Nitroderm TTS 10

Informazioni principali

  • Nome commerciale:
  • Nitroderm TTS 10 Nitroderm TTS 10
  • Forma farmaceutica:
  • Nitroderm TTS 10
  • Composizione:
  • glyceroli trinitras 50 mg, excipiens annuncio praeparationem pro 20 cm2 cum liberazione 10 mg/24h.
  • 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:
  • Nitroderm TTS 10 Nitroderm TTS 10
    Svizzera
  • Lingua:
  • italiano

Informazioni terapeutiche

  • Gruppo terapeutico:
  • Synthetika
  • Area terapeutica:
  • Koronartherapeutikum aus der Klasse der organischen Nitrato

Altre informazioni

Status

  • Fonte:
  • Swissmedic - Swiss Agency for Therapeutic Products
  • Numero dell'autorizzazione:
  • 44192
  • Data dell'autorizzazione:
  • 07-12-1981
  • Ultimo aggiornamento:
  • 19-10-2018

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

Patienteninformation

Nitroderm TTS®

Novartis Pharma Schweiz AG

Che cos’è Nitroderm TTS e quando si usa?

Nitroderm TTS è un sistema terapeutico transdermico che si applica sulla pelle come un cerotto e che

contiene il principio attivo nitroglicerina. Il principio attivo penetra nella pelle e da lì passa

direttamente nella circolazione sanguigna. Finché Nitroderm TTS rimane sulla pelle, esso cede

continuamente una quantità costante di principio attivo all'organismo. La nitroglicerina dilata i vasi

sanguigni e allevia in questo modo il lavoro che il cuore deve svolgere.

Nitroderm TTS si usa su prescrizione medica per prevenire attacchi di cuore (angina pectoris) e come

coadiuvante nella terapia della debolezza cardiaca cronica.

Quando non si può usare Nitroderm TTS?

Nitroderm TTS non è indicato per curare le crisi acute di angina pectoris. Per questi casi, il suo

medico le prescriverà un ulteriore medicamento.

Affinché il suo medico possa definire la terapia più adatta al suo caso lo informi nel caso in cui

·in passato, ha già avuto una qualsiasi reazione insolita o allergica (come p.es. un'eruzione cutanea)

alla nitroglicerina, ai nitrati od nitriti,

·soffre di collasso circolatorio con pressione arteriosa molto bassa come in uno stato di choc,

·ha una pressione intracranica aumentata (il suo medico lo saprà e la informerà in merito)

·soffre di una malattia delle valvole cardiache o di un'infiammazione del cuore.

Nitroderm TTS non è indicato per i bambini.

Avviso importante:

Se lei, paziente con una malattia cardiaca (per esempio angina pectoris), è in cura con Nitroderm

TTS, non può prendere in nessun' caso dei medicamenti per la cura dell'impotenza sessuale maschile

(p.es. Viagra®, [Sildenafil]). La somministrazione contemporanea di medicamenti appartenenti a

questo gruppo può provocare un aumento pericoloso dell'effetto di Nitroderm TTS che si manifesta

sotto forma di calo della pressione sanguigna e di collasso circolatorio.

Se nonostante ciò dovrebbe aver' assunto un medicamento appartenente a questo gruppo, la

somministrazione di Nitroderm TTS è rigorosamente vietata entro le susseguenti 24 ore. Questo vale

anche per i disturbi cardiaci improvvisi. In questo caso d'emergenza si rivolga ad un medico e lo

informi della somministrazione.

Quando è richiesta prudenza nell’uso di Nitroderm TTS?

Dato il suo effetto dilatante sui vasi sanguigni, la nitroglicerina può abbassare la pressione arteriosa e

provocare così vertigini, stordimento e la sensazione di un inizio di svenimento, soprattutto quando si

passa rapidamente dalla posizione coricata o seduta a quella eretta. Per evitare questo fenomeno

bisogna alzarsi lentamente. Se fa caldo o dopo esser stato in piedi a lungo potrebbero manifestarsi

mal di testa, vertigini o stordimento.

Durante la cura con Nitroderm TTS limiti il consumo di bevande alcoliche. Nitroderm TTS può,

soprattutto all'inizio della terapia, condurre a vertigini e stordimento. Ciò può influenzare in modo

importante la capacità di condurre un veicolo e la capacità di utilizzare attrezzi o macchine.

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

·soffre di altre malattie,

·soffre di allergie o

·assume o applica (medicamento per uso esterno) altri medicamenti (anche se acquistati di sua

iniziativa!).

Si può usare Nitroderm TTS durante la gravidanza o l’allattamento?

Informi il suo medico se

·è in stato di gravidanza o rimane incinta durante la terapia con Nitroderm TTS,

·allatta.

Come usare Nitroderm TTS?

Spetta al suo medico stabilire il formato del cerotto indicato nel suo caso o il numero di cerotti da

applicare. Egli le indicherà pure per quanto tempo deve portare il cerotto (p.es. soltanto durante il

giorno) e la frequenza con cui sostituirlo.

Non modifichi di propria iniziativa la posologia o la cronologia prescritte. Se ritiene che l'azione del

medicamento sia troppo debole o troppo forte ne parli al suo medico o al suo farmacista.

Ogni Nitroderm TTS è sigillato in una bustina. Lo strato adesivo è protetto da una pellicola di

protezione bianca.

1. Applicare Nitroderm TTS su una zona della pelle sana, senza peli e esente da eventuali residui di

crema o di olio. Come i normali cerotti adesivi, è possibile che anche Nitroderm TTS non aderisca

bene alla pelle umida o non pulita; perciò, prima di applicare il cerotto, è importante lavare la pelle

ed asciugarla.

2. Applicazione di Nitroderm TTS

Strappi la bustina partendo dalle incisioni ed estragga con cautela Nitroderm TTS nel senso della

lunghezza. Lo tenga in modo che la linguetta sia in alto e la pellicola di protezione bianca rivolta

verso lei.

Col pollice pieghi energicamente la linguetta in avanti. Partendo dalla linguetta, stacchi la pellicola

di protezione bianca usando ambedue i pollici. Non si tocca la superficie collasa del cerotto.

Avviso: una volta staccata la pellicola di protezione, attraverso lo strato adesivo sarà visibile il

principio attivo di colore bianco. Potrebbero essere presenti anche bolle d'aria dovute al processo di

produzione, le quali in ogni caso non pregiudicano la qualità del preparato.

Con lo strato adesivo privo della pellicola di protezione applichi il sistema sulla zona cutanea scelta

(p.es. sulla parte laterale della gabbia toracica, lungo le costole) e lo premi forte col palmo della

mano per alcuni secondi.

3. Stacchi il cerotto seguendo le istruzioni del suo medico e lo elimini con le precauzioni necessarie

per evitare che esso vada a finire nelle mani di bambini.

4. Per la prossima applicazione, incolli un nuovo Nitroderm TTS in un'altra posizione (p. es. sul lato

opposto della gabbia toracica). Lo stesso punto della cute deve essere usato soltanto dopo alcuni

giorni.

Per pulire la pelle da eventuali residui di adesivo, si consiglia di usare un solvente appropriato, p. es.

alcool o benzina rettificata.

Nitroderm TTS aderisce bene alla pelle e continua a funzionare anche durante il bagno, la doccia e

l'attività fisica. Se il cerotto dovesse staccarsi, lo getti e ne incolli uno nuovo in un'altra posizione.

Se avesse dimenticato di sostituire Nitroderm TTS al momento consueto non ha motivo di

preoccuparsi: lo cambi però il più presto possibile. Il successivo Nitroderm TTS sarà applicato come

di consueto. Tenga sempre in considerazione gli intervalli temporali relativi all'applicazione di un

nuovo cerotto decisi dal medico.

Osservazione: il Nitroderm TTS costituisce un'unità completa e quindi non deve essere tagliato.

Quali effetti collaterali può avere Nitroderm TTS?

Ogni medicamento può causare reazioni non auspicate o indesiderate, i cosiddetti effetti collaterali.

Sono stati osservati i seguenti effetti collaterali: Molto frequentemente: mal di testa, sensazione di

vertigini, nausea e vomito.

Frequentemente: stordimento, pressione arteriosa bassa.

Occasionalmente: allergia da contatto, arrossamento temporaneo della pelle (flush), reazioni

allergiche, reazioni sul sito di applicazione: arrossamento, prurito, bruciore, irritazioni. Leggeri

arrossamenti della pelle scompaiono solitamente qualche ora dopo aver tolto il cerotto. Si consiglia

di trattare queste reazioni, dopo aver tolto il cerotto, con una crema blanda per la pelle. Di regola

l'arrossamento scompare in poche ore. È però importante che applichi ogni cerotto nuovo su un altro

punto della pelle.

Raramente: aumento della frequenza cardiaca, caduta improvvisa della pressione dopo essersi alzati,

arrossamenti della pelle, disturbi della digestione.

Nel caso in cui la pelle sotto il cerotto è molto arrossata o gonfia, se si formano delle vesciche o si

manifesta un'eruzione cutanea su tutto il corpo ne informi il suo medico.

Con frequenza sconosciuta possono insorgere palpitazioni che lei può sentire come battiti del cuore

insolitamente veloci, forti o irregolari. Inoltre con frequenza sconosciuta possono insorgere eruzioni

cutanee in tutto il corpo. In questi casi consulti il suo medico.

Gli effetti collaterali seguenti possono essere sintomi di un iperdosaggio; nel caso in cui si manifesta

uno di essi avverta il suo medico:

·forti vertigini o svenimento

·sensazione di forte tensione nella testa

·difficoltà di respirazione

·stanchezza inconsueta o debolezza

·battito cardiaco debole e insolitamente rapido.

Se osserva effetti collaterali qui non descritti dovrebbe informare il suo medico o il suo farmacista.

Di che altro occorre tener conto?

Se ha usato regolarmente Nitroderm TTS per alcune settimane o ancor più a lungo non può cessare

improvvisamente la terapia. Un'interruzione improvvisa potrebbe provocare delle crisi di angina

pectoris. Il suo medico stabilirà il piano di terapia più adatto alla sua situazione: si attenga

scrupolosamente alle sue istruzioni.

Non conservare il medicamento al di sopra dei 25 °C. Non congelare.

Conservare questo cerotto sia prima che dopo l'uso fuori dalla portata dei bambini. Eliminare il

cerotto in modo che sia lontano dalla portata dei bambini.

Il medicamento non dev'essere utilizzato oltre la data indicata con «EXP» sulla confezione.

Il medico o il farmacista, che sono in possesso di documentazione professionale, possono darle

ulteriori informazioni.

Cosa contiene Nitroderm TTS?

Nitroderm TTS contiene il principio attivo nitroglicerina: 25 mg (TTS 5), 50 mg (TTS 10).

Numero dell’omologazione

44192 (Swissmedic)

Dove è ottenibile Nitroderm TTS? Quali confezioni sono disponibili?

In farmacia dietro presentazione della prescrizione medica.

Nitroderm TTS 5: 10, 30 e 100.

Nitroderm TTS 10: 10 e 30.

Titolare dell’omologazione

Novartis Pharma Schweiz AG, Risch; Domicilio: 6343 Rotkreuz.

Questo foglietto illustrativo è stato controllato l'ultima volta nell'agosto 2015 dall'autorità competente

in materia di medicamenti (Swissmedic).

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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

24-9-2018

FDA Announces Availability of Resources for Animal Drug Sponsors

FDA Announces Availability of Resources for Animal Drug Sponsors

The FDA is making available two pre-recorded webinars and a slide presentation to help drug sponsors understand recent changes to the submission process for new animal drug applications and related submissions. The changes take effect 10/1/2018.

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