Varlon 12 5 mg filmom obložene

Glavna informacija

  • Trgovački naziv:
  • Varlon 12,5 mg filmom obložene tablete
  • Doziranje:
  • 12,5 mg
  • Farmaceutski oblik:
  • filmom obložena tableta
  • Sastav:
  • Urbroj: jedna filmom obložena tableta sadrži 12,5 mg diklofenakkalija
  • Tip recepta:
  • na recept, u ljekarni neponovljivi recept
  • Koristi za:
  • Ljudi
  • Vrsta lijekova:
  • alopatski lijek
  • Proizveden od:
  • Medochemie Ltd., Limassol, Cipar

Dokument

Lokalizacija

  • Na raspolaganju u:
  • Varlon 12,5 mg filmom obložene tablete
    Hrvatska
  • Jezik:
  • hrvatski

Terapeutski informacija

  • Proizvod sažetak:
  • Pakiranje: 10 tableta u blisteru, u kutiji [HR-H-416137588-01]; 20 tableta u blisteru, u kutiji [HR-H-416137588-02]; 30 tableta u blisteru, u kutiji [HR-H-416137588-03]; 40 tableta u blisteru, u kutiji [HR-H-416137588-04] Urbroj: 381-12-01/30-17-08

Druge informacije

Status

  • Izvor:
  • HALMED Agencija za lijekove i medicinske proizvode - Agency for medicinal products and medical devices of Croatia
  • Broj odobrenja:
  • HR-H-416137588
  • Datum autorizacije:
  • 21-07-2017
  • Zadnje ažuriranje:
  • 05-06-2018

Uputu o lijeku

Uputa o lijeku: Informacije za bolesnika

Varlon 12,5 mg filmom obložene tablete

diklofenakkalij

Pažljivo pročitajte cijelu uputu prije nego počnete uzimati ovaj lijek jer sadrži Vama važne

podatke.

Sačuvajte ovu uputu. Možda ćete je trebati ponovno pročitati.

Ako imate dodatnih pitanja, obratite se liječniku ili ljekarniku.

- Ovaj je lijek propisan samo Vama. Nemojte ga davati drugima. Može im naškoditi, čak i ako su

njihovi znakovi bolesti jednaki Vašima.

- Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili ljekarnika. To uključuje i

svaku moguću nuspojavu koja nije navedena u ovoj uputi. Pogledajte dio 4.

Što se nalazi u ovoj uputi:

Što je Varlon i za što se koristi

Što morate znati prije nego počnete uzimati Varlon

Kako uzimati Varlon

Moguće nuspojave

Kako čuvati Varlon

Sadržaj pakiranja i druge informacije

1.

Što je Varlon i za što se koristi

Varlon je lijek protiv bolova, koji takoĎer smanjuje upalu (oticanje) i snižava povišenu tjelesnu

temperaturu.

Varlon se koristi za liječenje reumatske boli, boli u mišićima, glavobolje, zubobolje, menstrualne boli,

akutne boli u donjem dijelu leĎa, boli i vrućice povezane s gripom, grloboljom i prehladom.

2.

Što morate znati prije nego počnete uzimati Varlon

Ako Vam je ovaj lijek propisao liječnik, pažljivo pratite upute liječnika. Upute liječnika se mogu

razlikovati od općenitih informacija u ovoj uputi o lijeku.

Nemojte uzimati Varlon:

ako ste alergični na diklofenak, sojino ulje, ulje kikirikija ili neki drugi sastojak ovog lijeka

(naveden u dijelu 6.).

ako Vam je utvrĎena bolest srca i/ili cerebrovaskularna bolest, npr. ako ste pretrpjeli srčani udar,

moždani udar, mali moždani udar (TIA - tranzitorna ishemijska ataka) ili su Vam začepljene krvne

žile koje vode do srca ili mozga ili ste imali operativni zahvat radi uklanjanja ili premošćivanja

začepljenja; ili Vam je smanjena snaga srca da pumpa krv što uzrokuje umor, osjećaj lupanja srca

i nedostatak zraka (zatajenje srca).

ako imate ili ste ikada imali čir na želucu ili čir u probavnom sustavu.

ako ste ikad primijetili krv u stolici ili crnu stolicu (znakovi krvarenja u probavnom sustavu).

ako bolujete od teškog oboljenja jetre ili bubrega.

ako imate ili ste imali probleme s cirkulacijom krvi (bolest perifernih arterija).

ako ste u zadnjem tromjesečju trudnoće.

ako ste ikada imali astmu ili piskanje (pri disanju), opsežni osip na koži (koprivnjača) ili peludnu

groznicu poput curenja nosa nakon uzimanja acetilsalicilatne kiseline ili drugih lijekova iz skupine

nesteroidnih protuupalnih lijekove (NSAIL) poput ibuprofena.

ako imate moždani udar, krvarenje ili drugi poremećaj krvarenja.

ako imate poremećaj krvi.

ako imate odreĎene abnormalnosti u koštanoj srži.

H A L M E D

21 - 07 - 2017

O D O B R E N O

Ako se bilo što od navedenog odnosi na Vas ili ako niste sigurni obratite se svom liječniku ili

ljekarniku.

Upozorenja i mjere opreza

Obratite se svom liječniku ili ljekarniku prije nego uzmete Varlon:

ako ste ikada imali bilo kakvih problema sa želucem ili žgaravicom nakon uzimanja lijekova

protiv boli ili protuupalnih lijekova.

ako bolujete od teških reakcija na koži.

ako bolujete od astme, peludne groznice ili ste imali dugotrajnih problema s dišnim sustavom,

poput nazalnih polipa ili kronične opstruktivne bolesti dišnih puteva.

ako imate sklonost razvoju alergijskih bolesti na koži, svrbeža na koži ili koprivnjače.

imate

povijesti

bolesti

oboljenja

probavnog

sustava,

primjer

ulcerozni

kolitis

Crohnovu bolest.

ako imate poremećaj krvarenja ili neki drugi poremećaj krvi, uključujući rijetko stanje zvano

porfirija.

ako imate upalnu bolest zvanu sistemski eritemski lupus ili drugu bolest vezivnog tkiva.

ako imate problema s jetrom ili bubrezima.

ako mislite da ste dehidrirani (npr. uslijed bolesti, proljeva, prije ili nakon velikih operacija).

ako imate vodene kozice (varičele).

Lijekovi poput Varlona mogu biti povezani s blago povećanim rizikom od srčanog udara (infarkt

miokarda) ili moždanog udara. Rizik je vjerojatniji uz primjenu visokih doza i produljeno liječenje.

Prije nego primijenite diklofenak, svakako obavijestite svog liječnika ili ljekarnika:

ako pušite.

ako imate šećernu bolest (diabetes mellitus).

ako imate stežući, bolni osjećaj u prsnom košu (angina), krvne ugruške, visoki krvni tlak, povišen

kolesterol ili povišene razine kolesterola ili triglicerida (odreĎene masti) u Vašoj krvi.

Nuspojave se mogu minimizirati primjenom najniže učinkovite doze kroz najkraće moguće razdoblje.

Nemojte prekoračiti preporučene doze i nemojte lijek uzimati dulje od preporučenog trajanja liječenja

(3 dana za sniženje vrućice i 5 dana za ublažavanje boli).

Starije osobe mogu biti osjetljivije na učinak diklofenaka od ostalih odraslih osoba. Ako ste stariji od

65 godina, važno je da pažljivo pratite upute i koristite najmanju moguću dozu koja zadovoljavajuće

olakšava simptome. Posebno je važno za starije osobe da odmah prijave svaku nuspojavu svom

liječniku ili ljekarniku.

Diklofenak može umanjiti simptome infekcije (npr. glavobolju, visoku tjelesnu temperaturu). Stoga

može otežati otkrivanje ili liječenje infekcije. Ako se ne osjećate dobro i trebate posjetiti liječnika, ne

zaboravite ga obavijestiti da uzimate diklofenak.

Produljena primjena bilo koje vrste lijeka protiv bolova za glavobolju može pogoršati glavobolju. Ako

mislite da se ovo odnosi na Vas, obratite se svom liječniku za savjet.

Drugi lijekovi i Varlon

Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje

druge lijekove.

Sljedeći lijekovi mogu, ako se koriste istovremeno s diklofenakom, povećati rizik od krvarenja ili čira.

Morate obavijestiti svog liječnika ako uzimate bilo koji od ovih lijekova:

kortikosteroide (za ublažavanje upale).

antikoagulanse ili lijekove koji sprječavaju zgrušavanje krvi (lijekovi za razrjeĎivanje krvi).

selektivne inhibitore ponovne pohrane serotonina (SSRI) koji se koriste za liječenje nekih vrsta

depresije.

H A L M E D

21 - 07 - 2017

O D O B R E N O

druge lijekove iz skupine NSAIL, poput acetilsalicilatne kiseline i ibuprofena (koji se koriste za

ublažavanje upale/boli). Krvarenje iz probavnog sustava ili nastanak čira se može pojaviti kao

nuspojava svih lijekova iz skupine NSAIL, uključujući diklofenak. Ovaj se problem, koji u starijih

bolesnika može biti ozbiljniji, može pojaviti u bilo koje vrijeme tijekom liječenja sa ili bez

upozoravajućih simptoma ili s teškim problemima probavnog sustava u anamnezi.

Morate obavijestiti liječnika ako koristite bilo koji od sljedećih lijekova:

litij (lijek koji se, meĎu ostalim, koristi za liječenje manične depresije).

digoksin (lijek koji se koristi za liječenje problema sa srcem).

diuretike (lijekovi koji se koriste za povećanje količine urina).

antihipertenzive poput ACE inhibitora ili beta-blokatora (lijekovi koji se koriste za liječenje

visokog krvnog tlaka ili odreĎenih drugih stanja sa srcem).

lijekove koji se uzimaju oralno za liječenje šećerne bolesti (oralni antidijabetici).

metotreksat (lijek koji se koristi za liječenje odreĎenih vrsta karcinoma ili artritisa).

ciklosporin (lijek koji se koristi za sprječavanje

imunoloških reakcija nakon transplantacije

organa).

kinolone (odreĎeni antibiotici), koji se koriste za liječenje odreĎenih infekcija.

sulfinpirazon (lijek koji se koristi za liječenje gihta) ili vorikonazol (lijek koji se koristi za

liječenje gljivičnih infekcija).

fenitoin (lijek koji se koristi za liječenje napadaja).

kolestipol

kolestiramin

koji

mogu

odgoditi

smanjiti

apsorpciju

diklofenaka.

Stoga

preporučuje uzimati diklofenak najmanje jedan sat prije ili 4 do 6 sati nakon primjene kolestipola/

kolestiramina.

Varlon s hranom, pićem i alkoholom

Ne preporučuje se uzimati diklofenak tijekom ili odmah nakon obroka, jer je brzina apsorpcije

diklofenaka smanjena kada se tablete uzimaju uz obrok.

Trudnoća, dojenje i plodnost

Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom

liječniku ili ljekarniku za savjet prije nego uzmete ovaj lijek.

Trudnoća

Nemojte koristiti diklofenak tijekom trudnoće osim ako Vam ga liječnik preporuči.

smijete

uzimati

diklofenak

tijekom

zadnja

mjeseca

trudnoće

može

naškoditi

Vašem

neroĎenom djetetu ili uzrokovati probleme pri porodu.

Dojenje

Ne smijete uzimati diklofenak ako dojite jer može biti štetan za Vaše dijete.

Plodnost

Kao i drugi protuupalni lijekovi, primjena diklofenaka može otežati začeće. Ne smijete uzimati ovaj

lijek ako planirate trudnoću ili ako imate poteškoća sa začećem.

Upravljanje vozilima i strojevima

Najčešće ovaj lijek nema utjecaj na sposobnost upravljanja vozilima ili strojevima. MeĎutim, u

rijetkim slučajevima mogu se pojaviti poremećaji vida, omaglica ili omamljenost (vidjeti dio 4). Ako

primijetite

takve

učinke,

nemojte

upravljati

vozilima

ili strojevima

odmah

kontaktirajte

svog

liječnika.

Varlon sadrži laktozu i sojino ulje.

Ako Vam je liječnik rekao da ne podnosite neke šećere, savjetujte se s liječnikom prije uzimanja ovog

lijeka.

Ako ste alergični na kikiriki ili soju, nemojte uzimati ovaj lijek.

H A L M E D

21 - 07 - 2017

O D O B R E N O

3.

Kako uzimati Varlon

Uvijek uzmite ovaj lijek točno onako kako Vam je rekao liječnik ili ljekarnik. Provjerite s liječnikom

ili ljekarnikom ako niste sigurni.

Kao opća preporuka je važno da koristite najnižu dozu koja kontrolira bol i da ne koristite diklofenak

dulje nego što je potrebno.

Odrasli i adolescenti u dobi od 14 godina i stariji

Uzmite početnu dozu od 2 tablete kada se pojave simptomi. Ako je potrebno, nastavite uzimati 1

tabletu svakih 4 do 6 sati. Nemojte uzeti više od 6 tableta u 24 sata. Progutajte cijelu tabletu s vodom,

preporučljivo prije obroka. Nemojte prekoračiti preporučenu dozu.

Primjena u djece i adolescenata

Nemojte davati Varlon 12,5 mg filmom obložene tablete djeci mlaĎoj od 14 godina.

Stariji

U oslabljenih starijih bolesnika treba primijeniti najnižu dozu koja kontrolira bol.

Nemojte uzimati diklofenak dulje od 5 dana za ublažavanje boli i 3 dana za snižavanje vrućice.

Ako simptomi potraju ili se pogoršaju, obavijestite o tome svog liječnika kako biste bili sigurni da nisu

povezani s drugom bolešću.

Ako uzmete više Varlona nego što ste trebali

Ako slučajno uzmete previše tableta, odmah o tome obavijestite svog liječnika ili ljekarnika. Možda

ćete trebati pomoć liječnika. Simptomi predoziranja mogu uključivati povraćanje, proljev, omaglicu,

zvonjavu u ušima (tinitus), konvulzije/napadaje, jaku bol u trbuhu ili krvavu ili crnu stolicu.

Ako ste zaboravili uzeti Varlon

Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu dozu.

Ako prestanete uzimati Varlon

Uzmite diklofenak samo kada se pojave simptomi.

U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se liječniku ili ljekarniku.

4.

Moguće nuspojave

Kao i svi lijekovi, ovaj lijek može uzrokovati nuspojave iako se one neće javiti kod svakoga.

Unutar svake skupine po učestalosti, nuspojave su navedene prema padajućoj ozbiljnosti.

Sljedeće

nuspojave

takoĎer

uključuju

nuspojave

koje

zabilježene

dugotrajnoj

primjeni

diklofenaka u visokim dozama.

Često (može se javiti u do 1 na 10 osoba)

glavobolja, omaglica

poremećaj ravnoteže povezan s mučninom (vrtoglavica)

mučnina, povraćanje, proljev, probavne tegobe, bol u trbuhu, vjetrovi, gubitak apetita

promjene u funkciji jetre (npr. razina transaminaza)

osip

Rijetko (može se javiti u do 1 na 1 000 osoba)

preosjetljivost, alergijske reakcije uključujući sniženi krvni tlak i šok (nizak krvni tlak, bljedoća,

nemir, slabi ubrzan puls, ljepljiva koža, smanjena svijest)

omamljenost

H A L M E D

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O D O B R E N O

iznenadno otežano disanje i osjećaj stezanja u prsnom košu uz piskanje ili kašalj (znakovi astme),

uključujući nedostatak zraka

upala želuca, krvarenje u probavnom sustavu, povraćanje krvi, crni ili krvavi proljev, čirevi u

probavnom sustavu (s ili bez krvareće perforacije)

upala jetre (hepatitis), žuto obojenje kože ili oka (žutica), poremećaji jetre

osip praćen jakim svrbežom i koprivnjačom (urtikarija)

oticanje ruku, dlanova, nogu i stopala (edem)

Vrlo rijetko (može se javiti u do 1 na 10 000 osoba)

poremećaj krvi uključujući trombocitopeniju (smanjenje broja trombocita u krvi) povezanom s

češćom

pojavom

modrica

krvarenja;

leukopeniju

(smanjenje

broja

bijelih

krvnih

stanica)

praćenom s povećanom osjetljivošću na infekcije; anemiju (smanjenje broja crvenih krvnih

stanica), uključujući hemolitičku i aplastičnu anemiju; agranulocitozu, vrlo ozbiljan poremećaj

krvi uslijed nemogućnosti koštane srži da proizvede dovoljan broj novih krvnih stanica koje bi

zamijenile stare krvne stanice praćenom s iznenadnom visokom vrućicom, teškom grloboljom i

čirevima u ustima.

iznenadno zadržavanje tekućine u koži i sluznicama (npr. oticanje grla, jezika ili lica), problemi s

disanjem i/ili osip i svrbež, često kao alergijska reakcija (angioedem).

dezorijentacija, depresija, nesanica, noćne more, razdražljivost, teške mentalne reakcije koje

preuzimaju kontrolu nad bolesnikovim ponašanjem i akcijama (psihotični poremećaj), tjeskoba.

trnci ili utrnulost dlanova ili stopala (parestezija), problem s pamćenjem, konvulzije/napadaji,

drhtanje,

ukočenost

vrata

(znakovi

meningitisa,

uključujući

aseptični

meningitis),

poremećaj

okusa, iznenadna i teška glavobolja, mučnina, omaglica, utrnulost, nemogućnost govora ili otežan

govor, paraliza (znakovi moždanog udara).

poremećaji vida, zamagljen vid, dvoslike.

zvonjenje u ušima (tinitus), poremećaji sluha.

osjećaj lupanja srca, bol u prsnom košu, nedovoljna snaga srca za pumpanje (zatajenje srca),

srčani udar (infarkt miokarda).

povišeni krvi tlak (hipertenzija), upala krvnih žila (vaskulitis).

upala pluća (pneumonitis).

kolitis uključujući hemoragijski kolitis (upala debelog crijeva s krvavim proljevom), pogoršanje

ulceroznog kolitisa (upalna bolest crijeva s ulceracijama) i Crohnove bolesti (kronična upala

tankog crijeva i/ili debelog crijeva), zatvor, upala oralne sluznice (stomatitis), upala jezika

(glositis), bolesti jednjaka, suženja u probavnom sustavu, upala gušterače praćena jakom boli u

gornjem dijelu trbuha koja se reflektira u leĎa, mučnina i povraćanje (pankreatitis).

brzo napredujuća progresivna upala jetre, nekroza tkiva jetre, zatajenje jetre.

mjehurići, ekcem, crvenilo kože (eritem), osip uz crvene mrlje nepravilnog oblika (eritema

multiforme), teška reakcija preosjetljivosti uz visoku vrućicu, crvene mrlje na koži, boli u

zglobovima

i/ili

upalom

(Stevens-Johnsonov

sindrom),

teška

iznenadna

reakcija

preosjetljivosti uz vrućicu i ljuštenje kože (toksična epidermalna nekroliza), teška upala kože s

gubitkom epidermisa i kose (eksfolijativni dermatitis), gubitak kose, preosjetljivost na sunce

(fotoosjetljivost), stvaranje modrica (uključujući alergijsku purpuru), svrbež (pruritus).

zatajenje bubrega (nedovoljno funkcioniranje bubrega), krv u urinu, višak proteina u urinu,

poremećaj u kojem bubrezi ne mogu dobro filtrirati krv (nefrotski sindrom), upala bubrega

povezana s krvi u urinu, vrućica i bol u bokovima (intersticijski nefritis), nekroza tkiva bubrega

(renalna papilarna nekroza).

Najčešće nuspojave su gastrointestinalne. Mogu se pojaviti čirevi na želucu, perforacija ili krvarenje u

probavnom sustavu, ponekad sa smrtnim ishodom, posebno u starijih (vidjeti dio 2). Nakon primjene

diklofenaka zabilježeni su mučnina, povraćanje, proljev, vjetrovi, zatvor, probavne tegobe, bol u

trbuhu, krv u stolici, povraćanje krvi, upala oralne sluznice s ulceracijama, pogoršanje kolitisa i

Crohnove bolesti (kronična upala tankog i/ili debelog crijeva) (vidjeti dio 2). Upala sluznice želuca je

primijećena manje često.

Diklofenak može biti povezan s blago povećanim rizikom od srčanog udara ("infarkt miokarda") ili

moždanog udara.

H A L M E D

21 - 07 - 2017

O D O B R E N O

Prijavljivanje nuspojava

Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili ljekarnika. To uključuje i

svaku moguću nuspojavu koja nije navedena u ovoj uputi. Nuspojave možete prijaviti izravno putem

nacionalnog sustava za prijavu nuspojava: navedenog u Dodatku V. Prijavljivanjem nuspojava možete

pridonijeti u procjeni sigurnosti ovog lijeka.

5.

Kako čuvati Varlon

Lijek čuvajte izvan pogleda i dohvata djece.

Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na pakiranju iza oznake

EXP. Rok valjanosti odnosi se na zadnji dan navedenog mjeseca.

Čuvati na temperaturi ispod 30°C.

Nikada nemojte nikakve lijekove bacati u otpadne vode ili kućni otpad. Pitajte svog ljekarnika kako

baciti lijekove koje više ne koristite. Ove će mjere pomoći u očuvanju okoliša.

6.

Sadržaj pakiranja i druge informacije

Što Varlon sadrži:

Djelatna tvar je diklofenakkalij. Svaka filmom obložena tableta sadrži 12,5 mg diklofenakkalija.

Drugi sastojci su:

Jezgra: laktoza hidrat, kalcijev fosfat, natrijev škroboglikolat vrsta A, kukuruzni škrob,

povidon K30, mikrokristalična celuloza 101, bezvodni koloidni silicijev dioksid, magnezijev

stearat;

Obloga: Opadry White OY-B-28920 (poli(vinilni alkohol), titanijev dioksid (E171), talk,

lecitin (soja) (E322), ksantanska guma).

Kako Varlon izgleda i sadržaj pakiranja:

Bijele, bikonveksne tablete u obliku kapsule s dimenzijama 5x10 mm.

Varlon je dostupan u hladno oblikovanim aluminijskim/istiskujućim aluminijskim OPA-Al-PVC/Al

blisterima koji sadrže 10 tableta. Dostupan je u pakiranjima od 10, 20, 30 i 40 tableta.

Na tržištu se ne moraju nalaziti sve veličine pakiranja.

Nositelj odobrenja za stavljanje lijeka u promet i proizvoĎač

MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cipar

Predstavnik nositelja odobrenja za Republiku Hrvatsku:

Medicuspharma d.o.o.

Rokov perivoj 6/a

10000 Zagreb

Tel: 01/4920231

Način i mjesto izdavanja lijeka

Lijek se izdaje na recept, u ljekarni.

Ova uputa je zadnji puta revidirana u srpnju 2017.

H A L M E D

21 - 07 - 2017

O D O B R E N O

17-11-2018

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

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

Published on: Fri, 16 Nov 2018 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 tau‐fluvalinate. To assess the occurrence of tau‐fluvalinate 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 St...

Europe - EFSA - European Food Safety Authority Publications

17-11-2018

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

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

Published on: Fri, 16 Nov 2018 The applicant BASF Agro B.V. submitted a request to the competent national authority in Germany to evaluate the confirmatory data that were identified for picolinafen 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, a new validated analytical method for enforcement of the residue in dry/high starch‐, high water content‐, high acid content‐ and high oil content commodities ...

Europe - EFSA - European Food Safety Authority Publications

16-11-2018

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

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

Published on: Thu, 15 Nov 2018 The applicant BASF SE submitted a request to the competent national authority in Germany to evaluate the confirmatory data that were identified for pyraclostrobin in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, residues trials supporting the existing use of pyraclostrobin on table grapes authorised in southern EU Member States and an analytical method for analysing residues of pyraclostrobin in ...

Europe - EFSA - European Food Safety Authority Publications

14-11-2018

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

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

Published on: Tue, 13 Nov 2018 The applicant ISK Biosciences Europe N.V. submitted a request to the competent national authority in France to evaluate the confirmatory data that were identified in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005 as not available. The data gap which was related to information on freezer storage conditions for the residue trials reported on potatoes, tomatoes and cucurbits with edible and inedible peel was considered satisfactorily addressed...

Europe - EFSA - European Food Safety Authority Publications

13-11-2018

Peer review of the pesticide risk assessment of the active substance napropamide‐M

Peer review of the pesticide risk assessment of the active substance napropamide‐M

Published on: Mon, 12 Nov 2018 00:00:00 +0100 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State the United Kingdom for the pesticide active substance napropamide‐M are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative uses of napropamid...

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

6-11-2018

Evaluation of confirmatory data following the Article 12 MRL review for kresoxim‐methyl

Evaluation of confirmatory data following the Article 12 MRL review for kresoxim‐methyl

Published on: Fri, 02 Nov 2018 00:00:00 +0100 The applicant BASF SE submitted a request to the competent national authority in Belgium to evaluate the confirmatory data that were identified for kresoxim‐methyl 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 confirmatory data requirement, a new study on the storage stability of kresoxim‐methyl residues in animal matrices was submitted. The data gap was considered ...

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

26-10-2018

Multi-country outbreak of Listeria monocytogenes sequence type 8 infections linked to consumption of salmon products

Multi-country outbreak of Listeria monocytogenes sequence type 8 infections linked to consumption of salmon products

Published on: Thu, 25 Oct 2018 00:00:00 +0200 A multi-country outbreak of 12 listeriosis cases caused by Listeria monocytogenes sequence type (ST) 8 has been identified through whole genome sequencing (WGS) analysis in three EU/EEA countries: Denmark (6 cases), Germany (5) and France (1). Four of these cases have died due to or with the disease. It is likely that the extent of this outbreak has been underestimated since the outbreak was identified through sequencing and only a subset of the EU/EEA count...

Europe - EFSA - European Food Safety Authority Publications

24-10-2018

FDA approves new drug to treat influenza

FDA approves new drug to treat influenza

FDA approved Xofluza (baloxavir marboxil) to treat acute uncomplicated flu in patients 12 years old and older who have been symptomatic for less than 48 hours.

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 dimethomorph

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

Published on: Fri, 19 Oct 2018 00:00:00 +0200 The applicant BASF SE submitted a request to the competent national authority in Germany to evaluate the confirmatory data that were identified for dimethomorph in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. The submitted residue data on raspberries were satisfactorily addressing the data gaps on raspberries and blackberries. Considering the new information provided, it is appropri...

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

18-10-2018

Scientific Opinion on Flavouring Group Evaluation 201 Revision 2 (FGE.201Rev2): 2‐alkylated, aliphatic, acyclic alpha,beta‐unsaturated aldehydes and precursors, with or without additional double‐bonds, from chemical subgroup 1.1.2 of FGE.19

Scientific Opinion on Flavouring Group Evaluation 201 Revision 2 (FGE.201Rev2): 2‐alkylated, aliphatic, acyclic alpha,beta‐unsaturated aldehydes and precursors, with or without additional double‐bonds, from chemical subgroup 1.1.2 of FGE.19

Published on: Wed, 17 Oct 2018 00:00:00 +0200 The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to consider in this revision 2 of Flavouring Group Evaluation 201, the additional data on genotoxicity submitted by the Industry on two substances, 2‐methylpent‐2‐enal [FL‐no: 05.090] and 2 methylcrotonaldehyde [FL‐no: 05.095], from subgroup 1.1.2 of FGE.19. In FGE.201Rev1, the Panel concluded that further data were required in order to clarify the genotoxic poten...

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Clackamas Bakery Recalls Fred Meyer Bakery Angel Food Cake Bar Due to Undeclared Allergens

Clackamas Bakery Recalls Fred Meyer Bakery Angel Food Cake Bar Due to Undeclared Allergens

Clackamas Bakery has recalled Fred Meyer Bakery Angel Food Cake Bar (12 oz.) sold in its retail stores because the product may contain milk and soy not listed on the label. Clackamas Bakery initiated the recall when it was discovered that the Fred Meyer Bakery Angel Food Cake Bar label had been incorrectly applied to packages of cornbread.

FDA - U.S. Food and Drug Administration

16-10-2018

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

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

Published on: Mon, 15 Oct 2018 00:00:00 +0200 The applicant BASF Agro BV submitted a request to the competent national authority in United Kingdom to evaluate the confirmatory data that were identified for teflubenzuron 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, a new metabolism study on leafy crops, a study investigating the nature of residues under standard hydrolytic conditions and a validated ...

Europe - EFSA - European Food Safety Authority Publications

5-10-2018

Consumer Alert: Sprout Creek Farm “Margie” Cheese Batch Recalled

Consumer Alert: Sprout Creek Farm “Margie” Cheese Batch Recalled

Today the New York State Department of Agriculture and Markets alerted consumers to a pasteurization problem with one of Sprout Creek Farm's pasteurized cow's milk cheeses, "Margie," made on 8/28/2018. Sprout Creek Farm is located in Poughkeepsie, NY. The reason for the recall is the air temperature at the start and end of the pasteurization process is required to be above 150deg F per the Grade "A" Pasteurized Milk Ordinance; the batch in question did not meet that standard. The recall pertains only to...

FDA - U.S. Food and Drug Administration

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

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

24-9-2018

FDA awards 12 grants to fund new clinical trials to advance the development of medical products for the treatment of rare diseases

FDA awards 12 grants to fund new clinical trials to advance the development of medical products for the treatment of rare diseases

FDA has awarded 12 new clinical trial research grants to enhance the development of medical products for patients with rare diseases

FDA - U.S. Food and Drug Administration

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

12-9-2018

Enforcement Report for the Week of September 12, 2018

Enforcement Report for the Week of September 12, 2018

Recently Updated Records for the Week of September 12, 2018 Last Modified Date: Friday, September 07, 2018

FDA - U.S. Food and Drug Administration

7-9-2018

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

Camber Pharmaceuticals, Inc. is voluntarily recalling one single lot of Montelukast Sodium Tablets, USP 10mg, to the consumer level. This recall of one batch of Montelukast Sodium Tablets, USP 10mg, lot# MON17384 Exp. 12/31/2019, was prompted because a complaint of a sealed bottle labeled as Montelukast 10mg 30 ct found to contain 90 tablets of Losartan Potassium Tablets, USP 50mg

FDA - U.S. Food and Drug Administration

7-9-2018

Orphan designation:  Recombinant human beta-glucuronidase (vestronidase alfa),  for the: Treatment of mucopolysaccharidosis type VII (Sly syndrome)

Orphan designation: Recombinant human beta-glucuronidase (vestronidase alfa), for the: Treatment of mucopolysaccharidosis type VII (Sly syndrome)

On 21 March 2012, orphan designation (EU/3/12/973) was granted by the European Commission to NDA Regulatory Science Ltd, United Kingdom, for recombinant human beta-glucuronidase for the treatment of mucopolysaccharidosis type VII (Sly syndrome).

Europe - EMA - European Medicines Agency

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

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

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

Published on: Tue, 07 Aug 2018 00:00:00 +0200 During the project seven standard operating procedures (SOP) were developed for the four data domains (zoonoses, chemical contaminant, pesticide residues and veterinary medical products residues). The SOPs describe 1) How the national governance of risk assessment data is organised, 2) how data are collected and validated before delivering to EFSA covering all four domains, 3) How data is transferred to EFSA, 4) how to respond to EFSA request for clarificati...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Product Quest Manufacturing LLC Recalls All Nasal Products and Baby Oral Gels Manufactured at Florida Facility Due to Possible Microbial Contamination

Product Quest Manufacturing LLC Recalls All Nasal Products and Baby Oral Gels Manufactured at Florida Facility Due to Possible Microbial Contamination

Product Quest Manufacturing (“Product Quest”) announced its voluntary recall of Lot# 173089J of CVS Health 12 Hour Sinus Relief Nasal Mist due to a finding of microbial contamination identified as Pseudomonas aeruginosa.

FDA - U.S. Food and Drug Administration

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

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

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

Outcome of the public consultation on a draft protocol for the Scientific Opinion on dietary sugars

Outcome of the public consultation on a draft protocol for the Scientific Opinion on dietary sugars

Published on: Fri, 10 Aug 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) carried out a public consultation to receive input from the scientific community and all interested parties on a draft protocol for the Scientific Opinion on free sugars from all dietary sources, prepared by the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA Panel), supported by the ad‐hoc Working Group on Sugars. The draft protocol was endorsed by the Panel for public consultation at its plenary meeti...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Protocol for the scientific opinion on the Tolerable Upper Intake Level of dietary sugars

Protocol for the scientific opinion on the Tolerable Upper Intake Level of dietary sugars

Published on: Fri, 10 Aug 2018 00:00:00 +0200 In June 2016, EFSA received a mandate from the national food competent authorities of five European countries (Denmark, Finland, Iceland, Norway and Sweden) to provide a dietary reference value (DRV) for sugars, with particular attention to added sugars. A draft protocol was developed with the aim of defining as much as possible beforehand the strategy that will be applied for collecting data, appraising the relevant evidence, and analysing and integrating t...

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

22-8-2018

Radagast Pet Food Voluntarily Expands Recall to Include Rad Cat Raw Diet Products With Best By Dates of 10/19/18 Through 12/3/19 Due to Potential Health Risk

Radagast Pet Food Voluntarily Expands Recall to Include Rad Cat Raw Diet Products With Best By Dates of 10/19/18 Through 12/3/19 Due to Potential Health Risk

Radagast Pet Food, Inc. of Portland, OR is expanding its voluntary recall to include an additional quantity of Rad Cat Raw Diet across all varieties with Best By dates of 10/19/18 through 12/3/19 because it has the potential to be contaminated with Listeria monocytogenes. Radagast Pet Food is conducting this voluntary recall out of an abundance of caution because of its strong commitment to food safety and quality.

FDA - U.S. Food and Drug Administration

8-8-2018

Product Quest Manufacturing LLC Issues Voluntary Nationwide Recall of CVS Health 12 Hour Sinus Relief Nasal Mist Due to Microbiological Contamination

Product Quest Manufacturing LLC Issues Voluntary Nationwide Recall of CVS Health 12 Hour Sinus Relief Nasal Mist Due to Microbiological Contamination

Holly Hill, FL, Product Quest Manufacturing (“Product Quest”) is voluntarily recalling Lot# 173089J of CVS Health 12 Hour Sinus Relief Nasal Mist, a clear, colorless liquid, to the consumer level. The product was found to have had microbiological contamination identified as Pseudomonas aeruginosa.

FDA - U.S. Food and Drug Administration

12-11-2018

Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva (Zentiva, k.s.)

Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva (Zentiva, k.s.)

Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva (Active substance: efavirenz / emtricitabine / tenofovir disoproxil) - Centralised - Yearly update - Commission Decision (2018)7547 of Mon, 12 Nov 2018

Europe -DG Health and Food Safety

12-11-2018

Ruconest (Pharming Group N.V.)

Ruconest (Pharming Group N.V.)

Ruconest (Active substance: Conestat alfa) - Centralised - Yearly update - Commission Decision (2018)7548 of Mon, 12 Nov 2018

Europe -DG Health and Food Safety

12-11-2018

Spinraza (Biogen Netherlands B.V.)

Spinraza (Biogen Netherlands B.V.)

Spinraza (Active substance: nusinersen) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7550 of Mon, 12 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4312/T/10

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

1-10-2018

EU/3/05/328 (Celgene Europe B.V.)

EU/3/05/328 (Celgene Europe B.V.)

EU/3/05/328 (Active substance: (E)-(1S,4S,10S,21R)-7-[(Z)-ethylidene]-4,21-diisopropyl-2-oxa-12,13-dithia-5,8,20,23- tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone) - Transfer of orphan designation - Commission Decision (2018)6434 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/056/05/T/03

Europe -DG Health and Food Safety

1-10-2018

EU/3/05/279 (Celgene Europe B.V.)

EU/3/05/279 (Celgene Europe B.V.)

EU/3/05/279 (Active substance: (E)-(1S,4S,10S,21R)-7-[(Z)-ethylidene]-4,21-diisopropyl-2-oxa-12,13-dithia-5,8,20,23- tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone) - Transfer of orphan designation - Commission Decision (2018)6433 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/001/05/T/03

Europe -DG Health and Food Safety

26-9-2018

Today, Wednesday, September 26th 2018 at 12 pm EST is the last day that the #FDA will be soliciting site visit proposals for the 2018 Experiential Learning Program. Click the link to find more about the program & submit your application:   http://go.usa.g

Today, Wednesday, September 26th 2018 at 12 pm EST is the last day that the #FDA will be soliciting site visit proposals for the 2018 Experiential Learning Program. Click the link to find more about the program & submit your application: http://go.usa.g

Today, Wednesday, September 26th 2018 at 12 pm EST is the last day that the #FDA will be soliciting site visit proposals for the 2018 Experiential Learning Program. Click the link to find more about the program & submit your application: http://go.usa.gov/xPrum  #MedicalDevice pic.twitter.com/Zsmq00NCdd

FDA - U.S. Food and Drug Administration

19-9-2018

Reminder: #FDA site visit proposal solicitation period for the 2018  Experiential Learning Program is currently OPEN through Wednesday,  9/26/18 @ 12 pm EST. Click the link to find more about the  program & to submit your application  https://go.usa.gov/x

Reminder: #FDA site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, 9/26/18 @ 12 pm EST. Click the link to find more about the program & to submit your application https://go.usa.gov/x

Reminder: #FDA site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, 9/26/18 @ 12 pm EST. Click the link to find more about the program & to submit your application https://go.usa.gov/xPrum  #MedicalDevice pic.twitter.com/FN1mNN65dD

FDA - U.S. Food and Drug Administration

19-9-2018

Memantine Mylan (Mylan S.A.S.)

Memantine Mylan (Mylan S.A.S.)

Memantine Mylan (Active substance: Memantine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5972 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2660/T/12

Europe -DG Health and Food Safety

14-9-2018

Agenda:  Agenda - CAT agenda of the 12-14 September 2018 meeting

Agenda: Agenda - CAT agenda of the 12-14 September 2018 meeting

Europe - EMA - European Medicines Agency

12-9-2018

The FDA site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, September 26th 2018 12 pm EST. Click the link to find more about the program & to submit your application  https://go.usa.gov/x

The FDA site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, September 26th 2018 12 pm EST. Click the link to find more about the program & to submit your application https://go.usa.gov/x

The FDA site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, September 26th 2018 12 pm EST. Click the link to find more about the program & to submit your application https://go.usa.gov/xPrum  #FDA #MedicalDevice pic.twitter.com/Kyo5z44Os4

FDA - U.S. Food and Drug Administration

12-9-2018

ADCETRIS (Takeda Pharma A/S)

ADCETRIS (Takeda Pharma A/S)

ADCETRIS (Active substance: Brentuximab vedotin) - Centralised - Annual renewal - Commission Decision (2018)5973 of Wed, 12 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2455/R/58

Europe -DG Health and Food Safety

11-9-2018

 Focus group meeting  on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics harmonisation, European Medicines Agency, London, UK, From: 12-Oct-2018, To: 12-Oct-2018

Focus group meeting on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics harmonisation, European Medicines Agency, London, UK, From: 12-Oct-2018, To: 12-Oct-2018

This meeting will allow a direct exchange of views between the Agency’s working party and stakeholders on its draft reflection paper on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics (SPC) harmonisation (EMA/CVMP/849775/2017). It complements the public consultation on this reflection paper ending on 31 January 2019. The reflection paper follows considerations in the report on a pilot project that aimed to develop and test non-experimental appr...

Europe - EMA - European Medicines Agency

5-9-2018

The FDA's site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, September 26th 2018 at 12 pm EST. Click the link to find more about the program and to submit your application:  https://go.u

The FDA's site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, September 26th 2018 at 12 pm EST. Click the link to find more about the program and to submit your application: https://go.u

The FDA's site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, September 26th 2018 at 12 pm EST. Click the link to find more about the program and to submit your application: https://go.usa.gov/xPcpn  #MedicalDevice

FDA - U.S. Food and Drug Administration