Dalmadorm mite

Informazioni principali

  • Nome commerciale:
  • Dalmadorm mite Filmtabletten
  • Forma farmaceutica:
  • Filmtabletten
  • Composizione:
  • flurazepami monohydrochloridum 15 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:
  • Dalmadorm mite Filmtabletten
    Svizzera
  • Lingua:
  • italiano

Informazioni terapeutiche

  • Gruppo terapeutico:
  • Synthetika
  • Area terapeutica:
  • Schlafmittel

Altre informazioni

Status

  • Fonte:
  • Swissmedic - Swiss Agency for Therapeutic Products
  • Numero dell'autorizzazione:
  • 40536
  • Data dell'autorizzazione:
  • 25-01-1977
  • Ultimo aggiornamento:
  • 19-10-2018

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

Patienteninformation

Dalmadorm® compresse rivestite

MEDA Pharmaceuticals Switzerland GmbH

Che cos'è Dalmadorm e quando si usa?

Dalmadorm le è stato prescritto dal medico e deve essere assunto unicamente secondo le sue

istruzioni. Il principio attivo di Dalmadorm è il flurazepam, che appartiene al gruppo delle

benzodiazepine. Dalmadorm ha un effetto pronunciato di induzione del sonno e procura un sonno

che dura da sei a otto ore. Il suo medico le prescrive Dalmadorm, se lei soffre di una delle seguenti

forme di disturbi del sonno: difficoltà ad addormentarsi, frequenti risvegli nel corso della notte,

risveglio prematuro al mattino, disturbi del sonno associati a stati ansiosi o conseguenti a malattie

croniche.

Di che cosa occorre inoltre tener conto durante il trattamento?

Non tutti i disturbi del sonno necessitano di una terapia con medicamenti. Spesso basta modificare le

abitudini di vita e l'ambiente che ci circonda per ritrovare un sonno riposante.

Quando non si può assumere Dalmadorm?

Dalmadorm non deve essere usato in caso di:

·ipersensibilità al principio attivo flurazepam, ad altre benzodiazepine o a uno degli altri componenti

del medicamento,

·grave debolezza muscolare (miastenia grave),

·gravi malattie dei polmoni o grave compromissione della funzione respiratoria,

·sospensione del respiro durante il sonno (sindrome da apnea del sonno),

·gravi disturbi psichiatrici (stati ansiosi, disturbi compulsivi, psicosi),

·gravi disturbi della funzione del fegato.

Quando è richiesta prudenza nell'uso di Dalmadorm?

Assuefazione

Dopo l'assunzione per alcune settimane, può comparire un certo grado di perdita dell'effetto

favorente il sonno.

Dipendenza

L'assunzione di Dalmadorm può condurre, come gli altri preparati a base di benzodiazepine, a

dipendenza. Questa può comparire soprattutto in caso di assunzione prolungata senza interruzioni (in

alcuni casi già dopo qualche settimana) e in seguito ad assunzione di dosi più elevate. Il rischio è

maggiore in caso di dipendenza dall'alcool o dalle droghe e di determinate malattie psichiatriche.

Per ridurre al minimo il rischio di sviluppo di una dipendenza, osservi le seguenti avvertenze:

·prenda Dalmadorm solo su prescrizione medica;

·non aumenti mai la dose prescritta dal medico;

·informi il suo medico se intende sospendere l'assunzione del medicamento; nel trattamento a lungo

termine, si accomanda di ridurre gradualmente la dose;

·il medico deciderà periodicamente se il trattamento va continuato;

·l'assunzione a lungo termine (di regola oltre le quattro settimane) può avvenire solo sotto stretto

controllo medico;

·i bambini e gli adolescenti non devono assumere il preparato, tranne quando il medico non lo ritenga

necessario.

Sintomi di astinenza

Una brusca interruzione può causare la comparsa di sintomi di astinenza, persino quando il

medicamento è stato assunto per poco tempo e in dosi normali. Possono comparire depressioni,

nervosismo, debolezza muscolare, ansia insolita, stati di tensione, tremore, irrequietezza, confusione,

alterazioni dell'umore, ricomparsa dei disturbi del sonno, irritabilità, sudorazione, diarrea, mal di

testa, nonché crampi muscolari e addominali. In casi gravi, possono comparire anche: alterata

percezione dell'ambiente circostante, depersonalizzazione, intorpidimento e formicolii alle braccia e

alle gambe, ipersensibilità alla luce, ai rumori e al contatto fisico, allucinazione e crisi epilettiche. In

rari casi, la sospensione dopo un dosaggio elevato può provocare anche la comparsa di stati

confusionali, disturbi di tipo psicotico e crisi convulsive. La comparsa dei sintomi di astinenza può

variare, a seconda della durata dell'effetto della sostanza, da un paio d'ore a oltre una settimana

dall'interruzione della terapia.

Ricomparsa di insonnia e ansia in forma aggravata

Alla sospensione del trattamento, possono ricomparire in forma transitoria e aggravata gli stessi

sintomi che avevano portato al trattamento con Dalmadorm. Essi possono essere accompagnati da

altre reazioni, quali alterazioni dell'umore, ansia, disturbi del sonno e agitazione.

Disturbi della memoria

L'assunzione di benzodiazepine (tra cui il principio attivo di Dalmadorm) può causare vuoti di

memoria. Questo fenomeno compare di solito 1-2 ore dopo l'assunzione e può durare parecchie ore.

Ciò significa che lei potrebbe fare delle cose di cui in seguito potrebbe non ricordarsi più. Questo

rischio aumenta con l'aumentare del dosaggio e in caso di concomitante consumo di alcool. Un sonno

ininterrotto e di durata sufficiente (7-8 ore) può ridurre questo rischio. In caso di risveglio nel

momento di massimo effetto del medicamento, la capacità di memoria può essere limitata.

Reazioni psichiatriche e «paradosse»

In seguito all'assunzione di benzodiazepine, soprattutto nei pazienti anziani e nei bambini, possono

comparire reazioni psichiatriche e cosiddette reazioni «paradosse», cioè reazioni contrarie all'effetto

auspicato del medicamento, quali ad esempio aggressività, eccitazione, confusione, agitazione,

eccitabilità, irritabilità, idee deliranti, accessi di collera, incubi, allucinazioni, psicosi,

comportamento inadeguato e altri disturbi del comportamento. Possono emergere depressioni già

presenti in forma latente, con tendenza al suicidio. In tali casi, si deve interrompere il trattamento con

questo medicamento.

Il passaggio da un medicamento a base di benzodiazepine a un altro deve avvenire esclusivamente su

prescrizione medica.

Informi il suo medico in caso di eventuali malattie del cuore, delle vie respiratorie, dei reni o del

fegato e qualora manifesti o abbia manifestato in passato una dipendenza da alcool, da medicamenti

o da stupefacenti.

A causa dell'effetto rilassante sulla muscolatura, può aumentare il rischio di cadute e di conseguenti

fratture, soprattutto nelle persone anziane che hanno l'abitudine di alzarsi durante la notte.

Le bevande alcoliche potenziano l'effetto di Dalmadorm. Le reazioni individuali non sono

prevedibili. Queste potrebbero essere, ad esempio, poco accurate, maldestre o lente. È meglio,

quindi, rinunciare completamente alle bevande alcoliche durante la terapia con Dalmadorm.

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

capacità di utilizzare attrezzi o macchine. Se la durata del sonno è insufficiente, aumenta

ulteriormente il rischio di compromissione dello stato di vigilanza.

Assuma altri medicamenti contemporaneamente a Dalmadorm solo se il suo medico è d'accordo.

Possono potenziare l'azione di Dalmadorm: altri sonniferi, i medicamenti che agiscono su cervello,

nervi e psiche, i tranquillanti, i medicamenti contro gli stati ansiosi o le depressioni, diversi

antidolorifici, le sostanze miorilassanti, i medicamenti contro le allergie, i medicamenti contro

l'epilessia, i narcotici, gli antipertensivi e i betabloccanti.

L'associazione con potenti antidolorifici (p. es. oppiacei) può provocare un'euforia accentuata

(eccessiva esaltazione dell'umore) e, quindi, a una dipendenza psichica più rapida.

Anche altri principi attivi possono potenziare l'azione delle benzodiazepine e dei principi attivi simil-

benzodiazepinici. Ad esempio i medicamenti contro l'acidità di stomaco (la cimetidina o gli inibitori

della pompa protonica quali l'omeprazolo), i medicamenti utilizzati in caso di dipendenza dall'alcool

(p. es. il disulfiram/Antabus®) o gli antiepilettici (p. es. le idantoine o i barbiturici). L'associazione di

questi antiepilettici con Dalmadorm può aumentare anche la comparsa degli effetti indesiderati di

Dalmadorm.

I medicamenti quali la teofillina o l'aminofillina e determinati medicamenti contro gravi malattie

infettive (p. es. la rifampicina contro la tubercolosi) possono influenzare l'azione o la durata

dell'effetto delle benzodiazepine.

Informi il suo medico o il suo farmacista nel caso in cui

·soffra di altre malattie,

·soffra di allergie o

·assuma altri medicamenti (anche se acquistati di sua iniziativa).

Si può usare Dalmadorm durante la gravidanza o l'allattamento?

Informi il suo medico, se è in gravidanza, se desidera una gravidanza o se è in allattamento.

Se è incinta o prevede una gravidanza, può prendere Dalmadorm esclusivamente dopo aver

consultato il medico. Dalmadorm passa nel latte materno; perciò, durante l'allattamento deve

rinunciare a prendere Dalmadorm, altrimenti il suo bambino potrebbe manifestare riduzione dello

stimolo a succhiare o sonnolenza.

Come usare Dalmadorm?

Adulti

Di regola il medico prescrive 15 o 30 mg di Dalmadorm. Per persone anziane o debilitate bastano di

solito 15 mg al giorno.

Bambini e adolescenti

Dalmadorm non è destinato all'uso nei bambini e negli adolescenti.

Le compresse rivestite Dalmadorm si prendono poco prima di coricarsi, preferibilmente con acqua.

Le compresse rivestite presentano una linea di frattura decorativa. Esse possono essere dimezzate per

facilitarne l'assunzione, non per somministrare la metà della dose. Spetta al suo medico stabilire la

durata della terapia con Dalmadorm.

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 Dalmadorm?

Comuni: apatia, sonnolenza durante il giorno, riduzione dell'attenzione, disturbi della coordinazione

motoria, stordimento, capogiri, mal di testa, alterazioni del gusto, debolezza muscolare (che può

aumentare il rischio di cadute e di conseguenti fratture), stanchezza.

Occasionali: persistente inibizione del sistema nervoso (sedazione) negli anziani e nei pazienti

debilitati, stati confusionali.

Rari: reazioni di ipersensibilità, stati di eccitazione paradossa, disturbi visivi (visione doppia),

vertigini rotatorie, pressione arteriosa bassa, inibizione della respirazione (specialmente di notte),

disturbi gastrointestinali, nausea, sapore amaro in bocca, reazioni cutanee (eruzioni), ritenzione

urinaria, disturbi dell'impulso sessuale.

Molto rari: ittero.

Frequenza non nota: alterazioni del quadro ematico, confusione, dipendenza, sindrome di astinenza,

ricomparsa in forma aggravata dei sintomi originari in seguito a sospensione, depressione, reazioni

paradosse quali ansia, disturbi del sonno, insonnia, incubi, agitazione, eccitazione, irritabilità,

aggressività, idee deliranti, disturbi di tipo psicotico, comportamento anormale, disturbi emozionali,

tentativi di suicidio, pensieri di suicidio, disturbi della sequenza dei movimenti, vuoti di memoria

dopo l'assunzione.

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 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 Dalmadorm?

Dalmadorm: 1 compressa rivestita con linea di frattura decorativa (giallo ocra) contiene, come

principio attivo, 30 mg di flurazepam cloridrato.

Dalmadorm mite: 1 compressa rivestita con linea di frattura decorativa (giallo ocra) contiene, come

principio attivo, 15 mg di flurazepam cloridrato.

Sostanze ausiliarie

Amido di mais, mannitolo, cellulosa microcristallina, talco, ipromellosa, acido stearico, magnesio

stearato.

Nel film di rivestimento: ipromellosa, talco, etilcellulosa, macrogol 400, macrogol 6000, sostanze

coloranti: ossido di ferro e idrossido di ferro (E 172), titanio diossido (E 171).

Numero dell'omologazione

40536 (Swissmedic).

Dov'è ottenibile Dalmadorm? Quali confezioni sono disponibili?

In farmacia, dietro presentazione della prescrizione medica.

Dalmadorm: compresse rivestite (con linea di frattura decorativa) da 30 mg: 10, 30, 100.

Dalmadorm mite: compresse rivestite (con linea di frattura decorativa) da 15 mg: 10, 30, 100.

Titolare dell’omologazione

MEDA Pharmaceuticals Switzerland GmbH, 8602 Wangen-Brüttisellen.

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 -DG Health and Food Safety

12-12-2018

TGA operations over the holiday period 2018-19

TGA operations over the holiday period 2018-19

The TGA will have limited operations from Monday 24 December 2018 until Wednesday 2 January 2018

Therapeutic Goods Administration - Australia

11-12-2018

Rubraca (Clovis Oncology Ireland Limited)

Rubraca (Clovis Oncology Ireland Limited)

Rubraca (Active substance: rucaparib) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8686 of Tue, 11 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4272/T/5

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/3/17/1906 (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/3/09/628 (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

29-11-2018

alli (GlaxoSmithKline Dungarvan Limited)

alli (GlaxoSmithKline Dungarvan Limited)

alli (Active substance: Orlistat) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8041 of Thu, 29 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/854/T/59

Europe -DG Health and Food Safety

29-11-2018

Inflacam (Chanelle Pharmaceuticals Manufacturing Limited)

Inflacam (Chanelle Pharmaceuticals Manufacturing Limited)

Inflacam (Active substance: Meloxicam) - Centralised - Variation - Commission Decision (2018)8036 of Thu, 29 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2497/X/15

Europe -DG Health and Food Safety

28-11-2018

Zeffix (GlaxoSmithKline (Ireland) Limited)

Zeffix (GlaxoSmithKline (Ireland) Limited)

Zeffix (Active substance: Lamivudine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8044 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/242/T/73

Europe -DG Health and Food Safety

28-11-2018

Orkambi (Vertex Pharmaceuticals (Ireland) Limited)

Orkambi (Vertex Pharmaceuticals (Ireland) Limited)

Orkambi (Active substance: Lumacaftor/Ivacaftor) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8042 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3954/T/39

Europe -DG Health and Food Safety

28-11-2018

GILENYA (Novartis Europharm Limited)

GILENYA (Novartis Europharm Limited)

GILENYA (Active substance: Fingolimod) - Centralised - Variation - Commission Decision (2018)7969 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2202/X/44

Europe -DG Health and Food Safety

28-11-2018

Kalydeco (Vertex Pharmaceuticals (Ireland) Limited)

Kalydeco (Vertex Pharmaceuticals (Ireland) Limited)

Kalydeco (Active substance: ivacaftor) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8047 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2494/T/71

Europe -DG Health and Food Safety

26-11-2018

Atripla (Bristol-Myers Squibb and Gilead Sciences Limited)

Atripla (Bristol-Myers Squibb and Gilead Sciences Limited)

Atripla (Active substance: efavirenz / emtricitabine / tenofovir disoproxil fumarate) - Centralised - 2-Monthly update - Commission Decision (2018)7982 of Mon, 26 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/797/II/130

Europe -DG Health and Food Safety

26-11-2018

Nyxoid (Mundipharma Corporation (Ireland) Limited)

Nyxoid (Mundipharma Corporation (Ireland) Limited)

Nyxoid (Active substance: naloxone) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7966 of Mon, 26 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4325/T/04

Europe -DG Health and Food Safety

26-11-2018

TAKHZYRO (Shire Pharmaceuticals Ireland Limited)

TAKHZYRO (Shire Pharmaceuticals Ireland Limited)

TAKHZYRO (Active substance: lanadelumab) - Centralised - Authorisation - Commission Decision (2018)7971 of Mon, 26 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/004806/0000

Europe -DG Health and Food Safety

22-11-2018

Brineura (BioMarin International Limited)

Brineura (BioMarin International Limited)

Brineura (Active substance: cerliponase alfa) - Centralised - Yearly update - Commission Decision (2018)7885 of Thu, 22 Nov 2018

Europe -DG Health and Food Safety

22-11-2018

Incruse Ellipta (GlaxoSmithKline (Ireland) Limited)

Incruse Ellipta (GlaxoSmithKline (Ireland) Limited)

Incruse Ellipta (Active substance: umeclidinium bromide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7876 of Thu, 22 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2809/T/22

Europe -DG Health and Food Safety

22-11-2018

Levetiracetam Hospira (Hospira UK Limited)

Levetiracetam Hospira (Hospira UK Limited)

Levetiracetam Hospira (Active substance: levetiracetam) - Centralised - Renewal - Commission Decision (2018)7895 of Thu, 22 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2783/R/18

Europe -DG Health and Food Safety

22-11-2018

Vabomere (Rempex London Limited)

Vabomere (Rempex London Limited)

Vabomere (Active substance: meropenem/vaborbactam) - Centralised - Authorisation - Commission Decision (2018)7888 of Thu, 22 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4669/00

Europe -DG Health and Food Safety

21-11-2018

Rheumocam (Chanelle Pharmaceuticals Manufacturing Limited)

Rheumocam (Chanelle Pharmaceuticals Manufacturing Limited)

Rheumocam (Active substance: Meloxicam) - Centralised - Variation - Commission Decision (2018)7841 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/121/X/22

Europe -DG Health and Food Safety

21-11-2018

EU/3/15/1567 (TMC Pharma (EU) Limited)

EU/3/15/1567 (TMC Pharma (EU) Limited)

EU/3/15/1567 (Active substance: Recombinant human interleukin-3 truncated diphtheria toxin fusion protein) - Transfer of orphan designation - Commission Decision (2018)7816 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/064/15/T/02

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2102 (IQVIA RDS Ireland Limited)

EU/3/18/2102 (IQVIA RDS Ireland Limited)

EU/3/18/2102 (Active substance: Apraglutide) - Orphan designation - Commission Decision (2018)7812 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/115/18

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2100 (Quality Regulatory Clinical Ireland Limited)

EU/3/18/2100 (Quality Regulatory Clinical Ireland Limited)

EU/3/18/2100 (Active substance: Propagermanium) - Orphan designation - Commission Decision (2018)7810 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/103/18

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2099 (Celgene Europe Limited)

EU/3/18/2099 (Celgene Europe Limited)

EU/3/18/2099 (Active substance: Lisocabtagene maraleucel) - Orphan designation - Commission Decision (2018)7809 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/124/18

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2095 (United Neuroscience Limited)

EU/3/18/2095 (United Neuroscience Limited)

EU/3/18/2095 (Active substance: Ile-Ser-Ile-Thr-Glu-Ile-Lys-Gly-Val-Ile-Val-His-Arg-Ile-Glu-Thr-Ile-Leu-Phe-Lys-Lys-Lys-Lys-Glu-Met-Pro-Ser-Glu-Glu-Gly-Tyr-Gln-Asp) - Orphan designation - Commission Decision (2018)7805 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/146/18

Europe -DG Health and Food Safety

21-11-2018

EU/3/08/556 (Vertex Pharmaceuticals (Ireland) Limited)

EU/3/08/556 (Vertex Pharmaceuticals (Ireland) Limited)

EU/3/08/556 (Active substance: N-(2,4-Di-tert-butyl-5-hydroxyphenyl)-1,4-dihydro-4-oxoquinoline-3-carboxamide) - Transfer of orphan designation - Commission Decision (2018)7814 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/010/08/T/03

Europe -DG Health and Food Safety

16-11-2018

Daptomycin Hospira (Hospira UK Limited)

Daptomycin Hospira (Hospira UK Limited)

Daptomycin Hospira (Active substance: daptomycin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7678 of Fri, 16 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/004310/T/0008

Europe -DG Health and Food Safety

16-11-2018

Benlysta (GlaxoSmithKline (Ireland) Limited)

Benlysta (GlaxoSmithKline (Ireland) Limited)

Benlysta (Active substance: belimumab) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7679 of Fri, 16 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2015/T/60

Europe -DG Health and Food Safety

16-11-2018

Laventair Ellipta (GlaxoSmithKline (Ireland) Limited)

Laventair Ellipta (GlaxoSmithKline (Ireland) Limited)

Laventair Ellipta (Active substance: umeclidinium bromide / vilanterol trifenatate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7673 of Fri, 16 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3754/T/26

Europe -DG Health and Food Safety

9-11-2018

Recent Ebola outbreaks in remote areas with limited resources can benefit from rapid diagnostic tools, and the issuance of today’s EUA is an important step in addressing these outbreaks.  http://go.usa.gov/xPvs4 pic.twitter.com/o2I1dYUQCx

Recent Ebola outbreaks in remote areas with limited resources can benefit from rapid diagnostic tools, and the issuance of today’s EUA is an important step in addressing these outbreaks. http://go.usa.gov/xPvs4 pic.twitter.com/o2I1dYUQCx

Recent Ebola outbreaks in remote areas with limited resources can benefit from rapid diagnostic tools, and the issuance of today’s EUA is an important step in addressing these outbreaks. http://go.usa.gov/xPvs4  pic.twitter.com/o2I1dYUQCx

FDA - U.S. Food and Drug Administration

6-11-2018

Symkevi (Vertex Pharmaceuticals (Europe) Limited)

Symkevi (Vertex Pharmaceuticals (Europe) Limited)

Symkevi (Active substance: tezacaftor/ivacaftor) - Centralised - Authorisation - Commission Decision (2018)7415 of Tue, 06 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4682

Europe -DG Health and Food Safety

6-11-2018

Trelegy Ellipta (GlaxoSmithKline Trading Services Limited)

Trelegy Ellipta (GlaxoSmithKline Trading Services Limited)

Trelegy Ellipta (Active substance: fluticasone furoate/umeclidinium/vilanterol) - Centralised - 2-Monthly update - Commission Decision (2018)7416 of Tue, 06 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4363/WS/1369

Europe -DG Health and Food Safety

6-11-2018

Elebrato Ellipta (GlaxoSmithKline Trading Services Limited)

Elebrato Ellipta (GlaxoSmithKline Trading Services Limited)

Elebrato Ellipta (Active substance: fluticasone furoate/umeclidinium/vilanterol) - Centralised - 2-Monthly update - Commission Decision (2018)7417 of Tue, 06 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4781/WS/1369

Europe -DG Health and Food Safety

1-11-2018

Taxespira (Hospira UK Limited)

Taxespira (Hospira UK Limited)

Taxespira (Active substance: docetaxel) - Centralised - Withdrawal - Commission Decision (2018)7368 of Thu, 01 Nov 2018

Europe -DG Health and Food Safety

31-10-2018

Integrilin (GlaxoSmithKline (Ireland) Limited)

Integrilin (GlaxoSmithKline (Ireland) Limited)

Integrilin (Active substance: Eptifibatide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7340 of Wed, 31 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/230/T/79

Europe -DG Health and Food Safety

31-10-2018

Volibris (GlaxoSmithKline (Ireland) Limited)

Volibris (GlaxoSmithKline (Ireland) Limited)

Volibris (Active substance: Ambrisentan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7339 of Wed, 31 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/839/T/56

Europe -DG Health and Food Safety

30-10-2018

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

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

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

Europe -DG Health and Food Safety

30-10-2018

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

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

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

Europe -DG Health and Food Safety

22-10-2018

EU/3/17/1966 (Sirius Regulatory Consulting EU Limited)

EU/3/17/1966 (Sirius Regulatory Consulting EU Limited)

EU/3/17/1966 (Active substance: N-(bromoacetyl)-3,3-dinitroazetidine) - Transfer of orphan designation - Commission Decision (2018)6986 of Mon, 22 Oct 2018

Europe -DG Health and Food Safety

22-10-2018

EU/3/15/1532 (Sirius Regulatory Consulting EU Limited)

EU/3/15/1532 (Sirius Regulatory Consulting EU Limited)

EU/3/15/1532 (Active substance: Insulin human) - Transfer of orphan designation - Commission Decision (2018)6985 of Mon, 22 Oct 2018

Europe -DG Health and Food Safety