Tranxilium 10

Informazioni principali

  • Nome commerciale:
  • Tranxilium 10 capsule
  • Forma farmaceutica:
  • capsule
  • Composizione:
  • dikalii clorazepas 10 mg, colore.: E 127, excipiens pro il capsula.
  • 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:
  • Tranxilium 10 capsule
    Svizzera
  • Lingua:
  • italiano

Informazioni terapeutiche

  • Gruppo terapeutico:
  • Synthetika
  • Area terapeutica:
  • Ansiolitico

Altre informazioni

Status

  • Fonte:
  • Swissmedic - Swiss Agency for Therapeutic Products
  • Numero dell'autorizzazione:
  • 33866
  • Data dell'autorizzazione:
  • 14-06-1971
  • Ultimo aggiornamento:
  • 19-10-2018

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

Patienteninformation

Tranxilium® capsule/tabs/compresse rivestite con film

Sanofi-Aventis (Suisse) SA

Che cos’è Tranxilium e quando si usa?

Tranxilium è un medicamento appartenente alla classe delle «benzodiazepine». Ha un'azione

tranquillante sul sistema nervoso ed attenua gli stati d'ansia causati da disturbi psichici o fisici.

Tuttavia, non è in grado di eliminare le cause dell'ansia.

Il medico le prescrive Tranxilium nei casi d'ansia e di tensione, che possono comparire singolarmente

o associate ad altri sintomi fisici o psichici.

Di che cosa occorre inoltre tener conto durante il trattamento?

Durante la cura con Tranxilium cerchi di riconoscere ed eliminare le cause dell'ansia e/o dell'insonnia

in modo che dopo un certo periodo di tempo, con il consenso del medico, possa interrompere

l'assunzione.

Il suo medico può senz'altro ritenere opportuna una ripetizione della cura in un secondo tempo.

Quando non si può assumere Tranxilium?

Quando i pazienti soffrono di gravi disturbi respiratori.

I bambini al di sotto dei 9 anni, come pure i pazienti con ipersensibilità nota nei confronti delle

benzodiazepine o agli altri costituenti non dovrebbero assumere Tranxilium.

Le persone che soffrono di atrofia muscolare in fase avanzata (miastenia grave) non dovrebbero far

uso di Tranxilium.

Quando è richiesta prudenza nella somministrazione di Tranxilium?

Disturbi psichici di grave entità non possono essere curati unicamente con Tranxilium.

Deve assolutamente informare il medico se constata che, durante il sonno, compaiono interruzioni

momentanee della respirazione (cosiddetta sindrome da apnea del sonno). L'uso di Tranxilium può,

come tutti i preparati contenenti benzodiazepine, condurre a reazioni psichiatriche e paradosse, quali:

agitazione incessante, irritabilità, aggressività, delusioni, collera, incubi, allucinazioni, psicosi,

comportamento inappropriato e altri effetti comportamentali negativi.

Il trattamento deve essere interrotto al manifestarsi di questi sintomi. Tali reazioni si verificano più

facilmente nei bambini e nelle persone anziane.

Si sconsiglia di utilizzare unicamente le benzodiazepine nei pazienti depressi o che presentano la

componente ansiosa della depressione.

Pericolo di dipendenza

L'assunzione di Tranxilium può, come tutti i preparati contenenti benzodiazepine, condurre a uno

stato di dipendenza. Questo stato di dipendenza si manifesta soprattutto nel caso di una

somministrazione ininterrotta per un tempo prolungato (in alcuni casi già dopo qualche settimana); se

l'assunzione del medicamento viene interrotta bruscamente provoca i sintomi dell'astinenza:

agitazione, ansia, insonnia, difficoltà di concentrazione, mal di testa, sudorazione. Tali sintomi

scompaiono, di norma, dopo due - tre settimane.

Per ridurre al minimo il rischio di sviluppare una dipendenza, le consigliamo di rispettare le seguenti

indicazioni:

·assuma Tranxilium soltanto dietro prescrizione medica

·non aumenti in nessun caso la dose prescritta dal medico

·informi il suo medico se vuole interrompere l'assunzione del medicamento

·il suo medico esaminerà periodicamente se è necessario continuare il trattamento

·la somministrazione per un periodo di tempo prolungato (di norma più di quattro settimane) è

possibile solo sotto stretta sorveglianza medica

Tranquillanti, sonniferi, analgesici potenti e altri medicamenti con azione calmante sul cervello e sul

sistema nervoso, come pure i farmaci che rilassano i muscoli, possono aumentare o viceversa ridurre

l'azione di Tranxilium.

L'assunzione di benzodiazepine e di altri sedativi, tra cui Tranxilium, può aumentare il rischio

suicidario indipendentemente dalla presenza di una condizione depressiva.

Tranxilium può ridurre la capacità di reazione, la capacità di condurre un veicolo e la capacità di

utilizzare attrezzi o macchine. Dato che questo effetto è potenziato dall'alcol, durante la terapia con

Tranxilium eviti di consumare bevande alcoliche.

Informi il suo medico o il suo farmacista se:

·soffre di altre malattie,

·soffre di allergie o

·assume o applica altri medicamenti (anche se acquistati di sua iniziativa!).

Le persone anziane sono più soggette agli effetti indesiderati, quali sonnolenza, stordimento,

debolezza muscolare, che possono favorire le cadute con conseguenze gravi in questa popolazione.

In tal caso, si raccomanda una diminuzione della dose.

Deve essere evitato l'utilizzo concomitante di benzodiazepine e sodio oxibato perché può aumentare

il rischio di depressione respiratoria.

L'assunzione simultanea di Tranxilium e di oppioidi può causare sedazione, distress respiratorio, fino

al coma o al decesso. È dunque importante identificare ogni segnale e sintomo di distress respiratorio

e di sedazione e, in un caso del genere, consultare immediatamente il medico.

Le compresse di Tranxilium rivestite con film contengono lattosio. I pazienti affetti da una rara

intolleranza ereditaria al galattosio, una carenza di lattasi o un malassorbimento di glucosio e

galattosio non devono quindi assumere tale medicamento. Se ha un'intolleranza ad alcuni zuccheri,

contatti il suo medico prima di assumere questo medicamento.

Si può assumere Tranxilium durante la gravidanza o l’allattamento?

Informi il suo medico se è incinta o c'è la possibilità di una gravidanza.

Per principio Tranxilium non deve essere somministrato durante la gravidanza, a meno che il suo

medico consideri questa terapia assolutamente indispensabile. Esistono indizi che fanno ritenere che

medicamenti di questo tipo potrebbero comportare dei rischi per il feto. La somministrazione del

farmaco durante il parto può provocare dei disturbi al neonato.

Tranxilium passa nel latte materno e può agire sul bambino causandogli sonnolenza e pigrizia nel

poppare. Di conseguenza occorre rinunciare all'assunzione di Tranxilium durante l'allattamento.

Come usare Tranxilium?

La posologia normale per adulti varia tra 5 e 30 mg al giorno. Il medico può prescrivere, se

necessario, una dose maggiore o minore (in modo particolare nei bambini e nelle persone anziane).

Prenda il numero prescritto di capsule, Tabs o compresse rivestite con film secondo prescrizione,

suddivise in più dosi al giorno oppure come dose unica alla sera tra le ore 18.00 e le ore 20.00, con

un bicchiere d'acqua senza masticarle.

Non modifichi di sua 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 Tranxilium?

L'assunzione di Tranxilium può provocare i seguenti effetti collaterali:

Effetti indesiderati molto frequenti: sonnolenza (soprattutto negli anziani).

Effetti indesiderati frequenti: rallentamento delle funzioni mentali, affaticamento, vertigini.

Effetti indesiderati occasionali: reazione allergica e ipersensibilità al medicamento,

irritabilità, stato d'agitazione, incubi, . In presenza di tali sintomi consulti immediatamente il suo

medico.

Effetti indesiderati dalla frequenza sconosciuta: allucinazioni, debolezza muscolare, incertezza nel

camminare, cadute, disturbi della concentrazione e della memoria, disturbi del linguaggio,

diminuzione della pressione arteriosa, rallentamento del ritmo cardiaco e disturbi della respirazione.

L'assunzione di Tranxilium, soprattutto se a dosi elevate, può determinare una farmacodipendenza e,

in caso di brusca interruzione della terapia, causare sintomi di astinenza (si veda «Quando è richiesta

prudenza nella somministrazione di Tranxilium?»).

Sono stati riferiti anche effetti collaterali comuni a tutti i preparati contenenti benzodiazepine:

insensibilità emotiva, vigilanza ridotta, mal di testa, disturbi della coordinazione, diplopia, disturbi

gastrointestinali, disturbi della libido, amnesia che possono essere associati a un comportamento

inappropriato.

Reazioni psichiatriche e paradosse: agitazione incessante, irritabilità, aggressività, illusione, collera,

incubi, allucinazioni, psicosi, comportamento inappropriato e altri effetti comportamentali negativi.

Una depressione preesistente al trattamento può manifestarsi durante la cura con benzodiazepine.

Se osserva effetti collaterali qui non descritti, informi il suo medico o il suo farmacista.

Di che altro occorre tener conto?

Tranxilium deve essere conservato fuori dalla portata dei bambini, nella confezione originale

(protezione contro l'umidità!) e a temperatura ambiente (15-25 °C).

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

Trascorso questo termine, Tranxilium non deve più essere somministrato, ma riportato in farmacia.

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

ulteriori informazioni.

Cosa contiene Tranxilium?

Il principio attivo di Tranxilium è il clorazepato dipotassico.

1 capsula Tranxilium 5 resp. 10 contiene 5 mg resp. 10 mg di clorazepato dipotassico, il colorante

eritrosina (E 127) ed eccipienti.

1 capsula Tranxilium 20 contiene 20 mg di clorazepato dipotassico, il colorante indigotina (E 132),

ed eccipienti.

1 Tabs contiene 20 mg di clorazepato dipotassico, il colorante indigotina (E 132), lattosio, ftalato di

dietile e altri eccipienti.

Le Tabs possono essere divise, grazie alle 3 infossature, in 4 porzioni contenenti ognuna 5 mg di

principio attivo.

1 compressa rivestita con film contiene 50 mg di clorazepato dipotassico, il colorante eritrosina (E

127), lattosio, ftalato di dietile e altri eccipienti.

Le compresse con l'infossatura possono essere divise in 2 porzioni contenenti ognuna 25 mg di

principio attivo.

Numero dell’omologazione

33866, 48285, 45388 (Swissmedic).

Dov’è ottenibile Tranxilium? Quali confezioni sono disponibili?

In farmacia, dietro presentazione della prescrizione medica.

Capsule da 5, 10 e 20 mg: confezioni da 20 e 50 capsule.

Tabs da 20 mg (con 3 infossature): confezioni da 20 e 50 compresse.

Compresse rivestite con film (divisibili) da 50 mg: confezione da 30 compresse.

Titolare dell’omologazione

sanofi-aventis (svizzera) sa, 1214 Vernier/GE.

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

competente in materia di medicamenti (Swissmedic).

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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

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FDA - U.S. Food and Drug Administration

21-11-2018

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24-10-2018

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18-10-2018

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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

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