Clopixol 10 mg

Informazioni principali

  • Nome commerciale:
  • Clopixol 10 mg Filmdragées
  • Forma farmaceutica:
  • Filmdragées
  • Composizione:
  • zuclopenthixolum 10 mg ut zuclopenthixoli dihydrochloridum, 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:
  • Clopixol 10 mg Filmdragées
    Svizzera
  • Lingua:
  • italiano

Informazioni terapeutiche

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

Altre informazioni

Status

  • Fonte:
  • Swissmedic - Swiss Agency for Therapeutic Products
  • Numero dell'autorizzazione:
  • 44744
  • Data dell'autorizzazione:
  • 06-12-1982
  • Ultimo aggiornamento:
  • 19-10-2018

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

Patienteninformation

Clopixol®

Lundbeck (Schweiz) AG

Che cos'è Clopixol e quando si usa?

Clopixol contiene il principio attivo zuclopentixolo e appartiene al gruppo di medicamenti cosiddetti

neurolettici. Clopixol si usa per la terapia di malattie psichiche in cui ci sono problemi a livello di

pensiero, sensazioni e/o azioni. Ne sono tipici sintomi stati confusionali, allucinazioni (udire o

vedere cose che effettivamente non ci sono) e idee deliranti. Inoltre è possibile che i pazienti siano

ansiosi, tesi o aggressivi. Clopixol ha effetto calmante ed elimina gli stati ansiosi e le sensazioni di

tensione interna. Clopixol si può usare solamente su prescrizione del medico.

Quando non si può usare Clopixol?

Clopixol non si può usare in caso di ipersensibilità al principio attivo o a una delle sostanze ausiliarie

di Clopixol, oppure a un principio attivo simile, in caso di intossicazione da alcool, sonniferi e

oppiacei.

Quando è richiesta prudenza nella somministrazione di Clopixol?

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

capacità di utilizzare attrezzi o macchine!

Clopixol può ridurre la capacità di concentrazione e potenziare l'effetto dell'alcool, per cui durante la

terapia è opportuno rinunciare all'alcool.

Se nel corso della terapia si manifestano stanchezza, inappetenza, nausea, prurito, un'eruzione sulla

pelle o colorazione gialla della pelle deve avvertire subito il medico.

Questi sintomi possono essere conseguenza di un'infiammazione del fegato che occasionalmente è

causata da Clopixol (cosiddetta epatite medicamentosa). Essi richiedono accertamenti da parte del

medico.

Clopixol deve essere usato con prudenza nei pazienti che soffrono di disfunzioni del fegato o dei

reni, di malattie cardiovascolari (soprattutto pressione sanguigna troppo bassa o disturbi del ritmo

cardiaco), di miastenia grave (debolezza muscolare patologica con maggior facilità all'affaticamento

della muscolatura volontaria), di malattia di Parkinson, di epilessia o di malattie organiche del

cervello, nonché nei pazienti con fattori di rischio di ictus (p. es. fumo, ipertensione), con diabete (la

terapia antidiabetica va eventualmente modificata), o con livelli ematici di potassio o magnesio

troppo bassi o con predisposizione genetica a valori troppo bassi.

Informi il suo medico nel caso in cui lei o qualcuno dei suoi familiari soffre di coaguli del sangue.

Clopixol può potenziare l'effetto di altri medicamenti ad azione deprimente sul sistema nervoso (per

esempio sonniferi, calmanti, forti analgesici, antidepressivi). L'uso concomitante di altri neurolettici

deve essere evitato. L'effetto di farmaci contro la pressione sanguigna troppo alta o troppo bassa può

essere modificato, quello di medicamenti contro la malattia di Parkinson può essere diminuito. In

questi casi spetta al medico decidere quali farmaci si possono prendere contemporaneamente a

Clopixol.

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!)

Informi il suo medico o il suo farmacista nel caso in cui prende uno dei seguenti medicamenti:

·Antidepressivi triciclici

·Litio

·Farmaci antipertensivi

·Medicamenti ad azione deprimente centrale e barbiturici (medicamenti che possono provocare

sonnolenza)

·Antiepilettici

·Levodopa e medicamenti simili per il trattamento della malattia di Parkinson

·Metoclopramide contro i disturbi gastrointestinali

·Alcuni antibiotici

·Medicamenti che influiscono sull'equilibrio idrico o salino (valori ematici di potassio o magnesio

troppo bassi)

·Medicamenti che possono aumentare la concentrazione di Clopixol nel sangue

·Adrenergici (medicamenti con effetti analoghi a quelli dell'adrenalina)

·Antistaminici (trattamento di malattie/reazioni allergiche, prurito)

I seguenti medicamenti non devono essere assunti in concomitanza con Clopixol:

·Medicamenti che alterano la frequenza cardiaca

·Altri neurolettici

C'è la possibilità, che la sessualità rispettivamente la fertilità possano essere compromesse dal

trattamento con Clopixol (vedi «Quali effetti collaterali può avere Clopixol?»). Si prega di consultare

il medico.

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

Se è incinta, presume di esserlo, prevede una gravidanza oppure allatta lo comunichi al suo medico.

Se si utilizza Clopixol durante l'ultimo trimestre di gravidanza, nel neonato possono comparire

tremore, rigidità muscolare, debolezza, sonnolenza, agitazione, difficoltà respiratoria o problemi di

alimentazione.

Informi immediatamente il suo medico in caso di gravidanza, in modo da decidere come procedere.

In nessun caso il trattamento deve essere interrotto di propria iniziativa. L'interruzione improvvisa di

Clopixol può avere conseguenze gravi.

Informi immediatamente anche il suo ginecologo o il suo ostetrico in caso di assunzione del

medicamento durante la gravidanza, in particolare se, dopo il parto, il suo bambino manifesta i

disturbi descritti.

Clopixol non si deve prendere durante la gravidanza se non espressamente prescritto dal medico.

Durante l'allattamento non si deve prendere Clopixol. Se fosse tuttavia necessario, bisogna

interrompere l'allattamento.

Come usare Clopixol?

Clopixol è un medicamento di grande efficacia. Il medico adegua la posologia personalmente ad ogni

paziente e giudica quanto deve durare la terapia. Bisogna attenersi rigorosamente alla prescrizione

del medico. La posologia di Clopixol dipende dal tipo e dalla gravità della malattia. All'inizio della

terapia si individua la dose ottimale aumentando gradualmente la dose (ogni 2-3 giorni). Di norma

Clopixol si prende a diverse riprese nel corso della giornata.

Clopixol gocce (20 mg/ml) va preso mescolato solamente con acqua, succo d'arancia o succo di

mele.

Nei casi acuti il medico può iniziare la terapia con Clopixol Acutard (soluzione per iniezioni). Per la

terapia a lunga scadenza il medico può passare a Clopixol Depot (soluzione per iniezioni

somministrata ogni 2-4 settimane).

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.

Clopixol non deve essere somministrato ai pazienti di meno di 18 anni.

Quali effetti collaterali può avere Clopixol?

Se osserva uno dei seguenti sintomi, si rivolga immediatamente al medico o si rechi in ospedale.

Non comuni:

·Movimenti insoliti di bocca e lingua; potrebbe trattarsi di un segno precoce di un disturbo motorio

(discinesia tardiva).

Molto rari:

·Febbre alta, insolita rigidità muscolare e disturbi della coscienza, se si manifestano insieme a

sudorazione e battito cardiaco accelerato, questo potrebbe essere segni di un quadro clinico raro e

grave (sindrome neurolettica maligna).

·Una colorazione gialla della pelle e degli occhi potrebbe indicare un interessamento del fegato e

costituire un segno di ittero.

I seguenti effetti collaterali sono più pronunciati all'inizio del trattamento e diminuiscono

gradualmente fino a scomparire proseguendo la terapia:

Molto comuni:

·Sonnolenza, incapacità di stare seduti tranquillamente o di rimanere immobili, movimenti

involontari, movimenti lenti o ridotti

·Secchezza della bocca

Comuni:

·Palpitazioni, battito cardiaco accelerato, più forte o irregolare

·Tremore, ripetute rotazioni degli arti, movimenti ripetuti o postura anormale a causa di tensione

muscolare persistente, aumento della rigidità muscolare, vertigini, mal di testa, formicolii, fitte o

insensibilità della pelle, attenzione ridotta, perdita di memoria, andatura anormale

·Difficoltà nel mettere a fuoco gli oggetti, disturbi della vista

·Senso di vertigine

·Naso chiuso, respirazione difficile o dolorosa

·Aumento del flusso salivare, stitichezza, vomito, problemi digestivi o disturbi dell'addome

superiore, diarrea

·Difficoltà ad urinare, ritenzione urinaria, aumento del volume urinario

·Aumento della sudorazione, prurito

·Dolori muscolari

·Aumento dell'appetito, aumento del peso corporeo

·Stanchezza, debolezza, malessere, dolori

·Insonnia, depressione, stati d'ansia, nervosismo, sogni anomali, eccitazione, diminuzionedel

desiderio sessuale

Non comuni:

·Riflessi accentuati, movimenti bruschi, parkinsonismo, svenimenti, difficoltà di coordinazione dei

movimenti, disturbi della parola, diminuzione della tensione muscolare, crampi, emicrania

·Rotazione degli occhi, dilatazione delle pupille

·Ipersensibilità verso determinate frequenze sonore o rumori comuni, tinnito (ronzio auricolare)

·Dolori all'addome, nausea, meteorismo

·Eruzioni cutanee, sensibilità della cute alla luce, disturbi della pigmentazione, pelle grassa, lucida e

giallastra a causa di un aumento della produzione di sebo, eczemi o infiammazioni cutanee,

emorragie sottocutanee con colorazione rossastra o violacea della pelle

·Rigidità muscolare, difficoltà ad aprire normalmente la bocca, postura anomala della testa

·Diminuzione dell'appetito, diminuzione del peso corporeo

·Pressione arteriosa bassa, calo della pressione arteriosa nel cambio di posizione (p. es. alzandosi in

piedi rapidamente), vampate di calore

·Sete, temperatura corporea bassa, febbre

·Alterazioni del fegato

·Disturbi sessuali (eiaculazione ritardata, disturbi dell'erezione, disturbi nell'orgasmo femminile,

secchezza della vagina)

·Marcata indifferenza verso l'ambiente circostante, incubi, aumento del desiderio sessuale, stati

confusionali

Rari:

·Alterazioni del quadro ematico (diminuzione del numero dei globuli bianchi e delle piastrine)

·Aumento del livello ematico dell'ormone prolattina

·Glicemia elevata, ridotta tolleranza allo zucchero, aumento dei lipidi del sangue

·Ipersensibilità, reazioni allergiche acute

·Ingrossamento delle ghiandole mammarie maschili, secrezione lattea, disturbi mestruali, erezione

permanente e dolorosa in assenza di eccitazione o desiderio sessuale

·Battito cardiaco lento e alterazioni dell'ECG

·Battito cardiaco irregolare

In rari casi un'aritmia cardiaca potrebbe provocare la morte improvvisa.

I coaguli del sangue nelle vene, soprattutto in quelle nelle gambe (i sintomi comprendono gonfiore,

dolore e arrossamento della gamba), che tramite il circolo sanguigno arrivano ai polmoni, possono

causare dolore al petto o difficoltà respiratorie. Se nota uno di questi sintomi, consulti

immediatamente il suo medico.

É stato registrato un lieve aumento dei decessi di persone anziane con demenza che assumono

antipsicotici, rispetto a quelle che non ne assumono.

Se si utilizza Clopixol durante l'ultimo trimestre di gravidanza, nel neonato possono comparire

tremore, rigidità muscolare, debolezza, sonnolenza, agitazione, difficoltà respiratoria o problemi di

alimentazione.

Se gli effetti collaterali aumentano di intensità o se osserva effetti collaterali qui non descritti

dovrebbe informare il suo medico o il suo farmacista.

Di che altro occorre tener conto?

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

farmacia i confetti non utilizzati o scaduti affinché vengano eliminati.

Conservare i confetti a temperatura ambiente (15-25 °C).

Conservare le gocce in frigorifero (2-8 °C). Dopo la prima apertura del flacone, il Clopixol gocce è

valido per 6 settimane se conservato a temperatura inferiore a 25 °C. Per proteggere il contenuto

dalla luce, tenere il flacone nell'imballaggio originale.

Clopixol gocce contiene 14 vol.% d'alcool.

Conservare fuori dalla portata dei bambini.

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

darle ulteriori informazioni.

Cosa contiene Clopixol?

1 confetto contiene 2 mg, 10 mg risp. 25 mg di zuclopentixolo sotto forma di zuclopentixolo

dicloridrato. Eccipienti: amido di patate, lattosio, cellulosa microcristallina, copovidone, glicerina,

talco, olio di ricino, stearato di magnesio. Rivestimento: ipromellosa, macrogol, coloranti: titanio

biossido (E171), ossido di ferro (E172).

Aspetto dei confetti:

I confetti sono rotondi, biconvessi e di colori diversi: 2 mg rosso pallido/10 mg rosso-marrone

tenue/25 mg rosso-marrone.

1 ml di gocce contiene 20 mg di zuclopentixolo sotto forma di zuclopentixolo dicloridrato, alcool

(14.2 vol. % - 120 mg/ml), acqua depurata. 20 gocce = 1 ml.

Aspetto delle gocce:

Chiara, da quasi incolore a giallognola, soluzione inodore con un sapore leggermente amaro.

Numero dell’omologazione

Confetti 44744, Gocce 44747 (Swissmedic).

Dove è ottenibile Clopixol? Quali confezioni sono disponibili?

In farmacia, dietro presentazione della prescrizione medica.

Sono disponibili le confezioni seguenti:

Confetti da 2 mg: confezioni da 100.

Confetti da 10 mg: confezioni da 50.

Confetti da 25 mg: confezioni da 50.

Gocce 20 mg/ml: 20 ml.

Titolare dell’omologazione

Lundbeck (Suisse) SA, Opfikon.

Questo foglietto illustrativo è stato controllato l’ultima volta nel marzo 2014 dall’autorità competente

in materia di medicamenti (Swissmedic).

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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