Androcur-10

Informazioni principali

  • Nome commerciale:
  • Androcur-10 Tabletten
  • Forma farmaceutica:
  • Tabletten
  • Composizione:
  • cyproteroni acetas 10 mg, excipiens pro compresso.
  • 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:
  • Androcur-10 Tabletten
    Svizzera
  • Lingua:
  • italiano

Informazioni terapeutiche

  • Gruppo terapeutico:
  • Synthetika
  • Area terapeutica:
  • Androgenisierungserscheinungen (Frau); Sexualtriebdämpfung, Prostatakarzinom (Mann)

Altre informazioni

Status

  • Fonte:
  • Swissmedic - Swiss Agency for Therapeutic Products
  • Numero dell'autorizzazione:
  • 37482
  • Data dell'autorizzazione:
  • 13-10-1972
  • Ultimo aggiornamento:
  • 19-10-2018

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

Patienteninformation

Androcur®-10

Bayer (Schweiz) AG

Che cos'è Androcur-10 e quando si usa?

Androcur-10 è un preparato ormonale che inibisce l’azione degli ormoni maschili (androgeni),

presenti anche nell’organismo femminile. Androcur-10 permette di trattare alterazioni morbose

femminili, provocate dalla produzione di una maggiore quantità di androgeni oppure da una più

elevata sensibilità dell’organismo a questi ormoni: forme medio-gravi di crescita patologicamente

aumentata dei peli sul corpo e sul viso androgeno-dipendenti, forme medio-gravi di caduta dei capelli

androgeno-dipendenti, forme gravi e medio-gravi di acne e seborrea (pelle grassa e capelli grassi con

forfora) andregono-dipendenti.

Androcur-10 deve essere impiegato esclusivamente su prescrizione medica e sotto costante controllo

medico.

Di che cosa occorre inoltre tener conto durante il trattamento?

Androcur-10 non deve essere somministrato durante la gravidanza. Prima di iniziare la terapia deve

essere esclusa una possibile gravidanza.

Androcur-10 va utilizzato assieme ad uno specifico mezzo contraccettivo orale (ad es. Diane-35) per

garantire la necessaria contraccezione e per evitare cicli mestruali irregolari. Si devono quindi

osservare anche le indicazioni relative allo specifico contraccettivo.

Quando non si può assumere Androcur-10?

Androcur-10 non deve essere somministrato durante la gravidanza e l’allattamento oppure in caso di

comparsa di ittero, prurito persistente o herpes durante una precedente gravidanza; in caso di malattie

epatiche inclusi determinati disturbi di secrezione del fegato (sindrome di Dubin-Johnson, sindrome

di Rotor), tumori epatici in corso o pregressi, malattie debilitanti, gravi depressioni croniche, malattie

vascolari in corso o pregresse, diabete grave o anomalie dei globuli rossi (anemia falciforme),

nonché in caso di ipersensibilità (una forma di allergia) a uno dei componenti di Androcur-10.

Si rimanda inoltre alle indicazioni sui limiti di impiego riportati nel foglietto illustrativo del

contraccettivo prescritto.

Quando è richiesta prudenza nell'uso di Androcur-10?

Androcur-10 da solo può provocare disturbi mestruali (perdite intermestruali, variazioni della durata

delle mestruazioni). Per ovviare a questo inconveniente occorre assumere contemporaneamente ad

Androcur-10 uno speciale contraccettivo (ad es. Diane-35). Se con questa terapia combinata si

verificano casi di spotting durante le 3 settimane di assunzione delle compresse, occorre continuare

regolarmente con l’assunzione delle compresse. Tuttavia, in caso di perdite persistenti o ricorrenti ad

intervalli irregolari, occorre consultare il medico.

Come con altri steroidi sessuali, sono state osservate, in casi particolari, alterazioni epatiche di natura

benigna e maligna. I tumori epatici possono dar luogo sporadicamente ad emorragie intra-addominali

potenzialmente letali. Occorre pertanto informare assolutamente il medico se compaiono disturbi

insoliti nella parte alta dell’addome che non si risolvono spontaneamente in breve tempo.

In pazienti trattati con Androcur-10 sono state osservate alterazioni della funzione epatica in parte

anche gravi (ittero, epatite [infiammazione del fegato]). Le alterazioni della funzione epatica

dipendono dalla dose e si sviluppano solitamente nel corso di alcuni mesi dopo l’inizio del

trattamento. Pertanto il suo medico procederà all’analisi della sua funzione epatica prima dell’inizio

della terapia e durante la terapia, a intervalli regolari, soprattutto nel caso della comparsa di disturbi o

sintomi che facessero presupporre un danneggiamento del fegato. Qualora il sospetto di un danno al

fegato dovesse essere confermato, il suo medico interromperà il trattamento con Androcur-10.

Informi immediatamente il suo medico se dovesse lamentare uno dei seguenti disturbi:

Malessere generale, febbre, nausea, vomito, inappetenza, prurito su tutto il corpo, colorazione

giallastra di pelle e occhi, feci chiare, orina scura. Questi disturbi possono essere sintomi di un danno

al fegato, inclusa un’infiammazione del fegato (epatite).

Informi il suo medico se soffre di diabete, poiché questa malattia necessita di un controllo accurato e

perché il fabbisogno di farmaci antidiabetici potrebbe variare con l’assunzione di Androcur-10.

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

utilizzare attrezzi e macchine.

L’assunzione contemporanea di altri farmaci può potenziare l’azione e gli effetti collaterali di

Androcur-10 (per esempio nel caso di medicamenti contro le infezioni da funghi o di antibiotici)

oppure ridurli (per esempio nel caso di medicamenti contro l’epilessia o la tubercolosi o nel caso di

medicamenti di origine vegetale contro la depressione (preparati a base di estratti dell’erba di San

Giovanni)).

Anche i farmaci contro un’infezione da HIV possono alterare l’azione di Androcur-10.

Allo stesso modo, anche la dose necessaria di antidiabetici e di insulina può cambiare se si fa uso

concomitante di Androcur-10.

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

·soffre di altre malattie,

·soffre di allergie o

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

Si può usare Androcur-10 durante la gravidanza o l'allattamento?

Androcur-10 può provocare effetti dannosi al feto e anche al neonato durante l’allattamento.

Pertanto, non deve essere somministrato né durante la gravidanza né durante l’allattamento.

Come usare Androcur-10?

Le compresse vanno assunte dopo i pasti con un po’ di liquido.

Salvo diversa prescrizione medica, assumere ogni giorno 1 compressa di Androcur-10 dal 1° al 15°

giorno (= 15 giorni) di ogni ciclo di trattamento assieme ad un 1 confetto del contraccettivo

prescritto, che dovrà essere assunto dal 1° al 21° giorno (= 21 giorni).

Si deve iniziare l’assunzione di entrambi i preparati il primo giorno del ciclo (= primo giorno delle

mestruazioni).

Estrarre la prima compressa di Androcur-10 dalla casella contrassegnata con il giorno della settimana

in cui si inizia il trattamento (ad es. «Lun» per lunedì) e deglutirla senza masticarla con un po’ di

liquido.

Il momento di assunzione durante la giornata è indifferente, tuttavia si raccomanda di rispettare

l’orario di assunzione scelto la prima volta, preferibilmente dopo colazione o dopo cena.

Nei giorni successivi estrarre ogni giorno una compressa seguendo la direzione della freccia (per un

totale di 14) e, alla fine del trattamento con Androcur-10, assumere la compressa dalla casella

contrassegnata con «15». Quando poi, nei 6 giorni successivi, si terminerà anche la confezione

calendario del contraccettivo prescritto (dopo 21 giorni), seguirà una pausa di 7 giorni, durante la

quale compariranno le mestruazioni.

Dopo la pausa di 7 giorni si proseguirà il trattamento con una nuova confezione calendario di

Androcur-10 e del contraccettivo, non importa che le mestruazioni siano ancora in corso o già

terminate.

Mancanza delle mestruazioni

Qualora, eccezionalmente, non fossero comparse le mestruazioni, non continuare il trattamento e

consultare il medico per escludere una possibile gravidanza.

Compresse dimenticate

Nel caso si fosse dimenticato di assumere la compressa di Androcur-10 e/o il confetto del

contraccettivo all’ora consueta, occorre assumerli al più tardi entro le 12 ore successive. In caso di

dimenticanza che superi di oltre 12 ore l’ora consueta di assunzione, non è più garantita l’azione

contraccettiva per il ciclo in corso.

Per i dati specifici sulla sicurezza contraccettiva e sul comportamento da osservare in caso di

dimenticanza della pillola, si rimanda al foglietto illustrativo del contraccettivo prescritto. In ogni

caso, se durante la pausa non dovessero comparire le mestruazioni, prima di ricominciare a prendere

la pillola occorre escludere una possibile gravidanza.

La dimenticanza di una o più compresse di Androcur-10 può ridurne l’efficacia terapeutica e causare

perdite intermestruali. Una compressa di Androcur-10 dimenticata non deve essere assunta appena

possibile, ma si deve proseguire con il consueto schema di assunzione insieme al contraccettivo, ogni

giorno alla stessa ora. Per sostituire la compressa dimenticata, non deve essere assunta una doppia

dose.

Durata del trattamento

La durata del trattamento dovrà essere stabilita dal medico e dipende dal tipo e dalla gravità delle

manifestazioni morbose di androgenizzazione e dalla loro risposta alla terapia. Il trattamento deve

avere una durata di diversi mesi. Acne e seborrea (pelle grassa e capelli grassi con forfora)

rispondono meglio della crescita anomala di peli (irsutismo) o della caduta dei capelli androgeno-

dipendente (alopecia). Una volta ottenuto il miglioramento desiderato, si potrebbe proseguire la

terapia con il solo contraccettivo orale speciale (ad es. Diane-35).

Raccomandazioni specifiche sulla posologia

Bambini e adolescenti:

Studi relativi alla sicurezza e all’efficacia di Androcur-10 sono stati condotti su donne di 18 o più

anni di età. L’uso di Androcur-10 non è indicato in bambini in età prepuberale. Nel caso di

adolescenti in età postpuberale viene consigliata, in caso di prescrizione medica, la stessa posologia

degli adulti.

Pazienti più anziani (65 anni di età o più anziani):

Androcur-10 è indicato solo per donne in età fertile.

Pazienti con patologie epatiche:

Non assuma Androcur-10 se soffre di una patologia del fegato (vedi anche il paragrafo «Quando non

si può usare Androcur-10?»).

Pazienti con insufficienza renale:

Non sono disponibili dati relativi all’impiego di Androcur-10 in pazienti con insufficienza renale.

Pertanto non è possibile fare raccomandazioni sulla posologia.

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 Androcur-10?

Con l'assunzione di Androcur-10 possono manifestarsi i seguenti effetti collaterali:

Oltre alla tensione al seno, si verifica spesso un aumento del peso corporeo. Spesso possono

verificarsi anche alterazioni dell’umore in senso depressivo.

Occasionalmente si è osservata una riduzione della libido. Occasionalmente possono manifestarsi

cefalea, vertigini, disturbi gastroenterici, disturbi mestruali, galattorrea, eruzioni cutanee e alterazioni

della pressione arteriosa.

In rari casi possono comparire reazioni di ipersensibilità (una forma di allergia) oppure può

verificarsi un calo di peso. Raramente è stato osservato anche un aumento della libido.

Molto raramente si osservano malattie vascolari (cosiddette tromboembolie, vale a dire la formazione

di coaguli di sangue nei vasi) e tumori epatici.

Dopo la commercializzazione sono stati riportati anche casi di alterazione della funzione epatica,

ittero o epatite (infiammazione del fegato).

Occorre tenere conto anche degli effetti collaterali descritti nel foglietto illustrativo del

contraccettivo prescritto.

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

Di che altro occorre tener conto?

Androcur-10 va conservato a temperatura ambiente (15-25 °C) e fuori dalla portata dei bambini. Il

medicamento non dev’essere utilizzato oltre la data indicata con «EXP» sul contenitore.

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

darle ulteriori informazioni.

Cosa contiene Androcur-10?

1 compressa contiene come principio attivo 10 mg di ciproterone acetato e sostanze ausiliarie.

Numero dell'omologazione

37482 (Swissmedic).

Dov'è ottenibile Androcur-10? Quali confezioni sono disponibili?

In farmacia dietro presentazione della prescrizione medica.

Sono disponibili confezioni calendario da 3x 15 compresse.

Titolare dell’omologazione

Bayer (Schweiz) AG, 8045 Zurigo.

Questo foglietto illustrativo è stato controllato l’ultima volta nel marzo 2013 dall’autorità competente

in materia di medicamenti (Swissmedic).

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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

Mylan N.V. (NASDAQ: MYL) today announced that its U.S. based Mylan Pharmaceuticals business is conducting a voluntary nationwide recall to the consumer level of select lots of Valsartan-containing products, including six lots of Amlodipine and Valsartan Tablets, USP (including the 5mg/160mg, 10mg/160mg, and 10mg/320mg strengths), seven lots of Valsartan Tablets, USP (including 40 mg, 80 mg, 160 mg, and 320 mg strengths), and two lots of Valsartan and Hydrochlorothiazide Tablets, USP 320mg/25mg strength. ...

FDA - U.S. Food and Drug Administration

21-11-2018

Risk for animal and human health related to the presence of dioxins and dioxin-like PCBs in feed and food

Risk for animal and human health related to the presence of dioxins and dioxin-like PCBs in feed and food

Published on: Tue, 20 Nov 2018 The European Commission asked EFSA for a scientific opinion on the risks for animal and human health related to the presence of dioxins (PCDD/Fs) and DL‐PCBs in feed and food. The data from experimental animal and epidemiological studies were reviewed and it was decided to base the human risk assessment on effects observed in humans and to use animal data as supportive evidence. The critical effect was on semen quality, following pre‐ and postnatal exposure. The critical s...

Europe - EFSA - European Food Safety Authority Publications

24-10-2018

Vita Health Products Recall (2018-10-24)

Vita Health Products Recall (2018-10-24)

Health Canada

18-10-2018

Mom Life Market recalls 10" & 16" Personalized Stuffed Plush Bunnies

Mom Life Market recalls 10" & 16" Personalized Stuffed Plush Bunnies

The recalled products may contain phthalate levels that exceed the allowable levels.

Health Canada

18-10-2018

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