Atoris 30 mg filmom obložene

Glavna informacija

  • Trgovački naziv:
  • Atoris 30 mg filmom obložene tablete
  • Doziranje:
  • 30 mg
  • Farmaceutski oblik:
  • filmom obložena tableta
  • Sastav:
  • Urbroj: svaka filmom obložena tableta sadrži 30 mg atorvastatina u obliku atorvastatinkalcija
  • Tip recepta:
  • na recept, u ljekarni ponovljivi recept
  • Koristi za:
  • Ljudi
  • Vrsta lijekova:
  • alopatski lijek
  • Proizveden od:
  • Krka d.d., Novo mesto, Slovenija

Dokument

Lokalizacija

  • Na raspolaganju u:
  • Atoris 30 mg filmom obložene tablete
    Hrvatska
  • Jezik:
  • hrvatski

Terapeutski informacija

  • Proizvod sažetak:
  • Pakiranje: 4 tablete u blisteru, u kutiji [HR-H-099895884-01]; 7 tableta u blisteru, u kutiji [HR-H-099895884-02]; 10 tableta u blisteru, u kutiji [HR-H-099895884-03]; 14 tableta u blisteru, u kutiji [HR-H-099895884-04]; 20 tableta u blisteru, u kutiji [HR-H-099895884-05]; 28 tableta u blisteru, u kutiji [HR-H-099895884-06]; 30 tableta u blisteru, u kutiji [HR-H-099895884-07]; 50 tableta u blisteru, u kutiji [HR-H-099895884-08]; 56 tableta u blisteru, u kutiji [HR-H-099895884-09]; 60 tableta u blisteru, u kutiji [HR-H-099895884-10]; 84 tablete u blisteru, u kutiji [HR-H-099895884-11]; 90 tableta u blisteru, u kutiji [HR-H-099895884-12]; 98 tableta u blisteru, u kutiji [HR-H-099895884-13]; 100 tableta u blisteru, u kutiji [HR-H-099895884-14] Urbroj: 381-12-01/70-17-07

Druge informacije

Status

  • Izvor:
  • HALMED Agencija za lijekove i medicinske proizvode - Agency for medicinal products and medical devices of Croatia
  • Broj odobrenja:
  • HR-H-099895884
  • Datum autorizacije:
  • 27-07-2017
  • Zadnje ažuriranje:
  • 04-06-2018

Uputu o lijeku

Uputa o lijeku: Informacije za bolesnika

Atoris 30 mg filmom obložene tablete

Atoris 60 mg filmom obložene tablete

Atoris 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 ponovo pročitati.

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

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

Što se nalazi u ovoj uputi:

Što je Atoris i za što se koristi?

Što morate znati prije nego počnete uzimati Atoris?

Kako uzimati Atoris?

Moguće nuspojave

Kako čuvati Atoris?

Sadržaj pakiranja i druge informacije

1.

Što je Atoris i za što se koristi?

Atoris pripada skupini lijekova poznatih pod nazivom statini; lijekovi za reguliranje lipida (masnoća).

Atoris se koristi za smanjivanje razine lipida u krvi koji su poznati pod nazivom kolesterol i

trigliceridi, kada dijeta s niskim udjelom masnoća i promjene životnih navika zasebno nisu dali

rezultata. Ako imate povećan rizik pojave bolesti srca, Atoris je moguće takoĎer koristiti za snižavanje

tog rizika, čak i ako su razine kolesterola normalne. Tijekom liječenja se morate pridržavati standardne

dijete za snižavanje kolesterola.

2.

Što morate znati prije nego počnete uzimati Atoris?

Nemojte uzimati Atoris

ako ste alergični na atorvastatin ili slične lijekove za snižavanje masnoća u krvi ili neki drugi

sastojak ovog lijeka (naveden u dijelu 6.),

ako imate ili ste imali neku bolest jetre,

ako ste ikada imali neobjašnjiva odstupanja od normale u testovima jetrenih funkcija,

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

(kontracepcijske mjere),

ako ste trudni ili pokušavate zatrudnjeti,

ako dojite.

Upozorenja i mjere opreza

Obratite se Vašem liječniku ili ljekarniku prije nego uzmete Atoris.

Mogući razlozi zašto Atoris možda nije prikladan lijek za Vas:

ako ste imali moždani udar s krvarenjem u mozgu ili imate male prostore s tekućinom u mozgu

koji su nastali od prethodnih moždanih udara,

ako imate poteškoća s bubrezima,

ako imate smanjenu funkciju štitnjače (hipotireoidizam),

ako ste imali grčeve ili bolove u mišićima koji se ponavljaju ili su nejasnog uzroka, odnosno

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ako ste Vi ili netko od članova obitelji imali problema s mišićima,

ako ste ranije uzimali neki drugi lijek za snižavanje masnoća u krvi (drugi statin ili fibrat) te

pritom imali problema s mišićima,

ako redovito pijete znatne količine alkohola,

ako ste imali poteškoće s jetrom,

ako ste stariji od 70 godina,

ako uzimate ili ste u proteklih 7 dana uzeli, kroz usta ili injekcijom, lijek koji se zove fusidatna

kiselina (lijek koji se primjenjuje za liječenje bakterijske infekcije). Kombinacija fusidatne

kiseline i ovog lijeka može dovesti do ozbiljnih poteškoća s mišićima (rabdomiolize).

Prije uzimanja Atorisa, posavjetujte se sa svojim liječnikom ili ljekarnikom:

ako imate teško zatajenje pluća.

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.

TakoĎer obavijestite svog 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 navedenog odnosi na Vas, Vaš će liječnik morati napraviti pretrage krvi prije, a

možda i tijekom liječenja Atorisom kako bi predvidio rizik nuspojava vezan za mišiće.

Poznato je da se rizik nuspojava vezanih za mišiće, kao na primjer rabdomioliza, povećava prilikom

istodobnog uzimanja odreĎenih lijekova (vidjeti dio 2 „Drugi lijekovi i Atoris“).

Drugi lijekovi i Atoris

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

druge lijekove.

Neki lijekovi mogu djelovati na učinak Atorisa ili Atoris može djelovati na njihov učinak. Ovaj tip

interakcija može dovesti do manje djelotvornosti jednog ili oba lijeka. Posljedično bi to moglo

povećati rizik ili ozbiljnost nuspojava, uključujući značajno stanje razgradnje mišića poznato pod

nazivom rabdomioliza, kako je opisano u dijelu 4.:

lijekovi koji mijenjaju način djelovanja imunološkog sustava, npr. ciklosporin;

neki antibiotici ili lijekovi protiv gljivičnih bolesti, npr. eritromicin, klaritromicin, telitromicin,

ketokonazol, itrakonazol, vorikonazol, flukonazol, posakonazol, rifampicin, fusidatna kiselina;

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

pojedini blokatori kalcijevih kanala koji se koriste za liječenje angine pektoris ili povišenog

krvnog tlaka, npr. amlodipin, diltiazem;

lijekovi za regulaciju srčanog ritma, npr. digoksin, verapamil, amiodaron;

lijekovi koji se koriste za liječenje infekcije HIV-om, npr. ritonavir, lopinavir, atazanavir,

indinavir, darunavir kombinacija tipranavira/ritonavira itd.;

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

drugi lijekovi za koje se zna da ulaze u interakcije s Atorisom, a uključuju ezetimib (koji

smanjuje razinu kolesterola), varfarin (koji smanjuje stvaranje krvnih ugrušaka), oralni

kontraceptivi (lijekovi za sprječavanje začeća), stiripentol (antikonvulziv, protiv epileptičnih

napadaja), cimetidin (koristi se za liječenje žgaravice i čireva u želucu), fenazon (lijek za

ublažavanje bolova), kolhicin (koristi se za liječenje gihta), antacidi (lijekovi za probavne

poremećaje koji sadrže aluminij ili magnezij) i boceprevir (koristi se za liječenje bolesti jetre

kao što je hepatitis C);

lijekovi koji se izdaju bez recepta poput gospine trave;

ako morate uzimati fusidatnu kiselinu kroz usta za liječenje bakterijske infekcije, morat ćete

privremeno prestati uzimati ovaj lijek. Liječnik će Vam reći kada je sigurno nastaviti s

uzimanjem Atorisa. Uzimanje ovog lijeka s fusidatnom kiselinom može rijetko dovesti do

mišićne slabosti, osjetljivosti ili boli (rabdomioliza). Za više informacija vezanih uz

rabdomiolizu pogledajte dio 4.

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Atoris s hranom, pićem i alkoholom

Vidjeti dio 3. za uputu o uzimanju Atorisa. 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 Atorisa.

Alkohol

Izbjegavajte uzimanje alkohola u većim količinama tijekom liječenja Atorisom. Za detalje vidjeti 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 Atoris ako ste trudni ili nastojite zatrudnjeti.

Nemojte uzimati Atoris ako ste žena u dobi kad još možete raĎati, a ne primjenjujete pouzdane

kontracepcijske mjere.

Nemojte uzimati Atoris ako dojite.

Sigurnost primjene Atorisa tijekom trudnoće i dojenja zasada nije dokazana.

Upravljanje vozilima i strojevima

Uobičajeno ovaj lijek ne utječe na Vašu sposobnost upravljanja vozilima i rada sa strojevima.

MeĎutim, nemojte upravljati vozilima ako ovaj lijek utječe na Vaše sposobnosti za vožnju. Nemojte

koristiti alate ili strojeve ako ovaj lijek utječe na Vašu sposobnost rukovanja alatima ili strojevima.

Atoris sadrži laktozu

Ako Vam je liječnik rekao da imate bolest nepodnošenja nekih šećera, prije nego što počnete uzimati

ovaj lijek posavjetujete se sa svojim liječnikom.

3.

Kako uzimati Atoris?

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, liječnik će Vam odrediti dijetu za snižavanje kolesterola, s

kojom morate nastaviti i tijekom uzimanja Atorisa.

Uobičajena početna doza Atorisa je 10 mg jednom dnevno za odrasle osobe i djecu u dobi od

10 godina ili starijih. Liječnik može povećati dozu ako je to potrebno dok se ne postigne željeni

terapijski učinak. Liječnik će dozu prilagoĎavati u intervalima od po 4 tjedna ili dulje. Maksimalna

doza Atorisa je 80 mg jednom dnevno za odrasle i 20 mg jednom dnevno za djecu.

Atoris tablete se moraju progutati čitave uz malo vode, a mogu se uzeti u bilo koje doba dana,

neovisno o obrocima. Pokušajte uzeti tabletu svakoga dana u isto vrijeme.

Trajanje liječenja Atorisom odreĎuje Vaš liječnik.

Ako smatrate da je učinak ovog lijeka prejak ili preslab, posavjetujte se s liječnikom ili ljekarnikom.

Ako uzmete više Atorisa nego što ste trebali

Ako ste uzeli veću dozu lijeka (više od svoje uobičajene dnevne doze), kontaktirajte svog liječnika ili

najbližu bolnicu.

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Ako ste zaboravili uzeti Atoris

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

Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu dozu.

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.

Ako 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: nuspojave se mogu javiti u manje od 1 na 1000 osoba:

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

tegobe (tzv. angioedem)

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

genitalijama (spolnim organima) te vrućicom

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

plikova

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

moguće je da je došlo do neuobičajenog oštećenja mišića. Neuobičajeno oštećenje mišića ne

mora uvijek proći, čak i ako ste prestali s uzimanjem atorvastatina te može biti opasno po život i

dovesti do problema s bubrezima.

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

ako 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 Atorisa:

Česte nuspojave (mogu se javiti u manje od 1 na 10 osoba):

upala nosnih putova, grlobolja, krvarenje iz nosa

alergijske reakcije

porast vrijednosti šećera u krvi (ako imate šećernu bolest, nastavite pozorno pratiti razinu šećera

u svojoj krvi), porast vrijednosti kreatin kinaze u krvi

glavobolja

mučnina, zatvor, vjetrovi, probavne tegobe, proljev

bol u zglobovima i mišićima, bolovi u leĎima

rezultati krvnih pretraga koji ukazuju na promjenu jetrenih funkcija

Manje česte nuspojave (mogu se javiti u manje od 1 na 100 osoba):

gubitak apetita (anoreksija), porast tjelesne težine

pad vrijednosti šećera u krvi (ako imate šećernu bolest nastavite pozorno pratiti razinu šećera u

svojoj 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 kože, urtike, ispadanje kose

bolovi u vratu, zamor mišića

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umor, osjećaj malaksalosti, slabost, bolovi u prsištu, oticanje udova - posebice nogu (edemi),

povišena tjelesna temperatura

urin pozitivan na bijele krvne stanice

Rijetke nuspojave (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 rijetke nuspojave (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 i žena (ginekomastija)

Nuspojave nepoznate učestalosti (učestalost se ne može procijeniti iz dostupnih podataka):

mišićnu slabost koja je konstantna

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

seksualne tegobe

depresija

tegobe s disanjem, uključujući stalni kašalj i/ili zaduhu, 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 Atoris?

Ovaj lijek čuvajte izvan pogleda i dohvata djece.

Čuvati u originalnom pakiranju radi zaštite od vlage.

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

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

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 Atoris sadrži?

Djelatna tvar je atorvastatin. Svaka filmom obložena tableta sadrži 30 mg, 60 mg ili 80 mg

atorvastatina u obliku atorvastatinkalcija.

Drugi sastojci u jezgri tablete su: natrijev hidroksid; hidroksipropilceluloza; laktoza hidrat;

mikrokristalična celuloza; umrežena karmelozanatrij; krospovidon (tip A); polisorbat 80 i

magnezijev stearat. Drugi sastojci u film ovojnici tablete su: poli(vinilni alkohol); titanijev

H A L M E D

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O D O B R E N O

dioksid (E171); makrogol 3000 i talk.

Kako Atoris izgleda i sadržaj pakiranja?

30 mg filmom obložene tablete: bijele do gotovo bijele, okrugle, blago izbočene, filmom obložene

tablete, zakošenih rubova, promjera 9 mm.

60 mg filmom obložene tablete: bijele do gotovo bijele, ovalne, bikonveksne, filmom obložene tablete,

dimenzija 16 mm x 8,5 mm.

80 mg filmom obložene tablete: bijele do gotovo bijele, bikonveksne, filmom obložene tablete oblika

kapsule, dimenzija 18 mm x 9 mm.

Atoris je dostupan u blisterima, a svaka kutija sadrži ukupno 4, 7, 10, 14, 20, 28, 30, 50, 56, 60, 84, 90,

98 i 100 filmom obloženih tableta.

Na tržištu se ne moraju nalaziti sve veličine pakiranja.

Nositelj odobrenja za stavljanje lijeka u promet i proizvođač

Nositelj odobrenja:

KRKA - FARMA d.o.o., Radnička cesta 48, 10000 Zagreb

Proizvođač:

KRKA, d. d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenija

Način i mjesto izdavanja lijeka

Lijek se izdaje na recept, u ljekarni.

Ova uputa je zadnji puta revidirana u srpnju 2017.

H A L M E D

27 - 07 - 2017

O D O B R E N O

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31-10-2018

Outcome of a public consultation on the draft guidance on the scientific requirements for health claims related to muscle function and physical performance

Outcome of a public consultation on the draft guidance on the scientific requirements for health claims related to muscle function and physical performance

Published on: Tue, 30 Oct 2018 00:00:00 +0100 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 guidance on the scientific requirements for health claims related to muscle function and physical performance, prepared by the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA), supported by the Working Group on Claims. The draft guidance was endorsed by the Panel for public consultation ...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Peer review of the pesticide risk assessment of the active substance dimethoate

Peer review of the pesticide risk assessment of the active substance dimethoate

Published on: Tue, 30 Oct 2018 00:00:00 +0100 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Italy and co‐rapporteur Member State Bulgaria for the pesticide active substance dimethoate 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 dimetho...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Updated review of the existing maximum residue levels for imazalil according to Article 12 of Regulation (EC) No 396/2005 following new toxicological information

Updated review of the existing maximum residue levels for imazalil according to Article 12 of Regulation (EC) No 396/2005 following new toxicological information

Published on: Tue, 30 Oct 2018 00:00:00 +0100 In compliance with Article 43 of Regulation (EC) No 396/2005, EFSA received a mandate from the European Commission to provide an update of the reasoned opinion on the review of existing maximum residue levels (MRLs) for imazalil published on 5 September 2017, taking into account the additional information provided on the toxicity of the metabolites R014821, FK‐772 and FK‐284. EFSA did not derive MRL proposals from the post‐harvest uses reported on citrus fru...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos when used as a feed flavouring for all animal species

Safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos when used as a feed flavouring for all animal species

Published on: Tue, 30 Oct 2018 00:00:00 +0100 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 a super critical carbon dioxide extract of Humulus lupulus L. flos (hop strobiles) when used as a sensory feed additive for all animal species. The additive is specified to containing 40% beta acids and less than 0.2% alpha acids. Known substances of conce...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Efficacy of Bergazym® P100 (endo‐1,4‐β‐xylanase) as a feed additive for chickens for fattening and weaned piglets

Efficacy of Bergazym® P100 (endo‐1,4‐β‐xylanase) as a feed additive for chickens for fattening and weaned piglets

Published on: Tue, 30 Oct 2018 00:00:00 +0100 The product Bergazym® P100 contains a xylanase which is produced by a non‐genetically modified strain of Trichoderma reesei. The additive is available in a coated granular form and it is intended to be used as a zootechnical additive (functional group: digestibility enhancers) for chickens for fattening, and weaned piglets at the dose of 1,500 EPU/kg feed. The production strain and the additive were fully characterised in a previous assessment of the Panel o...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Guidance on the scientific requirements for health claims related to muscle function and physical performance

Guidance on the scientific requirements for health claims related to muscle function and physical performance

Published on: Tue, 30 Oct 2018 00:00:00 +0100 EFSA has asked the Panel on Nutrition, Novel Foods and Food Allergens (NDA) to update the guidance on the scientific requirements for health claims related to physical performance published in 2012. The update takes into account the experience gained by the NDA Panel with the evaluation of additional health claim applications, changes introduced to the general scientific guidance for stakeholders for health claims applications and information collected from ...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Peer review of the pesticide risk assessment of the active substance methiocarb

Peer review of the pesticide risk assessment of the active substance methiocarb

Published on: Tue, 30 Oct 2018 00:00:00 +0100 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State the United Kingdom and co‐rapporteur Member State Germany for the pesticide active substance methiocarb 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 use...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Safety and efficacy of Lactobacillus hilgardii CNCM I‐4785 and Lactobacillus buchneri CNCM I‐4323/NCIMB 40788 as a silage additive for all animal species

Safety and efficacy of Lactobacillus hilgardii CNCM I‐4785 and Lactobacillus buchneri CNCM I‐4323/NCIMB 40788 as a silage additive for all animal species

Published on: Tue, 30 Oct 2018 00:00:00 +0100 Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed was asked to deliver a scientific opinion on the safety and efficacy of a strain of Lactobacillus hilgardii and of Lactobacillus buchneri when used as a technological additive intended to improve ensiling at a proposed application rate of 3.0 x 108 colony forming units (CFU)/kg fresh material. The two bacterial species are considered by EFS...

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Published on: Fri, 19 Oct 2018 00:00:00 +0200 EFSA was requested to deliver a scientific opinion on the implications for human health of the flavouring substance 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide [FL‐no: 16.133], in the Flavouring Group Evaluation 411 (FGE.411), according to Regulation (EC) No 1331/2008 of the European Parliament and of the Council. The substance has not been reported to occur in natural source materials of botanical or animal origin. It is intende...

Europe - EFSA - European Food Safety Authority Publications

18-10-2018

P. East Trading Corp. Issues Alert on Undeclared Sulfites In Fruits Du Sud Golden Seedless Raisins

P. East Trading Corp. Issues Alert on Undeclared Sulfites In Fruits Du Sud Golden Seedless Raisins

P. EAST TRADING CORP. of Bronx, NY is recalling Fruits Du Sud Golden Seedless Raisins (Lot No. FDS T499/18) 30 lbs Box, because they contain undeclared SULFITES. People who have a severe sensitivity to sulfites run the risk of serious or life-threatening reactions if they consume these products.

FDA - U.S. Food and Drug Administration

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

25-9-2018

Voluntary Recall on Harris Teeter Low Fat Cookies & Cream Frozen Yogurt Due to Undeclared Peanut Product

Voluntary Recall on Harris Teeter Low Fat Cookies & Cream Frozen Yogurt Due to Undeclared Peanut Product

Harris Teeter is notifying shoppers of a voluntarily recall of Harris Teeter Low Fat Frozen Yogurt Cookies & Cream 1.5 qt laminated cartons, UPC 0 72036 98182 0, with all SELL BY DATES up to 07/30/19 due to undeclared peanut product.

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

31-8-2018

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

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

Published on: Thu, 30 Aug 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 Germany for the pesticide active substance 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 cype...

Europe - EFSA - European Food Safety Authority Publications

10-8-2018

Westminster Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Levothyroxine and Liothyronine (Thyroid Tablets, USP) Due to Risk of Adulteration

Westminster Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Levothyroxine and Liothyronine (Thyroid Tablets, USP) Due to Risk of Adulteration

Westminster Pharmaceuticals, LLC is voluntarily recalling all lots, within expiry, of Levothyroxine and Liothyronine (Thyroid Tablets, USP) 15 mg, 30 mg, 60 mg, 90 mg, & 120 mg to the wholesale level. These products are being recalled as a precaution because they were manufactured using active pharmaceutical ingredients that were sourced prior to the FDA’s Import Alert of Sichuan Friendly Pharmaceutical Co., Ltd., which as a result of a 2017 inspection were found to have deficiencies with Current Good Ma...

FDA - U.S. Food and Drug Administration

6-8-2018

G & C Raw, LLC Recalls Pat's Cat Turkey, and Ground Lamb Pet Food, because of Possible Listeria Monocytogenes Health Risk

G & C Raw, LLC Recalls Pat's Cat Turkey, and Ground Lamb Pet Food, because of Possible Listeria Monocytogenes Health Risk

G & C Raw, of Versailles, OH is recalling 30 1-lb containers of Pat's Cat Turkey Cat Food and 40 2-lb containers of Ground Lamb Dog Food because it has the potential to be contaminated with Listeria monocytogenes. Listeria monocytogenes can cause serious and sometimes fatal infections in animals eating the products.

FDA - U.S. Food and Drug Administration

31-7-2018

July 30, 2018: Two People Guilty of Distributing Tramadol Pills

July 30, 2018: Two People Guilty of Distributing Tramadol Pills

July 30, 2018: Two People Guilty of Distributing Tramadol Pills

FDA - U.S. Food and Drug Administration

17-7-2018

Blokhuis kondigt grootschalige extra vaccinatie aan: Ruim half miljoen kinderen krijgen oproep

Blokhuis kondigt grootschalige extra vaccinatie aan: Ruim half miljoen kinderen krijgen oproep

Volgend jaar worden zo’n 650.000 kinderen extra opgeroepen om zich te laten inenten tegen de zeer ernstige infectieziekte meningokokken. Het gaat om kinderen die zijn geboren na 1 januari 2001 en voor mei 2004. Dat laat staatssecretaris Paul Blokhuis (VWS) weten in een brief aan de Tweede Kamer. Reden voor deze maatregel is dat in de afgelopen jaren een stijging te zien is van het aantal mensen dat de infectie meningokokken type W oploopt. Met deze extra vaccinatieronde moet die groei worden ingedamd. He...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

15-11-2018

Flixabi (Samsung Bioepis NL B.V.)

Flixabi (Samsung Bioepis NL B.V.)

Flixabi (Active substance: infliximab) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7549 of Thu, 15 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4020/T/30

Europe -DG Health and Food Safety

30-10-2018

EU/3/14/1250 (Akcea Therapeutics UK Ltd)

EU/3/14/1250 (Akcea Therapeutics UK Ltd)

EU/3/14/1250 (Active substance: Phosphorothioate oligonucleotide targeted to transthyretin) - Transfer of orphan designation - Commission Decision (2018)7282 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/098/13/T/01

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2080 (Freeline Therapeutics Ltd)

EU/3/18/2080 (Freeline Therapeutics Ltd)

EU/3/18/2080 (Active substance: Recombinant adeno-associated viral vector serotype S3 containing codon-optimised expression cassette encoding human coagulation factor IX variant) - Orphan designation - Commission Decision (2018)7281 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/127/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2079 (Spark Therapeutics Ireland Ltd)

EU/3/18/2079 (Spark Therapeutics Ireland Ltd)

EU/3/18/2079 (Active substance: Recombinant adeno-associated viral vector containing a bioengineered capsid and a codon-optimised expression cassette to drive the expression of the SQ form of a B-domain deleted human coagulation factor VIII) - Orphan designation - Commission Decision (2018)7280 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/104/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2078 (Sellas Life Sciences Limited)

EU/3/18/2078 (Sellas Life Sciences Limited)

EU/3/18/2078 (Active substance: Peptides YMFPNAPYL, SGQAYMFPNAPYLPSCLES, RSDELVRHHNMHQRNMTKL and PGCNKRYFKLSHLQMHSRKHTG) - Orphan designation - Commission Decision (2018)7279 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/091/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2077 (Worphmed Srl)

EU/3/18/2077 (Worphmed Srl)

EU/3/18/2077 (Active substance: Melatonin) - Orphan designation - Commission Decision (2018)7278 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/077/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2076 (Orphan Europe S.A.R.L.)

EU/3/18/2076 (Orphan Europe S.A.R.L.)

EU/3/18/2076 (Active substance: Glycine, L-alanine, L-arginine, L-aspartic acid, L-cysteine, L-cystine, L-glutamic acid, L-histidine, L-lysine monohydrate, L-methionine, L-phenylalanine, L-proline, L-serine, L-threonine, L-tryptophan, L-tyrosine, taurine) - Orphan designation - Commission Decision (2018)7277 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/100/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2075 (Consorcio Centro de InvestigaciOn BiomEdica en Red M.P.)

EU/3/18/2075 (Consorcio Centro de InvestigaciOn BiomEdica en Red M.P.)

EU/3/18/2075 (Active substance: Gefitinib) - Orphan designation - Commission Decision (2018)7276 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/090/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2074 (PhaRA bvba)

EU/3/18/2074 (PhaRA bvba)

EU/3/18/2074 (Active substance: Avapritinib) - Orphan designation - Commission Decision (2018)7275 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/079/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2073 (Fondazione Telethon)

EU/3/18/2073 (Fondazione Telethon)

EU/3/18/2073 (Active substance: Autologous CD34+ haematopoietic stem and progenitor cells genetically modified with the lentiviral vector IDUA LV, encoding for the alpha-L-iduronidase cDNA) - Orphan designation - Commission Decision (2018)7274 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/113/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2071 (Loxo Oncology Limited)

EU/3/18/2071 (Loxo Oncology Limited)

EU/3/18/2071 (Active substance: 6-(2-hydroxy-2-methylpropoxy)-4-(6-(6-((6-methoxypyridin-3-yl)methyl)-3,6-diazabicyclo[3.1.1]heptan-3-yl)pyridin-3-yl)pyrazolo[1,5-a]pyridine-3-carbonitrile) - Orphan designation - Commission Decision (2018)7272 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/125/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2072 (FGK Representative Service GmbH)

EU/3/18/2072 (FGK Representative Service GmbH)

EU/3/18/2072 (Active substance: 6'-(R)-methyl-5-O-(5-amino-5,6-dideoxy-alpha-L-talofuranosyl)-paromamine sulfate) - Orphan designation - Commission Decision (2018)7273 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/102/18

Europe -DG Health and Food Safety

30-9-2018

Roteas (Daiichi Sankyo Europe GmbH)

Roteas (Daiichi Sankyo Europe GmbH)

Roteas (Active substance: edoxaban) - PSUSA - Modification - Commission Decision (2018)5089 of Sun, 30 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10387/201710

Europe -DG Health and Food Safety

17-9-2018

Reminder: the FDA is accepting applications through Sept. 30, 2018, for the #FDAInnovationChallenge for devices to help combat #opioid addiction.   Submissions will be evaluated based on the feasibility, potential public health impact and novelty of the c

Reminder: the FDA is accepting applications through Sept. 30, 2018, for the #FDAInnovationChallenge for devices to help combat #opioid addiction. Submissions will be evaluated based on the feasibility, potential public health impact and novelty of the c

Reminder: the FDA is accepting applications through Sept. 30, 2018, for the #FDAInnovationChallenge for devices to help combat #opioid addiction. Submissions will be evaluated based on the feasibility, potential public health impact and novelty of the concept.

FDA - U.S. Food and Drug Administration

30-8-2018

Steglatro (Merck Sharp and Dohme B.V.)

Steglatro (Merck Sharp and Dohme B.V.)

Steglatro (Active substance: ertugliflozin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5789 of Thu, 30 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4315/T/2

Europe -DG Health and Food Safety

30-8-2018

Fluenz Tetra (AstraZeneca AB)

Fluenz Tetra (AstraZeneca AB)

Fluenz Tetra (Active substance: influenza vaccine (live attenuated, nasal)) - Centralised - Variation - Commission Decision (2018)5815 of Thu, 30 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2617/II/82

Europe -DG Health and Food Safety

3-8-2018

Scandonest and associated names

Scandonest and associated names

Scandonest and associated names (Active substance: mepivacaine) - Community Referrals - Art 30 - Commission Decision (2018)5380 of Fri, 03 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/A-30/1455

Europe -DG Health and Food Safety

1-8-2018

Bridion (Merck Sharp and Dohme B.V.)

Bridion (Merck Sharp and Dohme B.V.)

Bridion (Active substance: sugammadex) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5213 of Wed, 01 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/885/T/30

Europe -DG Health and Food Safety

30-7-2018

Nityr (Cycle Pharmaceuticals Ltd)

Nityr (Cycle Pharmaceuticals Ltd)

Nityr (Active substance: nitisinone) - Centralised - Authorisation - Commission Decision (2018)5446 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4582

Europe -DG Health and Food Safety

30-7-2018

Esmya (Gedeon Richter Plc.)

Esmya (Gedeon Richter Plc.)

Esmya (Active substance: ulipristal) - Referral - Commission Decision (2018)5101 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2041/A-20

Europe -DG Health and Food Safety

30-7-2018

Aimovig (Novartis Europharm Limited)

Aimovig (Novartis Europharm Limited)

Aimovig (Active substance: erenumab) - Centralised - Authorisation - Commission Decision (2018)5102 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4447

Europe -DG Health and Food Safety

30-7-2018

Besponsa (Pfizer Europe MA EEIG)

Besponsa (Pfizer Europe MA EEIG)

Besponsa (Active substance: inotuzumab ozogamicin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5104 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4119/T/7

Europe -DG Health and Food Safety

30-7-2018

Segluromet (Merck Sharp and Dohme B.V.)

Segluromet (Merck Sharp and Dohme B.V.)

Segluromet (Active substance: ertugliflozin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5103 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4314/T/2

Europe -DG Health and Food Safety

30-7-2018

Invokana (Janssen-Cilag International NV)

Invokana (Janssen-Cilag International NV)

Invokana (Active substance: canagliflozin) - Centralised - Renewal - Commission Decision (2018)5105 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2649/R/37

Europe -DG Health and Food Safety

30-7-2018

NovoEight (Novo Nordisk A/S)

NovoEight (Novo Nordisk A/S)

NovoEight (Active substance: turoctocog alfa) - Centralised - 2-Monthly update - Commission Decision (2018)5093 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2719/II/23

Europe -DG Health and Food Safety

30-7-2018

Hyrimoz (Sandoz GmbH)

Hyrimoz (Sandoz GmbH)

Hyrimoz (Active substance: adalimumab) - Centralised - Authorisation - Commission Decision (2018)5097 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4320

Europe -DG Health and Food Safety

30-7-2018

Halimatoz (Sandoz GmbH)

Halimatoz (Sandoz GmbH)

Halimatoz (Active substance: adalimumab) - Centralised - Authorisation - Commission Decision (2018)5098 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4866

Europe -DG Health and Food Safety

30-7-2018

Rasagiline ratiopharm (Teva B.V.)

Rasagiline ratiopharm (Teva B.V.)

Rasagiline ratiopharm (Active substance: rasagiline) - Centralised - Yearly update - Commission Decision (2018)5108 of Mon, 30 Jul 2018

Europe -DG Health and Food Safety

30-7-2018

Hefiya (Sandoz GmbH)

Hefiya (Sandoz GmbH)

Hefiya (Active substance: adalimumab) - Centralised - Authorisation - Commission Decision (2018)5099 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4865

Europe -DG Health and Food Safety

30-7-2018

Alsitek (AB Science)

Alsitek (AB Science)

Alsitek (Active substance: masitinib) - Refusal of authorisation - Commission Decision (2018)5109 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4398

Europe -DG Health and Food Safety

30-7-2018

UBAC (Laboratorios Hipra, S.A.)

UBAC (Laboratorios Hipra, S.A.)

UBAC (Active substance: Streptococcus uberis vaccine (inactivated)) - Centralised - Authorisation - Commission Decision (2018)5152 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/4595

Europe -DG Health and Food Safety

30-7-2018

Apoquel (Zoetis Belgium S.A.)

Apoquel (Zoetis Belgium S.A.)

Apoquel (Active substance: Oclacitinib maleate) - Centralised - Renewal - Commission Decision (2018)5153 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2688/R/13

Europe -DG Health and Food Safety

30-7-2018

Ofev (Boehringer Ingelheim International GmbH)

Ofev (Boehringer Ingelheim International GmbH)

Ofev (Active substance: Nintedanib) - PSUSA - Modification - Commission Decision (2018)5115 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10319/201710

Europe -DG Health and Food Safety

30-7-2018

Ceplene (Noventia Pharma Srl)

Ceplene (Noventia Pharma Srl)

Ceplene (Active substance: Histamine dihydrochloride) - Centralised - Renewal - Commission Decision (2018)5116 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/796/R/36

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

30-7-2018

Trazimera (Pfizer Europe MA EEIG)

Trazimera (Pfizer Europe MA EEIG)

Trazimera (Active substance: trastuzumab) - Centralised - Authorisation - Commission Decision (2018)5095 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4463

Europe -DG Health and Food Safety

30-7-2018

RXULTI (Otsuka Pharmaceutical Europe Ltd)

RXULTI (Otsuka Pharmaceutical Europe Ltd)

RXULTI (Active substance: brexpiprazole) - Centralised - Authorisation - Commission Decision (2018)5088 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3841

Europe -DG Health and Food Safety

24-7-2018

ACV meeting statement, Meeting 8, 30 May 2018

ACV meeting statement, Meeting 8, 30 May 2018

Advisory Committee on Vaccines meeting statement

Therapeutic Goods Administration - Australia