Ziora 10 mg raspadljiva

Glavna informacija

  • Trgovački naziv:
  • Ziora 10 mg raspadljiva tableta za usta
  • Doziranje:
  • 10 mg
  • Farmaceutski oblik:
  • raspadljiva tableta za usta
  • Sastav:
  • Urbroj: jedna raspadljiva tableta za usta sadrži 10 mg olanzapina
  • Tip recepta:
  • na recept, u ljekarni ponovljivi recept
  • Koristi za:
  • Ljudi
  • Vrsta lijekova:
  • alopatski lijek
  • Proizveden od:
  • Jadran Galenski laboratorij d.d., Rijeka, Republika Hrvatska

Dokument

Lokalizacija

  • Na raspolaganju u:
  • Ziora 10 mg raspadljiva tableta za usta
    Hrvatska
  • Jezik:
  • hrvatski

Terapeutski informacija

  • Proizvod sažetak:
  • Pakiranje: 30 tableta u perforiranom blisteru, u kutiji [HR-H-923149502-01] Urbroj: 381-12-01/70-17-03

Druge informacije

Status

  • Izvor:
  • HALMED Agencija za lijekove i medicinske proizvode - Agency for medicinal products and medical devices of Croatia
  • Broj odobrenja:
  • HR-H-923149502
  • Datum autorizacije:
  • 18-05-2017
  • Zadnje ažuriranje:
  • 05-06-2018

Uputu o lijeku

Uputa o lijeku: Informacije za bolesnika

Ziora 5 mg raspadljiva tableta za usta

Ziora 10 mg raspadljiva tableta za usta

olanzapin

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 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 Ziora i za što se koristi?

Što morate znati prije nego počnete uzimati Zioru?

Kako uzimati Zioru?

Moguće nuspojave

Kako čuvati Zioru?

Sadržaj pakiranja i druge informacije

1. Što je Ziora i za što se koristi?

Ziora sadrži djelatnu tvar olanzapin. Ziora pripada skupini lijekova koji se zovu antipsihotici i koristi se

za liječenje sljedećih stanja:

shizofrenije, bolesti sa simptomima kao što su slušna, vidna ili osjetilna priviĎenja stvari koje

nisu prisutne, iluzije, neuobičajena sumnjičavost i povučenost. Osobe s tom bolešću mogu se

takoĎer osjećati depresivno, tjeskobno ili napeto.

umjerenih do teških epizoda manije, stanja sa simptomima uzbuĎenja ili euforije.

Pokazalo se da Ziora sprječava ponavljanje tih simptoma u bolesnika s bipolarnim poremećajem u kojih

je epizoda manije reagirala na liječenje olanzapinom.

2. Što morate znati prije nego počnete uzimati Zioru?

Nemojte uzimati Zioru:

- ako ste alergični na olanzapin ili bilo koji sastojak ovog lijeka (naveden u dijelu 6.). Alergijska reakcija

može se prepoznati kao osip, svrbež, otečeno lice, otečene usnice ili nedostatak zraka. Ako Vam se ovo

pojavi, obavijestite svog liječnika.

- ako od ranije imate dijagnosticirane tegobe s očima kao što su odreĎene vrste glaukoma (povišeni očni

tlak)

Upozorenja i mjere opreza

Obratite se Vašem liječniku ili ljekarniku prije nego uzmete Zioru.

Primjena lijeka Ziora u starijih bolesnika s demencijom (zaboravljivošću) se ne preporučuje jer

mogu nastati teške nuspojave.

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O D O B R E N O

Lijekovi ove vrste mogu uzrokovati pojavu neuobičajenih pokreta, uglavnom lica ili jezika. Ako

Vam se ovo pojavi nakon uzimanja lijeka Ziora, obratite se Vašem liječniku.

Vrlo rijetko lijekovi ovog tipa uzrokuju kombinaciju vrućice, ubrzanog disanja, znojenja,

ukočenosti mišića te omamljenosti ili pospanosti. Ako do ovog doĎe, odmah se obratite

Vašem liječniku.

Zapaženo je povećanje tjelesne težine u bolesnika koji uzimaju Zioru. Sa svojim liječnikom

redovito kontrolirajte tjelesnu težinu. Po potrebi razmotrite da Vas liječnik uputi nutricionistu

ili zatražite pomoć oko planiranja prehrane.

U bolesnika koji uzimaju Zioru uočena je visoka razina šećera i masnoća u krvi (trigliceridi i

kolesterol). Prije početka uzimanja lijeka Ziora te redovito tijekom liječenja, liječnik bi Vam

trebao obaviti krvne pretrage kako bi provjerio razinu šećera i odreĎenih masnoća u krvi.

Obavijestite svog liječnika ako ste Vi ili netko drugi u Vašoj obitelji ranije imali krvne ugruške,

jer su lijekovi poput ovih povezani sa stvaranjem krvnih ugrušaka.

Ako bolujete od bilo koje od slijedećih bolesti, obavijestite Vašeg liječnika što je prije moguće.

moždani udar ili “mali” moždani udar (kratkotrajni simptomi moždanog udara)

Parkinsonova bolest

tegobe s prostatom

zatvor crijeva (paralitički ileus)

bolest jetre ili bubrega

poremećaji krvi

srčana bolest

šećerna bolest

napadaji

ako znate da možda imate nedovoljno soli u organizmu kao posljedicu dugotrajnog teškog

proljeva i povraćanja ili zbog uzimanja diuretika (tableta za izlučivanje vode iz organizma)

Ako bolujete od zaboravljivosti (demencije), a imali ste moždani udar ili “manji” moždani udar, Vi ili

Vaš skrbnik/član obitelji morate o tome obavijestiti liječnika.

Ako ste stariji od 65 godina, liječnik će Vam možda kao rutinsku mjeru opreza redovito kontrolirati krvni

tlak.

Djeca i adolescenti

Ziora nije namijenjena za primjenu bolesnika mlaĎih od 18 godina.

Drugi lijekovi i Ziora

Dok uzimate Zioru, druge lijekove uzimajte samo ako Vam liječnik kaže da to možete. Ako uzimate

Zioru u kombinaciji s antidepresivima, lijekovima za tjeskobu ili lijekovima koji Vam pomažu zaspati

(trankvilizeri), možete se osjećati omamljeno.

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

druge lijekove.

Posebno obavijestite svog liječnika ako uzimate:

lijekove protiv Parkinsonove bolesti.

karbamazepin (antiepileptik i stabilizator raspoloženja), fluvoksamin (antidepresiv) ili ciprofloksacin

(antibiotik) – možda će biti potrebno promijeniti dozu lijeka Ziora.

Ziora s alkoholom

Nemojte piti alkohol ako uzimate Zioru jer u kombinaciji s alkoholom može izazvati omamljenost.

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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.

Ne biste smjeli uzimati ovaj lijek dok dojite, jer se male količine lijeka Ziora mogu izlučiti u majčino

mlijeko.

Sljedeći simptomi mogu se pojaviti u novoroĎenčadi majki koje su koristile Zioru u posljednjem

tromjesečju

(zadnja

mjeseca

trudnoće):

drhtanje,

ukočenost

mišića

i/ili

slabost,

pospanost,

uznemirenost, tegobe s disanjem te poteškoće u hranjenju. Ako se u Vašeg djeteta razvije bilo koji od

ovih simptoma, možda ćete se trebati obratiti svom liječniku.

Upravljanje vozilima i strojevima

Kad uzimate Zioru postoji rizik da se osjećate omamljeno. Ako se ovo dogodi, nemojte upravljati

vozilima niti rukovati bilo kakvim alatima ili strojevima. Obavijestite svog liječnika.

Ziora sadrži aspartam i laktozu

Ziora sadrži aspartam koji je izvor fenilalanina. Može naškoditi osobama koje boluju od fenilketonurije.

Ziora sadrži laktozu. Ako Vam je liječnik rekao da ne podnosite neke šećere, savjetujte se s liječnikom

prije uzimanja ovog lijeka.

3. Kako uzimati Zioru?

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

liječnikom ili ljekarnikom ako niste sigurni.

Liječnik će Vam reći koliko Ziora tableta trebate uzeti i koliko ćete ih dugo uzimati. Dnevna doza lijeka

Ziora iznosi izmeĎu 5 mg i 20 mg. Ako Vam se simptomi vrate, posavjetujte se sa svojim liječnikom, ali

nemojte prestati uzimati Zioru dok Vam liječnik to ne kaže.

Ziora tablete morate uzimati jednom dnevno pridržavajući se savjeta svog liječnika.

Pokušajte uzimati tablete svaki dan u isto vrijeme. Nije važno uzimate li lijek s hranom ili bez nje.

Ziora tablete lako se lome te njima treba pažljivo rukovati. Ne uzimajte tablete mokrim rukama jer se

mogu prelomiti.

Primite blister za rubove i odvojite jedno polje blistera od ostatka trake, pažljivo trgajući duž

perforacija koje ga okružuju.

Pažljivo odvojite stražnji dio.

3. Nježno istisnite tabletu .

Stavite tabletu u usta. Rastopit će se izravno u vašim ustima, pa ćete je moći lako progutati.

Tabletu takoĎer možete staviti u punu čašu ili šalicu vode, soka od naranče, soka od jabuke, mlijeka ili

kave te promiješati. Ako se lijek uzima s pićem, mješavina može promijeniti boju i postati mutna. Popijte

odmah.

Ako uzmete više Ziora tableta nego što ste trebali

Bolesnici koji su uzeli više lijeka Ziora nego što su trebali imaju sljedeće simptome: ubrzan rad srca,

uznemirenost/agresivnost, poteškoće s govorom, neuobičajene pokrete (osobito lica ili jezika) i sniženu

razinu svijesti. Ostali simptomi mogu biti: akutna smetenost, napadaji (epilepsija), koma, kombinacija

vrućice, ubrzanog disanja, znojenja, ukočenosti mišića i omamljenosti ili pospanosti, usporavanje disanja,

aspiracija, visok krvni tlak ili nizak krvni tlak, poremećaj srčanog ritma. Ako imate bilo koji od navedenih

simptoma, odmah se obratite svom liječniku ili bolnici. Pokažite liječniku pakiranje tableta.

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Ako ste zaboravili uzeti Zioru

Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu dozu. Uzmite tablete čim se sjetite. Ne

uzimajte dvostruku dozu u jednom danu.

Ako prestanete uzimati Zioru

Nemojte prestati uzimati tablete samo zato jer se osjećate bolje. Važno je da nastavite uzimati Zioru

onoliko dugo koliko Vam je liječnik rekao.

Ako naglo prestanete s uzimanjem lijeka Ziora mogu se pojaviti simptomi poput znojenja, nesanice,

nevoljnog drhtanja, tjeskobe ili mučnine i povraćanja. Liječnik Vam može savjetovati da postupno

smanjujete dozu prije prekida liječenja.

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.

Odmah obavijestite svog liječnika ako imate:

neuobičajene pokrete (česta nuspojava koja se može pojaviti u najviše 1 na 10 osoba) uglavnom na

licu ili jeziku;

krvne ugruške u venama (manje česta nuspojava koja se može pojaviti u najviše 1 na 100 osoba),

posebno u nogama (simptomi uključuju oticanje, bol i crvenilo nogu), koji mogu putovati krvnim

žilama do pluća, uzrokujući bol u prsima i otežano disanje. Ako primijetite bilo koji od ovih

simptoma, odmah zatražite liječnički savjet;

kombinaciju vrućice, ubrzanog disanja, znojenja, ukočenosti mišića te omamljenosti ili pospanosti

(učestalost ove nuspojave ne može se procijeniti iz dostupnih podataka).

Vrlo česte nuspojave (mogu se pojaviti u najviše 1 na 10 osoba) uključuju povećanje tjelesne težine,

pospanost i povišene razine prolaktina u krvi. U ranim fazama liječenja neki bolesnici mogu osjećati

omaglicu ili nesvjesticu (uz usporen rad srca), posebno pri uspravljanju iz ležećeg ili sjedećeg položaja

tijela. Ovo obično prolazi samo po sebi, ali ako ne proĎe, javite se liječniku.

Česte nuspojave (mogu se pojaviti u najviše 1 na 10 osoba) uključuju promjene razina nekih krvnih

stanica, cirkulirajućih masti u krvi te, u ranim fazama liječenja, privremena povećanja razine jetrenih

enzima; povišene razine šećera u krvi i mokraći; povećanje razine mokraćne kiseline i kreatin fosfokinaze

u krvi; pojačan apetit; omaglicu; nemir; nevoljno drhtanje; neuobičajene pokrete (diskinezije); zatvor;

suha usta; osip; slabost; pojačan umor; zadržavanje vode u tijelu koje dovodi do oticanja ruku, zglobova

ili stopala; vrućicu; bol u zglobovima; te seksualne poremećaje kao što su smanjeni libido u muškaraca i

žena ili erektilna disfunkcija u muškaraca.

Manje česte nuspojave (mogu se pojaviti u najviše 1 na 100 osoba) uključuju preosjetljivost (npr. oticanje

u ustima i grlu, svrbež; osip); šećernu bolest ili pogoršanje šećerne bolesti, ponekad povezano s

ketoacidozom (ketonima u krvi i mokraći) ili komom; napadaje, obično povezane s napadajima u

povijesti bolesti (epilepsija); mišićnu ukočenost ili grč (uključujući pokrete očiju); sindrom nemirnih

nogu; poteškoće s govorom; usporen rad srca; osjetljivost na sunčevu svjetlost; krvarenje iz nosa;

nadimanje

trbuha;

gubitak

pamćenja

zaboravljivost;

nemogućnost

zadržavanja

mokraće

(inkontinencija); nemogućnost mokrenja; ispadanje kose; izostanak ili smanjenje mjesečnice i promjene

na grudima u muškaraca i žena, kao što je poremećaj stvaranja majčinog mlijeka ili abnormalan rast.

Rijetke nuspojave (mogu se pojaviti u najviše 1 na 1000 osoba) uključuju sniženje normalne tjelesne

temperature; poremećaj srčanog ritma; naglu neobjašnjivu smrt; upalu gušterače koja uzrokuje jaku bol u

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trbuhu, vrućicu i mučninu; bolest jetre koja se očituje žutilom kože i bjeloočnica; bolest mišića koja se

manifestira neobjašnjivim bolovima; te produljenu i/ili bolnu erekciju.

Vrlo rijetke nuspojave uključuju ozbiljne alergijske reakcije poput reakcije na lijek s eozinofilijom i

sistemskim simptomima (engl. Drug Reaction with Eosinophilia and Systemic Symptoms, DRESS).

DRESS se na početku očituje simptomima nalik gripi s osipom po licu, a kasnije i proširenim osipom,

visokom temperaturom, povećanim limfnih čvorovima, povišenim razinama jetrenih enzima koji su

vidljivi u krvnim pretragama te povećanjem broja jedne vrste bijelih krvnih stanica (eozinofilija).

Tijekom liječenja olanzapinom u starijih bolesnika s demencijom (zaboravljivošću) mogu nastati moždani

udar, upala pluća, inkontinencija mokraće, padanje, izraziti umor, vidna priviĎanja, povišenje tjelesne

temperature, crvenilo kože i teškoće pri hodu. Prijavljeno je i nekoliko smrtnih slučajeva u ovoj

specifičnoj skupini bolesnika.

U bolesnika koji boluju od Parkinsonove bolesti, Ziora može pogoršati simptome

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 Zioru?

Ovaj lijek čuvajte izvan pogleda i dohvata djece.

Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na pakiranju iza oznake „EXP”.

Rok valjanosti odnosi se na zadnji dan navedenog mjeseca.

Čuvati u originalnom pakiranju radi zaštite od vlage.

Nikada nemojte nikakve lijekove bacati u otpadne vode. Pitajte svog ljekarnika kako baciti lijekove koje

više ne koristite. Ove će mjere pomoći u očuvanju okoliša.

6. Sadržaj pakiranja i druge informacije

Što Ziora sadrži?

- Djelatna tvar je olanzapin. Jedna Ziora raspadljiva tableta za usta sadrži 5 mg odnosno 10 mg

olanzapina.

- Druge pomoćne tvari su kalcijev karbonat; škrob, prethodno geliran; kukuruzni škrob; laktoza hidrat;

krospovidon; aspartam; magnezijev staerat.

Kako Ziora izgleda i sadržaj pakiranja?

Ziora 5 mg raspadljiva tableta za usta: blijedožute do žute okrugle, bikonveksne tablete s oznakom 5 na

jednoj strani

promjera 6,4 mm.

Ziora 10 mg raspadljiva tableta za usta: blijedožute do žute okrugle, bikonveksne tablete s oznakom 10 na

jednoj strani, promjera 9,1 mm.

30 (3x10) raspadljivih tableta za usta u OPA/Al/PVC//Al perforiranom blisteru, u kutiji.

Nositelj odobrenja za stavljanje lijeka u promet i proizvođač

JADRAN -GALENSKI LABORATORIJ d.d., Svilno 20, 51000 Rijeka

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O D O B R E N O

Način i mjesto izdavanja lijeka

Lijek se izdaje na recept, u ljekarni.

Ova uputa je zadnji puta revidirana u svibnju 2017.

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O D O B R E N O

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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

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