Elanix 10 mg tablete

Glavna informacija

  • Trgovački naziv:
  • Elanix 10 mg tablete
  • Doziranje:
  • 10 mg
  • Farmaceutski oblik:
  • tableta
  • Sastav:
  • Urbroj: svaka tableta sadrži 10 mg ezetimiba
  • Tip recepta:
  • na recept, u ljekarni ponovljivi recept
  • Koristi za:
  • Ljudi
  • Vrsta lijekova:
  • alopatski lijek
  • Proizveden od:
  • Lek Pharmaceuticals d.d., Ljubljana, Slovenija; Salutas Pharma GmbH, Barleben, Njemačka; Lek S.A., Varšava, Poljska; S.C. San

Dokument

Lokalizacija

  • Na raspolaganju u:
  • Elanix 10 mg tablete
    Hrvatska
  • Jezik:
  • hrvatski

Terapeutski informacija

  • Proizvod sažetak:
  • Pakiranje: 7 tableta u blisteru, u kutiji [HR-H-949302548-01]; 10 tableta u blisteru, u kutiji [HR-H-949302548-02]; 14 tableta u blisteru, u kutiji [HR-H-949302548-03]; 20 tableta u blisteru, u kutiji [HR-H-949302548-04]; 28 tableta u blisteru, u kutiji [HR-H-949302548-05]; 30 tableta u blisteru, u kutiji [HR-H-949302548-06]; 50 tableta u blisteru, u kutiji [HR-H-949302548-07]; 56 tableta u blisteru, u kutiji [HR-H-949302548-08]; 60 tableta u blisteru, u kutiji [HR-H-949302548-09]; 84 tableta u blisteru, u kutiji [HR-H-949302548-10]; 90 tableta u blisteru, u kutiji [HR-H-949302548-11]; 98 tableta u blisteru, u kutiji [HR-H-949302548-12]; 100 tableta u blisteru, u kutiji [HR-H-949302548-13]; 100 tableta u blisteru, u kutiji (bolničko pakiranje) [HR-H-949302548-14]; 100 tableta u bočici, u kutiji [HR-H-949302548-15]; 250 tableta u bočici, u kutiji (bolničko pakiranje) [HR-H-949302548-16] Urbroj: 381-12-01/70-18-04

Druge informacije

Status

  • Izvor:
  • HALMED Agencija za lijekove i medicinske proizvode - Agency for medicinal products and medical devices of Croatia
  • Broj odobrenja:
  • HR-H-949302548
  • Datum autorizacije:
  • 19-01-2018
  • Zadnje ažuriranje:
  • 04-06-2018

Uputu o lijeku

Uputa o lijeku: Informacija za bolesnika

Elanix 10 mg tablete

ezetimib

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 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:

1. Što je Elanix i za što se koristi

2. Što morate znati prije nego počnete uzimati Elanix

3. Kako uzimati Elanix

4. Moguće nuspojave

5. Kako čuvati Elanix

6. Sadržaj pakiranja i druge informacije

1. Što je Elanix i za što se koristi

Elanix je lijek koji snižava razinu ukupnog kolesterola.

Elanix snižava razinu ukupnog kolesterola,

štetnog

kolesterola (LDL kolesterol) i masnih tvari

zvanih trigliceridi u krvi. Osim toga ovaj lijek povisuje vrijednosti

korisnog

kolesterola (HDL

kolesterol) koji tijelo stvara samo.

Ezetimib, djelatna tvar Elanixa smanjuje apsorpciju kolesterola u probavnom traktu

Elanix pojačava učinak smanjenja kolesterola koji imaju statini, skupina lijekova koja snižava razinu

kolesterola kojeg stvara samo tijelo.

Kolesterol je jedna od nekoliko masnih tvari koje se nalaze u krvotoku. Vaš ukupni kolesterol sastoji

se uglavnom od LDL i HDL kolesterola.

LDL kolesterol često se naziva

štetnim

kolesterolom zato što se može nakupljati u stijenkama

arterija i stvarati plak. Nakupljeni plak naposljetku može dovesti do suženja arterija. Suženje arterija

može usporiti ili prekinuti protok krvi do vitalnih organa, kao što su srce i mozak. Takav prekid

protoka krvi može rezultirati srčanim ili moždanim udarom.

HDL kolesterol često se naziva

korisnim

kolesterolom, zato što pomaže u sprječavanju nakupljanja

štetnog

kolesterola u arterijama i štiti od srčane bolesti.

Trigliceridi su još jedan oblik masti u krvi koji mogu povećati Vaš rizik od srčane bolesti.

Ovaj lijek namijenjen je bolesnicima koji ne mogu regulirati razinu kolesterola samo dijetom

snižavanje kolesterola. Za vrijeme uzimanja ovog lijeka nužno je da nastavite s dijetom za snižavanje

kolesterola.

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19 - 01 - 2018

O D O B R E N O

Elanix se uzima kao dodatak dijeti za snižavanje kolesterola ako imate:

povišene vrijednosti kolesterola u krvi (primarna hiperkolesterolemija [heterozigotna obiteljska i

ne-obiteljska])

zajedno s statinom, kada razina kolesterola nije odgovarajuće kontrolirana samo sa statinom,

samostalno, kada liječenje statinom nije primjereno ili se ne podnosi.

nasljednu bolest (homozigotna obiteljska hiperkolesterolemija) koja povisuje vrijednosti

kolesterola u krvi. TakoĎer će Vam biti propisan statin, a mogli biste primati i druge oblike

liječenja.

nasljednu bolest (homozigotna sitosterolemija, poznata i kao fitosterolemija) koja povisuje

vrijednosti biljnih sterola u krvi.

Ako imate bolest srca, ovaj lijek u kombinaciji s lijekovima za snižavanje kolesterola koji se nazivaju

statini smanjuje rizik od srčanog udara, moždanog udara, operacije povećanja protoka krvi srca ili

hospitalizaciju zbog bolova u prsima.

Elanix Vam ne pomaže u smanjivanju tjelesne težine.

2. Što morate znati prije nego počnete uzimati Elanix

Ako uzmete Elanix zajedno sa statinom, molimo Vas da pročitate odgovarajuću uputu o lijeku za taj

lijek.

NEMOJTE uzimati Elanix:

ako ste alergični (preosjetljivi) na ezetimib ili na bilo koji drugi sastojak ovog lijeka (naveden u

dijelu 6).

NEMOJTE uzimati Elanix zajedno sa statinom ako:

imate tegobe s jetrom

ako ste trudni ili dojite.

Upozorenja i mjere opreza

Obratite se svom liječniku ili ljekarniku prije uzimanja lijeka Elanix.

Obavijestite svog liječnika o svim Vašim zdravstvenim tegobama koje imate uključujući i alergije.

Prije nego započnete s uzimanjem ovog lijeka zajedno s statinom Vaš liječnik treba provesti

pretragu krvi. To je potrebno kako bi se provjerio rad Vaše jetre.

Vaš će liječnik možda željeti provjeriti krvne pretrage nakon početka istodobne primjene ovog

lijeka i statina kako bi provjerio kako radi Vaša jetra.

Ako imate umjerene ili teške tegobe s jetrom, Elanix se ne preporučuje.

Istodobnu primjenu Elanixa i fibrata (lijekovi za snižavanje kolesterola) treba izbjegavati budući da

kod kombinirane primjene Elanixa i fibrata sigurnost i djelotvornost nije utvrĎena.

Obratite se odmah svom liječnika ako opazite

bol u mišićima nepoznatog uzroka, osjetljivost ili slabost.

To je zbog toga što se u rijetkim slučajevima jave problemi s mišićima uključujući i razgradnju

mišićnog tkiva, što može dovesti do oštećenja bubrega, to može biti ozbiljno i opasno po život.

Opasnost od mišićne razgradnje je veća u nekih bolesnika koji uzimaju Elanix sa lijekovima za

snižavanje kolesterola poput statina.

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O D O B R E N O

Djeca i adolescenti

Nemojte davati ovaj lijek djeci i adolescenatima (od 6 do 17 godina), osim ako ga je propisao liječnik

specijalist, jer postoje ograničeni podaci o sigurnosti i djelotvornosti. Nemojte davati ovaj lijek djeci

mlaĎoj od 6 godina jer nema informacija u ovoj dobnoj skupini.

Drugi lijekovi i Elanix

Obavijestite svog liječnika ili ljekarnika ako uzimate ili ste nedavno uzeli bilo koje druge lijekove.

Veoma je važno da svog liječnika obavijestite ako uzimate nešto od niže navedenog:

ciklosporin (lijek kojeg često uzimaju bolesnici s presaĎenim organima)

lijekove s djelatnom tvari za sprječavanje zgrušavanja krvi, kao što su varfarin, fenoprokumon,

acenokumarol ili fluinidon (antikoagulansi)

kolestiramin (lijek za snižavanje kolesterola), jer on mijenja učinak ezetimiba (vidjeti dio 3)

fibrate (lijekovi za snižavanje kolesterola) (takoĎer vidjeti dio 2: Upozorenja i mjere opreza).

Trudnoća i dojenje

Ako ste trudni ili dojite, mislite da ste trudni ili planirate zatrudnjeti, posavjetujte se sa svojim

liječnikom ili ljekarnikom prije nego uzmete ovaj lijek.

Trudnoća

Nemojte uzeti Elanix zajedno sa statinom ako ste trudni, pokušavate zatrudnjeti ili mislite da biste

mogli biti trudni. Zatrudnite li dok uzimate Elanix zajedno sa statinom, odmah prekinite uzimanje oba

lijeka i obavijestite svog liječnika.

Nema iskustava o primjeni lijeka Elanix bez statina tijekom trudnoće.

Dojenje

Nemojte uzimati Elanix zajedno sa statinom ako dojite jer nije poznato izlučuju li se ti lijekovi u

majčino mlijeko.

Elanix bez statina ne smijete uzimati ako dojite. Posavjetujte se sa svojim liječnikom.

Upravljanje vozilima i rad na strojevima

Ne očekuje se da će Elanix utjecati na Vašu sposobnost upravljanja vozilima ili rada na strojevima.

MeĎutim, neki ljudi mogu osjetiti omaglicu nakon uzimanja Elanixa. Ako vam se to desi nemojte

upravljati vozilom ili raditi na strojevima dok Vam ne bude bolje.

Elanix sadrži laktozu

Ako Vam je liječnik rekao da ne podnosite odreĎene vrste šećera, razgovarajte s njim prije nego što

počnete uzimati ovaj lijek.

3. Kako uzimati Elanix

Uvijek uzmite Elanix točno onako kako Vam je rekao Vaš liječnik. Nastavite uzimati druge lijekove

za snižavanje kolesterola sve dok Vam vaš liječnik ne kaže da prestanete. Provjerite sa svojim

liječnikom ili ljekarnikom ako niste sigurni.

Prije početka liječenja ovim lijekom, morate biti na odgovarajućoj dijeti za snižavanje

kolesterola.

Za vrijeme liječenja ovim lijekom trebate nastaviti s dijetom za snižavanje kolesterola.

Preporučena doza je jedna tableta jedanput na dan, kroz usta.

Ovaj lijek možete uzimati u bilo koje doba dana. Može se uzimati s hranom ili bez nje.

H A L M E D

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O D O B R E N O

Ako Vam je liječnik propisao liječenje lijekom Elanix zajedno s nekim od statina, oba se lijeka mogu

uzimati istodobno. U tom slučaju, molimo Vas da pročitate odgovarajuću uputu o lijeku za taj lijek.

Ako Vam je liječnik propisao liječenje lijekom Elanix zajedno s drugim lijekom za snižavanje

kolesterola koji sadrži djelatnu tvar kolestiramin ili neki drugi adsorbens žučnih kiselina (lijek za

snižavanje kolesterola), Elanix morate uzimati najmanje 2 sata prije ili 4 sata nakon adsorbensa

žučnih kiselina.

Ako uzmete više lijeka Elanix nego što ste trebali

Obratite se svom liječniku ili ljekarniku ako ste uzeli više lijeka Elanix nego što ste trebali.

Ako ste zaboravili uzeti lijek Elanix

Nemojte uzeti dvostruku dozu kako bi nadoknadili propuštenu. Nastavite uzimati uobičajenu dozu

Elanixa u isto vrijeme sljedeći dan.

Ako prestanete uzimati Elanix

Obratite se svom liječniku ili ljekarniku jer Vam se kolesterol može ponovo povećati ako prestanete

uzimati ovaj lijek.

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

4. Moguće nuspojave

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

Obratite se odmah svom liječnika ako primijetite

bol u mišićima nepoznatog uzroka

osjetljivost ili slabost u mišićima.

To je zbog toga što se u rijetkim slučajevima jave problemi s mišićima uključujući i razgradnju

mišićnog tkiva, što može dovesti do oštećenja bubrega, to može biti ozbiljno i opasno po život.

Alergijske reakcije, uključujući

oticanje lica, usana, jezika, i/ili grla s mogućim otežanim disanjem ili gutanjem,

omaglica ili nesvjestica i neuobičajeno brzi ili nepravilan otkucaj srca koje zahtjeva hitno

liječenje, prijavljene su u širokoj primjeni.

Ostale nuspojave prijavljene u kliničkim pokusima

Kada se lijek uzimao sam, bile su prijavljene sljedeće nuspojave:

Česte nuspojave (javljaju se u manje od 1 na 10 bolesnika)

bol u trbuhu

proljev

vjetrovi

osjećaj umora.

Manje česte nuspojave (javljaju se u manje od 1 na 100 bolesnika)

povišene vrijednosti nekih laboratorijskih krvnih pretraga funkcije jetre (jetrene transaminaze) ili

mišića (kreatin kinaze);

kašalj

probavne smetnje

žgaravica

mučnina

bol u zglobovima

H A L M E D

19 - 01 - 2018

O D O B R E N O

grčevi u mišićima

bol u vratu

smanjen tek

bol u prsima

navale vrućine

visok krvni tlak.

Osim toga, kada se lijek uzimao sa statinom, bile su prijavljene sljedeće nuspojave:

Česte nuspojave (javljaju se u manje od 1 na 10 bolesnika)

povišene vrijednosti nekih laboratorijskih krvnih pretraga funkcije jetre (transaminaze)

glavobolja

osjetljivost ili slabost u mišićima.

Manje česte nuspojave (javljaju se u manje od 1 na 100 bolesnika)

osjećaj trnaca (poput uboda igle)

suha usta

upala želučane sluznice

svrbež

osip

koprivnjača

bol u leĎima

slabost u mišićima

bol u rukama i nogama

neuobičajeni umor ili slabost

oticanje, osobito šaka i stopala.

Kad se lijek uzimao istodobno s fenofibratom (lijek za visok kolesterol), bile su prijavljene sljedeće

nuspojave:

Česte nuspojave (javljaju se u manje od 1 na 10 bolesnika)

bol u trbuhu

Osim toga, bile su prijavljene sljedeće nuspojave nakon široke primjene (prijavljene nakon

prvog stavljanja u promet):

Nepoznata nuspojava (učestalost se ne može procijeniti iz dostupnih podataka):

omaglica

tegobe s jetrom

alergijske reakcije uključujući osip i koprivnjaču, oticanje lica, jezika ili grla i nesvjestica

osip crvene boje iznad razine kože, ponekad s promjerom u obliku mete, ružičasto crveni prsten

oko blijedog središta

bolovi u mišićima/osjetljivost na dodir

slabost mišića: grčevi, ukočenost ili grč

jaka mišićna bol ili slabost, crveno smeĎa mokraća zbog razgradnje mišića

žučni kamenci ili upala žučnog mjehura (što uzrokuje jaku bol u trbuhu, mučninu, povraćanje)

upala gušterače često s jakom boli u trbuhu

zatvor

smanjenje broja krvnih stanica što može uzrokovati modrice/krvarenje (trombocitopenija)

osjećaj trnaca

depresija

neuobičajeni umor ili slabost

H A L M E D

19 - 01 - 2018

O D O B R E N O

nedostatak zraka.

Prijavljivanje nuspojava

Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika, ljekarnika ili medicinsku

sestru. Ovo 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 Elanix

Ovaj lijek čuvajte izvan pogleda i dohvata djece.

Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na blisteru, kutiji i bočici

iza "Rok valjanosti". Rok valjanosti odnosi se na zadnji dan navedenog mjeseca.

Blisteri: Čuvajte u originalnom pakiranju radi zaštite od vlage.

Bočice: Čuvajte u originalnom pakiranju radi zaštite od vlage.

Nakon prvog otvaranja: Čuvati na temperaturi ispod 25°C. Upotrijebite unutar 9 mjeseci.

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 Elanix sadrži

Djelatna tvar je ezetimib.

Svaka tableta sadrži 10 mg ezetimiba.

Drugi sastojci su: laktoza hidrat (vidjeti dio 2, za dodatne informacije), hipromeloza,

karmeloza natrij, mikrokristaličnaceluloza, natrijev laurilsulfat i magnezijev stearat.

Kako Elanix izgleda i sadržaj pakiranja

Elanix je bijela do gotovo bijela, ovalna tableta (7,4 mm x 4,1 mm) s utisnutim “10” na jednoj strani i

“EZT” na drugoj strani.

Al/Al blister ili PVC/PVDC/Al blister: 7, 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98, 100 i 100

(bolničko pakiranje) tableta.

HDPE bočica sa polipropilenskim zatvaračem: 100 tableta i 250 tableta (bolničko pakiranje).

Na tržištu se ne moraju nalaziti sve veličine pakiranja.

Nositelj odobrenja za stavljanje lijeka u promet i proizvoĎač

Nositelj odobrenja za stavljanje lijeka u promet

Sandoz d.o.o., Maksimirska 120, Zagreb, Republika Hrvatska

ProizvoĎač

Lek Pharmaceuticals d.d., Verovškova 57, Ljubljana, Slovenija

LEK S.A., Domaniewska str. 50 C, 02-672 Varšava, Poljska

S.C. Sandoz S.R.L., 7A Livezeni St., Tg. Mures, Mures District, Rumunjska

Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Njemačka

H A L M E D

19 - 01 - 2018

O D O B R E N O

Ovaj lijek je odobren u državama članicama Europskog ekonomskog prostora (EEA) pod

sljedećim nazivima:

Austrija

Ezetimib Sandoz 10 mg – Tabletten

Belgija

Ezetimibe Sandoz 10 mg tabletten

Cipar

Ezetimibe Sandoz 10 mg

Češka

Tezzimi 10 mg

Danska

Ezetimib Sandoz

Estonija

Kolxip

Finska

Ezetimib Sandoz 10 mg tabletti

Francuska

EZETIMIBE SANDOZ 10 mg,comprimé

Njemačka

Ezetimib – 1 A Pharma 10 mg Tabletten

Grčka

Ezetimibe/Sandoz

MaĎarska

Ezetimibe Sandoz 10 mg tabletta

Italija

EZETIMIBE SANDOZ

Latvija

Kolxip 10 mg tablets

Litva

Kolxip 10 mg tablets

Luksemburg

Ezetimib Sandoz 10 mg comprimés

Malta

Ezetimibe 10mg Tablets

Nizozemska

Ezetimibe Sandoz 10 mg, tabletten

Norveška

Ezetimib Sandoz 10 mg tabletter

Poljska

Tactus

Portugal

Ezetimiba Sandoz

Rumunjska

EZETIMIB SANDOZ 10 mg comprimate

Slovačka

Ezetimibe Sandoz 10 mg

Slovenija

Elanix 10 mg tablete

Španjolska

Ezetimiba Sandoz 10 mg comprimidos EFG

Švedska

Ezetimib Sandoz 10 mg tabletter

Velika Britanija

Ezetimibe 10mg Tablets

Način i mjesto izdavanja lijeka

Lijek se izdaje na recept, u ljekarni.

Ova uputa je zadnji puta revidirana u siječnju 2018.

H A L M E D

19 - 01 - 2018

O D O B R E N O

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Mom Life Market recalls 10" & 16" Personalized Stuffed Plush Bunnies

Mom Life Market recalls 10" & 16" Personalized Stuffed Plush Bunnies

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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

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Applicability of in silico tools for the prediction of dermal absorption for pesticides

Applicability of in silico tools for the prediction of dermal absorption for pesticides

Published on: Tue, 16 Oct 2018 00:00:00 +0200 Based on the “Human in vitro dermal absorption datasets” published as supporting information to the revised EFSA Guidance on Dermal Absorption, in silico models for prediction of absorption across the skin have been evaluated. For this evaluation, a systematic literature search and review was performed, identifying 288 publications describing mathematical models for prediction of dermal absorption. Eleven models potentially relevant to the regulatory assessm...

Europe - EFSA - European Food Safety Authority Publications

11-10-2018

Re‐evaluation of oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (E 479b) as a food additive

Re‐evaluation of oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (E 479b) as a food additive

Published on: Wed, 10 Oct 2018 00:00:00 +0200 The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion re‐evaluating the safety of thermally oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (TOSOM) (E 479b) when used as a food additive. The Scientific Committee on Food (SCF) and the Joint FAO/WHO Expert Committee on Food Additives (JECFA) derived an acceptable daily intake (ADI) of 25 and 30 mg/kg body weight (bw) per day, respectively. There was n...

Europe - EFSA - European Food Safety Authority Publications

11-10-2018

Wild boar in focus: Review of existing models on spatial distribution and density of wild boar and proposal for next steps

Wild boar in focus: Review of existing models on spatial distribution and density of wild boar and proposal for next steps

Published on: Wed, 10 Oct 2018 00:00:00 +0200 This report provides a review of existing models for predicting the spatial distribution and abundance of wild boar at various scales (global, continental, national and regional) in order to inform the development of a new model to produce estimates of wild boar abundance at European level. The review identifies and discusses a range of models based on a wide variety of data types, corresponding to those targeted by the data collection model set by ENETwild,...

Europe - EFSA - European Food Safety Authority Publications

10-10-2018

Sprayology Issues Voluntary Nationwide Recall of Homeopathic Aqueous-Based Medicines Due to Microbial Contamination

Sprayology Issues Voluntary Nationwide Recall of Homeopathic Aqueous-Based Medicines Due to Microbial Contamination

Eight and Company LLC, d/b/a Sprayology is voluntarily recalling all lots within expiry from 10/18-7/22 of its aqueous-based homeopathic product line for human use. All products manufactured by the contract manufacturer, King Bio, have been recalled due to possible microbial contamination.

FDA - U.S. Food and Drug Administration

10-10-2018

Enforcement Report for the Week of October 10, 2018

Enforcement Report for the Week of October 10, 2018

Recently Updated Records for the Week of October 10, 2018 Last Modified Date: Tuesday, October 09, 2018

FDA - U.S. Food and Drug Administration

24-9-2018

FDA Announces Availability of Resources for Animal Drug Sponsors

FDA Announces Availability of Resources for Animal Drug Sponsors

The FDA is making available two pre-recorded webinars and a slide presentation to help drug sponsors understand recent changes to the submission process for new animal drug applications and related submissions. The changes take effect 10/1/2018.

FDA - U.S. Food and Drug Administration

19-9-2018

National dietary survey in 2012‐2016 on the general population aged 1‐79 years in the Netherlands

National dietary survey in 2012‐2016 on the general population aged 1‐79 years in the Netherlands

Published on: Tue, 18 Sep 2018 00:00:00 +0200 During the years 2012‐2016, the Dutch National Food Consumption survey was conducted in the Netherlands. For the survey, a random sample was drawn from consumer panels stratified by age and gender and maintained representative to the population with regard to region, address density and educational level. Complete results were obtained for 4,313 persons (response rate 65%); including toddlers, children, adolescents, adults and elderly. Pregnant or lactating ...

Europe - EFSA - European Food Safety Authority Publications

13-9-2018

October 10, 2018: Meeting of the Oncologic Drugs Advisory Committee

October 10, 2018: Meeting of the Oncologic Drugs Advisory Committee

October 10, 2018: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement

FDA - U.S. Food and Drug Administration

11-9-2018

Peer review of the pesticide risk assessment of the active substance alpha‐cypermethrin

Peer review of the pesticide risk assessment of the active substance alpha‐cypermethrin

Published on: Mon, 10 Sep 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Belgium and co‐rapporteur Member State Greece for the pesticide active substance alpha‐cypermethrin are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Update of the Xylella spp. host plant database

Update of the Xylella spp. host plant database

Published on: Mon, 10 Sep 2018 00:00:00 +0200 Following a request from the European Commission, EFSA periodically updates the database on the host plants of Xylella spp. While previous editions of the database (2015 and 2016) dealt with the species Xylella fastidiosa only, this database version addresses the whole genus Xylella, including therefore both species X. fastidiosa and Xylella taiwanensis. The database now includes information on host plants of Xylella spp. retrieved from scientific literature...

Europe - EFSA - European Food Safety Authority Publications

10-9-2018

USDA and FDA announce joint public meeting on use of animal cell culture technology to develop products derived from livestock and poultry

USDA and FDA announce joint public meeting on use of animal cell culture technology to develop products derived from livestock and poultry

WASHINGTON, Sept. 10, 2018 – U.S. Secretary of Agriculture Sonny Perdue, DVM and U.S. Food and Drug Administration Commissioner Scott Gottlieb, M.D. today announced a joint public meeting to be held on Oct. 23-24, 2018 to discuss the use of cell culture technology to develop products derived from livestock and poultry.

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

1-9-2018

Spodoptera frugiperda partial risk assessment

Spodoptera frugiperda partial risk assessment

Published on: Fri, 31 Aug 2018 00:00:00 +0200 EFSA was asked for a partial risk assessment of Spodoptera frugiperda for the territory of the EU focussing on the main pathways for entry, factors affecting establishment, risk reduction options and pest management. As a polyphagous pest, five commodity pathways were examined in detail. Aggregating across these and other pathways, we estimate that tens of thousands to over a million individual larvae could enter the EU annually on host commodities. Instigat...

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

Safety assessment of the process ‘General Plastic’, based on Starlinger Decon technology, used to recycle post‐consumer PET into food contact materials

Safety assessment of the process ‘General Plastic’, based on Starlinger Decon technology, used to recycle post‐consumer PET into food contact materials

Published on: Fri, 10 Aug 2018 00:00:00 +0200 This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety evaluation of the recycling process General Plastic (EU register No RECYC153), which is based on the Starlinger Decon technology. The decontamination efficiency of the process was demonstrated by a challenge test. The input of this process is hot caustic washed and dried poly(ethylene terephthalate) (PET) flakes orig...

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

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

10-8-2018

Enforcement Report for the Week of July 25, 2018

Enforcement Report for the Week of July 25, 2018

Recently Updated Records for the Week of July 25, 2018 Last Modified Date: Friday, August 10, 2018

FDA - U.S. Food and Drug Administration

18-7-2018

Orphan designation:  Recombinant humanised anti-human interleukin-1 beta monoclonal antibody,  for the: Treatment of Behçet’s disease

Orphan designation: Recombinant humanised anti-human interleukin-1 beta monoclonal antibody, for the: Treatment of Behçet’s disease

On 1 October 2010, orphan designation (EU/3/10/796) was granted by the European Commission to XOMA Ireland Ltd, Ireland, for recombinant humanised anti-human interleukin-1 beta monoclonal antibody for the treatment of Behçet’s disease.

Europe - EMA - European Medicines Agency

23-10-2018

EU/3/16/1804 (Eli Lilly Nederland B.V.)

EU/3/16/1804 (Eli Lilly Nederland B.V.)

EU/3/16/1804 (Active substance: Pegylated recombinant human interleukin-10) - Transfer of orphan designation - Commission Decision (2018)6994 of Tue, 23 Oct 2018

Europe -DG Health and Food Safety

22-10-2018

EU/3/10/815 (Pfizer Europe MA EEIG)

EU/3/10/815 (Pfizer Europe MA EEIG)

EU/3/10/815 (Active substance: Sildenafil citrate) - Transfer of orphan designation - Commission Decision (2018)6993 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/068/10/T/01

Europe -DG Health and Food Safety

19-10-2018

Recocam (Bimeda Animal Health Limited)

Recocam (Bimeda Animal Health Limited)

Recocam (Active substance: Meloxicam) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6954 of Fri, 19 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2247/T/10

Europe -DG Health and Food Safety

26-9-2018

Kexxtone (Elanco GmbH)

Kexxtone (Elanco GmbH)

Kexxtone (Active substance: Monensin sodium) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6324 of Wed, 26 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2235/T/10

Europe -DG Health and Food Safety

19-9-2018

Lartruvo (Eli Lilly Nederland B.V.)

Lartruvo (Eli Lilly Nederland B.V.)

Lartruvo (Active substance: olaratumab) - Centralised - Annual renewal - Commission Decision (2018)6105 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4216/R/10

Europe -DG Health and Food Safety

19-9-2018

Pregabalin Mylan (Mylan S.A.S.)

Pregabalin Mylan (Mylan S.A.S.)

Pregabalin Mylan (Active substance: pregabalin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 5971 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4078/T/10

Europe -DG Health and Food Safety

10-9-2018

Akynzeo (Helsinn Birex Pharmaceuticals Ltd)

Akynzeo (Helsinn Birex Pharmaceuticals Ltd)

Akynzeo (Active substance: netupitant / palonosetron) - Centralised - Yearly update - Commission Decision (2018)5947 of Mon, 10 Sep 2018

Europe -DG Health and Food Safety

10-9-2018

Alkindi (Diurnal Limited)

Alkindi (Diurnal Limited)

Alkindi (Active substance: hydrocortisone) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5945 of Mon, 10 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4416/T/03

Europe -DG Health and Food Safety

10-9-2018

Retacrit (Hospira UK Limited)

Retacrit (Hospira UK Limited)

Retacrit (Active substance: epoetin zeta) - Centralised - Yearly update - Commission Decision (2018)5946 of Mon, 10 Sep 2018

Europe -DG Health and Food Safety

10-9-2018

Silapo (STADA Arzneimittel AG)

Silapo (STADA Arzneimittel AG)

Silapo (Active substance: epoetin zeta) - Centralised - Yearly update - Commission Decision (2018)5944 of Mon, 10 Sep 2018

Europe -DG Health and Food Safety

4-9-2018

ACM meeting statement, Meeting 10, 2 August 2018

ACM meeting statement, Meeting 10, 2 August 2018

The Advisory Committee on Medicines meeting statement is now available

Therapeutic Goods Administration - Australia

22-8-2018

BTVPUR (Merial)

BTVPUR (Merial)

BTVPUR (Active substance: Bluetongue virus vaccine (inactivated) (multistrain: 1-2 strains out of a set of 4)) - Centralised - 2-Monthly update - Commission Decision (2018)5630 of Wed, 22 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2231/II/10

Europe -DG Health and Food Safety

10-8-2018

Torisel (Pfizer Europe MA EEIG)

Torisel (Pfizer Europe MA EEIG)

Torisel (Active substance: Temsirolimus) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5521 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/799/T/71

Europe -DG Health and Food Safety

10-8-2018

Brinavess (Correvio)

Brinavess (Correvio)

Brinavess (Active substance: vernakalant hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5523 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1215/T/31

Europe -DG Health and Food Safety

10-8-2018

Lymphoseek (Norgine B.V.)

Lymphoseek (Norgine B.V.)

Lymphoseek (Active substance: tilmanocept) - Centralised - Yearly update - Commission Decision (2018)5520 of Fri, 10 Aug 2018

Europe -DG Health and Food Safety

10-8-2018

Sivextro (Merck Sharp and Dohme B.V.)

Sivextro (Merck Sharp and Dohme B.V.)

Sivextro (Active substance: tedizolid phosphate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5522 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2846/T/28

Europe -DG Health and Food Safety

10-8-2018

Cubicin (Merck Sharp and Dohme B.V.)

Cubicin (Merck Sharp and Dohme B.V.)

Cubicin (Active substance: Daptomycin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5519 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/637/T/69

Europe -DG Health and Food Safety

10-8-2018

Thalidomide Celgene (Celgene Europe B.V.)

Thalidomide Celgene (Celgene Europe B.V.)

Thalidomide Celgene (Active substance: Thalidomide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5524 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/823/T/57

Europe -DG Health and Food Safety

10-8-2018

CANCIDAS (Merck Sharp and Dohme B.V.)

CANCIDAS (Merck Sharp and Dohme B.V.)

CANCIDAS (Active substance: caspofungin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5517 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/379/T/67

Europe -DG Health and Food Safety

10-8-2018

Tesavel (Merck Sharp and Dohme B.V.)

Tesavel (Merck Sharp and Dohme B.V.)

Tesavel (Active substance: sitagliptin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5518 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/910/T/65

Europe -DG Health and Food Safety

10-8-2018

Januvia (Merck Sharp and Dohme B.V.)

Januvia (Merck Sharp and Dohme B.V.)

Januvia (Active substance: sitagliptin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4511 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/722/T/65

Europe -DG Health and Food Safety

10-8-2018

Bortezomib Hospira (Pfizer Europe MA EEIG)

Bortezomib Hospira (Pfizer Europe MA EEIG)

Bortezomib Hospira (Active substance: bortezomib) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5515 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4207/T/10

Europe -DG Health and Food Safety

7-8-2018

By Aug. 10, all packages and advertisements for “covered” tobacco products (except for cigars and pipe tobacco) and roll-your-own/cigarette tobacco products must have the required nicotine warning statement. https://cards.twitter.com/cards/2m2m96/5xn98 …

By Aug. 10, all packages and advertisements for “covered” tobacco products (except for cigars and pipe tobacco) and roll-your-own/cigarette tobacco products must have the required nicotine warning statement. https://cards.twitter.com/cards/2m2m96/5xn98 …

By Aug. 10, all packages and advertisements for “covered” tobacco products (except for cigars and pipe tobacco) and roll-your-own/cigarette tobacco products must have the required nicotine warning statement. https://cards.twitter.com/cards/2m2m96/5xn98 …

FDA - U.S. Food and Drug Administration

7-8-2018

Memantine Accord (Accord Healthcare Limited)

Memantine Accord (Accord Healthcare Limited)

Memantine Accord (Active substance: memantine) - Centralised - Renewal - Commission Decision (2018)5421 of Tue, 07 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2766/R/10

Europe -DG Health and Food Safety

30-7-2018

Zalmoxis (MolMed S.p.A.)

Zalmoxis (MolMed S.p.A.)

Zalmoxis (Active substance: Allogeneic T cells genetically modified with a retroviral vector encoding for a truncated form of the human low affinity nerve growth factor receptor (?LNGFR) and the herpes simplex I virus thymidine kinase (HSV-TK Mut2)) - Centralised - Renewal - Commission Decision (2018)5118 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2801/R/10

Europe -DG Health and Food Safety

27-7-2018

EU/3/11/868 (Celgene Europe B.V.)

EU/3/11/868 (Celgene Europe B.V.)

EU/3/11/868 (Active substance: Lenalidomide) - Transfer of orphan designation - Commission Decision (2018)5045 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/160/10/T/01

Europe -DG Health and Food Safety