Pregabalin Axapharm 75 mg

Informazioni principali

  • Nome commerciale:
  • Pregabalin Axapharm 75 mg Kapseln
  • Forma farmaceutica:
  • Kapseln
  • Composizione:
  • pregabalinum 75 mg, excipiens pro il capsula.
  • Utilizzare per:
  • Esseri umani
  • Tipo di medicina:
  • Farmaco biologico

Documenti

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


    Richiedi il foglio illustrativo per i professionisti.

Localizzazione

  • Disponibile in:
  • Pregabalin Axapharm 75 mg Kapseln
    Svizzera
  • Lingua:
  • italiano

Informazioni terapeutiche

  • Gruppo terapeutico:
  • Synthetika
  • Area terapeutica:
  • Neuropathische Schmerzen, Epilessia, generalisierte Angststörungen

Altre informazioni

Status

  • Fonte:
  • Swissmedic - Swiss Agency for Therapeutic Products
  • Numero dell'autorizzazione:
  • 66392
  • Data dell'autorizzazione:
  • 15-02-2018
  • Ultimo aggiornamento:
  • 19-10-2018

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

Patienteninformation

Informazione destinata ai pazienti

Legga attentamente il foglietto illustrativo prima di far uso del medicamento.

Questo medicamento le è stato prescritto personalmente e quindi non deve essere consegnato ad altre

persone, anche se i sintomi sono gli stessi. Il medicamento potrebbe nuocere alla loro salute.

Conservi il foglietto illustrativo per poterlo rileggere all’occorrenza.

Pregabalina Axapharm, capsule

Che cos’è Pregabalina Axapharm e quando si usa?

Pregabalina Axapharm appartiene alla classe dei farmaci chiamati ligandi di alfa-2-delta. Questi

medicamenti vengono impiegati nella terapia dell’epilessia e dei dolori neuropatici nell’adulto.

Inoltre, Pregabalina Axapharm viene impiegato negli adulti nel trattamento dei disturbi d’ansia

generalizzata.

Dolori neuropatici periferici e centrali

Pregabalina Axapharm è utilizzato nell’adulto per il trattamento di dolori persistenti che insorgono a

causa di lesioni dei nervi. Il dolore è descrivibile come scottante, bruciante, pulsante, a fitte o

lancinante. Può insorgere anche intorpidimento, prurito o formicolio. Il dolore neuropatico può

essere accompagnato da cambiamenti dello stato d’animo, disturbi del sonno e stanchezza.

Epilessia

Pregabalina Axapharm è utilizzato per il trattamento di una forma specifica di epilessia nell’adulto

(crisi parziali con o senza generalizzazione secondaria). Il suo medico le prescriverà Pregabalina

Axapharm se la sua terapia attuale non fosse sufficiente per tenere la malattia completamente sotto

controllo. Pregabalina Axapharm va preso in aggiunta alla sua terapia medicamentosa attuale.

Disturbi d’ansia generalizzati

Pregabalina Axapharm viene utilizzato nell’adulto per la terapia dei disturbi d’ansia generalizzati. I

sintomi dei disturbi d’ansia generalizzati sono stati d’ansia e di preoccupazione prolungati e

difficilmente curabili. I disturbi d’ansia generalizzati possono provocare anche inquietudine, stati di

tensione, tendenza alla spossatezza, disturbi della concentrazione e mancanza di pensieri, irritabilità,

contratture muscolari o disturbi del sonno.

Pregabalina Axapharm deve essere assunto solo su prescrizione medica.

Finora non è stato studiato l’impiego di Pregabalina Axapharm nei bambini e negli adolescenti sotto i

18 anni, perciò se ne sconsiglia l’uso in questa fascia d’età.

Quando non si può assumere Pregabalina Axapharm?

Non deve assumere Pregabalina Axapharm se lei è allergica/o al principio attivo pregabalina, a un

altro farmaco della stessa classe (per es. il Neurontin) o a una delle sostanze ausiliarie.

Quando è richiesta prudenza nella somministrazione di Pregabalina Axapharm?

Pregabalina Axapharm può provocare senso di stordimento, sonnolenza o stanchezza. Sono state

anche descritte perdita di coscienza, confusione e alterazione dello stato mentale. Di conseguenza,

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

capacità di utilizzare attrezzi o macchine. Inoltre, può accrescere la possibilità di infortuni (rischio di

cadute). Si raccomanda quindi al paziente di fare particolare attenzione finché non si sarà abituato a

tutti gli effetti che il farmaco potrebbe avere.

Informi il medico prima di assumere questo medicamento se soffre o ha sofferto di una patologia

cardiaca (indebolimento della funzione del cuore, efficienza cardiaca insufficiente).

Alcuni pazienti che hanno assunto Pregabalina Axapharm hanno riferito disturbi che potrebbero far

supporre una reazione allergica. Questi disturbi comprendevano, per esempio, tumefazioni a carico

del volto, delle labbra, della lingua o delle vie respiratorie o anche un vasto arrossamento cutaneo.

Nel caso in cui compaiano questi disturbi, dovrà recarsi immediatamente presso il suo medico.

Durante l’assunzione di Pregabalina Axapharm possono manifestarsi visione indistinta o altri disturbi

della vista. Informi immediatamente il medico qualora dovesse notare qualsiasi alterazione della sua

capacità visiva.

In caso di limitata funzione renale, il suo medico regolerà di conseguenza la dose di Pregabalina

Axapharm. In caso di funzione renale gravemente limitata, lei non deve assumere Pregabalina

Axapharm.

Nei pazienti con disturbi della funzione epatica, Pregabalina Axapharm deve essere assunto con

cautela.

In alcuni pazienti, è stata segnalata insufficienza renale in seguito all’assunzione di Pregabalina

Axapharm. Se durante l’assunzione di Pregabalina Axapharm nota una riduzione della quantità di

urina, deve contattare il suo medico perché ciò può essere eventualmente corretto tramite una

riduzione della dose del medicamento.

Un limitato numero di pazienti trattati con antiepilettici come Pregabalina Axapharm hanno

presentato pensieri di ferire se stessi o di togliersi la vita. Se in un momento qualsiasi si dovessero

presentare pensieri di questo tipo, si metta immediatamente in contatto con il suo medico.

Se è o è stato affetto da dipendenza da alcool o da stupefacenti, è opportuno che lei consulti il suo

medico prima di assumere questo medicamento. Informi il suo medico se ritiene di avere bisogno di

una quantità di medicamento maggiore di quanto le sia stato prescritto.

In alcuni pazienti con diabete che in seguito al trattamento con pregabalina aumentano di peso, può

essere necessario regolare il medicamento antidiabetico.

In pazienti con lesioni del midollo spinale si possono verificare con maggiore frequenza effetti

indesiderati come, per esempio, la sonnolenza, visto che tali pazienti assumono probabilmente anche

medicamenti per il trattamento del dolore o dei crampi (spasticità) che hanno effetti collaterali simili

a quelli di Pregabalina Axapharm. Ciò può aumentare l’intensità di tali effetti collaterali.

Pregabalina Axapharm e alcuni altri farmaci possono interagire, ossia influenzarsi a vicenda. In

particolare, l’oxicodone (un analgesico) e il lorazepam (un ansiolitico) possono peggiorare l’entità

del torpore e della sonnolenza e ridurre ulteriormente la capacità di concentrazione. L’effetto

costipante di altri medicamenti, per es. degli oppioidi (antidolorifici), può essere accentuato

dall’impiego concomitante con Pregabalina Axapharm.

Pregabalina Axapharm può essere preso insieme alla pillola anticoncezionale.

Durante la terapia con Pregabalina Axapharm è possibile che l’effetto dell’alcool venga potenziato.

Dopo interruzione di una terapia a breve o a lungo termine con Pregabalina Axapharm sono stati

osservati, in alcuni pazienti, dei sintomi da astinenza (quali per es. disturbi del sonno, mal di testa,

nausea, diarrea, sintomi influenzali, nervosismo, depressione, sensazione di ansia, dolori,

sudorazione e stordimento), che possono essere anche interpretati come sintomi dovuti a dipendenza

fisica.

Informi il medico o il 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 somministrare Pregabalina Axapharm durante la gravidanza o l’allattamento?

Pregabalina Axapharm non deve essere utilizzato durante la gravidanza, salvo diversa prescrizione

del medico. Le donne in età fertile devono adottare un metodo contraccettivo efficace. Informi

immediatamente il medico se durante il trattamento con Pregabalina Axapharm rimane incinta.

Il principio attivo di Pregabalina Axapharm, la pregabalina, passa nel latte materno. È quindi

necessario interrompere o l’allattamento al seno o il trattamento con Pregabalina Axapharm. Il suo

medico le illustrerà la soluzione più adatta al suo caso tenuti conto i benefici della terapia.

Come usare Pregabalina Axapharm?

Prenda Pregabalina Axapharm seguendo sempre attentamente le indicazioni del medico, che stabilirà

la dose adeguata al suo caso. La dose adatta a lei e alla sua malattia in genere è compresa tra 150 mg

e 600 mg al giorno.

Pregabalina Axapharm deve essere assunto due o tre volte al giorno. Per esempio, per una dose

giornaliera di 150 mg prenda una capsula da 75 mg la mattina e una la sera, oppure una capsula da 50

mg la mattina, una a mezzogiorno e una la sera. Il medico, se lo riterrà opportuno, aumenterà

progressivamente la dose, regolandosi sulla sua reazione al medicamento.

Deglutisca le capsule senza masticarle con abbastanza d’acqua. Le capsule di Pregabalina Axapharm

possono essere prese sia durante che tra i pasti.

Prenda Pregabalina Axapharm regolarmente finché il medico non deciderà di cessare la terapia.

Dopo la conclusione del trattamento con pregabalina possono comparire alcuni effetti collaterali,

come manifestazioni di astinenza. Questi comprendono: disturbi del sonno, mal di testa, nausea,

diarrea, sintomi similinfluenzali, nervosismo, depressioni, sensazione di ansia, dolori, sudorazione e

senso di stordimento.

Finora non sono state sperimentate l’efficacia e la sicurezza di pregabalina nei bambini e negli

adolescenti sotto i 18 anni, perciò se ne sconsiglia l’uso in questa fascia d’età.

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.

Se ha assunto una dose eccessiva di Pregabalina Axapharm

Informi immediatamente il medico o si rechi al pronto soccorso più vicino: porti con sé la confezione

con le capsule di Pregabalina Axapharm.

Se ha dimenticato di prendere il medicamento

È importante assumere Pregabalina Axapharm regolarmente, ogni giorno circa alla stessa ora. Se una

volta si dimentica di prenderlo, assuma la capsula appena se ne accorge, a meno che non sia già l’ora

della dose successiva. In questo caso prenda solo la dose successiva, come d’abitudine. Non assuma

mai due dosi contemporaneamente per recuperarne una dimenticata.

Quali effetti collaterali può avere Pregabalina Axapharm?

In seguito all’assunzione di Pregabalina Axapharm possono manifestarsi i seguenti effetti collaterali:

Molto frequenti (possono presentarsi in più di 1 paziente su 10): senso di stordimento, sonnolenza.

Frequenti (possono presentarsi in più di 1 paziente su 100): infezioni delle alte vie respiratorie,

aumento dell’appetito, euforia, confusione, irritabilità, depressione, disorientamento, insonnia,

diminuzione della libido, disturbi nell’esecuzione dei movimenti, amnesia, difficoltà a mantenere

l’attenzione, disturbi della coordinazione, dell’equilibrio, della memoria e del linguaggio, tremori,

disturbi sensitivi quali formicolio, bruciore o intorpidimento (parestesie), ridotta sensibilità agli

stimoli tattili, apatia, vista annebbiata, visione sdoppiata, vomito, stipsi, flatulenza, secchezza della

bocca, crampi muscolari, dolori alle articolazioni, agli arti e alla schiena, spasmi nella regione del

collo, ritenzione di liquidi nei tessuti (edema), andatura anomala, cadute, sensazione di ebbrezza,

intorpidimento, esaurimento, aumento di peso.

Occasionali (possono presentarsi in più di 1 paziente su 1000): riduzione del numero di globuli

bianchi nel sangue, mancanza d’appetito, glicemia troppo alta o troppo bassa, allucinazioni,

irrequietezza, depressione, sbalzi d’umore, cambiamenti della personalità, sogni anormali, problemi

nel trovare le parole, aumento della libido, incapacità di raggiungere l’orgasmo, svenimenti

improvvisi, scosse muscolari, iperattività, disturbi del movimento in una regione del corpo o in una

parte del corpo, capogiri nel cambiare posizione, tremori da movimento, movimenti oculari insoliti,

disturbi del pensiero, disturbi del linguaggio, riflessi attenuati, aumentata sensibilità agli stimoli

tattili, sensazione di bruciore, visione a tunnel, visione offuscata, occhi gonfi, secchi, doloranti o

lacrimanti, riduzione del campo visivo, ridotta acuità visiva, affaticamento della vista, disturbi della

percezione visiva, irritazione oculare, aumento o diminuzione della frequenza del polso, disturbi del

ritmo cardiaco, pressione arteriosa elevata o diminuita, arrossamento del viso o della cute, vampate

di calore, problemi respiratori, sangue dal naso, tosse, naso chiuso o raffreddore, russamento, riflusso

d’acidità, aumento della salivazione, riduzione della sensibilità al tocco e al dolore nella zona della

bocca, eruzione cutanea, orticaria, sudorazione, gonfiore delle articolazioni, dolori ai muscoli, spasmi

muscolari, dolori al collo, rigidità della muscolatura, perdita d’urina involontaria (incontinenza),

dolori e difficoltà nella minzione, disturbi dell’erezione, disturbi della funzione sessuale,

eiaculazione ritardata, mestruazioni dolorose, sensazione di restringimento al petto, dolori, febbre,

sete, brividi, sensazione di debolezza, perdita di peso.

Rari (possono presentarsi in meno di 1 paziente su 1000): attacchi di panico, disinibizione, apatia,

irrigidimento (totale perdita di attività durante lo stato cosciente), allucinazioni olfattive, perdita del

gusto, riduzione della capacità di movimento, disturbi della scrittura, oscillopsia (un disturbo della

vista caratterizzato dalla percezione di movimento degli oggetti circostanti), modificazione della

visione tridimensionale, disfunzione pupillare, strabismo, sensibilità alla luce, aumentata sensibilità

al rumore, mani e piedi freddi, sensazione di ristrettezza nella gola, naso secco, ascite, pancreatite,

disturbi di deglutizione, sudorazione fredda, cedimento muscolare, disfunzione renale, diuresi ridotta,

dolori al seno, mancata mestruazione, secrezione dal capezzolo, ingrossamento delle mammelle.

Dopo l’introduzione sul mercato sono stati osservati inoltre i seguenti effetti collaterali: mal di testa,

nausea, diarrea, reazioni allergiche, (comprese tumefazioni a carico del volto o della lingua o disturbi

respiratori o anche una grave reazione cutanea caratterizzata da eruzione, formazione di bolle,

esfoliazione della cute e dolore), edema polmonare (accumulo di liquido nei polmoni), perdita di

coscienza, alterazione dello stato psichico, ritenzione urinaria, insufficienza cardiaca, prurito,

infiammazione degli occhi, malessere, ingrossamento della ghiandola mammaria.

Nel caso in cui notasse la comparsa di tumefazioni del volto o della lingua o un arrossamento della

pelle che iniziasse a formare bolle o a esfoliarsi, ne informi immediatamente il suo medico.

Se uno di questi effetti collaterali le crea disturbi o non si attenua nel corso del trattamento, informi 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?

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

Conservare Pregabalina Axapharm a temperatura ambiente (15-25°C) nella confezione originale e

fuori dalla portata dei bambini.

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

darle ulteriori informazioni.

Cosa contiene Pregabalina Axapharm?

1 capsula da 25 mg contiene 25 mg di pregabalina. Le capsule da 25 mg sono bianche e hanno un

timbro nero «138»/«J».

1 capsula da 50 mg contiene 50 mg di pregabalina. Le capsule da 50 mg sono bianche e hanno un

timbro nero «139»/«J».

1 capsula da 75 mg contiene 75 mg di pregabalina. Le capsule da 75 mg sono bianche e arancioni e

hanno un timbro nero «140»/«J».

1 capsula da 100 mg contiene 100 mg di pregabalina. Le capsule da 100 mg sono arancioni e hanno

un timbro nero «141»/«J».

1 capsula da 150 mg contiene 150 mg di pregabalina. Le capsule da 150 mg sono bianche e hanno un

timbro nero «142»/«J».

1 capsula da 200 mg contiene 200 mg di pregabalina. Le capsule da 200 mg sono arancione chiaro e

hanno un timbro nero «143»/«J».

1 capsula da 300 mg contiene 300 mg di pregabalina. Le capsule da 300 mg sono bianche e

arancione e hanno un timbro nero «145»/«J».

Le capsule contengono sostanze ausiliarie.

Numero dell’omologazione

66392 (Swissmedic).

Dove è ottenibile Pregabalina Axapharm? Quali confezioni sono disponibili?

In farmacia, solo dietro presentazione della prescrizione medica.

Pregabalina Axapharm 25 mg: 14 e 56 capsule.

Pregabalina Axapharm 50 mg: 14 e 84 capsule.

Pregabalina Axapharm 75 mg: 14 e 56 capsule.

Pregabalina Axapharm 100 mg: 84 capsule.

Pregabalina Axapharm 150 mg: 56 e 168 capsule.

Pregabalina Axapharm 200 mg: 84 capsule.

Pregabalina Axapharm 300 mg: 56 e 168 capsule.

Titolare dell’omologazione

Axapharm SA, 6340 Baar.

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

competente in materia di medicamenti (Swissmedic).

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Safety of annatto E and the exposure to the annatto colouring principles bixin and norbixin (E 160b) when used as a food additive

Safety of annatto E and the exposure to the annatto colouring principles bixin and norbixin (E 160b) when used as a food additive

Published on: Wed, 13 Mar 2019 The Scientific Panel on Food Additives and Flavouring (FAF) provides a scientific opinion on the safety evaluation of annatto E and an exposure assessment of the annatto colouring principles bixin and norbixin (E 160b) when used as a food additive, taking into account new proposed uses and use levels. In 2016, the EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) adopted a scientific opinion on the safety of annatto extracts (E 160b) as a food additive....

Europe - EFSA - European Food Safety Authority EFSA Journal

14-3-2019

Safety evaluation of the food enzyme β‐glucanase, xylanase and cellulase from Mycothermus thermophiloides (strain NZYM‐ST)

Safety evaluation of the food enzyme β‐glucanase, xylanase and cellulase from Mycothermus thermophiloides (strain NZYM‐ST)

Published on: Fri, 08 Mar 2019 The food enzyme has three declared activities (endo‐1,3(4)‐β‐glucanase EC 3.2.1.6, endo‐1,4‐β‐xylanase EC 3.2.1.8 and cellulase (endo‐1,4‐β‐d‐glucanase EC 3.2.1.4)) and is produced with a non‐genetically modified Mycothermus thermophiloides strain by Novozymes A/S. It is intended to be used in baking and brewing processes. For the two intended uses, based on the maximum use levels recommended and individual data from the EFSA Comprehensive European Food Database, dietary e...

Europe - EFSA - European Food Safety Authority EFSA Journal

13-3-2019

Safety evaluation of the food enzyme triacylglycerol lipase from Aspergillus niger (strain LFS)

Safety evaluation of the food enzyme triacylglycerol lipase from Aspergillus niger (strain LFS)

Published on: Tue, 12 Mar 2019 The food enzyme triacylglycerol lipase (triacylglycerol acylhydrolase, EC 3.1.1.3) is produced with a genetically modified Aspergillus niger strain LFS by DSM Food Specialties B.V.. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. The triacylglycerol lipase food enzyme is intended to be used in baking processes. Based on the maximum use levels, dietary exposure to the fo...

Europe - EFSA - European Food Safety Authority EFSA Journal

13-3-2019

Safety evaluation of the food enzyme glucose oxidase from Aspergillus niger (strain ZGL)

Safety evaluation of the food enzyme glucose oxidase from Aspergillus niger (strain ZGL)

Published on: Tue, 12 Mar 2019 The food enzyme glucose oxidase (β‐d‐glucose:oxygen 1‐oxidoreductase; EC 1.1.3.4) is produced with a genetically modified Aspergillus niger strain ZGL by DSM Food Specialties B.V.. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. The glucose oxidase is intended to be used in baking processes. Based on the maximum use levels, dietary exposure to the food enzyme‐total orga...

Europe - EFSA - European Food Safety Authority EFSA Journal

9-3-2019

Safety evaluation of the food enzyme 4‐α‐glucanotransferase from Aeribacillus pallidus (strain AE‐SAS)

Safety evaluation of the food enzyme 4‐α‐glucanotransferase from Aeribacillus pallidus (strain AE‐SAS)

Published on: Fri, 08 Mar 2019 The food enzyme 4‐α‐glucanotransferase (1,4‐α‐d‐glucan:1,4‐α‐d‐glucan 4‐α‐d‐glycosyltransferase, EC 2.4.1.25) is produced with a non‐genetically modified Aeribacillus pallidus (previously identified as Geobacillus pallidus) strain from Amano Enzyme Inc. The food enzyme is intended to be used in baking processes and in starch processing for the production of modified dextrins. For baking processes, based on the maximum use levels recommended and individual data from the EFS...

Europe - EFSA - European Food Safety Authority EFSA Journal

9-3-2019

Safety of ethyl lauroyl arginate (E 243) as a food additive in the light of the new information provided and the proposed extension of use

Safety of ethyl lauroyl arginate (E 243) as a food additive in the light of the new information provided and the proposed extension of use

Published on: Fri, 08 Mar 2019 The present scientific opinion deals with the evaluation of the safety of the food additive ethyl lauroyl arginate (E 243) in the light of a new interpretation of the available toxicological data and with respect to the proposed changes to the currently authorised conditions of use. Ethyl lauroyl arginate (E 243) is an already authorised food additive in the EU for use in heat‐treated meat products only, with some exceptions. The safety of ethyl lauroyl arginate (E 243) as...

Europe - EFSA - European Food Safety Authority EFSA Journal

8-3-2019


Draft Colchicine tablet 0.5 mg and 1 mg product-specific bioequivalence guidance

Draft Colchicine tablet 0.5 mg and 1 mg product-specific bioequivalence guidance

Draft Colchicine tablet 0.5 mg and 1 mg product-specific bioequivalence guidance

Europe - EMA - European Medicines Agency

7-3-2019

American Health Packaging Issues Voluntary Nationwide Recall of Valsartan Tablets Due to the Detection of NDEA (N-Nitrosodiethylamine) Impurity

American Health Packaging Issues Voluntary Nationwide Recall of Valsartan Tablets Due to the Detection of NDEA (N-Nitrosodiethylamine) Impurity

American Health Packaging is voluntarily recalling one lot of Valsartan Tablets, USP, 160 mg to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug product. The impurity detected in the finished drug product is N-Nitrosodiethylamine (NDEA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Resea...

FDA - U.S. Food and Drug Administration

7-3-2019

Re‐evaluation of Quillaia extract (E 999) as a food additive and safety of the proposed extension of use

Re‐evaluation of Quillaia extract (E 999) as a food additive and safety of the proposed extension of use

Published on: Wed, 06 Mar 2019 The EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion on Quillaia extract (E 999) when used as a food additive and the evaluation of the safety of its proposed extension of use as a food additive in flavourings. The Scientific Committee for Food (SCF) in 1978 established an acceptable daily intake (ADI) of 0–5 mg spray‐dried extract/kg body weight (bw) per day for E 999. The Joint FAO/WHO Expert Committee on Food Additives ...

Europe - EFSA - European Food Safety Authority EFSA Journal

7-3-2019

Safety and efficacy of Robenz® 66G (robenidine hydrochloride) for chickens for fattening and turkeys for fattening

Safety and efficacy of Robenz® 66G (robenidine hydrochloride) for chickens for fattening and turkeys for fattening

Published on: Tue, 05 Mar 2019 Following a request from European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of Robenz® 66G (robenidine hydrochloride (HCl)) when used as a feed additive for chickens for fattening and turkeys for fattening. The coccidiostat Robenz®66G is considered safe for chickens for fattening at the highest proposed level of 36 mg robenidine HCl/kg complete feed with a ...

Europe - EFSA - European Food Safety Authority EFSA Journal

5-3-2019

Morphine Sulfate Injection BP 30 mg in 1 mL ampoule

Morphine Sulfate Injection BP 30 mg in 1 mL ampoule

Safety advisory – Section 19A product not for epidural or intrathecal use

Therapeutic Goods Administration - Australia

5-3-2019

Opinion on the follow‐up of the re‐evaluation of sorbic acid (E200) and potassium sorbate (E202) as food additives

Opinion on the follow‐up of the re‐evaluation of sorbic acid (E200) and potassium sorbate (E202) as food additives

Published on: Fri, 01 Mar 2019 In this opinion, the EFSA Panel on Food Additives and Flavourings (FAF Panel) was requested by the European Commission to carry out a scientific evaluation of an extended one‐generation reproductive toxicity study (EOGRTS) to determine whether it would allow reconsideration of the temporary group acceptable daily intake (ADI) for sorbic acid (E 200) and potassium sorbate (E 202), established by the Panel on Food Additives and Nutrient Sources added to Food (ANS Panel) in 2...

Europe - EFSA - European Food Safety Authority EFSA Journal

1-3-2019

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 25 mg, 50 mg and 100 mg Due to the Detection of Trace Amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) Impurity found in the Active Pharmaceutical

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 25 mg, 50 mg and 100 mg Due to the Detection of Trace Amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) Impurity found in the Active Pharmaceutical

Camber Pharmaceuticals, Inc. is recalling 87 lots of Losartan Tablets USP 25 mg, 50 mg, and 100 mg to consumer level. This recall was prompted due to the detection of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, Unit – I (API manufacturer).

FDA - U.S. Food and Drug Administration

26-2-2019

Safety and efficacy of TYFER™ (ferric tyrosine chelate) as a zootechnical feed additive for chickens, turkeys and minor poultry species for fattening or reared for laying/breading

Safety and efficacy of TYFER™ (ferric tyrosine chelate) as a zootechnical feed additive for chickens, turkeys and minor poultry species for fattening or reared for laying/breading

Published on: Mon, 25 Feb 2019 Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the product TYFER™ (ferric tyrosine chelate) as zootechnical feed additive for chickens, turkeys and minor poultry species for fattening or reared for laying/breeding. The additive is safe for chickens for fattening at the maximum expected level of 200 mg TYFER™/kg complete feed; this conclusion can be extended to chickens reared for laying/breedin...

Europe - EFSA - European Food Safety Authority EFSA Journal

25-2-2019

Macleods Pharmaceuticals Limited Issues Voluntary Nationwide Consumer Level Recall of One Lot (BLM 715A) of Losartan Potassium/Hydrochlorothiazide Combination Tablets 100mg/25mg Due to detection of NDEA (N-Nitrosodiethylamine) Impurity

Macleods Pharmaceuticals Limited Issues Voluntary Nationwide Consumer Level Recall of One Lot (BLM 715A) of Losartan Potassium/Hydrochlorothiazide Combination Tablets 100mg/25mg Due to detection of NDEA (N-Nitrosodiethylamine) Impurity

Macleods Pharmaceuticals Limited is voluntarily recalling one lot of Losartan Potassium/Hydrochlorothiazide combination tablets 100mg/25mg to the consumer level due to the detection of trace amounts of an unexpected impurity (NDEA) found in finished product manufactured with active pharmaceutical ingredient made by Hetero Labs Limited.

FDA - U.S. Food and Drug Administration

25-2-2019

Xeljanz, Xeljanz XR (tofacitinib): Safety Communication - Safety Trial Finds Increased Risk of Blood Clots in the Lungs and Death with Higher Dose in Rheumatoid Arthritis Patients

Xeljanz, Xeljanz XR (tofacitinib): Safety Communication - Safety Trial Finds Increased Risk of Blood Clots in the Lungs and Death with Higher Dose in Rheumatoid Arthritis Patients

FDA is alerting the public that a safety clinical trial found an increased risk of blood clots in the lungs and death when a 10 mg twice daily dose of tofacitinib (Xeljanz, Xeljanz XR) was used in patients with rheumatoid arthritis (RA). FDA has not approved this 10 mg twice daily dose for RA; this dose is only approved in the dosing regimen for patients with ulcerative colitis

FDA - U.S. Food and Drug Administration

14-2-2019

Modification of the existing maximum residue levels for mandipropamid in various crops

Modification of the existing maximum residue levels for mandipropamid in various crops

Published on: Wed, 13 Feb 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicants Syngenta Crop Protection B.V. and Agriculture and Horticulture Development Board (AHDB) submitted, respectively, a request to the competent national authorities in the Netherlands and United Kingdom to modify the existing maximum residue levels (MRLs) for the active substance mandipropamid in various crops. The data submitted in support of the request were found to be sufficient to derive MRL propo...

Europe - EFSA - European Food Safety Authority EFSA Journal

4-2-2019

Dr. Reddy's Laboratories Continues its Voluntary Nationwide Recall of Levetiracetam in 0.54% Sodium Chloride Injection 1500mg/100mL Due to Mislabeling

Dr. Reddy's Laboratories Continues its Voluntary Nationwide Recall of Levetiracetam in 0.54% Sodium Chloride Injection 1500mg/100mL Due to Mislabeling

Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY) announced that it’s wholly owned subsidiary, Dr Reddy’s Laboratories, Inc is continuing its voluntary nationwide recall of lot ABD807 of Levetiracetram in 0.54% Sodium Chloride Injection, 1,500 mg/100 mL (15 mg/mL) single-dose infusion bags to the hospital level in U.S.A.

FDA - U.S. Food and Drug Administration

30-1-2019

Tris Pharma, Inc Expands Its Voluntary Nationwide Retail Recall of Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 mL, Due to Higher Concentration of Ibuprofen

Tris Pharma, Inc Expands Its Voluntary Nationwide Retail Recall of Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 mL, Due to Higher Concentration of Ibuprofen

Monmouth Junction, NJ, Tris Pharma, Inc. is expanding the scope of its November 2018 recall by adding three (3) additional lots of Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 mL, to the retail (pharmacy) level. Some units from these batches have been found to have higher levels of Ibuprofen concentration.

FDA - U.S. Food and Drug Administration

26-1-2019

Safety assessment of the substance poly((R)‐3‐hydroxybutyrate‐co‐(R)‐3‐hydroxyhexanoate) for use in food contact materials

Safety assessment of the substance poly((R)‐3‐hydroxybutyrate‐co‐(R)‐3‐hydroxyhexanoate) for use in food contact materials

Published on: Fri, 25 Jan 2019 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP Panel) assessed the safety of poly((R)‐3‐hydroxybutyrate‐co‐(R)‐3‐hydroxyhexanoate) (PHBH), CAS No 147398‐31‐0 and food contact material (FCM) substance No 1059. This biodegradable copolymer is produced by fermentation of palm oil using a genetically modified microorganism (Cupriavidus necator). Overall migration was up to 5.4 mg/kg. Oligomers are hydroxyl‐terminated or with crotyl‐ and hexenyl end‐...

Europe - EFSA - European Food Safety Authority EFSA Journal

23-1-2019

Safety evaluation of the food enzyme lysophospholipase from Trichoderma reesei (strain RF7206)

Safety evaluation of the food enzyme lysophospholipase from Trichoderma reesei (strain RF7206)

Published on: Tue, 22 Jan 2019 The food enzyme lysophospholipase (EC 3.1.1.5) is produced with the genetically modified Trichoderma reesei strain RF7206 by AB Enzymes GmbH. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. The lysophospholipase food enzyme is intended to be used in starch processing for the production of glucose syrups. Residual amounts of total organic solids (TOS) are removed by the ...

Europe - EFSA - European Food Safety Authority EFSA Journal

22-1-2019

Modification of the existing maximum residue level for trifloxystrobin in broccoli

Modification of the existing maximum residue level for trifloxystrobin in broccoli

Published on: Mon, 21 Jan 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer Hellas AG submitted a request to the competent national authority in Greece to modify the existing maximum residue level (MRL) for the active substance trifloxystrobin in broccoli. The data submitted in support of the request were found to be sufficient to derive an MRL proposal for broccoli. Adequate analytical methods for enforcement are available to control the residues of trifloxystrobin o...

Europe - EFSA - European Food Safety Authority EFSA Journal

22-1-2019

Modification of the existing maximum residue levels for aclonifen in celeriacs and certain fresh herbs

Modification of the existing maximum residue levels for aclonifen in celeriacs and certain fresh herbs

Published on: Mon, 21 Jan 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicants Landesanstalt für Landwirtschaft und Gartenbau Sachsen‐Anhalt (LSA) and Dienstleistungszentrum Ländlicher Raum Rheinpfalz (DLR), respectively, submitted a request to the competent national authority in Germany to modify the existing maximum residue levels (MRL) for the active substance aclonifen in chives, parsley, celery leaves/dill leaves, thyme/savoury and in celeriacs/turnip‐rooted celery. The ...

Europe - EFSA - European Food Safety Authority EFSA Journal

22-1-2019

Modification of the existing maximum residue levels for aminopyralid in certain cereals

Modification of the existing maximum residue levels for aminopyralid in certain cereals

Published on: Mon, 21 Jan 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Dow AgroSciences Denmark submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue levels (MRLs) for the active substance aminopyralid in cereals. The data submitted in support of the request were found to be sufficient to derive MRL proposals for barley, rye, sorghum, millet and oats. A modification of the existing MRL of aminopyralid in wh...

Europe - EFSA - European Food Safety Authority EFSA Journal

19-1-2019

Safety for the environment of vitamin D3 for salmonids

Safety for the environment of vitamin D3 for salmonids

Published on: Thu, 17 Jan 2019 The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) of EFSA assessed the safety for the target species and the consumer of the use of a maximum total level of 1.5 mg vitamin D3/kg feed in fish nutrition (2017). The assessment was based on data that had been provided by the Norwegian Food Safety Authority (NFSA). Since the data set provided by the NFSA did not include any new information concerning the safety for the user and the environment...

Europe - EFSA - European Food Safety Authority EFSA Journal

17-1-2019

Safety of cassia gum as a feed additive for cats and dogs based on a dossier submitted by Glycomer GmbH

Safety of cassia gum as a feed additive for cats and dogs based on a dossier submitted by Glycomer GmbH

Published on: Wed, 16 Jan 2019 The additive cassia gum consists mainly of high-molecular weight polysaccharides composed primarily of a linear chain of 1,4-b-D-mannopyranose units with 1,6-linked a-D-galactopyranose units. In 2014, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) delivered an opinion on the safety and efficacy of cassia gum in cats and dogs. The Panel concluded, based on positive findings observed in a bacterial reverse mutation test with a semi-refined cassia...

Europe - EFSA - European Food Safety Authority EFSA Journal

17-1-2019

Safety and efficacy of 8‐mercapto‐p‐menthan‐3‐one and p‐menth‐1‐ene‐8‐thiol belonging to chemical group 20 when used as flavourings for all animal species

Safety and efficacy of 8‐mercapto‐p‐menthan‐3‐one and p‐menth‐1‐ene‐8‐thiol belonging to chemical group 20 when used as flavourings for all animal species

Published on: Wed, 16 Jan 2019 Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of two compounds belonging to chemical group 20 (aliphatic and aromatic mono‐ and di‐thiols and mono‐, di‐, tri‐, and polysulfides with or without additional oxygenated functional groups). 8‐Mercapto‐p‐menthan‐3‐one [12.038] and p‐menth‐1‐ene‐8‐thiol [12.085] are currently ...

Europe - EFSA - European Food Safety Authority EFSA Journal

17-1-2019

Safety and efficacy of benzoic acid as a technological feed additive for weaned piglets and pigs for fattening

Safety and efficacy of benzoic acid as a technological feed additive for weaned piglets and pigs for fattening

Published on: Wed, 16 Jan 2019 The additive under assessment is pure benzoic acid (> 99.8%), manufactured in the form of flakes. It is intended to be used as a technological feed additive (acidity regulator) in feedingstuffs for weaned piglets and pigs for fattening, with maximum contents of 5,000 and 10,000 mg/kg complete feed, respectively. Benzoic acid is safe for weaned piglets at 5,000 mg/kg complete feed, and at 10,000 mg/kg complete feed for pigs for fattening. The use of benzoic acid in feedings...

Europe - EFSA - European Food Safety Authority EFSA Journal

16-1-2019

Safety and efficacy of Deccox® (decoquinate) for chickens for fattening

Safety and efficacy of Deccox® (decoquinate) for chickens for fattening

Published on: Mon, 14 Jan 2019 Deccox®, containing decoquinate as the active substance, is a feed additive intended to be used for the prevention of coccidiosis in chickens for fattening at a dose range of 20–40 mg/kg complete feed. Decoquinate from Deccox® is safe for chickens for fattening at the highest applied concentration in complete feed of 40 mg/kg. No practically relevant interactions with other additives or veterinary drugs exist except with bentonite. Decoquinate does not have antibacterial a...

Europe - EFSA - European Food Safety Authority EFSA Journal

15-1-2019

Setting of an import tolerance for spiromesifen in coffee beans

Setting of an import tolerance for spiromesifen in coffee beans

Published on: Mon, 14 Jan 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer CropScience submitted a request to the competent national authority in Greece to set an import tolerance for the active substance spiromesifen in coffee beans. The data submitted in support of the request were found to be sufficient to derive a maximum residue level (MRL) proposal for coffee beans. Adequate analytical methods for enforcement are available to control the residues of spiromesife...

Europe - EFSA - European Food Safety Authority EFSA Journal

14-1-2019

Germany Black Ant 2000mg tablets (Zhansheng Weige Chaoyue Xilishi)

Germany Black Ant 2000mg tablets (Zhansheng Weige Chaoyue Xilishi)

These tablets pose a serious risk to your health and should not be taken

Therapeutic Goods Administration - Australia

12-1-2019

Assessment of the application for renewal of authorisation of selenomethionine produced by Saccharomyces cerevisiae NCYC R397 for all animal species

Assessment of the application for renewal of authorisation of selenomethionine produced by Saccharomyces cerevisiae NCYC R397 for all animal species

Published on: Fri, 11 Jan 2019 The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the application for renewal of authorisation of organic form of selenium produced by Saccharomyces cerevisiae NCYC R397 (Alkosel®) for all animal species. The FEEDAP Panel has delivered two opinions (on 2007 and 2016) on the safety and efficacy of the additive. The additive is characterised as organic selenium mainly selenomethionine (63%); it was ini...

Europe - EFSA - European Food Safety Authority EFSA Journal

10-1-2019

Safety evaluation of the food enzyme alpha‐amylase from a genetically modified Trichoderma reesei (strain DP‐Nzb48)

Safety evaluation of the food enzyme alpha‐amylase from a genetically modified Trichoderma reesei (strain DP‐Nzb48)

Published on: Wed, 09 Jan 2019 The food enzyme alpha‐amylase (4‐α‐d‐glucan glucanohydrolase; EC 3.2.1.1) is produced with a genetically modified strain of Trichoderma reesei by Danisco US Inc. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This α‐amylase is intended to be used in distilled alcohol production and brewing processes. Residual amounts of total organic solids (TOS) are removed by distill...

Europe - EFSA - European Food Safety Authority EFSA Journal

8-1-2019

Sun Pharmaceutical Industries, Inc. Issues Voluntary Nationwide Recall of Vecuronium Bromide for Injection Due to the Presence of Particulate Matter Identified as Glass

Sun Pharmaceutical Industries, Inc. Issues Voluntary Nationwide Recall of Vecuronium Bromide for Injection Due to the Presence of Particulate Matter Identified as Glass

Sun Pharmaceutical Industries, Inc. (SPII), a wholly owned subsidiary of Sun Pharmaceutical Industries, Ltd. is voluntarily recalling three lots of Vecuronium Bromide for Injection, 10 mg (lyophilized powder), and one lot of Vecuronium Bromide for Injection, 20 mg (lyophilized powder) to the hospital level. The Vecuronium Bromide for Injection has been found to contain particulate matter identified as glass.

FDA - U.S. Food and Drug Administration

6-1-2019

Lupin Pharmaceuticals, Inc. Issues Voluntary Recall of Ceftriaxone for Injection USP, 250mg, 500mg, 1g and 2g

Lupin Pharmaceuticals, Inc. Issues Voluntary Recall of Ceftriaxone for Injection USP, 250mg, 500mg, 1g and 2g

Lupin Pharmaceuticals, Inc. is voluntarily recalling 5 lots of Ceftriaxone for Injection, USP, 250mg, 10 lots of Ceftriaxone for Injection, USP, 500mg, 24 lots of Ceftriaxone for Injection, USP, 1g and 3 lots of Ceftriaxone for Injection, USP 2g, to the hospital/physician level. The products have been found to contain visual grey particulate matter in reconstituted vials.

FDA - U.S. Food and Drug Administration

22-12-2018

Modification of the existing maximum residue level for captan in cranberries

Modification of the existing maximum residue level for captan in cranberries

Published on: Fri, 21 Dec 2018 In accordance with Article 6 of Regulation (EC) No 396/2005, the Belgian Federal Public Service (FPS) for Health, Food chain safety and Environment, submitted an application as the competent national authority in Belgium to modify the existing maximum residue level (MRL) for the active substance captan in cranberries. The data submitted in support of the request were found to be sufficient to derive MRL proposal for cranberries. Adequate analytical methods for enforcement ...

Europe - EFSA - European Food Safety Authority EFSA Journal

18-12-2018

Apo-Prednisone 5 mg Tablet (2018-12-18)

Apo-Prednisone 5 mg Tablet (2018-12-18)

Health Canada

17-12-2018


Draft cabozantinib tablet 20 mg, 40 mg and 60 mg, capsule 20 4 mg and 80 mg product-specific bioequivalence guidance

Draft cabozantinib tablet 20 mg, 40 mg and 60 mg, capsule 20 4 mg and 80 mg product-specific bioequivalence guidance

Draft cabozantinib tablet 20 mg, 40 mg and 60 mg, capsule 20 4 mg and 80 mg product-specific bioequivalence guidance

Europe - EMA - European Medicines Agency

17-12-2018


Draft ezetimibe tablet 10 mg product-specific bioequivalence guidance

Draft ezetimibe tablet 10 mg product-specific bioequivalence guidance

Draft ezetimibe tablet 10 mg product-specific bioequivalence guidance

Europe - EMA - European Medicines Agency

17-12-2018

Vijf jaar NIX brengt normverandering roken en drinken op gang

Vijf jaar NIX brengt normverandering roken en drinken op gang

Op 1 januari is het precies vijf jaar geleden dat de leeftijdsgrens voor roken en drinken werd verhoogd naar 18 jaar. In deze periode is er veel veranderd, blijkt uit een recente peiling in opdracht van het ministerie van VWS. Zo vindt ongeveer driekwart van de ouders en tieners het ‘normaal’ dat je pas mag roken en drinken vanaf 18 jaar. 78,2% van de ouders vindt dit tegenover 75,4% van de jongeren. De afgelopen jaren is het gebruik van alcohol onder tieners teruggelopen. Sinds 2011 gaat het in de total...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

14-12-2018

Statement on the safety of d‐ribose

Statement on the safety of d‐ribose

Published on: Thu, 13 Dec 2018 In 2018, the EFSA NDA Panel adopted the Scientific Opinion on the safety of d‐ribose as a novel food pursuant to Regulation (EU) 2015/2283 when used in a variety of food, concluding that d‐ribose is safe for the general population at intake levels up to 36 mg/kg body weight (bw) per day, but that its safety at the intended uses and use levels as proposed by the applicant could not be established. Following a request from the European Commission, the EFSA NDA Panel was aske...

Europe - EFSA - European Food Safety Authority Publications

7-12-2018

Magnesium citrate malate as a source of magnesium added for nutritional purposes to food supplements

Magnesium citrate malate as a source of magnesium added for nutritional purposes to food supplements

Published on: Thu, 06 Dec 2018 The present scientific opinion deals with the assessment of the bioavailability of magnesium, from the proposed nutrient source, magnesium citrate malate (MgCM), when added for nutritional purposes to food supplements. MgCM is a mixed salt consisting of magnesium cations and citrate and malate anions, and with a magnesium content of 12–15%. MgCM is proposed to be used in food supplements that are intended to provide up to 300–540 mg/day magnesium. The data provided demonst...

Europe - EFSA - European Food Safety Authority Publications

7-12-2018

Re‐evaluation of propane‐1,2‐diol esters of fatty acids (E 477) as a food additive

Re‐evaluation of propane‐1,2‐diol esters of fatty acids (E 477) as a food additive

Published on: Thu, 06 Dec 2018 The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion re‐evaluating the safety of propane‐1,2‐diol esters of fatty acids (E 477) when used as a food additive. The Scientific Committee on Food (SCF) in 1978 endorsed the acceptable daily intake (ADI) of 25 mg/kg body weight (bw) per day, expressed as propane‐1,2‐diol, established by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 1974. No adverse effects were observed in short‐t...

Europe - EFSA - European Food Safety Authority Publications

6-12-2018

Tris Pharma Issues Voluntary Nationwide Recall of Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, Due to Potential Higher Concentrations of Ibuprofen

Tris Pharma Issues Voluntary Nationwide Recall of Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, Due to Potential Higher Concentrations of Ibuprofen

Tris Pharma, Inc. has voluntarily recalled three (3) lots of Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, to the retail level. The recalled lots of the product have been found to potentially have higher concentrations of ibuprofen.

FDA - U.S. Food and Drug Administration

4-12-2018

Mylan Expands Its Voluntary Nationwide Recall of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, to all Lots Within Expiry Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylam

Mylan Expands Its Voluntary Nationwide Recall of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, to all Lots Within Expiry Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylam

– Mylan N.V. (NASDAQ: MYL) today announced that its U.S. based Mylan Pharmaceuticals business is expanding its consumer-level voluntary nationwide recall to include all lots of Valsartan-containing products within expiry. The 104 additional lots include 26 lots of Amlodipine and Valsartan Tablets, USP (including the 5mg/160mg, 10mg/160mg, 5mg/320mg and 10mg/320mg strengths), 51 lots of Valsartan Tablets, USP (including 40 mg, 80 mg, 160 mg and 320 mg strengths), and 27 lots of Valsartan and Hydrochloroth...

FDA - U.S. Food and Drug Administration

7-3-2019

Pregabalin Accord (Accord Healthcare S.L.U.)

Pregabalin Accord (Accord Healthcare S.L.U.)

Pregabalin Accord (Active substance: pregabalin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)1913 of Thu, 07 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/4024/T/10

Europe -DG Health and Food Safety

1-2-2019

Diotop 75 mg / 20 mg modified-release capsules, hard and associated names

Diotop 75 mg / 20 mg modified-release capsules, hard and associated names

Diotop 75 mg / 20 mg modified-release capsules, hard and associated names (Active substance: diclofenac/omeprazole) - Community Referrals - Art 29 - Commission Decision (2019)845 of Fri, 01 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/A-29(4)/1474

Europe -DG Health and Food Safety

25-1-2019

Pregabalin Accord (Accord Healthcare Limited)

Pregabalin Accord (Accord Healthcare Limited)

Pregabalin Accord (Active substance: pregabalin) - Centralised - Yearly update - Commission Decision (2019)683 of Fri, 25 Jan 2019

Europe -DG Health and Food Safety

9-1-2019

Pregabalin Sandoz (Sandoz GmbH)

Pregabalin Sandoz (Sandoz GmbH)

Pregabalin Sandoz (Active substance: pregabalin) - Centralised - Yearly update - Commission Decision (2019)67 of Wed, 09 Jan 2019

Europe -DG Health and Food Safety

9-1-2019

Pregabalin Sandoz GmbH (Sandoz GmbH)

Pregabalin Sandoz GmbH (Sandoz GmbH)

Pregabalin Sandoz GmbH (Active substance: pregabalin) - Centralised - Yearly update - Commission Decision (2019)66 of Wed, 09 Jan 2019

Europe -DG Health and Food Safety

19-12-2018

Ingelvac CircoFLEX (Boehringer Ingelheim Vetmedica GmbH)

Ingelvac CircoFLEX (Boehringer Ingelheim Vetmedica GmbH)

Ingelvac CircoFLEX (Active substance: Porcine circovirus type 2 ORF2 protein minimum RP1.0 Maximum RP 3.75) - Centralised - Yearly update - Commission Decision (2018)9073 of Wed, 19 Dec 2018

Europe -DG Health and Food Safety

14-12-2018

Pregabalin Pfizer (Pfizer Europe MA EEIG)

Pregabalin Pfizer (Pfizer Europe MA EEIG)

Pregabalin Pfizer (Active substance: pregabalin) - Centralised - Renewal - Commission Decision (2018)8908 of Fri, 14 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3880/R/25

Europe -DG Health and Food Safety

13-12-2018


Overview of comments received on 'Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance' (EMA/CHMP/800775/2017)

Overview of comments received on 'Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance' (EMA/CHMP/800775/2017)

Overview of comments received on 'Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance' (EMA/CHMP/800775/2017)

Europe - EMA - European Medicines Agency

13-12-2018


Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance

Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance

Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance

Europe - EMA - European Medicines Agency