MST Continus 10 mg

Informazioni principali

  • Nome commerciale:
  • MST Continus 10 mg Tabletten ritardo
  • Forma farmaceutica:
  • Tabletten ritardo
  • Composizione:
  • morphini zolfo pentahydricus 10 mg corrisp. morphinum 7.5 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:
  • MST Continus 10 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).

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Draft ezetimibe tablet 10 mg product-specific bioequivalence guidance

Draft ezetimibe tablet 10 mg product-specific bioequivalence guidance

Draft ezetimibe tablet 10 mg product-specific bioequivalence guidance

Europe - EMA - European Medicines Agency

14-12-2018

Risk to human health related to the presence of perfluorooctane sulfonic acid and perfluorooctanoic acid in food

Risk to human health related to the presence of perfluorooctane sulfonic acid and perfluorooctanoic acid in food

Published on: Thu, 13 Dec 2018 The European Commission asked EFSA for a scientific evaluation on the risks to human health related to the presence of perfluorooctane sulfonic acid (PFOS) and perfluorooctanoic acid (PFOA) in food. Regarding PFOS and PFOA occurrence, the final data set available for dietary exposure assessment contained a total of 20,019 analytical results (PFOS n = 10,191 and PFOA n = 9,828). There were large differences between upper and lower bound exposure due to analytical methods with i...

Europe - EFSA - European Food Safety Authority Publications

12-12-2018

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

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

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

24-10-2018

Vita Health Products Recall (2018-10-24)

Vita Health Products Recall (2018-10-24)

Health Canada

16-1-2019

EU/3/10/833 (FGK Representative Service GmbH)

EU/3/10/833 (FGK Representative Service GmbH)

EU/3/10/833 (Active substance: Doxorubicin hydrochloride (in heat-sensitive liposomes)) - Transfer of orphan designation - Commission Decision (2019)237 of Wed, 16 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003113

Europe -DG Health and Food Safety

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

10-1-2019

Strensiq (Alexion Europe SAS)

Strensiq (Alexion Europe SAS)

Strensiq (Active substance: asfotase alfa) - Centralised - Yearly update - Commission Decision (2019)69 of Thu, 10 Jan 2019

Europe -DG Health and Food Safety

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

21-11-2018

EU/3/10/726 (Pfizer Europe MA EEIG)

EU/3/10/726 (Pfizer Europe MA EEIG)

EU/3/10/726 (Active substance: Taliglucerase alfa) - Transfer of orphan designation - Commission Decision (2018)7830 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/OD/125/09/T/02

Europe -DG Health and Food Safety

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