Fluvastatin Accord

Glavne informacije

  • Zaščiteno ime:
  • Fluvastatin Accord 80 mg tablete s podaljšanim sproščanjem
  • Farmacevtska oblika:
  • tableta s podaljšanim sproščanjem
  • Sestava:
  • fluvastatin 80 mg / 1 tableta
  • Pot uporabe:
  • Peroralna uporaba
  • Enote v paketu:
  • škatla z 28 tabletami (2 x 14 tablet v pretisnem omotu)
  • Tip zastaranja:
  • Rp - Predpisovanje in izdaja zdravila je le na recept
  • Uporabi za:
  • ljudje
  • Vrsta medicine:
  • Alopatska drog

Dokumentov

Lokalizacija

  • Na voljo v:
  • Fluvastatin Accord 80 mg tablete s podaljšanim sproščanjem
    Slovenija
  • Jezik:
  • slovenščina

Terapevtski podatki

  • Terapevtska skupina:
  • fluvastatin

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-2030/12
  • Datum dovoljenje:
  • 01-10-2012
  • EAN koda:
  • 3837000137552
  • Zadnja posodobitev:
  • 19-01-2018

Podatki za bolnike

Navodilo za uporabo

Fluvastatin Accord 80 mg

tablete s podaljšanim sproščanjem

fluvastatin

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 s svojim 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 opazite kateri koli neželeni učinek, se posvetujte s svojim zdravnikom ali farmacevtom.

Posvetujte se tudi, če opazite katere koli neželene učinke, ki niso navedeni v tem navodilu.

Kaj vsebuje navodilo

Kaj je zdravilo Fluvastatin Accord in za kaj ga uporabljamo

Kaj morate vedeti, preden boste vzeli zdravilo Fluvastatin Accord

Kako jemati zdravilo Fluvastatin Accord

Možni neželeni učinki

Shranjevanje zdravila Fluvastatin Accord

Vsebina pakiranja in dodatne informacije

1.

Kaj je zdravilo Fluvastatin Accord in za kaj ga uporabljamo

Zdravilo Fluvastatin Accord vsebuje zdravilno učinkovino natrijev fluvastatinat, ki sodi v skupino

zdravil z imenom statini in so zdravila za zniževanje maščob: znižujejo raven maščob (lipidov) v

krvi. Uporabljajo jih bolniki, pri katerih dieta in telesna vadba ne zadoščata za uravnavanje ravni

maščob v krvi.

Fluvastatin Accord je zdravilo, ki ga

pri odraslih uporabljamo za uravnavanje zvišane ravni

maščob v krvi, zlasti ravni skupnega holesterola in tako imenovanega "slabega" oziroma LDL

holesterola, ki je povezan s povečanim tveganjem za bolezni srca in možgansko kap.

pri odraslih bolnikih, ki imajo zvišano raven holesterola,

pri odraslih bolnikih, ki imajo zvišano raven tako holesterola kot trigliceridov (ki so še ena

vrsta lipidov v krvi).

Zdravnik lahko predpiše zdravilo Fluvastatin Accord tudi za preprečevanje nadaljnjih resnih

dogodkov povezanih s srcem (na primer srčnega infarkta) pri bolnikih po srčni kateterizaciji s

posegom na kateri od srčnih žil.

Pogovorite s svojim zdravnikom, če se ne počutite bolje ali se počutite slabše.

2.

Kaj morate vedeti, preden boste vzeli zdravilo Fluvastatin Accord

Natančno upoštevajte zdravnikova navodila, tudi če se razlikujejo od podatkov v tem navodilu.

Preden vzamete zdravilo Fluvastatin Accord, preberite spodnja pojasnila.

Ne jemljite zdravila Fluvastatin Accord:

če ste alergični na fluvastatin ali katero koli sestavino tega zdravila (navedeno v poglavju 6),

če imate trenutno težave z jetri ali nepojasnjeno trajno zvišane ravni določenih jetrnih encimov

(aminotransferaz),

če ste noseči ali če dojite (glejte “Nosečnost in dojenje”).

Če karkoli od navedenega velja za vas, ne jemljite zdravila Fluvastatin Accord, ampak obvestite

zdravnika.

Opozorila in previdnostni ukrepi

Pred začetkom jemanja zdravila Fluvastatin Accord se posvetujte s svojim zdravnikom ali

farmacevtom.

če ste že imeli bolezen jeter. Za odkrivanje morebitnih neželenih učinkov vam bodo opravljali

teste jetrne funkcije najprej preden začnete zdravljenje z zdravilom Fluvastatin Accord tablete s

podaljšanim sproščanjem, ko vam bodo zviševali odmerke in nato v različnih intervalih med

zdravljenjem;

če imate bolezen ledvic;

če imate bolezen ščitnice (hipotiroidizem);

če ste kdaj imeli bolezen mišic oziroma imate to v družini;

če ste imeli težave z mišicami ob jemanju kakega drugega zdravila, ki znižuje raven lipidov;

če redno pijete velike količine alkohola.

Med zdravljenjem s tem zdravnikom vas bo vaš zdravnik skrbno nadziral, če imate sladkorno bolezen

ali pri vas obstaja tveganje, da se razvije. Obstaja verjetnost, da zbolite za sladkorno boleznijo, če imate

visoke ravni sladkorja in maščob v krvi, preveliko telesno maso ali visok krvni tlak.

Posvetujte se z zdravnikom ali s farmacevtom, preden začnete jemati zdravilo

Fluvastatin

Accord:

če imate hude motnje dihanja.

Če kaj od zgoraj navedenega velja za vas,

to povejte svojemu zdravniku, preden vzamete

zdravilo

Fluvastatin Accord tablete s podaljšanim sproščanjem. Zdravnik vas bo napotil na krvno preiskavo,

preden vam bo predpisal zdravilo Fluvastatin Accord.

Zdravilo Fluvastatin Accord in ljudje, starejši od 70 let

Če ste starejši od 70 let, bo zdravnik morda želel preveriti, ali imate dejavnike tveganja za bolezni

mišic, zato boste morali morda opraviti posebne krvne preiskave.

Zdravilo Fluvastatin Accord in otroci/mladostniki

Zdravila Fluvastatin Accord niso proučevali pri otrocih, mlajših od 9 let, in ni namenjeno takim

otrokom. Za podatke o odmerjanju pri otrocih in mladostnikih, ki so starejši od 9 let, glejte poglavje 3.

O uporabi zdravila Fluvastatin Accord v kombinaciji z nikotinsko kislino, s holestiraminom ali s fibrati

pri otrocih in mladostnikih ni nobenih izkušenj.

Druga zdravila in zdravilo Fluvastatin Accord

Obvestite svojegazdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda

začeli jemati katero koli drugo zdravilo.

Zdravilo Fluvastatin Accord lahko jemljete samostojno ali skupaj z drugimi zdravili za zniževanje ravni

holesterola, ki vam jih predpiše vaš zdravnik.

Po zaužitju smole, na primer holestiramina (ki jo uporabljamo predvsem za zniževanje previsoke ravni

holesterola), počakajte vsaj 4 ure, preden vzamete zdravilo Fluvastatin Accord.

Povejte svojemu zdravniku in farmacevtu, če jemljete katero od naslednjih zdravil:

ciklosporin (zdravilo za zaviranje imunskega sistema),

fibrate (na primer gemfibrozil), nikotinsko kislino ali izmenjevalne smole, ki vežejo žolčne

kisline (zdravila, ki se uporabljajo za zniževanje ravni slabega holesterola),

flukonazol (zdravilo za zdravljenje glivičnih okužb),

rifampicin (antibiotik),

fenitoin (zdravilo za zdravljenje epilepsije),

peroralne antikoagulante, na primer varfarin (zdravila proti strjevanju krvi),

glibenklamid (zdravilo za zdravljenje sladkorne bolezni),

kolhicine (za zdravljenje protina).

Zdravilo Fluvastatin Accord

skupaj s z hrano in pijačo

Zdravilo Fluvastatin Accord lahko jemljete skupaj s hrano ali brez nje.

Nosečnost,

dojenje in plodnost

Če ste noseči ali če dojite, ne jemljite zdravila Fluvastatin Accord, saj zdravilna učinkovina lahko

škoduje nerojenemu otroku in ni znano, ali se zdravilna učinkovina pri ljudeh izloča v materino mleko.

Ves čas zdravljenja z zdravilom Fluvastatin Accord uporabljajte zanesljivo kontracepcijsko metodo.

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

zdravnikom ali s farmacevtom, preden vzamete to zdravilo.

Vpliv na sposobnost upravljanja vozil in strojev

O vplivu zdravila Fluvastatin Accord na sposobnost za upravljanje vozil in uporabo strojev ni podatkov.

3.

Kako jemati zdravilo Fluvastatin Accord

Pri jemanju tega zdravila natančno upoštevajte navodila svojega zdravnika ali farmacevta. Če ste

negotovi, se posvetujte s svojim zdravnikom ali s farmacevtom.

Skrbno upoštevajte navodila svojega zdravnika. Ne prekoračite priporočenega odmerka.

Zdravnik vam bo priporočil dieto z malo holesterola. Te diete se držite tudi v času jemanja tega

zdravila.

Koliko zdravila je treba jemati

Priporočeni odmerek je za odrasle je od 20 do 80 mg na dan, pri čemer je višina odmerka odvisna od

tega, koliko je treba znižati raven holesterola. Zdravnik vam lahko odmerek prilagodi vsake

4 tedne ali v daljših intervalih.

Običajni začetni odmerek za otroke (stare 9 let ali starejše) je 20 mg na dan. Najvišji dnevni

odmerek je 80 mg. Zdravnik vam lahko odmerek prilagodi vsakih 6 tednov.

Vaš zdravnik vam bo natančno povedal, koliko tablet zdravila morate jemati. Odvisno od tega, kako se

odzivate na zdravljenje, vam bo zdravnik morda predlagal višji ali nižji odmerek.

Kdaj je treba vzeti zdravilo Fluvastatin Accord

Če jemljete zdravilo Fluvastatin Accord, lahko svoj odmerek vzamete kadar koli v dnevu.

Zdravilo Fluvastatin Accord lahko jemljete skupaj z obrokom hrane ali brez njega. Zdravilo

pogoltnite celo, zaužijte ga s kozarcem vode.

Če ste vzeli večji odmerek zdravila

Fluvastatin Accord, kot bi smeli

Če ste pomotoma vzeli prevelik odmerek zdravila Fluvastatin Accord, to takoj sporočite svojemu

zdravniku. Morda boste potrebovali zdravniško pomoč.

Če ste poz

abili vzeti zdravilo Fluvastatin Accord

Vzemite en odmerek takoj, ko se spomnite, razen če morate naslednji odmerek vzeti čez manj kot 4 ure.

V tem primeru vzemite naslednji odmerek ob običajnem času.

Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.

Če ste prenehali jemati zdravilo

Fluvastatin Accord

Če hočete ohraniti koristen vpliv zdravljenja, ne smete prenehati z jemanjem zdravila Fluvastatin

Accord, razen če vam to svetuje zdravnik. Zdravilo Fluvastatin Accord morate jemati še naprej tako,

kot vam naroči zdravnik, da bo raven vašega‘slabega’ holesterola ostala nizka. Zdravilo Fluvastatin

Accord ne bo ozdravilo vaše bolezni, pomaga pa jo nadzorovati. Zdravnik bo moral redno določati

raven vašega holesterola, da bo lahko spremljal potek vaše bolezni.

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

4.

Možni neželeni učinki

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

Zelo pogosti: pojavijo se lahko pri več kot 1 od 10 bolnikov.

Pogosti: pojavijo se lahko pri največ 1 od 10 bolnikov.

Občasni: pojavijo se lahko pri največ 1 od 100 bolnikov.

Redki: pojavijo se lahko pri največ 1 od 1.000 bolnikov.

Zelo redki: pojavijo se lahko pri največ 1 od 10.000 bolnikov.

Neznana: pogostnosti ni mogoče oceniti iz razpoložljivih podatkov.

Nekateri redki ali zelo redki neželeni učinki so lahko resni - takoj poiščite zdravniško pomoč:

če imate nepojasnjene bolečine v mišicah, če so mišice občutljive ali oslabele. To bi lahko bili

zgodnji znaki razgradnje mišic, ki je lahko huda in se ji lahko izognete, če zdravnik čim prej

prekine vaše zdravljenje s fluvastatinom. Ti neželeni učinki se pojavljajo tudi pri podobnih

zdravilih iz te skupine (statinih),

če ste nenavadno utrujeni ali imate zvišano telesno temperaturo, porumenelo kožo in oči, temno

obarvan urin (znaki hepatitisa),

če imate znake kožnih reakcij, na primer kožni izpuščaj, koprivnico, rdečino, srbenje, otekanje

obraza, vek in ustnic,

če imate otekline na koži, če težko dihate, ste omotični (znaki hude alergične reakcije)

če pride hitreje do krvavitev ali do podplutbe kot normalno (znaki zmanjšanega števila krvnih

ploščic),

če imate rdeče ali škrlatne spremembe na koži (znaki vnetja krvnih žil),

če imate rdeč izpuščaj v obliki madežev, predvsem po obrazu, ki ga lahko spremljajo utrujenost,

zvišana telesna temperatura, slabost s siljenjem na bruhanje, izguba apetita (znaki reakcije,

podobne eritematoznemu lupusu),

če imate hude bolečine v zgornjem delu trebuha (znak vnetja trebušne slinavke).

Če se pri vas pojavi kateri od zgoraj navedenih učinkov, takoj sporočite zdravniku.

Drugi neželeni učinki: zdravniku povejte, če ste zaskrbljeni.

Pogosti:

nespečnost, glavobol, želodčne težave, bolečine v trebuhu, slabost s siljenjem na bruhanje.

Zelo redki:

mravljinčenje ali odrevenelost dlani ali stopal, moteno ali zmanjšano občutljivost za dotik.

Drugi možni neželeni učinki:

motnje spanja, med drugim nespečnost in nočne more

izguba spomina

težave v spolnosti

depresija

težave pri dihanju, med drugim trdovraten kašelj in/ali zadihanost ali zvišana telesna temperatura

sladkorna bolezen. Bolj verjetno je, da jo boste dobili, če imate visoke ravni sladkorja ali maščob

v krvi, preveliko telesno maso ali visok krvni tlak. Vaš zdravnik vas bo med uporabo tega zdravila

nadziral.

Če opazite kateri koli neželeni učinek, se posvetujte s svojim zdravnikom ali s farmacevtom. Posvetujte

se tudi, če opazite neželene učinke, ki niso navedeni v tem navodilu.

5.

Shranjevanje zdravila Fluvastatin Accord

Zdravilo shranjujte nedosegljivo otrokom!

Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki

in škatli poleg oznake ‘EXP’. Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega

meseca.

Shranjujte pri temperaturi do 30

C v originalni ovojnini za zagotovitev zaščite pred svetlobo in

vlago.

Zdravila

smete

odvreči

odpadne

vode

gospodinjske

odpadke.

načinu

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

pomagajo varovati okolje.

6.

Vsebina pakiranja in dodatne informacije

Kaj vsebuje zdravilo Fluvastatin Accord

Zdravilna učinkovina je natrijev fluvastatin.

Ena tableta s podaljšanim sproščanjem zdravila Fluvastatin vsebuje 84.280 mg natrijevega

fluvastatinata, kar ustreza 80 mg fluvastatina.

Druge sestavine zdravila so:

Jedro tablete:

mikrokristalna celuloza, kalijev hidrogenkarbonat, povidon K-30, hidroksipropilceluloza, hipromeloza

K 100, hipromeloza K 4M, magnezijev stearat.

Filmska obloga:

polivinilalkohol, titanov dioksid (E171), makrogol 3350, smukec, rumeni železov oksid (E172).

Izgled zdravila Fluvastatin Accord in vsebina pakiranja

Rumeno obarvana, okrogla, bikonveksna, filmsko obložena tableta s poševnim robom, z oznako "F80"

na eni strani in gladka na drugi strani.

Fluvastatin Accord tablete s podaljšanim so na voljo v pretisnih omotih OPA-Al-PVC/Al, s pakiranji po

7, 14, 28, 30, 56, 70, 84, 90 in 98 tablet.

Na trgu morda ni vseh navedenih pakiranj.

Imetnik dovoljenja za promet z zdravilom in izdelovalec

Accord Healthcare Limited,

Sage house, 319 Pinner road,

Harrow, HA1 4HF

Velika Britanija

Način in režim izdaje zdravila

Predpisovanje in izdaja zdravila je le na recept.

Zdravilo je v

državah članicah EGP pridobilo dovoljenje za promet z naslednjimi imeni

:

Ime države članice

Ime zdravila

Avstrija

Fluvastatin Accord 80mg Retardtabletten

Belgija

Fluvastatin Accord 80mg prolonger comprimé à

liberation/ tabletten met verlengde afgifte/

Retardtabletten

Bolgarija

Fluvastatin Accord 80mg таблетки с удължено

освобождаване

Ciper

Fluvastatin Accord 80 mg δισκία παρατεταμένης

αποδέσμευσης

Češka republika

Fluvastatin Accord 80mg tablety s prodlouženým

uvolňováním

Nemčija

Fluvastatin Accord 80mg Retardtabletten

Danska

Fluvastatin Accord

Estonija

Fluvastatin Accord

Grčija

Fluvastatin Accord 80mg παρατείνει δισκίο

ελεγχόμενης αποδέσμευσης

Španija

Fluvastatin Accord 80mg comprimidos de liberación

prolongada

Finska

Fluvastatin Accord 80mg depottabletit

Francija

Fluvastatin Accord 80 mg, comprimé pelliculé à

libération prolongée

Madžarska

Fluvastatin Accord 80mg retard tabletta

Irska

Flavustenol 80mg XL Prolonged release Tablets

Italija

Fluvastatina Accord

Latvija

Fluvastatin Accord 80mg ilgstošās darbības

apvalkotās tabletes

Litva

Fluvastatin Accord 80mg pailginto atpalaidavimo

tabletės

Malta

Flavustenol 80mg XL Prolonged-release tablets

Nizozemska

Fluvastatine Accord 80 mg tabletten met verlengde

afgifte

Norveška

Fluvastatin Accord

Poljska

Fluvastatinum Accord

Portugalska

Fluvastatin Accord

Romunija

Fluvastatina Accord 80mg comprimate cu eliberare

prelungită

Švedska

Fluvastatin Accord 80mg depottabletter

Slovenija

Fluvastatin Accord 80mg tablete s podaljšanim

sproščanjem

Slovaška

Fluvastatin Accord 80 mg tablety s predĺženým

uvoľňovaním

Velika Britanija

Sinfatix 80mg XL Prolonged-release Tablets

Navodilo je bilo nazadnje revidirano dne 06/2012

15-11-2018

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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