Propranolol Helvepharm 10 mg

Informazioni principali

  • Nome commerciale:
  • Propranolol Helvepharm 10 mg Filmtabletten
  • Forma farmaceutica:
  • Filmtabletten
  • Composizione:
  • propranololi hydrochloridum 10 mg, excipiens pro compresso obducto.
  • Utilizzare per:
  • Esseri umani
  • Tipo di medicina:
  • Farmaco biologico

Documenti

  • per i professionisti:
  • Il foglio illustrativo per questo prodotto non è al momento disponibile, é possibile inviare una richiesta al nostro Servizio Clienti ed essere avvisati nel momento in cui è disponibile sulla nostra piattaforma.


    Richiedi il foglio illustrativo per i professionisti.

Localizzazione

  • Disponibile in:
  • Propranolol Helvepharm 10 mg Filmtabletten
    Svizzera
  • Lingua:
  • italiano

Informazioni terapeutiche

  • Gruppo terapeutico:
  • Synthetika
  • Area terapeutica:
  • Beta-Rezeptorenblocker

Altre informazioni

Status

  • Fonte:
  • Swissmedic - Swiss Agency for Therapeutic Products
  • Numero dell'autorizzazione:
  • 47025
  • Data dell'autorizzazione:
  • 10-10-1985
  • Ultimo aggiornamento:
  • 19-10-2018

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

Patienteninformation

Propranolol Helvepharm

Helvepharm AG

Che cos'è Propranolol Helvepharm e quando si usa?

Propranolol Helvepharm contengono il principio attivo propranololo, che protegge il cuore dalle

sollecitazioni eccessive.

Il lavoro del cuore viene diminuito e la reazione del cuore al carico viene smorzata. Propranolol

Helvepharm riducono la pressione arteriosa elevata. L'angina pectoris (forte dolore oppressivo nella

parte sinistra del torace, che può irradiarsi al braccio sinistra) compare quando il cuore, in condizioni

di sforzo, non riceve ossigeno a sufficienza.

Propranolol Helvepharm impediscono questi attacchi o ne riducono la frequenza e l'intensità del

dolore. Propranolol Helvepharm vengono impiegati anche dopo un infarto miocardico, per prevenire

altri infarti. Un ritmo cardiaco irregolare o un polso accelerato in seguito a malattia o stress possono

essere normalizzati tramite Propranolol Helvepharm. Propranolol Helvepharm prevengono il mal di

testa e l'emicrania dovuti alla circolazione.

Altri campi di applicazione di Propranolol Helvepharm sono: tremore essenziale, malattie della

tiroide (eccessiva funzione della tiroide), tumore delle surrenali (feocromocitoma; solo in

associazione ad altri medicamenti) e stati d'ansia.

Propranolol Helvepharm possono essere impiegati solo su prescrizione medica e sotto stretto

controllo di un medico.

Quando non si può usare il Propranolol Helvepharm?

Se in passato ha già sofferto di asma o di disturbi respiratori di tipo asmatico non può prendere il

Propranolol Helvepharm. Ne informi il medico o il farmacista.

Informi il medico curante anche se in passato ha già avuto una reazione allergica al principio attivo

propranololo o ad un altro costituente del medicamento.

In presenza delle seguenti malattie deve rinunciare a prendere Propranolol Helvepharm: insufficienza

cardiaca (debolezza di cuore), blocco cardiaco (meno di 50 battiti al minuto), polso molto lento o

irregolare, pressione arteriosa bassa, cattiva irrorazione sanguigna, dolori al petto (angina di

Prinzmetal) o feocromocitoma non curato con altri medicamenti. Anche dopo un digiuno prolungato

non deve Propranolol Helvepharm. Se soffre di una queste malattie lo comunichi al medico affinché

possa prescriverle un trattamento adatto al suo caso.

Quando e richiesta prudenza nella somministrazione il Propranolol Helvepharm?

Questo medicamento può ridurre la capacità di reazione, la capacità di condurreun veicolo e la

capacità di utilizzare attrezzi o macchine! Se nel corsodella terapia constata vertigini o stanchezza

non guidi l'automobile e non usidelle macchine di qualsiasi genere.

Informi il medico o il farmacista se soffre di disturbi respiratori, caviglie gonfie, diabete o disturbi

dell'irrorazione sanguigna oppure ha problemi al cuore, alfegato, ai reni o alla tiroide.

Comunichi pure al medico se prende medicamenti per il cuore, anticoagulanti, farmaci contro

l'emicrania, analgesici oppure medicamenti contro l'ipertensione, l'angina pectoris, dolori di stomaco,

la tubercolosi, l'asma o il diabete.

Se usa degli spray nasali decongestionanti o dei farmaci contro le infreddaturene parli al medico.

Se prende clonidina contro l'ipertensione o l'emicrania non smetta di sua iniziativadi prendere né la

clonidina né il Propranolol Helvepharm senza averne parlato al medico.

Nei diabetici il Propranolol Helvepharmpuò modificare la risposta a un trattamento con insulina o

con antidiabetici orali come pure i sintomi di un'ipoglicemia. Occasionalmente il Propranolol

Helvepharm può modificare la reazione normale dell'organismo all'insulina e ad un basso tasso

sanguigno dello zucchero. Propranolol Helvepharm puòinibire o mascherare i sintomi di ipoglicemia.

Specialmente un polso accelerato quale sintomo di ipoglicemia viene percepito in modo meno

pronunciato.

Se lei soffre di diabete ed e curato con insulina o con antidiabetici orali deve quindi prestare

particolare attenzione ai sintomi di ipoglicemia. Raramente il tasso sanguigno dello zucchero può

scendere ad un livello molto basso e causare crisi epilettiche o perdita della conoscenza.

Occasionalmente il Propranolol Helvepharmpuò determinare un tasso sanguigno basso dello

zucchero anche in pazienti che non soffrono di diabete, specialmente nei bambini, nelle persone

anziane, nei pazienti sotto emodialisi (depurazione del sangue col rene artificiale) e in quelli con

malattie croniche del fegato, come pure in caso di iperdosaggio e dopo un digiuno prolungato.Vada

immediatamente dal suo medico se nel corso della terapia il suo polso ariposo scende sotto i 50

battiti al minuto oppure se la sua pressione arteriosae troppo bassa. Sintomi di queste situazioni sono

stanchezza, mancanzad'energia e vertigini alzandosi in piedi troppo rapidamente.

Tenga presente che prima di un intervento chirurgico I'anestesista dev'essere informato di tutti i

medicamenti che lei prende.

In caso di frequente consumo di alcool, l'azione di Propranolol Helvepharm potrebbe essere

influenzata. La somministrazione di Propranolol Helvepharm, come quella di tutti i medicamenti di

questo tipo, dev'essere cessata gradualmente.

Si attenga perciò rigorosamente allo schema di somministrazione che le ha prescritto il medico.

Propranolol Helvepharm compresse filmate contiene del lattosio (zucchero contenuto nel latte). Se

soffre di intolleranza al lattosio, non deve usare Propranolol Helvepharm compresse filmate.

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

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

Si può somministrare il Propranolol Helvepharm durante la gravidanza o l’allattamento?

Durante la gravidanza o l'allattamento non può prendere il Propranolol Helvepharm a meno che il

suo medico gliel'abbia prescritto espressamente.

Come usare il Propranolol Helvepharm?

Prenda il Propranolol Helvepharm soltanto sotto regolare controllo medico e secondo le prescrizioni

del suo medico. Dato che la risposta ai medicamenti per il cuore è molto diversa da una persona

all'altra, la posologia ottimale può essere determinata solo assumendo il farmaco scrupolosamente

sotto controllo medico.

In generale, all'inizio della terapia, la dose per adulti à di 80–120 mg al giorno e sarà poi aumentata

fino a 160–240 mg al giorno. Se necessario questa dose può essere ulteriormente aumentata.

Il suo medico diminuirà o aumenterà la dose a seconda della malattia da curare e le spiegherà quali

compresse filmate Propranolol Helvepharm (da 10 mg, da 40 mg o da 80 mg) sono adatte al suo

caso. Per i bambini adeguerà la dose alla situazione.

Prenda il Propranolol Helvepharm prima dei pasti, senza masticarlo, con un po' di liquido,

preferibilmente sempre alla stessa ora della giornata. Se una volta avesse dimenticato di prendere una

compressa o una capsula la prenda appena se ne accorge. Non prenda però due compresse

contemporaneamente.

Non modifichi di propria iniziativa la posologia prescritta. Se ritiene che l'azione del medicamento

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

Quali effetti collaterali può avere il Propranolol Helvepharm?

Con l'assunzione di Propranolol Helvepharm possono manmesiarsi i seguenti effetti collaterali:

spesso sono stati constatati stanchezza e spossatezza, disturbi del sonno, incubi, rallentamentodel

battito cardiaco, sensazione di freddo alle dita delle mani o dei piedi, disturbi della sensibilità alle

mani e dolori di tipo spastico alle dita.

Occasionalmente si sono manifestati diarrea, vomito e nausea.

In rari casi sonostati riferiti emorragie a piccole macchie nella pelle o nelle mucose (porpora),bassi

tassi sanguigni dello zucchero, allucinazioni, instabilità dell'umore, confusione, formicolii alle mani

ed ai piedi, occhi secchi, disturbi della vista, aggravamento di un'insufficienza cardiaca già presente,

vertigini alzandosi in piedi troppo rapidamente, aggravamento di disturbi respiratori negli asmatici,

caduta dei capelli, eruzioni sulla pelle, aggravamento di una psoriasi, aumentato rischio di ematomi e

vertigini.

Possono verificarsi anche allergie, secchezza della bocca, stitichezza, dolori diventre, impotenza, mal

di testa e debolezza muscolare.

Come con tutti i medicamenti per regolare la frequenza del battito cardiaco, per effetto di

Propranolol Helvepharm possono manifestarsi dei disturbi del ritmo cardiaco.

Bassi tassi sanguigni dello zucchero possono verificarsi nei diabetici, ma anche in pazienti non

diabetici, specialmente nei bambini, nelle persone anziane,nei pazienti sotto emodialisi (depurazione

del sangue col rene artificiale), inquelli con malattie croniche del fegato e dopo un digiuno

prolungato.

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

Di che altro occorre tener conto?

Conservare le compresse filmate Propranolol Helvepharm a temperatura ambiente (15–25 °C), al

riparo dalla luce e dall'umidità e fuori dalla portata dei bambini.

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

avesse compresse filmate la cui data di scadenzae trascorsa le riporti per favore in farmacia per

l'eliminazione.

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

darle ulteriori informazioni.

Che cosa contiene Propranolol Helvepharm?

Le compresse filmate Propranolol Helvepharm contengono il principio attivo propranololo-

idrocloruro nonche sostanze ausiliarie e sono disponibili come compresse filmate da 10 mg, da 40 e

da 80 mg.

Numero dell'omologazione

47025 (Swissmedic).

Dov’è ottenibile il Propranolol Helvepharm? Quali confezioni sono disponibili?

In farmacia dietro presentazione della prescrizione medica.

Propranolol Helvepharm compresse filmate da 10 mg: confezioni da 60.

Propranolol Helvepharm compresse filmate da 40 e 80 mg: confezioni da 60 e 180 pezzi.

Titolare dell’omologazione

Helvepharm AG, Frauenfeld.

Questo foglietto illustrativo è stato controllato l'ultima volta nel marzo 2008 dall'autorità competente

in materia di medicamenti (Swissmedic).

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Scientific Opinion on Flavouring Group Evaluation 201 Revision 2 (FGE.201Rev2): 2‐alkylated, aliphatic, acyclic alpha,beta‐unsaturated aldehydes and precursors, with or without additional double‐bonds, from chemical subgroup 1.1.2 of FGE.19

Scientific Opinion on Flavouring Group Evaluation 201 Revision 2 (FGE.201Rev2): 2‐alkylated, aliphatic, acyclic alpha,beta‐unsaturated aldehydes and precursors, with or without additional double‐bonds, from chemical subgroup 1.1.2 of FGE.19

Published on: Wed, 17 Oct 2018 00:00:00 +0200 The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to consider in this revision 2 of Flavouring Group Evaluation 201, the additional data on genotoxicity submitted by the Industry on two substances, 2‐methylpent‐2‐enal [FL‐no: 05.090] and 2 methylcrotonaldehyde [FL‐no: 05.095], from subgroup 1.1.2 of FGE.19. In FGE.201Rev1, the Panel concluded that further data were required in order to clarify the genotoxic poten...

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Applicability of in silico tools for the prediction of dermal absorption for pesticides

Applicability of in silico tools for the prediction of dermal absorption for pesticides

Published on: Tue, 16 Oct 2018 00:00:00 +0200 Based on the “Human in vitro dermal absorption datasets” published as supporting information to the revised EFSA Guidance on Dermal Absorption, in silico models for prediction of absorption across the skin have been evaluated. For this evaluation, a systematic literature search and review was performed, identifying 288 publications describing mathematical models for prediction of dermal absorption. Eleven models potentially relevant to the regulatory assessm...

Europe - EFSA - European Food Safety Authority Publications

11-10-2018

Re‐evaluation of oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (E 479b) as a food additive

Re‐evaluation of oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (E 479b) as a food additive

Published on: Wed, 10 Oct 2018 00:00:00 +0200 The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion re‐evaluating the safety of thermally oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (TOSOM) (E 479b) when used as a food additive. The Scientific Committee on Food (SCF) and the Joint FAO/WHO Expert Committee on Food Additives (JECFA) derived an acceptable daily intake (ADI) of 25 and 30 mg/kg body weight (bw) per day, respectively. There was n...

Europe - EFSA - European Food Safety Authority Publications

11-10-2018

Wild boar in focus: Review of existing models on spatial distribution and density of wild boar and proposal for next steps

Wild boar in focus: Review of existing models on spatial distribution and density of wild boar and proposal for next steps

Published on: Wed, 10 Oct 2018 00:00:00 +0200 This report provides a review of existing models for predicting the spatial distribution and abundance of wild boar at various scales (global, continental, national and regional) in order to inform the development of a new model to produce estimates of wild boar abundance at European level. The review identifies and discusses a range of models based on a wide variety of data types, corresponding to those targeted by the data collection model set by ENETwild,...

Europe - EFSA - European Food Safety Authority Publications

10-10-2018

Sprayology Issues Voluntary Nationwide Recall of Homeopathic Aqueous-Based Medicines Due to Microbial Contamination

Sprayology Issues Voluntary Nationwide Recall of Homeopathic Aqueous-Based Medicines Due to Microbial Contamination

Eight and Company LLC, d/b/a Sprayology is voluntarily recalling all lots within expiry from 10/18-7/22 of its aqueous-based homeopathic product line for human use. All products manufactured by the contract manufacturer, King Bio, have been recalled due to possible microbial contamination.

FDA - U.S. Food and Drug Administration

10-10-2018

Enforcement Report for the Week of October 10, 2018

Enforcement Report for the Week of October 10, 2018

Recently Updated Records for the Week of October 10, 2018 Last Modified Date: Tuesday, October 09, 2018

FDA - U.S. Food and Drug Administration

11-1-2019


Orphan designation: 6-(R)-methyl-5-O-(5-amino-5,6-dideoxy-alpha-L-talofuranosyl)-paromamine sulfate, Treatment of cystic fibrosis, 26/10/2018, Positive

Orphan designation: 6-(R)-methyl-5-O-(5-amino-5,6-dideoxy-alpha-L-talofuranosyl)-paromamine sulfate, Treatment of cystic fibrosis, 26/10/2018, Positive

Orphan designation: 6-(R)-methyl-5-O-(5-amino-5,6-dideoxy-alpha-L-talofuranosyl)-paromamine sulfate, Treatment of cystic fibrosis, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

11-1-2019


Orphan designation: Recombinant adeno-associated viral vector serotype S3 containing codon-optimised expression cassette encoding human coagulation factor IX variant, Treatment of haemophilia B, 26/10/2018, Positive

Orphan designation: Recombinant adeno-associated viral vector serotype S3 containing codon-optimised expression cassette encoding human coagulation factor IX variant, Treatment of haemophilia B, 26/10/2018, Positive

Orphan designation: Recombinant adeno-associated viral vector serotype S3 containing codon-optimised expression cassette encoding human coagulation factor IX variant, Treatment of haemophilia B, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

11-1-2019


Orphan designation: 6-(2-hydroxy-2-methylpropoxy)-4-(6-(6-((6-methoxypyridin-3-yl)methyl)-3,6-diazabicyclo[3.1.1]heptan-3-yl)pyridin-3-yl)pyrazolo[1,5-a]pyridine-3-carbonitrile, Treatment of medullary thyroid carcinoma, 26/10/2018, Positive

Orphan designation: 6-(2-hydroxy-2-methylpropoxy)-4-(6-(6-((6-methoxypyridin-3-yl)methyl)-3,6-diazabicyclo[3.1.1]heptan-3-yl)pyridin-3-yl)pyrazolo[1,5-a]pyridine-3-carbonitrile, Treatment of medullary thyroid carcinoma, 26/10/2018, Positive

Orphan designation: 6-(2-hydroxy-2-methylpropoxy)-4-(6-(6-((6-methoxypyridin-3-yl)methyl)-3,6-diazabicyclo[3.1.1]heptan-3-yl)pyridin-3-yl)pyrazolo[1,5-a]pyridine-3-carbonitrile, Treatment of medullary thyroid carcinoma, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

10-1-2019


Orphan designation: autologous CD34+ haematopoietic stem and progenitor cells genetically modified with the lentiviral vector IDUA LV, encoding for the alpha-L-iduronidase cDNA, Treatment of mucopolysaccharidosis type I, 26/10/2018, Positive

Orphan designation: autologous CD34+ haematopoietic stem and progenitor cells genetically modified with the lentiviral vector IDUA LV, encoding for the alpha-L-iduronidase cDNA, Treatment of mucopolysaccharidosis type I, 26/10/2018, Positive

Orphan designation: autologous CD34+ haematopoietic stem and progenitor cells genetically modified with the lentiviral vector IDUA LV, encoding for the alpha-L-iduronidase cDNA, Treatment of mucopolysaccharidosis type I, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

10-1-2019


Orphan designation: Recombinant adeno-associated viral vector containing a bioengineered capsid and a codon-optimised expression cassette to drive the expression of the SQ form of a B-domain deleted human coagulation factor VIII, Treatment of haemophilia

Orphan designation: Recombinant adeno-associated viral vector containing a bioengineered capsid and a codon-optimised expression cassette to drive the expression of the SQ form of a B-domain deleted human coagulation factor VIII, Treatment of haemophilia

Orphan designation: Recombinant adeno-associated viral vector containing a bioengineered capsid and a codon-optimised expression cassette to drive the expression of the SQ form of a B-domain deleted human coagulation factor VIII, Treatment of haemophilia A, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

10-1-2019


Orphan designation: glycine, L-alanine, L-arginine, L-aspartic acid, L-cysteine, L-cystine, L-glutamic acid, L-histidine, L-lysine monohydrate, L-methionine, L-phenylalanine, L-proline, L-serine, L-threonine, L-tryptophan, L-tyrosine, taurine, Treatment

Orphan designation: glycine, L-alanine, L-arginine, L-aspartic acid, L-cysteine, L-cystine, L-glutamic acid, L-histidine, L-lysine monohydrate, L-methionine, L-phenylalanine, L-proline, L-serine, L-threonine, L-tryptophan, L-tyrosine, taurine, Treatment

Orphan designation: glycine, L-alanine, L-arginine, L-aspartic acid, L-cysteine, L-cystine, L-glutamic acid, L-histidine, L-lysine monohydrate, L-methionine, L-phenylalanine, L-proline, L-serine, L-threonine, L-tryptophan, L-tyrosine, taurine, Treatment of maple syrup urine disease, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

10-1-2019


Orphan designation: gefinitib, Treatment of Fanconi anaemia type A, 26/10/2018, Positive

Orphan designation: gefinitib, Treatment of Fanconi anaemia type A, 26/10/2018, Positive

Orphan designation: gefinitib, Treatment of Fanconi anaemia type A, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

10-1-2019


Orphan designation: Peptides YMFPNAPYL, SGQAYMFPNAPYLPSCLES, RSDELVRHHNMHQRNMTKL and PGCNKRYFKLSHLQMHSRKHTG, Treatment of multiple myeloma, 26/10/2018, Positive

Orphan designation: Peptides YMFPNAPYL, SGQAYMFPNAPYLPSCLES, RSDELVRHHNMHQRNMTKL and PGCNKRYFKLSHLQMHSRKHTG, Treatment of multiple myeloma, 26/10/2018, Positive

Orphan designation: Peptides YMFPNAPYL, SGQAYMFPNAPYLPSCLES, RSDELVRHHNMHQRNMTKL and PGCNKRYFKLSHLQMHSRKHTG, Treatment of multiple myeloma, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

4-1-2019


Orphan designation: avapritinib, Treatment of mastocytosis, 26/10/2018, Positive

Orphan designation: avapritinib, Treatment of mastocytosis, 26/10/2018, Positive

Orphan designation: avapritinib, Treatment of mastocytosis, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

19-12-2018


Orphan designation: melatonin, Treatment of acute radiation syndrome, 26/10/2018, Positive

Orphan designation: melatonin, Treatment of acute radiation syndrome, 26/10/2018, Positive

Orphan designation: melatonin, Treatment of acute radiation syndrome, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

19-12-2018


Recommendations on eligibility to PRIME scheme -  Adopted at the CHMP meeting of 10-13 December 2018

Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 10-13 December 2018

Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 10-13 December 2018

Europe - EMA - European Medicines Agency

14-12-2018


Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 December 2018

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 December 2018

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 December 2018

Europe - EMA - European Medicines Agency

10-12-2018

Exondys (AVI BioPharma International Ltd)

Exondys (AVI BioPharma International Ltd)

Exondys (Active substance: eteplirsen) - Centralised - Refusal of marketing authorisation - Commission Decision (2018)8620 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4355

Europe -DG Health and Food Safety

10-12-2018

Ivabradine JensonR (JensonR+ Limited)

Ivabradine JensonR (JensonR+ Limited)

Ivabradine JensonR (Active substance: ivabradine) - Centralised - Withdrawal - Commission Decision (2018)8623 of Mon, 10 Dec 2018

Europe -DG Health and Food Safety

10-12-2018

EU/3/16/1662 (QRC Ireland)

EU/3/16/1662 (QRC Ireland)

EU/3/16/1662 (Active substance: H-Phe-Ser-Arg-Tyr-Ala-Arg-OH acetate) - Transfer of orphan designation - Commission Decision (2018)8626 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/011/16/T/01

Europe -DG Health and Food Safety

10-12-2018

EU/3/17/1906 (PTC Therapeutics International Limited)

EU/3/17/1906 (PTC Therapeutics International Limited)

EU/3/17/1906 (Active substance: Recombinant adeno-associated viral vector serotype 5 carrying the gene for the human frataxin protein) - Transfer of orphan designation - Commission Decision (2018)8634 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002509

Europe -DG Health and Food Safety

10-12-2018

EU/3/16/1786 (PTC Therapeutics International Limited)

EU/3/16/1786 (PTC Therapeutics International Limited)

EU/3/16/1786 (Active substance: Recombinant adeno-associated viral vector serotype 2 carrying the gene for the human aromatic L-amino acid decarboxylase protein) - Transfer of orphan designation - Commission Decision (2018)8630 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002507

Europe -DG Health and Food Safety

10-12-2018

EU/3/16/1651 (PTC Therapeutics International Limited)

EU/3/16/1651 (PTC Therapeutics International Limited)

EU/3/16/1651 (Active substance: Recombinant adeno-associated viral vector serotype 9 carrying the gene for the human E6-AP ubiquitin protein ligase) - Transfer of orphan designation - Commission Decision (2018)8632 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002508

Europe -DG Health and Food Safety

10-12-2018

EU/3/16/1802 (FGK Representative Service GmbH)

EU/3/16/1802 (FGK Representative Service GmbH)

EU/3/16/1802 (Active substance: Ivosidenib) - Transfer of orphan designation - Commission Decision (2018)8627 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002422

Europe -DG Health and Food Safety

10-12-2018

EU/3/10/760 (TESARO Bio Netherlands B.V.)

EU/3/10/760 (TESARO Bio Netherlands B.V.)

EU/3/10/760 (Active substance: (3S)-3-{4-[7-(aminocarbonyl)-2H-indazol-2-yl] phenyl} piperidine tosylate monohydrate salt) - Transfer of orphan designation - Commission Decision (2018)8636 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002385

Europe -DG Health and Food Safety

10-12-2018

EU/3/17/1893 (SFL Regulatory Services GmbH)

EU/3/17/1893 (SFL Regulatory Services GmbH)

EU/3/17/1893 (Active substance: Polyphenyl(disodium 3-O-sulfo-beta-D-glucopyranuronate)-(1?3)-beta-D-galactopyranoside) - Transfer of orphan designation - Commission Decision (2018)8628 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/048/17/T/01

Europe -DG Health and Food Safety

10-12-2018

EU/3/09/628 (Nova Laboratories Ireland Limited)

EU/3/09/628 (Nova Laboratories Ireland Limited)

EU/3/09/628 (Active substance: Mercaptopurine (oral suspension)) - Transfer of orphan designation - Commission Decision (2018)8629 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002301

Europe -DG Health and Food Safety

10-12-2018

EU/3/11/933 (Les Laboratoires Servier)

EU/3/11/933 (Les Laboratoires Servier)

EU/3/11/933 (Active substance: Nanoliposomal irinotecan) - Transfer of orphan designation - Commission Decision (2018)8625 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/051/11/T/02

Europe -DG Health and Food Safety

7-12-2018


Orphan designation: (1'R,6'R)-3-(benzylamine)-6-hydroxy-3'-methyl-4-pentyl-6'-(prop-1-en-2-yl)-[1,1'-bi(cyclohexane)]-2',3,6-triene-2,5-dione, Treatment of systemic sclerosis, 12/10/2017, Positive

Orphan designation: (1'R,6'R)-3-(benzylamine)-6-hydroxy-3'-methyl-4-pentyl-6'-(prop-1-en-2-yl)-[1,1'-bi(cyclohexane)]-2',3,6-triene-2,5-dione, Treatment of systemic sclerosis, 12/10/2017, Positive

Orphan designation: (1'R,6'R)-3-(benzylamine)-6-hydroxy-3'-methyl-4-pentyl-6'-(prop-1-en-2-yl)-[1,1'-bi(cyclohexane)]-2',3,6-triene-2,5-dione, Treatment of systemic sclerosis, 12/10/2017, Positive

Europe - EMA - European Medicines Agency

7-12-2018


Orphan designation: tiratricol, Treatment of Allan-Herndon-Dudley syndrome, 12/10/2017, Positive

Orphan designation: tiratricol, Treatment of Allan-Herndon-Dudley syndrome, 12/10/2017, Positive

Orphan designation: tiratricol, Treatment of Allan-Herndon-Dudley syndrome, 12/10/2017, Positive

Europe - EMA - European Medicines Agency

26-11-2018

In the next few months CDRH will make public on its website cleared devices that demonstrated substantial equivalence to older predicate devices. We’re considering focusing on predicates that are >10 years old as a starting point, so the public is aware o

In the next few months CDRH will make public on its website cleared devices that demonstrated substantial equivalence to older predicate devices. We’re considering focusing on predicates that are >10 years old as a starting point, so the public is aware o

In the next few months CDRH will make public on its website cleared devices that demonstrated substantial equivalence to older predicate devices. We’re considering focusing on predicates that are >10 years old as a starting point, so the public is aware of those technologies.

FDA - U.S. Food and Drug Administration

26-11-2018

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health te

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health te

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health technologies.

FDA - U.S. Food and Drug Administration

22-11-2018

Emtricitabine/Tenofovir disoproxil Krka (Krka d. d., Novo mesto)

Emtricitabine/Tenofovir disoproxil Krka (Krka d. d., Novo mesto)

Emtricitabine/Tenofovir disoproxil Krka (Active substance: emtricitabine / tenofovir disoproxil) - Centralised - 2-Monthly update - Commission Decision (2018)7884 of Thu, 22 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4215/IB/10G

Europe -DG Health and Food Safety

22-11-2018


Human medicines European public assessment report (EPAR): Symkevi, tezacaftor / ivacaftor, Cystic Fibrosis, Date of authorisation: 31/10/2018, Status: Authorised

Human medicines European public assessment report (EPAR): Symkevi, tezacaftor / ivacaftor, Cystic Fibrosis, Date of authorisation: 31/10/2018, Status: Authorised

Human medicines European public assessment report (EPAR): Symkevi, tezacaftor / ivacaftor, Cystic Fibrosis, Date of authorisation: 31/10/2018, Status: Authorised

Europe - EMA - European Medicines Agency

12-11-2018

Spinraza (Biogen Netherlands B.V.)

Spinraza (Biogen Netherlands B.V.)

Spinraza (Active substance: nusinersen) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7550 of Mon, 12 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4312/T/10

Europe -DG Health and Food Safety

23-10-2018

EU/3/16/1804 (Eli Lilly Nederland B.V.)

EU/3/16/1804 (Eli Lilly Nederland B.V.)

EU/3/16/1804 (Active substance: Pegylated recombinant human interleukin-10) - Transfer of orphan designation - Commission Decision (2018)6994 of Tue, 23 Oct 2018

Europe -DG Health and Food Safety

22-10-2018

EU/3/10/815 (Pfizer Europe MA EEIG)

EU/3/10/815 (Pfizer Europe MA EEIG)

EU/3/10/815 (Active substance: Sildenafil citrate) - Transfer of orphan designation - Commission Decision (2018)6993 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/068/10/T/01

Europe -DG Health and Food Safety

19-10-2018

Recocam (Bimeda Animal Health Limited)

Recocam (Bimeda Animal Health Limited)

Recocam (Active substance: Meloxicam) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6954 of Fri, 19 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2247/T/10

Europe -DG Health and Food Safety

26-9-2018

Kexxtone (Elanco GmbH)

Kexxtone (Elanco GmbH)

Kexxtone (Active substance: Monensin sodium) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6324 of Wed, 26 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2235/T/10

Europe -DG Health and Food Safety