Sortis 10 mg filmom obložene

Glavna informacija

  • Trgovački naziv:
  • Sortis 10 mg filmom obložene tablete
  • Doziranje:
  • 10 mg
  • Farmaceutski oblik:
  • filmom obložena tableta
  • Sastav:
  • Urbroj: svaka filmom obložena tableta sadrži 10 mg atorvastatina u obliku atorvastatinkalcij trihidrata
  • Tip recepta:
  • na recept, u ljekarni ponovljivi recept
  • Koristi za:
  • Ljudi
  • Vrsta lijekova:
  • alopatski lijek
  • Proizveden od:
  • Pfizer Manufacturing Deutschland GmbH, Freiburg, Njemačka

Dokument

Lokalizacija

  • Na raspolaganju u:
  • Sortis 10 mg filmom obložene tablete
    Hrvatska
  • Jezik:
  • hrvatski

Terapeutski informacija

  • Proizvod sažetak:
  • Pakiranje: 30 tableta u blisteru, u kutiji [HR-H-943745481-01]; 100 tableta u blisteru, u kutiji [HR-H-943745481-02] Urbroj: 381-12-01/38-17-11

Druge informacije

Status

  • Izvor:
  • HALMED Agencija za lijekove i medicinske proizvode - Agency for medicinal products and medical devices of Croatia
  • Broj odobrenja:
  • HR-H-943745481
  • Datum autorizacije:
  • 21-12-2017
  • Zadnje ažuriranje:
  • 04-06-2018

Uputu o lijeku

Uputa o lijeku: Informacije za bolesnika

Sortis 10 mg filmom obložene tablete

Sortis 20 mg filmom obložene tablete

Sortis 40 mg filmom obložene tablete

Sortis 80 mg filmom obložene tablete

atorvastatin

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

podatke.

Sačuvajte ovu uputu. Možda ćete je trebati ponovno pročitati.

Ako imate dodatnih pitanja, obratite se Vašemliječniku 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 Vašeg liječnika ili ljekarnika. To

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

Što se nalazi u ovoj uputi:

Što je Sortis i za što se koristi?

Što morate znati prije nego počnete uzimati Sortis?

Kako uzimati Sortis?

Moguće nuspojave

Kako čuvati Sortis?

Sadržaj pakiranja i druge informacije

1.

Što je Sortis i za što se koristi?

Sortis je jedan od lijekova koji pripadaju skupini pod nazivom statini, a to su lijekovi za

regulaciju masnoća (lipida) u krvi.

Sortis se koristi za snižavanje lipida (kolesterola i triglicerida) u krvi u slučajevima kada ishrana

sa smanjenim unosom masnoća i promjena načina života nisu dale očekivani rezultat. Ukoliko ste

osoba s povećanim rizikom od srčanih oboljenja, Sortis se takoĎer može koristiti u svrhu

snižavanja toga rizika, čak i u slučaju da su Vam razine kolesterola u granicama normale.

Tijekom liječenja morate se i dalje pridržavati standardne dijete za snižavanje kolesterola.

2.

Što morate znati prije nego počnete uzimati Sortis?

Nemojte uzimati Sortis:

ako ste alergični na atorvastatin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.)

ako imate ili ste imali neko oboljenje jetre

ako ste imali neobjašnjiva odstupanja od normale u testovima jetrenih funkcija

ako ste žena koja može raĎati, a ne primjenjujete pouzdane metode sprječavanja neželjene

trudnoće (kontracepcijske mjere)

ako ste trudni ili pokušavate zatrudnjeti

ako dojite

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Upozorenja i mjere opreza

Obratite se Vašem liječniku ili ljekarniku prije nego uzmete Sortis:

ako bolujete od ozbiljnih problema s disanjem (respiratorna insuficijencija)

ako uzimate ili ste uzeli lijek u zadnjih 7 dana koji se zove fusidatna kiselina (lijek za

bakterijsku infekciju) kroz usta ili kao injekciju. Kombinacija fusidatne kiseline i Sortisa

može dovesti do ozbiljnih problema sa mišićima (rabdomiolize).

ako ste pretrpjeli moždani udar s krvarenjem u mozgu, ili u mozgu imate male tekućinom

ispunjene prostore zaostale od prethodnih moždanih udara

ako imate problema s bubrezima

ako bolujete od smanjene funkcije štitnjače (hipotireoze)

ako imate neobjašnjive ili ponavljajuće bolove u mišićima, odnosno ako ste u prošlosti Vi

ili netko od Vaših bliskih roĎaka imali problema s mišićima

ako ste prethodno imali mišićnih problema tijekom uzimanja nekih drugih lijekova za

snižavanje masnoća u krvi (npr. drugi lijekovi iz skupine ,,statina'' ili ,,fibrata'')

ako redovito konzumirate veće količine alkohola

ako ste imali ili imate problema s jetrom

ako ste stariji od 70 godina

TakoĎer obavijestite Vašeg liječnika ili ljekarnika ako imate konstantnu mišićnu slabost. Možda

će biti potrebni dodatni testovi i lijekovi kako bi se to dijagnosticiralo i liječilo.

Ako se bilo što od gore navedenoga odnosi na Vas, Vaš će liječnik morati napraviti krvnu

pretragu prije, a možda i tijekom, Vašeg liječenja Sortisom kako bi predvidio Vaš rizik od

mogućih mišićnih nuspojava. Poznato je da se rizik od mogućih mišićnih nuspojava, npr.

rabdomiolize, povećava prigodom istodobnog uzimanja odreĎenih lijekova (pogledajte dio 2.

„Drugi lijekovi i Sortis''.)

Dok uzimate ovaj lijek, liječnik Vas može pomnije pratiti ako imate šećernu bolest ili imate rizik

od razvoja šećerne bolesti. Postoji veća vjerojatnost za rizik od razvoja šećerne bolesti ako imate

visoke razine šećera i masnoća u krvi, prekomjernu tjelesnu težinu ili visok krvni tlak.

Djeca i adolescenti

Sortis se smije primjenjivati u djece u dobi od 10 godina i starije samo ako je to odredio liječnik s

iskustvom liječenja poremećaja masnoća (lipida) u djece.

Lijek se ne smije primjenjivati u djece mlaĎe od 10 godina jer su podaci o primjeni u toj dobnoj

skupini ograničeni. Provedena ispitivanja nisu utvrdila neškodljivost primjene lijeka na razvoj

djece.

Drugi lijekovi i Sortis

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

koje druge lijekove.

Postoje odreĎeni lijekovi koji mogu promijeniti učinak Sortisa ili se njihov učinak može

promijeniti uzimanjem Sortisa. Ovakva vrsta interakcije može dovesti do smanjenog učinka

jednog ili obaju lijekova. U suprotnom slučaju, može doći i do povećanja rizika ili izraženosti

nuspojava, uključujući i ozbiljno stanje razgradnje mišića pod nazivom rabdomioliza, opisano u

dijelu 4.:

lijekovi koji mijenjaju rad Vašeg imunološkog sustava, npr. ciklosporin

odreĎeni lijekovi za liječenje infekcija, poput antibiotika ili lijekova protiv gljivičnih

oboljenja, npr. eritromicin, klaritromicin, telitromicin, ketokonazol (za liječenje endogenog

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Cushingovog sindroma), itrakonazol, vorikonazol, flukonazol, posakonazol, rifampicin,

fusidatna kiselina

drugi lijekovi za regulaciju razina masnoća u krvi, npr. gemfibrozil, drugi fibrati, kolestipol

lijekovi koji se koriste za liječenje angine pektoris ili povišenog krvnog tlaka, poput nekih od

blokatora kalcijevih kanala, npr. amlodipin, diltiazem

lijekovi za regulaciju srčanoga ritma, npr. digoksin, verapamil, amiodaron

lijekovi koji se koriste u liječenju infekcije HIV-om, npr. ritonavir, lopinavir, atazanavir,

indinavir, darunavir, kombinacija tipranavir/ritonavir

itd.

neki lijekovi koji se koriste za liječenje infekcije virusnog hepatitisa C, npr. telaprevir

drugi lijekovi za koje je poznato da stupaju u interakciju sa Sortisom, uključujući:

ezetimib - lijek koji se koristi za snižavanje kolesterola

varfarin - lijek koji sprečava stvaranje krvnih ugrušaka

oralne kontraceptive – lijekove za sprečavanje začeća

stiripentol - lijek protiv epileptičkih napadaja

cimetidin – lijek koji se koristi u liječenju žgaravice i čira na želucu

fenazon - lijek protiv bolova

kolhicin – lijek za liječenje gihta

lijekove za smanjivanje želučane kiseline, odnosno lijekove protiv probavnih tegoba, koji

sadrže aluminij ili magnezij

boceprevir – koristi se za liječenje bolesti jetre kao što je hepatitis C

lijekove koji se mogu nabaviti bez recepta, poput gospine trave

ako trebate uzeti fusidatnu kiselinu kroz usta za liječenje bakterijskih infekcija, morat ćete

privremeno prestati uzimati ovaj lijek. Liječnik će Vam reći kad je sigurno da ponovno

počnete uzimati Sortis. Uzimanjem Sortisa sa fusidatnom kiselinom može rijetko doći do

slabosti u mišićima, pojačane osjetljivosti ili boli (rabdomioliza). Za više informacija o

rabdomiolizi pogledajte dio 4.

Sortis s hranom i pićem

Pogledajte dio 3. „Kako uzimati Sortis?“ za uputu o uzimanju Sortisa. Molimo obratite pozornost

na sljedeće:

Sok od grejpa

Nemojte uzimati više od jedne do dvije male čaše soka od grejpa na dan jer sok od grejpa u

velikim količinama može promijeniti učinke Sortisa.

Alkohol

Izbjegavajte uzimanje alkohola u većim količinama tijekom liječenja Sortisom. Za detalje

pogledajte dio 2. „Upozorenja i mjere opreza“.

Trudnoća i dojenje

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

liječniku ili ljekarniku za savjet prije nego uzmete ovaj lijek.

Nemojte uzimati Sortis ukoliko ste trudni ili pokušavate zatrudnjeti.

Nemojte uzimati Sortis ukoliko ste žena u dobi kad možete ostati trudni, a ne primjenjujete

pouzdane kontracepcijske mjere.

Nemojte uzimati Sortis ukoliko dojite.

Sigurnost primjene Sortisa tijekom trudnoće i dojenja zasada nije dokazana.

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Upravljanje vozilima i strojevima

Sortis ima zanemariv utjecaj na Vašu sposobnost upravljanja vozilima i strojevima. MeĎutim,

ukoliko osjetite da ovaj lijek utječe na Vašu sposobnost upravljanja vozilima i strojevima,

nemojte voziti odnosno nemojte koristiti alate.

Sortis sadrži laktozu

Sortis sadrži laktozu. Ako Vam je liječnik rekao da ne podnosite neke šećere, obratite se liječniku

prije uzimanja ovog lijeka.

3. Kako uzimati Sortis?

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

Vašim liječnikom ili ljekarnikom ako niste sigurni.

Prije nego što započnete s liječenjem, Vaš će Vam liječnik odrediti dijetu za snižavanje

kolesterola, s kojom morate nastaviti i tijekom uzimanja Sortisa.

Uobičajena početna doza Sortisa je 10 mg jednom na dan za odrasle osobe i djecu u dobi od

10 godina i stariju. Ukoliko je potrebno, liječnik može povisivati dozu sve dok se ne postigne

željeni terapijski učinak. Liječnik će dozu prilagoĎavati u razmacima od 4 tjedna ili dulje.

Maksimalna doza Sortisa je 80 mg jednom na dan.

Ovaj lijek nije namijenjen za liječenje bolesnika mlaĎih od 10 godina.

Za primjenu u djece mogu biti prikladni drugi oblici lijeka.

Sortis tablete treba progutati cijele uz malo vode, a mogu se uzimati u bilo koje doba dana, s ili

bez hrane. Ipak, pokušajte svoju tabletu uzimati u isto vrijeme svakoga dana.

Trajanje liječenja Sortisom određuje Vaš liječnik.

Obratite se Vašem liječniku ukoliko Vam se čini da je učinak Sortisa prejak ili preslab.

Ako uzmete više Sortisa nego što ste trebali

Ako slučajno uzmete previše Sortis tableta (više od svoje uobičajene dnevne doze), odmah za

savjet kontaktirajte svog liječnika ili najbližu bolnicu.

Ako ste zaboravili uzeti Sortis

Ako ste zaboravili uzeti jednu dozu, sljedeću dozu uzmite prema uobičajenom rasporedu.

Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu dozu.

Ako prestanete uzimati Sortis

Ako imate dodatnih pitanja u vezi s primjenom ovog lijeka, ili ako želite prekinuti liječenje,

obratite se Vašem liječniku ili ljekarniku.

Ako imate bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se Vašem liječniku ili

ljekarniku.

4. Moguće nuspojave

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

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Ukoliko dođe do pojave bilo koje od niže navedenih ozbiljnih nuspojava, prestanite s

uzimanjem tableta i odmah obavijestite svoga liječnika ili se uputite u hitnu službu najbliže

bolnice.

Rijetko: mogu se javiti u manje od 1 na 1000 osoba

ozbiljna alergijska reakcija s oticanjem lica, jezika i grla koja može prouzročiti teške dišne

tegobe (tzv. angioedem).

ozbiljna bolest s jakim ljuštenjem i oticanjem kože, stvaranjem plikova na koži, ustima,

očima i spolnim organima, uz povišenu tjelesnu temperaturu.

kožni osip s ružičasto-crvenim mrljama, posebice na dlanovima i tabanima, uz moguću

pojavu plikova.

mišićna slabost, osjetljivost ili bol; ukoliko pritom osjećate i slabost ili imate visoku

temperaturu, moguće je da je došlo do neuobičajenog oštećenja mišića (rabdomioliza), koje

može biti opasno po život i dovesti do problema s bubrezima.

Vrlo rijetko: mogu se javiti u manje od 1 na 10 000 osoba

ukoliko se pojavi neočekivano ili neuobičajeno krvarenje ili se pojave modrice, to može

ukazivati na oštećenje jetre. U tom se slučaju što je prije moguće posavjetujte s liječnikom.

Druge moguće nuspojave Sortisa:

Često: mogu se javiti u manje od 1 na 10 osoba

upala nosnih putova, grlobolja, krvarenje iz nosa

alergijske reakcije

porast vrijednosti šećera u krvi (ukoliko bolujete od šećerne bolesti, nastavite pozorno pratiti

razinu šećera u krvi), porast vrijednosti kreatin kinaze u krvi

glavobolja

mučnina, zatvor, vjetrovi probavne tegobe, proljev

bolovi u zglobovima i mišićima, bolovi u leĎima, bol u udovima, oticanje zglobova

rezultati krvnih pretraga koji ukazuju na promjenu funkcije jetre

Manje često: mogu se javiti u manje od 1 na 100 osoba

gubitak apetita (anoreksija), porast tjelesne težine

pad vrijednosti šećera u krvi (ukoliko bolujete od šećerne bolesti, nastavite pozorno pratiti

razinu šećera u krvi)

noćne more, nesanica

omaglica, obamrlost ili trnci u prstima ruku i nogu, smanjen osjet boli ili dodira, promjene

osjeta okusa, gubitak pamćenja

zamućen vid

zvonjenje u ušima i/ili glavi

povraćanje, podrigivanje, bol u želucu i trbuhu, upala gušterače povezana s bolovima u

želucu (pankreatitis)

upala jetre (hepatitis)

osip, kožni osip i svrbež, urtike, ispadanje kose

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bolovi u vratu, zamor mišića

umor, osjećaj malaksalosti, slabost, bolovi u prsištu, oticanje udova - posebice gležnjeva

(edemi), povišena tjelesna temperatura

urin pozitivan na bijele krvne stanice

Rijetko: mogu se javiti u manje od 1 na 1000 osoba

smetnje vida

neočekivana krvarenja ili pojavu modrica

žutilo kože i bjeloočnica (kolestaza)

ozljede tetiva

Vrlo rijetko: mogu se javiti u manje od 1 na 10 000 osoba

alergijska reakcija – simptomi mogu uključivati naglu pojavu piskutavog disanja praćenu

bolovima ili osjećajem stezanja u prsištu, oticanje očnih kapaka, lica, usana, usta, jezika ili

grla, otežanog disanja, kolapsa (anafilaksija)

gubitak sluha

povećanje dojki u muškaraca (ginekomastija)

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

mišićna slabost koja je konstantna

Na temelju dostupnih podataka, očekuje se da će učestalost, vrsta i težina nuspojava u djece i

adolescenata biti ista kao i kod odraslih.

Moguće nuspojave zabilježene pri uporabi nekih statina (lijekova iste vrste):

seksualne tegobe

depresija

tegobe s disanjem, uključujući stalni kašalj i/ili nedostatak zraka, ili povišena tjelesna

temperatura

šećerna bolest. Razvoj šećerne bolesti je vjerojatniji ako imate visoke razine šećera i

masnoća u krvi, prekomjernu tjelesnu težinu ili visok krvni tlak. Liječnik će Vas nadzirati

dok uzimate ovaj lijek.

Prijavljivanje nuspojava

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

uključuje i svaku moguću nuspojavu koja nije navedena u ovoj uputi. Nuspojave možete prijaviti

izravno putem nacionalnog sustava za prijavu nuspojava: navedenog u Dodatku V.

Prijavljivanjem nuspojava možete pridonijeti u procjeni sigurnosti ovog lijeka.

5. Kako čuvati Sortis?

Ovaj lijek čuvajte izvan pogleda i dohvata djece.

Ovaj lijek ne zahtijeva posebne uvjete čuvanja.

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

valjanosti odnosi se na zadnji dan navedenog mjeseca.

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

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

6. Sadržaj pakiranja i druge informacije

Što Sortis sadrži?

Djelatna tvar je atorvastatin.

Svaka filmom obložena tableta sadrži 10 mg atorvastatina u obliku atorvastatinkalcij trihidrata.

Svaka filmom obložena tableta sadrži 20 mg atorvastatina u obliku atorvastatinkalcij trihidrata.

Svaka filmom obložena tableta sadrži 40 mg atorvastatina u obliku atorvastatinkalcij trihidrata.

Svaka filmom obložena tableta sadrži 80 mg atorvastatina u obliku atorvastatinkalcij trihidrata.

Pomoćne tvari su:

Jezgra tablete: kalcijev karbonat, mikrokristalična celuloza, laktoza hidrat,

umrežena karmelozanatrij, polisorbat 80, hidroksipropilceluloza, magnezijev stearat, pročišćena

voda.

Ovojnica: Opadry White YS-1-7040 (sadrži: hipromelozu, polietilenglikol 8000, titanijev dioksid

(E 171), talk); simetikon emulzija (sadrži: simetikon, benzoatnu kiselinu zgušnjivače stearatni

emulgator; sorbatnu kiselinu; pročišćenu vodu).

Kako Sortis izgleda i sadržaj pakiranja?

SORTIS 10 mg: bijele, okrugle, filmom obložene tablete s oznakom ”10” na jednoj strani i

oznakom ”ATV” na drugoj, promjera 5,6 mm.

SORTIS 20 mg: bijele, okrugle, filmom obložene tablete s oznakom ”20” na jednoj strani i

oznakom ”ATV” na drugoj, promjera 7,1 mm.

SORTIS 40 mg: bijele, okrugle, filmom obložene tablete s oznakom ”40” na jednoj strani i

oznakom ”ATV” na drugoj, promjera 9,5 mm.

SORTIS 80 mg: bijele, okrugle, filmom obložene tablete s oznakom ”80” na jednoj strani i

oznakom ”ATV” na drugoj, promjera 11,9 mm.

30 (3x10) filmom obloženih tableta u blisteru (oPA/Al/PVC//Al)

100 (10x10) filmom obloženih tableta u blisteru (oPA/Al/PVC//Al)

Nositelj odobrenja za stavljanje lijeka u promet i proizvođač

Nositelj odobrenja

Pfizer Croatia d.o.o.

Slavonska avenija 6

Zagreb

Proizvođač

Pfizer Manufacturing Deutschland GmbH

Betriebsstätte

Mooswaldallee 1

79090 Freiburg

Njemačka

Način i mjesto izdavanja lijeka

Lijek se izdaje na recept, u ljekarni.

Ova uputa je posljednji puta revidirana u prosincu 2017.

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Ostali izvori informacija

Detaljnije informacije o ovom lijeku dostupne su na internetskim stranicama Agencije za lijekove

i medicinske proizvode na http://www.halmed.hr.

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18-10-2018

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

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

The recalled products may contain phthalate levels that exceed the allowable levels.

Health Canada

18-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

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

12-11-2018

Spinraza (Biogen Netherlands B.V.)

Spinraza (Biogen Netherlands B.V.)

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

Europe -DG Health and Food Safety

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