Haldol 10 mg

Informazioni principali

  • Nome commerciale:
  • Haldol 10 mg Tabletten
  • Forma farmaceutica:
  • Tabletten
  • Composizione:
  • haloperidolum 10 mg, colore.: E 104, excipiens pro compresso.
  • Utilizzare per:
  • Esseri umani
  • Tipo di medicina:
  • Farmaco biologico

Documenti

  • per i professionisti:
  • Il foglio illustrativo per questo prodotto non è al momento disponibile, é possibile inviare una richiesta al nostro Servizio Clienti ed essere avvisati nel momento in cui è disponibile sulla nostra piattaforma.


    Richiedi il foglio illustrativo per i professionisti.

Localizzazione

  • Disponibile in:
  • Haldol 10 mg Tabletten
    Svizzera
  • Lingua:
  • italiano

Informazioni terapeutiche

  • Gruppo terapeutico:
  • Synthetika
  • Area terapeutica:
  • Neurolepticum

Altre informazioni

Status

  • Fonte:
  • Swissmedic - Swiss Agency for Therapeutic Products
  • Numero dell'autorizzazione:
  • 27304
  • Data dell'autorizzazione:
  • 18-10-1961
  • Ultimo aggiornamento:
  • 19-10-2018

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

Patienteninformation

Haldol®

Janssen-Cilag AG

Che cos'è Haldol e quando si usa?

Haldol fa parte del gruppo dei cosiddetti preparati «neurolettici». Haldol si usa in caso di alterazioni

del pensiero, della sensibilità o del comportamento, segnatamente: idee deliranti, insolita diffidenza,

allucinazioni (udire, vedere o percepire qualcosa che non c'è); confusione mentale; stati di forte

eccitazione.

Inoltre, si usa talvolta Haldol in caso di movimenti incontrollati come i tic nervosi accompagnati da

un notevole disturbo, nonché nei casi di nausea e vomito quando risultano inefficaci i medicamenti

solitamente utilizzati contro questi disturbi.

Haldol va usato esclusivamente su prescrizione medica.

Quando non si può usare Haldol?

In caso di ipersensibilità nota all'aloperidolo (principio attivo) o a una delle sostanze ausiliarie

contenute nella formulazione di Haldol.

Per i bambini al di sotto dei 3 anni.

Se lei soffre o ha sofferto in passato di paralisi agitante (morbo di Parkinson).

Dopo l'assunzione di alcool o di medicamenti che esplicano azione sedativa sul sistema nervoso.

Quando è richiesta prudenza nella somministrazione di Haldol?

Dovrebbe segnalare al medico se ha o ha avuto in passato una delle malattie di seguito elencate,

poiché potrebbe rendersi necessario un controllo più stretto delle sue condizioni di salute o la

somministrazione di altri medicamenti: cardiopatie; emorragia cerebrale; rischio di colpo apoplettico;

depressioni; problemi al fegato; epilessia o altre condizioni che potrebbero suscitare crisi (ad

esempio durante una cura di disassuefazione dall'alcool) o in caso di iperfunzione tiroidea

(ipertiroidismo), coaguli di sangue o coaguli di sangue nell'anamnesi familiare. Sono stati osservati

coaguli di sangue nei polmoni o nelle gambe nei pazienti che assumevano medicamenti antipsicotici.

Non consumare alcoolici durante una terapia con Haldol, poiché il farmaco potenzia l'azione

dell'alcool.

Possono verificarsi interazioni medicamentose fra Haldol e i seguenti farmaci: medicamenti che

rallentano i riflessi, in particolare sonniferi, calmanti, alcuni analgesici potenti, medicamenti

antidepressivi, medicamenti contro l'ipertensione arteriosa, medicamenti antiepilettici.

Deve quindi informare il medico se prende medicamenti di questo o di altro genere. Sarà il medico a

decidere quali medicamenti può prendere in associazione con Haldol.

Haldol può provocare sonnolenza e quindi ridurre la capacità di reazione, la capacità di condurre un

veicolo e la capacità di utilizzare attrezzi o macchine. Inoltre, Haldol può causare disturbi motori.

Non deve quindi manovrare macchine o guidare veicoli, finché il medico non abbia accertato come

lei reagisce al medicamento.

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

assume altri medicamenti (anche se acquistati di sua iniziativa!)

Si può somministrare Haldol durante la gravidanza o l'allattamento?

Se è incinta o sta programmando una gravidanza, non può prendere Haldol a meno che il medico non

glielo prescriva esplicitamente. Assumendo Haldol durante l'ultimo trimestre di gravidanza, nel

neonato possono manifestarsi tremore, rigidità muscolare, debolezza, sonnolenza, agitazione,

difficoltà respiratorie o problemi nell'alimentazione.

La preghiamo di informare il suo medico immediatamente in caso di gravidanza, per considerare

l'ulteriore procedere. Il trattamento non deve in nessun caso essere sospeso di propria iniziativa. Una

sospensione repentina può avere conseguenze severe.

Per favore, informi immediatamente anche il suo ginecologo o il personale ostetrico nel caso di

un'assunzione durante la gravidanza, in particolare se dopo la nascita suo figlio dovesse presentare le

manifestazioni su descritte.

Poiché Haldol passa nel latte materno, non si può prendere il medicamento durante l'allattamento o si

dovrebbe smettere di allattare.

Come usare Haldol?

Haldol è presentato sotto forma di compresse e gocce. Si può prendere il preparato durante i pasti o

fra un pasto e l'altro.

Si consiglia di inghiottire la compressa con un po' d'acqua.

Mescolare le gocce con un po' d'acqua o succo di frutta e bere la miscela.

Il medico modificherà il dosaggio finché troverà la quantità più opportuna per lei. Il medico le

indicherà esattamente quante compresse o quante gocce risp. quanti millilitri (ml) deve prendere. Di

solito si comincia il trattamento con una dose bassa che verrà poi aumentata fino a ottenere l'effetto

desiderato. È importante che lei si attenga esattamente alla posologia prescritta.

Osservazione importante

Può trascorrere qualche tempo prima che s'instauri la piena azione di Haldol. Termini la terapia solo

quando il medico glielo consente. Se sospende prematuramente la terapia senza il consenso del

medico, il suo problema può ripresentarsi. Se il medico le propone di smettere la cura, deve attenersi

esattamente alle sue istruzioni, poiché altrimenti potrebbero verificarsi ad esempio nausea e vomito.

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.

Istruzioni per l'apertura del flacone di vetro e per l'uso della pipetta dosatrice.

Istruzioni per l'apertura del flacone da 100 ml (100 ml di gocce da 2 mg/ml) e l'uso della siringa

dosatrice (cfr. illustrazioni alla fine del presente foglietto)

Fig. 1: il flacone è munito di una chiusura «a prova di bambino» e deve essere aperto nel modo

seguente:

Premere verso il basso il tappo di plastica girandolo contemporaneamente in senso antiorario.

Togliere il tappo di plastica dal flacone.

Assicurarsi che la parte inferiore dello stantuffo si trovi completamente al fondo della siringa

dosatrice (premere sull'anello superiore della siringa fino all'arresto).

Fig. 2: introdurre la siringa di plastica nel flacone. Tenere saldamente l'anello inferiore con una mano

e con l'altra tirare verso l'alto l'anello superiore della siringa fino a che sullo stantuffo, esattamente

all'altezza dell'anello inferiore della siringa, non appaia la tacca di graduazione desiderata in millilitri

(ml).

Fig. 3: estrarre con cautela la siringa dal flacone servendosi dell'anello inferiore.

Per svuotare il contenuto della siringa in un bicchiere d'acqua o di succo di frutta, spingere verso il

basso l'anello superiore della siringa fino all'arresto. Richiudere il flacone con il tappo di plastica.

Dopo ogni uso, pulire accuratamente la siringa dosatrice tirando fuori lo stantuffo dal cilindro e

sciacquando le due parti sotto acqua corrente. Dopo l'asciugatura riassemblare le parti della siringa,

lasciar asciugare e custodire in luogo asciutto.

Istruzioni per l'apertura del flacone in plastica

Il flacone in plastica contenente Haldol 2 mg/ml gocce 1× 30 ml è munito di una chiusura «a prova di

bambino» e deve essere aperto nel modo seguente: premere verso il basso la chiusura girandola

contemporaneamente in senso antiorario. Una volta aperta la chiusura conti il numero di gocce

necessario e le assuma con un po' di liquido.

Quali effetti collaterali può avere Haldol?

Durante il trattamento con Haldol possono verificarsi i seguenti effetti collaterali:

Molto frequentemente:

·stati di eccitazione.

·disturbi dell'addormentamento e del mantenimento del sonno.

·disturbi della coordinazione motoria o movimenti muscolari involontari (detti anche sintomi

extrapiramidali). I sintomi extrapiramidali possono includere movimenti lenti, rigidi o a scatto degli

arti, del collo, del viso, degli occhi o della bocca e della lingua, che possono tradursi in postura o

mimica insolita e involontaria.

·movimenti anomali eccessivi del corpo o degli arti.

·cefalea.

Frequentemente:

·umore triste o abbattuto.

·disturbi psicotici (quali idee deliranti, insolita diffidenza, allucinazioni).

·dopo un trattamento prolungato: scosse della lingua, del viso, della bocca o della mascella ed

eventualmente lenti movimenti vermiformi della lingua e della bocca, che possono associarsi anche a

una ridotta capacità di aprire completamente la bocca. Pur sospendendo la terapia, è probabile che

tutti questi sintomi non si risolvano.

·disturbi della coordinazione motoria e movimenti muscolari involontari, in particolare movimento

spastico del globo oculare in una posizione fissa, per lo più rivolta verso l'alto; rallentamento della

sequenza del movimento; movimenti a scatto, tremore, rigidità muscolare, contratture muscolari

associate a scosse e movimenti stereotipati o posture abnormi, viso privo di espressione;

deambulazione anomala, incapacità di stare fermi quando si è seduti.

·ipertensione arteriosa.

·vertigini.

·eccessiva sonnolenza.

·stordimento.

·disturbi visivi.

·pressione arteriosa patologicamente bassa (detta ipotensione); pressione arteriosa anormalmente

bassa alzandosi in piedi o cambiando posizione.

·stitichezza, secchezza della bocca, ipersalivazione, nausea, vomito.

·eruzione cutanea.

·incapacità di urinare.

·impotenza o disturbi dell'erezione.

·imprevisto aumento o calo di peso.

Occasionalmente:

·reazioni allergiche, ad esempio orticaria o tumefazione del viso.

·confusione mentale.

·calo del desiderio sessuale e della libido.

·mancanza di appetito.

·bruciore di stomaco.

·irrequietezza.

·convulsioni.

·sintomi simili a quelli del morbo di Parkinson.

·povertà di movimento.

·cedimento a scatti di un muscolo mobilizzato passivamente (fenomeno della ruota dentata).

·sedazione.

·contrazioni muscolari involontarie.

·visione sfocata.

·frequenza cardiaca patologicamente accelerata.

·difficoltà respiratorie (dispnea). Infiammazione del fegato (detta epatite); eccesso di componenti

della bile nel sangue con conseguente colorazione gialla della pelle, delle gengive e degli occhi

(ittero).

·fotosensibilità cutanea aumentata.

·prurito cutaneo.

·sudorazione eccessiva.

·disturbi mestruali quali dolori durante il ciclo e/o amenorrea (assenza di mestruazioni).

·secrezione di liquido dai capezzoli, sensibilità o dolori al seno.

·disturbi della deambulazione.

·aumento anomalo della temperatura corporea.

·gonfiore agli arti provocato da ritenzione idrica.

Raramente:

·produzione di latte nel seno.

·sindrome neurolettica maligna (emergenza medica che si accompagna a irrigidimento di tutto il

corpo e febbre alta). In questo caso, ci si deve rivolgere subito al medico curante.

·oscillazioni del bulbo oculare in direzione laterale, cui si accompagna la sensazione che l'ambiente

circostante stia ruotando attorno.

·restringimento delle vie respiratorie che si accompagna a respiro sibilante.

·perdite mestruali particolarmente abbondanti.

·disfunzione sessuale.

Molto raramente:

·possibile forte diminuzione del numero dei globuli del sangue responsabili per la difesa contro le

infezioni (globuli bianchi risp. piastrine).

·reazione allergica particolarmente accentuata che può accompagnarsi a:

·gonfiore del viso, delle labbra, della bocca, della lingua e della gola,

·difficoltà a inghiottire o respirare,

·eruzioni cutanee pruriginose (orticaria).

·disturbo nell'eliminazione dell'acqua attraverso le urine, e quindi possibile accumulo di liquidi nei

tessuti.

·diminuzione accentuata del tasso di zucchero nel sangue.

·battiti cardiaci aggiunti; contrazioni rapide ancora coordinate del miocardio; contrazioni rapide non

più coordinate del miocardio. Non trattate, queste contrazioni possono portare rapidamente alla

morte.

·tumefazione delle corde vocali e della laringe in seguito a ritenzione idrica, spasmi delle corde

vocali e della laringe.

·arresto della funzione epatica.

·formazione di piccole chiazze purpuree sulla pelle o su altri tessuti del corpo, in seguito a vasculite

(infiammazione dei vasi sanguigni), che talvolta si accompagnano a noduli doloranti; eruzione

cutanea con desquamazione dell'epidermide.

·Distruzione del tessuto muscolare (indicata come rabdomiolisi)

·ingrossamento della ghiandola mammaria anche nell'uomo.

·erezione prolungata anomala non associata a eccitazione sessuale.

·gonfiore al viso in seguito a ritenzione idrica.

·temperatura corporea anormalmente bassa.

·impiegando Haldol durante l'ultimo trimestre di gravidanza, nel neonato possono manifestarsi

tremore, rigidità muscolare, debolezza, sonnolenza, agitazione, difficoltà respiratorie o problemi

nell'alimentazione.

Altre informazioni importanti

I pazienti anziani affetti da demenza, che a causa di disturbi comportamentali necessitano di un

trattamento con Haldol, presentano un maggiore rischio di morte rispetto a quello dei pazienti non

trattati.

Se compaiono febbre alta, rigidità muscolare, respirazione affannosa, sudorazione anomala o

diminuzione della coscienza, dovrebbe darne subito notizia al medico. Potrebbe darsi che il suo

organismo non reagisca bene al medicamento.

Se osserva altri effetti collaterali qui non sono descritti, dovrebbe informare il suo medico o il suo

farmacista.

Di che altro occorre tener conto?

Conservare le compresse e le gocce di Haldol nella confezione originale chiusa (al riparo dalla luce),

a temperatura ambiente (15-25 °C) e fuori dalla portata dei bambini.

Il medicamento non dev'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 Haldol?

1 compressa di Haldol da 1 mg contiene come principio attivo 1 mg di aloperidolo, lattosio

monoidrato, olio di semi di cotone idrogenato (prodotto da semi di cotone geneticamente modificato)

e ulteriori sostanze ausiliarie.

1 compressa di Haldol da 10 mg contiene come principio attivo 10 mg di aloperidolo, colorante:

giallo di chinolina (E104) e altre sostanze ausiliarie.

1 ml di Haldol gocce da 2mg/ml contiene come principio attivo 2 mg di aloperidolo. Conservanti:

paraidrossibenzoato di metile (E218) nonché altre sostanze ausiliarie. 1 ml = 20 gocce.

Numero dell’omologazione

26891, 26892, 27304 (Swissmedic).

Dove è ottenibile Haldol? Quali confezioni sono disponibili?

In farmacia, dietro presentazione della prescrizione medica.

Haldol compresse da 1 mg: confezioni da 50 compresse.

Haldol compresse da 10 mg: confezioni da 20 compresse.

Haldol gocce da 2 mg/ml: confezioni da 30 ml (flacone di plastica) e da 100 ml (flacone di vetro).

Haldol gocce da 2 mg/ml in confezione da 30 ml è contenuto in un flacone di plastica munito di

contagocce. Le altre preparazioni di Haldol gocce sono disponibili in flacone di vetro, al quale è

accluso una siringa dosatrice separata (Haldol da 2 mg/ml, flacone da 100 ml), per facilitare il

corretto prelievo delle gocce.

Titolare dell’omologazione

Janssen-Cilag AG, Zugo, ZG.

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

competente in materia di medicamenti (Swissmedic).

Illustrazioni

30 ml – flacone di plastica munito di contagocce:

100 ml – flacone di vetro:

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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

10-10-2018

Enforcement Report for the Week of October 10, 2018

Enforcement Report for the Week of October 10, 2018

Recently Updated Records for the Week of October 10, 2018 Last Modified Date: Tuesday, October 09, 2018

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

26-9-2018

Kexxtone (Elanco GmbH)

Kexxtone (Elanco GmbH)

Kexxtone (Active substance: Monensin sodium) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6324 of Wed, 26 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2235/T/10

Europe -DG Health and Food Safety