Prevymis 240 mg/12 ml

Informazioni principali

  • Nome commerciale:
  • Prevymis 240 mg/12 ml Konzentrat zur Herstellung einer Infusionslösung
  • Forma farmaceutica:
  • Konzentrat zur Herstellung einer Infusionslösung
  • Composizione:
  • letermovirum 240 mg, idrossipropil betadexum, natrii chloridum, aqua ad iniectabilia q s. annuncio solutionem pro da 12 ml.
  • 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:
  • Prevymis 240 mg/12 ml Konzentrat zur Herstellung einer Infusionslösung
    Svizzera
  • Lingua:
  • italiano

Informazioni terapeutiche

  • Gruppo terapeutico:
  • Synthetika
  • Area terapeutica:
  • Virostatikum

Altre informazioni

Status

  • Fonte:
  • Swissmedic - Swiss Agency for Therapeutic Products
  • Numero dell'autorizzazione:
  • 66653
  • Data dell'autorizzazione:
  • 05-04-2018
  • Ultimo aggiornamento:
  • 19-10-2018

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

Patienteninformation

Prevymis

MSD Merck Sharp & Dohme AG

Che cos’è Prevymis e quando si usa?

Prevymis è un medicamento antivirale che contiene il principio attivo letermovir e che le è stato

prescritto personalmente. Prevymis è un medicamento per gli adulti che hanno ricevuto da poco

tempo un trapianto di midollo osseo. Questo medicamento contribuisce a prevenire la malattia da

CMV («citomegalovirus»).

Quando non si può usare Prevymis?

Se è allergico al letermovir o a un altro componente di questo medicamento (vedere «Cosa contiene

Prevymis?»).

Se assume uno dei seguenti medicamenti:

·Pimozide (contro la sindrome di Tourette)

·Alcaloidi della segale cornuta quali ad esempio l'ergotamina e la diidroergotamina (contro la cefalea

emicranica)

Se assume Prevymis con ciclosporina:

Se assume Prevymis con ciclosporina, non prenda:

·Pitavastatina né simvastatina

Se uno dei punti precedenti corrisponde al suo caso, non assuma Prevymis. In caso di incertezze, si

rivolga al suo medico, al suo farmacista o al suo infermiere prima di assumere Prevymis.

Quando è richiesta prudenza nell’assunzione di Prevymis?

Se prende uno dei seguenti medicamenti, si rivolga al suo medico, al suo farmacista o al suo

infermiere prima di assumere Prevymis:

·Alfentanil (contro i dolori forti)

·Fentanil (contro i dolori forti)

·Chinidina (contro le aritmie cardiache)

Se uno dei punti precedenti corrisponde al suo caso (o se non è sicuro), consulti il suo medico, il suo

farmacista o il suo infermiere, prima di assumere Prevymis.

Bambini e adolescenti

Non è noto se Prevymis sia sicuro ed efficace nelle persone sotto i 18 anni di età, perché Prevymis in

questa fascia di età non è stato ancora esaminato.

Altri medicamenti e Prevymis

Riferisca al suo medico o al suo farmacista, se assume attualmente anche altri medicamenti, se ne ha

assunti fino a poco tempo fa o se ha intenzione di assumerne in un prossimo futuro. Di questi

medicamenti fanno parte quelli soggetti e non soggetti a prescrizione medica, le vitamine e gli

integratori alimentari di origine vegetale. Prevymis può influenzare, infatti, il meccanismo d'azione

di altri medicamenti e, viceversa, il meccanismo d'azione di Prevymis può essere influenzato

dall'assunzione di altri medicamenti. Il suo medico o il suo farmacista le dirà se l'assunzione di

Prevymis assieme ad altri medicamenti è sicura.

Informi il suo medico soprattutto se assume uno dei seguenti medicamenti:

·Alfentanil (contro i dolori forti)

·Fentanil (contro i dolori forti)

·Chinidina (contro le aritmie cardiache)

·Amiodarone (utilizzato per correggere le aritmie cardiache)

·Midazolam (utilizzato come tranquillante)

·Ciclosporina, tacrolimus, sirolimus (per prevenire il rigetto di trapianto)

·Voriconazolo (contro le infezioni da funghi)

·Statine, quali ad esempio atorvastatina pitavastatina, simvastatina, lovastatina, pravastatina,

rosuvastatina (contro i valori elevati di colesterolo)

·Omeprazolo, pantoprazolo (in caso di ulcera gastrica e altri problemi dello stomaco)

·Glibenclamide, repaglinide, rosiglitazone (contro i valori elevati della glicemia)

·Fenitoina (contro le convulsioni)

·Warfarin (come anticoagulante e contro i coaguli di sangue)

Chieda al suo medico o al suo farmacista una lista dei medicamenti che potrebbero avere delle

interazioni con Prevymis.

Il suo medico dovrà eventualmente modificare i medicamenti o il loro dosaggio.

Si informi in maniera approfondita sui medicamenti che assume. Compili una lista dei suoi

medicamenti e la mostri al suo medico o al suo farmacista quando riceve un nuovo medicamento.

Prevymis contiene lattosio

Prevymis contiene lattosio monoidrato. Se soffre di intolleranza al lattosio o se le è stata

diagnosticata un'intolleranza a determinati tipi di zuccheri, chieda consiglio al suo medico prima di

assumere questo medicamento.

Capacità di condurre un veicolo e di utilizzare macchine

Prevymis probabilmente non influisce sulla capacità di condurre un veicolo e di utilizzare macchine.

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

assuma o applichi esternamente altri medicamenti (anche se acquistati di sua iniziativa).

Si può assumere/usare Prevymis durante la gravidanza o l'allattamento?

Gravidanza

Se è in gravidanza o se sospetta o desidera una gravidanza, lo riferisca al suo medico prima di

assumere questo medicamento, perché non è noto se Prevymis possa danneggiare il bambino durante

la gravidanza.

Allattamento

Se è in allattamento o se desidera allattare al seno, informi il suo medico prima di assumere questo

medicamento, perché non è noto se Prevymis passi nel latte materno e venga assunto dal bambino.

Come usare Prevymis?

La dose raccomandata è di 1 compressa una volta al giorno.

·Assuma Prevymis ogni giorno alla stessa ora.

·Assuma il medicamento con o senza i pasti.

·Deglutisca la compressa intera, senza frantumarla, schiacciarla o masticarla.

·Assuma Prevymis esattamente secondo le istruzioni del suo medico.

·Conservi il medicamento nella confezione originale, fino al momento dell'assunzione.

·Si accerti che le compresse di Prevymis non si esauriscano.

Come comportarsi se si assumono troppe compresse di Prevymis?

Se ha assunto un numero eccessivo di compresse PREVYMIS, lo riferisca immediatamente al suo

medico.

Come comportarsi se si dimentica di assumere una compressa di Prevymis?

È molto importante ricordarsi di assumere le dosi di Prevymis.

·Se ha dimenticato di prendere una dose, la assuma non appena se ne accorge. Se però è quasi ora di

prendere la dose successiva, salti la dose dimenticata e assuma la dose successiva come al solito.

·Non prenda mai due dosi di Prevymis per compensare una dose dimenticata.

·Se non è sicuro su cosa fare, si rivolga al suo medico o al suo farmacista.

Non interrompa l'assunzione di Prevymis

Non modifichi di propria iniziativa l'assunzione di Prevymis, senza averne prima parlato con il suo

medico.

In caso di altre domande sull'uso di questo medicamento, si rivolga al suo medico o al suo

farmacista.

Si attenga sempre strettamente alla posologia prescritta dal suo medico. 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 Prevymis?

Come tutti i medicamenti, anche questo medicamento può avere effetti collaterali, sebbene non tutte

le persone li manifestino.

Chieda consiglio al suo medico, se compaiono uno o più dei seguenti effetti collaterali.

Molto comuni: possono interessare più di 1 persona su 10

·Nausea

·Diarrea

·Vomito

·Gonfiore di mani o piedi

·Tosse

·Mal di testa

·Stanchezza/esaurimento

·Dolori addominali.

Occasionali: possono comparire in meno di 1 persona trattata su 100

·Reazioni allergiche (ipersensibilità). I segni possono essere: respiro ansimante, fame d'aria, eruzione

cutanea od orticaria, prurito, gonfiore.

Se osserva effetti collaterali non descritti in questo foglietto illustrativo, dovrebbe informare il suo

medico o il suo farmacista.

Di che altro occorre tener conto?

Prevymis non dev'essere utilizzato oltre la data indicata con «EXP» sull'etichetta e sul contenitore in

cartone. La data di scadenza si riferisce all'ultimo giorno del mese indicato.

Come conservare Prevymis?

Conservare a temperatura non superiore a 30 °C.

Tenere nella confezione blister originale fino al momento dell'uso.

Conservare fuori dalla portata e dalla vista dei bambini.

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

darle ulteriori informazioni.

Cosa contiene Prevymis?

1 compressa rivestita con film contiene:

Principio attivo: letermovir.

Sostanze ausiliarie: cellulosa microcristallina, croscarmellosa sodica, povidone 25, diossido di silicio

colloidale, magnesio stearato e le seguenti sostanze ausiliarie nella pellicola di rivestimento: lattosio

monoidrato, ipromellosa 2910, diossido di titanio, triacetina, ossido di ferro giallo, ossido di ferro

rosso (solo compresse da 480 mg), cera di carnauba come lucidante.

Numero dell’omologazione

66652, 66653 (Swissmedic).

Dov’è ottenibile Prevymis? Quali confezioni sono disponibili?

In farmacia, dietro presentazione della prescrizione medica non rinnovabile.

Prevymis confezioni da 240 mg con 1× 28 compresse rivestite con film. (A)

Prevymis confezioni da 480 mg con 1× 28 compresse rivestite con film. (A)

Titolare dell’omologazione

MSD MERCK SHARP & DOHME AG, Lucerna.

Questo foglietto illustrativo è stato controllato l'ultima volta nel gennaio 2018 dall'autorità

competente in materia di medicamenti (Swissmedic).

CCDS-MK8228-MF-032017/ MK8228-CHE-2018-017039

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Safety and efficacy of Beltherm MP/ML (endo‐1,4‐beta‐xylanase) as a feed additive for chickens for fattening, chickens reared for laying, turkeys for fattening, turkeys reared for breeding, turkeys for breeding purposes and minor poultry species

Safety and efficacy of Beltherm MP/ML (endo‐1,4‐beta‐xylanase) as a feed additive for chickens for fattening, chickens reared for laying, turkeys for fattening, turkeys reared for breeding, turkeys for breeding purposes and minor poultry species

Published on: Fri, 01 Mar 2019 Beltherm MP/ML contains endo‐1,4‐beta‐xylanase and is intended to be used as a zootechnical additive for poultry species. The safety and efficacy of the additive have been evaluated by the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) in 2017. In that assessment, the additive and the production strain, a genetically modified strain of Bacillus subtilis, were characterised in full. No viable cells of the production strain were detecte...

Europe - EFSA - European Food Safety Authority EFSA Journal

5-3-2019

Opinion on the follow‐up of the re‐evaluation of sorbic acid (E200) and potassium sorbate (E202) as food additives

Opinion on the follow‐up of the re‐evaluation of sorbic acid (E200) and potassium sorbate (E202) as food additives

Published on: Fri, 01 Mar 2019 In this opinion, the EFSA Panel on Food Additives and Flavourings (FAF Panel) was requested by the European Commission to carry out a scientific evaluation of an extended one‐generation reproductive toxicity study (EOGRTS) to determine whether it would allow reconsideration of the temporary group acceptable daily intake (ADI) for sorbic acid (E 200) and potassium sorbate (E 202), established by the Panel on Food Additives and Nutrient Sources added to Food (ANS Panel) in 2...

Europe - EFSA - European Food Safety Authority EFSA Journal

1-3-2019

AurobindoPharma USA, Inc. Initiates a Voluntary Nationwide Consumer Level Recall Expansion of 38 Lots of Amlodipine Valsartan Tablets USP and Valsartan Tablets, USP due to the detection of NDEA (N-Nitrosodiethylamine) Impurity.

AurobindoPharma USA, Inc. Initiates a Voluntary Nationwide Consumer Level Recall Expansion of 38 Lots of Amlodipine Valsartan Tablets USP and Valsartan Tablets, USP due to the detection of NDEA (N-Nitrosodiethylamine) Impurity.

AurobindoPharma USA, Inc. is conducting a voluntary recall expansion of 38 lots of Valsartan and Amlodipine and Valsartan tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug product. This recall is an expansion of the recall initiated 12/31/18 The impurity detected in the finished drug product is N-nitrosodiethylamine (NDEA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial proc...

FDA - U.S. Food and Drug Administration

1-3-2019

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 25 mg, 50 mg and 100 mg Due to the Detection of Trace Amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) Impurity found in the Active Pharmaceutical

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 25 mg, 50 mg and 100 mg Due to the Detection of Trace Amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) Impurity found in the Active Pharmaceutical

Camber Pharmaceuticals, Inc. is recalling 87 lots of Losartan Tablets USP 25 mg, 50 mg, and 100 mg to consumer level. This recall was prompted due to the detection of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, Unit – I (API manufacturer).

FDA - U.S. Food and Drug Administration

26-2-2019

Safety and efficacy of TYFER™ (ferric tyrosine chelate) as a zootechnical feed additive for chickens, turkeys and minor poultry species for fattening or reared for laying/breading

Safety and efficacy of TYFER™ (ferric tyrosine chelate) as a zootechnical feed additive for chickens, turkeys and minor poultry species for fattening or reared for laying/breading

Published on: Mon, 25 Feb 2019 Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the product TYFER™ (ferric tyrosine chelate) as zootechnical feed additive for chickens, turkeys and minor poultry species for fattening or reared for laying/breeding. The additive is safe for chickens for fattening at the maximum expected level of 200 mg TYFER™/kg complete feed; this conclusion can be extended to chickens reared for laying/breedin...

Europe - EFSA - European Food Safety Authority EFSA Journal

25-2-2019

Macleods Pharmaceuticals Limited Issues Voluntary Nationwide Consumer Level Recall of One Lot (BLM 715A) of Losartan Potassium/Hydrochlorothiazide Combination Tablets 100mg/25mg Due to detection of NDEA (N-Nitrosodiethylamine) Impurity

Macleods Pharmaceuticals Limited Issues Voluntary Nationwide Consumer Level Recall of One Lot (BLM 715A) of Losartan Potassium/Hydrochlorothiazide Combination Tablets 100mg/25mg Due to detection of NDEA (N-Nitrosodiethylamine) Impurity

Macleods Pharmaceuticals Limited is voluntarily recalling one lot of Losartan Potassium/Hydrochlorothiazide combination tablets 100mg/25mg to the consumer level due to the detection of trace amounts of an unexpected impurity (NDEA) found in finished product manufactured with active pharmaceutical ingredient made by Hetero Labs Limited.

FDA - U.S. Food and Drug Administration

25-2-2019

Xeljanz, Xeljanz XR (tofacitinib): Safety Communication - Safety Trial Finds Increased Risk of Blood Clots in the Lungs and Death with Higher Dose in Rheumatoid Arthritis Patients

Xeljanz, Xeljanz XR (tofacitinib): Safety Communication - Safety Trial Finds Increased Risk of Blood Clots in the Lungs and Death with Higher Dose in Rheumatoid Arthritis Patients

FDA is alerting the public that a safety clinical trial found an increased risk of blood clots in the lungs and death when a 10 mg twice daily dose of tofacitinib (Xeljanz, Xeljanz XR) was used in patients with rheumatoid arthritis (RA). FDA has not approved this 10 mg twice daily dose for RA; this dose is only approved in the dosing regimen for patients with ulcerative colitis

FDA - U.S. Food and Drug Administration

18-3-2019


Orphan designation: Human haptoglobin, Treatment of sickle cell disease, 09/12/2011, Positive

Orphan designation: Human haptoglobin, Treatment of sickle cell disease, 09/12/2011, Positive

Orphan designation: Human haptoglobin, Treatment of sickle cell disease, 09/12/2011, Positive

Europe - EMA - European Medicines Agency

18-3-2019


Orphan designation: Lomitapide, Treatment of familial chylomicronaemia, 17/12/2010, Positive

Orphan designation: Lomitapide, Treatment of familial chylomicronaemia, 17/12/2010, Positive

Orphan designation: Lomitapide, Treatment of familial chylomicronaemia, 17/12/2010, Positive

Europe - EMA - European Medicines Agency

15-3-2019


Orphan designation: Dantrolene sodium, Treatment of Wolfram syndrome, 12/12/2016, Positive

Orphan designation: Dantrolene sodium, Treatment of Wolfram syndrome, 12/12/2016, Positive

Orphan designation: Dantrolene sodium, Treatment of Wolfram syndrome, 12/12/2016, Positive

Europe - EMA - European Medicines Agency

15-3-2019


Orphan designation: Adenovirus serotype 5 containing partial E1A deletion and an integrin-binding domain, Treatment of glioma, 16/12/2014, Positive

Orphan designation: Adenovirus serotype 5 containing partial E1A deletion and an integrin-binding domain, Treatment of glioma, 16/12/2014, Positive

Orphan designation: Adenovirus serotype 5 containing partial E1A deletion and an integrin-binding domain, Treatment of glioma, 16/12/2014, Positive

Europe - EMA - European Medicines Agency

15-3-2019


Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 12-15 March 2019

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 12-15 March 2019

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 12-15 March 2019

Europe - EMA - European Medicines Agency

12-3-2019


Orphan designation: C1 esterase inhibitor (human), Treatment in solid organ transplantation, 14/12/2018, Positive

Orphan designation: C1 esterase inhibitor (human), Treatment in solid organ transplantation, 14/12/2018, Positive

Orphan designation: C1 esterase inhibitor (human), Treatment in solid organ transplantation, 14/12/2018, Positive

Europe - EMA - European Medicines Agency

12-3-2019


Orphan designation: 6-fluoro-9-methyl-9H-pyrido[3,4-b]-indole, Treatment of sudden sensorineural hearing loss, 14/12/2018, Positive

Orphan designation: 6-fluoro-9-methyl-9H-pyrido[3,4-b]-indole, Treatment of sudden sensorineural hearing loss, 14/12/2018, Positive

Orphan designation: 6-fluoro-9-methyl-9H-pyrido[3,4-b]-indole, Treatment of sudden sensorineural hearing loss, 14/12/2018, Positive

Europe - EMA - European Medicines Agency

12-3-2019

Quinolone and fluoroquinolone medicinal products for systemic and inhalation use

Quinolone and fluoroquinolone medicinal products for systemic and inhalation use

Quinolone and fluoroquinolone medicinal products for systemic and inhalation use (Active substance: nalidixic acid, pipemidic acid, cinoxacin, enoxacin, pefloxacin, lomefloxacin, ciprofloxacin, levofloxacin, ofloxacin, moxifloxacin, norfloxacin, prulifloxacin, rufloxacin, flumequine) - Community Referrals - Art 31 - Commission Decision (2019)2050 of Tue, 12 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/A-31/1452/C/2789

Europe -DG Health and Food Safety

12-3-2019


Orphan designation: 6,8-bis(benzylthio)octanoic acid, Treatment of acute myeloid leukaemia, 14/12/2018, Positive

Orphan designation: 6,8-bis(benzylthio)octanoic acid, Treatment of acute myeloid leukaemia, 14/12/2018, Positive

Orphan designation: 6,8-bis(benzylthio)octanoic acid, Treatment of acute myeloid leukaemia, 14/12/2018, Positive

Europe - EMA - European Medicines Agency

12-3-2019


Orphan designation: (2S)-2-{[(2R)-2-[({[3,3-dibutyl-7-(methylthio)-1,1-dioxido-5-phenyl-2,3,4,5-tetrahydro- 1,2,5-benzothiadiazepin-8-yl]oxy}acetyl)amino]-2-(4-hydroxyphenyl)acetyl]amino}butanoic acid, Treatment of biliary atresia, 14/12/2018, Positive

Orphan designation: (2S)-2-{[(2R)-2-[({[3,3-dibutyl-7-(methylthio)-1,1-dioxido-5-phenyl-2,3,4,5-tetrahydro- 1,2,5-benzothiadiazepin-8-yl]oxy}acetyl)amino]-2-(4-hydroxyphenyl)acetyl]amino}butanoic acid, Treatment of biliary atresia, 14/12/2018, Positive

Orphan designation: (2S)-2-{[(2R)-2-[({[3,3-dibutyl-7-(methylthio)-1,1-dioxido-5-phenyl-2,3,4,5-tetrahydro- 1,2,5-benzothiadiazepin-8-yl]oxy}acetyl)amino]-2-(4-hydroxyphenyl)acetyl]amino}butanoic acid, Treatment of biliary atresia, 14/12/2018, Positive

Europe - EMA - European Medicines Agency

12-3-2019


Orphan designation: Pevonedistat, Treatment of myelodysplastic syndromes, 14/12/2018, Positive

Orphan designation: Pevonedistat, Treatment of myelodysplastic syndromes, 14/12/2018, Positive

Orphan designation: Pevonedistat, Treatment of myelodysplastic syndromes, 14/12/2018, Positive

Europe - EMA - European Medicines Agency

12-3-2019


Orphan designation: Marizomib, Treatment of glioma, 14/12/2019, Positive

Orphan designation: Marizomib, Treatment of glioma, 14/12/2019, Positive

Orphan designation: Marizomib, Treatment of glioma, 14/12/2019, Positive

Europe - EMA - European Medicines Agency

11-3-2019


Orphan designation: Lonafarnib, Treatment of Hutchinson-Gilford progeria, 14/12/2018, Positive

Orphan designation: Lonafarnib, Treatment of Hutchinson-Gilford progeria, 14/12/2018, Positive

Orphan designation: Lonafarnib, Treatment of Hutchinson-Gilford progeria, 14/12/2018, Positive

Europe - EMA - European Medicines Agency

11-3-2019


Orphan designation: (4-{(2S,4S)-4-ethoxy-1-[(5-methoxy-7-methyl-1H-indol-4-yl)methyl]piperidin-2-yl}benzoic acid-hydrogen chloride(1/1)), Treatment of C3 glomerulopathy, 14/12/2018, Positive

Orphan designation: (4-{(2S,4S)-4-ethoxy-1-[(5-methoxy-7-methyl-1H-indol-4-yl)methyl]piperidin-2-yl}benzoic acid-hydrogen chloride(1/1)), Treatment of C3 glomerulopathy, 14/12/2018, Positive

Orphan designation: (4-{(2S,4S)-4-ethoxy-1-[(5-methoxy-7-methyl-1H-indol-4-yl)methyl]piperidin-2-yl}benzoic acid-hydrogen chloride(1/1)), Treatment of C3 glomerulopathy, 14/12/2018, Positive

Europe - EMA - European Medicines Agency

11-3-2019


Orphan designation: Allogeneic ABCB5-positive limbal stem cells, Treatment of limbal stem cell deficiency, 14/12/2018, Positive

Orphan designation: Allogeneic ABCB5-positive limbal stem cells, Treatment of limbal stem cell deficiency, 14/12/2018, Positive

Orphan designation: Allogeneic ABCB5-positive limbal stem cells, Treatment of limbal stem cell deficiency, 14/12/2018, Positive

Europe - EMA - European Medicines Agency

11-3-2019


Orphan designation: Bifunctional fusion protein composed of two extracellular domains of transforming growth factor beta receptor II fused with a human immunoglobulin G1 monoclonal antibody against programmed death ligand 1, Treatment of biliary tract ca

Orphan designation: Bifunctional fusion protein composed of two extracellular domains of transforming growth factor beta receptor II fused with a human immunoglobulin G1 monoclonal antibody against programmed death ligand 1, Treatment of biliary tract ca

Orphan designation: Bifunctional fusion protein composed of two extracellular domains of transforming growth factor beta receptor II fused with a human immunoglobulin G1 monoclonal antibody against programmed death ligand 1, Treatment of biliary tract cancer, 14/12/2018, Positive

Europe - EMA - European Medicines Agency

8-3-2019

EU/3/12/968 (Clinical Network Services (NL) B.V.)

EU/3/12/968 (Clinical Network Services (NL) B.V.)

EU/3/12/968 (Active substance: Human monoclonal antibody targeting Staphylococcus aureus alpha-toxin) - Transfer of orphan designation - Commission Decision (2019)1940 of Fri, 08 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004447

Europe -DG Health and Food Safety

8-3-2019


Orphan designation: Adeno-associated virus serotype HSC15 expressing human phenylalanine hydroxylase, Treatment of phenylalanine hydroxylase deficiency, 14/12/2018, Positive

Orphan designation: Adeno-associated virus serotype HSC15 expressing human phenylalanine hydroxylase, Treatment of phenylalanine hydroxylase deficiency, 14/12/2018, Positive

Orphan designation: Adeno-associated virus serotype HSC15 expressing human phenylalanine hydroxylase, Treatment of phenylalanine hydroxylase deficiency, 14/12/2018, Positive

Europe - EMA - European Medicines Agency

8-3-2019


Orphan designation: Acetylcysteine, Treatment of pseudomyxoma peritonei, 14/12/2018, Positive

Orphan designation: Acetylcysteine, Treatment of pseudomyxoma peritonei, 14/12/2018, Positive

Orphan designation: Acetylcysteine, Treatment of pseudomyxoma peritonei, 14/12/2018, Positive

Europe - EMA - European Medicines Agency

8-3-2019


Orphan designation: Venglustat, Treatment of autosomal dominant polycystic kidney disease, 14/12/2018, Positive

Orphan designation: Venglustat, Treatment of autosomal dominant polycystic kidney disease, 14/12/2018, Positive

Orphan designation: Venglustat, Treatment of autosomal dominant polycystic kidney disease, 14/12/2018, Positive

Europe - EMA - European Medicines Agency

8-3-2019


Orphan designation: Bromelain, Treatment of pseudomyxoma peritonei, 14/12/2018, Positive

Orphan designation: Bromelain, Treatment of pseudomyxoma peritonei, 14/12/2018, Positive

Orphan designation: Bromelain, Treatment of pseudomyxoma peritonei, 14/12/2018, Positive

Europe - EMA - European Medicines Agency

8-3-2019


Orphan designation: Sodium 2-hydroxylinoleate, Treatment of biliary tract cancer, 14/12/2018, Positive

Orphan designation: Sodium 2-hydroxylinoleate, Treatment of biliary tract cancer, 14/12/2018, Positive

Orphan designation: Sodium 2-hydroxylinoleate, Treatment of biliary tract cancer, 14/12/2018, Positive

Europe - EMA - European Medicines Agency

8-3-2019


Orphan designation: afatinib, Treatment of Fanconi anaemia, 14/12/2018, Positive

Orphan designation: afatinib, Treatment of Fanconi anaemia, 14/12/2018, Positive

Orphan designation: afatinib, Treatment of Fanconi anaemia, 14/12/2018, Positive

Europe - EMA - European Medicines Agency

7-3-2019


Orphan designation: Adeno-associated viral vector expressing human 21- hydroxylase, Treatment of congenital adrenal hyperplasia, 14/12/2018, Positive

Orphan designation: Adeno-associated viral vector expressing human 21- hydroxylase, Treatment of congenital adrenal hyperplasia, 14/12/2018, Positive

Orphan designation: Adeno-associated viral vector expressing human 21- hydroxylase, Treatment of congenital adrenal hyperplasia, 14/12/2018, Positive

Europe - EMA - European Medicines Agency

7-3-2019


Orphan designation: Ivacaftor, potassium(benzenesulfonyl)({[6-(3-{2-[1-(trifluoromethyl) cyclopropyl]ethoxy}-1H-pyrazol-1-yl)-2-[(4S)-2,2,4-trimethylpyrrolidin-1-yl]pyridin-3-yl]carbonyl})azanide, tezacaftor, Treatment of cystic fibrosis, 14/12/2018, Pos

Orphan designation: Ivacaftor, potassium(benzenesulfonyl)({[6-(3-{2-[1-(trifluoromethyl) cyclopropyl]ethoxy}-1H-pyrazol-1-yl)-2-[(4S)-2,2,4-trimethylpyrrolidin-1-yl]pyridin-3-yl]carbonyl})azanide, tezacaftor, Treatment of cystic fibrosis, 14/12/2018, Pos

Orphan designation: Ivacaftor, potassium(benzenesulfonyl)({[6-(3-{2-[1-(trifluoromethyl) cyclopropyl]ethoxy}-1H-pyrazol-1-yl)-2-[(4S)-2,2,4-trimethylpyrrolidin-1-yl]pyridin-3-yl]carbonyl})azanide, tezacaftor, Treatment of cystic fibrosis, 14/12/2018, Positive

Europe - EMA - European Medicines Agency

7-3-2019


Orphan designation: Human anti-promyostatin monoclonal antibody, Treatment of spinal muscular atrophy, 14/12/2018, Positive

Orphan designation: Human anti-promyostatin monoclonal antibody, Treatment of spinal muscular atrophy, 14/12/2018, Positive

Orphan designation: Human anti-promyostatin monoclonal antibody, Treatment of spinal muscular atrophy, 14/12/2018, Positive

Europe - EMA - European Medicines Agency

28-2-2019

EU/3/19/2134 (FGK Representative Service GmbH)

EU/3/19/2134 (FGK Representative Service GmbH)

EU/3/19/2134 (Active substance: 9-cis, 12-cis-11,11-D2-linoleic acid ethyl ester) - Orphan designation - Commission Decision (2019)1726 of Thu, 28 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000002279

Europe -DG Health and Food Safety

28-2-2019

EU/3/12/997 (Sinus Regulatory Consulting EU Limited)

EU/3/12/997 (Sinus Regulatory Consulting EU Limited)

EU/3/12/997 (Active substance: N-hydroxy-4-(3-methyl-2-(S)-phenyl-butyrylamino) benzamide) - Transfer of orphan designation - Commission Decision (2019)1750 of Thu, 28 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004372

Europe -DG Health and Food Safety

28-2-2019

EU/3/12/996 (Sinus Regulatory Consulting EU Limited)

EU/3/12/996 (Sinus Regulatory Consulting EU Limited)

EU/3/12/996 (Active substance: N-hydroxy-4-(3-methyl-2-(S)-phenyl-butyrylamino) benzamide) - Transfer of orphan designation - Commission Decision (2019)1749 of Thu, 28 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004369

Europe -DG Health and Food Safety

28-2-2019

EU/3/12/993 (Sinus Regulatory Consulting EU Limited)

EU/3/12/993 (Sinus Regulatory Consulting EU Limited)

EU/3/12/993 (Active substance: N-hydroxy-4-(3-methyl-2-(S)-phenyl-butyrylamino) benzamide) - Transfer of orphan designation - Commission Decision (2019)1748 of Thu, 28 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004343

Europe -DG Health and Food Safety

25-2-2019

EU/3/12/1091 (bluebird bio (Netherlands) B.V.)

EU/3/12/1091 (bluebird bio (Netherlands) B.V.)

EU/3/12/1091 (Active substance: Autologous CD34+ haematopoietic stem cells transduced with lentiviral vector encoding the human betaA-T87Q-globin gene) - Transfer of orphan designation - Commission Decision (2019)1626 of Mon, 25 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003556

Europe -DG Health and Food Safety

25-2-2019

EU/3/12/1003 (bluebird bio (Netherlands) B.V.)

EU/3/12/1003 (bluebird bio (Netherlands) B.V.)

EU/3/12/1003 (Active substance: Autologous haematopoietic stem cells transduced with lentiviral vector Lenti-D encoding the human ABCD1 cDNA) - Transfer of orphan designation - Commission Decision (2019)1634 of Mon, 25 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003636

Europe -DG Health and Food Safety

25-2-2019

EU/3/12/981 (Novartis Europharm Limited)

EU/3/12/981 (Novartis Europharm Limited)

EU/3/12/981 (Active substance: Adenovirus associated viral vector serotype 2 containing the human RPE65 gene) - Transfer of orphan designation - Commission Decision (2019)1627 of Mon, 25 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003485

Europe -DG Health and Food Safety