MST Continus 30 mg

Informazioni principali

  • Nome commerciale:
  • MST Continus 30 mg Tabletten ritardo
  • Forma farmaceutica:
  • Tabletten ritardo
  • Composizione:
  • morphini zolfo pentahydricus 30 mg corrisp. morphinum 22,5 mg, colore.: E 110, E 127, E 132, excipiens pro compresso obducto.
  • 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:
  • MST Continus 30 mg Tabletten ritardo
    Svizzera
  • Lingua:
  • italiano

Informazioni terapeutiche

  • Gruppo terapeutico:
  • Synthetika
  • Area terapeutica:
  • Analgetikum

Altre informazioni

Status

  • Fonte:
  • Swissmedic - Swiss Agency for Therapeutic Products
  • Numero dell'autorizzazione:
  • 44246
  • Data dell'autorizzazione:
  • 29-03-1982
  • Ultimo aggiornamento:
  • 19-10-2018

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

Patienteninformation

MST® Continus®

Mundipharma Medical Company

Che cos'è MST Continus e quando si usa?

MST Continus è un antidolorifico per il trattamento di dolori persistenti di intensità media o forte.

Contiene il principio attivo morfina. Dopo I'assunzione di MST Continus, la morfina viene rilasciata

lentamente nel tratto gastrointestinale ed assorbita nella circolazione sanguigna.

MST Continus deve essere usato esclusivamente su prescrizione medica e sotto regolare controllo

medico.

Quando non si può assumere MST Continus?

·Se è ipersensibile (allergico) al principio attivo morfina o a una delle sostanze ausiliarie,

·se soffre di gravi disturbi respiratori, cioè se il suo respiro è superficiale e rallentato (depressione

respiratoria grave),

·se soffre di una malattia cronica grave dei polmoni che comporta un restringimento delle vie

respiratorie (broncopneumopatia cronica ostruttiva (BPCO) grave),

·in caso di dolori addominali acuti,

·in presenza di paralisi dell'attività intestinale (ileo paralitico).

Quando è richiesta prudenza nella somministrazione di MST Continus?

·In presenza di grave aumento della pressione nel cuore destro in seguito a ipertensione polmonare

(cuore polmonare grave), asma bronchiale grave o disturbi respiratori,

·in caso di insufficienza epatica grave o insufficienza renale,

·in caso di insufficienza della tiroide (ipotiroidismo),

·in caso di insufficienza delle ghiandole surrenali (malattia di Addison),

·in caso di disturbi psichici causati dall'alcool o da intossicazioni, alcolismo o reazioni gravi a una

disintossicazione dall'alcool,

·in presenza di calcoli biliari o altre malattie delle vie biliari,

·in caso di infiammazione del pancreas (pancreatite),

·in presenza di malattie intestinali ostruttive o infiammatorie,

·in caso di ipertrofia prostatica con difficoltà a urinare,

·in presenza di pressione bassa o alta o di malattie cardiocircolatorie preesistenti,

·in caso di lesioni al capo, epilessia o tendenza a convulsioni,

·in caso di assunzione di medicamenti del gruppo degli inibitori delle monoaminossidasi (IMAO);

l'assunzione di MST Continus non è indicata in concomitanza con una terapia a base di IMAO o nei

14 giorni successivi all'interruzione di una terapia di questo tipo,

·se sta allattando.

Se lei è in età avanzata o è fisicamente debole, è più probabile che possa manifestare effetti

collaterali. Sia quindi particolarmente prudente.

Con l'impiego prolungato di MST Continus può svilupparsi assuefazione. In tal caso è possibile che

per ottenere l'effetto analgesico desiderato, lei abbia bisogno di una dose maggiore.

L'assunzione prolungata di MST Continus può inoltre causare una dipendenza fisica. In caso di

interruzione improvvisa del trattamento, possono verificarsi sintomi da astinenza, come

irrequietezza, attacchi di sudorazione e dolori muscolari. Se non necessita più della terapia, deve

ridurre gradualmente la dose quotidiana d'intesa con il suo medico.

Il principio attivo morfina ha un potenziale di abuso simile a quello di tutti gli altri analgesici forti

simili alla morfina. Esiste la possibilità di sviluppare una dipendenza psichica. In caso di abuso di

alcolici, droghe o medicamenti, attuale o pregresso, l'assunzione di MST Continus va evitata.

Nel caso dovesse sottoporsi a un intervento chirurgico, informi i medici che sta assumendo MST

Continus.

Un’assunzione prolungata di antidolorifici morfinosimili come MST Continus può determinare

variazioni ormonali reversibili come ad esempio una diminuita funzionalità della corteccia surrenale

con sintomi quali nausea, vomito, perdita di appetito, affaticamento, debolezza, capogiri o

ipotensione arteriosa o una diminuita funzionalità degli organi sessuali con sintomi quali calo della

libido, disfunzioni erettili o amenorrea.

Alcuni medicamenti possono aumentare la probabilità che si manifestino effetti collaterali (in

particolare compromissione della funzionalità respiratoria, ipotensione, sonnolenza e/o riduzione

dell'attenzione), che nei casi più gravi possono determinare un profondo obnubilamento, il coma e la

morte:

·altri analgesici simili alla morfina (oppioidi),

·sonniferi e tranquillanti (come ad es. le benzodiazepine),

·alcuni medicamenti contro allergie, mal d'auto o nausea,

·alcuni medicamenti contro la depressione e le psicosi,

·alcuni medicamenti per il trattamento delle convulsioni e di alcuni tipi di dolore (ad es. fenitoina,

gabapentin o pregabalin),

·medicamenti per il rilassamento muscolare (miorilassanti).

Informi immediatamente il suo medico o il suo farmacista in caso di utilizzo di uno di questi

medicamenti.

Non beva alcol durante il trattamento con MST Continus. L’assunzione di alcol durante il

trattamento con MST Continus può portare a sonnolenza eccessiva e aumentare il rischio che si

manifestino gravi effetti collaterali quali la respirazione superficiale e il conseguente rischio di

arresto respiratorio e perdita di coscienza, il che in casi gravi può portare al coma e alla morte.

I medicamenti contro l'iperacidità gastrica (antiacidi) vanno assunti con un intervallo di almeno 2 ore

dall'assunzione di MST Continus sospensione retard.

L'uso di MST Continus può portare a risultati positivi ai controlli anti-doping.

MST Continus può ridurre la capacità di reazione, la capacità di condurre un veicolo e la capacità di

utilizzare attrezzi o macchine. Chieda quindi al suo medico se può guidare l'auto, utilizzare macchine

o eseguire lavori pericolosi.

MST Continus compresse retard da 10 mg, 30 mg e 60 mg contengono lattosio. Pertanto se soffre di

intolleranza a determinati zuccheri, le raccomandiamo di consultare il suo medico prima di assumere

questi dosaggi di MST Continus.

I pazienti ipersensibili alle sostanze coloranti azoiche, agli acidi acetilsalicilici nonché agli

antireumatici ed analgesici (inibitori della prostaglandina), devono astenersi dall'uso di MST

Continus 30 mg e 60 mg compresse retard e di MST Continus sospensione retard.

Informi il suo medico o il suo farmacista nel caso in cui soffre di altre malattie, soffre di allergie o

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

Si può assumere MST Continus durante la gravidanza o l'allattamento?

Gravidanza

Un'assunzione prolungata di MST Continus durante la gravidanza può provocare l'insorgenza di

sintomi da astinenza nel neonato. Se MST Continus viene utilizzato durante il parto, può causare un

rallentamento e appiattimento del respiro (depressione respiratoria) nel neonato. MST Continus non

dev'essere somministrato durante la gravidanza. Il suo medico può tuttavia fare delle eccezioni.

Allattamento

Se sta allattando, deve assumere MST Continus solo se il suo medico lo ritiene assolutamente

necessario.

Come usare MST Continus?

Assuma MST Continus sempre esattamente secondo le indicazioni del medico. In caso di dubbio, si

rivolga al suo medico o al suo farmacista. Il dosaggio dipende da quanto sono forti i dolori e dalla

sua sensibilità individuale e viene definito dal suo medico.

MST Continus compresse retard vanno assunte due volte al giorno, all'incirca alla stessa ora, durante

o fra un pasto e l'altro, con una sufficiente quantità di liquido. Le compresse retard non devono essere

divise, masticate o frantumate.

Mescolare il contenuto della bustina della sospensione retard di MST Continus 20 mg, 30 mg o

60 mg con almeno 10 ml (2 cucchiaini) di acqua. Mescolare il contenuto delle bustine da 100 mg con

almeno 20 ml e delle bustine da 200 mg con almeno 30 ml di acqua. Mescolare bene per circa 10

secondi e bere subito. Se nel bicchiere rimane ancora del granulato, riempirlo nuovamente con acqua

e bere il contenuto rimasto.

Il contenuto della bustina si può prendere dopo averlo cosparso su alimenti freddi di consistenza

morbida (p.es. yogurt, gelato, pappe). Abbia cura di assumere subito l'intero contenuto della bustina

(p.es. cosparso su un cucchiaio di alimento di consistenza morbida).

In caso di peso corporeo sotto i 70 kg, età avanzata o debolezza fisica, la dose normale all'inizio della

terapia è di due compresse retard da 10 mg o il contenuto di una bustina da 20 mg ogni 12 ore. Se il

peso supera i 70 kg, la dose è di una compressa retard o il contenuto di una bustina da 30 mg ogni 12

ore. In caso di necessità, il medico aumenterà gradualmente la dose.

Per i bambini il medico stabilirà individualmente lo schema posologico a seconda dell'età e delle

circostanze.

Informi il suo medico se dovessero comparire dolori fra le assunzioni di MST Continus. Il medico le

potrà prescrivere un antidolorifico a rilascio rapido (analgesico di riserva) per la terapia di questi

dolori episodici.

Se ha assunto più MST Continus di quanto prescritto, informi immediatamente il suo medico.

Si attenga scrupolosamente ai tempi di assunzione prescritti dal medico. Per avere una protezione

ottimale contro i dolori o la loro ricomparsa è importante assumere le compresse retard o la

sospensione retard ad intervalli regolari stabiliti dal medico. Non aspetti a prendere il preparato fino

a quando comincia a sentire nuovamente dolore.

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.

Quali effetti collaterali può avere MST Continus?

Molto spesso l'assunzione di MST Continus può causare stitichezza. Si può combattere questo

disturbo con un'alimentazione ricca di fibre e con l'assunzione di sufficienti quantità di liquidi, ma

spesso sarà necessario che il medico prescriva, in aggiunta, un lassativo.

Soprattutto all'inizio della terapia possono verificarsi molto frequentemente nausea e frequentemente

vomito. Se ha nausea o le viene il vomito, informi il suo medico, che le può prescrivere un

trattamento.

Con l'assunzione di MST Continus possono inoltre manifestarsi i seguenti effetti collaterali:

Frequenti: diminuzione o perdita dell'appetito, confusione, insonnia, vertigini, mal di testa, spasmi

muscolari involontari, grave sonnolenza o stordimento (sedazione), dolori addominali, secchezza

delle fauci, sudorazione, eruzioni cutanee, prurito, debolezza, stanchezza, malessere.

Occasionali: reazioni da ipersensibilità, eccitazione, euforia, allucinazioni, alterazioni dell'umore,

convulsioni, contratture muscolari, parestesie, disturbi della vista, vertigini, palpitazioni,

arrossamento del volto, calo di pressione, svenimento (sincope), accumulo di fluidi nei polmoni

(dopo un repentino aumento del dosaggio), rallentamento e appiattimento della respirazione

(depressione respiratoria), compromissione della funzione respiratoria, affanno, occlusione

intestinale, alterazioni del gusto, disturbi digestivi, aumento dei valori epatici, eruzioni cutanee

pruriginose (orticaria), ritenzione urinaria, ritenzione idrica (edemi).

Possono inoltre verificarsi reazioni allergiche generali acute, disturbi del pensiero, disforia,

farmacodipendenza, eccessiva sensibilità al dolore (iperalgesia), restringimento delle pupille,

rallentamento della frequenza cardiaca, diminuzione dello stimolo della tosse, alterazioni dell'olfatto,

dolori alla cistifellea (coliche biliari), assenza di mestruazioni (amenorrea), disturbi erettili, riduzione

della libido, assuefazione in caso di utilizzo prolungato o sintomi da astinenza.

MST Continus compresse retard da 30 mg e 60 mg e MST Continus sospensione retard possono

provocare reazioni di ipersensibilità della pelle e del sistema respiratorio, in particolare nei pazienti

affetti da asma, orticaria, ipersensibilità agli acidi acetilsalicilici e ad altri antireumatici o analgesici.

Tenga conto che, nonostante l'assenza di mestruazioni, è possibile che insorga una gravidanza e

quindi, anche in assenza di mestruazioni, è necessario utilizzare un contraccettivo efficace durante la

terapia con MST Continus.

In caso di presunto sovradosaggio informare immediatamente il medico che adotterà le contromisure

adeguate. Segni di sovradosaggio sono: restringimento delle pupille, estremo rallentamento della

respirazione, pressione bassa, stato simile alla narcosi.

La paralisi respiratoria è il pericolo più grave correlato al sovradosaggio.

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

Di che altro occorre tener conto?

Conservare a temperatura ambiente (15–25 °C) e in luogo inaccessibile ai bambini.

A cura ultimata portare il medicamento residuo presso un luogo di raccolta (studio medico, farmacia)

per il corretto smaltimento.

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

II medico o il farmacista, che sono in possesso di un'informazione professionale dettagliata, possono

darle ulteriori informazioni.

Cosa contiene MST Continus?

MST Continus 10 mg contiene 10 mg di morfina solfato pentaidrato (corrispondenti a 7,5 mg di

morfina) nonché sostanze ausiliarie (compressa retard: tra cui lattosio; sospensione retard: tra

cui aromatizzanti, colorante Ponceau 4R (E 124)).

MST Continus 20 mg contiene 20 mg di morfina solfato pentaidrato (corrispondenti a 15 mg di

morfina) nonché sostanze ausiliarie (sospensione retard: tra cui aromatizzanti, colorante Ponceau 4R

(E 124)).

MST Continus 30 mg contiene 30 mg di morfina solfato pentaidrato (corrispondenti a 22,5 mg di

morfina) nonché sostanze ausiliarie (compressa retard: tra cui lattosio, coloranti giallo arancio S

(E 110), eritrosina (E 127), indigotina (E 132); sospensione retard: tra cui aromatizzanti, colorante

Ponceau 4R (E 124)).

MST Continus 60 mg contiene 60 mg di morfina solfato pentaidrato (corrispondenti a 45 mg di

morfina) nonché sostanze ausiliarie (compressa retard: tra cui lattosio, coloranti giallo di chinolina

(E 104), giallo arancio S (E 110), eritrosina (E 127); sospensione retard: tra cui aromatizzanti,

colorante Ponceau 4R (E 124)).

MST Continus 100 mg contiene 100 mg di morfina solfato pentaidrato (corrispondenti a 75 mg di

morfina) nonché sostanze ausiliarie (compressa retard: tra cui colorante indigotina (E 132);

sospensione retard: tra cui aromatizzanti, colorante Ponceau 4R (E 124)).

MST Continus 200 mg contiene 200 mg di morfina solfato pentaidrato (corrispondenti a 150 mg di

morfina) nonché sostanze ausiliarie (compressa retard: tra cui coloranti giallo di chinolina (E 104),

blu brillante FCF (E133); sospensione retard: tra cui aromatizzanti, colorante Ponceau 4R (E 124)).

Numero dell’omologazione

44246 (compresse retard), 51697 (sospensione retard) (Swissmedic).

Dove è ottenibile MST Continus? Quali confezioni sono disponibili?

In farmacia, dietro presentazione della prescrizione medica non rinnovabile.

MST Continus è sottoposto alla legge federale sugli stupefacenti e sulle sostanze psicotrope.

MST Continus compresse retard

MST Continus 10 mg, 30 mg: confezioni da 60 compresse retard.

MST Continus 60 mg, 100 mg, 200 mg: confezioni da 30 compresse retard.

MST Continus sospensione retard

Confezioni da 30 bustine.

Titolare dell'omologazione

Mundipharma Medical Company, Hamilton/Bermuda, filiale di Basilea.

Questo foglietto illustrativo è stato controllato l'ultima volta nel dicembre 2017 dall'autorità

competente in materia di medicamenti (Swissmedic).

16-1-2019

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Europe - EMA - European Medicines Agency

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Europe - EMA - European Medicines Agency

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Danone North America Issues Allergy Alert and Recall for Light & Fit Greek Crunch S’mores Flavor

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Enforcement Report for the Week of December 05, 2018

Recently Updated Records for the Week of December 05, 2018 Last Modified Date: Friday, November 30, 2018

FDA - U.S. Food and Drug Administration

1-12-2018

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Trichoderma reesei (strain DP‐Nzd22)

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Trichoderma reesei (strain DP‐Nzd22)

Published on: Fri, 30 Nov 2018 The food enzyme endo‐1,4‐β‐xylanase (EC 3.2.1.8) is produced with a genetically modified Trichoderma reesei (strain DP‐Nzd22) by DuPont. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. The endo‐1,4‐β‐xylanase is intended to be used in distilled alcohol production, bakery and brewery. Residual amounts of total organic solids (TOS) are removed during the production of dis...

Europe - EFSA - European Food Safety Authority Publications

1-12-2018

Safety assessment of the process ‘RecyPET Hungária’, based on RecyPET Hungária technology, used to recycle post‐consumer PET into food contact materials

Safety assessment of the process ‘RecyPET Hungária’, based on RecyPET Hungária technology, used to recycle post‐consumer PET into food contact materials

Published on: Fri, 30 Nov 2018 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of the recycling process RecyPET Hungária (EU register number RECYC0146). The input is hot caustic washed and dried poly(ethylene terephthalate) (PET) flakes originating from collected post‐consumer PET containers, containing no more than 5% of PET from non‐food applications. The flakes are dried and extruded. The output of the extrusion step is cut into pellets in an underwater...

Europe - EFSA - European Food Safety Authority Publications

27-11-2018


15th Joint European Medicines Agency/European network for Health Technology Assessment dialogue meeting, Amsterdam, The Netherlands, from 05/07/2018 to 05/07/2018

15th Joint European Medicines Agency/European network for Health Technology Assessment dialogue meeting, Amsterdam, The Netherlands, from 05/07/2018 to 05/07/2018

15th Joint European Medicines Agency/European network for Health Technology Assessment dialogue meeting, Amsterdam, The Netherlands, from 05/07/2018 to 05/07/2018

Europe - EMA - European Medicines Agency

27-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

Risk for animal and human health related to the presence of dioxins and dioxin-like PCBs in feed and food

Risk for animal and human health related to the presence of dioxins and dioxin-like PCBs in feed and food

Published on: Tue, 20 Nov 2018 The European Commission asked EFSA for a scientific opinion on the risks for animal and human health related to the presence of dioxins (PCDD/Fs) and DL‐PCBs in feed and food. The data from experimental animal and epidemiological studies were reviewed and it was decided to base the human risk assessment on effects observed in humans and to use animal data as supportive evidence. The critical effect was on semen quality, following pre‐ and postnatal exposure. The critical s...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

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

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

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

FDA - U.S. Food and Drug Administration

7-11-2018

Reactie op berichtgeving over nota Waarborgfonds

Reactie op berichtgeving over nota Waarborgfonds

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

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

2-11-2018

Afspraken over beheerste afbouw Slotervaart Ziekenhuis Amsterdam

Afspraken over beheerste afbouw Slotervaart Ziekenhuis Amsterdam

Vandaag, vrijdag 2 november, zijn alle betrokken partijen op uitnodiging van minister Bruins van Medische Zorg en Sport bij elkaar geweest om nadere afspraken te maken over een beheerste afbouw van het Slotervaartziekenhuis met het oog op de veilige overdracht van patiënten.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

2-11-2018

Commissie buigt zich over de zorg voor ouderen thuis in 2030

Commissie buigt zich over de zorg voor ouderen thuis in 2030

Wat is er nodig om de zorg voor thuiswonende ouderen ook in de toekomst op peil te houden? Om die vraag te beantwoorden stelt het kabinet een commissie in die wordt voorgezeten door Leon van Halder, bestuursvoorzitter van het Radboudumc te Nijmegen. De commissie zal uiterlijk eind 2019 advies uitbrengen. 

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

1-11-2018

Publiekscampagne Ik Zorg van start

Publiekscampagne Ik Zorg van start

Vandaag gaven minister Hugo de Jonge, minister Bruno Bruins en staatssecretaris Paul Blokhuis het startsein voor de publiekscampagne Ik Zorg. Hiermee willen de sector Zorg en Welzijn en de overheid nieuwe werknemers aantrekken. Dat is hard nodig, om ook in de toekomst iedereen goede zorg te kunnen blijven bieden. Als we nu niks doen, hebben we in 2022 een tekort van 125.000 mensen.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

31-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

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

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

Published on: Tue, 30 Oct 2018 00:00:00 +0100 EFSA has asked the Panel on Nutrition, Novel Foods and Food Allergens (NDA) to update the guidance on the scientific requirements for health claims related to physical performance published in 2012. The update takes into account the experience gained by the NDA Panel with the evaluation of additional health claim applications, changes introduced to the general scientific guidance for stakeholders for health claims applications and information collected from ...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Published on: Fri, 19 Oct 2018 00:00:00 +0200 EFSA was requested to deliver a scientific opinion on the implications for human health of the flavouring substance 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide [FL‐no: 16.133], in the Flavouring Group Evaluation 411 (FGE.411), according to Regulation (EC) No 1331/2008 of the European Parliament and of the Council. The substance has not been reported to occur in natural source materials of botanical or animal origin. It is intende...

Europe - EFSA - European Food Safety Authority Publications

18-10-2018

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

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

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

FDA - U.S. Food and Drug Administration

11-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

10-10-2018

Minister Bruins tekent Green Deal voor duurzame zorg

Minister Bruins tekent Green Deal voor duurzame zorg

Minister Bruno Bruins voor Medische Zorg en Sport heeft vandaag de Green Deal ‘Duurzame zorg voor een gezonde toekomst’ getekend. Hiermee maken 132 partijen uit de zorg, overheid en bedrijfsleven afspraken om de zorg in Nederland duurzamer te maken. Inzet is het terugdringen van CO2-uitstoot, zuiniger gebruik van grondstoffen, minder medicijnresten in het water en een gezonde leefomgeving voor patiënt, cliënt en zorgmedewerkers.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

4-10-2018

Nederland organiseert wereldwijde conferentie tegen antibioticaresistentie

Nederland organiseert wereldwijde conferentie tegen antibioticaresistentie

Samen met de Wereldgezondheidorganisatie (WHO) zal Nederland in april 2019 een wereldwijde ministeriële conferentie organiseren over de strijd tegen antibioticaresistentie. Dat heeft minister Bruno Bruins (Medische Zorg) bekend gemaakt tijdens de G20-bijeenkomst in Argentinië. Bij deze bijeenkomst maakte Bruins afspraken met zijn collega’s uit de grootste 20 economieën van de wereld over een gezamenlijke aanpak van gezondheidsvraagstukken. Mede door jarenlange inzet van Nederland, staat antibioticaresist...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

1-10-2018

Minister Bruno Bruins naar ministeriële G20-bijeenkomst over gezondheid

Minister Bruno Bruins naar ministeriële G20-bijeenkomst over gezondheid

Op woensdag 3 en donderdag 4 oktober is minister Bruno Bruins (Medische Zorg) namens Nederland aanwezig bij de G20-bijeenkomst over gezondheid. Tijdens deze bijeenkomst in Argentinië komen alle gezondheidsministers van de grootste economieën van de wereld samen. Op de agenda staat onder andere de gezamenlijke strijd tegen antibioticaresistentie. Onderdeel hiervan is een crisissimulatie over een internationale infectieziekte-uitbraak met een multiresistente bacterie. Ook wordt er gesproken over het verste...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

27-9-2018

Staatssecretaris Blokhuis: “Bij aanpak personen met verward gedrag is de regio aan zet”

Staatssecretaris Blokhuis: “Bij aanpak personen met verward gedrag is de regio aan zet”

Met het beëindigen van het Schakelteam Personen met Verward Gedrag per 1 oktober gaat de aanpak van personen met verward gedrag een nieuwe fase tegemoet. In zijn eindrapport geeft het Schakelteam een inventarisatie van de huidige stand van zaken en worden aanbevelingen gedaan voor de toekomst. Het Schakelteam constateert dat er veel is gebeurd in de afgelopen twee jaar. Zo is er een landelijk dekkende structuur gerealiseerd waarin hard wordt gewerkt aan goede zorg en ondersteuning van mensen met verward ...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

25-9-2018

Voluntary Recall on Harris Teeter Low Fat Cookies & Cream Frozen Yogurt Due to Undeclared Peanut Product

Voluntary Recall on Harris Teeter Low Fat Cookies & Cream Frozen Yogurt Due to Undeclared Peanut Product

Harris Teeter is notifying shoppers of a voluntarily recall of Harris Teeter Low Fat Frozen Yogurt Cookies & Cream 1.5 qt laminated cartons, UPC 0 72036 98182 0, with all SELL BY DATES up to 07/30/19 due to undeclared peanut product.

FDA - U.S. Food and Drug Administration

13-9-2018

Hoogste punt kern EMA-gebouw Zuidas

Hoogste punt kern EMA-gebouw Zuidas

Aankomende week wordt het hoogste punt van de kern van de nieuwbouw voor het Europees Geneesmiddelenagentschap bereikt, dat heeft minister Bruins (Medische Zorg) aan de Tweede Kamer gemeld. Dit is een belangrijke mijlpaal in de verhuizing van het EMA naar Amsterdam als gevolg van de Brexit. In slechts anderhalf jaar tijd wordt een voor EMA op maat gemaakt kantoorgebouw met conferentiecentrum aan de Zuidas gerealiseerd. Voordat de nieuwbouw gereed is dient het EMA-personeel tijdelijke gehuisvest te worden...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

19-12-2018

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

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

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

FDA - U.S. Food and Drug Administration

18-12-2018


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

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

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

Europe - EMA - European Medicines Agency

18-12-2018


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

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

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

Europe - EMA - European Medicines Agency

30-11-2018

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

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

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

Europe -DG Health and Food Safety

30-11-2018

Pioglitazone Teva (Teva B.V.)

Pioglitazone Teva (Teva B.V.)

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

Europe -DG Health and Food Safety

30-11-2018

Keppra (UCB Pharma S.A.)

Keppra (UCB Pharma S.A.)

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

Europe -DG Health and Food Safety

30-11-2018

Pioglitazone Teva Pharma (Teva B.V.)

Pioglitazone Teva Pharma (Teva B.V.)

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

Europe -DG Health and Food Safety

15-11-2018

Flixabi (Samsung Bioepis NL B.V.)

Flixabi (Samsung Bioepis NL B.V.)

Flixabi (Active substance: infliximab) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7549 of Thu, 15 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4020/T/30

Europe -DG Health and Food Safety

30-10-2018

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

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

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

Europe -DG Health and Food Safety

30-10-2018

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

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

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

Europe -DG Health and Food Safety

30-10-2018

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

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

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

Europe -DG Health and Food Safety

30-10-2018

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

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

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

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2077 (Worphmed Srl)

EU/3/18/2077 (Worphmed Srl)

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

Europe -DG Health and Food Safety

30-10-2018

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

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

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

Europe -DG Health and Food Safety

30-10-2018

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

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

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

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2074 (PhaRA bvba)

EU/3/18/2074 (PhaRA bvba)

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

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2073 (Fondazione Telethon)

EU/3/18/2073 (Fondazione Telethon)

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

Europe -DG Health and Food Safety

30-10-2018

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

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

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

Europe -DG Health and Food Safety

30-10-2018

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

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

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

Europe -DG Health and Food Safety

30-9-2018

Roteas (Daiichi Sankyo Europe GmbH)

Roteas (Daiichi Sankyo Europe GmbH)

Roteas (Active substance: edoxaban) - PSUSA - Modification - Commission Decision (2018)5089 of Sun, 30 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10387/201710

Europe -DG Health and Food Safety

17-9-2018

Reminder: the FDA is accepting applications through Sept. 30, 2018, for the #FDAInnovationChallenge for devices to help combat #opioid addiction.   Submissions will be evaluated based on the feasibility, potential public health impact and novelty of the c

Reminder: the FDA is accepting applications through Sept. 30, 2018, for the #FDAInnovationChallenge for devices to help combat #opioid addiction. Submissions will be evaluated based on the feasibility, potential public health impact and novelty of the c

Reminder: the FDA is accepting applications through Sept. 30, 2018, for the #FDAInnovationChallenge for devices to help combat #opioid addiction. Submissions will be evaluated based on the feasibility, potential public health impact and novelty of the concept.

FDA - U.S. Food and Drug Administration