano almeno

32,6 kg possono prendere le compresse da 0,5 mg oppure può essere disponibile una soluzione orale di

entecavir. Una soluzione orale di entecavir è raccomandata per i pazienti che pesano da 10 kg a 32,5

kg. Ciascun dosaggio sarà somministrato una volta al giorno per via orale (per bocca). Non ci sono

raccomandazioni per entecavir in bambini di età inferiore ai 2 anni di età o di peso corporeo inferiore a

10 kg.

Il medico la informerà sul dosaggio corretto. Affinché il medicinale sia pienamente efficace e per

ridurre lo sviluppo di resistenza alla terapia, prenda sempre la dose raccomandata dal medico. Prenda

Entecavir Accord per tutto il periodo indicato dal medico. Il medico le dirà se e quando interrompere il

trattamento.

Alcuni pazienti devono prendere Entecavir Accord a stomaco vuoto (vedere

Entecavir Accord con

cibi e bevande

paragrafo 2

). Se il medico le ha detto che deve prendere Entecavir Accord a

stomaco vuoto, significa almeno 2 ore dopo un pasto e almeno 2 ore prima del prossimo pasto.

Entecavir Accord è disponibile solo sotto forma di compresse rivestite con film da 0,5 mg e 1 mg. Per

i pazienti con difficoltà di deglutizione o per i quali si consiglia una riduzione della dose possono

essere disponibili altre formulazioni contenenti entecavir più adatte.

Se prende più Entecavir Accord di quanto deve

Contatti immediatamente il medico.

Se dimentica di prendere Entecavir Accord

E' importante che non dimentichi alcuna dose. Se dimentica una dose di Entecavir Accord, la prenda

appena possibile, ed in seguito prenda la dose successiva al momento stabilito. Se è quasi ora della

dose successiva, non prenda la dose dimenticata. Aspetti e prenda la dose successiva al momento

stabilito. Non prenda una dose doppia per compensare la dimenticanza della dose.

Non interrompa il trattamento con Entecavir Accord senza il parere del medico

Molte persone hanno sintomi di epatite molto gravi quando interrompono l'assunzione di Entecavir

Accord. Riferisca immediatamente al medico se nota qualsiasi variazione nei sintomi dopo

l'interruzione del trattamento.

Documento reso disponibile da AIFA il 20/10/2017

Esula dalla competenza dell’AIFA ogni eventuale disputa concernente i diritti di proprietà industriale e la tutela brevettuale dei dati relativi all’AIC dei

medicinali e, pertanto, l’Agenzia non può essere ritenuta responsabile in alcun modo di eventuali violazioni da parte del titolare dell'autorizzazione

all'immissione in commercio (o titolare AIC).

Se ha qualsiasi dubbio sull’uso di questo medicinale, si rivolga al medico o al farmacista.

4.

Possibili effetti indesiderati

Come tutti i medicinali, questo medicinale può causare effetti indesiderati sebbene non tutte le persone

li manifestino.

I pazienti trattati con Entecavir Accord hanno riportato i seguenti effetti indesiderati:

comuni (almeno 1 su 100 pazienti): cefalea, insonnia (incapacità a dormire), affaticamento (eccessivo

senso di stanchezza), capogiro, sonnolenza (sopore), vomito, diarrea, nausea, dispepsia (indigestione)

ed elevati livelli di enzimi del fegato nel sangue.

non comuni (almeno 1 su 1.000 pazienti): eruzione cutanea, perdita di capelli.

rari (almeno 1 su 10.000 pazienti): reazione allergica grave.

Se si manifesta un qualsiasi effetto indesiderato, compresi quelli non elencati in questo foglio, si

rivolga al medico o al farmacista.

Segnalazione degli effetti indesiderati

Se manifesta un qualsiasi effetto indesiderato, compresi quelli non elencati in questo foglio, si rivolga

al medico o al farmacista. Può inoltre segnalare gli effetti indesiderati direttamente tramite il sistema

nazionale di segnalazione elencato nell'Appendice V. Segnalando gli effetti indesiderati può

contribuire a fornire maggiori informazioni sulla sicurezza di questo medicinale.

5.

Come conservare Entecavir Accord

Conservi questo medicinale fuori dalla vista e dalla portata dei bambini.

Non usi questo medicinale dopo la data di scadenza che è riportata sul flacone, sul blister o sul cartone

dopo Scad. La data di scadenza si riferisce all’ultimo giorno di quel mese.

Utilizzare entro 90 giorni dall’apertura del flacone.

Questo medicinale non richiede condizioni particolari di conservazione.

Non getti alcun medicinale nell’acqua di scarico e nei rifiuti domestici. Chieda al farmacista come

eliminare i medicinali che non utilizza più. Questo aiuterà a proteggere l'ambiente.

6.

Contenuto della confezione e altre informazioni

Cosa contiene Entecavir Accord

Il principio attivo è entecavir.

Entecavir Accord 0,5 mg compresse rivestite con film

Ogni compressa contiene entecavir monoidrato equivalente a 0,5 mg di entecavir.

Entecavir Accord 1mg compresse rivestite con film

Ogni compressa contiene entecavir monoidrato equivalente a 1 mg di entecavir.

Gli altri eccipienti sono:

Nucleo della compressa:

carbonato di calcio, amido pregelatinizzato, carmellosa sodica, polisaccaride

di soia, acido citrico monoidrato, sodio stearil fumarato.

Rivestimento della compressa:

Entecavir Accord 0,5 mg compresse rivestite con film

Documento reso disponibile da AIFA il 20/10/2017

Esula dalla competenza dell’AIFA ogni eventuale disputa concernente i diritti di proprietà industriale e la tutela brevettuale dei dati relativi all’AIC dei

medicinali e, pertanto, l’Agenzia non può essere ritenuta responsabile in alcun modo di eventuali violazioni da parte del titolare dell'autorizzazione

all'immissione in commercio (o titolare AIC).

Ipromellosa, titanio diossido (E171), macrogol, polisorbato 80

Entecavir Accord 1 mg compresse rivestite con film

Ipromellosa, titanio diossido (E171), macrogol, ossido di ferro rosso (E172)

Descrizione dell’aspetto di Entecavir Accord e contenuto della confezione

Entecavir Accord 0,5 mg: compresse biconvesse da bianco a quasi bianco, di forma triangolare e

rivestimento con film, marcate con "J" su un lato e "110" sull'altro.

Entecavir Accord 1 mg: compresse biconvesse rosa, di forma triangolare e rivestimento con film,

marcate con "J" su un lato e "111" sull'altro.

Entecavir Accord è disponibile in astucci contenenti 30 x 1 o 90 x 1 compresse rivestite con film (in

blister divisibili per dose unitaria) ed in flaconi contenenti 30 compresse rivestite con film.

E' possibile che non tutte le confezioni siano commercializzate.

Titolare dell'autorizzazione all'immissione in commercio

Titolare dell'autorizzazione all'immissione in commercio

Accord Healthcare Limited

Sage House, 319 Pinner Road

North Harrow, Middlesex, HA1 4HF

Regno Unito

Produttore

Accord Healthcare Limited

Sage House, 319 Pinner Road

North Harrow, Middlesex, HA1 4HF

Regno Unito

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park

Paola, PLA 3000

Malta

Per ulteriori informazioni su questo medicinale, contatti il rappresentante locale del titolare

dell'autorizzazione all’immissione in commercio:

Accord Healthcare Limited, UK

Tel: 0044 208 863 1427

Questo foglio illustrativo è stato aggiornato il {MM/AAAA}

Altre fonti di informazioni

Informazioni più dettagliate su questo medicinale sono disponibili sul sito web dell'Agenzia europea

dei medicinali: http://www.ema.europa.eu/.

Documento reso disponibile da AIFA il 20/10/2017

Esula dalla competenza dell’AIFA ogni eventuale disputa concernente i diritti di proprietà industriale e la tutela brevettuale dei dati relativi all’AIC dei

medicinali e, pertanto, l’Agenzia non può essere ritenuta responsabile in alcun modo di eventuali violazioni da parte del titolare dell'autorizzazione

all'immissione in commercio (o titolare AIC).

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Europe - EFSA - European Food Safety Authority Publications

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

2-10-2018

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

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

Published on: Mon, 01 Oct 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance cyflufenamid. To assess the occurrence of cyflufenamid residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as the European authorisations reported by Member States (in...

Europe - EFSA - European Food Safety Authority Publications

28-9-2018

Avian influenza overview May – August 2018

Avian influenza overview May – August 2018

Published on: Thu, 27 Sep 2018 00:00:00 +0200 Between 16 May and 15 August 2018, three highly pathogenic avian influenza (HPAI) A(H5N8) outbreaks in poultry establishments and three HPAI A(H5N6) outbreaks in wild birds were reported in Europe. Three low pathogenic avian influenza (LPAI) outbreaks were reported in three Member States. Few HPAI and LPAI bird cases have been detected in this period of the year, in accordance with the seasonal expected pattern of LPAI and HPAI. There is no evidence to date ...

Europe - EFSA - European Food Safety Authority Publications

27-9-2018

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

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

Published on: Wed, 26 Sep 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance tembotrione. To assess the occurrence of tembotrione residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EU) No 188/2011 as well as the import tolerances and European author...

Europe - EFSA - European Food Safety Authority Publications

27-9-2018

Outcome of the consultation on confirmatory data used in risk assessment for the active substance  copper (I), copper (II) variants

Outcome of the consultation on confirmatory data used in risk assessment for the active substance copper (I), copper (II) variants

Published on: Wed, 26 Sep 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the risk assessment for an active substance in light of confirmatory data requested following the first approval in accordance with Article 6(1) of Directive 91/414/EEC and Article 6(f) of Regulation (EC) No 1107/2009. In this context EFSA's scientific views on the specific points raised during the commenting phase conducted with Me...

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

25-9-2018

Daiso Holdings Ltd. recalls Daiso Brand Consumer Chemical Products

Daiso Holdings Ltd. recalls Daiso Brand Consumer Chemical Products

The recalled products have not been properly classified according to the Consumer Chemicals and Containers Regulations, 2001, in order to ensure appropriate hazard labelling. These regulations are empowered by the Canada Consumer Product Safety Act. Improper labelling could result in unintentional exposure to these products and lead to serious illness, injury or death.

Health Canada

21-9-2018

Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for sulfoxaflor in light of confirmatory data

Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for sulfoxaflor in light of confirmatory data

Published on: Thu, 20 Sep 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the risk assessment for an active substance in light of confirmatory data requested following approval in accordance with Article 6(1) of Directive 91/414/EEC and Article 6(f) of Regulation (EC) No 1107/2009. In this context EFSA's scientific views on the specific points raised during the commenting phase conducted with Member State...

Europe - EFSA - European Food Safety Authority Publications

21-9-2018

Modification of the existing maximum residue level for clothianidin in potatoes

Modification of the existing maximum residue level for clothianidin in potatoes

Published on: Thu, 20 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer CropScience AG submitted a request to the competent national authority in Germany to modify the existing maximum residue level (MRL) for the active substance clothianidin to accommodate the use on potatoes imported from Canada. The data submitted in support of the request were found to be sufficient to derive a MRL proposal. Adequate analytical methods for enforcement are availa...

Europe - EFSA - European Food Safety Authority Publications

19-9-2018

Modification of the existing maximum residue levels for potassium phosphonates in certain berries and small fruits

Modification of the existing maximum residue levels for potassium phosphonates in certain berries and small fruits

Published on: Tue, 18 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant LTZ Augustenberg submitted a request to the competent national authority in Germany to modify the existing maximum residue levels (MRLs) for the active substance potassium phosphonates in raspberries, blackberries, currants, blueberries, gooseberries and elderberries. The data submitted in support of the request were found to be sufficient to derive MRL proposals for all crops under c...

Europe - EFSA - European Food Safety Authority Publications

19-9-2018

Modification of the existing maximum residue levels for flonicamid in various root crops

Modification of the existing maximum residue levels for flonicamid in various root crops

Published on: Tue, 18 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the Agriculture and Horticulture Development Council submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue levels (MRL) for the active substance flonicamid in beetroots, carrots, celeriacs/turnip rooted celeries, horseradishes, Jerusalem artichokes, parsnips, parsley roots/Hamburg roots parsley, radishes, salsifies, swedes/rutabagas, tu...

Europe - EFSA - European Food Safety Authority Publications

13-9-2018

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

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

Published on: Wed, 12 Sep 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance fluquinconazole. Considering the information provided by Member States, neither EU uses nor import tolerances are currently authorised for fluquinconazole within the European Union. Furthermore, no MRLs are established by the Codex Alimentarius Commission (codex maximum residue ...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Risk assessment of substances used in food supplements: the example of the botanical Gymnema sylvestre

Risk assessment of substances used in food supplements: the example of the botanical Gymnema sylvestre

Published on: Tue, 28 Aug 2018 00:00:00 +0200 Botanicals and preparations derived from these are among the substances frequently added to foods and food supplements, yet the safety of many botanicals has not been systematically assessed. In the context of the EU‐FORA fellowship programme, the fellow performed an assessment on the safety of the botanical Gymnema sylvestre, in accordance with EFSA's guidance on the assessment of safety of botanicals. Although preparations of G. sylvestre are marketed as f...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Modelling of inactivation through heating for quantitative microbiological risk assessment (QMRA)

Modelling of inactivation through heating for quantitative microbiological risk assessment (QMRA)

Published on: Mon, 27 Aug 2018 00:00:00 +0200 EFSA regards the household as a stage in the food chain that is important for the final number of food‐borne infections. The fate of a pathogen in the private kitchen largely depends on consumer hygiene during preparation of food and on its proper cooking, especially in the case of meat. Unfortunately, detailed information on the microbiological survival in meat products after heating in the consumer kitchen is lacking. The aim of the study was to improve th...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Assessment of occupational and dietary exposure to pesticide residues

Assessment of occupational and dietary exposure to pesticide residues

Published on: Mon, 27 Aug 2018 00:00:00 +0200 Plant protection products (PPPs) are pesticides containing at least one active substance that drives specific actions against pests (diseases). PPPs are regulated in the EU and cannot be placed on the market or used without prior authorisation. EFSA assesses the possible risks of the use of active substances to humans and environment. Member States decide whether or not to approve their use at EU level. Furthermore, Member States decide at national level on ...

Europe - EFSA - European Food Safety Authority Publications

4-9-2018

Outcome of the consultation with Member States and EFSA on the basic substance application for milk for use in plant protection as fungicide

Outcome of the consultation with Member States and EFSA on the basic substance application for milk for use in plant protection as fungicide

Published on: Mon, 03 Sep 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the evaluation of applications received by the European Commission concerning basic substances. In this context, EFSA's scientific views on the specific points raised during the commenting phase conducted with Member States and EFSA on the basic substance application for milk are presented. The context of the evaluation was that req...

Europe - EFSA - European Food Safety Authority Publications

1-9-2018

Multiple “Dr. King’s” homeopathic and “Natural Pet” veterinary products recalled due to potential microbial contamination

Multiple “Dr. King’s” homeopathic and “Natural Pet” veterinary products recalled due to potential microbial contamination

Health Canada is advising consumers and pet owners not to use homeopathic and veterinary products made by King Bio Inc. and labeled as "Dr. King's," "Dr King's Natural Pet" or "Natural Pet." These products may pose a health risk to people and pets, especially children, pregnant women and those with compromised immune systems, because of potential microbial contamination. According to the United States Food and Drug Administration, high levels of microbial contamination were identified at the manufacturin...

Health Canada

1-9-2018

Acknowledgement:EFSA  wishes  to  thank  the  rapporteur  Member  State  Denmark  for  thepreparatory work on this scientific output.Suggested citation:EFSA (European Food Safety Authority), Brancato A, Brocca D, Carrasco Cabrera L,De Lentdecker C, Erdos

Acknowledgement:EFSA wishes to thank the rapporteur Member State Denmark for thepreparatory work on this scientific output.Suggested citation:EFSA (European Food Safety Authority), Brancato A, Brocca D, Carrasco Cabrera L,De Lentdecker C, Erdos

Published on: Fri, 31 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance napropamide. To assess the occurrence of napropamide residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as the European authorisations reported by Member States (incl...

Europe - EFSA - European Food Safety Authority Publications

1-9-2018

Review of the existing MRLs for fenbuconazole

Review of the existing MRLs for fenbuconazole

Published on: Fri, 31 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance fenbuconazole. To assess the occurrence of fenbuconazole residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC, the MRLs established by the Codex Alimentarius Commission as well...

Europe - EFSA - European Food Safety Authority Publications

30-8-2018

National summary reports on pesticide residue analysis performed in 2016

National summary reports on pesticide residue analysis performed in 2016

Published on: Tue, 07 Aug 2018 00:00:00 +0200 In accordance with Article 31 of Regulation (EC) No 396/2005, European Union (EU) Member States have to communicate to the European Food Safety Authority (EFSA) the results of their official controls on pesticide residues in food. In the framework of this communication, the EU Member States, Iceland and Norway provided a short summary report outlining the main findings of the control activities during the reference year. This technical report is the compilat...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

Published on: Tue, 28 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance sintofen. To assess the occurrence of sintofen residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008, as well as the European authorisations reported by Member ...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

Published on: Mon, 27 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance prochloraz. To assess the occurrence of prochloraz residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC, the MRLs established by the Codex Alimentarius Commission as well as th...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Modification of the existing maximum residue levels for prohexadione in various oilseeds

Modification of the existing maximum residue levels for prohexadione in various oilseeds

Published on: Mon, 27 Aug 2018 00:00:00 +0200 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 levels (MRL) for the active substance prohexadione in linseeds, poppy seeds, sunflower seeds, rape seeds, mustard seeds and gold of pleasure seeds. The data submitted in support of the request were found to be sufficient to derive MRL proposals for all oilseeds under consid...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

Published on: Fri, 24 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance napropamide. To assess the occurrence of napropamide residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as the European authorisations reported by Member States (incl...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Explanatory note on the determination of newly expressed protein levels in the context of genetically modified plant applications for EU market authorisation

Explanatory note on the determination of newly expressed protein levels in the context of genetically modified plant applications for EU market authorisation

Published on: Mon, 20 Aug 2018 00:00:00 +0200 Genetically modified organisms are subject to a risk assessment and regulatory approval before entering the European market. According to legislation (Directive 2001/18/EC, Regulation (EC) No 1829/2003 and Regulation (EU) No 503/2013) and the EFSA guidance documents on the risk assessment of food and feed from genetically modified (GM) plants and on the environmental risk assessment of GM plants, applicants need to perform a molecular characterisation of any...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Setting of import tolerances for mandestrobin in strawberries and table and wine grapes

Setting of import tolerances for mandestrobin in strawberries and table and wine grapes

Published on: Thu, 16 Aug 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Sumitomo Chemical Agro Europe SAS submitted a request to the competent national authority in Austria to set an import tolerance for the active substance mandestrobin in strawberries, table grapes and wine grapes. The data submitted in support of the request were found to be sufficient to derive maximum residue level (MRL) proposals for the crops under consideration. Adequate analytica...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Modification of the existing maximum residue levels for fluoxastrobin in oilseeds

Modification of the existing maximum residue levels for fluoxastrobin in oilseeds

Published on: Mon, 13 Aug 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Arysta LifeSciences SAS submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue levels (MRL) for the active substance fluoxastrobin in certain oilseeds. The data submitted in support of the request were found to be sufficient to derive MRL proposals for the oilseeds for which a modification was requested. Adequate analytical...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

Published on: Mon, 13 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance myclobutanil. To assess the occurrence of myclobutanil residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008, the MRLs established by the Codex Alimentarius Com...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Evaluation of data concerning the necessity of bromoxynil as herbicide to control a serious danger to plant health which cannot be contained by other available means, including non‐chemical methods

Evaluation of data concerning the necessity of bromoxynil as herbicide to control a serious danger to plant health which cannot be contained by other available means, including non‐chemical methods

Published on: Mon, 13 Aug 2018 00:00:00 +0200 EFSA was requested by the European Commission to provide scientific assistance under Article 31 of Regulation (EC) No 178/2002 regarding the evaluation of data concerning the necessity of bromoxynil as a herbicide to control a serious danger to plant health which cannot be contained by other available means including non‐chemical methods, in accordance with Article 4(7) of Regulation (EC) No 1107/2009. In this context, EFSA organised a commenting phase with ...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Slovakia and EFSA – Final report

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Slovakia and EFSA – Final report

Published on: Tue, 07 Aug 2018 00:00:00 +0200 Presented document is the final report of the project GA/EFSA/DATA/2017/01: “Strategic Partnership with Slovakia on Data Quality (Pilot project)”. The report describes national processes and tools in order to implement internal validation and quality control of collected data according to EFSA requirements. A description of the data transmission processes from the National Databases to the EFSA databases, terminology, data mapping and data transformations fo...

Europe - EFSA - European Food Safety Authority Publications

28-8-2018

Accord Healthcare Inc. Issues Voluntary Nationwide Recall of Hydrochlorothiazide Tablets USP 12.5 Mg Due to Labeling Mix-up

Accord Healthcare Inc. Issues Voluntary Nationwide Recall of Hydrochlorothiazide Tablets USP 12.5 Mg Due to Labeling Mix-up

A 100 count bottle of Hydrochlorothiazide Tablets USP 12.5 mg has been found to contain 100 Spironolactone Tablets USP 25 mg. Since the individual lot, PW05264, of the product is involved in a potential mix-up of labeling, Accord is recalling this individual lot from the market.

FDA - U.S. Food and Drug Administration

2-7-2018

Blissful Remedies Issues Voluntary Nationwide Recall of Certain Kratom Powder Capsule

Blissful Remedies Issues Voluntary Nationwide Recall of Certain Kratom Powder Capsule

Blissful Remedies., is voluntarily recalling only Lot No.: 112710 with expiration 03/2019 found embedded on the top of package of kratom ( mitragyn a speciosa) powder products, it manufactured, processed, packed, and/or held, between “March 1, 2018” to “April 30, 2018” to the consumer level. The products have been found by the U.S. Food and Drug Administration (“FDA”) via sample testing to have salmonella contamination. Blissful Remedies has not received reports of adverse events related to this recall. ...

FDA - U.S. Food and Drug Administration

22-6-2018

Kratom (mitragyna speciosa) Powder Products by Gaia Ethnobotanical: Recall - Due to Potential Salmonella Contamination

Kratom (mitragyna speciosa) Powder Products by Gaia Ethnobotanical: Recall - Due to Potential Salmonella Contamination

The products have been found by the FDA via sample testing and finding to have salmonella contamination. In lieu of such FDA findings the company has implemented standard operating procedures and sterilization processes in accordance to FDA guidelines

FDA - U.S. Food and Drug Administration

21-6-2018

Gaia Ethnobotanical, LLC., Voluntarily Recalls Kratom Products Due to Potential Salmonella Contamination

Gaia Ethnobotanical, LLC., Voluntarily Recalls Kratom Products Due to Potential Salmonella Contamination

Gaia Ethnobotanical, LLC., is voluntarily recalling all kratom (mitragyna speciosa) powder products, with Lot No.: 0102031800 it manufactured, processed, packed, and/or held, between March 18, 2018 to March 30, 2018 to the consumer level. The products have been found by the U.S. Food and Drug Administration (“FDA”) via sample testing and finding to have salmonella contamination. In lieu of such FDA findings the company has implemented standard operating procedures and sterilization processes in accordanc...

FDA - U.S. Food and Drug Administration

25-9-2018

Pelgraz (Accord Healthcare Limited)

Pelgraz (Accord Healthcare Limited)

Pelgraz (Active substance: pegfilgrastim) - Centralised - Authorisation - Commission Decision (2018)6288 of Tue, 25 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/003961/0000

Europe -DG Health and Food Safety

24-9-2018

Lenalidomide Accord (Accord Healthcare Limited)

Lenalidomide Accord (Accord Healthcare Limited)

Lenalidomide Accord (Active substance: lenalidomide) - Centralised - Authorisation - Commission Decision (2018)6237 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4857

Europe -DG Health and Food Safety

7-8-2018

Accofil (Accord Healthcare Limited)

Accofil (Accord Healthcare Limited)

Accofil (Active substance: Filgrastim) - Centralised - Yearly update - Commission Decision (2018)5428 of Tue, 07 Aug 2018

Europe -DG Health and Food Safety

7-8-2018

Memantine Accord (Accord Healthcare Limited)

Memantine Accord (Accord Healthcare Limited)

Memantine Accord (Active substance: memantine) - Centralised - Renewal - Commission Decision (2018)5421 of Tue, 07 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2766/R/10

Europe -DG Health and Food Safety

6-8-2018

Zoledronic acid Accord (Accord Healthcare Limited)

Zoledronic acid Accord (Accord Healthcare Limited)

Zoledronic acid Accord (Active substance: zoledronic acid) - Centralised - Yearly update - Commission Decision (2018)5386 of Mon, 06 Aug 2018

Europe -DG Health and Food Safety

18-7-2018

#ICYMI - According to @PAPATIENTSAFETY June 2018 report, the number of reported surgical fires has decreased since 2011.  Read more about preventing surgical fires here:  https://go.usa.gov/xU5zs  #FDA #MedicalDevice

#ICYMI - According to @PAPATIENTSAFETY June 2018 report, the number of reported surgical fires has decreased since 2011. Read more about preventing surgical fires here: https://go.usa.gov/xU5zs  #FDA #MedicalDevice

#ICYMI - According to @PAPATIENTSAFETY June 2018 report, the number of reported surgical fires has decreased since 2011. Read more about preventing surgical fires here: https://go.usa.gov/xU5zs  #FDA #MedicalDevice

FDA - U.S. Food and Drug Administration

4-7-2018

Docetaxel Accord (Accord Healthcare Limited)

Docetaxel Accord (Accord Healthcare Limited)

Docetaxel Accord (Active substance: Docetaxel) - Centralised - Yearly update - Commission Decision (2018)4341 of Wed, 04 Jul 2018

Europe -DG Health and Food Safety

3-7-2018

Temozolomide Accord (Accord Healthcare Limited)

Temozolomide Accord (Accord Healthcare Limited)

Temozolomide Accord (Active substance: temozolomide) - Centralised - Yearly update - Commission Decision (2018) 4240 of Tue, 03 Jul 2018

Europe -DG Health and Food Safety

11-6-2018

Pemetrexed Accord (Accord Healthcare Limited)

Pemetrexed Accord (Accord Healthcare Limited)

Pemetrexed Accord (Active substance: pemetrexed) - Centralised - Yearly update - Commission Decision (2018)3761 of Mon, 11 Jun 2018

Europe -DG Health and Food Safety

4-6-2018

Accordi transattivi 2013-2015 - Determina AIFA n° 854/2018

Accordi transattivi 2013-2015 - Determina AIFA n° 854/2018

Si comunica che in data 30 maggio 2018 è stata adottata la Determina n. 854/2018 avente per oggetto “Riepilogo degli importi a carico di ciascuna azienda farmaceutica titolare di AIC per ciascuno degli anni 2013, 2014 e 2015", ai sensi dell’articolo 1, comma 391, della legge 27 dicembre 2017, n. 205, recante “Bilancio di previsione dello Stato per l’anno finanziario 2018 e bilancio pluriennale per il triennio 2018-2020”.Continua

Italia - AIFA - Agenzia Italiana del Farmaco

30-5-2018

Bortezomib Accord (Accord Healthcare Limited)

Bortezomib Accord (Accord Healthcare Limited)

Bortezomib Accord (Active substance: bortezomib) - Centralised - Variation - Commission Decision (2018)3460 of Wed, 30 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3984/X/8

Europe -DG Health and Food Safety

23-5-2018

Scientific guideline:  Draft guideline on the responsibilities of the sponsor with regard to handling and shipping of investigational medicinal products for human use in accordance with good clinical practice and good manufacturing practice, draft: consul

Scientific guideline: Draft guideline on the responsibilities of the sponsor with regard to handling and shipping of investigational medicinal products for human use in accordance with good clinical practice and good manufacturing practice, draft: consul

The guideline lays down the principles for the two-step release and shipping of the investigational medicinal products by the qualified person and the sponsor. The guideline also describes the areas of interface between the manufacturer and the sponsor and the required contractual agreements.

Europe - EMA - European Medicines Agency

15-5-2018

Pramipexole Accord (Accord Healthcare Limited)

Pramipexole Accord (Accord Healthcare Limited)

Pramipexole Accord (Active substance: pramipexole) - Centralised - Yearly update - Commission Decision (2018)2995 of Tue, 15 May 2018

Europe -DG Health and Food Safety