Mofetilmikofenolat Accord

Glavne informacije

  • Zaščiteno ime:
  • Mofetilmikofenolat Accord 500 mg filmsko obložene tablete
  • Farmacevtska oblika:
  • filmsko obložena tableta
  • Sestava:
  • mofetilmikofenolat 500 mg / 1 tableta
  • Pot uporabe:
  • Peroralna uporaba
  • Enote v paketu:
  • škatla s 50 tabletami (5 x 10 tablet v pretisnem omotu)
  • Tip zastaranja:
  • H/Rp - Predpisovanje in izdaja zdravila je le na recept, zdravilo pa se uporablja samo v bolnišnicah. Izjemoma se lahko uporablj
  • Uporabi za:
  • ljudje
  • Vrsta medicine:
  • Alopatska drog

Dokumentov

Lokalizacija

  • Na voljo v:
  • Mofetilmikofenolat Accord 500 mg filmsko obložene tablete
    Slovenija
  • Jezik:
  • slovenščina

Terapevtski podatki

  • Terapevtska skupina:
  • mikofenolna kislina

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:
  • 5363-I-198/13
  • Datum dovoljenje:
  • 30-01-2013
  • EAN koda:
  • 3837000041804
  • Zadnja posodobitev:
  • 19-01-2018

Podatki za bolnike

NAVODILO ZA UPORABO

Mofetilmikofenolat Accord 500 mg filmsko obložene tablete

mofetilmikofenolat

Pred začetkom jemanja natančno preberite navodilo!

Navodilo shranite. Morda ga boste želeli ponovno prebrati.

Če imate dodatna vprašanja, se posvetujte z zdravnikom ali s 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 katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni

omenjen v tem navodilu, o tem obvestite svojega zdravnika ali farmacevta.

Navodilo vsebuje:

Kaj je zdravilo Mofetilmikofenolat Accord in za kaj ga uporabljamo

Kaj morate vedeti, preden boste vzeli zdravilo Mofetilmikofenolat Accord

Kako jemati zdravilo Mofetilmikofenolat Accord

Možni neželeni učinki

Shranjevanje zdravila Mofetilmikofenolat Accord

Dodatne informacije

1.

KAJ JE ZDRAVILO MOFETILMIKOFENOLAT ACCORD IN ZA KAJ GA

UPORABLJAMO

imunosupresivi

Zdravilo Mofetilmikofenolat Accord se uporablja za preprečevanje zavrnitve presajene ledvice, srca

jeter.

Zdravilo

Mofetilmikofenolat

Accord

uporablja

skupaj

drugimi

zdravili,

ciklosporin in kortikosteroidi.

2.

KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO

MOFETILMIKOFENOLAT ACCORD

Ne jemljite zdravila Mofetilmikofenolat Accord:

če ste alergični (preobčutljivi) na mofetilmikofenolat, mikofenolno kislino ali katerokoli

sestavino zdravila Mofetilmikofenolat Accord

če dojite

Bodite posebno previdni pri jemanju zdravila Mofetilmikofenolat Accord

Svojega zdravnika morate nemudoma obvestiti:

če opazite znake okužbe (npr. povišano telesno temperaturo, vneto grlo), nepričakovane

modrice in/ali krvavitve;

če imate ali ste imeli kakršnekoli težave s prebavili, npr. želodčne razjede.

če načrtujete nosečnost ali zanosite med jemanjem zdravila Mofetilmikofenolat Accord

Mofetilmikofenolat

tablete

zmanjšajo

vaš

telesni

obrambni

mehanizem.

Zaradi

tega

poveča

tveganje za nastanek kožnega raka. Zato se morate zaščititi pred sončnimi žarki in UV svetlobo, tako

da nosite primerna oblačila in uporabljate kremo za sončenje z visokim zaščitnim faktorjem.

Jemanje drugih zdravil:

Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo,

tudi če ste ga dobili brez recepta.

Če na katero od naslednjih vprašanj odgovorite z »da«, se posvetujte s svojim zdravnikom, preden

začnete jemati Mofetilmikofenolat Accord:

– Ali jemljete kakšna zdravila, ki vsebujejo: azatioprin ali druge imunosupresive

(ki se včasih dajejo bolnikom po presaditvi organov), holestiramin (uporablja se za zdravljenje

bolnikov s povišanim holesterolom), rifampicin (antibiotik), antacide, vezalce fosfatov

(uporabljajo se pri bolnikih s kronično odpovedjo ledvic, za zmanjševanje absorpcije fosfatov)

ali katera koli druga zdravila (vključno z zdravili brez recepta), za katera vaš zdravnik ne ve?

– Ali prejemate cepiva (živa cepiva)? Vaš zdravnik vam bo moral svetovati, kaj je za vas

primerno.

Jemanje zdravila Mofetilmikofenolat Accord skupaj s hrano in pijačo:

Hrana in pijača ne vplivata na vaše zdravljenje z zdravilom Mofetilmikofenolat Accord..

Nosečnost in dojenje:

Uporaba zdravila Mofetilmikofenolat Accord med nosečnostjo lahko povzroči spontani splav ali

poškodbe vašega nerojenega otroka (npr. nenormalen razvoj ušes).

Če načrtujete nosečnost, se pogovorite z vašim zdravnikom glede jemanja nadomestnih zdravil, s

katerimi boste preprečili zavrnitev vašega presajenega organa. V nekaterih okoliščinah se lahko

skupaj z vašim zdravnikom odločite, da so prednosti jemanja zdravila Mofetilmikofenolat Accord za

vaše zdravje večje kot je možno tveganje za vašega nerojenega otroka.

Če ste zanosili med jemanjem zdravila Mofetilmikofenolat Accord, ne prenehajte z jemanjem zdravila

in čimprej obvestite vašega zdravnika o nosečnosti.

Ne jemljite zdravila Mofetilmikofenolat Accord če:

- dojite

- ste noseči (razen, če vam vaš osebni zdravnik to izrecno naroči)

Nemudoma se posvetujte s svojim zdravnikom:

če mislite, da ste zanosili

če dojite

če načrtujete nosečnost v bližnji prihodnosti

Vedno morate uporabljati zanesljivo metodo kontracepcije:

- pred začetkom jemanja zdravila Mofetilmikofenolat Accord

- med zdravljenjem z zdravilom Mofetilmikofenolat Accord

- 6 tednov po prenehanju zdravljenja z zdravilom Mofetilmikofenolat Accord

Posvetujete se z vašim zdravnikom o za vas najbolj primerni metodi kontracepcije.

Ženske, ki bi lahko zanosile, morajo imeti negativen rezultat testa za nosečnost PRED začetkom

zdravljenja z zdravilom Mofetilmikofenolat Accord.

Če se na vas nanašajo sledeče trditve ste ženska, ki več ne more zanositi:

- Ste že v postmenopavzalnem obdobju, t.j. ste stari vsaj 50 let in ste imeli zadnjo menstruacijo že več

kot eno leto nazaj (v primeru, da ste izgubili menstruacijo zaradi zdravljenja raka, potem še obstaja

možnost zanositve).

- So vam odstranili jajcevode in oba jajčnika (bilateralna salpingo- ooforektomija).

- So vam odstranili maternico (histerektomija).

Imate predčasno odpoved delovanja jajčnikov in je to potrdil vaš ginekolog.

- So vas diagnosticirali z redko prirojeno boleznijo, ki vam onemogoča zanositev: genotip XY,

Turnerjev sindrom ali agenezija maternice (prirojeno manjkanje ali močna nerazvitost maternice).

- Ste otrok ali madostnica, ki še nima menstruacije in zanositev ni možna.

Vpliv na sposobnost upravljanja vozil in strojev:

Pri zdravilu Mofetilmikofenolat Accord niso opazili nobenih učinkov, ki bi lahko vplivali na

sposobnost upravljanja vozil ali strojev.

3.

KAKO JEMATI ZDRAVILO MOFETILMIKOFENOLAT ACCORD

Pri jemanju zdravila Mofetilmikofenolat Accord natančno upoštevajte zdravnikova navodila. Če ste

negotovi, se posvetujte z zdravnikom ali s farmacevtom.

Običajen način jemanja zdravila Mofetilmikofenolat Accord je naslednji:

Pri presaditvi ledvic:

Odrasli:

Prvi odmerek se daje 72 ur po presaditvi. Priporočen dnevni odmerek je 4 tablete dnevno (2g zdravilne

učinkovine) v dveh ločenih odmerkih. To pomeni, da vzamete 2 tableti zjutraj in 2 zvečer.

Otroci (od 2. do 18. leta):

Odmerek je odvisen od velikosti otroka. Zdravnik se bo odločil kateri je primeren dnevni odmerek

glede na telesno zgradbo (višino in maso) otroka. Priporočen dnevni odmerek je 600 mg/m

dvakrat

dnevno.

Pri presaditvi srca:

Odrasli:

Prvi odmerek se daje 5 dni po presaditvi. Priporočen dnevni odmerek je 6 tablet dnevno (3g zdravilne

učinkovine) v dveh ločenih odmerkih. To pomeni, da vzamete 3 tablete zjutraj in 3 zvečer.

Otroci:

Ni podatkov, na podlagi katerih bi lahko priporočili, kako uporabljati zdravilo Mofetilmikofenolat

Accord pri otrocih, ki so jim presadili srce.

Pri presaditvi jeter:

Odrasli:

Prvi peroralni odmerek tablete Mofetilmikofenolata Accord boste dobili najmanj 4 dni po operaciji za

presaditev in ko boste tablete lahko požirali. Priporočen dnevni odmerek je 6 tablet dnevno (3 g

zdravilne učinkovine) v dveh ločenih odmerkih. To pomeni, da vzamete 3 tablete zjutraj in 3 zvečer.

Otroci:

Ni podatkov, na podlagi katerih bi lahko priporočili, kako uporabljati zdravilo Mofetilmikofenolat

Accord pri otrocih, ki so jim presadili jetra.

Postopek in pot(i) uporabe zdravila:

Pogoltnite celo tableto s kozarcem vode. Tablete ne smete lomiti ali drobiti.

Zdravljenje bo trajalo toliko časa,dokler boste potrebovali imunosupresive, da vaše telo ne bo več

zavračalo presajenega organa.

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

Če ste pomotoma vzeli več tablet zdravila Mofetilmikofenolat Accord, kot bi smeli, ali če je nekdo

drug

pomotoma

vzel

vašo

tableto

zdravila

Mofetilmikofenolat

Accord,

takoj

obiščite

svojega

zdravnika ali pojdite v bolnišnico.

Če ste pozabili vzeti zdravilo Mofetilmikofenolat Accord

Če ste kadarkoli pozabili vzeti tableto zdravila Mofetilmikofenolat Accord, jo vzemite takoj, ko se

spomnite. Nato vzemite naslednji odmerek ob običajni uri.

Če ste prenehali jemati zdravilo Mofetilmikofenolat Accord

prenehanju

jemanja

zdravila

Mofetilmikofenolat

Accord

poveča

verjetnost

zavrnitve

presajenega organa. Ne prenehajte z jemanjem tablet, če vam zdravnik tega ni naročil.

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

4.

MOŽNI NEŽELENI UČINKI

Kot vsa zdravila ima lahko tudi zdravilo Mofetilmikofenolat Accord neželene učinke, ki pa se ne

pojavijo pri vseh bolnikih. Pogostejše težave so: driska, zmanjšanje števila belih krvničk in/ali rdečih

krvničk v krvi, okužbe in bruhanje. Vaš zdravnik bo opravil redne krvne preiskave in spremljal

kakršnekoli spremembe v številu vaših krvničk ali spremembe v koncentracijah katerekoli snovi v vaši

krvi, kot so sladkor, maščobe, holesterol.

Pri otrocih je večja verjetnost kot pri odraslih, da se pojavijo neželeni učinki, kot so driska, okužbe,

zmanjšanje števila belih krvnih telesc in povečanje števila rdečih krvničk v krvi.

Mofetilmikofenolat zmanjša vaš telesni obrambni mehanizem, da bi preprečil zavračanje presajene

ledvice, srca ali jeter. Posledično vaše telo v boju z okužbami ne bo več tako učinkovito kot običajno.

Zato lahko v primeru, da jemljete mofetilmikofenolat, dobite več okužb kot običajno, npr. okužbo

možganov, kože, ust, želodca in črevesja, pljuč in sečil. Kot se to pri jemanju tega zdravila lahko

zgodi, je nekaj bolnikov, ki se zdravijo z mofetilmikofenolatom, zbolelo za rakom na žleznem tkivu in

koži.

Splošni neželeni učinki, ki se nanašajo na vaše telo kot celoto, lahko vključujejo preobčutljivost (npr.

anafilaksa, angioedem), povišano telesno temperaturo, utrujenost, težave s spanjem, bolečine (npr. v

trebuhu, prsih, sklepih/mišicah, bolečino pri uriniranju), glavobol, simptome gripe in otekline.

Drugi neželeni učinki, ki se lahko pojavijo, so:

Bolezni kože, kot so akne, občutljivost na mraz, pasasti izpuščaji, debelitev kože, izpadanje las, kožni

izpuščaji in srbenje.

Motnje v uriniranju, kot so težave z ledvicami ali nujna potreba po odvajanju seča.

Bolezni v prebavilih in ustih, kot so zaprtje, slabost, slaba prebava, vnetje trebušne slinavke,

črevesne motnje, vključno s krvavitvami, vnetje želodčne sluznice, težave z jetri, vnetje debelega

črevesa, izguba teka, napenjanje in razjede v ustih.

Bolezni živčevja in čutil, kot so krči, tresenje, omotica, depresija, zaspanost, otrplost, mišični krči,

tesnobnost in hitro menjavanje misli ali razpoloženja.

Presnovne motnje, bolezni krvi in žilne bolezni, kot so izguba telesne mase, protin, povišanje

krvnega sladkorja, krvavitve, strdki in modrice, nihanje krvnega tlaka, nenormalen srčni utrip, širjenje

krvnih žil.

Pljučne bolezni, kot so pljučnica, bronhitis, zadihanost, kašelj, tekočina v pljučih/prsni votlini, težave

s sinusi.

Če katerikoli neželeni učinek postane resen ali če opazite med jemanjem zdravila Mofetilmikofenolat

Accord katerikoli neželeni učinek, ki ni omenjen v tem navodilu, o tem obvestite svojega zdravnika ali

farmacevta. V nobenem primeru pa ne smete prenehati z jemanjem zdravila, razen po naročilu vašega

zdravnika.

5.

SHRANJEVANJE ZDRAVILA MOFETILMIKOFENOLAT ACCORD

Zdravilo shranjujte pri temperaturi do 25 C. Pretisni omot shranjujte v zunanji škatli zaradi

zaščite pred svetlobo.

Zdravilo shranjujte nedosegljivo otrokom!

Zdravila Mofetilmikofenolat Accord ne uporabljajte po datumu izteka roka uporabnosti, ki je

naveden na kartonski škatli poleg oznake (EXP). Datum izteka roka uporabnosti se nanaša na

zadnji dan navedenega meseca.

Prosimo, da preostanek zdravila vedno vrnete farmacevtu v lekarno. Obdržite ga le, če vaš

zdravnik tako svetuje.

Zdravila

smete

odvreči

odpadne

vode

gospodinjske

odpadke.

načinu

odstranjevanja zdravila, ki ga ne potrebujete več, se posvetujte s farmacevtom. Taki ukrepi

pomagajo varovati okolje.

6.

DODATNE INFORMACIJE

Kaj vsebuje zdravilo Mofetilmikofenolat Accord:

Zdravilna učinkovina je 500 mg mofetilmikofenolata.

Druge sestavine so:

Jedro

tablete:

mikrokristalna

celuloza,

povidon,

hidroksipropil

celuloza,

premreženi

natrijev

karmezolat, smukec , magnezijev stearat.

Obloga tablete: hipromeloza 6 cps, titanov dioksid (E171), makrogol 400, rdeči železov oksid (E172),

indigotin (E132), črni železov oksid (E172).

Izgled zdravila Mofetilmikofenolat Accord in vsebina pakiranja:

Mofetilmikofenolat Accord 500 mg filmsko obložene tablete so vijolične barve, v obliki kapsule,

bikonveksne filmsko obložene tablete z vtisnjeno oznako »AHI« na eni strani in »500«, na drugi

strani.

Mofetilmikofenolat Accord 500 mg filmsko obložene tablete so na voljo v pretisnih omotih v

pakiranjih po 50 in 150 tablet.

Na trgu morda ni vseh navedenih pakiranj.

Način in režim izdaje zdravila

Predpisovanje in izdaja zdravila je le na recept, zdravilo pa se uporablja samo v bolnišnicah. Izjemoma

se lahko uporablja pri nadaljevanju zdravljenja na domu ob odpustu iz bolnišnice in nadaljnjem

zdravljenju.

Imetnik dovoljenja za promet z zdravilom

Accord Healthcare Limited, Sage House, 319, Pinner Road, North Harrow, Middlesex, HA1 4HF,

Združeno kraljestvo

Izdelovalec:

CEMELOG- BRS

2040 Budaors, Vasut u.13

Madžarska

ACCORD HEALTHCARE LIMITED

Sage house,

319, Pinner Road,

North Harrow,

Middlesex HA1 4HF

Združeno kraljestvo

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

Ime države

članice

Ime zdravila

Avstrija

Mycophenolate Mofetil Accord 500 mg Filmtabletten

Belgija

Mycophenolate Mofetil Accord Healthcare 500 mg comprimés

pelliculés

Ciper

Mycophenolate Mofetil Accord 500 mg επικαλυμμένα με

λεπτό υμένιο δισκία

Češka republika

Mycophenolate Mofetil Accord 500 mg potahované tablety

Danska

Mycophenolate Mofetil Accord 500 mg Filmovertrukne

tabletter

Estonija

Mycophenolate Mofetil Accord 500 mg õhukese

polümeerikattega tabletid

Finska

Mycophenolate Mofetil Accord 500 mg Tabletti,

kalvopäällysteinen / Filmdragerade tabletter

Francija

Mycophenolate Mofetil Accord Healthcare 500 mg Comprimé

pelliculés

Nemčija

Mycophenolate Mofetil Accord 500 mg Filmtabletten

Grčija

Myfetil

500 mg επικαλυμμένα με λεπτό υμένιο δισκία

Madžarska

Mycophenolate Mofetil Accord 500 mg filmtabletta

Irska

Mycophenolate Mofetil 500 mg film-coated Tablets

Italija

Micofenolato mofetile AHCL 500mg compresse rivestite con

film

Latvija

Mycophenolate Mofetil Accord 500 mg apvalkotās tabletes

Litva

Mycophenolate Mofetil Accord 500 mg plėvele dengtos

tabletės

Malta

Mycophenolate Mofetil Accord 500 mg

Norveška

Mycophenolate Mofetil Accord 500 mg Tablets, filmdrasjert

Poljska

Mycophenolate Mofetil Accord

Portugalska

Mycophenolate Mofetil Accord 500 mg comprimidos

revestidos por pelicula

Romunija

Mycophenolate Mofetil Accord 500 mg comprimate filmate

Slovaška

Mycophenolate Mofetil 500mg filmom obalené tablety

Slovenija

Mofetilmikofenolat Accord 500 mg filmsko obložene tablete

Španija

Micofenolato de mofetilo STADA 500 mg comprimidos

recubiertos con película EFG

Švedska

Mycophenolate Accord 500 mg Filmdragerade tabletter

Nizozemska

Mycophenolate Mofetil Accord 500 mg Filmonhulde Tabletten

Združeno

kraljestvo

Mycophenolate Mofetil 500 mg Film–coated Tablets

Navodilo je bilo nazadnje odobreno: 21.11.2012

17-11-2018

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Setting of import tolerances for teflubenzuron in grapefruits, mandarins and broccoli

Setting of import tolerances for teflubenzuron in grapefruits, mandarins and broccoli

Published on: Mon, 12 Nov 2018 00:00:00 +0100 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF Agro BV submitted a request to the competent national authority in the United Kingdom to set import tolerances for the active substance teflubenzuron in grapefruits and mandarins imported from Brazil and for broccoli imported from Paraguay. The data submitted were found to be sufficient to derive maximum residue level (MRL) proposals for grapefruits and broccoli. The MRL derived ...

Europe - EFSA - European Food Safety Authority Publications

13-11-2018

The importance of vector abundance and seasonality

The importance of vector abundance and seasonality

Published on: Mon, 12 Nov 2018 00:00:00 +0100 This joint ECDC‐EFSA report assesses whether vector count data (abundance) and the way these change throughout the year (seasonality) can provide useful information about vector‐borne diseases epidemiological processes of interest, and therefore, whether resources should be devoted to collecting such data. The document also summarises what measures of abundance and seasonality can be collected for each vector group (mosquitoes, sandflies, midges and ticks), ...

Europe - EFSA - European Food Safety Authority Publications

10-11-2018

Outcome of the consultation with Member States and EFSA on the basic substance application for propolis extract (admissibility accepted when named water‐soluble extract of propolis) for use in plant protection as fungicide and bactericide

Outcome of the consultation with Member States and EFSA on the basic substance application for propolis extract (admissibility accepted when named water‐soluble extract of propolis) for use in plant protection as fungicide and bactericide

Published on: Fri, 09 Nov 2018 00:00:00 +0100 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 propolis extract are presented. The context of the evaluation ...

Europe - EFSA - European Food Safety Authority Publications

6-11-2018

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

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

Published on: Fri, 02 Nov 2018 00:00:00 +0100 In accordance with Article 6 of Regulation (EC) No 396/2005, the Australian Government Department of Agriculture and Water Resources submitted two requests to the competent national authority in Denmark to set import tolerances for the active substance haloxyfop‐P in linseed and rapeseed. The data submitted in support of the request were found to be sufficient to derive maximum residue level (MRL) proposals for linseed and rapeseed. Adequate analytical metho...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

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

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

Published on: Tue, 30 Oct 2018 00:00:00 +0100 In compliance with Article 43 of Regulation (EC) No 396/2005, EFSA received a mandate from the European Commission to provide an update of the reasoned opinion on the review of existing maximum residue levels (MRLs) for imazalil published on 5 September 2017, taking into account the additional information provided on the toxicity of the metabolites R014821, FK‐772 and FK‐284. EFSA did not derive MRL proposals from the post‐harvest uses reported on citrus fru...

Europe - EFSA - European Food Safety Authority Publications

23-10-2018

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

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

Published on: Mon, 22 Oct 2018 00:00:00 +0200 The applicant BASF Agro BV submitted a request to the competent national authority in the Netherlands to evaluate the confirmatory data that were identified in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, residue trials on strawberries, onions, garlic, tomatoes, peppers, cucumbers, artichokes, leeks and rape seeds were submitted. The data gaps are considere...

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

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

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

Published on: Fri, 19 Oct 2018 00:00:00 +0200 The applicant, Nichino Europe Co. Ltd., submitted application request to the competent national authority in the Netherlands to evaluate confirmatory data that were identified for pyraflufen‐ethyl in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. The submitted data were sufficient to confirm the MRLs for citrus fruits, tree nuts, pome fruits, stone fruits, table and wine grapes, curra...

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

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