Dogmatil 200 mg

Informazioni principali

  • Nome commerciale:
  • Dogmatil 200 mg compresse
  • Forma farmaceutica:
  • compresse
  • Composizione:
  • sulpiridum 200 mg, excipiens pro compresso.
  • 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:
  • Dogmatil 200 mg compresse
    Svizzera
  • Lingua:
  • italiano

Informazioni terapeutiche

  • Gruppo terapeutico:
  • Synthetika
  • Area terapeutica:
  • Antipsicotici

Altre informazioni

Status

  • Fonte:
  • Swissmedic - Swiss Agency for Therapeutic Products
  • Numero dell'autorizzazione:
  • 40706
  • Data dell'autorizzazione:
  • 14-01-1981
  • Ultimo aggiornamento:
  • 19-10-2018

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

Patienteninformation

Dogmatil®

Sanofi-Aventis (Suisse) SA

Legga attentamente il foglietto illustrativo prima di far uso del medicamento.

Questo medicamento le è stato prescritto personalmente e quindi non deve essere consegnato ad altre

persone, anche se i sintomi sono gli stessi. Il medicamento potrebbe nuocere alla loro salute.

Conservi il foglietto illustrativo per poterlo rileggere all’occorrenza.

Che cos'è Dogmatil e quando si usa?

Dogmatil contiene il principio attivo sulpiride, un neurolettico. Si usa su prescrizione medica in certi

disturbi psichici: schizofrenia, stati nevrotici, disturbi gravi del comportamento in occasione di

consumo di alcol e deficit mentale.

Quando non si può assumere Dogmatil?

Se è allergico a uno dei componenti di Dogmatil. A causa della presenza di lattosio nelle compresse e

nelle capsule di Dogmatil, queste forme farmaceutiche sono controindicate in caso d'intolleranza al

lattosio.

In caso di feocromocitoma (affezione della ghiandola surrenale con mal di testa, vampate di calore

ed episodi d'ipertensione), di tumori prolattino-dipendenti e in associazione con la levodopa o

farmaci antiparkinsoniani come il ropinirole.

In caso di porfiria acuta.

Quando è richiesta prudenza nella somministrazione di Dogmatil?

Durante la terapia astenersi dal consumare bevande alcoliche.

Questo medicamento deve essere usato con prudenza se si soffre del morbo di Parkinson. Informi il

suo medico se soffre di questa malattia, d'insufficienza renale, di disturbi cardiaci, di altri disturbi

psichici, in particolare se è una persona anziana, o se ha già sofferto di trombosi.

Se soffre di epilessia, il suo medico dovrà intensificare i suoi controlli.

In caso d'infezione e/o di febbre inspiegabile, di rigidità muscolare, di mal di testa e di crisi

ipertensive, cessi immediatamente la terapia e avvisi subito il suo medico.

Le compresse e le capsule di Dogmatil contengono lattosio (zucchero derivante dal latte). Se soffre

di un'intolleranza a uno zucchero del latte, non deve utilizzare queste forme farmaceutiche.

Se soffre di diabete mellito o presenta fattori di rischio di diabete, il suo medico controllerà

regolarmente la sua glicemia.

A causa della presenza di lattosio, questo medicamento è controindicato in caso d'intolleranza al

lattosio.

Dogmatil ha un effetto anticolinergico e, di conseguenza, deve essere somministrato con prudenza

nei pazienti che hanno precedenti di glaucoma, occlusione intestinale, stenosi congenita dell'apparato

digerente, ritenzione urinaria o iperplasia della prostata.

A causa del rischio di crisi ipertensive, Dogmatil va usato con cautela nei pazienti ipertesi –

soprattutto anziani – che devono essere monitorati in maniera adeguata.

L'associazione di Dogmatil con altri medicamenti può causare interazioni ed effetti collaterali, quali

disturbi gravi del ritmo cardiaco o depressione del sistema nervoso centrale. Informi il suo medico se

prende altri medicamenti. Il medico deciderà quali medicamenti possono essere somministrati

assieme a Dogmatil e quali associazioni vanno evitate.

Elenco non esauriente dei medicamenti che possono interagire con Dogmatil:

antiaritmici (ad es. chinidina, procainamide, amiodarone, sotalolo, flecainide); certi medicamenti per

il trattamento delle malattie psichiche (ad es. risperidone, aloperidolo, quetiapina); antidepressivi

(antidepressivi imipraminici, venlafaxina); medicamenti per il trattamento delle ulcere

gastrointestinali (cimetidina); antibiotici (ad es. eritromicina, spiramicina, pentamidina,

levofloxacina); medicamenti vasopressori (ad es. dobutamina, epinefrina); antinausea (ad es.

domperidone, ondansetrone); decongestionanti (ad es. efedrina); broncodilatatori (ad es. salmeterolo,

terbutalina); medicamenti che possono causare un'ipokaliemia (ad es. diuretici, lassativi);

medicamenti che possono provocare una diminuzione del ritmo cardiaco (ad es. betabloccanti,

digitalici, diltiazem), antipertensivi; analgesici (morfina e derivati morfinici); certi medicamenti

antiallergici; il fenorbitale (antiepilettico); medicamenti calmanti e tranquillanti (benzodiazepine);

diversi altri principi attivi (ad es. amantadina, indapamide, metadone, tamoxifene). Il litio può anche

aumentare il rischio di effetti collaterali extrapiramidali (cioè movimenti involontari).

Quando è necessaria la somministrazione di antiacidi e di sucralfato (medicamenti che contengono

alluminio e/o magnesio per il trattamento delle ulcere gastrointestinali), somministrare la sulpiride

almeno 2 ore prima di questi medicamenti.

Questo medicamento può causare effetti collaterali come insonnia, sonnolenza, vertigini o nausea e,

quindi, ridurre la capacità di reazione, la capacità di condurre un veicolo e la capacità di utilizzare

attrezzi o macchine. In caso di comparsa di questi sintomi, eviti di guidare un veicolo e di utilizzare

attrezzi.

Informi il suo medico o il suo farmacista se

·soffre di altre malattie,

·ha precedenti di tumore al seno (poiché questo medicamento può aumentare i livelli di un ormone

chiamato «prolattina»).

·soffre di allergie o

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

Si può assumere Dogmatil durante la gravidanza o l'allattamento?

L'impiego di Dogmatil è sconsigliato in gravidanza.

Informi il suo medico in caso di gravidanza accertata o presunta.

Qualora Dogmatil sia impiegato nel terzo trimestre di gravidanza, può causare nel neonato effetti

collaterali quali tremori, rigidità muscolare, debolezza, sonnolenza, eccitazione, difficoltà

respiratorie o nell'alimentazione.

Comunichi immediatamente al suo medico un'eventuale gravidanza per discutere la prosecuzione del

trattamento. Non sospenda in nessun caso di sua iniziativa la terapia, poiché un'interruzione

improvvisa può avere conseguenze serie.

Se fa uso di questo farmaco in gravidanza, ne informi immediatamente anche il suo ginecologo e la

sua ostetrica, soprattutto se il neonato manifesta gli effetti collaterali sopra descritti.

Questo medicamento passa nel latte materno, pertanto non si deve allattare durante il trattamento con

Dogmatil.

Come usare Dogmatil?

La posologia è stata fissata dal suo medico in modo strettamente individuale, in funzione dei suoi

sintomi e del suo stato di salute. Attenersi strettamente alla prescrizione medica.

Il medicamento può essere preso indifferentemente con i pasti o tra un pasto e l'altro.

Se ha dimenticato una dose di Dogmatil, può prenderla durante la giornata, a condizione di rispettare

un intervallo di 4 ore tra una somministrazione e la successiva.

L'efficacia e la sicurezza di Dogmatil nei bambini e negli adolescenti non sono state ancora

dimostrate. Dogmatil non è adattato all'uso pediatrico e negli adolescenti.

Iperdosaggio: in caso di notevole superamento della dose, consulti il suo medico curante.

Non modifichi di propria 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.

Consigli:

a causa degli effetti stimolanti a livello centrale della sulpiride, si raccomanda di prendere l'ultima

dose, in generale, prima delle ore 16 per evitare episodi di insonnia.

Nel trattamento della schizofrenia e di altre psicosi, i neurolettici permettono di controllare

efficacemente la malattia, ma una modifica o una sospensione intempestiva del trattamento

espongono a una ricaduta grave.

Nel corso del trattamento, si può osservare un aumento del peso corporeo. Un'alimentazione

equilibrata e, se necessario, i consigli di un nutrizionista, possono prevenire e limitare questo

fenomeno.

Quali effetti collaterali può avere Dogmatil?

Con l'assunzione di Dogmatil possono manifestarsi i seguenti effetti collaterali:

Effetti collaterali molto frequenti: sedazione, sonnolenza.

Effetti collaterali frequenti: insonnia, depressione, agitazione, tremori, disturbi motori, movimenti

involontari, rigidità muscolare, difficoltà a rimanere seduti senza muoversi, reazioni allergiche della

pelle, eruzioni, prurito, aumento della traspirazione cutanea, aumento di peso, disturbi mestruali,

tensione al seno, frigidità, impotenza, perdite di latte, aumento del volume del seno, costipazione.

Effetti collaterali occasionali: ipotensione, sensazioni di vertigini quando ci si alza bruscamente

(ipotensione ortostatica) aumento della produzione di saliva.

Effetti collaterali rari: movimenti involontari degli occhi, febbre, rigidità muscolare e riduzione del

livello di coscienza.

Effetto collaterale molto raro: convulsioni (soprattutto se soffre di epilessia).

Casi isolati: reazioni anafilattiche quali orticaria, insufficienza respiratoria, ipotensione e shock

anafilattico (collasso della pressione sanguigna), disturbi della concentrazione, stati confusionali,

vertigini, mal di testa, secchezza della bocca, nausea, lesioni nel fegato, disturbi della vista,

iponatremia, (livelli bassi di sodio nel sangue), anomalie dell'elettrocardiogramma e disturbi del

ritmo cardiaco, palpitazioni, tromboembolismo venoso (embolia polmonare e trombosi venosa

profonda), difficoltà a urinare, polmonite da aspirazione (ostruzione delle vie respiratorie a carico

degli alimenti contenuti nello stomaco).

Se dovesse notare l'insorgenza di tali disturbi, consulti immediatamente il suo medico.

I seguenti sintomi, di cui non è nota la frequenza, sono stati osservati nel neonato con l'uso di

Dogmatil nel terzo trimestre di gravidanza: tremori, rigidità muscolare, debolezza, sonnolenza,

eccitazione, difficoltà respiratorie o problemi nell'alimentazione.

Se osserva effetti collaterali qui non descritti, dovrebbe informare il suo medico o il suo farmacista.

Di che altro occorre tener conto?

Dogmatil deve essere conservato nella sua confezione originale e fuori dalla portata dei bambini.

Compresse e capsule non devono essere conservate al di sopra di 30 °C.

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

Il medico o il farmacista, che sono in possesso di una documentazione professionale dettagliata,

possono darle ulteriori informazioni.

Cosa contiene Dogmatil?

Dogmatil è disponibile sotto forma di compresse e capsule.

1 compressa contiene 200 mg di sulpiride, lattosio e altri eccipienti.

1 capsula contiene 50 mg di sulpiride, il conservante diossido di zolfo (E220), lattosio e altri

eccipienti.

Numero dell’omologazione

34316, 40706 (Swissmedic).

Dov’è ottenibile Dogmatil? Quali confezioni sono disponibili?

In farmacia, dietro presentazione della prescrizione medica.

Dogmatil compresse: confezioni da 12 e 60 compresse.

Dogmatil capsule: confezioni da 30 capsule.

Titolare dell’omologazione

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

Questo foglietto illustrativo è stato controllato l'ultima volta nel mese di settembre 2017 dall'autorità

competente in materia di medicamenti (Swissmedic).

22-1-2019

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Published on: Mon, 21 Jan 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer Hellas AG submitted a request to the competent national authority in Greece to modify the existing maximum residue level (MRL) for the active substance trifloxystrobin in broccoli. The data submitted in support of the request were found to be sufficient to derive an MRL proposal for broccoli. Adequate analytical methods for enforcement are available to control the residues of trifloxystrobin o...

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Published on: Mon, 21 Jan 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Isagro S.p.A submitted a request to the competent national authority in Italy to modify the existing maximum residue levels (MRLs) for the active substance tetraconazole in various crops and animal commodities. The data submitted in support of the request were found to be sufficient to derive MRL proposals for tetraconazole in kaki/Japanese persimmon, linseeds and poppy seeds. Adequate analytical me...

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Modification of the existing maximum residue levels for aminopyralid in certain cereals

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Published on: Mon, 21 Jan 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Dow AgroSciences Denmark submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue levels (MRLs) for the active substance aminopyralid in cereals. The data submitted in support of the request were found to be sufficient to derive MRL proposals for barley, rye, sorghum, millet and oats. A modification of the existing MRL of aminopyralid in wh...

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Modification of the existing maximum residue levels for spirotetramat in various crops

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Europe - EFSA - European Food Safety Authority EFSA Journal

17-1-2019

Safety of cassia gum as a feed additive for cats and dogs based on a dossier submitted by Glycomer GmbH

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Europe - EFSA - European Food Safety Authority EFSA Journal

17-1-2019

Assessment of genetically modified maize MON 89034 × 1507 × NK603 × DAS‐40278‐9 and subcombinations independently of their origin for food and feed uses, import and processing, under Regulation (EC) No 1829‐2003 (application EFSA‐GMO‐NL‐2013‐112)

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Europe - EFSA - European Food Safety Authority EFSA Journal

16-1-2019

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

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Published on: Tue, 15 Jan 2019 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 dazomet. To assess the occurrence of dazomet 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 (including the supporting re...

Europe - EFSA - European Food Safety Authority EFSA Journal

15-1-2019

Assessment of genetically modified maize MON 89034 × 1507 × MON 88017 × 59122 × DAS‐40278‐9 and subcombinations independently of their origin for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2013‐11

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Europe - EFSA - European Food Safety Authority EFSA Journal

15-1-2019

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

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15-1-2019

Setting of an import tolerance for spiromesifen in coffee beans

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Published on: Mon, 14 Jan 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer CropScience submitted a request to the competent national authority in Greece to set an import tolerance for the active substance spiromesifen in coffee beans. The data submitted in support of the request were found to be sufficient to derive a maximum residue level (MRL) proposal for coffee beans. Adequate analytical methods for enforcement are available to control the residues of spiromesife...

Europe - EFSA - European Food Safety Authority EFSA Journal

15-1-2019

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

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12-1-2019

Assessment of the application for renewal of authorisation of selenomethionine produced by Saccharomyces cerevisiae NCYC R397 for all animal species

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Europe - EFSA - European Food Safety Authority EFSA Journal

12-1-2019

Assessment of the application for renewal of authorisation of Lantharenol® (lanthanum carbonate octahydrate) for cats

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9-1-2019

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

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

Published on: Tue, 08 Jan 2019 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 sedaxane. To assess the occurrence of sedaxane residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EU) No 188/2011, the MRLs established by the Codex Alimentarius Commission as well as the...

Europe - EFSA - European Food Safety Authority EFSA Journal

9-1-2019

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

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Published on: Tue, 08 Jan 2019 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 triazoxide. To assess the occurrence of triazoxide 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 States. Bas...

Europe - EFSA - European Food Safety Authority EFSA Journal

9-1-2019

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

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

Published on: Tue, 08 Jan 2019 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 chromafenozide. Considering the information provided by Member States, neither EU uses nor import tolerances are currently authorised for chromafenozide within the EU. Furthermore, no MRLs are established by the Codex Alimentarius Commission (codex maximum residue limits) for this active subst...

Europe - EFSA - European Food Safety Authority EFSA Journal

4-1-2019

Modification of the existing maximum residue levels for lambda‐cyhalothrin in celeries, fennel and rice

Modification of the existing maximum residue levels for lambda‐cyhalothrin in celeries, fennel and rice

Published on: Thu, 03 Jan 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Syngenta Crop Protection AG submitted a request to the competent national authority in Greece to modify the existing maximum residue levels (MRLs) for lambda‐cyhalothrin in celeries, fennel and rice. The data submitted in support of the request were found to be sufficient to derive tentative MRL proposals for the concerned crops. They are tentative as formally the general data gap identified in the ...

Europe - EFSA - European Food Safety Authority EFSA Journal

28-12-2018

The red palm weevil

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France - Agence Nationale du Médicament Vétérinaire

22-12-2018

Modification of the existing maximum residue level for captan in hops

Modification of the existing maximum residue level for captan in hops

Published on: Fri, 21 Dec 2018 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant ADAMA Agriculture BV on behalf of ADAMA Makhteshim Ltd. submitted a request to the competent national authority in the Netherlands to modify the existing maximum residue level for the active substance captan in hops. The data submitted in support of the request were found to be insufficient to conclude whether the existing residue definitions are appropriate for hops. Although the number of residue ...

Europe - EFSA - European Food Safety Authority EFSA Journal

22-12-2018

Modification of the existing maximum residue level for captan in cranberries

Modification of the existing maximum residue level for captan in cranberries

Published on: Fri, 21 Dec 2018 In accordance with Article 6 of Regulation (EC) No 396/2005, the Belgian Federal Public Service (FPS) for Health, Food chain safety and Environment, submitted an application as the competent national authority in Belgium to modify the existing maximum residue level (MRL) for the active substance captan in cranberries. The data submitted in support of the request were found to be sufficient to derive MRL proposal for cranberries. Adequate analytical methods for enforcement ...

Europe - EFSA - European Food Safety Authority EFSA Journal

21-12-2018

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

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

Published on: Thu, 20 Dec 2018 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State Italy for the pesticide active substance propanil and the assessment of applications for maximum residue levels (MRLs) are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of t...

Europe - EFSA - European Food Safety Authority EFSA Journal

20-12-2018

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

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

Published on: Wed, 19 Dec 2018 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 States, the applican...

Europe - EFSA - European Food Safety Authority EFSA Journal

19-12-2018

The red palm weevil:  combating the loss of palm trees on the Mediterranean coast

The red palm weevil: combating the loss of palm trees on the Mediterranean coast

The palm weevil is one of the most damaging insect pests of palm trees, and is a threat to plant biodiversity in many countries. This insect has spread rapidly along the Mediterranean coast in the last ten years or more, and is classified as a regulated quarantine pest and a major danger to plant health in France. It is therefore subject to compulsory control measures. In order to curb the spread of the pest, which was introduced into the country in 2006, control strategies are being implemented at local...

France - Agence Nationale du Médicament Vétérinaire

18-12-2018

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

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

Published on: Mon, 17 Dec 2018 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 pencycuron. To assess the occurrence of pencycuron 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 States (incl...

Europe - EFSA - European Food Safety Authority Publications

15-12-2018

Annual report of the Scientific Network on Microbiological Risk Assessment 2018

Annual report of the Scientific Network on Microbiological Risk Assessment 2018

Published on: Fri, 14 Dec 2018 Among the tasks of EFSA, according to its founding regulation (Regulation (EC) No 178/2002), there is the establishment of a system of Networks of organisations operating in the fields within EFSA's mission, the objective being to facilitate a scientific cooperation framework by the coordination of activities, the exchange of information, the development and implementation of joint projects, the exchange of expertise and best practices. Additionally, the EFSA Science Strat...

Europe - EFSA - European Food Safety Authority Publications

14-12-2018

Response to comments on the Scientific Opinion on the scientific substantiation of a health claim related to Symbiosal® and lowering of blood pressure and reduced risk of hypertension pursuant to Article 14 of Regulation (EC) No 1924/2006

Response to comments on the Scientific Opinion on the scientific substantiation of a health claim related to Symbiosal® and lowering of blood pressure and reduced risk of hypertension pursuant to Article 14 of Regulation (EC) No 1924/2006

Published on: Thu, 13 Dec 2018 Following a request from the European Commission, EFSA was asked to review the comments received on the Scientific Opinion of the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) on the scientific substantiation of a health claim related to Symbiosal® and lowering of blood pressure and reduced risk of hypertension pursuant to Article 14 of Regulation (EC) No 1924/2006. Comments originating from the applicant (Han‐Biotech GmbH) were submitted to EFSA via the E...

Europe - EFSA - European Food Safety Authority Publications

13-12-2018

The European Union summary report on trends and sources of zoonoses, zoonotic agents and food-borne outbreaks in 2017

The European Union summary report on trends and sources of zoonoses, zoonotic agents and food-borne outbreaks in 2017

Published on: Wed, 12 Dec 2018 This report of the European Food Safety Authority and the European Centre for Disease Prevention and Control presents the results of zoonoses monitoring activities carried out in 2017 in 37 European countries (28 Member States (MS) and nine non-MS). Campylobacteriosis was the commonest reported zoonosis and its EU trend for confirmed human cases increasing since 2008 stabilised during 2013–2017. The decreasing EU trend for confirmed human salmonellosis cases since 2008 end...

Europe - EFSA - European Food Safety Authority Publications

27-11-2018

Risk assessment of new sequencing information for genetically modified soybean A2704‐12

Risk assessment of new sequencing information for genetically modified soybean A2704‐12

Published on: Mon, 26 Nov 2018 The GMO Panel has previously assessed genetically modified (GM) soybean A2704‐12. This soybean was found to be as safe and nutritious as its conventional counterpart with respect to potential effects on human and animal health and the environment in the context of its intended uses. On 5 June 2018, the European Commission requested EFSA to analyse new nucleic acid sequencing data and updated bioinformatics data for GM soybean A2704‐12 and to indicate whether the previous c...

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

20-11-2018

Peer review of the pesticide risk assessment of the active substance (EZ)‐1,3‐dichloropropene

Peer review of the pesticide risk assessment of the active substance (EZ)‐1,3‐dichloropropene

Published on: Mon, 19 Nov 2018 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State, Spain, for the pesticide active substance (EZ)‐1,3‐dichloropropene are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative uses of (EZ)‐1,3‐dichloropropene ...

Europe - EFSA - European Food Safety Authority Publications

17-11-2018

Assessment of genetically modified soybean MON 89788 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐011)

Assessment of genetically modified soybean MON 89788 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐011)

Published on: Fri, 16 Nov 2018 Following the submission of application EFSA‐GMO‐RX‐011 under Regulation (EC) No 1829/2003 from Monsanto Europe, the Panel on Genetically Modified Organisms of the European Food Safety Authority (GMO Panel) was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the herbicide‐tolerant genetically modified soybean MON 89788, for food and feed uses, excluding cultivation within the European Union....

Europe - EFSA - European Food Safety Authority Publications

17-11-2018

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

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

Published on: Fri, 16 Nov 2018 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 tau‐fluvalinate. To assess the occurrence of tau‐fluvalinate 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 St...

Europe - EFSA - European Food Safety Authority Publications

17-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

16-11-2018

Setting of an import tolerance for pyraclostrobin in rice

Setting of an import tolerance for pyraclostrobin in rice

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

Europe - EFSA - European Food Safety Authority Publications

16-11-2018

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

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

Published on: Thu, 15 Nov 2018 The applicant BASF SE submitted a request to the competent national authority in Germany to evaluate the confirmatory data that were identified for pyraclostrobin in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, residues trials supporting the existing use of pyraclostrobin on table grapes authorised in southern EU Member States and an analytical method for analysing residues of pyraclostrobin in ...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Assessment of genetically modified LLCotton25 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐010)

Assessment of genetically modified LLCotton25 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐010)

Published on: Wed, 14 Nov 2018 Following the submission of application EFSA‐GMO‐RX‐010 under Regulation (EC) No 1829/2003 from Bayer, the Panel on Genetically Modified Organisms of the European Food Safety Authority (GMO Panel) was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the herbicide‐tolerant genetically modified LLCotton25, for food and feed uses, import and processing, excluding cultivation within the EU. The d...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Assessment of genetically modified maize MZHG0JG for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐DE‐2016‐133)

Assessment of genetically modified maize MZHG0JG for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐DE‐2016‐133)

Published on: Wed, 14 Nov 2018 The scope of application EFSA‐GMO‐DE‐2016‐133 is for food and feed uses, import and processing of genetically modified (GM) maize MZHG0JG in the European Union. Maize MZHG0JG was developed to confer tolerance to the herbicidal active substances glyphosate and glufosinate‐ammonium. The molecular characterisation data and bioinformatic analyses do not identify issues requiring food/feed safety assessment. None of the identified differences in the agronomic/phenotypic and com...

Europe - EFSA - European Food Safety Authority Publications

14-11-2018

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

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

Published on: Tue, 13 Nov 2018 The applicant ISK Biosciences Europe N.V. submitted a request to the competent national authority in France to evaluate the confirmatory data that were identified in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005 as not available. The data gap which was related to information on freezer storage conditions for the residue trials reported on potatoes, tomatoes and cucurbits with edible and inedible peel was considered satisfactorily addressed...

Europe - EFSA - European Food Safety Authority Publications

13-11-2018

Peer review of the pesticide risk assessment of the active substance napropamide‐M

Peer review of the pesticide risk assessment of the active substance napropamide‐M

Published on: Mon, 12 Nov 2018 00:00:00 +0100 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State the United Kingdom for the pesticide active substance napropamide‐M are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative uses of napropamid...

Europe - EFSA - European Food Safety Authority Publications

13-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

10-11-2018

Outcome of the consultation with Member States and EFSA on the basic substance application for propolis extract (admissibility accepted when named water‐soluble extract of propolis) for use in plant protection as fungicide and bactericide

Outcome of the consultation with Member States and EFSA on the basic substance application for propolis extract (admissibility accepted when named water‐soluble extract of propolis) for use in plant protection as fungicide and bactericide

Published on: Fri, 09 Nov 2018 00:00:00 +0100 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 propolis extract are presented. The context of the evaluation ...

Europe - EFSA - European Food Safety Authority Publications

9-11-2018

Influenza A (H1N1) 2009 Monovalent Vaccines Composition and Lot Release

Influenza A (H1N1) 2009 Monovalent Vaccines Composition and Lot Release

Vaccine lot release information updated on 3/3/2010.

FDA - U.S. Food and Drug Administration

6-11-2018

Evaluation of confirmatory data following the Article 12 MRL review for kresoxim‐methyl

Evaluation of confirmatory data following the Article 12 MRL review for kresoxim‐methyl

Published on: Fri, 02 Nov 2018 00:00:00 +0100 The applicant BASF SE submitted a request to the competent national authority in Belgium to evaluate the confirmatory data that were identified for kresoxim‐methyl 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 confirmatory data requirement, a new study on the storage stability of kresoxim‐methyl residues in animal matrices was submitted. The data gap was considered ...

Europe - EFSA - European Food Safety Authority Publications

6-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

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

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 dimethomorph

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

Published on: Fri, 19 Oct 2018 00:00:00 +0200 The applicant BASF SE submitted a request to the competent national authority in Germany to evaluate the confirmatory data that were identified for dimethomorph in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. The submitted residue data on raspberries were satisfactorily addressing the data gaps on raspberries and blackberries. Considering the new information provided, it is appropri...

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

20-10-2018

Scientific Opinion on Flavouring Group Evaluation 200, Revision 1 (FGE.200 Rev.1): 74 α,β‐unsaturated aliphatic aldehydes and precursors from chemical subgroup 1.1.1 of FGE.19

Scientific Opinion on Flavouring Group Evaluation 200, Revision 1 (FGE.200 Rev.1): 74 α,β‐unsaturated aliphatic aldehydes and precursors from chemical subgroup 1.1.1 of FGE.19

Published on: Fri, 19 Oct 2018 00:00:00 +0200 The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to evaluate the genotoxic potential of 74 flavouring substances from subgroup 1.1.1 of FGE.19 in the Flavouring Group Evaluation 200 Revision 1 (FGE.200 Rev1). In FGE.200, genotoxicity studies were provided for one representative substance, namely hex‐2(trans)‐enal [FL‐no: 05.073], and for other two substances in the same subgroup, namely 2‐dodecenal [FL‐no: 05.03...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

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

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

5-12-2018


Orphan designation: Paclitaxel (micellar), Treatment of ovarian cancer, 17/12/2006, Positive

Orphan designation: Paclitaxel (micellar), Treatment of ovarian cancer, 17/12/2006, Positive

Orphan designation: Paclitaxel (micellar), Treatment of ovarian cancer, 17/12/2006, Positive

Europe - EMA - European Medicines Agency

4-12-2018


Overview of comments received on Ibuprofen 200 – 800 mg oral use, immediate release formulations product-specific bioequivalence guidance

Overview of comments received on Ibuprofen 200 – 800 mg oral use, immediate release formulations product-specific bioequivalence guidance

Overview of comments received on Ibuprofen 200 – 800 mg oral use, immediate release formulations product-specific bioequivalence guidance

Europe - EMA - European Medicines Agency

26-11-2018

Today’s statement highlights increased expectations for information required in 510(k) submissions; each averages 1,185 pages, compared to 475 pages in 2009. Reviewers spend more time reviewing applications, but time to decision has become more efficient

Today’s statement highlights increased expectations for information required in 510(k) submissions; each averages 1,185 pages, compared to 475 pages in 2009. Reviewers spend more time reviewing applications, but time to decision has become more efficient

Today’s statement highlights increased expectations for information required in 510(k) submissions; each averages 1,185 pages, compared to 475 pages in 2009. Reviewers spend more time reviewing applications, but time to decision has become more efficient https://go.usa.gov/xPHdE 

FDA - U.S. Food and Drug Administration

26-11-2018

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

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

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

FDA - U.S. Food and Drug Administration