Ziaxel 10 mg filmom obložene

Glavna informacija

  • Trgovački naziv:
  • Ziaxel 10 mg filmom obložene tablete
  • Doziranje:
  • 10 mg
  • Farmaceutski oblik:
  • filmom obložena tableta
  • Sastav:
  • Urbroj: svaka filmom obložena tableta sadrži 10 mg olanzapina
  • Tip recepta:
  • na recept, u ljekarni ponovljivi recept
  • Koristi za:
  • Ljudi
  • Vrsta lijekova:
  • alopatski lijek
  • Proizveden od:
  • Genera d.d., Rakov Potok, Republika Hrvatska

Dokument

Lokalizacija

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

Terapeutski informacija

  • Proizvod sažetak:
  • Pakiranje: 28 tableta u blisteru, u kutiji [HR-H-365776371-01] Urbroj: 381-12-01/38-17-09

Druge informacije

Status

  • Izvor:
  • HALMED Agencija za lijekove i medicinske proizvode - Agency for medicinal products and medical devices of Croatia
  • Broj odobrenja:
  • HR-H-365776371
  • Datum autorizacije:
  • 11-12-2017
  • Zadnje ažuriranje:
  • 05-06-2018

Uputu o lijeku

Uputa o lijeku: Informacije za bolesnika

Ziaxel 5 mg filmom obložene tablete

Ziaxel 10 mg filmom obložene tablete

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 svom liječniku ili ljekarniku.

Ovaj je lijek propisan samo Vama. Nemojte ga davati drugima. Može im štetiti, čak i ako su

njihovi znakovi bolesti jednaki Vašima.

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

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

Što se nalazi u ovoj uputi:

Što su Ziaxel

filmom obložene tablete

i za što se koriste?

Što morate znati prije nego počnete uzimati Ziaxel filmom obložene tablete?

Kako uzimati Ziaxel filmom obložene tablete?

Moguće nuspojave

Kako čuvati Ziaxel filmom obložene tablete?

Sadržaj pakiranja i druge informacije

1.

Što su Ziaxel filmom obložene tablete i za što se koriste?

Ziaxel filmom obložene tablete sadrže djelatnu tvar olanzapin. Ziaxel filmom obložene tablete

pripadaju skupini lijekova koji se zovu antipsihotici i koriste 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 Ziaxel filmom obložene tablete sprječavaju ponavljanje tih simptoma u bolesnika s

bipolarnim poremećajem kod kojih je epizoda manije reagirala na liječenje olanzapinom.

2.

Što morate znati prije nego počnete uzimati Ziaxel filmom obložene tablete?

Nemojte uzimati Ziaxel filmom obložene tablete:

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

dijelu 6.). Alergijska reakcija može se prepoznati po pojavi osipa, svrbeža, otečenosti lica,

otečenosti usnica ili nedostatku zraka. Ako se kod Vas pojave ovi simptomi, obavijestite svog

liječnika.

ako od ranije imate dijagnosticirane probleme s očima, kao što su odreĎene vrste glaukoma

(povišeni očni tlak).

Upozorenja i mjere opreza

Obratite se svom liječniku ili ljekarniku prije nego uzmete Ziaxel filmom obložene tablete.

Primjena lijeka Ziaxel filmom obložene tablete ne preporučuje se u starijih bolesnika s

demencijom (zaboravljivošću) jer mogu nastati teške nuspojave.

Lijekovi iz ove skupine mogu uzrokovati neuobičajene pokrete, uglavnom lica ili jezika.

Obavijestite svog liječnika ako se to i Vama dogodi nakon uzimanja Ziaxel filmom obloženih

tableta.

H A L M E D

11 - 12 - 2017

O D O B R E N O

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

ukočenosti mišića te omamljenosti ili pospanosti. Ako se kod Vas pojave ovi simptomi, odmah

o tome obavijestite svog liječnika.

Zapaženo je povećanje tjelesne težine u bolesnika koji uzimaju Ziaxel filmom obložene tablete.

Redovito kontrolirajte tjelesnu težinu sa svojim liječnikom. Po potrebi razmotrite da Vas

liječnik uputi nutricionistu ili zatražite pomoć oko planiranja prehrane.

U bolesnika koji uzimaju Ziaxel filmom obložene tablete uočena je visoka razina šećera i

masnoća u krvi (trigliceridi i kolesterol). Prije početka uzimanja lijeka Ziaxel filmom obložene

tablete 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 sljedećih bolesti, obavijestite svog liječnika što je prije moguće:

moždani udar ili ''mali'' moždani udar (kratkotrajni simptomi moždanog udara)

Parkinsonova bolest

tegobe s prostatom

paralitički ileus (zatvor crijeva)

bolesti jetre ili bubrega

poremećaji krvi

bolesti srca

šećerna bolest

napadaji (epilepsija)

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 demencije (zaboravljivosti), 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

Ziaxel filmom obložene tablete nisu namijenjene za liječenje bolesnika mlaĎih od 18 godina.

Drugi lijekovi i Ziaxel filmom obložene tablete

Dok uzimate Ziaxel filmom obložene tablete uzimajte druge lijekove samo ako Vam liječnik kaže da

smijete. Ako uzimate Ziaxel filmom obložene tablete u kombinaciji s lijekovima protiv depresije, ili

lijekovima protiv tjeskobe ili lijekovima koji Vam pomažu zaspati (sedativima) možda ćete se

osjećati omamljeno.

Obavijestite svog liječnika ako uzimate, ste nedavno 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), jer će možda biti potrebno promijeniti dozu Ziaxel filmom

obloženih tableta.

Ziaxel filmom obložene tablete s alkoholom

Nemojte piti alkohol tijekom liječenja Ziaxel filmom obloženim tabletama jer u kombinaciji s

alkoholom mogu izazvati omamljenost.

Trudnoća i dojenje

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

liječniku ili ljekarniku za savjet prije nego uzmete ovaj lijek.

H A L M E D

11 - 12 - 2017

O D O B R E N O

Ne biste smjeli uzimati ovaj lijek dok dojite, jer se male količine Ziaxel filmom obloženih tableta

mogu izlučiti u majčino mlijeko.

Sljedeći simptomi mogu se pojaviti kod novoroĎenčadi majki koje su koristile Ziaxel filmom

obložene tablete u posljednjem tromjesečju (posljednja tri mjeseca trudnoće): drhtanje, ukočenost

mišića i/ili slabost, pospanost, uznemirenost, tegobe s disanjem te poteškoće u hranjenju. Ako se kod

Vašeg djeteta razvije bilo koji od navedenih simptoma, možda ćete trebati obavijestiti svog liječnika.

Upravljanje vozilima i strojevima

Ziaxel filmom obložene tablete mogu uzrokovati omamljenost. Ako se to dogodi, nemojte upravljati

vozilima ili rukovati bilo kakvim alatima ili strojevima. Obavijestite svog liječnika o tome.

Ziaxel filmom obložene tablete sadrže laktozu

Ako Vam je liječnik rekao da ne podnosite neke šećere, prije nego što počnete uzimati ovaj lijek

posavjetujte se sa svojim liječnikom.

3.

Kako uzimati Ziaxel filmom obložene tablete?

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

ili ljekarnikom ako niste sigurni.

Liječnik će Vam reći koliko Ziaxel filmom obloženih tableta trebate uzeti i koliko dugo ćete ih

uzimati.

Dnevna doza Ziaxel filmom obloženih tableta iznosi izmeĎu 5 mg i 20 mg.

Ako Vam se simptomi vrate, posavjetujte se sa svojim liječnikom, ali nemojte prestati uzimati Ziaxel

filmom obložene tablete dok Vam liječnik to ne kaže.

Ziaxel filmom obložene tablete morate uzimati jednom dnevno u skladu s uputama liječnika.

Pokušajte uzimati tablete svaki dan u isto vrijeme.

Nije važno uzimate li lijek s hranom ili bez nje.

Ziaxel filmom obložene tablete uzimaju se kroz usta te

se moraju progutati cijele s vodom.

Ako uzmete više Ziaxel filmom obloženih tableta nego što ste trebali

Ako uzmete više Ziaxel filmom obloženih tableta nego što ste trebali mogu se javiti sljedeći

simptomi: ubrzan rad srca, uznemirenost/agresivnost, poteškoće s govorom, neuobičajeni pokreti

(osobito lica ili jezika) i snižena razina 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 te poremećaji srčanog ritma.

Ako imate bilo koji od navedenih simptoma, odmah se obratite svom liječniku ili u najbližu

zdravstvenu ustanovu. Pokažite liječniku pakiranje tableta.

Ako ste zaboravili uzeti Ziaxel filmom obložene tablete

Ako ste zaboravili uzeti jednu dozu, uzmite je čim se sjetite. Nemojte uzeti dvostruku dozu kako biste

nadoknadili zaboravljenu dozu.

Ako prestanete uzimati Ziaxel filmom obložene tablete

Nemojte prestati uzimati tablete samo zato što se osjećate bolje. Važno je da nastavite uzimati Ziaxel

filmom obložene tablete onoliko dugo koliko Vam je liječnik rekao.

Ako naglo prekinete s uzimanjem Ziaxel filmom obloženih tableta, mogu se pojaviti simptomi kao što

su znojenje, nesanica, nevoljno drhtanje, tjeskoba, mučnina ili povraćanje. Liječnik Vam može

savjetovati kako da postupno smanjujete dozu prije prekida liječenja.

H A L M E D

11 - 12 - 2017

O D O B R E N O

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

ili ljekarniku.

4.

Moguće nuspojave

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

Odmah obavijestite svog liječnika ako imate:

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

ili jezika

krvne ugruške u venama (manje česta nuspojava koja se može pojaviti u do 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 primjetite bilo koji od

ovih simptoma, odmah zatražite savjet liječnika.

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 javiti u više od 1 na 10 osoba):

porast tjelesne težine

pospanost

porast razine prolaktina u krvi.

U nekih se bolesnika na početku liječenja može javiti osjećaj omaglice ili nesvjestica (s usporenim

radom srca), osobito prilikom ustajanja iz ležećeg ili sjedećeg položaja. To obično prolazi samo po

sebi, ali ako ne proĎe obavijestite o tome svog liječnika.

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

promjene razina nekih krvnih stanica i cirkulirajućih masnoća u krvi te na početku liječenja

privremeni porast razine jetrenih enzima

porast razine šećera u krvi i mokraći

povećane razine mokraćne kiseline i kreatin fosfokinaze u krvi

pojačan apetit

omaglica

nemir

nevoljno drhtanje

neuobičajeni pokreti (diskinezija)

zatvor

suhoća usta

osip

slabost

pojačan umor

zadržavanje vode u tijelu koje dovodi do oticanja ruku, zglobova ili stopala

vrućica

bolovi u zglobovima

seksualni poremećaji kao što su smanjeni libido kod muškaraca i žena ili erektilna disfunkcija

kod muškaraca.

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

preosjetljivost (oticanje u ustima i grlu, svrbež, osip)

šećerna bolest ili pogoršanje šećerne bolesti, ponekad povezano s nalazom ketona u krvi i

mokraći (ketoacidoza) ili koma

napadaji, obično kod bolesnika koji su već prije imali epileptičke napadaje

ukočenost ili grčevi mišića (uključujući pokrete očiju)

H A L M E D

11 - 12 - 2017

O D O B R E N O

sindrom nemirnih nogu

problemi s govorom

usporeni rad srca

osjetljivost na sunčevu svjetlost

krvarenje iz nosa

nadimanje trbuha

gubitak pamćenja ili zaboravljivost

nemogućnost zadržavanja mokraće (inkontinencija)

nemogućnost mokrenja

gubitak kose

izostanak menstruacije ili neredovite menstruacije

promjene na grudima kod muškaraca i žena kao što su poremećaj stvaranja majčinog mlijeka ili

abnormalan rast.

Rijetke nuspojave (mogu se pojaviti u manje od 1 na 1000 osoba):

sniženje normalne tjelesne temperature

poremećen ritam rada srca

iznenadna neobjašnjiva smrt

upala gušterače koja uzrokuje jaku bol u trbuhu, vrućicu i osjećaj mučnine

bolest jetre koja se manifestira žutilom kože i bjeloočnica

bolest mišića koja se manifestira neobjašnjivim bolovima u mišićima

produljena i/ili bolna erekcija.

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 limfnim čvorovima, povišenim razinama jetrenih enzima koji su

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

U starijih bolesnika sa zaboravljivošću (demencijom) tijekom liječenja olanzapinom može doći do

moždanog udara, upale pluća, nemogućnosti kontrole mokrenja, padova, izrazitog umora, vidnih

priviĎanja, povećanja tjelesne temperature, crvenila kože i otežanog hoda. U ovoj skupini bolesnika

zabilježeno je i nekoliko slučajeva sa smrtnim ishodom.

Kod bolesnika s Parkinsonovom bolešću Ziaxel filmom obložene tablete mogu dovesti do pogoršanja

simptoma.

Prijavljivanje nuspojava

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

svaku moguću nuspojavu koja nije navedena u ovoj uputi. Nuspojave možete prijaviti izravno putem

nacionalnog sustava prijave nuspojava: navedenog u Dodatku V.

Prijavljivanjem nuspojava možete pridonijeti u procjeni sigurnosti ovog lijeka.

5.

Kako čuvati Ziaxel filmom obložene tablete?

Ovaj lijek čuvajte izvan pogleda i dohvata djece.

Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kartonskoj kutiji iza

oznake „Rok valjanosti“ ili otisnutog na blisteru. Rok valjanosti odnosi se na zadnji dan navedenog

mjeseca.

Lijek ne zahtijeva posebne uvjete čuvanja.

H A L M E D

11 - 12 - 2017

O D O B R E N O

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 Ziaxel filmom obložene tablete sadrže

Djelatna tvar je olanzapin. Svaka Ziaxel filmom obložena tableta sadrži 5 mg ili 10 mg olanzapina.

Pomoćne tvari su:

Jezgra:

laktoza

hidrat;

mikrokristalinična

celuloza;

krospovidon;

hidroksipropilceluloza;

talk;

magnezijev stearat.

Ovojnica: Opadry AMB White OY-B-28920: titanijev dioksid (E 171); talk; lecitin; ksantanska

guma.

Kako Ziaxel filmom obložene tablete izgledaju i sadržaj pakiranja

Ziaxel 5 mg filmom obložene tablete su bijele, okrugle, zaobljene tablete, promjera 8,1 mm ± 0,1mm

i debljine 3,1 mm ± 0,2mm.

Ziaxel 10 mg filmom obložene tablete su bijele, okrugle, zaobljene tablete, promjera 10,1 mm ±

0,1mm i debljine 4,1 mm ± 0,2mm..

Ziaxel 5 mg i 10 mg filmom obložene tablete dostupne su u pakiranju od 28 (4x7) tableta u

PA/Al/PVC//Al blisteru, u kutiji.

Nositelj odobrenja za stavljanje lijeka u promet i proizvođač

Nositelj odobrenja:

Mylan Hrvatska d.o.o.,

Koranska 2

10000 Zagreb

Proizvođač:

Genera d.d

Svetonedeljska 2

Kalinovica, 10436 Rakov Potok

Način i mjesto izdavanja lijeka

Lijek se izdaje na recept, u ljekarni.

Ova uputa je zadnji puta revidirana u prosincu 2017.

H A L M E D

11 - 12 - 2017

O D O B R E N O

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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

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