Prodafem 10 mg

Informazioni principali

  • Nome commerciale:
  • Prodafem 10 mg Tabletten
  • Forma farmaceutica:
  • Tabletten
  • Composizione:
  • medroxyprogesteroni 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:
  • Prodafem 10 mg Tabletten
    Svizzera
  • Lingua:
  • italiano

Informazioni terapeutiche

  • Gruppo terapeutico:
  • Synthetika
  • Area terapeutica:
  • Gestagen-Therapie

Altre informazioni

Status

  • Fonte:
  • Swissmedic - Swiss Agency for Therapeutic Products
  • Numero dell'autorizzazione:
  • 30773
  • Data dell'autorizzazione:
  • 03-06-1964
  • Ultimo aggiornamento:
  • 19-10-2018

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

Patienteninformation

Prodafem®

Pfizer PFE Switzerland GmbH

Che cos'è Prodafem e quando si usa?

Prodafem è un preparato ormonale che contiene il principio attivo medrossiprogesterone acetato, una

sostanza simile al progesterone, un ormone sessuale naturale.

Dietro prescrizione del medico, Prodafem è impiegato come segue: come complemento nel

trattamento con estrogeni (un altro ormone sessuale) nella terapia ormonale sostitutiva nella

menopausa, allo scopo di ridurre il rischio di carcinoma dell'utero che si corre somministrando solo

estrogeno.

Nel trattamento dei disturbi caratteristici della menopausa (vampate di calore, sudorazione), se non è

possibile somministrare estrogeni.

Nel trattamento di disturbi mestruali, se causati soltanto da turbe degli ormoni sessuali e non da

alterazioni patologiche delle ovaie o dell'utero.

Di che cosa occorre inoltre tener conto durante il trattamento?

In alcune donne nella menopausa si può manifestare atrofia delle ossa, con un aumento della fragilità

ossea (osteoporosi). Per prevenire o curare l'osteoporosi, Prodafem va somministrato sempre insieme

a un preparato contenente estrogeni. Soltanto il medico può decidere qual è il trattamento combinato

ideale per lei.

Se assume Prodafem insieme a un estrogeno, specialmente in caso di terapia prolungata, occorre

tener conto di quanto segue: una terapia sostitutiva ormonale di lunga durata può comportare un

aumento del rischio di cancro del seno e dell'ovaia, di malattie cardiocircolatorie come infarto

cardiaco, ictus, trombosi venose ed embolie polmonari (coaguli di sangue). In donne di età avanzata

è stato osservato anche un rischio aumentato di diminuzione della memoria e della capacità di

rendimento intellettuale. Il suo medico valuterà e discuterà con lei questi rischi rispetto ai benefici

previsti.

Alla posologia impiegata, Prodafem non protegge da una gravidanza.

Si raccomanda di evitare un consumo eccessivo di alcool e nicotina poiché questo potrebbe

compromettere l'efficacia di Prodafem.

Quando non si può usare Prodafem?

Prodafem non è indicato in caso di ipersensibilità accertata (allergia) verso il principio attivo o verso

un'altra sostanza in esso contenuta, né in caso di trombosi, tromboembolie, ictus cerebrale, aborto,

tumore al seno o all'utero, emorragie ginecologiche non accertate e disturbi della funzionalità del

fegato, nel caso di una malattia rara del metabolismo (porfiria) e durante la gravidanza e

l'allattamento.

Quando è richiesta prudenza nella somministrazione/nell’uso di Prodafem?

Il suo medico la sottoporrà a un esame approfondito generale e ginecologico prima del trattamento

con Prodafem. Durante il trattamento si raccomandano esami di controllo regolari.

Situazioni che richiedono l'immediata interruzione della terapia

Qualora durante la cura con Prodafem si dovessero presentare disturbi tromboembolici (es. flebite

acuta o embolia polmonare che si manifestano per es. con gonfiore e dolore alla gamba, dolori

improvvisi al torace o dispnea), comparsa per la prima volta di un mal di testa simile all'emicrania o

insolitamente forte, affezioni biliari o epatiche o peggioramento acuto della vista, sospendere

immediatamente l'assunzione del farmaco e consultare il medico curante.

Situazioni che richiedono una sorveglianza particolare

In caso di malattie dei reni, malattie del cuore, asma, diabete e forti emicranie, epilessia e

depressione, oppure di trattamento concomitante a causa dei tassi elevati di grassi nel sangue

(iperlipidemia) è necessaria una sorveglianza medica regolare e accurata.

Ulteriori precauzioni

Se nel corso della terapia si dovessero manifestare emorragie o malumore di tipo depressivo, simile

alla sindrome premestruale, lo comunichi al medico.

Se si prende Prodafem senza interruzione come parte della terapia ormonale sostitutiva nella

menopausa, si possono presentare all'inizio perdite di sangue che in genere, tuttavia, cessano con il

tempo.

Prodafem può influenzare il metabolismo dello zucchero. Se dovesse essere affetto da diabete e

prendere farmaci ipoglicemizzanti (antidiabetici per via orale), il suo medico dovrà controllare la

posologia ed eventualmente adattarla.

In relazione al trattamento con ormoni sessuali sono state segnalate le seguenti malattie: ittero e/o

prurito associato a stasi biliare, calcoli biliari; porfiria (una malattia del metabolismo); lupus

eritematoso sistemico (eritema a farfalla); sindrome emolitico-uremica (una malattia dei vasi

sanguigni, delle cellule del sangue e dei reni); corea di Sydenham (una malattia neurologica); herpes

gestationis (malattia autoimmune della cute con formazione di vescicole); perdita dell'udito causata

da una malattia dell'orecchio interno.

Durante il trattamento con Prodafem possono insorgere casi occasionali di cloasma (macchie marroni

sul viso), in particolare quando si è già manifestato nel corso di una precedente gravidanza. Se

presenta una predisposizione in tal senso, dovrebbe evitare l'esposizione alla luce solare e ai raggi

ultravioletti durante il trattamento con Prodafem.

Il consumo eccessivo di alcool e il fumo sono sconsigliati.

Cancro al seno

Nell'ambito di ricerche scientifiche è stato riferito che, nelle donne che hanno ricevuto per più anni

una terapia ormonale sostitutiva (TOS), il rischio di cancro al seno è lievemente aumentato. Questo

rischio aumenta con la durata della terapia e diminuisce nuovamente dopo l'interruzione

dell'assunzione della TOS fino a diventare, dopo 10 anni, comparabile al rischio delle donne non

trattate.

Prima dell'inizio della terapia ormonale sostitutiva, così come poi annualmente, il medico dovrebbe

effettuare un esame del seno. Lei stessa dovrebbe effettuare mensilmente un autoesame del seno.

Cancro dell'ovaia

Alcune ricerche scientifiche evidenziano che, nelle donne trattate con estrogeni in monoterapia o

associati a gestageni, il rischio di cancro dell'ovaia è aumentato.

Osteoporosi

I gestageni possono avere un effetto negativo sul metabolismo minerale delle ossa ed aumentare il

rischio di osteoporosi. Presti dunque attenzione ad assumere calcio e vitamina D in quantità

sufficienti. Informi il suo medico nel caso in cui presenti altri fattori di rischio per l'osteoporosi (per

es. forte consumo di alcool o nicotina, terapia a lungo termine con cortisone o antiepilettici, malattie

metaboliche, malattie che sono accompagnate da una diminuzione dell'assorbimento intestinale di

componenti alimentari (sindromi da malassorbimento), gravi casi di osteoporosi in famiglia).

Coagulazione e malattie vascolari

Nelle donne che utilizzano una terapia ormonale sostitutiva combinata, sussiste un rischio

leggermente aumentato di formazione di trombi nelle vene e nelle arterie (malattie tromboemboliche

venose e arteriose) che possono in alcuni casi avere delle gravi conseguenze. Non è noto in che

misura queste conoscenze possano essere applicate ad una monoterapia con solo gestageni. Il rischio

di formazione di trombi è più alto durante il primo anno di utilizzo. La formazione di trombi nelle

vene può portare ad una trombosi venosa profonda (tromboflebite) o ad un'embolia polmonare, nelle

arterie ad un ictus o ad un infarto cardiaco. Contatti immediatamente il suo medico se nota un

possibile sintomo di una tromboembolia (vedi «Situazioni che richiedono l'immediata interruzione

della terapia»).

Disturbi della funzione cerebrale (demenza)

I risultati di un ampio studio sembrano indicare che le donne di età pari o superiore ai 65 anni

all'avvio della terapia ormonale sostitutiva a base di estrogeni, in monoterapia o associati a gestageni,

possono presentare un rischio più elevato di disturbi della memoria. Non è noto se tali evidenze siano

applicabili anche ad altre terapie ormonali sostitutive.

Interazioni con altri medicamenti

L'assunzione contemporanea di determinati altri medicamenti può pregiudicare l'efficacia di

Prodafem. Di questi medicamenti fanno parte per esempio alcuni medicamenti per la cura

dell'epilessia, di malattie infettive (antibiotici), medicamenti per la cura delle infezioni da HIV o da

epatite C (per es. efavirenz, nevirapina, boceprevir, nelfinavir, telaprevir), o di malattie cancerose

(aminoglutetimide) così come preparati a base di iperico.

Interazioni con esami di laboratorio

La terapia ormonale sostitutiva può influenzare determinati esami di laboratorio. Per questo informi

il suo medico o il personale del laboratorio del fatto che utilizza Prodafem.

Reazioni di ipersensibilità ai componenti

Il colorante giallo arancio (E110) contenuto nelle compresse di Prodafem da 2.5 mg può causare

reazioni di ipersensibilità della pelle e degli organi respiratori specialmente nelle pazienti affette da

asma, orticaria cronica o ipersensibili all'acido acetilsalicilico e ad altri analgesici o antireumatici.

Contatti immediatamente il suo medico nel caso in cui si verificassero eruzioni cutanee o fastidi

respiratori dopo l'assunzione delle compresse da 2.5 mg.

Prodafem contiene lattosio e saccarosio. Nel caso in cui lei soffra di un'intolleranza verso determinati

zuccheri, dovrebbe consultare o informare il suo medico prima di assumere Prodafem.

Effetto sulla capacità di condurre veicoli e sull'impiego di macchine

A questo proposito non sono stati effettuati studi. Durante la terapia con Prodafem sono però stati

osservati quali effetti indesiderati stanchezza, sonnolenza e vertigini.

Informi il suo medico o il suo farmacista se: soffre di altre malattie, soffre di allergie o assume o

applica (in caso di farmaci per uso esterno) altri medicamenti (anche se acquistati di sua iniziativa!).

Si può somministrare Prodafem durante la gravidanza o l'allattamento?

Se è incinta o se sospetta di esserlo, non deve assumere Prodafem.

Fino ad ora non sono completamente chiariti i possibili effetti del principio attivo trasmesso al

lattante attraverso il latte materno. Prodafem non deve perciò essere somministrato durante

l'allattamento.

Come usare Prodafem?

Il medico stabilisce la posologia esatta. In generale si consigliano le dosi seguenti:

Come parte della terapia ormonale sostitutiva nella menopausa:

Sia l'estrogeno che Prodafem possono essere somministrati in modo ciclico oppure senza

interruzione. Se si prende Prodafem in modo ciclico, dopo circa tre giorni dall'assunzione dell'ultima

compressa si presenta un'emorragia simile alla mestruazione. Se il farmaco viene somministrato

senza interruzione, all'inizio del trattamento potrebbero presentarsi delle emorragie irregolari o delle

perdite di sangue, anche se non ha più mestruazioni regolari. Tali emorragie o perdite scompaiono

generalmente alcuni mesi dopo l'inizio del trattamento.

La posologia consigliata è schematizzata come segue:

a) Prodafem ed estrogeni in modo ciclico:

Negli ultimi 10-12 giorni di una terapia di tre settimane con estrogeni si prende ogni giorno anche

una compressa di Prodafem da 5 mg o da 10 mg. Segue poi un intervallo di una settimana fino alla

seguente assunzione degli estrogeni.

b) Prodafem in modo ciclico ed estrogeni senza interruzione:

Se si prendono estrogeni senza interruzione, nei primi 10-12 giorni del mese prendere ogni giorno

anche una compressa di Prodafem da 5 mg o da 10 mg.

c) Prodafem ed estrogeni senza interruzione:

Se la terapia di estrogeni non prevede interruzioni, prendere tutti i giorni, senza interruzione, anche 1

compressa di Prodafem da 2.5 mg o da 5 mg.

Nella menopausa come terapia unica in caso di vampate di calore/sudorazioni (se non si possono

somministrare estrogeni):

Da 1 a 2 compresse al giorno di Prodafem da 10 mg.

Disturbi del ciclo (se le cause non sono organiche):

A partire dal 16º giorno del ciclo prendere una compressa da 5 mg o da 10 mg al giorno per 10

giorni. La mestruazione si presenta dopo circa 3-7 giorni.

Prodafem non è adatto ai bambini e agli adolescenti.

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

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

Quali effetti collaterali può avere Prodafem?

Con l'assunzione di Prodafem possono manifestarsi i seguenti effetti collaterali:

Molto frequenti: mal di testa, nausea, disturbi mestruali (mestruazione irregolare, più abbondante,

più debole, scarso, comprese perdite di sangue).

Frequenti: reazioni di ipersensibilità (come arrossamento della pelle, prurito) (in particolare anche al

colorante giallo arancio delle compresse da 2.5 mg), aumento di peso, alterazioni della libido,

depressione, insonnia, nervosismo, vertigini, vomito, dolori alla pancia, flatulenza, acne, orticaria,

prurito, caduta dei capelli, senso di tensione al seno, sensibilità al seno, dolore mammario, perdite

vaginali, stanchezza, febbre.

Occasionali: incremento della crescita dei peli sul corpo, aumento della pigmentazione cutanea

(cloasma), secrezione di latte anormala, accumulo di liquidi nei tessuti (edema).

Frequenza non nota (segnalazione spontanea, non è possibile stabilire la frequenza): Angioedema

(gonfiore della pelle e delle mucose), segni degli effetti tipici dei cortisonici («faccia da luna piena»,

aumento di peso), perdita di peso, malattie tromboemboliche venose e arteriose (per es. embolia

polmonare, ictus, disturbi dell'irrorazione sanguigna del cervello, occlusione dei vasi sanguigni degli

occhi, infarto cardiaco, infiammazione delle vene con formazione di trombosi, trombosi venosa

profonda, occlusione dei vasi sanguigni dell'intestino) (vedi anche «Quando è richiesta prudenza

nella somministrazione/nell'uso di Prodafem?»), sonnolenza, ittero, eruzione della pelle, assenza di

mestruazioni.

Consulti immediatamente il medico se dovessero insorgere per la prima volta mal di testa simile

all'emicrania o insolitamente forte, disturbi alla vista, nonché segni di flebite o trombosi che si

manifestano per es. con gonfiore e dolore alla gamba, dolori improvvisi al torace o dispnea.

Nel caso in cui uno di questi effetti collaterali la disturbasse o non diminuisse nel corso della terapia,

dovrebbe informarne il suo medico.

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

Di che altro occorre tener conto?

Conservare a temperatura ambiente (15-25 °C) e fuori dalla portata dei bambini. Il medicamento non

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

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

darle ulteriori informazioni.

Che cosa contiene Prodafem?

Le compresse di Prodafem contengono 2.5 mg, 5 mg o 10 mg di medrossiprogesterone acetato come

principio attivo.

Sostanze ausiliarie: lattosio monoidrato, amido di mais, talco, saccarosio, stearato di calcio, paraffina

liquida.

Le compresse da 2.5 mg contengono inoltre il colorante giallo arancio (E110), quelle da 5 mg

indigotina (E132).

Numero dell’omologazione

30773 (Swissmedic).

Dov'è ottenibile Prodafem? Quali confezioni sono disponibili?

Prodafem è ottenibile in farmacia dietro presentazione della prescrizione medica.

Nelle seguenti confezioni:

Prodafem 2.5 mg: 3× 28 compresse.

Prodafem 5 mg: 3× 10, 3× 12 e 3× 28 compresse.

Prodafem 10 mg: 3× 10 e 3× 12 compresse.

Titolare dell’omologazione

Pfizer PFE Switzerland GmbH, Zürich.

Questo foglietto illustrativo è stato controllato l'ultima volta nel dicembre 2017 dall'autorità

competente in materia di medicamenti (Swissmedic).

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FDA - U.S. Food and Drug Administration

4-12-2018


European network of paediatric research at the European Medicines Agency (Enpr-EMA) Coordinating Group and networks meeting, European Medicines Agency via Adobe Connect, from 22/10/2018 to 22/10/2018

European network of paediatric research at the European Medicines Agency (Enpr-EMA) Coordinating Group and networks meeting, European Medicines Agency via Adobe Connect, from 22/10/2018 to 22/10/2018

European network of paediatric research at the European Medicines Agency (Enpr-EMA) Coordinating Group and networks meeting, European Medicines Agency via Adobe Connect, from 22/10/2018 to 22/10/2018

Europe - EMA - European Medicines Agency

29-11-2018


Committee for Medicinal Products for Human Use (CHMP): 15-18 October 2018, European Medicines Agency, London, UK, from 15/10/2018 to 18/10/2018

Committee for Medicinal Products for Human Use (CHMP): 15-18 October 2018, European Medicines Agency, London, UK, from 15/10/2018 to 18/10/2018

Committee for Medicinal Products for Human Use (CHMP): 15-18 October 2018, European Medicines Agency, London, UK, from 15/10/2018 to 18/10/2018

Europe - EMA - European Medicines Agency

28-11-2018

Sprout Creek Farm Recalls “Kinkead” Cheese due to Possible Health Risk

Sprout Creek Farm Recalls “Kinkead” Cheese due to Possible Health Risk

Sprout Creek Farm of Poughkeepsie, New York is recalling 4 wheels of “Kinkead” cheese made on 5-10-18, because it has the potential to be contaminated with Listeria monocytogenes. Listeria monocytogenes is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, L...

FDA - U.S. Food and Drug Administration

24-11-2018

The EFSA‐funded collection of dietary and related data in the general population aged 10‐74 years in Greece

The EFSA‐funded collection of dietary and related data in the general population aged 10‐74 years in Greece

Published on: Fri, 23 Nov 2018 The Hellenic Health Foundation received support from the European Food Safety Authority in order to organise a national nutrition survey according to the methodology described in the EFSA Guidance document and to collect food consumption and related information among 780 adolescents, adults and elderly residing permanently in Greece. The EFSA‐funded data collection was largely based on the protocol of a large scale Greek national nutrition and health survey, called HYDRIA....

Europe - EFSA - European Food Safety Authority Publications

22-11-2018


Paediatric Committee (PDCO): 16-19 October 2018, European Medicines Agency, London, UK, from 16/10/2018 to 19/10/2018

Paediatric Committee (PDCO): 16-19 October 2018, European Medicines Agency, London, UK, from 16/10/2018 to 19/10/2018

Paediatric Committee (PDCO): 16-19 October 2018, European Medicines Agency, London, UK, from 16/10/2018 to 19/10/2018

Europe - EMA - European Medicines Agency

21-11-2018

Fresenius Kabi Issues Voluntary Nationwide Recall of Sodium Chloride Injection, USP, 0.9% Due to Product Labeling Incorrectly Stating Stoppers Do Not Contain Latex

Fresenius Kabi Issues Voluntary Nationwide Recall of Sodium Chloride Injection, USP, 0.9% Due to Product Labeling Incorrectly Stating Stoppers Do Not Contain Latex

Fresenius Kabi USA is voluntarily recalling 163 lots of Sodium Chloride Injection, USP, 0.9%, 10 mL fill in a 10 mL vial and Sodium Chloride Injection, USP, 0.9%, 20 mL fill in a 20 mL vial to the user level. The product insert states that stoppers for both the 10mL and the 20mL vials do not contain natural rubber latex; the tray label for the two vial sizes and the vial label for the 20mL vial also state that the stoppers do not contain latex. The product is being recalled because the stoppers contain n...

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

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