Lubor 20 mg tvrde kapsule

Glavna informacija

  • Trgovački naziv:
  • Lubor 20 mg tvrde kapsule
  • Doziranje:
  • 20 mg
  • Farmaceutski oblik:
  • kapsula, tvrda
  • Sastav:
  • Urbroj: jedna kapsula sadrži 20 mg piroksikama
  • Tip recepta:
  • na recept, u ljekarni neponovljivi recept
  • Koristi za:
  • Ljudi
  • Vrsta lijekova:
  • alopatski lijek
  • Proizveden od:
  • Belupo lijekovi i kozmetika d.d., Koprivnica, Republika Hrvatska

Dokument

Lokalizacija

  • Na raspolaganju u:
  • Lubor 20 mg tvrde kapsule
    Hrvatska
  • Jezik:
  • hrvatski

Terapeutski informacija

  • Proizvod sažetak:
  • Pakiranje: 20 kapsula u blisteru, u kutiji [HR-H-870036982-01] Urbroj: 381-12-01/30-16-04

Druge informacije

Status

  • Izvor:
  • HALMED Agencija za lijekove i medicinske proizvode - Agency for medicinal products and medical devices of Croatia
  • Broj odobrenja:
  • HR-H-870036982
  • Datum autorizacije:
  • 22-07-2016
  • Zadnje ažuriranje:
  • 04-06-2018

Uputu o lijeku: sastav, indikacije, doziranje, nuspojave, interakcija, trudnoća, dojenje

Uputa o lijeku: Informacije za bolesnika

LUBOR 10 mg tvrde kapsule

LUBOR 20 mg tvrde kapsule

piroksikam

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

podatke.

Sačuvajte ovu uputu. Možda ćete je trebati ponovo pročitati.

Ako imate dodatnih pitanja, obratite se svom liječniku ili ljekarniku.

Ovaj je lijek propisan samo Vama. Nemojte ga davati drugima. Može im štetiti, 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, vidjeti dio 4.

Što se nalazi u ovoj uputi:

Što su LUBOR kapsule i za što se koriste?

Što morate znati prije nego prije nego počnete uzimati LUBOR kapsule?

Kako uzimati LUBOR kapsule?

Moguće nuspojave

Kako čuvati LUBOR kapsule?

Sadržaj pakiranja i druge informacije

1.

Što su LUBOR kapsule i za što se koriste?

LUBOR kapsule sadrže piroksikam, koji pripada skupini nesteroidnih protuupalnih lijekova. Ovi lijekovi

pomažu pri ublažavanju boli i smanjuju otok oboljelih zglobova i mišića.

LUBOR kapsule primjenjuju se za ublažavanje simptoma reumatoidnog artritisa, osteoartritisa (artroza,

degenerativna bolest zglobova) i ankilozantnog spondilitisa (reumatska bolest kralježnice) kao što su

otok, ukočenost i bol u zglobu. LUBOR kapsule neće izliječiti navedene bolesti, već će pomoći u

ublažavanju simptoma tijekom terapije.

Liječnik će Vam propisati ovaj lijek samo u slučaju kada primjena drugih nesteroidnih protuupalnih

lijekova neće imati zadovoljavajući učinak.

2.

Što morate znati prije nego prije nego počnete uzimati LUBOR kapsule?

Nemojte uzimati LUBOR kapsule:

-

ako ste alergični na piroksikam ili bilo koji drugi sastojak ovog lijeka (naveden u dijelu 6.)

-

ako imate ili ste u prošlosti imali čir (vrijed) želuca ili dvanaestnika, odnosno ako ste nekad krvarili

iz probavnog sustava ili imali puknuće stjenke probavnog sustava

-

ako bolujete od bolesti probavnog sustava (upala želuca ili crijeva) koji mogu prokrvariti kao što su

ulcerozni kolitis, Crohnova bolest, tumori probavnog sustava, divertikulitis (upaljena vrećasta

proširenja stjenke debelog crijeva)

-

uzimate

druge

nesteroidne

protuupalne

lijekove,

uključujući

selektivne

inhibitore

ciklooksigenaze-2 i acetilsalicilatnu kiselinu (prisutna je u mnogim lijekovima za ublažavanje

bolova i snižavanje povišene tjelesne temperature)

-

ako uzimate lijekove protiv zgrušavanja krvi, kao što je varfarin

-

ako ste imali ozbiljnu alergijsku reakciju na piroksikam, druge nesteroidne protuupalne lijekove i

druge lijekove, a posebno ozbiljne kožne reakcije (bez obzira na jačinu) kao što su eksfolijativni

dermatitis (jako crvenilo kože, s ljuštenjem kože u ljuskama ili tankim slojevima), vezikulo-

H A L M E D

22-07-2016

O D O B R E N O

bulozne reakcije (Stevens-Johnsonov sindrom, stanje s pojavom crvenih mjehura i/ili rana koje

mogu krvariti ili biti pokrivene krastama) i epidermalna toksična nekroliza (bolest s pojavom

mjehura i ljuštenja gornjeg sloja kože)

-

ako bolujete od zatajivanja srca

-

ako ste u zadnjem tromjesečju trudnoće.

Ako se nešto od gore navedenog odnosi na Vas, ne smijete uzimati LUBOR kapsule i odmah se

javite svom liječniku.

Upozorenja i mjere opreza

Obratite se svom liječniku ili ljekarniku prije nego uzmete LUBOR kapsule.

Budite oprezni s uzimanjem ovog lijeka i javite se svom liječniku:

-

u slučaju pojave alergijske reakcije, kao što je kožni osip, oticanje lica, neobjašnjeno piskanje u

prsima ili poteškoće s disanjem -

odmah prekinite primjenu lijeka i obratite se liječniku

-

u slučaju pojave crvenila kože, oštećenja sluznica ili neke druge promjene na koži -

odmah

prekinite primjenu lijeka i javite se liječniku

-

u slučaju pojave bolova u trbuhu ili bilo kojeg znaka krvarenja iz želuca ili crijeva, kao što su crna

ili krvava stolica ili povraćanje krvi -

odmah prekinite primjenu lijeka i javite se liječniku

-

u slučaju dugotrajne primjene piroksikama zbog moguće pojave problema s očima (poremećaj

oštrine vida i/ili opažanja boja, pojave mrlja pred očima ili nekontroliranog titranja očiju) –

potrebne su povremene kontrole specijalista

-

ako ste stariji od 70 godina - liječnik će htjeti trajanje liječenja skratiti na najkraće moguće vrijeme

i češće će Vas kontrolirati tijekom primjene piroksikama

-

ako ste stariji od 70 godina ili uzimate druge lijekove poput kortikosteroida ili lijekova za liječenje

depresije, kao što su selektivni inhibitori ponovne pohrane serotonina ili acetilsalicilatnu kiselinu

za sprječavanje nastanka ugrušaka – liječnik Vam može propisati LUBOR kapsule zajedno s

lijekom koji štiti Vaš želudac i crijeva

-

ako trebate obaviti krvne pretrage ili kakve druge pretrage ili ako idete na operaciju, recite to svom

liječniku jer rezultati pretraga mogu biti promijenjeni

-

ako ste stariji od 80 godina ne preporučuje se primjena LUBOR kapsula

-

ako ste trudni ili planirate trudnoću, odnosno ako dojite

-

ako imate problema s bubrezima

-

ako imate problema s jetrom

-

ako imate povišen krvni tlak ili bolujete od drugih bolesti srca

-

ako ste imali krvarenje u mozgu ili kakve druge poremećaje krvarenja.

Lijekovi iz skupine nesteroidnih protuupalnih lijekova, uključujući i LUBOR kapsule, mogu biti povezani

s malim povećanjem rizika od nastanka srčanog ili moždanog udara. Rizik je veći uz primjenu većih doza

i dugotrajne primjene. Ne primjenjujte lijek u dozama većim od preporučenih niti tijekom duljeg vremena

od preporučenog. Ako imate problema sa srcem ili ste preboljeli moždani udar ili mislite da imate

povećan rizik za nastanak tih bolesti (npr. imate povišen krvni tlak, šećernu bolest, povišene vrijednosti

kolesterola u krvi ili ste pušač), javite se svom liječniku ili ljekarniku.

Tijekom

primjene

piroksikama

zabilježeni

potencijalno

život

opasni

kožni

osipi

(Stevens-

Johnsonov sindrom, toksična epidermalna nekroliza), koji se na početku javljaju kao crvenkaste pjege

izgleda mete ili okrugle mrlje često sa središnjim mjehurićima na trupu.

Dodatni znakovi na koje treba obratiti pozornost uključuju pojavu čireva u ustima, grlu, nosu, spolnim

organima i konjunktivitis (crvene i otečene oči).

Ove potencijalno po život opasne kožne osipe često prate simptomi nalik gripi. Osip može napredovati do

rasprostranjenog stvaranja mjehurića ili ljuštenja kože.

H A L M E D

22-07-2016

O D O B R E N O

Unutar prvih tjedana liječenja najveći je rizik od pojave ozbiljnih kožnih reakcija. Ako je kod primjene

piroksikama došlo do razvoja Stevens-Johnsonovog sindroma ili toksične epidermalne nekrolize, ne

smijete ponovno početi uzimati LUBOR kapsule.

Ako Vam se razvije osip ili navedeni simptomi po koži, odmah zatražite savjet liječnika i recite mu da

uzimate ovaj lijek.

Ako se nešto od gore navedenog odnosi na Vas ili, pak, niste sigurni, javite se svom liječniku.

Starije osobe

U osoba starijih od 65 godina češće su uočene nuspojave pri uzimanju nesteroidnih protuupalnih lijekova.

Kao i kod ostalih nesteroidnih protuupalnih lijekova, oprez je potreban pri liječenju starijih osoba koje

češće imaju poremećenu funkciju bubrega, jetre ili srca.

U slučaju pojave bilo kojeg simptoma probavnog sustava (naročito ako se pojavi krvarenje), odmah se

javite svom liječniku.

Djeca

LUBOR kapsule nisu namijenjene za primjenu u djece.

Drugi lijekovi i LUBOR kapsule

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

druge lijekove.

Prije primjene LUBOR kapsula obavijestite liječnika ako uzimate:

-

acetilsalicilatnu kiselinu i druge nesteroidne protuupalne lijekove

-

lijekove za sprječavanje zgrušavanja krvi, kao što je varfarin ili acetilsalicilatna kiselina

-

lijekove koji izazivaju pojačano mokrenje (diuretike), kao što je hidroklortiazid za liječenje

povišenog krvnog tlaka ili bolesti bubrega

-

litij

lijek

za liječenje depresije

-

selektivne inhibitore ponovne pohrane serotonina - lijekove za liječenje depresije

-

lijekove za liječenje povišenog krvnog tlaka, kao što su atenolol (beta blokator) ili klonidin

-

srčane glikozide kao što je digoksin za liječenje srčanih bolesti

-

metotreksat – lijek za liječenje različitih vrsta tumora, psorijaze i reumatoidnog artritisa

-

ciklosporin, takrolimus – lijekovi za sprječavanje odbacivanja organa nakon presađivanja

-

kortikosteroide – lijekove koji smanjuju upalni odgovor organizma

-

aminoglikozide i kinolonske antibiotike – lijekove za liječenje različitih infekcija

-

mifepriston – lijek za izazivanje prekida trudnoće

-

probenecid – lijek za liječenje gihta

-

lijekove za liječenje šećerne bolesti iz skupine sulfonilureje, kao što je klorpropamid.

LUBOR kapsule s hranom i pićem

Lijek treba uzeti nakon jela, s punom čašom vode.

Trudnoća, dojenje i plodnost

Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate trudnoću, obratite se svom liječniku

ili ljekarniku za savjet prije nego uzmete ovaj lijek.

Ne preporučuje se primjena LUBOR kapsula u trudnica, budući da lijek prolazi posteljicu i može štetno

utjecati na plod. Ovaj lijek se ne smije primjenjivati u zadnjem tromjesečju trudnoće.

Ne preporučuje se primjena LUBOR kapsula u dojilja, jer se lijek izlučuje u majčino mlijeko i postoji

opasnost od štetnog utjecaja na dojenče.

LUBOR kapsule pripadaju skupini lijekova koji imaju blagi utjecaj na ovulaciju te može doći do

prolaznog smanjenja plodnosti u žena. Obavijestite svog liječnika ako planirate trudnoću ili imate

problema sa začećem.

H A L M E D

22-07-2016

O D O B R E N O

Upravljanje vozilima i strojevima

Ovaj lijek može u nekih ljudi izazvati omaglicu, pospanost, umor i smetnje vida. U slučaju pojave ovih

simptoma, nemojte voziti i upravljati strojevima.

LUBOR 10 mg kapsule i LUBOR 20 mg kapsule sadrže laktozu.

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

lijeka.

LUBOR 10 mg kapsule sadrže boju azorubine, a LUBOR 20 mg kapsule sadrže boju brilliant black

PN.

Mogu uzrokovati alergijske reakcije.

3.

Kako uzimati LUBOR kapsule?

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

liječnikom ili ljekarnikom ako niste sigurni.

Uobičajena početna doza je 2 kapsule od 10 mg ili 1 kapsula od 20 mg jedanput na dan. Doza održavanja

je u većini slučajeva ista kao i početna, dok je u manjeg broja bolesnika dovoljna doza održavanja od

1 kapsule od 10 mg jedanput na dan. Ni u kojem slučaju ne smijete sami mijenjati dozu lijeka bez

prethodnog savjetovanja s liječnikom.

Liječnik treba procijeniti učinak liječenja 14 dana nakon početka primjene lijeka.

Vaš liječnik će razmotriti potrebu istodobnog propisivanja lijeka koji sprječava oštećenje sluznice želuca

ili crijeva.

Najveća preporučena dnevna doza je 20 mg i treba je primjenjivati kroz najkraće moguće vrijeme

liječenja.

Primjena u djece

LUBOR kapsule nisu namijenjene za primjenu u djece.

Ako uzmete više LUBOR kapsula nego što ste trebali

U slučaju da ste uslijed nepažnje ili nehotično popili veću količinu lijeka odmah se javite se svom

liječniku ili najbližoj hitnoj pomoći. Uzmite preostale kapsule ili uputu o lijeku sa sobom kako bi

zdravstveni radnici kojima ste se obratili znali točno koji ste lijek uzeli.

Ako ste zaboravili uzeti LUBOR kapsule

Ako ste propustili uzeti jednu dozu LUBOR kapsula, učinite to čim se sjetite, osim ako se već približilo

vrijeme za sljedeću dozu. U tom slučaju izostavljenu dozu nemojte uopće uzeti. Nemojte uzeti dvostruku

dozu kako biste nadoknadili zaboravljenu dozu.

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

ljekarniku.

4.

Moguće nuspojave

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

U slučaju pojave bilo kojeg od sljedećih simptoma, odmah se obratite svom liječniku i prekinite

uzimati lijek:

simptome krvarenja u probavnom sustavu kao što je pojava crne stolice, krvi u stolici ili povraćanje

krvi

teška reakcija preosjetljivosti s oteklinom lica, jezika i grkljana, otežanim disanjem, ubrzanim radom

srca i padom krvnog tlaka (anafilaksija)

H A L M E D

22-07-2016

O D O B R E N O

stezanje mišića bronha s piskanjem u prsima i/ili otežano disanje

teška reakcija preosjetljivosti s oteklinom lica, jezika i grkljana (angioneurotski edem)

žuta obojenost kože i bjeloočnica (žutica) koja može biti znak upale jete (hepatitisa) ili drugih jetrenih

problema

ozbiljne, potencijalno po život opasne kožne promjene s pojavom mjehura, ljuštenja ili pečenja kao

što su Stevens-Johnsonov sindrom i toksična epidermalna nekroliza (Lyellova bolest) zabilježene su

vrlo rijetko (vidjeti dio 2.

Što morate znati prije nego počnete uzimati LUBOR kapsule?

Najčešće zabilježene nuspojave tijekom primjene LUBOR kapsula vezane su uz probavni sustav

upala usne šupljine uz stvaranje čireva, nelagoda u trbuhu, mučnina, povraćanje, zatvor, probavne tegobe,

nadutost, proljev, bol u trbuhu, loša probava, pogoršanje simptoma postojećih bolesti probavnog sustava

kao što su ulcerozni kolitis i Crohnova bolest, upala želučane sluznice (gastritis), čir (vrijed) želuca,

puknuće stjenke ili krvarenje iz probavnog sustava, crna stolica, povraćanje krvi, rijetko upala gušterače

što može dovesti do jake boli u gornjem dijelu trbuha i leđima.

Ostale nuspojave zabilježene tijekom primjene LUBOR kapsula:

otečeni gležnjevi i/ili stopala, povišen krvni tlak, srčano zatajivanje, rijetko osjećaj lupanja srca

otežano disanje

omaglica, glavobolja, pospanost, umor, nesanica, depresija, razdražljivost, priviđanja slika i zvukova

koji ne postoje (halucinacije), promjene raspoloženja, poremećaji spavanja, stanje dezorijentacije s

djelomičnim gubitkom svijesti (mentalna konfuzija), spontani osjećaj trnjenja, bockanja, mravinjanja,

žarenja u nekom dijelu tijela, vrtoglavica

upala stjenke krvnih žila (vaskulitis) i oblik ozbiljne reakcije preosjetljivosti obično praćen vrućicom,

bolovima u mišićima i zglobovima, osipom (serumska bolest)

smanjenje broja krvnih stanica različitog stupnja što može imati za posljedicu pojavu modrica i

krvarenje (npr. krvarenje iz nosa)

prolazno može doći do blagog pogoršanja testova jetrene funkcije. U starijih osoba u rijetkim

slučajevima može doći do pojave akutne upale jetre kod kojeg postoji opasnost pogoršanja u smislu

ozbiljnog oštećenja tkiva jetre.

tijekom dugotrajne primjene može doći do pojave oteklina zbog nakupljanja tekućine i otežanog

bolnog mokrenja, a u rijetkim slučajevima može se razviti ozbiljan poremećaj rada bubrega s

mogućim prestankom rada bubrega

kožni

osip,

pojačana

osjetljivost

kože

sunčevo

zračenje

(fotoosjetljivost),

svrbež,

crvenilo,

zatezanje kože, zadebljanje ili ljuštenje kože, gubitak ili listanje noktiju, gubitak kose, rijetko pojava

crvenih mjehura i/ili rana koje mogu krvariti ili biti pokrivene krastama (vezikulo-bulozne reakcije),

jako crvenilo kože, s ljuštenjem kože u ljuskama ili tankim slojevima (eksfolijativni dermatitis),

upalna reakcija, obilježena promjenama na koži u obliku “mete” (

er

thema multiforme

), pojava

neobjašnjivih modrica ili krvarenja na koži, koprivnjača

u rijetkim slučajevima može doći do zamagljenog vida, otoka vjeđa i iritacije očiju

u rijetkim slučajevima može doći do zujanja u ušima. Zabilježeni su pojedinačni slučajevi poremećaja

sluha.

gubitak apetita. Opisani su slučajevi poremećenih vrijednosti elektrolita u krvi koji su se očitovali

simptomima

što

zbunjenost

dezorijentacija

(izgubljenost).

Zabilježeni

pojedinačni

slučajevi snižene vrijednosti glukoze u krvi (hipoglikemija) i povišene vrijednosti glukoze u krvi

(hiperglikemija).

slabost ili umor, smanjenje ili povećanje tjelesne mase.

Prijavljivanje nuspojava

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

moguću

nuspojavu

koja

nije

navedena

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.

H A L M E D

22-07-2016

O D O B R E N O

5.

Kako čuvati LUBOR kapsule?

Ovaj lijek čuvajte izvan pogleda i dohvata djece.

Ovaj lijek čuvajte na temperaturi ispod 25 °C.

Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji. Rok valjanosti odnosi

se na zadnji dan navedenog mjeseca.

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 LUBOR 10 mg tvrda kapsula sadrži?

Djelatna tvar je piroksikam.

Jedna kapsula sadrži 10 mg piroksikama.

Druge pomoćne tvari su laktoza hidrat; kukuruzni škrob; povidon; talk; magnezijev stearat; želatina; boje

azorubine, carmoisine (E122), titanijev dioksid (E171) i željezov oksid, crni (E172).

Što LUBOR 20 mg tvrda kapsula sadrži?

Djelatna tvar je piroksikam.

Jedna kapsula sadrži 20 mg piroksikama.

Druge pomoćne tvari su laktoza hidrat; kukuruzni škrob; povidon; talk; magnezijev stearat; želatina; boje

brilliant blue FCF (E133), brilliant black PN (E151) i titanijev dioksid (E171).

Kako LUBOR kapsula izgleda i sadržaj pakiranja?

LUBOR 10 mg je crveno-siva kapsula.

LUBOR 20 mg je plavo-svijetloplava kapsula.

20 (1x20) kapsula u blister PVC/Al pakovanju, u kutiji.

Nositelj odobrenja za stavljanje lijeka u promet i proizvođač

BELUPO lijekovi i kozmetika d.d.

Ulica Danica 5

48 000 Koprivnica

Način i mjesto izdavanja lijeka

Lijek se izdaje na recept, u ljekarni.

Ova uputa je zadnji puta revidirana u srpnju 2016.

H A L M E D

22-07-2016

O D O B R E N O

20-3-2019

Safety and efficacy of eight compounds belonging to different chemical groups when used as flavourings for cats and dogs

Safety and efficacy of eight compounds belonging to different chemical groups when used as flavourings for cats and dogs

Published on: Tue, 19 Mar 2019 Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of 23 compounds belonging to different chemical groups. This opinion concerns eight out of the 23 compounds, which are currently authorised for use as flavours in food. The Panel concludes that the eight additives are safe for cats and dogs at the proposed use level: phenyl...

Europe - EFSA - European Food Safety Authority EFSA Journal

20-3-2019

Safety and efficacy of 26 compounds belonging to chemical group 3 (α,β‐unsaturated straight‐chain and branched‐chain aliphatic primary alcohols, aldehydes, acids and esters) when used as flavourings for all animal species and categories

Safety and efficacy of 26 compounds belonging to chemical group 3 (α,β‐unsaturated straight‐chain and branched‐chain aliphatic primary alcohols, aldehydes, acids and esters) when used as flavourings for all animal species and categories

Published on: Tue, 19 Mar 2019 Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of 26 compounds belonging to chemical group 3 (α,β‐unsaturated straight‐chain and branched‐chain aliphatic primary alcohols, aldehydes, acids and esters). They are all currently authorised as flavours in food. The FEEDAP Panel was unable to perform the assessment of non‐2(c...

Europe - EFSA - European Food Safety Authority EFSA Journal

18-3-2019

Mylan Institutional LLC Initiates Voluntary Nationwide Recall of Levoleucovorin Injection Due to the Presence of Particulate Matter

Mylan Institutional LLC Initiates Voluntary Nationwide Recall of Levoleucovorin Injection Due to the Presence of Particulate Matter

Mylan Institutional LLC is conducting a voluntary nationwide recall of two lots (see table below) of Levoleucovorin Injection, 250 mg/25 mL to the consumer/user level. The lots were manufactured by Alidac Pharmaceuticals Limited and distributed by Mylan Institutional LLC.

FDA - U.S. Food and Drug Administration

16-3-2019

Efficacy of sodium formate as a technological feed additive (hygiene condition enhancer) for all animal species

Efficacy of sodium formate as a technological feed additive (hygiene condition enhancer) for all animal species

Published on: Fri, 15 Mar 2019 In 2015, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) issued an opinion on the safety and efficacy of formic acid, ammonium formate and sodium formate as feed hygiene agents for all animal species. In this opinion, two forms of the additive sodium formate, a solid form (specified to contain ≥ 98% sodium formate (w/w)) and a liquid form (specified to contain a minimum of 15% sodium formate, a maximum of 75% free formic acid and a maxim...

Europe - EFSA - European Food Safety Authority EFSA Journal

16-3-2019

Legacy Pharmaceutical Packaging, LLC Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 50mg Due to the Detection of Trace Amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) Impurity found in the Active Pharmaceutical Ingredient

Legacy Pharmaceutical Packaging, LLC Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 50mg Due to the Detection of Trace Amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) Impurity found in the Active Pharmaceutical Ingredient

Legacy Pharmaceutical Packaging, LLC is recalling 3 repackaged lots of Losartan Tablets USP 50mg to the consumer level. This recall was prompted due to Torrent Pharmaceuticals LTD issuing a Voluntary Nationwide Recall of Losartan Tablets, USP, due to the detection of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, (API manufacturer).

FDA - U.S. Food and Drug Administration

16-3-2019

Legacy Pharmaceutical Packaging, LLC Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 25mg, 50mg, And 100mg Due to The Detection of Trace Amounts Of N-Nitroso N-Methyl 4-Amino Butyric Acid (NMBA) Impurity Found in The Active Pharmace

Legacy Pharmaceutical Packaging, LLC Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 25mg, 50mg, And 100mg Due to The Detection of Trace Amounts Of N-Nitroso N-Methyl 4-Amino Butyric Acid (NMBA) Impurity Found in The Active Pharmace

Earth City, MO, Legacy Pharmaceutical Packaging, LLC is recalling 40 repackaged lots of Losartan Tablets USP 25mg, 50mg, and 100mg to the consumer level. This recall was prompted due to Camber Pharmaceuticals, Inc. issuing a Voluntary Nationwide Recall of Losartan Tablets, USP, due to the detection of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, (API manufacturer).

FDA - U.S. Food and Drug Administration

15-3-2019

Modification of the existing maximum residue level for fluopyram in broccoli

Modification of the existing maximum residue level for fluopyram in broccoli

Published on: Thu, 14 Mar 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer Hellas AG submitted a request to the competent national authority in Greece to modify the existing maximum residue level (MRL) for the active substance fluopyram in broccoli. The data submitted in support of the request were found to be sufficient to derive MRL proposals for broccoli. Adequate analytical methods for enforcement are available to control the residues of fluopyram on the commodit...

Europe - EFSA - European Food Safety Authority EFSA Journal

14-3-2019

Safety of annatto E and the exposure to the annatto colouring principles bixin and norbixin (E 160b) when used as a food additive

Safety of annatto E and the exposure to the annatto colouring principles bixin and norbixin (E 160b) when used as a food additive

Published on: Wed, 13 Mar 2019 The Scientific Panel on Food Additives and Flavouring (FAF) provides a scientific opinion on the safety evaluation of annatto E and an exposure assessment of the annatto colouring principles bixin and norbixin (E 160b) when used as a food additive, taking into account new proposed uses and use levels. In 2016, the EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) adopted a scientific opinion on the safety of annatto extracts (E 160b) as a food additive....

Europe - EFSA - European Food Safety Authority EFSA Journal

14-3-2019

Safety evaluation of the food enzyme β‐glucanase, xylanase and cellulase from Mycothermus thermophiloides (strain NZYM‐ST)

Safety evaluation of the food enzyme β‐glucanase, xylanase and cellulase from Mycothermus thermophiloides (strain NZYM‐ST)

Published on: Fri, 08 Mar 2019 The food enzyme has three declared activities (endo‐1,3(4)‐β‐glucanase EC 3.2.1.6, endo‐1,4‐β‐xylanase EC 3.2.1.8 and cellulase (endo‐1,4‐β‐d‐glucanase EC 3.2.1.4)) and is produced with a non‐genetically modified Mycothermus thermophiloides strain by Novozymes A/S. It is intended to be used in baking and brewing processes. For the two intended uses, based on the maximum use levels recommended and individual data from the EFSA Comprehensive European Food Database, dietary e...

Europe - EFSA - European Food Safety Authority EFSA Journal

13-3-2019

Hometown Food Company Recalls Two Production LOT Codes of Pillsbury® Unbleached All-Purpose 5lb Flour Due to Possible Health Risk

Hometown Food Company Recalls Two Production LOT Codes of Pillsbury® Unbleached All-Purpose 5lb Flour Due to Possible Health Risk

Please be advised the Hometown Food Company initiated a limited, voluntary retail-level recall on two specific lot codes of its Pillsbury® Unbleached All-Purpose 5 lb Flour (UPC 51500-22241) because it may be contaminated with Salmonella. Only Best If Used By Dates APR 19 2020 and APR 20 2020 are impacted.

FDA - U.S. Food and Drug Administration

13-3-2019

Safety evaluation of the food enzyme triacylglycerol lipase from Aspergillus niger (strain LFS)

Safety evaluation of the food enzyme triacylglycerol lipase from Aspergillus niger (strain LFS)

Published on: Tue, 12 Mar 2019 The food enzyme triacylglycerol lipase (triacylglycerol acylhydrolase, EC 3.1.1.3) is produced with a genetically modified Aspergillus niger strain LFS by DSM Food Specialties B.V.. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. The triacylglycerol lipase food enzyme is intended to be used in baking processes. Based on the maximum use levels, dietary exposure to the fo...

Europe - EFSA - European Food Safety Authority EFSA Journal

13-3-2019

Safety evaluation of the food enzyme glucose oxidase from Aspergillus niger (strain ZGL)

Safety evaluation of the food enzyme glucose oxidase from Aspergillus niger (strain ZGL)

Published on: Tue, 12 Mar 2019 The food enzyme glucose oxidase (β‐d‐glucose:oxygen 1‐oxidoreductase; EC 1.1.3.4) is produced with a genetically modified Aspergillus niger strain ZGL by DSM Food Specialties B.V.. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. The glucose oxidase is intended to be used in baking processes. Based on the maximum use levels, dietary exposure to the food enzyme‐total orga...

Europe - EFSA - European Food Safety Authority EFSA Journal

12-3-2019


Agenda - CAT agenda of the 20-22 February 2019 meeting

Agenda - CAT agenda of the 20-22 February 2019 meeting

Agenda - CAT agenda of the 20-22 February 2019 meeting

Europe - EMA - European Medicines Agency

9-3-2019

Safety evaluation of the food enzyme 4‐α‐glucanotransferase from Aeribacillus pallidus (strain AE‐SAS)

Safety evaluation of the food enzyme 4‐α‐glucanotransferase from Aeribacillus pallidus (strain AE‐SAS)

Published on: Fri, 08 Mar 2019 The food enzyme 4‐α‐glucanotransferase (1,4‐α‐d‐glucan:1,4‐α‐d‐glucan 4‐α‐d‐glycosyltransferase, EC 2.4.1.25) is produced with a non‐genetically modified Aeribacillus pallidus (previously identified as Geobacillus pallidus) strain from Amano Enzyme Inc. The food enzyme is intended to be used in baking processes and in starch processing for the production of modified dextrins. For baking processes, based on the maximum use levels recommended and individual data from the EFS...

Europe - EFSA - European Food Safety Authority EFSA Journal

9-3-2019

Safety of ethyl lauroyl arginate (E 243) as a food additive in the light of the new information provided and the proposed extension of use

Safety of ethyl lauroyl arginate (E 243) as a food additive in the light of the new information provided and the proposed extension of use

Published on: Fri, 08 Mar 2019 The present scientific opinion deals with the evaluation of the safety of the food additive ethyl lauroyl arginate (E 243) in the light of a new interpretation of the available toxicological data and with respect to the proposed changes to the currently authorised conditions of use. Ethyl lauroyl arginate (E 243) is an already authorised food additive in the EU for use in heat‐treated meat products only, with some exceptions. The safety of ethyl lauroyl arginate (E 243) as...

Europe - EFSA - European Food Safety Authority EFSA Journal

8-3-2019


Draft Colchicine tablet 0.5 mg and 1 mg product-specific bioequivalence guidance

Draft Colchicine tablet 0.5 mg and 1 mg product-specific bioequivalence guidance

Draft Colchicine tablet 0.5 mg and 1 mg product-specific bioequivalence guidance

Europe - EMA - European Medicines Agency

7-3-2019

American Health Packaging Issues Voluntary Nationwide Recall of Valsartan Tablets Due to the Detection of NDEA (N-Nitrosodiethylamine) Impurity

American Health Packaging Issues Voluntary Nationwide Recall of Valsartan Tablets Due to the Detection of NDEA (N-Nitrosodiethylamine) Impurity

American Health Packaging is voluntarily recalling one lot of Valsartan Tablets, USP, 160 mg to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug product. The impurity detected in the finished drug product is N-Nitrosodiethylamine (NDEA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Resea...

FDA - U.S. Food and Drug Administration

7-3-2019

Re‐evaluation of Quillaia extract (E 999) as a food additive and safety of the proposed extension of use

Re‐evaluation of Quillaia extract (E 999) as a food additive and safety of the proposed extension of use

Published on: Wed, 06 Mar 2019 The EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion on Quillaia extract (E 999) when used as a food additive and the evaluation of the safety of its proposed extension of use as a food additive in flavourings. The Scientific Committee for Food (SCF) in 1978 established an acceptable daily intake (ADI) of 0–5 mg spray‐dried extract/kg body weight (bw) per day for E 999. The Joint FAO/WHO Expert Committee on Food Additives ...

Europe - EFSA - European Food Safety Authority EFSA Journal

7-3-2019

Safety and efficacy of Robenz® 66G (robenidine hydrochloride) for chickens for fattening and turkeys for fattening

Safety and efficacy of Robenz® 66G (robenidine hydrochloride) for chickens for fattening and turkeys for fattening

Published on: Tue, 05 Mar 2019 Following a request from European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of Robenz® 66G (robenidine hydrochloride (HCl)) when used as a feed additive for chickens for fattening and turkeys for fattening. The coccidiostat Robenz®66G is considered safe for chickens for fattening at the highest proposed level of 36 mg robenidine HCl/kg complete feed with a ...

Europe - EFSA - European Food Safety Authority EFSA Journal

5-3-2019

Morphine Sulfate Injection BP 30 mg in 1 mL ampoule

Morphine Sulfate Injection BP 30 mg in 1 mL ampoule

Safety advisory – Section 19A product not for epidural or intrathecal use

Therapeutic Goods Administration - Australia

5-3-2019

Opinion on the follow‐up of the re‐evaluation of sorbic acid (E200) and potassium sorbate (E202) as food additives

Opinion on the follow‐up of the re‐evaluation of sorbic acid (E200) and potassium sorbate (E202) as food additives

Published on: Fri, 01 Mar 2019 In this opinion, the EFSA Panel on Food Additives and Flavourings (FAF Panel) was requested by the European Commission to carry out a scientific evaluation of an extended one‐generation reproductive toxicity study (EOGRTS) to determine whether it would allow reconsideration of the temporary group acceptable daily intake (ADI) for sorbic acid (E 200) and potassium sorbate (E 202), established by the Panel on Food Additives and Nutrient Sources added to Food (ANS Panel) in 2...

Europe - EFSA - European Food Safety Authority EFSA Journal

1-3-2019

Pest categorisation of Thrips palmi

Pest categorisation of Thrips palmi

Published on: Thu, 28 Feb 2019 The EFSA Panel on Plant Health (PLH) performed a pest categorisation of Thrips palmi(Thysanoptera: Thripidae), for the EU. T. palmi is listed in Annex IAI of 2000/29 EC. Using molecular methods, cryptic speciation has been shown although no new species from the group have been formally described. Here, we consider T. palmi sensu lato as a defined species native to southern Asia, which has spread to tropical and subtropical countries in Asia, the Pacific, North, Central and...

Europe - EFSA - European Food Safety Authority EFSA Journal

1-3-2019

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 25 mg, 50 mg and 100 mg Due to the Detection of Trace Amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) Impurity found in the Active Pharmaceutical

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 25 mg, 50 mg and 100 mg Due to the Detection of Trace Amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) Impurity found in the Active Pharmaceutical

Camber Pharmaceuticals, Inc. is recalling 87 lots of Losartan Tablets USP 25 mg, 50 mg, and 100 mg to consumer level. This recall was prompted due to the detection of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, Unit – I (API manufacturer).

FDA - U.S. Food and Drug Administration

27-2-2019

Enforcement Report for the Week of February 27, 2019

Enforcement Report for the Week of February 27, 2019

Recently Updated Records for the Week of February 27, 2019 Last Modified Date: Wednesday, February 20, 2019

FDA - U.S. Food and Drug Administration

26-2-2019

Safety and efficacy of TYFER™ (ferric tyrosine chelate) as a zootechnical feed additive for chickens, turkeys and minor poultry species for fattening or reared for laying/breading

Safety and efficacy of TYFER™ (ferric tyrosine chelate) as a zootechnical feed additive for chickens, turkeys and minor poultry species for fattening or reared for laying/breading

Published on: Mon, 25 Feb 2019 Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the product TYFER™ (ferric tyrosine chelate) as zootechnical feed additive for chickens, turkeys and minor poultry species for fattening or reared for laying/breeding. The additive is safe for chickens for fattening at the maximum expected level of 200 mg TYFER™/kg complete feed; this conclusion can be extended to chickens reared for laying/breedin...

Europe - EFSA - European Food Safety Authority EFSA Journal

25-2-2019

Macleods Pharmaceuticals Limited Issues Voluntary Nationwide Consumer Level Recall of One Lot (BLM 715A) of Losartan Potassium/Hydrochlorothiazide Combination Tablets 100mg/25mg Due to detection of NDEA (N-Nitrosodiethylamine) Impurity

Macleods Pharmaceuticals Limited Issues Voluntary Nationwide Consumer Level Recall of One Lot (BLM 715A) of Losartan Potassium/Hydrochlorothiazide Combination Tablets 100mg/25mg Due to detection of NDEA (N-Nitrosodiethylamine) Impurity

Macleods Pharmaceuticals Limited is voluntarily recalling one lot of Losartan Potassium/Hydrochlorothiazide combination tablets 100mg/25mg to the consumer level due to the detection of trace amounts of an unexpected impurity (NDEA) found in finished product manufactured with active pharmaceutical ingredient made by Hetero Labs Limited.

FDA - U.S. Food and Drug Administration

25-2-2019

Xeljanz, Xeljanz XR (tofacitinib): Safety Communication - Safety Trial Finds Increased Risk of Blood Clots in the Lungs and Death with Higher Dose in Rheumatoid Arthritis Patients

Xeljanz, Xeljanz XR (tofacitinib): Safety Communication - Safety Trial Finds Increased Risk of Blood Clots in the Lungs and Death with Higher Dose in Rheumatoid Arthritis Patients

FDA is alerting the public that a safety clinical trial found an increased risk of blood clots in the lungs and death when a 10 mg twice daily dose of tofacitinib (Xeljanz, Xeljanz XR) was used in patients with rheumatoid arthritis (RA). FDA has not approved this 10 mg twice daily dose for RA; this dose is only approved in the dosing regimen for patients with ulcerative colitis

FDA - U.S. Food and Drug Administration

22-2-2019

February 20, 2019: Home Health Nurse Sentenced to Federal Prison for Tampering with Patients' Medication

February 20, 2019: Home Health Nurse Sentenced to Federal Prison for Tampering with Patients' Medication

February 20, 2019: Home Health Nurse Sentenced to Federal Prison for Tampering with Patients' Medication

FDA - U.S. Food and Drug Administration

22-2-2019

Enforcement Report for the Week of February 20, 2019

Enforcement Report for the Week of February 20, 2019

Recently Updated Records for the Week of February 20, 2019 Last Modified Date: Friday, February 22, 2019

FDA - U.S. Food and Drug Administration

21-2-2019

Annual report of the EFSA Scientific Network for Risk Assessment of GMOs for 2018

Annual report of the EFSA Scientific Network for Risk Assessment of GMOs for 2018

Published on: Wed, 20 Feb 2019 The EFSA Scientific Network for Risk Assessment of GMOs (the GMO Network) was established in accordance with EFSA's strategy for cooperation and networking with Member States. The goals of the GMO Network are to improve dialogue among members, build mutual understanding of risk assessment principles, enhance knowledge and confidence in the scientific assessment carried out in the EU, and increase the transparency of the process among Member States and EFSA. The annual repo...

Europe - EFSA - European Food Safety Authority EFSA Journal

14-2-2019

Modification of the existing maximum residue levels for mandipropamid in various crops

Modification of the existing maximum residue levels for mandipropamid in various crops

Published on: Wed, 13 Feb 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicants Syngenta Crop Protection B.V. and Agriculture and Horticulture Development Board (AHDB) submitted, respectively, a request to the competent national authorities in the Netherlands and United Kingdom to modify the existing maximum residue levels (MRLs) for the active substance mandipropamid in various crops. The data submitted in support of the request were found to be sufficient to derive MRL propo...

Europe - EFSA - European Food Safety Authority EFSA Journal

4-2-2019

Dr. Reddy's Laboratories Continues its Voluntary Nationwide Recall of Levetiracetam in 0.54% Sodium Chloride Injection 1500mg/100mL Due to Mislabeling

Dr. Reddy's Laboratories Continues its Voluntary Nationwide Recall of Levetiracetam in 0.54% Sodium Chloride Injection 1500mg/100mL Due to Mislabeling

Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY) announced that it’s wholly owned subsidiary, Dr Reddy’s Laboratories, Inc is continuing its voluntary nationwide recall of lot ABD807 of Levetiracetram in 0.54% Sodium Chloride Injection, 1,500 mg/100 mL (15 mg/mL) single-dose infusion bags to the hospital level in U.S.A.

FDA - U.S. Food and Drug Administration

30-1-2019

Tris Pharma, Inc Expands Its Voluntary Nationwide Retail Recall of Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 mL, Due to Higher Concentration of Ibuprofen

Tris Pharma, Inc Expands Its Voluntary Nationwide Retail Recall of Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 mL, Due to Higher Concentration of Ibuprofen

Monmouth Junction, NJ, Tris Pharma, Inc. is expanding the scope of its November 2018 recall by adding three (3) additional lots of Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 mL, to the retail (pharmacy) level. Some units from these batches have been found to have higher levels of Ibuprofen concentration.

FDA - U.S. Food and Drug Administration

26-1-2019

Safety assessment of the substance poly((R)‐3‐hydroxybutyrate‐co‐(R)‐3‐hydroxyhexanoate) for use in food contact materials

Safety assessment of the substance poly((R)‐3‐hydroxybutyrate‐co‐(R)‐3‐hydroxyhexanoate) for use in food contact materials

Published on: Fri, 25 Jan 2019 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP Panel) assessed the safety of poly((R)‐3‐hydroxybutyrate‐co‐(R)‐3‐hydroxyhexanoate) (PHBH), CAS No 147398‐31‐0 and food contact material (FCM) substance No 1059. This biodegradable copolymer is produced by fermentation of palm oil using a genetically modified microorganism (Cupriavidus necator). Overall migration was up to 5.4 mg/kg. Oligomers are hydroxyl‐terminated or with crotyl‐ and hexenyl end‐...

Europe - EFSA - European Food Safety Authority EFSA Journal

24-1-2019

General Mills Recalls Five Pound Bags of Gold Medal Unbleached Flour

General Mills Recalls Five Pound Bags of Gold Medal Unbleached Flour

General Mills announced today a voluntary national recall of five-pound bags of its Gold Medal Unbleached Flour with a better if used by date of April 20, 2020. The recall is being issued for the potential presence of Salmonella which was discovered during sampling of the five-pound bag product.

FDA - U.S. Food and Drug Administration

23-1-2019

Safety evaluation of the food enzyme lysophospholipase from Trichoderma reesei (strain RF7206)

Safety evaluation of the food enzyme lysophospholipase from Trichoderma reesei (strain RF7206)

Published on: Tue, 22 Jan 2019 The food enzyme lysophospholipase (EC 3.1.1.5) is produced with the genetically modified Trichoderma reesei strain RF7206 by AB Enzymes GmbH. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. The lysophospholipase food enzyme is intended to be used in starch processing for the production of glucose syrups. Residual amounts of total organic solids (TOS) are removed by the ...

Europe - EFSA - European Food Safety Authority EFSA Journal

22-1-2019

Modification of the existing maximum residue level for trifloxystrobin in broccoli

Modification of the existing maximum residue level for trifloxystrobin in broccoli

Published on: Mon, 21 Jan 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer Hellas AG submitted a request to the competent national authority in Greece to modify the existing maximum residue level (MRL) for the active substance trifloxystrobin in broccoli. The data submitted in support of the request were found to be sufficient to derive an MRL proposal for broccoli. Adequate analytical methods for enforcement are available to control the residues of trifloxystrobin o...

Europe - EFSA - European Food Safety Authority EFSA Journal

22-1-2019

Modification of the existing maximum residue levels for aclonifen in celeriacs and certain fresh herbs

Modification of the existing maximum residue levels for aclonifen in celeriacs and certain fresh herbs

Published on: Mon, 21 Jan 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicants Landesanstalt für Landwirtschaft und Gartenbau Sachsen‐Anhalt (LSA) and Dienstleistungszentrum Ländlicher Raum Rheinpfalz (DLR), respectively, submitted a request to the competent national authority in Germany to modify the existing maximum residue levels (MRL) for the active substance aclonifen in chives, parsley, celery leaves/dill leaves, thyme/savoury and in celeriacs/turnip‐rooted celery. The ...

Europe - EFSA - European Food Safety Authority EFSA Journal

22-1-2019

Modification of the existing maximum residue levels for aminopyralid in certain cereals

Modification of the existing maximum residue levels for aminopyralid in certain cereals

Published on: Mon, 21 Jan 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Dow AgroSciences Denmark submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue levels (MRLs) for the active substance aminopyralid in cereals. The data submitted in support of the request were found to be sufficient to derive MRL proposals for barley, rye, sorghum, millet and oats. A modification of the existing MRL of aminopyralid in wh...

Europe - EFSA - European Food Safety Authority EFSA Journal

19-1-2019

Safety for the environment of vitamin D3 for salmonids

Safety for the environment of vitamin D3 for salmonids

Published on: Thu, 17 Jan 2019 The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) of EFSA assessed the safety for the target species and the consumer of the use of a maximum total level of 1.5 mg vitamin D3/kg feed in fish nutrition (2017). The assessment was based on data that had been provided by the Norwegian Food Safety Authority (NFSA). Since the data set provided by the NFSA did not include any new information concerning the safety for the user and the environment...

Europe - EFSA - European Food Safety Authority EFSA Journal

13-3-2019

Cresemba (Basilea Pharmaceutica Deutschland GmbH)

Cresemba (Basilea Pharmaceutica Deutschland GmbH)

Cresemba (Active substance: isavuconazole) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)2069 of Wed, 13 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/2734/T/20

Europe -DG Health and Food Safety

8-3-2019

Public submissions on scheduling matters referred to the ACMS #25, ACCS #23 and Joint ACMS-ACCS #20 meetings held in November 2018

Public submissions on scheduling matters referred to the ACMS #25, ACCS #23 and Joint ACMS-ACCS #20 meetings held in November 2018

Public submissions on scheduling matters referred to ACMS/ACCS meetings held in November 2018

Therapeutic Goods Administration - Australia

6-3-2019


Orphan designation: Avacopan, Treatment of C3 glomerulopathy, 20/06/2017, Positive

Orphan designation: Avacopan, Treatment of C3 glomerulopathy, 20/06/2017, Positive

Orphan designation: Avacopan, Treatment of C3 glomerulopathy, 20/06/2017, Positive

Europe - EMA - European Medicines Agency

20-2-2019


Orphan designation: Rufinamide, Treatment of Lennox-Gastaut syndrome, 20/10/2004, Expired

Orphan designation: Rufinamide, Treatment of Lennox-Gastaut syndrome, 20/10/2004, Expired

Orphan designation: Rufinamide, Treatment of Lennox-Gastaut syndrome, 20/10/2004, Expired

Europe - EMA - European Medicines Agency

20-2-2019

Rizmoic (Shionogi B.V.)

Rizmoic (Shionogi B.V.)

Rizmoic (Active substance: naldemedine) - Centralised - Authorisation - Commission Decision (2019)1520 of Wed, 20 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/4256

Europe -DG Health and Food Safety

20-2-2019

Tobramycin PARI (PARI Pharma GmbH)

Tobramycin PARI (PARI Pharma GmbH)

Tobramycin PARI (Active substance: tobramycin) - Centralised - Authorisation - Commission Decision (2019)1504 of Wed, 20 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/5086

Europe -DG Health and Food Safety

20-2-2019

Miglustat Dipharma (Dipharma B.V.)

Miglustat Dipharma (Dipharma B.V.)

Miglustat Dipharma (Active substance: miglustat) - Centralised - Authorisation - Commission Decision (2019)1512 of Wed, 20 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/004904/0000

Europe -DG Health and Food Safety

20-2-2019

Advagraf (Astellas Pharma Europe B.V.)

Advagraf (Astellas Pharma Europe B.V.)

Advagraf (Active substance: Tacrolimus) - PSUSA - Modification - Commission Decision (2019)1513 of Wed, 20 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/00002839/201803

Europe -DG Health and Food Safety

20-2-2019

Vantobra (PARI Pharma GmbH)

Vantobra (PARI Pharma GmbH)

Vantobra (Active substance: Tobramycin) - Centralised - Withdrawal - Commission Decision (2019)1511 of Wed, 20 Feb 2019

Europe -DG Health and Food Safety

20-2-2019

Silgard (Merck Sharp and Dohme Limited)

Silgard (Merck Sharp and Dohme Limited)

Silgard (Active substance: Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed)) - Centralised - Withdrawal - Commission Decision (2019)1516 of Wed, 20 Feb 2019

Europe -DG Health and Food Safety

20-2-2019

Lusutrombopag Shionogi (Shionogi B.V.)

Lusutrombopag Shionogi (Shionogi B.V.)

Lusutrombopag Shionogi (Active substance: lusutrombopag) - Centralised - Authorisation - Commission Decision (2019)1507 of Wed, 20 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/4720

Europe -DG Health and Food Safety

20-2-2019

ATryn (Laboratoire franCais du Fractionnement et des Biotechnologies)

ATryn (Laboratoire franCais du Fractionnement et des Biotechnologies)

ATryn (Active substance: antithrombin alfa) - Centralised - Annual reassessment - Commission Decision (2019)1509 of Wed, 20 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/587/S/35

Europe -DG Health and Food Safety

20-2-2019

Zelboraf (Roche Registration GmbH)

Zelboraf (Roche Registration GmbH)

Zelboraf (Active substance: vemurafenib) - Centralised - Yearly update - Commission Decision (2019)1506 of Wed, 20 Feb 2019

Europe -DG Health and Food Safety

20-2-2019

Pixuvri (CTI Life Sciences Deutschland GmbH)

Pixuvri (CTI Life Sciences Deutschland GmbH)

Pixuvri (Active substance: pixantrone) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)1510 of Wed, 20 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/002055/T/0045

Europe -DG Health and Food Safety

20-2-2019

Zyprexa (Eli Lilly Nederland B.V.)

Zyprexa (Eli Lilly Nederland B.V.)

Zyprexa (Active substance: Olanzapine) - Centralised - Yearly update - Commission Decision (2019)1515 of Wed, 20 Feb 2019

Europe -DG Health and Food Safety

20-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Autologous CD34+ hematopoietic stem cells transduced ex vivo with EFS lentiviral vector encoding for the human adenosine deaminase gene, decision type: , therapeutic area: , PIP number: P/0400/20

Opinion/decision on a Paediatric investigation plan (PIP): Autologous CD34+ hematopoietic stem cells transduced ex vivo with EFS lentiviral vector encoding for the human adenosine deaminase gene, decision type: , therapeutic area: , PIP number: P/0400/20

Opinion/decision on a Paediatric investigation plan (PIP): Autologous CD34+ hematopoietic stem cells transduced ex vivo with EFS lentiviral vector encoding for the human adenosine deaminase gene, decision type: , therapeutic area: , PIP number: P/0400/2018

Europe - EMA - European Medicines Agency

13-2-2019


Orphan designation: Adeno-associated viral vector serotype LK03 encoding human ornithine transcarbamylase, Treatment of ornithine transcarbamylase deficiency, 20/03/2017, Positive

Orphan designation: Adeno-associated viral vector serotype LK03 encoding human ornithine transcarbamylase, Treatment of ornithine transcarbamylase deficiency, 20/03/2017, Positive

Orphan designation: Adeno-associated viral vector serotype LK03 encoding human ornithine transcarbamylase, Treatment of ornithine transcarbamylase deficiency, 20/03/2017, Positive

Europe - EMA - European Medicines Agency

4-2-2019

Feraccru (Norgine B.V.)

Feraccru (Norgine B.V.)

Feraccru (Active substance: ferric maltol) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)857 of Mon, 04 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/2733/T/20

Europe -DG Health and Food Safety

1-2-2019

Diotop 75 mg / 20 mg modified-release capsules, hard and associated names

Diotop 75 mg / 20 mg modified-release capsules, hard and associated names

Diotop 75 mg / 20 mg modified-release capsules, hard and associated names (Active substance: diclofenac/omeprazole) - Community Referrals - Art 29 - Commission Decision (2019)845 of Fri, 01 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/A-29(4)/1474

Europe -DG Health and Food Safety

1-2-2019


Withdrawn application: Cavoley, pegfilgrastim, Date of withdrawal: 20/12/2018, Initial authorisation

Withdrawn application: Cavoley, pegfilgrastim, Date of withdrawal: 20/12/2018, Initial authorisation

Withdrawn application: Cavoley, pegfilgrastim, Date of withdrawal: 20/12/2018, Initial authorisation

Europe - EMA - European Medicines Agency

1-2-2019


Withdrawn application: Efgratin, pegfilgrastim, Date of withdrawal: 20/12/2019, Initial authorisation

Withdrawn application: Efgratin, pegfilgrastim, Date of withdrawal: 20/12/2019, Initial authorisation

Withdrawn application: Efgratin, pegfilgrastim, Date of withdrawal: 20/12/2019, Initial authorisation

Europe - EMA - European Medicines Agency

1-2-2019


Referral: Lartruvo, olaratumab, Article 20 procedures, 31/01/2019

Referral: Lartruvo, olaratumab, Article 20 procedures, 31/01/2019

Referral: Lartruvo, olaratumab, Article 20 procedures, 31/01/2019

Europe - EMA - European Medicines Agency

23-1-2019


Orphan designation: Allogeneic ex-vivo-expanded umbilical cord blood-derived haematopoietic CD34+ progenitor cells and allogeneic non-expanded umbilical cord blood-derived haematopoietic mature myeloid and lymphoid cells, Treatment in haematopoietic stem

Orphan designation: Allogeneic ex-vivo-expanded umbilical cord blood-derived haematopoietic CD34+ progenitor cells and allogeneic non-expanded umbilical cord blood-derived haematopoietic mature myeloid and lymphoid cells, Treatment in haematopoietic stem

Orphan designation: Allogeneic ex-vivo-expanded umbilical cord blood-derived haematopoietic CD34+ progenitor cells and allogeneic non-expanded umbilical cord blood-derived haematopoietic mature myeloid and lymphoid cells, Treatment in haematopoietic stem cell transplantation, 20/03/2017, Positive

Europe - EMA - European Medicines Agency

22-1-2019


Orphan designation: 17α,21-Dihydroxy-16α-methyl-pregna-1,4,9(11)-triene-3,20-dione, Treatment of Duchenne muscular dystrophy, 22/08/2014, Positive

Orphan designation: 17α,21-Dihydroxy-16α-methyl-pregna-1,4,9(11)-triene-3,20-dione, Treatment of Duchenne muscular dystrophy, 22/08/2014, Positive

Orphan designation: 17α,21-Dihydroxy-16α-methyl-pregna-1,4,9(11)-triene-3,20-dione, Treatment of Duchenne muscular dystrophy, 22/08/2014, Positive

Europe - EMA - European Medicines Agency