Truxal 15 mg

Informazioni principali

  • Nome commerciale:
  • Truxal 15 mg Filmtabletten
  • Forma farmaceutica:
  • Filmtabletten
  • Composizione:
  • chlorprothixeni hydrochloridum 15 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:
  • Truxal 15 mg Filmtabletten
    Svizzera
  • Lingua:
  • italiano

Informazioni terapeutiche

  • Gruppo terapeutico:
  • Synthetika
  • Area terapeutica:
  • Neurolepticum

Altre informazioni

Status

  • Fonte:
  • Swissmedic - Swiss Agency for Therapeutic Products
  • Numero dell'autorizzazione:
  • 25873
  • Data dell'autorizzazione:
  • 24-06-1960
  • Ultimo aggiornamento:
  • 19-10-2018

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

Patienteninformation

Truxal®

Lundbeck (Schweiz) AG

Che cos'è Truxal e quando si usa?

Truxal contiene il principio attivo cloroprotixene. Truxal appartiene al gruppo di medicamenti

cosiddetti neurolettici. Truxal si usa per la terapia di malattie psichiche contraddistinte da disturbi del

pensiero, della percezione e/o dell'azione. Ne sono tipici sintomi stati confusionali, allucinazioni

(alterazioni della percezione, p. es. l'udire o il vedere cose che effettivamente non ci sono) o idee

deliranti. Inoltre è possibile che i pazienti siano ansiosi, tesi o aggressivi.

In piccole dosi, Truxal ha inoltre un lieve effetto positivo sull'umore, un effetto calmante ed elimina

gli stati ansiosi e le sensazioni di tensione interna.

Truxal si può usare solamente su prescrizione del medico.

Quando non si può usare Truxal?

In caso di ipersensibilità al principio attivo cloroprotixene o ad un eccipiente di Truxal. In pazienti

con un'intossicazione da alcool o da medicamenti, con una storia clinica di patologia cardiovascolare

(p. es. disturbi del ritmo cardiaco, infarto del miocardo, battito cardiaco lento o battito cardiaco

irregolare), o con valori troppo bassi di potassio o magnesio nel sangue. In stati comatosi, di collasso

cardiovascolare, di ridotto stato di coscienza o in pazienti che prendono medicamenti che rallentano

la frequenza cardiaca.

Quando è richiesta prudenza nella somministrazione di Truxal?

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

capacità di utilizzare attrezzi o macchine!

L'effetto dell'alcool può essere potenziato da Truxal, per cui durante la terapia è opportuno rinunciare

all'alcool.

Truxal contiene lattosio. Se il suo medico le ha detto che ha un'intolleranza ad alcuni zuccheri, deve

consultarlo prima di assumere questo medicamento.

Consulti il suo medico o il suo farmacista prima di prendere Truxal

·in caso di malattia di Parkinson

·in caso di pressione sanguigna molto bassa o bassa pressione sanguigna quando si passa dalla una

posizione sdraiata a quella in piedi

·in caso di malattie del fegato o renali

·se in passato ha sofferto di convulsioni (disturbi epilettici)

·in caso di disturbi della funzione cerebrale (p. es. disturbi della memoria, disorientamento, pensiero

rallentato, cambiamento emotivo improvviso)

·in caso di miastenia gravis (una rara debolezza muscolare patologica con una maggiore affaticabilità

dei muscoli somatici)

·in caso di un ingrandimento della prostata

·in caso di una pressione intraoculare aumentata (cosiddetta glaucoma ad angolo acuto). Possono

verificarsi attacchi di glaucoma acuto.

·in caso di problemi durante la minzione, ritenzione urinaria, restringimento del piloro, blocco

intestinale

·in caso di diabete (potrebbe essere necessario regolare il trattamento antidiabetico)

·in caso di fattori di rischio per l'ictus (p. es. il fumo, ipertensione), antecedenti malattie cardiache e

circolatorie, con ECG alterato (uno studio sulla valutazione della funzione cardiaca), con un

prolungamento dell'intervallo QT nella storia familiare (rallentamento del battito cardiaco e

cambiamenti nel ECG)

·in caso di temperatura elevata del corpo, inusuale rigidità muscolare, sudorazione o ridotto livello di

coscienza (chiamata „sindrome neurolettica maligna"). In questi casi è necessario un trattamento

medico immediato.

·in caso di involontari movimenti ripetitivi della lingua, della bocca e del viso (chiamati discinesie

tardive)

·se lei è anziano: i pazienti anziani sono particolarmente a rischio di ipotensione ortostatica

(abbassamento della pressione sanguigna quando si passa dalla posizione sdraiata a quella in piedi)

·se lei o qualcuno nella sua famiglia soffre di coaguli del sangue

·se è stato trovato un tumore della ghiandola surrenale (feocromocitoma)

·se sono stati diagnosticati dei tumori specifici (tumori dipendenti dalla prolattina, p. es. tumore al

seno)

·se si soffre di malattie degli organi emopoietici

·in caso di un'iperattività della tiroide (ipertiroidismo)

·se sta assumendo altri neurolettici.

C'è la possibilità, che la sessualità rispettivamente la fertilità possano essere compromesse dal

trattamento con Truxal (vedi «Quali effetti collaterali può avere Truxal?»). Si prega di consultare il

medico.

Qualora lei soffra di epilessia, non deve in nessun caso sospendere il suo antiepilettico (preparato

anticonvulsivante) durante il trattamento.

Truxal può influenzare la regolazione della temperatura corporea. Deve essere usata cautela a

temperature estreme.

Se lei assume Truxal per un periodo prolungato, il medico la sottoporrà regolarmente a controlli del

quadro ematologico e della funzione epatica.

Truxal può potenziare notevolmente l'effetto di diversi altri medicamenti ad azione deprimente sul

sistema nervoso, per esempio i sonniferi, i calmanti, i forti analgesici, antidepressivi o medicamenti

contro reazioni allergiche. L'effetto dei medicamenti contro la pressione sanguigna troppo alta o

troppo bassa e contro la malattia di Parkinson, può essere modificato. Gli antiepilettici possono

ridurre l'effetto di Truxal. In tutti questi casi spetta al medico decidere quali medicamenti si possono

prendere contemporaneamente a Truxal.

Informi il suo medico o il suo farmacista nel caso in cui prende uno dei seguenti medicamenti:

·antidepressivi triciclici o altri (p. es. inibitori della MAO, paroxetina, fluoxetina, sertralina,

citalopram)

·medicamenti che abbassano la pressione del sangue, p. es. guanetidina

·medicamenti ad azione sedativa centrale e barbiturici (medicamenti che inducono sonnolenza)

·antiepilettici

·levodopa e medicamenti simili per il trattamento della malattia di Parkinson

·metoclopramide contro i disturbi gastrointestinali

·contraccettivi orali

·medicamenti che influenzano l'equilibrio idrico o salino (valori troppo bassi di potassio o magnesio

nel sangue), p. es. diuretici tiazidici

·disulfiram (un trattamento di dipendenza dall'alcool)

I seguenti medicamenti non devono essere assunti in concomitanza con Truxal:

·medicamenti che alterano la frequenza cardiaca (p. es. chinidina, amiodarone, sotalolo, dofetilide,

eritromicina, gatifloxacina, moxifloxacina, terfenadina, astemizolo, cisapride, litio)

·altri neurolettici (p. es. aloperidolo, quetiapina, tioridazina)

Alcuni medicamenti possono aumentare o diminuire la concentrazione di Truxal nel sangue.

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

·soffre di altre malattie,

·soffre di allergie o

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

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

Se è incinta, presume di esserlo, prevede una gravidanza oppure allatta lo comunichi al suo medico.

Truxal non deve essere assunto durante la gravidanza, salvo sotto esplicita prescrizione del medico.

Se si utilizza Truxal durante l'ultimo trimestre di gravidanza, nel neonato possono comparire tremore,

rigidità muscolare, debolezza, sonnolenza, agitazione, difficoltà respiratoria o problemi di

alimentazione.

Informi immediatamente il suo medico in caso di gravidanza, in modo da decidere come procedere.

In nessun caso il trattamento deve essere interrotto di propria iniziativa. L'interruzione improvvisa di

Truxal può avere conseguenze gravi.

Informi immediatamente anche il suo ginecologo o il suo ostetrico in caso di assunzione del

medicamento durante la gravidanza, in particolare se, dopo il parto, il suo bambino manifesta i

disturbi descritti.

Truxal non deve venire assunto durante l'allattamento poiché il medicamento viene escreto nel latte

materno. Se la terapia è però necessaria, non bisogna allattare.

Come usare Truxal?

Truxal è un medicamento molto potente. Bisogna quindi attenersi rigorosamente alle prescrizioni del

medico. Il medico adegua la posologia personalmente ad ogni paziente e giudica quanto deve durare

la terapia. Se si interrompe bruscamente l'assunzione di Truxal, può darsi che si verifichi un violento

peggioramento dello stato di salute. Il dosaggio del medicamento dipende dal tipo e dalla gravità

della malattia.

Il trattamento con Truxal è sconsigliato nei bambini e negli adolescenti al di sotto dei 18 anni.

Si attenga in ogni caso alle prescrizioni posologiche del medico. Di solito, Truxal si assume 3 volte

al giorno.

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 Truxal?

In seguito all'assunzione di Truxal possono manifestarsi effetti collaterali.

Se dovesse notare uno dei seguenti sintomi, informi subito il medico o si rechi in ospedale:

Occasionalmente (in più di 1 persona su 1'000 e in meno di 1 su 100):

·movimenti insoliti di bocca, lingua e viso; essi potrebbero essere i primi segni di un disturbo

motorio (discinesia tardiva). Questi sintomi possono persistere anche dopo la sospensione della

terapia. Avvisi il suo medico se si verificano questi sintomi.

Molto raramente (in meno di 1 persona su 10'000):

·febbre elevata, insolita rigidità muscolare e alterazione della coscienza, in particolare se

accompagnate da sudorazione eccessiva e accelerazione del battito cardiaco; possono essere segni di

un raro quadro clinico (sindrome neurolettica maligna) che può comparire in seguito all'assunzione di

neurolettici. Questo può essere pericoloso per la vita e richiede un trattamento immediato in

ospedale.

·una colorazione gialla della pelle e degli occhi può indicare un danno al fegato e la presenza di un

ittero.

I seguenti effetti collaterali sono più intensi all'inizio e di solito si attenuano proseguendo il

trattamento:

I sintomi extrapiramidali possono verificarsi soprattutto nella fase iniziale del trattamento. Si tratta di

disturbi di movimento (rigidità muscolare, mancanza di movimento, tremori, disturbi dell'andatura,

smorfie, movimenti incontrollati). Nella maggior parte dei casi, questi effetti collaterali possono

essere controllati in modo soddisfacente con una riduzione della dose e/o mediante l'applicazione di

medicamento contro la malattia di Parkinson.

Molto frequentemente (in 1 o più persone su 10):

·sonnolenza, capogiri

·secchezza della bocca, aumento della salivazione

Frequentemente (in più di 1 persona su 100 e in meno di 1 su 10):

·aumento dell'appetito, aumento di peso

·insonnia, nervosismo, agitazione, diminuzione del desiderio sessuale

·disturbi del movimento (contorsioni, movimenti involontari ripetitivi, movimenti esagerati o postura

anomala a causa di prolungata tensione muscolare), mal di testa

·difficoltà nel mettere a fuoco oggetti che si trovano vicino, disturbi della vista

·palpitazioni, battito cardiaco accellerato, forte o irregolare

·stitichezza, disturbi digestivi o della parte alta dell'addome, nausea

·sudorazione eccessiva

·dolori muscolari

·stanchezza, debolezza

Occasionalmente (in più di 1 persona su 1'000 e in meno di 1 su 100):

·riduzione dell'appetito, perdita di peso

·movimenti involontari (in particolare parkinsonismo (movimenti rallentati, rigidità, tremori)),

convulsioni, incapacità di restare seduti fermi o rimanere tranquilli

·rotazione degli occhi

·bassa pressione arteriosa, vampate di calore

·vomito, diarrea

·anomalie dei test di funzionalità epatica

·eruzione cutanea, prurito, aumento della sensibilità della pelle alla luce solare, eczema o

infiammazione cutanea

·rigidità dei muscoli

·difficoltà nell'urinare, ritenzione urinaria

·disturbi sessuali (eiaculazione ritardata, disturbi dell'erezione)

Raramente (in più di 1 persona su 10'000 e in meno di 1 su 1'000):

·alterazioni del quadro ematologico (riduzione del numero di globuli bianchi e piastrine). Una

marcata riduzione dei globuli bianchi può portare a infezioni. Informi immediatamente il suo medico

se ha febbre inspiegabile.

·ipersensibilità, reazioni allergiche acute

·aumento del livello di prolattina nel sangue

·alto valore della glicemia, ridotta tolleranza al glucosio

·respirazione difficoltosa o dolorosa

·ingrossamento delle ghiandole mammarie nei maschi, secrezione lattea, assenza del ciclo mestruale

Come con altri medicamenti che agiscono come cloroprotixene (principio attivo di Truxal), sono stati

osservati raramente i seguenti effetti collaterali:

·Variazioni dell'ECG. Questo è un esame per valutare la funzione cardiaca.

·Aritmie cardiache (battito cardiaco irregolare).

In casi rari, un disturbo del ritmo cardiaco può portare alla morte improvvisa.

·Morte improvvisa, inspiegabile.

·Erezione dolorosa e persistente. Contatti immediatamente il suo medico se si verifica questa

reazione.

I coaguli del sangue nelle vene, soprattutto in quelle nelle gambe (i sintomi comprendono gonfiore,

dolore e arrossamento della gamba), che tramite il circolo sanguigno arrivano ai polmoni, possono

causare dolore al petto o difficoltà respiratorie. Se nota uno di questi sintomi, consulti

immediatamente il suo medico.

É stato registrato un lieve aumento dei decessi di persone anziane con demenza che assumono

antipsicotici, rispetto a quelle che non ne assumono. Truxal non è indicato per i pazienti anziani con

demenza.

Se si utilizza Truxal durante l'ultimo trimestre di gravidanza, nel neonato possono comparire tremore,

rigidità muscolare, debolezza, sonnolenza, agitazione, difficoltà respiratoria o problemi di

alimentazione.

Se questi effetti collaterali dovessero diventare gravi o se osserva effetti collaterali qui non descritti,

informi il suo medico o il suo farmacista.

Di che altro occorre tener conto?

Tenere fuori dalla portata dei bambini.

Non conservare a temperatura superiore ai 25 °C.

Il medicamento non deve essere utilizzato oltre la data indicata con «EXP» sul contenitore.

Riporti in farmacia il medicamento non utilizzato o scaduto affinché venga eliminato.

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

darle ulteriori informazioni.

Che cosa contiene Truxal?

1 compressa rivestita contiene 15 mg risp. 50 mg di clorprotixene cloridrato come principio attivo e

eccipienti: amido di mais, lattosio, copovidone, glicerina, cellulosa microcristallina, sodio

croscaramelloso, talco, magnesio stearato, ipromellosa, macrogol 400 e i coloranti biossido di titanio

(E171), ossido di ferro rosso e nero (E172).

Aspetto delle compresse rivestite

15 mg: rotonda, biconvessa, di colore marrone scuro.

50 mg: ovale, biconvessa, di colore marrone scuro.

Numero dell’omologazione

25873 (Swissmedic).

Dov'è ottenibile Truxal? Quali confezioni sono disponibili?

In farmacia, dietro presentazione della prescrizione medica.

Truxal 15 mg con 50 compresse rivestite.

Truxal 50 mg con 50 compresse rivestite.

Titolare dell’omologazione

Lundbeck (Suisse) SA, Opfikon.

Questo foglietto illustrativo è stato controllato l'ultima volta nell'ottobre 2014 dall'autorità

competente in materia di medicamenti (Swissmedic).

30102014PI

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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

20-11-2018

Mariam, Floris en Mookie beëdigd tot kinderbewindspersonen van VWS

Mariam, Floris en Mookie beëdigd tot kinderbewindspersonen van VWS

Nederland is vandaag op de Internationale Dag van de Rechten van het Kind drie bewindspersonen rijker. Mariam Yousfi (13 jaar) en Floris Vooren (13 jaar) zijn door ministers Hugo de Jonge en Bruno Bruins benoemd tot kinderminister en Mookie Saluna (15 jaar) is door staatssecretaris Paul Blokhuis benoemd tot kinderstaatssecretaris. De kinderbewindspersonen zullen een jaar lang het ministerie van Volksgezondheid, Welzijn en Sport (VWS) met slimme tips en praktische adviezen helpen het beleid beter en kindv...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

16-11-2018

Setting of an import tolerance for pyraclostrobin in rice

Setting of an import tolerance for pyraclostrobin in rice

Published on: Thu, 15 Nov 2018 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted a request to the competent national authority in Germany to set an import tolerance for the active substance pyraclostrobin in rice. The data submitted in support of the request were found to be sufficient to derive a maximum residue level (MRL) proposal for rice. Based on the risk assessment results, EFSA concluded that the short‐term intake of residues resulting from the use of p...

Europe - EFSA - European Food Safety Authority Publications

16-11-2018

Evaluation of confirmatory data following the Article 12 MRL review for pyraclostrobin

Evaluation of confirmatory data following the Article 12 MRL review for pyraclostrobin

Published on: Thu, 15 Nov 2018 The applicant BASF SE submitted a request to the competent national authority in Germany to evaluate the confirmatory data that were identified for pyraclostrobin in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, residues trials supporting the existing use of pyraclostrobin on table grapes authorised in southern EU Member States and an analytical method for analysing residues of pyraclostrobin in ...

Europe - EFSA - European Food Safety Authority Publications

7-11-2018

Kadesh Incorporation Issues Voluntary Nationwide Recall of Puriton Eye Relief Drops Due to Non-Sterile Production Conditions

Kadesh Incorporation Issues Voluntary Nationwide Recall of Puriton Eye Relief Drops Due to Non-Sterile Production Conditions

Kadesh, Inc. of Garden Grove, CA is voluntarily recalling all lots of Puriton Eye Relief Drops, 0.5 oz. (15ml) bottle, UPC 7 36972 1679 0, to the consumer level. During a recent FDA inspection, investigators observed that ophthalmic drugs, which are required to be sterile, are manufactured without necessary production controls and conditions to assure sterility.

FDA - U.S. Food and Drug Administration

20-10-2018

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Published on: Fri, 19 Oct 2018 00:00:00 +0200 EFSA was requested to deliver a scientific opinion on the implications for human health of the flavouring substance 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide [FL‐no: 16.133], in the Flavouring Group Evaluation 411 (FGE.411), according to Regulation (EC) No 1331/2008 of the European Parliament and of the Council. The substance has not been reported to occur in natural source materials of botanical or animal origin. It is intende...

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Faribault Foods, Inc. Announces Voluntary Recall of a Limited Quantity of S&W Brand White Beans Due to the Presence of Undeclared (Sulfites)

Faribault Foods, Inc. Announces Voluntary Recall of a Limited Quantity of S&W Brand White Beans Due to the Presence of Undeclared (Sulfites)

Faribault Foods, Inc. of Faribault, MN is recalling its 15 ounce S&W White Beans because it contains undeclared sulfites. People who have an allergy or severe sensitivity to sulfites run the risk of serious or life-threatening allergic reaction if they consume this product.

FDA - U.S. Food and Drug Administration

17-10-2018

Enforcement Report for the Week of October 17, 2018

Enforcement Report for the Week of October 17, 2018

Recently Updated Records for the Week of October 17, 2018 Last Modified Date: Monday, October 15, 2018

FDA - U.S. Food and Drug Administration

16-10-2018

October 15, 2018: Leader of Fraudulent Prescription Conspiracy Sentenced to Six Years in Prison

October 15, 2018: Leader of Fraudulent Prescription Conspiracy Sentenced to Six Years in Prison

October 15, 2018: Leader of Fraudulent Prescription Conspiracy Sentenced to Six Years in Prison

FDA - U.S. Food and Drug Administration

16-10-2018

October 15, 2018: Four Men and Seven Companies Indicted for Billion-Dollar Telemedicine Fraud Conspiracy, Telemedicine Company and CEO Plead Guilty in Two Fraud Schemes

October 15, 2018: Four Men and Seven Companies Indicted for Billion-Dollar Telemedicine Fraud Conspiracy, Telemedicine Company and CEO Plead Guilty in Two Fraud Schemes

October 15, 2018: Four Men and Seven Companies Indicted for Billion-Dollar Telemedicine Fraud Conspiracy, Telemedicine Company and CEO Plead Guilty in Two Fraud Schemes

FDA - U.S. Food and Drug Administration

16-10-2018

Pest categorisation of Cronartium harknessii, Cronartium kurilense and Cronartium sahoanum

Pest categorisation of Cronartium harknessii, Cronartium kurilense and Cronartium sahoanum

Published on: Mon, 15 Oct 2018 00:00:00 +0200 Following a request from the European Commission, the EFSA Panel on Plant Health performed a pest categorisation of Cronartium harknessii, Cronartium kurilense and Cronartium sahoanum, which are well‐defined and distinguishable tree fungal pathogens of the family Cronartiaceae. In 2018, these species were moved from the genus Endocronartium to the genus Cronartium. These pathogens are not known to be present in the EU and are regulated in Council Directive 2...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Modification of the existing maximum residue levels for mepiquat in cotton seeds and animal commodities

Modification of the existing maximum residue levels for mepiquat in cotton seeds and animal commodities

Published on: Mon, 15 Oct 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant, BASF SE, submitted an application to the competent national authority in Greece to modify the existing maximum residue level (MRL) for the active substance mepiquat in cotton seeds. The data submitted in support of the application were found to be sufficient to derive a MRL proposal for cotton seeds and the previously derived MRL proposals for animal commodities were found to be stil...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Assessment of low pathogenic avian influenza virus transmission via raw poultry meat and raw table eggs

Assessment of low pathogenic avian influenza virus transmission via raw poultry meat and raw table eggs

Published on: Mon, 15 Oct 2018 00:00:00 +0200 A rapid qualitative assessment has been done by performing a theoretical analysis on the transmission of low pathogenic avian influenza (LPAI) via fresh meat from poultry reared or kept in captivity for the production of meat (raw poultry meat) or raw table eggs. A predetermined transmission pathway followed a number of steps from a commercial or non‐commercial poultry establishment within the EU exposed to LPAI virus (LPAIV) to the onward virus transmission...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Pest categorisation of Melampsora farlowii

Pest categorisation of Melampsora farlowii

Published on: Mon, 15 Oct 2018 00:00:00 +0200 Following a request from the European Commission, the EFSA Panel on Plant Health performed a pest categorisation of Melampsora farlowii, a well‐defined and distinguishable fungus of the family Melampsoraceae. M. farlowii is the causal agent of a leaf and twig rust of hemlocks (Tsuga spp.) in eastern North America. The pathogen is regulated in Council Directive 2000/29/EC (Annex IAI) as a harmful organism whose introduction into the EU is banned. M. farlowii ...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Evaluation of confirmatory data following the Article 12 MRL review for teflubenzuron

Evaluation of confirmatory data following the Article 12 MRL review for teflubenzuron

Published on: Mon, 15 Oct 2018 00:00:00 +0200 The applicant BASF Agro BV submitted a request to the competent national authority in United Kingdom to evaluate the confirmatory data that were identified for teflubenzuron in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, a new metabolism study on leafy crops, a study investigating the nature of residues under standard hydrolytic conditions and a validated ...

Europe - EFSA - European Food Safety Authority Publications

3-10-2018

Sportminister Bruno Bruins brengt verrassingsbezoek aan Talent TeamNL in Buenos Aires

Sportminister Bruno Bruins brengt verrassingsbezoek aan Talent TeamNL in Buenos Aires

Van 6 tot 18 oktober wordt in Buenos Aires, Argentinië, de derde editie van de Jeugd Olympische Spelen gehouden. Toptalenten uit 206 landen tussen de 15 en 18 jaar oud doen hieraan mee. Talent TeamNL bestaat uit 41 sporters die uitkomen in  19 disciplines. Minister voor Sport Bruno Bruins bracht vandaag een verrassingsbezoek aan de Nederlandse ploeg. Hij bezocht het Olympisch Dorp waar de talenten onder leiding van Chef de Mission Mark Huizinga zich voorbereiden op de Spelen die zaterdag beginnen. 

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

28-9-2018

EpiPen and EpiPen Jr auto-injectors may stick in their carrier tube

EpiPen and EpiPen Jr auto-injectors may stick in their carrier tube

Pfizer Canada has advised Health Canada that, in a very small number of cases, some EpiPen (0.3 mg) and EpiPen Jr (0.15 mg) auto-injector devices may not slide out of their carrier tube easily, or at all. This could delay or prevent emergency treatment, possibly leading to patient disability or death.

Health Canada

28-9-2018

Avian influenza overview May – August 2018

Avian influenza overview May – August 2018

Published on: Thu, 27 Sep 2018 00:00:00 +0200 Between 16 May and 15 August 2018, three highly pathogenic avian influenza (HPAI) A(H5N8) outbreaks in poultry establishments and three HPAI A(H5N6) outbreaks in wild birds were reported in Europe. Three low pathogenic avian influenza (LPAI) outbreaks were reported in three Member States. Few HPAI and LPAI bird cases have been detected in this period of the year, in accordance with the seasonal expected pattern of LPAI and HPAI. There is no evidence to date ...

Europe - EFSA - European Food Safety Authority Publications

26-9-2018

Technical Report on the notification of syrup from Sorghum bicolor (L.) Moench as a traditional food from a third country pursuant to Article 14 of Regulation (EU) 2015/2283

Technical Report on the notification of syrup from Sorghum bicolor (L.) Moench as a traditional food from a third country pursuant to Article 14 of Regulation (EU) 2015/2283

Published on: Tue, 25 Sep 2018 00:00:00 +0200 Abstract Following a notification from Sorghum Zrt., submitted to the European Commission under Article 14 of Regulation (EU) 2015/2283 to place on the market syrup from Sorghum bicolor (L.) Moench as a traditional food from a third country (TF), and in line with Article 15(2) of that Regulation, EFSA was asked by the European Commission whether there are duly reasoned safety objections to the placing on the market of the TF within the European Union. The ap...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Risk to human and animal health related to the presence of 4,15‐diacetoxyscirpenol in food and feed

Risk to human and animal health related to the presence of 4,15‐diacetoxyscirpenol in food and feed

Published on: Thu, 16 Aug 2018 00:00:00 +0200 4,15‐Diacetoxyscirpenol (DAS) is a mycotoxin primarily produced by Fusarium fungi and occurring predominantly in cereal grains. As requested by the European Commission, the EFSA Panel on Contaminants in the Food Chain (CONTAM) assessed the risk of DAS to human and animal health related to its presence in food and feed. Very limited information was available on toxicity and on toxicokinetics in experimental and farm animals. Due to the limitations in the avai...

Europe - EFSA - European Food Safety Authority Publications

16-8-2018

August 15, 2018: Florida Man Pleads Guilty to Scheme to Market Dietary Supplements

August 15, 2018: Florida Man Pleads Guilty to Scheme to Market Dietary Supplements

August 15, 2018: Florida Man Pleads Guilty to Scheme to Market Dietary Supplements

FDA - U.S. Food and Drug Administration

15-1-2019

Macimorelin Aeterna Zentaris (Aterna Zentaris GmbH)

Macimorelin Aeterna Zentaris (Aterna Zentaris GmbH)

Macimorelin Aeterna Zentaris (Active substance: macimorelin) - New authorisation - Commission Decision (2019)203 of Tue, 15 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/4660

Europe -DG Health and Food Safety

15-1-2019

Topotecan Actavis (Actavis Group PTC ehf.)

Topotecan Actavis (Actavis Group PTC ehf.)

Topotecan Actavis (Active substance: topotecan) - Withdrawal - Commission Decision (2019)207 of Tue, 15 Jan 2019

Europe -DG Health and Food Safety

4-1-2019


Orphan designation: Glibenclamide for the treatment of neonatal diabetes, Treatment of neonatal diabetes, 15/01/2016, Positive

Orphan designation: Glibenclamide for the treatment of neonatal diabetes, Treatment of neonatal diabetes, 15/01/2016, Positive

Orphan designation: Glibenclamide for the treatment of neonatal diabetes, Treatment of neonatal diabetes, 15/01/2016, Positive

Europe - EMA - European Medicines Agency

4-12-2018

TGA presentation: Advertising therapeutic goods in 2019: The Code basics, 13 and 15 November 2018

TGA presentation: Advertising therapeutic goods in 2019: The Code basics, 13 and 15 November 2018

A detailed walkthrough of the Code with examples to illustrate the application of the key sections.

Therapeutic Goods Administration - Australia

29-11-2018

Inflacam (Chanelle Pharmaceuticals Manufacturing Limited)

Inflacam (Chanelle Pharmaceuticals Manufacturing Limited)

Inflacam (Active substance: Meloxicam) - Centralised - Variation - Commission Decision (2018)8036 of Thu, 29 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2497/X/15

Europe -DG Health and Food Safety

23-11-2018

Presentations have been posted for the November 15, 2018 Patient Engagement Advisory Committee meeting. #PEAC2018 Read more:  https://go.usa.gov/xPHxf   #FDA #MedicalDevice

Presentations have been posted for the November 15, 2018 Patient Engagement Advisory Committee meeting. #PEAC2018 Read more: https://go.usa.gov/xPHxf  #FDA #MedicalDevice

Presentations have been posted for the November 15, 2018 Patient Engagement Advisory Committee meeting. #PEAC2018 Read more: https://go.usa.gov/xPHxf  #FDA #MedicalDevice

FDA - U.S. Food and Drug Administration

21-11-2018

EU/3/15/1567 (TMC Pharma (EU) Limited)

EU/3/15/1567 (TMC Pharma (EU) Limited)

EU/3/15/1567 (Active substance: Recombinant human interleukin-3 truncated diphtheria toxin fusion protein) - Transfer of orphan designation - Commission Decision (2018)7816 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/064/15/T/02

Europe -DG Health and Food Safety

15-11-2018

Flixabi (Samsung Bioepis NL B.V.)

Flixabi (Samsung Bioepis NL B.V.)

Flixabi (Active substance: infliximab) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7549 of Thu, 15 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4020/T/30

Europe -DG Health and Food Safety

15-11-2018

alitretinoin

alitretinoin

alitretinoin (Active substance: alitretinoin) - Centralised - Art 28 - (PSUR - Commission Decision (2018)7675 of Thu, 15 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/90/201801

Europe -DG Health and Food Safety

15-11-2018

Benepali (Samsung Bioepis NL B.V.)

Benepali (Samsung Bioepis NL B.V.)

Benepali (Active substance: etanercept) - Centralised - Yearly update - Commission Decision (2018) 7557 of Thu, 15 Nov 2018

Europe -DG Health and Food Safety

8-11-2018

There's only 1 week until the 2018 Patient Engagement Advisory Committee meeting. Join the @US_FDA on Nov 15 to discuss patient-generated health data from sources like social media, activity trackers, and patient-driven registries.pic.twitter.com/WkDNnXqm

There's only 1 week until the 2018 Patient Engagement Advisory Committee meeting. Join the @US_FDA on Nov 15 to discuss patient-generated health data from sources like social media, activity trackers, and patient-driven registries.pic.twitter.com/WkDNnXqm

There's only 1 week until the 2018 Patient Engagement Advisory Committee meeting. Join the @US_FDA on Nov 15 to discuss patient-generated health data from sources like social media, activity trackers, and patient-driven registries. pic.twitter.com/WkDNnXqmbw

FDA - U.S. Food and Drug Administration

31-10-2018

Imraldi (Samsung Bioepis NL B.V.)

Imraldi (Samsung Bioepis NL B.V.)

Imraldi (Active substance: adalimumab) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7344 of Wed, 31 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4279/T/15

Europe -DG Health and Food Safety

22-10-2018

EU/3/16/1640 (Celgene Europe B.V.)

EU/3/16/1640 (Celgene Europe B.V.)

EU/3/16/1640 (Active substance: 2-methyl-1-[(4-[6-(trifluoromethyl)pyridin-2-yl]-6-{[2-(trifluoromethyl)pyridin-4-yl]amino}-1,3,5-triazin-2-yl)amino]propan-2-ol methanesulfonate) - Transfer of orphan designation - Commission Decision (2018)6989 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/253/15/T/01

Europe -DG Health and Food Safety

22-10-2018

EU/3/15/1495 (Ultragenyx Netherlands B.V.)

EU/3/15/1495 (Ultragenyx Netherlands B.V.)

EU/3/15/1495 (Active substance: Triheptanoin) - Transfer of orphan designation - Commission Decision (2018)6992 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/007/15/T/02

Europe -DG Health and Food Safety

22-10-2018

EU/3/15/1532 (Sirius Regulatory Consulting EU Limited)

EU/3/15/1532 (Sirius Regulatory Consulting EU Limited)

EU/3/15/1532 (Active substance: Insulin human) - Transfer of orphan designation - Commission Decision (2018)6985 of Mon, 22 Oct 2018

Europe -DG Health and Food Safety

17-10-2018

Interact with experts from CDER, CBER & CDRH to learn what’s important when conducting clinical trials & preparing submissions for FDA review.

Register for FDA #CDERSBIA Clinical Investigator Training Course – November 13-15 in Silver Spring, MD.  https:

Interact with experts from CDER, CBER & CDRH to learn what’s important when conducting clinical trials & preparing submissions for FDA review. Register for FDA #CDERSBIA Clinical Investigator Training Course – November 13-15 in Silver Spring, MD. https:

Interact with experts from CDER, CBER & CDRH to learn what’s important when conducting clinical trials & preparing submissions for FDA review. Register for FDA #CDERSBIA Clinical Investigator Training Course – November 13-15 in Silver Spring, MD. https://go.usa.gov/xPqku  pic.twitter.com/EYNZANlgr9

FDA - U.S. Food and Drug Administration

15-10-2018

Riximyo (Sandoz GmbH)

Riximyo (Sandoz GmbH)

Riximyo (Active substance: rituximab) - Centralised - Yearly update - Commission Decision (2018)6811 of Mon, 15 Oct 2018

Europe -DG Health and Food Safety

1-10-2018

EU/3/16/1762 (Pharma Gateway AB)

EU/3/16/1762 (Pharma Gateway AB)

EU/3/16/1762 (Active substance: Synthetic 15-amino-acid macrocyclic peptide acylated with a polyethyleneglycol palmitoylated linker) - Transfer of orphan designation - Commission Decision (2018)6399 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/107/16/T/01

Europe -DG Health and Food Safety

25-9-2018

Conducting clinical trials & preparing a submission for #FDA review?

Register for #CDERSBIA’s Clinical Investigator Training Course: November 13-15 to learn about FDA regulations, scientific principles for conducting clinical trials, & more!  https://go.

Conducting clinical trials & preparing a submission for #FDA review? Register for #CDERSBIA’s Clinical Investigator Training Course: November 13-15 to learn about FDA regulations, scientific principles for conducting clinical trials, & more! https://go.

Conducting clinical trials & preparing a submission for #FDA review? Register for #CDERSBIA’s Clinical Investigator Training Course: November 13-15 to learn about FDA regulations, scientific principles for conducting clinical trials, & more! https://go.usa.gov/xPqku . pic.twitter.com/Ktqq9Slx0y

FDA - U.S. Food and Drug Administration

24-9-2018

Tomorrow, September 25th at 9:15 AM, join the #FDA for a session at #MedTechCon about our #DigitalHealth Software Precertification #FDAPrecert Pilot Program...

Tomorrow, September 25th at 9:15 AM, join the #FDA for a session at #MedTechCon about our #DigitalHealth Software Precertification #FDAPrecert Pilot Program...

Tomorrow, September 25th at 9:15 AM, join the #FDA for a session at #MedTechCon about our #DigitalHealth Software Precertification #FDAPrecert Pilot Program...

FDA - U.S. Food and Drug Administration

18-8-2018

EU/3/16/1645 (Salzman Group Ltd)

EU/3/16/1645 (Salzman Group Ltd)

EU/3/16/1645 (Active substance: Cannabidiol) - Transfer of orphan designation - Commission Decision (2018)4806 of Sat, 18 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/248/15/T/01

Europe -DG Health and Food Safety

15-8-2018

EU/3/18/1994 (Quality Regulatory Clinical Ireland Limited)

EU/3/18/1994 (Quality Regulatory Clinical Ireland Limited)

EU/3/18/1994 (Active substance: Ivosidenib) - Transfer of orphan designation - Commission Decision (2018)5555 of Wed, 15 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/172/17/T/01

Europe -DG Health and Food Safety

15-8-2018

Orbactiv (Rempex London Ltd)

Orbactiv (Rempex London Ltd)

Orbactiv (Active substance: oritavancin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5556 of Wed, 15 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3785/T/20

Europe -DG Health and Food Safety

15-8-2018

Komboglyze (AstraZeneca AB)

Komboglyze (AstraZeneca AB)

Komboglyze (Active substance: saxagliptin / metformin) - Centralised - 2-Monthly update - Commission Decision (2018)5559 of Wed, 15 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2059/WS/1289

Europe -DG Health and Food Safety

15-8-2018

Ivabradine Zentiva (Zentiva, k.s.)

Ivabradine Zentiva (Zentiva, k.s.)

Ivabradine Zentiva (Active substance: ivabradine) - Centralised - Yearly update - Commission Decision (2018)5558 of Wed, 15 Aug 2018

Europe -DG Health and Food Safety