Donepezil Accord

Glavne informacije

  • Zaščiteno ime:
  • Donepezil Accord 10 mg filmsko obložene tablete
  • Farmacevtska oblika:
  • filmsko obložena tableta
  • Sestava:
  • donepezil 9,12 mg / 1 tableta
  • Pot uporabe:
  • Peroralna uporaba
  • Enote v paketu:
  • škatla s plastenko s 100 tabletami
  • Tip zastaranja:
  • Rp - Predpisovanje in izdaja zdravila je le na recept
  • Uporabi za:
  • ljudje
  • Vrsta medicine:
  • Alopatska drog

Dokumentov

Lokalizacija

  • Na voljo v:
  • Donepezil Accord 10 mg filmsko obložene tablete
    Slovenija
  • Jezik:
  • slovenščina

Terapevtski podatki

  • Terapevtska skupina:
  • donepezil

Drugi podatki

Stanje

  • Source:
  • JAZMP - Javna agencija RS za zdravila in medicinske pripomočke - Slovenia Medicines Agency
  • Status dovoljenje:
  • Zdravilo z dovoljenjem za promet
  • Številka dovoljenja:
  • 1011-35/2014-7
  • Datum dovoljenje:
  • 01-04-2016
  • EAN koda:
  • 3837000126495
  • Zadnja posodobitev:
  • 18-01-2018

Podatki za bolnike

JAZMP – IB/010, IB/011, IA/013 – 05.12.2016

Navodilo za uporabo

Donepezil Accord 5 mg filmsko obložene tablete

Donepezil Accord 10 mg filmsko obložene tablete

donepezilijev hidroklorid

Pred začetkom jemanja zdravila natančno preberite navodilo, ker vsebuje za vas pomembne podatke!

Navodilo shranite. Morda ga boste želeli ponovno prebrati.

Če imate dodatna vprašanja, se posvetujte z zdravnikom ali farmacevtom.

Zdravilo je bilo predpisano vam osebno in ga ne smete dajati drugim. Njim bi lahko celo škodovalo, čeprav imajo

znake bolezni, podobne vašim.

Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom. Posvetujte se tudi, če opazite

katere koli neželene učinke, ki niso navedeni v tem navodilu. Glejte poglavje 4.

Kaj vsebuje navodilo

Kaj je zdravilo Donepezil Accord in za kaj ga uporabljamo

Kaj morate vedeti, preden boste vzeli zdravilo Donepezil Accord

Kako jemati zdravilo Donepezil Accord

Možni neželeni učinki

Shranjevanje zdravila Donepezil Accord

Vsebina pakiranja in dodatne informacije

1. Kaj je zdravilo Donepezil Accord in za kaj ga uporabljamo

Donepezil sodi v skupino zdravil, ki jih imenujemo zaviralci acetilholin-esteraze.

Uporablja se za zdravljenje simptomov demence pri bolnikih z ugotovljeno blago do zmerno hudo Alzheimerjevo

boleznijo. Simptomi vključujejo povečano izgubo spomina, zmedenost in spremembe vedenja. Posledično imajo oboleli

za Alzheimerjevo boleznijo vedno več težav z izvajanjem normalnih vsakodnevnih aktivnosti.

Donepezil lahko uporabljajo samo odrasli bolniki.

2. Kaj morate vedeti, preden boste vzeli zdravilo Donepezil Accord

Ne jemljite zdravila Donepezil Accord

če ste alergični na donepezilijev klorid, piperidinske derivate ali katero koli sestavino tega zdravila (navedeno v

poglavju 6).

Opozorila in previdnostni ukrepi

Pred začetkom jemanja zdravila

Donepezil Accord

se posvetujte z zdravnikom ali farmacevtom. Svojega zdravnika še

zlasti obvestite:

če imate ali ste imeli razjedo želodca ali dvanajstnika

če imate ali ste imeli epileptične napade (krče) ali konvulzije

če imate ali ste imeli bolezen srca (nepravilen ali zelo počasen srčni utrip)

če imate ali ste imeli astmo ali drugo dolgotrajno pljučno bolezen

če imate ali ste imeli kakršne koli težave z jetri ali hepatitis

če imate ali ste imeli težave pri uriniranju ali blago ledvično obolenje

Zdravilo Donepezil Accord lahko uporabljajo bolniki z ledvičnim obolenjem ali blagim do zmernim jetrnim obolenjem.

Svojemu zdravniku takoj povejte, če imate ledvično ali jetrno obolenje. Bolniki s hudim jetrnim obolenjem ne smejo

uporabljati zdravila Donepezil Accord.

Druga zdravila in zdravilo Donepezil Accord

Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo

zdravilo.

Povejte svojemu zdravniku, če uporabljate katero od naslednjih zdravil:

druga zdravila za zdravljenje Alzheimerjeve bolezni, npr. galantamin

JAZMP – IB/010, IB/011, IA/013 – 05.12.2016

analgetike ali zdravila za zdravljenje artritisa, npr. aspirin, nesteroidna protivnetna zdravila (NSAID) kot sta

ibuprofen ali natrijev diklofenak

antiholinergike, npr. tolterodin

antibiotike, npr. eritromicin, rifampicin

protiglivična zdravila, npr. ketokonazol

antidepresive, npr. fluoksetin

antikonvulzive, npr. fenitoin, karbamazepin,

zdravila za zdravljenje težav s srcem, npr. kinidin, zaviralci adrenergičnih receptorjev beta, propanolol in

atenolol,

mišične relaksante, npr. diazepam, sukcinilholin

splošne anestetike

zdravila, ki ste jih dobili brez recepta, npr. zeliščne preparate

Zdravnika in anestezista obvestite, da jemljete zdravilo Donepezil Accord, če imate predvideno operacijo, za katero je

potrebna splošna anestezija. To pa zato, ker zdravilo Donepezil Accord lahko vpliva na količino potrebnega anestetika.

Zdravilo Donepezil

Accord skupaj s hrano, pijačo in alkoholom

Hrana ne vpliva na učinke zdravila Donepezil Accord.

Med zdravljenjem z zdravilom Donepezil Accord ne uživajte alkohola, saj lahko to spremeni učinek zdravila.

Nosečnost, dojenje in plodnost

Zdravila Donepezil Accord se ne sme uporabljati med nosečnostjo, razen če je to nujno potrebno.

Zdravila Donepezil Accord ne smete uporabljati med dojenjem.

Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte s svojim

zdravnikom

farmacevtom

,

preden vzamete to zdravilo.

Vpliv na sposobnost upravljanja vozil in strojev

Alzheimerjeva bolezen lahko poslabša vašo sposobnost za vožnjo ali upravljanje s stroji, zato ne smete opravljati teh

aktivnosti, dokler vam zdravnik ne reče, da je to varno.

Poleg tega lahko vaše zdravilo povzroči utrujenost, omotičnost in mišične krče. Če opazite katere koli od teh učinkov,

ne smete voziti ali upravljati s stroji.

Zdravilo Donepezil Accord vsebuje laktozo

To zdravilo vsebuje laktozo. Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev, se pred uporabo zdravila

Donepezil Accord posvetujte z zdravnikom.

3. Kako jemati zdravilo Donepezil Accord

Pri jemanju tega zdravila natančno upoštevajte navodila zdravnika ali farmacevta. Če ste negotovi, se posvetujte z

zdravnikom ali farmacevtom.

Običajno boste pričeli z jemanjem 5-mg odmerka (ena bela tableta) vsak večer. Po enem mesecu vam bo zdravnik

morda naročil, da jemljite 10 mg (eno rumeno tableto) vsak večer.

Zdravilo Donepezil Accord zaužijte s požirkom vode, preden se zvečer odpravite spat.

Jakost tablete, ki jo boste jemali, se lahko spremeni glede na obdobje jemanja zdravila in na zdravnikova priporočila.

Največji priporočljivi odmerek je 10 mg vsak večer.

Vedno upoštevajte zdravnikov ali farmacevtov nasvet o načinu in času jemanja zdravila.

Odmerka ne spreminjajte sami brez posveta z zdravnikom.

Kako dolgo morate jemati zdravilo Donepezil Accord

Zdravnik ali farmacevt vam bo povedal, kako dolgo morate nadaljevati z jemanjem tablet. Zdravnika boste morali redno

obiskovati, da bo nadziral vaše zdravljenje in ocenjeval vaše simptome.

Če ste vzeli večji odmerek zdravila Donepezil Accord, kot bi smeli

Ne jemljite več kot ene tablete na dan. Če ste vzeli večji odmerek, kot bi smeli, takoj pokličite svojega zdravnika. Če ne

morete dobiti svojega zdravnika, takoj pokličite urgentni oddelek najbližje bolnišnice. Tablete in škatlo vedno vzemite s

seboj v bolnišnico, da bo zdravnik vedel, kaj jemljete.

JAZMP – IB/010, IB/011, IA/013 – 05.12.2016

Simptomi prevelikega odmerjanja lahko vključujejo slabost in bruhanje, slinjenje, znojenje, upočasnjen srčni utrip, nizek

krvni tlak (občutek prazne glave ali omotičnost med stanjem), težave z dihanjem, izgubo zavesti in epileptične napade

(krče) ali konvulzije.

Če ste pozabili vzeti zdravilo Donepezil Accord

Če ste pozabili vzeti odmerek, ga vzemite čim prej, ko to opazite, razen če je že čas za naslednji odmerek. Ne vzemite

dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.

Če ste pozabili jemati zdravilo več kot en teden, se posvetujte z zdravnikom, preden ga začnete jemati znova.

Če ste prenehali jemati zdravilo

Donepezil Accord

Ne prenehajte jemati zdravila Donepezil Accord, če vam tega ne naroči zdravnik. Če boste prenehali jemati zdravilo

Donepezil Accord, bodo koristni učinki zdravljenja sčasoma izginili.

Če imate dodatna vprašanja o uporabi zdravila, se posvetujte z zdravnikom ali farmacevtom.

4. Možni neželeni učinki

Kot vsa zdravila ima lahko tudi to zdravilo neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.

Bolniki, ki so uporabljali zdravilo Donepezil Accord, so poročali o naslednjih neželenih učinkih.

Resni neželeni učinki:

Če opazite katerega koli od resnih neželenih učinkov, takoj obvestite zdravnika. Morda potrebujete nijno medicinsko

pomoč.

Razjeda želodca ali dvanajstnika. Simptomi razjed so bolečine v želodcu in nelagodje (prebavne motnje), ki jih

čutite med popkom in prsnico (lahko prizadenejo do 1 od 100 bolnikov)

Krvavitev v želodcu ali črevesju. Zaradi tega boste morda izločali trdo črno smolasto blato ali vidno kri iz

rektuma (lahko prizadene do 1 od 100 bolnikov).

Epileptični napadi (krči) ali konvulzije (lahko prizadene do 1 od 100 bolnikov).

Poškodba jeter, npr. hepatitis. Simptomi hepatitisa so slabost ali bruhanje, izguba apetita, splošno slabo počutje,

povišana telesna temperatura, srbenje, porumenelost kože in oči in temno obarvan urin (lahko prizadene do 1 od

1.000 bolnikov).

Zvišana telesna temperatura z mišično togostjo, znojenjem ali zmanjšano ravnijo zavesti (motnja, imenovana

"nevroleptični maligni sindrom") (lahko prizadene do 1 od 10.000 bolnikov).

Mišična šibkost, občutljivost ali bolečine, zlasti v primeru istočasnega slabega počutja, močno zvišane telesne

temperature ali temnega urina. To je lahko posledica nenormalnega razpadanja mišic, kar je lahko smrtno

nevarno in lahko povzroči težave z ledvicami (stanje, ki se imenuje rabdomioliza) (pojavi se lahko pri največ 1

od 10.000 oseb).

Drugi neželeni učinki, ki se lahko pojavijo:

Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov):

driska

slabost

glavobol

Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov):

mišični krči

utrujenost

težave s spanjem (nespečnost)

običajni prehlad

izguba apetita

halucinacije (vidite ali slišite stvari, ki ne obstajajo)

nenavadne sanje vključno z nočnimi morami

vznemirjenost

napadalno vedenje

omedlevica

omotica

nelagodje v trebuhu

bruhanje

izpuščaj

srbenje

JAZMP – IB/010, IB/011, IA/013 – 05.12.2016

nenadzirano uriniranje

bolečina

nezgode (bolniki so bolj nagnjeni k padanju in nezgodnim poškodbam)

Občasni

neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov):

počasno bitje srca

majhno povečanje serumske koncentracije mišične kreatin-kinaze

epileptični napadi (krči)

Redki neželeni učinki (pojavijo se lahko pri največ 1 od 1.000 bolnikov):

togost, tresavica ali nehoteni gibi zlasti obraza in jezika, pa tudi okončin

motnje srčnega ritma

Poročanje o neželenih učinkih

Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom. Posvetujte se tudi, če opazite

neželene učinke, ki niso navedeni v tem navodilu. O neželenih učinkih lahko poročate tudi neposredno na nacionalni

center za poročanje:

Univerzitetni klinični center Ljubljana, Interna klinika

Center za zastrupitve

Zaloška cesta 2

SI-1000 Ljubljana

Faks: + 386 (0)1 434 76 46

e-pošta: farmakovigilanca@kclj.si

S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega zdravila.

5. Shranjevanje zdravila Donepezil Accord

Zdravilo shranjujte nedosegljivo otrokom!

Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in pretisnem omotu

poleg oznake "EXP". Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.

Za shranjevanje zdravila niso potrebna posebna navodila.

Zdravila ne smete odvreči v odpadne vode ali med gospodinjske odpadke. O načinu odstranjevanja zdravila, ki

ga ne potrebujete več, se posvetujte s farmacevtom. Taki ukrepi pomagajo varovati okolje.

6. Vsebina pakiranja in dodatne informacije

Kaj vsebuje zdravilo Donepezil Accord

Zdravilna učinkovina je donepezilijev klorid. Ena filmsko obložena tableta vsebuje donepezilijev klorid monohidrat, kar

ustreza 5 mg/10 mg donepezilijevega klorida

Druge sestavine zdravila so:

Jedro:

laktoza monohidrat, koruzni škrob, mikrokristalna celuloza, nizko substituirana hidroksipropil celuloza,

magnezijev stearat

Obloga:

5 mg: hipromeloza (E464), titanov dioksid (E171), makrogol 400, smukec (E553b)

10 mg: hipromeloza (E464), titanov dioksid (E171), makrogol 400, smukec (E553b), rumeni železov oksid (E172)

Izgled zdravila Donepezil Accord in vsebina pakiranja

Zdravilo Donepezil Accord je v obliki 5 mg in 10 mg tablet. Tablete so opisane spodaj.

5 mg: bele do belkaste, okrogle, bikonveksne, filmsko obložene tablete premera približno 7,14 mm s poševno prirezanimi

robovi z vtisnjenim napisom "5" na eni strani in gladke na drugi strani.

10 mg: rumene, okrogle, bikonveksne, filmsko obložene tablete premera približno 8,73 mm z vtisnjenim napisom "10"

na eni strani in gladke na drugi strani.

Zdravilo Donepezil Accord 5 mg / 10 mg tablete je na voljo v naslednjih pakiranjih:

Pretisni omot PVC/alu v zunanji škatli: 7, 28, 30, 50, 56, 60, 84, 98 in 120 tablet

JAZMP – IB/010, IB/011, IA/013 – 05.12.2016

Plastenka HDPE: 100 tablet

Na trgu morda ni vseh navedenih pakiranj.

Način in režim izdaje zdravila Donepezil Accord

Predpisovanje in izdaja zdravila je le na recept.

Imetnik dovoljenja za promet z zdravilom:

Accord Healthcare Limited

Sage House, 319, Pinner Road,

North Harrow, Middlesex, HA1 4HF,

Velika Britanija

Izdelovalec

Accord Healthcare Limited

Sage House, 319, Pinner Road,

North Harrow, Middlesex, HA1 4HF,

Velika Britanija

Zdravilo je v državah članicah EGP pridobilo dovoljenje za promet z naslednjimi imeni:

Ime države

članice

Ime zdravila

Bolgarija

Донепезил Акорд 5 mg / 10 mg филмирани таблетки

Češka republika

Donepezil Accord 5 mg / 10 mg potahované tablety

Estonija

Donepezil Accord

Madžarska

Donepezil Accord 5 mg / 10 mg filmtabletta

Litva

Donepezil Accord 5 mg / 10 mg plėvele dengtos tabletės

Poljska

Donepestan

Slovaška

Donepezil Accord 5 mg / 10 mg filmom obalené tablety

Slovenija

Donepezil Accord 5 mg/ 10 mg filmsko obložene tablete

Švedska

Donepezil Accord

Avstrija

Donepezil Accord 5 mg /10 mg Filmtabletten

Ciper

Donepezil Accord 5 mg / 10 mg επικαλυμμένα με λεπτό υμένιο δισκία

Danska

Donepezilhydrochlorid Accord 5 mg / 10 mg filmovertrukne tabletter

Finska

Donepezil Accord 5 mg / 10 mg

kalvopäällysteinen tabletti/ filmdragerade tabletter

Irska

Donepezil 5 mg /10 mg Film-coated Tablets

Italija

Donepezil Accord 5 mg / 10 mg Ccompresse Rvestite Ccon Film

Malta

Donepezil 5 mg / 10 mg Film-coated Tablets

Norveška

Donepezil Accord 5 mg / 10 mg Filmdrasjerte tabletter

Portugalska

Donepezilo Accord 5 mg /10 mg Comprimidos revestidos por película

Velika Britanija

Donepezil Hydrochloride 5 mg / 10 mg Film-coated Tablets

Navodilo je bilo nazadnje revidirano dne 05.12.2016.

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Setting of import tolerances for haloxyfop‐P in linseed and rapeseed

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Updated review of the existing maximum residue levels for imazalil according to Article 12 of Regulation (EC) No 396/2005 following new toxicological information

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

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Evaluation of confirmatory data following the Article 12 MRL review for pyraflufen‐ethyl

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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

Lumpy skin disease: scientific and technical assistance on control and surveillance activities

Lumpy skin disease: scientific and technical assistance on control and surveillance activities

Published on: Tue, 16 Oct 2018 00:00:00 +0200 The duration of the vaccination campaign sufficient to eliminate lumpy skin disease (LSD) mainly depends on the vaccination effectiveness and coverage achieved. By using a spread epidemiological model, assuming a vaccination effectiveness of 65%, with 50% and 90% coverage, 3 and 4 years campaigns, respectively, are needed to eliminate LSD. When vaccination effectiveness is 80% to 95%, 2 years of vaccination at coverage of 90% is sufficient to eliminate LSD vir...

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

6-10-2018

Modification of the existing maximum residue level for epoxiconazole in beetroots

Modification of the existing maximum residue level for epoxiconazole in beetroots

Published on: Fri, 05 Oct 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Agriculture & Horticulture Development Board submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue level (MRL) for the active substance epoxiconazole in beetroots. The data submitted in support of the request were found to be sufficient to derive a MRL proposal for beetroots. Adequate analytical methods for enforcement are...

Europe - EFSA - European Food Safety Authority Publications

2-10-2018

Review of the existing maximum residue levels for cyflufenamid according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for cyflufenamid according to Article 12 of Regulation (EC) No 396/2005

Published on: Mon, 01 Oct 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance cyflufenamid. To assess the occurrence of cyflufenamid residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as the European authorisations reported by Member States (in...

Europe - EFSA - European Food Safety Authority Publications

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

27-9-2018

Review of the existing maximum residue levels for tembotrione according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for tembotrione according to Article 12 of Regulation (EC) No 396/2005

Published on: Wed, 26 Sep 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance tembotrione. To assess the occurrence of tembotrione residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EU) No 188/2011 as well as the import tolerances and European author...

Europe - EFSA - European Food Safety Authority Publications

27-9-2018

Outcome of the consultation on confirmatory data used in risk assessment for the active substance  copper (I), copper (II) variants

Outcome of the consultation on confirmatory data used in risk assessment for the active substance copper (I), copper (II) variants

Published on: Wed, 26 Sep 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the risk assessment for an active substance in light of confirmatory data requested following the first approval in accordance with Article 6(1) of Directive 91/414/EEC and Article 6(f) of Regulation (EC) No 1107/2009. In this context EFSA's scientific views on the specific points raised during the commenting phase conducted with Me...

Europe - EFSA - European Food Safety Authority Publications

26-9-2018

Modification of the existing maximum residue level for flonicamid in various crops

Modification of the existing maximum residue level for flonicamid in various crops

Published on: Tue, 25 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Dienstleistungszentrum Ländlicher Raum submitted a request to the competent national authority in Germany to modify the existing maximum residue level (MRL) for the active substance flonicamid in radishes. Furthermore, in accordance with Article 6 of Regulation (EC) No 396/2005, the applicant ISK Biosciences Europe N.V. submitted a request to the competent national authority in the Ne...

Europe - EFSA - European Food Safety Authority Publications

25-9-2018

Daiso Holdings Ltd. recalls Daiso Brand Consumer Chemical Products

Daiso Holdings Ltd. recalls Daiso Brand Consumer Chemical Products

The recalled products have not been properly classified according to the Consumer Chemicals and Containers Regulations, 2001, in order to ensure appropriate hazard labelling. These regulations are empowered by the Canada Consumer Product Safety Act. Improper labelling could result in unintentional exposure to these products and lead to serious illness, injury or death.

Health Canada

21-9-2018

Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for sulfoxaflor in light of confirmatory data

Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for sulfoxaflor in light of confirmatory data

Published on: Thu, 20 Sep 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the risk assessment for an active substance in light of confirmatory data requested following approval in accordance with Article 6(1) of Directive 91/414/EEC and Article 6(f) of Regulation (EC) No 1107/2009. In this context EFSA's scientific views on the specific points raised during the commenting phase conducted with Member State...

Europe - EFSA - European Food Safety Authority Publications

21-9-2018

Modification of the existing maximum residue level for clothianidin in potatoes

Modification of the existing maximum residue level for clothianidin in potatoes

Published on: Thu, 20 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer CropScience AG submitted a request to the competent national authority in Germany to modify the existing maximum residue level (MRL) for the active substance clothianidin to accommodate the use on potatoes imported from Canada. The data submitted in support of the request were found to be sufficient to derive a MRL proposal. Adequate analytical methods for enforcement are availa...

Europe - EFSA - European Food Safety Authority Publications

19-9-2018

Modification of the existing maximum residue levels for potassium phosphonates in certain berries and small fruits

Modification of the existing maximum residue levels for potassium phosphonates in certain berries and small fruits

Published on: Tue, 18 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant LTZ Augustenberg submitted a request to the competent national authority in Germany to modify the existing maximum residue levels (MRLs) for the active substance potassium phosphonates in raspberries, blackberries, currants, blueberries, gooseberries and elderberries. The data submitted in support of the request were found to be sufficient to derive MRL proposals for all crops under c...

Europe - EFSA - European Food Safety Authority Publications

19-9-2018

Modification of the existing maximum residue levels for flonicamid in various root crops

Modification of the existing maximum residue levels for flonicamid in various root crops

Published on: Tue, 18 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the Agriculture and Horticulture Development Council submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue levels (MRL) for the active substance flonicamid in beetroots, carrots, celeriacs/turnip rooted celeries, horseradishes, Jerusalem artichokes, parsnips, parsley roots/Hamburg roots parsley, radishes, salsifies, swedes/rutabagas, tu...

Europe - EFSA - European Food Safety Authority Publications

13-9-2018

Review of the existing maximum residue levels for fluquinconazole according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for fluquinconazole according to Article 12 of Regulation (EC) No 396/2005

Published on: Wed, 12 Sep 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance fluquinconazole. Considering the information provided by Member States, neither EU uses nor import tolerances are currently authorised for fluquinconazole within the European Union. Furthermore, no MRLs are established by the Codex Alimentarius Commission (codex maximum residue ...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Risk assessment of substances used in food supplements: the example of the botanical Gymnema sylvestre

Risk assessment of substances used in food supplements: the example of the botanical Gymnema sylvestre

Published on: Tue, 28 Aug 2018 00:00:00 +0200 Botanicals and preparations derived from these are among the substances frequently added to foods and food supplements, yet the safety of many botanicals has not been systematically assessed. In the context of the EU‐FORA fellowship programme, the fellow performed an assessment on the safety of the botanical Gymnema sylvestre, in accordance with EFSA's guidance on the assessment of safety of botanicals. Although preparations of G. sylvestre are marketed as f...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Modelling of inactivation through heating for quantitative microbiological risk assessment (QMRA)

Modelling of inactivation through heating for quantitative microbiological risk assessment (QMRA)

Published on: Mon, 27 Aug 2018 00:00:00 +0200 EFSA regards the household as a stage in the food chain that is important for the final number of food‐borne infections. The fate of a pathogen in the private kitchen largely depends on consumer hygiene during preparation of food and on its proper cooking, especially in the case of meat. Unfortunately, detailed information on the microbiological survival in meat products after heating in the consumer kitchen is lacking. The aim of the study was to improve th...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Assessment of occupational and dietary exposure to pesticide residues

Assessment of occupational and dietary exposure to pesticide residues

Published on: Mon, 27 Aug 2018 00:00:00 +0200 Plant protection products (PPPs) are pesticides containing at least one active substance that drives specific actions against pests (diseases). PPPs are regulated in the EU and cannot be placed on the market or used without prior authorisation. EFSA assesses the possible risks of the use of active substances to humans and environment. Member States decide whether or not to approve their use at EU level. Furthermore, Member States decide at national level on ...

Europe - EFSA - European Food Safety Authority Publications

4-9-2018

Outcome of the consultation with Member States and EFSA on the basic substance application for milk for use in plant protection as fungicide

Outcome of the consultation with Member States and EFSA on the basic substance application for milk for use in plant protection as fungicide

Published on: Mon, 03 Sep 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the evaluation of applications received by the European Commission concerning basic substances. In this context, EFSA's scientific views on the specific points raised during the commenting phase conducted with Member States and EFSA on the basic substance application for milk are presented. The context of the evaluation was that req...

Europe - EFSA - European Food Safety Authority Publications

1-9-2018

Multiple “Dr. King’s” homeopathic and “Natural Pet” veterinary products recalled due to potential microbial contamination

Multiple “Dr. King’s” homeopathic and “Natural Pet” veterinary products recalled due to potential microbial contamination

Health Canada is advising consumers and pet owners not to use homeopathic and veterinary products made by King Bio Inc. and labeled as "Dr. King's," "Dr King's Natural Pet" or "Natural Pet." These products may pose a health risk to people and pets, especially children, pregnant women and those with compromised immune systems, because of potential microbial contamination. According to the United States Food and Drug Administration, high levels of microbial contamination were identified at the manufacturin...

Health Canada

1-9-2018

Acknowledgement:EFSA  wishes  to  thank  the  rapporteur  Member  State  Denmark  for  thepreparatory work on this scientific output.Suggested citation:EFSA (European Food Safety Authority), Brancato A, Brocca D, Carrasco Cabrera L,De Lentdecker C, Erdos

Acknowledgement:EFSA wishes to thank the rapporteur Member State Denmark for thepreparatory work on this scientific output.Suggested citation:EFSA (European Food Safety Authority), Brancato A, Brocca D, Carrasco Cabrera L,De Lentdecker C, Erdos

Published on: Fri, 31 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance napropamide. To assess the occurrence of napropamide residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as the European authorisations reported by Member States (incl...

Europe - EFSA - European Food Safety Authority Publications

1-9-2018

Review of the existing MRLs for fenbuconazole

Review of the existing MRLs for fenbuconazole

Published on: Fri, 31 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance fenbuconazole. To assess the occurrence of fenbuconazole residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC, the MRLs established by the Codex Alimentarius Commission as well...

Europe - EFSA - European Food Safety Authority Publications

30-8-2018

National summary reports on pesticide residue analysis performed in 2016

National summary reports on pesticide residue analysis performed in 2016

Published on: Tue, 07 Aug 2018 00:00:00 +0200 In accordance with Article 31 of Regulation (EC) No 396/2005, European Union (EU) Member States have to communicate to the European Food Safety Authority (EFSA) the results of their official controls on pesticide residues in food. In the framework of this communication, the EU Member States, Iceland and Norway provided a short summary report outlining the main findings of the control activities during the reference year. This technical report is the compilat...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Review of the existing maximum residue levels for sintofen according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for sintofen according to Article 12 of Regulation (EC) No 396/2005

Published on: Tue, 28 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance sintofen. To assess the occurrence of sintofen residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008, as well as the European authorisations reported by Member ...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Review of the existing maximum residue levels for prochloraz according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for prochloraz according to Article 12 of Regulation (EC) No 396/2005

Published on: Mon, 27 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance prochloraz. To assess the occurrence of prochloraz residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC, the MRLs established by the Codex Alimentarius Commission as well as th...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Modification of the existing maximum residue levels for prohexadione in various oilseeds

Modification of the existing maximum residue levels for prohexadione in various oilseeds

Published on: Mon, 27 Aug 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted a request to the competent national authority in France to modify the existing maximum residue levels (MRL) for the active substance prohexadione in linseeds, poppy seeds, sunflower seeds, rape seeds, mustard seeds and gold of pleasure seeds. The data submitted in support of the request were found to be sufficient to derive MRL proposals for all oilseeds under consid...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Review of the existing maximum residue levels for napropamide according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for napropamide according to Article 12 of Regulation (EC) No 396/2005

Published on: Fri, 24 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance napropamide. To assess the occurrence of napropamide residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as the European authorisations reported by Member States (incl...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Explanatory note on the determination of newly expressed protein levels in the context of genetically modified plant applications for EU market authorisation

Explanatory note on the determination of newly expressed protein levels in the context of genetically modified plant applications for EU market authorisation

Published on: Mon, 20 Aug 2018 00:00:00 +0200 Genetically modified organisms are subject to a risk assessment and regulatory approval before entering the European market. According to legislation (Directive 2001/18/EC, Regulation (EC) No 1829/2003 and Regulation (EU) No 503/2013) and the EFSA guidance documents on the risk assessment of food and feed from genetically modified (GM) plants and on the environmental risk assessment of GM plants, applicants need to perform a molecular characterisation of any...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Setting of import tolerances for mandestrobin in strawberries and table and wine grapes

Setting of import tolerances for mandestrobin in strawberries and table and wine grapes

Published on: Thu, 16 Aug 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Sumitomo Chemical Agro Europe SAS submitted a request to the competent national authority in Austria to set an import tolerance for the active substance mandestrobin in strawberries, table grapes and wine grapes. The data submitted in support of the request were found to be sufficient to derive maximum residue level (MRL) proposals for the crops under consideration. Adequate analytica...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Modification of the existing maximum residue levels for fluoxastrobin in oilseeds

Modification of the existing maximum residue levels for fluoxastrobin in oilseeds

Published on: Mon, 13 Aug 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Arysta LifeSciences SAS submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue levels (MRL) for the active substance fluoxastrobin in certain oilseeds. The data submitted in support of the request were found to be sufficient to derive MRL proposals for the oilseeds for which a modification was requested. Adequate analytical...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Review of the existing maximum residue levels for myclobutanil according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for myclobutanil according to Article 12 of Regulation (EC) No 396/2005

Published on: Mon, 13 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance myclobutanil. To assess the occurrence of myclobutanil residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008, the MRLs established by the Codex Alimentarius Com...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Evaluation of data concerning the necessity of bromoxynil as herbicide to control a serious danger to plant health which cannot be contained by other available means, including non‐chemical methods

Evaluation of data concerning the necessity of bromoxynil as herbicide to control a serious danger to plant health which cannot be contained by other available means, including non‐chemical methods

Published on: Mon, 13 Aug 2018 00:00:00 +0200 EFSA was requested by the European Commission to provide scientific assistance under Article 31 of Regulation (EC) No 178/2002 regarding the evaluation of data concerning the necessity of bromoxynil as a herbicide to control a serious danger to plant health which cannot be contained by other available means including non‐chemical methods, in accordance with Article 4(7) of Regulation (EC) No 1107/2009. In this context, EFSA organised a commenting phase with ...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Slovakia and EFSA – Final report

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Slovakia and EFSA – Final report

Published on: Tue, 07 Aug 2018 00:00:00 +0200 Presented document is the final report of the project GA/EFSA/DATA/2017/01: “Strategic Partnership with Slovakia on Data Quality (Pilot project)”. The report describes national processes and tools in order to implement internal validation and quality control of collected data according to EFSA requirements. A description of the data transmission processes from the National Databases to the EFSA databases, terminology, data mapping and data transformations fo...

Europe - EFSA - European Food Safety Authority Publications

28-8-2018

Accord Healthcare Inc. Issues Voluntary Nationwide Recall of Hydrochlorothiazide Tablets USP 12.5 Mg Due to Labeling Mix-up

Accord Healthcare Inc. Issues Voluntary Nationwide Recall of Hydrochlorothiazide Tablets USP 12.5 Mg Due to Labeling Mix-up

A 100 count bottle of Hydrochlorothiazide Tablets USP 12.5 mg has been found to contain 100 Spironolactone Tablets USP 25 mg. Since the individual lot, PW05264, of the product is involved in a potential mix-up of labeling, Accord is recalling this individual lot from the market.

FDA - U.S. Food and Drug Administration

2-7-2018

Blissful Remedies Issues Voluntary Nationwide Recall of Certain Kratom Powder Capsule

Blissful Remedies Issues Voluntary Nationwide Recall of Certain Kratom Powder Capsule

Blissful Remedies., is voluntarily recalling only Lot No.: 112710 with expiration 03/2019 found embedded on the top of package of kratom ( mitragyn a speciosa) powder products, it manufactured, processed, packed, and/or held, between “March 1, 2018” to “April 30, 2018” to the consumer level. The products have been found by the U.S. Food and Drug Administration (“FDA”) via sample testing to have salmonella contamination. Blissful Remedies has not received reports of adverse events related to this recall. ...

FDA - U.S. Food and Drug Administration

22-6-2018

Kratom (mitragyna speciosa) Powder Products by Gaia Ethnobotanical: Recall - Due to Potential Salmonella Contamination

Kratom (mitragyna speciosa) Powder Products by Gaia Ethnobotanical: Recall - Due to Potential Salmonella Contamination

The products have been found by the FDA via sample testing and finding to have salmonella contamination. In lieu of such FDA findings the company has implemented standard operating procedures and sterilization processes in accordance to FDA guidelines

FDA - U.S. Food and Drug Administration

21-6-2018

Gaia Ethnobotanical, LLC., Voluntarily Recalls Kratom Products Due to Potential Salmonella Contamination

Gaia Ethnobotanical, LLC., Voluntarily Recalls Kratom Products Due to Potential Salmonella Contamination

Gaia Ethnobotanical, LLC., is voluntarily recalling all kratom (mitragyna speciosa) powder products, with Lot No.: 0102031800 it manufactured, processed, packed, and/or held, between March 18, 2018 to March 30, 2018 to the consumer level. The products have been found by the U.S. Food and Drug Administration (“FDA”) via sample testing and finding to have salmonella contamination. In lieu of such FDA findings the company has implemented standard operating procedures and sterilization processes in accordanc...

FDA - U.S. Food and Drug Administration

25-9-2018

Pelgraz (Accord Healthcare Limited)

Pelgraz (Accord Healthcare Limited)

Pelgraz (Active substance: pegfilgrastim) - Centralised - Authorisation - Commission Decision (2018)6288 of Tue, 25 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/003961/0000

Europe -DG Health and Food Safety

24-9-2018

Lenalidomide Accord (Accord Healthcare Limited)

Lenalidomide Accord (Accord Healthcare Limited)

Lenalidomide Accord (Active substance: lenalidomide) - Centralised - Authorisation - Commission Decision (2018)6237 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4857

Europe -DG Health and Food Safety

7-8-2018

Accofil (Accord Healthcare Limited)

Accofil (Accord Healthcare Limited)

Accofil (Active substance: Filgrastim) - Centralised - Yearly update - Commission Decision (2018)5428 of Tue, 07 Aug 2018

Europe -DG Health and Food Safety

7-8-2018

Memantine Accord (Accord Healthcare Limited)

Memantine Accord (Accord Healthcare Limited)

Memantine Accord (Active substance: memantine) - Centralised - Renewal - Commission Decision (2018)5421 of Tue, 07 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2766/R/10

Europe -DG Health and Food Safety

6-8-2018

Zoledronic acid Accord (Accord Healthcare Limited)

Zoledronic acid Accord (Accord Healthcare Limited)

Zoledronic acid Accord (Active substance: zoledronic acid) - Centralised - Yearly update - Commission Decision (2018)5386 of Mon, 06 Aug 2018

Europe -DG Health and Food Safety

18-7-2018

#ICYMI - According to @PAPATIENTSAFETY June 2018 report, the number of reported surgical fires has decreased since 2011.  Read more about preventing surgical fires here:  https://go.usa.gov/xU5zs  #FDA #MedicalDevice

#ICYMI - According to @PAPATIENTSAFETY June 2018 report, the number of reported surgical fires has decreased since 2011. Read more about preventing surgical fires here: https://go.usa.gov/xU5zs  #FDA #MedicalDevice

#ICYMI - According to @PAPATIENTSAFETY June 2018 report, the number of reported surgical fires has decreased since 2011. Read more about preventing surgical fires here: https://go.usa.gov/xU5zs  #FDA #MedicalDevice

FDA - U.S. Food and Drug Administration

4-7-2018

Docetaxel Accord (Accord Healthcare Limited)

Docetaxel Accord (Accord Healthcare Limited)

Docetaxel Accord (Active substance: Docetaxel) - Centralised - Yearly update - Commission Decision (2018)4341 of Wed, 04 Jul 2018

Europe -DG Health and Food Safety

3-7-2018

Temozolomide Accord (Accord Healthcare Limited)

Temozolomide Accord (Accord Healthcare Limited)

Temozolomide Accord (Active substance: temozolomide) - Centralised - Yearly update - Commission Decision (2018) 4240 of Tue, 03 Jul 2018

Europe -DG Health and Food Safety

11-6-2018

Pemetrexed Accord (Accord Healthcare Limited)

Pemetrexed Accord (Accord Healthcare Limited)

Pemetrexed Accord (Active substance: pemetrexed) - Centralised - Yearly update - Commission Decision (2018)3761 of Mon, 11 Jun 2018

Europe -DG Health and Food Safety

30-5-2018

Bortezomib Accord (Accord Healthcare Limited)

Bortezomib Accord (Accord Healthcare Limited)

Bortezomib Accord (Active substance: bortezomib) - Centralised - Variation - Commission Decision (2018)3460 of Wed, 30 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3984/X/8

Europe -DG Health and Food Safety

23-5-2018

Scientific guideline:  Draft guideline on the responsibilities of the sponsor with regard to handling and shipping of investigational medicinal products for human use in accordance with good clinical practice and good manufacturing practice, draft: consul

Scientific guideline: Draft guideline on the responsibilities of the sponsor with regard to handling and shipping of investigational medicinal products for human use in accordance with good clinical practice and good manufacturing practice, draft: consul

The guideline lays down the principles for the two-step release and shipping of the investigational medicinal products by the qualified person and the sponsor. The guideline also describes the areas of interface between the manufacturer and the sponsor and the required contractual agreements.

Europe - EMA - European Medicines Agency

15-5-2018

Pramipexole Accord (Accord Healthcare Limited)

Pramipexole Accord (Accord Healthcare Limited)

Pramipexole Accord (Active substance: pramipexole) - Centralised - Yearly update - Commission Decision (2018)2995 of Tue, 15 May 2018

Europe -DG Health and Food Safety