Anafranil 10

Informazioni principali

  • Nome commerciale:
  • Anafranil 10 Confetti
  • Forma farmaceutica:
  • Confetti
  • Composizione:
  • clomipramini hydrochloridum 10 mg, 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:
  • Anafranil 10 Confetti
    Svizzera
  • Lingua:
  • italiano

Informazioni terapeutiche

  • Gruppo terapeutico:
  • Synthetika
  • Area terapeutica:
  • Antidepressivum

Altre informazioni

Status

  • Fonte:
  • Swissmedic - Swiss Agency for Therapeutic Products
  • Numero dell'autorizzazione:
  • 32934
  • Data dell'autorizzazione:
  • 25-10-1966
  • Ultimo aggiornamento:
  • 19-10-2018

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

Patienteninformation

Anafranil®

Novartis Pharma Schweiz AG

Che cos’è Anafranil e quando si usa?

Anafranil contiene il principio attivo clomipramina e appartiene a un gruppo di medicamenti

denominati antidepressivi triciclici.

Anafranil viene impiegato negli adulti per il trattamento delle depressioni di vario tipo, nei disturbi

ossessivi-compulsivi associati a ideazione ed azioni compulsive, a stati di panico e di ansia. Sia lo

stato d'animo, sia anche i sintomi fisici, quali l'insonnia, le vertigini, le palpitazioni cardiache e altri

disturbi, ne traggono un miglioramento.

Inoltre, questo medicamento viene impiegato in determinati stati dolorosi cronici.

Nei bambini a partire dai 6 anni e negli adolescenti, Anafranil viene impiegato contro l'enuresi.

Anche nei bambini a partire dai 10 anni e negli adolescenti viene impiegato in caso di disturbi

ossessivo-compulsivi.

Anafranil deve essere impiegato soltanto su prescrizione medica.

Di che cosa occorre inoltre tener conto durante il trattamento?

È importante che durante il trattamento con Anafranil sia lei sia i suoi familiari o le persone preposte

all'assistenza comunichiate un qualsiasi cambiamento di suo umore al suo medico.

Quando non si può usare Anafranil?

Il suo medico dovrà essere informato qualora

·lei reagisca o abbia reagito in passato in modo insolito oppure allergico al principio attivo di

Anafranil (clomipramina);

·lei reagisca o abbia reagito in passato in modo insolito oppure allergico a una sostanza ausiliaria di

Anafranil o a un altro antidepressivo triciclico;

·lei assuma già un altro antidepressivo o un altro medicamento facente parte dei cosiddetti inibitori

delle monoaminoossidasi (inibitori delle MAO);

·lei abbia subito nel recente passato un infarto cardiaco o soffra di una grave cardiopatia;

poiché in questi casi, Anafranil non deve essere assunto.

In determinate circostanze, è consigliabile non assumere Anafranil oppure dovrà essere assunto

soltanto dopo approfondita valutazione medica. Pertanto, informi il suo medico nel caso in cui

soffrisse o avesse sofferto di uno dei seguenti disturbi o malattia:

·tendenza agli attacchi convulsivi (epilessia)

·disturbi del ritmo cardiaco o altri problemi cardiaci

·altre malattie psichiche

·aumento della pressione interna dell'occhio (glaucoma)

·malattia del fegato o dei reni

·alterazioni del quadro ematico

·intossicazioni, per es. da stupefacenti

·disturbi dello svuotamento dello stomaco

·difficoltà durante la minzione o ingrandimento prostatico

·iperfunzione della ghiandola tiroide oppure assunzione concomitante di preparati tiroidei

·dipendenza dall'alcool

·stipsi frequente oppure occlusione intestinale

·lipotimie

·cambiamenti umorali oscillanti tra depressione e umore estremamente sollevato.

Quando è richiesta prudenza nella somministrazion di Anafranil?

Prudenza durante la guida e durante l'uso di macchine.

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

capacità di utilizzare attrezzi o macchine.

Anafranil può indurre sonnolenza, diminuire la sua attenzione o causare una visione sfocata. Nel

caso si verificassero questi eventi, rinunci a condurre un veicolo, a utilizzare macchine o a svolgere

altre attività che richiedano la sua piena attenzione. Questi effetti possono essere rafforzati

assumendo ulteriori farmaci o anche alcolici.

Anafranil può dare origine a secchezza della bocca, con il conseguente aumento del rischio di andare

incontro a carie. Durante una terapia a lungo termine, quindi, si consigliano periodici controlli

odontoiatrici.

Durante il trattamento si raccomanda di rinunciare all'assunzione di bevande alcoliche poiché

Anafranil può causare una diminuzione della tollerabilità dell'alcool. Le modificazioni delle abitudini

al fumo dovrebbero essere comunicate al medico.

Nel caso fosse portatore di lenti a contatto e notasse la comparsa di irritazioni degli occhi, ne informi

il suo medico.

Prima di ogni intervento chirurgico o all'inizio di un trattamento odontoiatrico, informi il medico o

l'odontoiatra responsabile che lei sta assumendo Anafranil.

Anafranil può determinare una maggiore sensibilità della sua pelle alla luce solare. Pertanto, non si

esponga alla diretta irradiazione solare, indossi degli occhiali da sole e si protegga con un

abbigliamento adeguato.

È importante che il suo medico controlli periodicamente i progressi del suo trattamento, in modo tale

da poter regolare di conseguenza la posologia e poter quindi ridurre gli effetti collaterali.

Probabilmente ordinerà anche esami del sangue, misurerà la sua pressione arteriosa e verificherà la

sua funzione cardiaca.

Anafranil può influenzare l'effetto di determinati altri medicamenti. Viceversa, l'effetto di Anafranil

può essere modificato da altri medicamenti, tra cui in particolare farmaci per la pressione arteriosa o

per il cuore, altri medicamenti contro le depressioni, tranquillanti, medicamenti contro l'epilessia,

(come per es. i barbiturici o l'acido valproico), sonniferi, forti antidolorifici, medicamenti per

impedire la coagulazione del sangue (anticoagulanti), medicamenti contro l'asma o le allergie,

medicamenti contro il morbo di Parkinson, preparati per la tiroide, medicamenti contro l'eccessiva

secrezione acida dello stomaco o contro le ulcere gastriche con il principio attivo cimetidina,

contraccettivi ormonali (anticoncezionali orali), estrogeni o metilfenidato (viene impiegato

soprattutto in caso di ADHD [sindrome da deficit di attenzione e iperattività]), determinati

medicamenti per rimuovere i lipidi dal sangue (cosiddette resine a scambio ionico), come anche il

pompelmo, il succo di pompelmo e il succo di mirtillo rosso.

Informi il suo medico o il suo farmacista nel caso in cui presenta episodi lipotimici, soffre di altre

malattie, soffre di allergie, presenta un'intolleranza a zuccheri (per es. lattosio, saccarosio) o assume

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

Quando Anafranil viene impiegato nei bambini a partire dai 6 anni e negli adolescenti per il

trattamento dell'enuresi, nonché nei bambini e negli adolescenti per il trattamento di disturbi

ossessivo-compulsivi, occorre sorvegliare l'eventuale comparsa di alterazioni comportamentali.

Durante il trattamento con Anafranil, i sintomi di una depressione potrebbero aggravarsi, in

particolare il comportamento finalizzato al suicidio. In questo caso dovrà immediatamente mettersi in

contatto con il suo medico.

Nei bambini, negli adolescenti e nei giovani adulti (fino a 25 anni) affetti da depressioni o con altre

diagnosi psichiatriche, è stato riportato, durante il trattamento con antidepressivi, un aumento dei

disturbi comportamentali, compreso un aumento del rischio di pensieri di suicidio, di autolesionismo

o di suicidio attuato. Ciò è stato dimostrato da dati raccolti durante studi clinici.

Un'interruzione del trattamento non deve essere messa in atto repentinamente, ma soltanto secondo

gli accordi presi con il suo medico, altrimenti potrebbero manifestarsi sintomi di astinenza.

Si può somministrare Anafranil durante la gravidanza o l’allattamento?

Informi il suo medico qualora fosse in gravidanza, stesse pianificando una gravidanza o allattasse.

Anafranil deve essere assunto in gravidanza soltanto nel caso in cui il suo medico glielo avesse

prescritto esplicitamente.

Il principio attivo di Anafranil passa nel latte materno. Pertanto le madri che assumono Anafranil non

devono allattare. Ne parli con il suo medico.

Come usare Anafranil?

Il suo medico stabilirà la posologia per lei più adeguata.

Adulti: le seguenti indicazioni posologiche sono valide soltanto indicativamente: nei casi di

depressione, stati di malumore, disturbi ossessivi-compulsivi e fobie, la dose giornaliera abituale è

tra 75 e 150 mg. Negli attacchi di panico e nella cosiddetta agorafobia la dose iniziale abituale è di

10 mg al giorno, aumentando dopo alcuni giorni gradualmente fino alla dose di 100 mg. Negli stati

dolorosi cronici la dose giornaliera abituale è tra 10 e 150 mg.

In alcuni casi, il suo medico può anche somministrarle delle iniezioni di Anafranil.

Bambini e adolescenti: contro l'enuresi nei bambini (con età superiore ai 6 anni) e negli adolescenti

la dose giornaliera abituale, a seconda dell'età, è tra 20 e 75 mg.

Nei disturbi ossessivo-compulsivi nei bambini a partire dai 10 anni e negli adolescenti, di regola, si

somministrano inizialmente 25 mg. Il medico in seguito aumenterà il dosaggio gradualmente fino a

100 mg/giorno dopo 2 settimane, oppure fino a un massimo di 200 mg nelle settimane successive.

Le compresse Anafranil Divitabs possono essere divise a metà, ma non devono essere masticate.

Anafranil deve essere assunto soltanto su indicazione medica.

Per favore, si attenga strettamente alle indicazioni posologiche del suo medico.

Una sospensione o un'interruzione del trattamento deve avvenire esclusivamente dopo aver

consultato il medico curante.

All'inizio del trattamento degli stati di panico o di ansia, le sue sensazioni di ansia potrebbero

eventualmente accentuarsi, questo effetto tuttavia di regola recede nell'arco di due settimane.

Gli stati d'ansia cronici e le depressioni richiedono un periodo di trattamento maggiore con Anafranil,

la durata deve essere stabilita dal medico.

Se per una volta avesse dimenticato l'assunzione di una dose di Anafranil, la assuma al più presto

possibile, e successivamente, assuma il medicamento nel momento in cui lo assume abitualmente.

Tuttavia, se il momento dell'assunzione della successiva dose fosse quasi arrivato, non assuma la

dose dimenticata, ma continui con l'assunzione del medicamento secondo gli orari abituali.

Se a questo proposito avesse delle domande, si rivolga al suo medico.

Se per una volta avesse assunto un numero considerevolmente maggiore di confetti o di compresse di

quante gliene ha prescritte il suo medico, si rechi immediatamente alla stazione di pronto soccorso

del più vicino ospedale o presso il suo medico o li contatti telefonicamente. I seguenti sintomi dovuti

a sovradosaggio generalmente si manifestano entro poche ore: intensa sonnolenza, difficoltà di

concentrazione; battito cardiaco rapido, lento o irregolare; irrequietezza e agitazione; perdita del

coordinamento muscolare e rigidità muscolare; difficoltà respiratoria; accessi convulsivi; vomito;

febbre.

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 Anafranil?

Durante l'assunzione di Anafranil possono manifestarsi i seguenti effetti collaterali:

Molto frequenti (in più di 1 paziente su 10):

Senso di stordimento, stanchezza transitoria, vertigini, tremore, irrequietezza, aumento dell'appetito,

aumento del peso, secchezza della bocca, disturbi dello svuotamento della vescica, scosse muscolari,

disturbi dell'accomodazione, visione sfocata, mal di testa, accessi di sudorazione, stitichezza.

Frequenti (in più di 1-10 pazienti su 100):

Confusione con disorientamento e allucinazioni, difficoltà di concentrazione, disturbi della parola,

disturbi del sonno, ansia, aumento dell'iniziativa e umore sollevato, eccitazione eccessiva,

comportamento aggressivo, disturbi comportamentali, disturbi della memoria, sbadigli, insonnia,

incubi, intorpidimento o formicolio nelle braccia e nelle gambe, debolezza muscolare, aumento del

tono muscolare, vampate di calore, pupille dilatate, tachicardia, pressione arteriosa bassa con

vertigini durante i cambiamenti di posizione, aggravamento della depressione, nausea, sensibilità alla

luce, reazioni cutanee allergiche, prurito cutaneo, aumento dei valori di laboratorio, disturbi della

libido e della potenza, ronzio auricolare.

Occasionali (in più di 1-10 pazienti su 1'000):

Febbre, aumento della pressione arteriosa, crisi convulsive, aritmie cardiache, mancanza d'appetito,

disturbi della coordinazione dei movimenti, modificazioni della percezione e delle sensazioni,

vomito, malattie gastrointestinali, diarrea, aumento delle ghiandole mammarie e secrezione lattea,

alterazioni del gusto.

Molto rari (meno di un paziente su 10'000):

Diminuzione del numero dei globuli bianchi (leucopenia), diminuzione del numero delle piastrine

(trombocitopenia), diminuzione del numero di specifici globuli bianchi (agranulocitosi) o aumento

del numero di specifici globuli bianchi (eosinofilia), sanguinamenti della pelle, reazioni da

ipersensibilità (allergia) comprese reazioni polmonari e dell'organismo intero con shock, disturbi dei

movimenti, glaucoma, disturbi della conduzione dell'impulso cardiaco, epatite con o senza ittero,

edemi (tumefazioni delle articolazioni, delle mani o di altre parti del corpo), caduta dei capelli,

insufficiente escrezione di acqua.

Si possono anche manifestare disturbi dell'equilibrio idrosalino p.es. con disorientamento,

allucinazioni, crisi convulsive ed edema cerebrale (tumefazione causata da un accumulo di liquidi nel

cervello). In questi casi, contatti immediatamente il suo medico

Molto raramente si verifica una cosiddetta sindrome neurolettica maligna che si manifesta

prevalentemente con febbre, polso irregolare, disturbi dello stato di coscienza e rigidità muscolare. In

questo caso, contatti immediatamente il suo medico.

Altri effetti collaterali sono (frequenza non nota):

irrequietezza interiore e costante pulsione al movimento, movimenti reiterati involontari e senza

scopo, aumento del livello di prolattina nel sangue e ritardo o assenza dell'eiaculazione. Durante il

trattamento con medicamenti quali Anafranil, soli o in associazione, si può verificare una cosiddetta

sindrome serotoninergica. I sintomi tipici di questa sindrome sono: febbre, scosse muscolari, crisi

convulsive, irrequietezza, disorientamento e perdita di coscienza. In un tale caso, occorre contattare

immediatamente il medico curante.

La maggior parte degli effetti collaterali su menzionati possono manifestarsi fino a quando il suo

organismo non si sarà abituato al medicamento per regredire poi durante il trattamento. Se questi

effetti collaterali dovessero durare più a lungo o se dovessero risultare per lei molto sgradevoli, si

rivolga al suo medico.

Nei bambini e negli adolescenti affetti da depressioni o con altre diagnosi psichiatriche, è stato

riportato, durante il trattamento con antidepressivi, un aumento dei disturbi comportamentali,

compreso un aumento del rischio di pensieri di suicidio, di autolesionismo o di suicidio attuato.

È stato osservato un aumento del rischio di fratture ossee nei pazienti di età superiore ai 50 anni che

assumono questo tipo di medicamento.

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

Di che altro occorre tener conto?

Conservare i medicamenti fuori dalla portata dei bambini.

Proteggere i confetti 10/25 mg e le divitabs da 75 mg dall'umidità.

Il medicamento non deve essere conservato a una temperatura superiore ai 25 °C.

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

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

darle ulteriori informazioni.

Cosa contiene Anafranil?

Anafranil 10 mg: Un confetto contiene 10 mg di clomipramina cloridrato, nonché lattosio e altre

sostanze ausiliarie.

Anafranil 25 mg: Un confettto contiene 25 mg di clomipramina cloridrato, nonché lattosio e altre

sostanze ausiliarie.

Anafranil SR 75 mg: Un divitab contiene 75 mg di clomipramina cloridrato, nonché sostanze

ausiliarie.

Numero dell'omologazione

32934, 44815 (Swissmedic).

Dove è ottenibile Anafranil? Quali confezioni sono disponibili?

In farmacia, solo dietro presentazione della prescrizione medica.

Anafranil da 10 mg: confezioni da 30 e da 200 confetti.

Anafranil da 25 mg: confezioni da 30 e da 200 confetti.

Anafranil SR da 75 mg: confezioni da 20 e da 100 divitabs (divisibili).

Titolare dell'omologazione

Novartis Pharma Schweiz AG, Risch; Domicilio: 6343 Rotkreuz.

Questo foglietto illustrativo è stato controllato l'ultima volta nel settembre 2015 dall'autorità

competente in materia di medicamenti (Swissmedic).

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December 10, 2018: Olympus Medical Systems Corporation, Former Senior Executive Plead Guilty to Distributing Endoscopes After Failing to File FDA-Required Adverse Event Reports of Serious Infections

December 10, 2018: Olympus Medical Systems Corporation, Former Senior Executive Plead Guilty to Distributing Endoscopes After Failing to File FDA-Required Adverse Event Reports of Serious Infections

FDA - U.S. Food and Drug Administration

11-12-2018


The new EudraVigilance system and the electronic reporting of individual case safety reports in the ISO/ICH E2B(R3) format: Hands-on training course, Amsterdam, The Netherlands, from 08/04/2019 to 10/04/2019

The new EudraVigilance system and the electronic reporting of individual case safety reports in the ISO/ICH E2B(R3) format: Hands-on training course, Amsterdam, The Netherlands, from 08/04/2019 to 10/04/2019

The new EudraVigilance system and the electronic reporting of individual case safety reports in the ISO/ICH E2B(R3) format: Hands-on training course, Amsterdam, The Netherlands, from 08/04/2019 to 10/04/2019

Europe - EMA - European Medicines Agency

10-12-2018


Agenda - CHMP agenda of the 10-13 December 2018

Agenda - CHMP agenda of the 10-13 December 2018

Agenda - CHMP agenda of the 10-13 December 2018

Europe - EMA - European Medicines Agency

4-12-2018

Mylan Expands Its Voluntary Nationwide Recall of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, to all Lots Within Expiry Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylam

Mylan Expands Its Voluntary Nationwide Recall of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, to all Lots Within Expiry Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylam

– Mylan N.V. (NASDAQ: MYL) today announced that its U.S. based Mylan Pharmaceuticals business is expanding its consumer-level voluntary nationwide recall to include all lots of Valsartan-containing products within expiry. The 104 additional lots include 26 lots of Amlodipine and Valsartan Tablets, USP (including the 5mg/160mg, 10mg/160mg, 5mg/320mg and 10mg/320mg strengths), 51 lots of Valsartan Tablets, USP (including 40 mg, 80 mg, 160 mg and 320 mg strengths), and 27 lots of Valsartan and Hydrochloroth...

FDA - U.S. Food and Drug Administration

4-12-2018


European network of paediatric research at the European Medicines Agency (Enpr-EMA) Coordinating Group and networks meeting, European Medicines Agency via Adobe Connect, from 22/10/2018 to 22/10/2018

European network of paediatric research at the European Medicines Agency (Enpr-EMA) Coordinating Group and networks meeting, European Medicines Agency via Adobe Connect, from 22/10/2018 to 22/10/2018

European network of paediatric research at the European Medicines Agency (Enpr-EMA) Coordinating Group and networks meeting, European Medicines Agency via Adobe Connect, from 22/10/2018 to 22/10/2018

Europe - EMA - European Medicines Agency

29-11-2018


Committee for Medicinal Products for Human Use (CHMP): 15-18 October 2018, European Medicines Agency, London, UK, from 15/10/2018 to 18/10/2018

Committee for Medicinal Products for Human Use (CHMP): 15-18 October 2018, European Medicines Agency, London, UK, from 15/10/2018 to 18/10/2018

Committee for Medicinal Products for Human Use (CHMP): 15-18 October 2018, European Medicines Agency, London, UK, from 15/10/2018 to 18/10/2018

Europe - EMA - European Medicines Agency

28-11-2018

Sprout Creek Farm Recalls “Kinkead” Cheese due to Possible Health Risk

Sprout Creek Farm Recalls “Kinkead” Cheese due to Possible Health Risk

Sprout Creek Farm of Poughkeepsie, New York is recalling 4 wheels of “Kinkead” cheese made on 5-10-18, because it has the potential to be contaminated with Listeria monocytogenes. Listeria monocytogenes is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, L...

FDA - U.S. Food and Drug Administration

24-11-2018

The EFSA‐funded collection of dietary and related data in the general population aged 10‐74 years in Greece

The EFSA‐funded collection of dietary and related data in the general population aged 10‐74 years in Greece

Published on: Fri, 23 Nov 2018 The Hellenic Health Foundation received support from the European Food Safety Authority in order to organise a national nutrition survey according to the methodology described in the EFSA Guidance document and to collect food consumption and related information among 780 adolescents, adults and elderly residing permanently in Greece. The EFSA‐funded data collection was largely based on the protocol of a large scale Greek national nutrition and health survey, called HYDRIA....

Europe - EFSA - European Food Safety Authority Publications

22-11-2018


Paediatric Committee (PDCO): 16-19 October 2018, European Medicines Agency, London, UK, from 16/10/2018 to 19/10/2018

Paediatric Committee (PDCO): 16-19 October 2018, European Medicines Agency, London, UK, from 16/10/2018 to 19/10/2018

Paediatric Committee (PDCO): 16-19 October 2018, European Medicines Agency, London, UK, from 16/10/2018 to 19/10/2018

Europe - EMA - European Medicines Agency

21-11-2018

Fresenius Kabi Issues Voluntary Nationwide Recall of Sodium Chloride Injection, USP, 0.9% Due to Product Labeling Incorrectly Stating Stoppers Do Not Contain Latex

Fresenius Kabi Issues Voluntary Nationwide Recall of Sodium Chloride Injection, USP, 0.9% Due to Product Labeling Incorrectly Stating Stoppers Do Not Contain Latex

Fresenius Kabi USA is voluntarily recalling 163 lots of Sodium Chloride Injection, USP, 0.9%, 10 mL fill in a 10 mL vial and Sodium Chloride Injection, USP, 0.9%, 20 mL fill in a 20 mL vial to the user level. The product insert states that stoppers for both the 10mL and the 20mL vials do not contain natural rubber latex; the tray label for the two vial sizes and the vial label for the 20mL vial also state that the stoppers do not contain latex. The product is being recalled because the stoppers contain n...

FDA - U.S. Food and Drug Administration

21-11-2018

Mylan Initiates Voluntary Nationwide Recall of 15 Lots of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Fou

Mylan Initiates Voluntary Nationwide Recall of 15 Lots of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Fou

Mylan N.V. (NASDAQ: MYL) today announced that its U.S. based Mylan Pharmaceuticals business is conducting a voluntary nationwide recall to the consumer level of select lots of Valsartan-containing products, including six lots of Amlodipine and Valsartan Tablets, USP (including the 5mg/160mg, 10mg/160mg, and 10mg/320mg strengths), seven lots of Valsartan Tablets, USP (including 40 mg, 80 mg, 160 mg, and 320 mg strengths), and two lots of Valsartan and Hydrochlorothiazide Tablets, USP 320mg/25mg strength. ...

FDA - U.S. Food and Drug Administration

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

24-10-2018

Vita Health Products Recall (2018-10-24)

Vita Health Products Recall (2018-10-24)

Health Canada

18-10-2018

Mom Life Market recalls 10" & 16" Personalized Stuffed Plush Bunnies

Mom Life Market recalls 10" & 16" Personalized Stuffed Plush Bunnies

The recalled products may contain phthalate levels that exceed the allowable levels.

Health Canada

18-10-2018

Scientific Opinion on Flavouring Group Evaluation 201 Revision 2 (FGE.201Rev2): 2‐alkylated, aliphatic, acyclic alpha,beta‐unsaturated aldehydes and precursors, with or without additional double‐bonds, from chemical subgroup 1.1.2 of FGE.19

Scientific Opinion on Flavouring Group Evaluation 201 Revision 2 (FGE.201Rev2): 2‐alkylated, aliphatic, acyclic alpha,beta‐unsaturated aldehydes and precursors, with or without additional double‐bonds, from chemical subgroup 1.1.2 of FGE.19

Published on: Wed, 17 Oct 2018 00:00:00 +0200 The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to consider in this revision 2 of Flavouring Group Evaluation 201, the additional data on genotoxicity submitted by the Industry on two substances, 2‐methylpent‐2‐enal [FL‐no: 05.090] and 2 methylcrotonaldehyde [FL‐no: 05.095], from subgroup 1.1.2 of FGE.19. In FGE.201Rev1, the Panel concluded that further data were required in order to clarify the genotoxic poten...

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Applicability of in silico tools for the prediction of dermal absorption for pesticides

Applicability of in silico tools for the prediction of dermal absorption for pesticides

Published on: Tue, 16 Oct 2018 00:00:00 +0200 Based on the “Human in vitro dermal absorption datasets” published as supporting information to the revised EFSA Guidance on Dermal Absorption, in silico models for prediction of absorption across the skin have been evaluated. For this evaluation, a systematic literature search and review was performed, identifying 288 publications describing mathematical models for prediction of dermal absorption. Eleven models potentially relevant to the regulatory assessm...

Europe - EFSA - European Food Safety Authority Publications

11-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

11-10-2018

Wild boar in focus: Review of existing models on spatial distribution and density of wild boar and proposal for next steps

Wild boar in focus: Review of existing models on spatial distribution and density of wild boar and proposal for next steps

Published on: Wed, 10 Oct 2018 00:00:00 +0200 This report provides a review of existing models for predicting the spatial distribution and abundance of wild boar at various scales (global, continental, national and regional) in order to inform the development of a new model to produce estimates of wild boar abundance at European level. The review identifies and discusses a range of models based on a wide variety of data types, corresponding to those targeted by the data collection model set by ENETwild,...

Europe - EFSA - European Food Safety Authority Publications

10-10-2018

Sprayology Issues Voluntary Nationwide Recall of Homeopathic Aqueous-Based Medicines Due to Microbial Contamination

Sprayology Issues Voluntary Nationwide Recall of Homeopathic Aqueous-Based Medicines Due to Microbial Contamination

Eight and Company LLC, d/b/a Sprayology is voluntarily recalling all lots within expiry from 10/18-7/22 of its aqueous-based homeopathic product line for human use. All products manufactured by the contract manufacturer, King Bio, have been recalled due to possible microbial contamination.

FDA - U.S. Food and Drug Administration

11-1-2019


Orphan designation: 6-(R)-methyl-5-O-(5-amino-5,6-dideoxy-alpha-L-talofuranosyl)-paromamine sulfate, Treatment of cystic fibrosis, 26/10/2018, Positive

Orphan designation: 6-(R)-methyl-5-O-(5-amino-5,6-dideoxy-alpha-L-talofuranosyl)-paromamine sulfate, Treatment of cystic fibrosis, 26/10/2018, Positive

Orphan designation: 6-(R)-methyl-5-O-(5-amino-5,6-dideoxy-alpha-L-talofuranosyl)-paromamine sulfate, Treatment of cystic fibrosis, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

11-1-2019


Orphan designation: Recombinant adeno-associated viral vector serotype S3 containing codon-optimised expression cassette encoding human coagulation factor IX variant, Treatment of haemophilia B, 26/10/2018, Positive

Orphan designation: Recombinant adeno-associated viral vector serotype S3 containing codon-optimised expression cassette encoding human coagulation factor IX variant, Treatment of haemophilia B, 26/10/2018, Positive

Orphan designation: Recombinant adeno-associated viral vector serotype S3 containing codon-optimised expression cassette encoding human coagulation factor IX variant, Treatment of haemophilia B, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

11-1-2019


Orphan designation: 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, Treatment of medullary thyroid carcinoma, 26/10/2018, Positive

Orphan designation: 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, Treatment of medullary thyroid carcinoma, 26/10/2018, Positive

Orphan designation: 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, Treatment of medullary thyroid carcinoma, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

10-1-2019


Orphan designation: autologous CD34+ haematopoietic stem and progenitor cells genetically modified with the lentiviral vector IDUA LV, encoding for the alpha-L-iduronidase cDNA, Treatment of mucopolysaccharidosis type I, 26/10/2018, Positive

Orphan designation: autologous CD34+ haematopoietic stem and progenitor cells genetically modified with the lentiviral vector IDUA LV, encoding for the alpha-L-iduronidase cDNA, Treatment of mucopolysaccharidosis type I, 26/10/2018, Positive

Orphan designation: autologous CD34+ haematopoietic stem and progenitor cells genetically modified with the lentiviral vector IDUA LV, encoding for the alpha-L-iduronidase cDNA, Treatment of mucopolysaccharidosis type I, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

10-1-2019


Orphan designation: 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, Treatment of haemophilia

Orphan designation: 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, Treatment of haemophilia

Orphan designation: 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, Treatment of haemophilia A, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

10-1-2019


Orphan designation: 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, Treatment

Orphan designation: 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, Treatment

Orphan designation: 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, Treatment of maple syrup urine disease, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

10-1-2019


Orphan designation: gefinitib, Treatment of Fanconi anaemia type A, 26/10/2018, Positive

Orphan designation: gefinitib, Treatment of Fanconi anaemia type A, 26/10/2018, Positive

Orphan designation: gefinitib, Treatment of Fanconi anaemia type A, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

10-1-2019


Orphan designation: Peptides YMFPNAPYL, SGQAYMFPNAPYLPSCLES, RSDELVRHHNMHQRNMTKL and PGCNKRYFKLSHLQMHSRKHTG, Treatment of multiple myeloma, 26/10/2018, Positive

Orphan designation: Peptides YMFPNAPYL, SGQAYMFPNAPYLPSCLES, RSDELVRHHNMHQRNMTKL and PGCNKRYFKLSHLQMHSRKHTG, Treatment of multiple myeloma, 26/10/2018, Positive

Orphan designation: Peptides YMFPNAPYL, SGQAYMFPNAPYLPSCLES, RSDELVRHHNMHQRNMTKL and PGCNKRYFKLSHLQMHSRKHTG, Treatment of multiple myeloma, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

4-1-2019


Orphan designation: avapritinib, Treatment of mastocytosis, 26/10/2018, Positive

Orphan designation: avapritinib, Treatment of mastocytosis, 26/10/2018, Positive

Orphan designation: avapritinib, Treatment of mastocytosis, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

19-12-2018


Orphan designation: melatonin, Treatment of acute radiation syndrome, 26/10/2018, Positive

Orphan designation: melatonin, Treatment of acute radiation syndrome, 26/10/2018, Positive

Orphan designation: melatonin, Treatment of acute radiation syndrome, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

19-12-2018


Recommendations on eligibility to PRIME scheme -  Adopted at the CHMP meeting of 10-13 December 2018

Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 10-13 December 2018

Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 10-13 December 2018

Europe - EMA - European Medicines Agency

14-12-2018


Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 December 2018

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 December 2018

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 December 2018

Europe - EMA - European Medicines Agency

10-12-2018

Exondys (AVI BioPharma International Ltd)

Exondys (AVI BioPharma International Ltd)

Exondys (Active substance: eteplirsen) - Centralised - Refusal of marketing authorisation - Commission Decision (2018)8620 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4355

Europe -DG Health and Food Safety

10-12-2018

Ivabradine JensonR (JensonR+ Limited)

Ivabradine JensonR (JensonR+ Limited)

Ivabradine JensonR (Active substance: ivabradine) - Centralised - Withdrawal - Commission Decision (2018)8623 of Mon, 10 Dec 2018

Europe -DG Health and Food Safety

10-12-2018

EU/3/16/1662 (QRC Ireland)

EU/3/16/1662 (QRC Ireland)

EU/3/16/1662 (Active substance: H-Phe-Ser-Arg-Tyr-Ala-Arg-OH acetate) - Transfer of orphan designation - Commission Decision (2018)8626 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/011/16/T/01

Europe -DG Health and Food Safety

10-12-2018

EU/3/17/1906 (PTC Therapeutics International Limited)

EU/3/17/1906 (PTC Therapeutics International Limited)

EU/3/17/1906 (Active substance: Recombinant adeno-associated viral vector serotype 5 carrying the gene for the human frataxin protein) - Transfer of orphan designation - Commission Decision (2018)8634 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002509

Europe -DG Health and Food Safety

10-12-2018

EU/3/16/1786 (PTC Therapeutics International Limited)

EU/3/16/1786 (PTC Therapeutics International Limited)

EU/3/16/1786 (Active substance: Recombinant adeno-associated viral vector serotype 2 carrying the gene for the human aromatic L-amino acid decarboxylase protein) - Transfer of orphan designation - Commission Decision (2018)8630 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002507

Europe -DG Health and Food Safety

10-12-2018

EU/3/16/1651 (PTC Therapeutics International Limited)

EU/3/16/1651 (PTC Therapeutics International Limited)

EU/3/16/1651 (Active substance: Recombinant adeno-associated viral vector serotype 9 carrying the gene for the human E6-AP ubiquitin protein ligase) - Transfer of orphan designation - Commission Decision (2018)8632 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002508

Europe -DG Health and Food Safety

10-12-2018

EU/3/16/1802 (FGK Representative Service GmbH)

EU/3/16/1802 (FGK Representative Service GmbH)

EU/3/16/1802 (Active substance: Ivosidenib) - Transfer of orphan designation - Commission Decision (2018)8627 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002422

Europe -DG Health and Food Safety

10-12-2018

EU/3/10/760 (TESARO Bio Netherlands B.V.)

EU/3/10/760 (TESARO Bio Netherlands B.V.)

EU/3/10/760 (Active substance: (3S)-3-{4-[7-(aminocarbonyl)-2H-indazol-2-yl] phenyl} piperidine tosylate monohydrate salt) - Transfer of orphan designation - Commission Decision (2018)8636 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002385

Europe -DG Health and Food Safety

10-12-2018

EU/3/17/1893 (SFL Regulatory Services GmbH)

EU/3/17/1893 (SFL Regulatory Services GmbH)

EU/3/17/1893 (Active substance: Polyphenyl(disodium 3-O-sulfo-beta-D-glucopyranuronate)-(1?3)-beta-D-galactopyranoside) - Transfer of orphan designation - Commission Decision (2018)8628 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/048/17/T/01

Europe -DG Health and Food Safety

10-12-2018

EU/3/09/628 (Nova Laboratories Ireland Limited)

EU/3/09/628 (Nova Laboratories Ireland Limited)

EU/3/09/628 (Active substance: Mercaptopurine (oral suspension)) - Transfer of orphan designation - Commission Decision (2018)8629 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002301

Europe -DG Health and Food Safety

10-12-2018

EU/3/11/933 (Les Laboratoires Servier)

EU/3/11/933 (Les Laboratoires Servier)

EU/3/11/933 (Active substance: Nanoliposomal irinotecan) - Transfer of orphan designation - Commission Decision (2018)8625 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/051/11/T/02

Europe -DG Health and Food Safety

7-12-2018


Orphan designation: (1'R,6'R)-3-(benzylamine)-6-hydroxy-3'-methyl-4-pentyl-6'-(prop-1-en-2-yl)-[1,1'-bi(cyclohexane)]-2',3,6-triene-2,5-dione, Treatment of systemic sclerosis, 12/10/2017, Positive

Orphan designation: (1'R,6'R)-3-(benzylamine)-6-hydroxy-3'-methyl-4-pentyl-6'-(prop-1-en-2-yl)-[1,1'-bi(cyclohexane)]-2',3,6-triene-2,5-dione, Treatment of systemic sclerosis, 12/10/2017, Positive

Orphan designation: (1'R,6'R)-3-(benzylamine)-6-hydroxy-3'-methyl-4-pentyl-6'-(prop-1-en-2-yl)-[1,1'-bi(cyclohexane)]-2',3,6-triene-2,5-dione, Treatment of systemic sclerosis, 12/10/2017, Positive

Europe - EMA - European Medicines Agency

7-12-2018


Orphan designation: tiratricol, Treatment of Allan-Herndon-Dudley syndrome, 12/10/2017, Positive

Orphan designation: tiratricol, Treatment of Allan-Herndon-Dudley syndrome, 12/10/2017, Positive

Orphan designation: tiratricol, Treatment of Allan-Herndon-Dudley syndrome, 12/10/2017, Positive

Europe - EMA - European Medicines Agency

26-11-2018

In the next few months CDRH will make public on its website cleared devices that demonstrated substantial equivalence to older predicate devices. We’re considering focusing on predicates that are >10 years old as a starting point, so the public is aware o

In the next few months CDRH will make public on its website cleared devices that demonstrated substantial equivalence to older predicate devices. We’re considering focusing on predicates that are >10 years old as a starting point, so the public is aware o

In the next few months CDRH will make public on its website cleared devices that demonstrated substantial equivalence to older predicate devices. We’re considering focusing on predicates that are >10 years old as a starting point, so the public is aware of those technologies.

FDA - U.S. Food and Drug Administration

26-11-2018

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health te

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health te

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health technologies.

FDA - U.S. Food and Drug Administration

22-11-2018

Emtricitabine/Tenofovir disoproxil Krka (Krka d. d., Novo mesto)

Emtricitabine/Tenofovir disoproxil Krka (Krka d. d., Novo mesto)

Emtricitabine/Tenofovir disoproxil Krka (Active substance: emtricitabine / tenofovir disoproxil) - Centralised - 2-Monthly update - Commission Decision (2018)7884 of Thu, 22 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4215/IB/10G

Europe -DG Health and Food Safety

22-11-2018


Human medicines European public assessment report (EPAR): Symkevi, tezacaftor / ivacaftor, Cystic Fibrosis, Date of authorisation: 31/10/2018, Status: Authorised

Human medicines European public assessment report (EPAR): Symkevi, tezacaftor / ivacaftor, Cystic Fibrosis, Date of authorisation: 31/10/2018, Status: Authorised

Human medicines European public assessment report (EPAR): Symkevi, tezacaftor / ivacaftor, Cystic Fibrosis, Date of authorisation: 31/10/2018, Status: Authorised

Europe - EMA - European Medicines Agency

12-11-2018

Spinraza (Biogen Netherlands B.V.)

Spinraza (Biogen Netherlands B.V.)

Spinraza (Active substance: nusinersen) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7550 of Mon, 12 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4312/T/10

Europe -DG Health and Food Safety

23-10-2018

EU/3/16/1804 (Eli Lilly Nederland B.V.)

EU/3/16/1804 (Eli Lilly Nederland B.V.)

EU/3/16/1804 (Active substance: Pegylated recombinant human interleukin-10) - Transfer of orphan designation - Commission Decision (2018)6994 of Tue, 23 Oct 2018

Europe -DG Health and Food Safety

22-10-2018

EU/3/10/815 (Pfizer Europe MA EEIG)

EU/3/10/815 (Pfizer Europe MA EEIG)

EU/3/10/815 (Active substance: Sildenafil citrate) - Transfer of orphan designation - Commission Decision (2018)6993 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/068/10/T/01

Europe -DG Health and Food Safety

19-10-2018

Recocam (Bimeda Animal Health Limited)

Recocam (Bimeda Animal Health Limited)

Recocam (Active substance: Meloxicam) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6954 of Fri, 19 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2247/T/10

Europe -DG Health and Food Safety