Irbesartan Accord

Glavne informacije

  • Zaščiteno ime:
  • Irbesartan Accord 300 mg filmsko obložene tablete
  • Farmacevtska oblika:
  • filmsko obložena tableta
  • Sestava:
  • irbesartan 300 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:
  • Irbesartan Accord 300 mg filmsko obložene tablete
    Slovenija
  • Jezik:
  • slovenščina

Terapevtski podatki

  • Terapevtska skupina:
  • irbesartan

Drugi podatki

Stanje

  • Source:
  • JAZMP - Javna agencija RS za zdravila in medicinske pripomočke - Slovenia Medicines Agency
  • Status dovoljenje:
  • Zdravilo z dovoljenjem za promet
  • Številka dovoljenja:
  • 1011-127/2012-4
  • Datum dovoljenje:
  • 30-11-2016
  • EAN koda:
  • 3837000067415
  • Zadnja posodobitev:
  • 19-01-2018

Podatki za bolnike

JAZMP-IB/002,IA/003,IB/004-30.11.2012

Navodilo za uporabo: Informacije za uporabnika

Irbesartan Accord 75 mg filmsko obložene tablete

Irbesartan Accord 150 mg filmsko obložene tablete

Irbesartan Accord 300 mg filmsko obložene tablete

irbesartan

Pred začetkom jemanja zdravila natančno preberete navodilo, ker vsebuje za vas pomembne

podatke.

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 opazite katerikoli neželeni učinek se posvetujte z zdravnikom ali farmacevtom. Posvetujte se

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

Kaj vsebuje navodilo

Kaj je zdravilo Irbesartan Accord in za kaj ga uporabljamo

Kaj morate vedeti, preden boste vzeli zdravilo Irbesartan Accord

Kako jemati zdravilo Irbesartan Accord

Možni neželeni učinki

Shranjevanje zdravila Irbesartan Accord

Vsebina pakiranja in dodatne informacije

1.

KAJ JE ZDRAVILO IRBESARTAN ACCORD IN ZA KAJ GA UPORABLJAMO

Zdravilo Irbesartan Accord spada v skupino zdravil, znanih kot antagonisti angiotenzina II.

Angiotenzin II je snov, ki nastaja v telesu in z vezavo na receptorje v krvnih žilah povzroči oženje žil

ter posledično zvišanje krvnega tlaka. Zdravilo Irbesartan Accord preprečuje vezavo angiotenzina II na

te receptorje in tako sprošča krvne žile ter znižuje krvni tlak. Pri bolnikih z visokim krvnim tlakom in

sladkorno boleznijo tipa 2 zdravilo Irbesartan Accord upočasni pešanje delovanja ledvic.

Zdravilo Irbesartan Accord uporabljajo odrasle osebe:

za zdravljenje povišanega krvnega tlaka (esencialne hipertenzije).

za zaščito ledvic pri bolnikih z visokim krvnim tlakom, ki imajo sladkorno bolezen tipa 2 in

laboratorijsko potrjeno okvaro delovanja ledvic.

2.

KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO IRBESARTAN

ACCORD

Ne jemljite zdravila Irbesartan Accord:

če ste alergični na irbesartan ali katerokoli sestavino tega zdravila (navedeno v poglavju 6)

če ste noseči več kot tri mesece (prav tako se je jemanju Irbesartan Accord bolje izogniti v

zgodnjem obdobju nosečnosti)

če dojite

Zdravila Irbesartan Accord ne smejo jemati otroci in mladostniki mlajši od 18 let.

Opozorila in previdnostni ukrepi:

Pred jemanjem zdravila Irbesartan Accord se pogovorite s svojim zdravnikom ali farmacevtom:

če začnete prekomerno bruhati ali dobite hudo drisko

če imate težave z ledvicami

če imate težave s srcem

JAZMP-IB/002,IA/003,IB/004-30.11.2012

če zdravilo Irbesartan Accord jemljete zaradi diabetične bolezni ledvic. V tem primeru bo

zdravnik morda moral redno opravljati krvne preiskave, še posebej tiste, s katerimi bo v primeru

slabega delovanja ledvic spremljal vrednosti kalija v krvi.

če boste imeli v bližnji prihodnosti operacijo ali boste prejeli anestetik

povejte zdravniku, če mislite, da ste noseči, ali če načrtujete nosečnost. Jemanje zdravila

Irbesartan Accord v zgodnjem obdobju nosečnosti ni priporočljivo in lahko po tretjem mesecu

nosečnosti povzroči resno škodo vašemu otroku (glejte poglavje o nosečnosti).

Otroci

Otrokom in mladostnikom uporaba zdravila ni dovoljena, ker njegova varnost in učinkovitost nista

dokončno ugotovljeni.

Druga zdravila in zdravilo Irbesartan Accord:

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

tudi če ste ga dobili brez recepta.

Zdravilo Irbesartan Accord običajno ne vpliva na delovanje drugih zdravil in obratno.

Morda bodo potrebne krvne preiskave, če jemljete:

dodatke kalija

nadomestke soli, ki vsebujejo kalij

zdravila, ki zadržujejo kalij (kot so nekateri diuretiki)

zdravila, ki vsebujejo litij

Če jemljete zdravila proti bolečinam iz skupine nesteroidnih protivnetnih zdravil, se učinek irbesartana

lahko zmanjša.

Jemanje zdravila Irbesartan Accord skupaj s hrano in pijačo

Zdravilo Irbesartan Accord lahko jemljete s hrano ali brez nje. Tableto pogoltnite celo s požirkom

vode.

Nosečnost in dojenje:

Nosečnost:

Svojemu zdravniku morate povedati, če mislite, da ste noseči, ali če načrtujete nosečnost. Vaš

zdravnik vam bo praviloma svetoval, da prenehate z jemanjem zdravila Irbesartan Accord preden

zanosite ali takoj, ko izveste, da ste noseči in vam bo namesto zdravila Irbesartan Accord svetoval

jemanje kakšnega drugega zdravila. Jemanje zdravila Irbesartan Accord v zgodnjem obdobju

nosečnosti ni priporočljivo, če pa ste noseči več kot tri mesece, tega zdravila ne smete jemati, saj lahko

po tretjem mesecu nosečnosti povzroči resno škodo vašemu otroku.

Dojenje

Povejte svojemu zdravniku če dojite, ali če nameravate z dojenjem začeti. Irbesartan Accord ni

priporočljiv za matere, ki dojijo. Zdravnik vam lahko v primeru, da želite dojiti, predpiše drugo

zdravljenje še zlasti, če je vaš otrok novorojenček ali nedonošenček.

Vpliv na sposobnost upravljanja vozil in strojev:

Študij o vplivu na sposobnost vožnje in upravljanja s stroji niso izvedli.

Verjetnost, da bi zdravilo Irbesartan Accord vplivalo na sposobnost upravljanja vozil ali strojev, je

majhna. Vendar pa se med zdravljenjem visokega krvnega tlaka občasno lahko pojavi omotica ali

utrujenost. V tem primeru se morate pred upravljanjem vozil ali strojev posvetovati s svojim

zdravnikom.

Zdravilo Irbesartan Accord vsebuje laktozo (v obliki laktoze monohidrata)

Zdravilo Irbesartan Accord vsebuje laktozo (v obliki laktoze monohidrata). Če vam je zdravnik

povedal, da ne prenašate nekaterih sladkorjev, se pred uporabo tega zdravila posvetujte s svojim

JAZMP-IB/002,IA/003,IB/004-30.11.2012

zdravnikom. Bolniki z redko dedno intoleranco za galaktozo, laponsko obliko zmanjšane aktivnosti

laktaze ali malabsorpcijo glukoze/galaktoze, ne smejo jemati tega zdravila.

3.

KAKO JEMATI ZDRAVILO IRBESARTAN ACCORD

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

posvetujte z zdravnikom ali s farmacevtom.

Priporočen odmerek je 150 mg enkrat na dan. Odmerek se lahko kasneje poveča na 300 mg enkrat na

dan, odvisno od odziva krvnega tlaka. Največji učinek na znižanje krvnega tlaka se običajno pojavi v

4-6 tednih po začetku zdravljenja.

Priporočeni vzdrževalni odmerek za zdravljenje bolezni ledvic, povezane z visokim krvnim tlakom in

sladkorno boleznijo tipa 2, je 300 mg enkrat na dan.

Nekaterim bolnikom, kot so bolniki, ki se zdravijo s hemodializo, in bolniki, starejši od 75 let, lahko

zdravnik predpiše manjši odmerek, še posebej na začetku zdravljenja.

Zdravilo Irbesartan Accord je treba zaužiti. Tablete morate pogoltniti z zadostno količino tekočine

(npr. z enim kozarcem vode). Zdravilo Irbesartan Accord lahko jemljete s hrano ali brez nje. Dnevni

odmerek poskušajte vzeti vsak dan ob približno istem času. Pomembno je, da zdravilo Irbesartan

Accord jemljete redno, vse dokler vam zdravnik ne predpiše drugače.

Uporaba pri otrocih

Otrokom, mlajšim od 18 let, uporaba zdravila Irbesartan Accord ni dovoljena. Če otrok zaužije nekaj

tablet, se nemudoma posvetujte s svojim zdravnikom.

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

Če ste pomotoma vzeli preveč tablet se nemudoma posvetujte s svojim zdravnikom.

Simptoma prevelikega odmerjanja sta hipotenzija (nizek krvni tlak) in tahikardija (hitro utripanje

srca).

Če ste pozabili vzeti zdravilo Irbesartan Accord

Če ste pozabili vzeti dnevni odmerek, vzemite naslednji predvideni odmerek ob običajnem času. Ne

vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.

Če ste prenehali jemati zdravilo Irbesartan Accord

Ne prekinite zdravljenja, ne da bi se posvetovali z zdravnikom. Pomembno je, da zdravilo Irbesartan

Accord tablete jemljete tako dolgo, kot je predpisal zdravnik. Tako bo vaš krvni tlak pod nadzorom

in/ali vaše ledvice zaščitene pred večjo škodo.

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

Nekateri od njih so lahko resni in lahko zahtevajo zdravniško pomoč.

Kot pri podobnih zdravilih so pri bolnikih, ki jemljejo irbesartan, v redkih primerih poročali o

alergijskih kožnih reakcijah (izpuščaj, koprivnica), kakor tudi o lokalizirani oteklini obraza, ustnic

in/ali jezika. Če ste opazili take simptome ali zasoplost, prenehajte uporabljati zdravilo in takoj

poiščite zdravniško pomoč.

JAZMP-IB/002,IA/003,IB/004-30.11.2012

Pogostnost spodaj navedenih neželenih učinkov je opisana po naslednjem dogovoru:

Zelo pogosti: vsaj 1 od 10 bolnikov ali več

Pogosti: vsaj 1 od 100 bolnikov in manj kot 1 od 10 bolnikov

Občasni: vsaj 1 od 1000 in manj kot 1 od 100 bolnikov

Redki: vsaj 1 od 10.000 in manj kot 1 od 1000 bolnikov

Zelo redki (manj kot 1 od 10.000 bolnikov)

Neznani (ni mogoče oceniti iz razpoložljivih podatkov)

Neželeni učinki, o katerih so poročali v kliničnih študijah za bolnike, ki so jemali zdravilo Irbesartan

Accord, so bili naslednji:

Zelo pogosti

če imate visok krvni tlak in sladkorno bolezen tipa 2 z boleznijo ledvic, lahko krvna preiskava

pokaže zvišanje vrednosti kalija v krvi.

Pogosti

omotica

siljenje na bruhanje/bruhanje in utrujenost

krvne preiskave lahko pokažejo zvišanje vrednosti encima, ki meri delovanje mišic in srca

(encim kreatin kinaze).

Pri bolnikih z visokim krvnim tlakom in sladkorno boleznijo tipa 2 z boleznijo ledvic so

poročali tudi o omotici pri vstajanju iz ležečega ali sedečega položaja, nizkem krvnem tlaku pri

vstajanju iz ležečega ali sedečega položaja, bolečinah v sklepih ali mišicah in znižanju vrednosti

beljakovine v rdečih krvnih celicah (hemoglobinu).

Občasni

hitro utripanje srca

zardevanje

kašelj

driska

motnje prebave/zgaga

motnje pri spolnih aktivnostih (težave s spolnostjo)

bolečina v prsih

Po prihodu zdravila Irbesartan Accord na tržišče so poročali še o nekaterih drugih neželenih učinkih.

Neželeni učinki, katerih pogostnost ni znana, so:

občutek vrtenja

glavobol

motnje okušanja

zvonjenje v ušesih

mišični krči

bolečine v sklepih in mišicah

nenormalno delovanje jeter

zvišane vrednosti kalija v krvi

okvara delovanja ledvic

vnetje malih krvnih žil, ki prizadenejo predvsem kožo (bolezen, znana kot levkocitoklastični

vaskulitis)

Poročali so tudi o občasnih primerih zlatenice (porumenelost kože ali beločnice).

Če opazite katerikoli neželeni učinek se posvetujte s svojim zdravnikom ali farmacevtom. Posvetujte

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

5.

SHRANJEVANJE ZDRAVILA IRBESARTAN ACCORD

JAZMP-IB/002,IA/003,IB/004-30.11.2012

Zdravilo shranjujte nedosegljivo otrokom!

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

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

meseca.

Za shranjevanje zdravila niso potrebna posebna navodila.

Tablet ne jemljite iz pretisnega omota, dokler niste pripravljeni, da jih vzamete.

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

zdravila, ki ga ne potrebujete več, se posvetujte s farmacevtom. Takšni ukrepi pomagajo varovati

okolje.

6.

VSEBINA PAKIRANJA IN DODATNE INFORMACIJE

Kaj vsebuje zdravilo Irbesartan Accord:

Zdravilna učinkovina je irbesartan. Ena filmsko obložena tableta zdravila Irbesartan Accord

75 mg, 150 mg, 300 mg vsebuje 75 mg, 150 mg, 300 mg irbesartana.

Pomožne snovi v jedru tablete so laktoza monohidrat, premreženi natrijev karmelozat (E468),

mikrokristalna celuloza (E460), hipromeloza E5 (E464), koloidni brezvodni silicijev dioksid

(E551), magnezijev stearat (E572).

Pomožne snovi v filmski oblogi tablete so hipromeloza E5 (E464), makrogol 400, laktoza

monohidrat in titanov dioksid (E171).

Izgled zdravila Irbesartan Accord in vsebina pakiranja:

Irbesartan Accord 75 mg filmsko obložene tablete so bele do belkaste barve, ovalne, bikonveksne

oblike z vtisnjeno številko "I 75" na eni strani in gladke na drugi strani.

Irbesartan Accord 150 mg filmsko obložene tablete so bele do belkaste barve, ovalne, bikonveksne

oblike z vtisnjeno številko "I 150" na eni strani in gladke na drugi strani.

Irbesartan Accord 300 mg filmsko obložene tablete so bele do belkaste barve, ovalne, bikonveksne

oblike z vtisnjeno številko "I 300" na eni strani in gladke na drugi strani.

Irbesartan Accord, 75 mg, 150 mg in 300 mg filmsko obložene tablete so na voljo v pretisnih omoti po

8, 14, 28, 30,56, 64, 90 in 98 tablet.

Na trgu ni vseh navedenih pakiranj.

Način in režim izdaje zdravila

Predpisovanje in izdaja zdravila je le na recept.

Imetnik dovoljenja za promet:

Accord Healthcare Limited

Sage House, 319, Pinner Road,

North Harrow, Middlesex, HA1 4HF,

Velika Britanija

Izdelovalec:

Accord Healthcare Limited,

Sage House, 319, Pinner Road,

North Harrow, Middlesex, HA1 4HF,

Velika Britanija

CEMELOG- BRS KFT

2040 Budaörs, Vasút u.13.

JAZMP-IB/002,IA/003,IB/004-30.11.2012

Madžarska

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

Ime države

Predlagano ime

Nizozemska

Irbesartan Accord 75/150/ 300 mg, filmomhulde tabletten

Češka

Irbesartan Accord 75/150/ 300 mg potahované tablety

Slovenija

Irbesartan Accord 75/ 150/ 300 mg filmsko obložene tablete

Slovaška

Irbesartan Accord 75/ 150/ 300 mg filmom obalene tablety

Romunija

Irbesartan Accord 75/ 150/ 300 mg comprimate filmate

Bolgarija

Irbesartan Акорд 75/150/300 mg филмирани таблетки

Poljska

Irbesartan Accord

Madžarska

Irbesartan Accord 75/150/300 mg filmtabletta

Grčija

Irbesartan Accord 75/150/300 mg επικαλυμμένα με λεπτό

υμένιο δισκία

Malta

Irbesartan 75/150/300 mg Film-coated Tablets

Estonija

Irbesartan Accord 75/150/300 mg õhukese polümeerikattega

tabletid

Latvija

Irbesartan Accord 75/150/300 mg apvalkotās tabletes

Litva

Irbesartan Accord 75/ 150/ 300 mg plėvele dengtos tabletės

Avstrija

Irbesartan Accord 75, 150, 300 mg Filmtabletten

Belgija

Irbesartan Accord 75, 150, 300 mg filmomhulde tabletten/

filmtabletten/ comprimés pelliculés

Ciper

Irbesartan Accord 75, 150, 300 mg επικαλυμμένα με λεπτό

υμένιοx δισκία

Nemčija

Irbesartan Accord 75 150, 300 mg Filmtabletten

Danska

Irbesartan Accord 75, 150, 300 mg filmovertrukne tabletter

Španija

Irbesartan Accord 75, 150, 300 mg comprimidos recubiertos

con pelicula

Finska

Irbesartan

Accord

150,

tabletti,

kalvopäällysteinen/ filmdragerade tabletter

Francija

Irbesartan Accord 75, 150, 300 mg comprimé pelliculé

Irska

Irbesartan Accord 75, 150, 300 mg Film-coated Tablets

Italija

Irbesartan Accord

Norveška

Irbesartan Accord

Portugalska

Irbesartan Accord

Švedska

Irbesartan Accord 75, 150, 300 mg filmdragerade tabletter

Velika Britanija

Irbesartan Accord 75, 150, 300 mg Film-coated Tablets

Navodilo je bilo pregledano 30.11.2012.

16-11-2018

Setting of an import tolerance for pyraclostrobin in rice

Setting of an import tolerance for pyraclostrobin in rice

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

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Assessment of genetically modified LLCotton25 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐010)

Assessment of genetically modified LLCotton25 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐010)

Published on: Wed, 14 Nov 2018 Following the submission of application EFSA‐GMO‐RX‐010 under Regulation (EC) No 1829/2003 from Bayer, the Panel on Genetically Modified Organisms of the European Food Safety Authority (GMO Panel) was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the herbicide‐tolerant genetically modified LLCotton25, for food and feed uses, import and processing, excluding cultivation within the EU. The d...

Europe - EFSA - European Food Safety Authority Publications

13-11-2018

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

30-10-2018

Sciegen Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Irbesartan Tablets, USP  75 Mg, 150 Mg, and 300 Mg Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in The Active Pharmaceutical Ingredient (API)

Sciegen Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Irbesartan Tablets, USP 75 Mg, 150 Mg, and 300 Mg Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in The Active Pharmaceutical Ingredient (API)

ScieGen Pharmaceuticals, Inc. is voluntarily recalling listed lots, within expiry, of Irbesartan Tablets, USP 75 mg, 150 mg, and 300 mg dosage forms to the consumer level. These products are being recalled due to the presence of an impurity, N-nitrosodiethylamine (NDEA) contained in the API Irbesartan, USP manufactured by Aurobindo Pharma Limited. This impurity, which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, has been classified as a...

FDA - U.S. Food and Drug Administration

29-10-2018

Aurobindo Pharma Limited Issues Voluntary Recall of Irbesartan Drug Substance due to the Detection of Trace Amounts of NDEA (NNitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)

Aurobindo Pharma Limited Issues Voluntary Recall of Irbesartan Drug Substance due to the Detection of Trace Amounts of NDEA (NNitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)

Aurobindo Pharma Limited is voluntarily recalling 22 Batches of the drug substance Irbesartan due to the presence of an impurity, N-nitrosodiethylamine (NDEA). The impurity, which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC).

FDA - U.S. Food and Drug Administration

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

22-10-2018

Irbesartan / Hydrochlorothiazide Teva (Teva B.V.)

Irbesartan / Hydrochlorothiazide Teva (Teva B.V.)

Irbesartan / Hydrochlorothiazide Teva (Active substance: irbesartan / hydrochlorothiazide) - Centralised - Yearly update - Commission Decision (2018) 6974 of Mon, 22 Oct 2018

Europe -DG Health and Food Safety

12-10-2018

Irbesartan Zentiva (Zentiva k.s.)

Irbesartan Zentiva (Zentiva k.s.)

Irbesartan Zentiva (Active substance: Irbesartan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6772 of Fri, 12 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/785T/79

Europe -DG Health and Food Safety

2-10-2018

CoAprovel (Sanofi Clir SNC)

CoAprovel (Sanofi Clir SNC)

CoAprovel (Active substance: Irbesartan / hydrochlorothiazide) - Centralised - Yearly update - Commission Decision (2018)6465 of Tue, 02 Oct 2018

Europe -DG Health and Food Safety

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

Karvezide (Sanofi-Aventis groupe)

Karvezide (Sanofi-Aventis groupe)

Karvezide (Active substance: Irbesartan / hydrochlorothiazide) - Centralised - Yearly update - Commission Decision (2018)6222 of Mon, 24 Sep 2018

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

1-8-2018

Aprovel (Sanofi Clir SNC)

Aprovel (Sanofi Clir SNC)

Aprovel (Active substance: Irbesartan) - Centralised - Yearly update - Commission Decision (2018)5198 of Wed, 01 Aug 2018

Europe -DG Health and Food Safety

23-7-2018

Irbesartan Zentiva (Sanofi-Aventis groupe)

Irbesartan Zentiva (Sanofi-Aventis groupe)

Irbesartan Zentiva (Active substance: Irbesartan) - Centralised - Yearly update - Commission Decision (2018)4892 of Mon, 23 Jul 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

17-7-2018

Karvea (Sanofi-Aventis groupe)

Karvea (Sanofi-Aventis groupe)

Karvea (Active substance: Irbesartan) - Centralised - Yearly update - Commission Decision (2018)4781 of Tue, 17 Jul 2018

Europe -DG Health and Food Safety

4-7-2018

Ifirmacombi (Krka d. d., Novo mesto)

Ifirmacombi (Krka d. d., Novo mesto)

Ifirmacombi (Active substance: Irbesartan / hydrochlorothiazide) - Centralised - Yearly update - Commission Decision (2018)4340 of Wed, 04 Jul 2018

Europe -DG Health and Food Safety

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