Azolar 15 mg tablete

Glavna informacija

  • Trgovački naziv:
  • Azolar 15 mg tablete
  • Doziranje:
  • 15 mg
  • Farmaceutski oblik:
  • tableta
  • Sastav:
  • Urbroj: jedna tableta sadrži 15 mg aripiprazola
  • Tip recepta:
  • na recept, u ljekarni ponovljivi recept
  • Koristi za:
  • Ljudi
  • Vrsta lijekova:
  • alopatski lijek
  • Proizveden od:
  • Belupo lijekovi i kozmetika d.d., Koprivnica, Republika Hrvatska

Dokument

Lokalizacija

  • Na raspolaganju u:
  • Azolar 15 mg tablete
    Hrvatska
  • Jezik:
  • hrvatski

Terapeutski informacija

  • Proizvod sažetak:
  • Pakiranje: 30 tableta u blisteru, u kutiji [HR-H-911811259-01] Urbroj: 381-12-01/30-14-07

Druge informacije

Status

  • Izvor:
  • HALMED Agencija za lijekove i medicinske proizvode - Agency for medicinal products and medical devices of Croatia
  • Broj odobrenja:
  • HR-H-911811259
  • Datum autorizacije:
  • 22-12-2014
  • Zadnje ažuriranje:
  • 04-06-2018

Uputu o lijeku

Uputa o lijeku: Informacija za korisnika

AZOLAR 10 mg tablete

AZOLAR 15 mg tablete

AZOLAR 30 mg tablete

aripiprazol

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 naškoditi, čak i ako

su njihovi znakovi bolesti jednaki Vašima.

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

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

Što se nalazi u ovoj uputi:

1. Što su AZOLAR tablete i za što se koriste

2. Što morate znati prije nego počnete uzimati AZOLAR tablete

3. Kako uzimati AZOLAR tablete

4. Moguće nuspojave

5. Kako čuvati AZOLAR tablete

6. Sadržaj pakiranja i druge informacije

1. ŠTO SU AZOLAR TABLETE I ZA ŠTO SE KORISTE

AZOLAR tablete pripadaju skupini lijekova koji se zovu antipsihotici.

Koristi se za liječenje odraslih i adolescenata u dobi od 15 ili više godina koji boluju od bolesti

karakterizirane simptomima poput onih da osoba čuje, vidi ili osjeća stvari kojih nema, a mogu

se javiti i sumnjičavost, pogrešno vjerovanje, nepovezan govor i ponašanje te emocionalna

tupost. Osobe s ovom bolešću također mogu osjećati depresiju, krivnju, tjeskobu ili napetost.

AZOLAR tablete koriste se za liječenje odraslih osoba te adolescenata u dobi od 13 godina i

starijih koji boluju od stanja čiji su simptomi “povišeno” raspoloženje, pretjerana količina

energije, potreba za manjom količinom sna nego obično, vrlo brz govor i ubrzan tijek misli te

ponekad teška razdražljivost.

Ovaj lijek također sprječava povratak takvog stanja u odraslih bolesnika koji su prethodno imali

odgovor na terapiju AZOLAR tabletama.

2. ŠTO MORATE ZNATI PRIJE NEGO POČNETE UZIMATI AZOLAR TABLETE

Nemojte uzimati AZOLAR tablete

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

Upozorenja i mjere opreza

Obratite se svom liječniku prije nego uzmete AZOLAR tablete ako imate:

povišen šećer u krvi (karakteriziran simptomima poput pretjerane žeđi, obilnog mokrenja,

povećanog apetita i osjećaja slabosti) ili šećernu bolest u obiteljskoj povijesti bolesti

H A L M E D

15-09-2016

O D O B R E N O

napadaje

nevoljne, nepravilne mišićne pokrete, osobito na licu

krvožilne bolesti, krvožilne bolesti u obiteljskoj povijesti bolesti, moždani udar ili „mali“

moždani udar, poremećen krvni tlak

krvne ugruške ili krvne ugruške u obiteljskoj povijesti bolesti, jer su antipsihotici povezani s

razvojem krvnih ugrušaka

ako ste u prošlosti imali problema s prekomjernim kockanjem.

Ako primijetite povećanje tjelesne težine, pojavu neuobičajenih pokreta, izrazitu pospanost koja

Vas ometa u obavljanju svakodnevnih aktivnosti, poteškoće s gutanjem ili alergijske simptome,

molimo obavijestite o tome svog liječnika.

Ako ste starija osoba i bolujete od demencije (gubitka pamćenja i drugih mentalnih sposobnosti),

Vi ili Vaš skrbnik/član obitelji morate obavijestiti liječnika ako ste preboljeli moždani udar ili

„mali“ moždani udar.

Odmah obavijestite svog liječnika ako imate misli o samoozljeđivanju ili osjećate da biste si

mogli nauditi. Samoubilačke misli i ponašanja prijavljena su tijekom liječenja ovim lijekom.

Odmah obavijestite svog liječnika ako bolujete od ukočenosti ili nesavitljivost mišića s visokom

tjelesnom temperaturom, znojenjem, promijenjenim mentalnim statusom ili jako ubrzanim ili

nepravilnim otkucajima srca.

Djeca i adolescenti

AZOLAR tablete nisu namijenjene za primjenu u djece i adolescenata mlađih od 13 godina.

Ako se nešto od gore navedenog odnosi na Vas ili pak niste sigurni, javite se svom liječniku.

Drugi lijekovi i AZOLAR tablete

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

bilo koje druge lijekove. Ovo se odnosi i na lijekove koje ste nabavili bez recepta te na biljne

lijekove i homeopatske pripravke.

Lijekovi za snižavanje krvnog tlaka:

AZOLAR tablete mogu pojačati učinak lijekova koji se koriste za snižavanje krvnog tlaka.

Obavezno obavijestite svog liječnika ako uzimate lijek za kontrolu krvnog tlaka.

Ako uzimate AZOLAR tablete s nekim drugim lijekovima, možda će biti potrebno promijeniti

dozu AZOLAR tableta koju uzimate.

U slučaju da uzimate sljedeće lijekove, osobito je važno da o tome obavijestite svog liječnika:

lijekove za ispravljanje srčanog ritma

antidepresive ili biljne lijekove za liječenje depresije i tjeskobe

lijekove za liječenje gljivičnih bolesti

određene lijekove za liječenje infekcije HIV-om

antikonvulzive za liječenje epilepsije.

Lijekovi koji povećavaju razinu serotonina:

Triptani, tramadol, triptofan, SSRI (kao paroksetin i fluoksetin), triciklički antidepresivi (kao

klomipramin, amitriptilin), petidin, gospina trava i venlafaksin. Ovi lijekovi povećavaju rizik od

nuspojava. Ako primijetite bilo kakav neobičan simptom dok uzimate neki od ovih lijekova

istodobno s AZOLAR tabletama, obavezno se javite svom liječniku.

H A L M E D

15-09-2016

O D O B R E N O

AZOLAR tablete s hranom, pićem i alkoholom

AZOLAR tablete mogu se uzimati neovisno o obrocima.

Za vrijeme liječenja AZOLAR tabletama moraju se izbjegavajti alkoholna pića.

Trudnoća i dojenje

Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se

svom liječniku za savjet prije nego uzmete ovaj lijek.

Ako ste trudni, ne smijete uzimati AZOLAR tablete

, osim ako ste o tome razgovarali s

liječnikom.

Sljedeći simptomi se mogu javiti u novorođenčadi majki koje su uzimale AZOLAR tablete u

posljednjem tromjesečju (posljednja tri mjeseca trudnoće): tresavica, ukočenost i/ili slabost

mišića, pospanost, uznemirenost, tegobe s disanjem i poteškoće s hranjenjem. Ako se kod Vašeg

djeteta razvije bilo koji od ovih simptoma, javite se svom liječniku.

Ako uzimate AZOLAR tablete, ne smijete dojiti.

Upravljanje vozilima i strojevima

Nemojte voziti niti koristiti bilo kakve alate ili strojeve prije nego što znate kako AZOLAR

tablete utječu na Vas.

AZOLAR tablete sadrže laktozu

AZOLAR tablete sadrže pomoćnu tvar laktozu hidrat. Ako Vam je liječnik rekao da ne podnosite

neke šećere, savjetujte se s liječnikom prije uzimanja ovog lijeka.

3. KAKO UZIMATI AZOLAR TABLETE

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

Vašim liječnikom ili ljekarnikom ako niste sigurni.

Preporučena doza za odrasle je 15 mg jedanput dnevno.

Međutim, liječnik Vam može

propisati manju ili veću dozu, koja smije iznositi najviše 30 mg jedanput dnevno.

Primjena u djece i adolescenata

Liječenje

aripiprazolom

može

započeti

nižom

jačinom

lijeka

obliku

oralne

otopine

(tekućine) drugog proizvođača. U nastavku liječenja doza se može postupno povećavati do

preporučene doze za adolescente od 10 mg jedanput dnevno

. Međutim, liječnik Vam može

propisati manju ili veću dozu, koja smije iznositi najviše 30 mg jedanput dnevno.

Ako imate dojam da je učinak AZOLAR tableta prejak ili preslab, obratite se svom liječniku ili

ljekarniku.

Pokušajte uzimati AZOLAR tablete svaki dan u isto vrijeme.

Nije važno uzimate li ih s hranom ili ne (vidjeti dio

AZOLAR tablete s hranom, pićem i

alkoholom

AZOLAR 10 mg tablete

Tableta ima razdjelni urez koji omogućava lomljenje tablete na dva dijela pri čemu se

osigurava da svaka polovica tablete sadrži 5 mg. U dogovoru s Vašim liječnikom, progutajte

polovicu ili cijelu tabletu s čašom vode, jedanput na dan.

H A L M E D

15-09-2016

O D O B R E N O

AZOLAR 15 mg tablete i AZOLAR 30 mg tablete

Uvijek progutajte cijelu tabletu s čašom vode, jedanput na dan.

Čak

osjećate

bolje,

nemojte mijenjati dozu niti prekidati svakodnevno uzimanje

AZOLAR tableta bez prethodnog savjetovanja s liječnikom.

Ako uzmete više AZOLAR tableta nego što ste trebali

Ukoliko ste slučajno uzeli više AZOLAR tableta nego što Vam je liječnik propisao (ili ako je

druga osoba popila Vaše AZOLAR tablete), odmah se javite najbližoj hitnoj medicinskoj službi

ili obavijestite svojeg liječnika. Uzmite preostale tablete ili uputu o lijeku sa sobom kako bi

zdravstveni djelatnici kojima ste se obratili točno znali koji ste lijek uzeli.

Ako ste zaboravili uzeti AZOLAR tablete

Ukoliko zaboravite uzeti dozu lijeka, uzmite ju čim se sjetite. Nemojte uzeti dvostruku dozu

kako biste nadoknadili zaboravljenu dozu.

U slučaju bilo kakvih 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 javiti kod svakoga.

Česte nuspojave (javljaju se u najviše 1 na 10 bolesnika):

nekontrolirano trzanje mišića ili trzajni pokreti, glavobolja, umor, mučnina, povraćanje,

neugodan osjećaj u želucu, zatvor, pojačano stvaranje sline, ošamućenost, poteškoće sa

spavanjem, nemir, osjećaj tjeskobe, pospanost, tresavica i zamagljen vid.

Manje česte nuspojave (javljaju se u najviše 1 na 100 bolesnika):

neke osobe mogu osjećati omaglicu, osobito pri ustajanju iz ležećeg ili sjedećeg položaja, ili

mogu osjetiti ubrzan rad srca. Neke osobe se mogu osjećati depresivno.

povišenje razine hormona prolaktina u krvi.

štucavica

Sljedeće nuspojave prijavljene su nakon stavljanja AZOLAR tableta u promet, ali nije

poznato kojom su se učestalošću javljale (učestalost se ne može odrediti iz dostupnih

podataka):

Promjene broja nekih krvnih stanica; nepravilni otkucaji srca, iznenadna neobjašnjiva smrt,

srčani udar; alergijska reakcija (npr. oteklina usta, jezika, lica i grla, svrbež, osip); povišen šećer

u krvi, početak ili pogoršanje šećerne bolesti, ketoacidoza (ketoni u krvi i mokraći) ili koma,

smanjena razina natrija u krvi; povećanje tjelesne težine, smanjenje tjelesne težine, anoreksija;

nervoza,

uznemirenost,

agresija,

osjećaj

tjeskobe,

prekomjerno

kockanje;

suicidalne

misli,

pokušaj

samoubojstva

samoubojstvo;

poremećaj

govora,

epileptički

napadi,

serotoninski

sindrom (reakcija koja

može

dovesti

osjećaja

velike

sreće, omamljenosti, nespretnosti,

nemira,

osjećaja

pijanstva,

vrućice,

znojenja

ukočenih

mišića),

kombinacija

vrućice,

ukočenosti mišića, ubrzanog disanja, znojenja, smanjene svijesti i iznenadnih promjena krvnog

tlaka i brzine otkucaja srca; nesvjestica, visoki krvni tlak, krvni ugrušci u venama osobito nogu

(simptomi uključuju oteklinu, bol i crvenilo noge), koji mogu putovati kroz krvne žile do pluća i

tamo prouzročiti bol u prsima i otežano disanje (

ako primijetite neki od navedenih simptoma,

odmah potražite liječničku pomoć

); grč mišića koji okružuju glasnice, slučajno udisanje hrane

uz rizik od razvoja upale pluća, poteškoće s gutanjem; upala gušterače; zatajenje jetre, upala

H A L M E D

15-09-2016

O D O B R E N O

jetre, žuta boja kože i bjeloočnica, abnormalne vrijednosti jetrenih pretraga, nelagoda u trbuhu i

želucu, proljev; kožni osip i osjetljivost na svjetlost, neobičan gubitak kose ili prorijeđenost kose,

pojačano znojenje; ukočenost ili grčevi, bol u mišićima, slabost; nemogućnost kontroliranja

mokrenja, poteškoće pri mokrenju; produljena i/ili bolna erekcija; poteškoće s kontroliranjem

osnovne tjelesne temperature ili pregrijavanje, bol u prsima i otekline ruku, gležnjeva ili stopala.

U starijih bolesnika s demencijom prijavljeno je više smrtnih slučajeva za vrijeme liječenja ovim

lijekom. Osim toga, prijavljeni su slučajevi moždanog udara ili „malog“ moždanog udara.

Dodatne nuspojave u djece i adolescenata

Adolescenti u dobi od 13 ili više godina imali su nuspojave slične učestalosti i vrste kao i odrasli

bolesnici, osim što su pospanost, nekontrolirano trzanje mišića ili trzajni pokreti, nemir i umor

bili vrlo česti (javljaju se u više od 1 na 10 bolesnika), dok su bol u gornjem dijelu trbuha, suha

usta,

ubrzani

otkucaji

srca,

povećanje

tjelesne

težine,

pojačan

apetit,

trzanje

mišića,

nekontrolirani pokreti udova i osjećaj omaglice, osobito pri ustajanju iz ležećeg ili sjedećeg

položaja, bili česti (javljaju se u najviše 1 na 100 bolesnika).

Prijavljivanje nuspojava

primijetite

bilo

koju

nuspojavu,

potrebno

obavijestiti

liječnika

ljekarnika.

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

izravno

putem

nacionalnog

sustava

prijavu

nuspojava

navedenog

Dodatku

Prijavljivanjem nuspojava možete pridonijeti u procjeni sigurnosti ovog lijeka.

5. KAKO ČUVATI AZOLAR TABLETE

Ovaj lijek čuvajte izvan pogleda i dohvata djece.

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

Rok valjanosti odnosi se na zadnji dan navedenog mjeseca.

Lijek ne zahtjeva posebne uvjete čuvanja.

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 AZOLAR tablete sadrže

Djelatna tvar je aripiprazol.

AZOLAR 10 mg tablete: jedna tableta sadrži 10 mg aripiprazola.

AZOLAR 15 mg tablete: jedna tableta sadrži 15 mg aripiprazola.

AZOLAR 30 mg tablete: jedna tableta sadrži 30 mg aripiprazola.

Pomoćne

tvari

laktoza

hidrat;

kukuruzni

škrob;

celuloza,

mikrokristalična;

hidroksipropilceluloza; magnezijev stearat.

AZOLAR 10 mg i 30 mg tablete sadrže i boju željezov oksid, crveni (E172).

AZOLAR 15 mg tablete sadrže i boju željezov oksid, žuti (E172).

Kako AZOLAR tablete izgledaju i sadržaj pakiranja

AZOLAR 10 mg tableta je pravokutna, bikonveksna, svijetlo ružičasta tableta s razdjelnim

urezom na jednoj strani. Tableta ima razdjelni urez koji omogućava lomljenje tablete na dva

dijela pri čemu se osigurava da svaka polovica tablete sadrži 5 mg.

H A L M E D

15-09-2016

O D O B R E N O

AZOLAR 15 mg tableta je okrugla, ravna, svijetlo žuta tableta.

AZOLAR 30 mg tableta je okrugla, bikonveksna, svijetlo ružičasta tableta.

30 (5x6) tableta u oPA/Al/PVC//Al blisteru, u kutiji.

Ime i adresa nositelja odobrenja za stavljanje gotovog lijeka u promet

BELUPO lijekovi i kozmetika d.d.

Ulica Danica 5

48 000 Koprivnica, Hrvatska

Ime i adresa proizvođača lijeka

BELUPO lijekovi i kozmetika d.d.

Ulica Danica 5

48 000 Koprivnica, Hrvatska

Način i mjesto izdavanja lijeka

Lijek se izdaje na recept, u ljekarni.

Ova uputa je zadnji puta revidirana u svibnju 2016.

H A L M E D

15-09-2016

O D O B R E N O

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Pest categorisation of Cronartium harknessii, Cronartium kurilense and Cronartium sahoanum

Published on: Mon, 15 Oct 2018 00:00:00 +0200 Following a request from the European Commission, the EFSA Panel on Plant Health performed a pest categorisation of Cronartium harknessii, Cronartium kurilense and Cronartium sahoanum, which are well‐defined and distinguishable tree fungal pathogens of the family Cronartiaceae. In 2018, these species were moved from the genus Endocronartium to the genus Cronartium. These pathogens are not known to be present in the EU and are regulated in Council Directive 2...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Modification of the existing maximum residue levels for mepiquat in cotton seeds and animal commodities

Modification of the existing maximum residue levels for mepiquat in cotton seeds and animal commodities

Published on: Mon, 15 Oct 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant, BASF SE, submitted an application to the competent national authority in Greece to modify the existing maximum residue level (MRL) for the active substance mepiquat in cotton seeds. The data submitted in support of the application were found to be sufficient to derive a MRL proposal for cotton seeds and the previously derived MRL proposals for animal commodities were found to be stil...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Assessment of low pathogenic avian influenza virus transmission via raw poultry meat and raw table eggs

Assessment of low pathogenic avian influenza virus transmission via raw poultry meat and raw table eggs

Published on: Mon, 15 Oct 2018 00:00:00 +0200 A rapid qualitative assessment has been done by performing a theoretical analysis on the transmission of low pathogenic avian influenza (LPAI) via fresh meat from poultry reared or kept in captivity for the production of meat (raw poultry meat) or raw table eggs. A predetermined transmission pathway followed a number of steps from a commercial or non‐commercial poultry establishment within the EU exposed to LPAI virus (LPAIV) to the onward virus transmission...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Pest categorisation of Melampsora farlowii

Pest categorisation of Melampsora farlowii

Published on: Mon, 15 Oct 2018 00:00:00 +0200 Following a request from the European Commission, the EFSA Panel on Plant Health performed a pest categorisation of Melampsora farlowii, a well‐defined and distinguishable fungus of the family Melampsoraceae. M. farlowii is the causal agent of a leaf and twig rust of hemlocks (Tsuga spp.) in eastern North America. The pathogen is regulated in Council Directive 2000/29/EC (Annex IAI) as a harmful organism whose introduction into the EU is banned. M. farlowii ...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Evaluation of confirmatory data following the Article 12 MRL review for teflubenzuron

Evaluation of confirmatory data following the Article 12 MRL review for teflubenzuron

Published on: Mon, 15 Oct 2018 00:00:00 +0200 The applicant BASF Agro BV submitted a request to the competent national authority in United Kingdom to evaluate the confirmatory data that were identified for teflubenzuron in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, a new metabolism study on leafy crops, a study investigating the nature of residues under standard hydrolytic conditions and a validated ...

Europe - EFSA - European Food Safety Authority Publications

3-10-2018

Sportminister Bruno Bruins brengt verrassingsbezoek aan Talent TeamNL in Buenos Aires

Sportminister Bruno Bruins brengt verrassingsbezoek aan Talent TeamNL in Buenos Aires

Van 6 tot 18 oktober wordt in Buenos Aires, Argentinië, de derde editie van de Jeugd Olympische Spelen gehouden. Toptalenten uit 206 landen tussen de 15 en 18 jaar oud doen hieraan mee. Talent TeamNL bestaat uit 41 sporters die uitkomen in  19 disciplines. Minister voor Sport Bruno Bruins bracht vandaag een verrassingsbezoek aan de Nederlandse ploeg. Hij bezocht het Olympisch Dorp waar de talenten onder leiding van Chef de Mission Mark Huizinga zich voorbereiden op de Spelen die zaterdag beginnen. 

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

28-9-2018

EpiPen and EpiPen Jr auto-injectors may stick in their carrier tube

EpiPen and EpiPen Jr auto-injectors may stick in their carrier tube

Pfizer Canada has advised Health Canada that, in a very small number of cases, some EpiPen (0.3 mg) and EpiPen Jr (0.15 mg) auto-injector devices may not slide out of their carrier tube easily, or at all. This could delay or prevent emergency treatment, possibly leading to patient disability or death.

Health Canada

28-9-2018

Avian influenza overview May – August 2018

Avian influenza overview May – August 2018

Published on: Thu, 27 Sep 2018 00:00:00 +0200 Between 16 May and 15 August 2018, three highly pathogenic avian influenza (HPAI) A(H5N8) outbreaks in poultry establishments and three HPAI A(H5N6) outbreaks in wild birds were reported in Europe. Three low pathogenic avian influenza (LPAI) outbreaks were reported in three Member States. Few HPAI and LPAI bird cases have been detected in this period of the year, in accordance with the seasonal expected pattern of LPAI and HPAI. There is no evidence to date ...

Europe - EFSA - European Food Safety Authority Publications

26-9-2018

Technical Report on the notification of syrup from Sorghum bicolor (L.) Moench as a traditional food from a third country pursuant to Article 14 of Regulation (EU) 2015/2283

Technical Report on the notification of syrup from Sorghum bicolor (L.) Moench as a traditional food from a third country pursuant to Article 14 of Regulation (EU) 2015/2283

Published on: Tue, 25 Sep 2018 00:00:00 +0200 Abstract Following a notification from Sorghum Zrt., submitted to the European Commission under Article 14 of Regulation (EU) 2015/2283 to place on the market syrup from Sorghum bicolor (L.) Moench as a traditional food from a third country (TF), and in line with Article 15(2) of that Regulation, EFSA was asked by the European Commission whether there are duly reasoned safety objections to the placing on the market of the TF within the European Union. The ap...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Risk to human and animal health related to the presence of 4,15‐diacetoxyscirpenol in food and feed

Risk to human and animal health related to the presence of 4,15‐diacetoxyscirpenol in food and feed

Published on: Thu, 16 Aug 2018 00:00:00 +0200 4,15‐Diacetoxyscirpenol (DAS) is a mycotoxin primarily produced by Fusarium fungi and occurring predominantly in cereal grains. As requested by the European Commission, the EFSA Panel on Contaminants in the Food Chain (CONTAM) assessed the risk of DAS to human and animal health related to its presence in food and feed. Very limited information was available on toxicity and on toxicokinetics in experimental and farm animals. Due to the limitations in the avai...

Europe - EFSA - European Food Safety Authority Publications

16-8-2018

August 15, 2018: Florida Man Pleads Guilty to Scheme to Market Dietary Supplements

August 15, 2018: Florida Man Pleads Guilty to Scheme to Market Dietary Supplements

August 15, 2018: Florida Man Pleads Guilty to Scheme to Market Dietary Supplements

FDA - U.S. Food and Drug Administration

15-8-2018

Enforcement Report for the Week of August 15, 2018

Enforcement Report for the Week of August 15, 2018

Recently Updated Records for the Week of August 15, 2018 Last Modified Date: Monday, August 13, 2018

FDA - U.S. Food and Drug Administration

14-8-2018

Minister-president Rutte bij herdenking capitulatie Japan

Minister-president Rutte bij herdenking capitulatie Japan

Minister-president Rutte neemt woensdagmiddag 15 augustus 2018 deel aan de herdenking van de capitulatie van Japan op 15 augustus 1945. De herdenking vindt plaats bij het Indisch Monument in Den Haag.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

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

31-7-2018

ADM Animal Nutrition Recalls Mintrate® 36-15 Breed Right Cattle Tub - A specific lot of product may contain elevated levels of non-protein nitrogen, could harm cattle

ADM Animal Nutrition Recalls Mintrate® 36-15 Breed Right Cattle Tub - A specific lot of product may contain elevated levels of non-protein nitrogen, could harm cattle

ADM Animal Nutrition, a division of Archer Daniels Midland Company (NYSE: ADM), is recalling 200-pound tubs of Mintrate® 36-15 Breed Right Tub cattle feed, product number 54549AAA6H, because the product may contain elevated levels of non-protein nitrogen, which could be harmful to cattle. Excessive levels of non-protein nitrogen can be toxic to cattle and can cause muscle tremors (especially of face and ears), abdominal pain, bloat, frothy salivation, excessive urination, teeth grinding, incoordination, ...

FDA - U.S. Food and Drug Administration

18-7-2018

Blokhuis: jaarlijkse subsidie voor 113Zelfmoordpreventie omhoog naar 5,4 miljoen

Blokhuis: jaarlijkse subsidie voor 113Zelfmoordpreventie omhoog naar 5,4 miljoen

Staatssecretaris Paul Blokhuis (VWS) wil het aantal zelfmoorden en zelfmoordpogingen terugdringen. Om dat te bereiken geeft hij structureel 2 miljoen per jaar extra instellingssubsidie aan 113Zelfmoordpreventie. Het jaarlijkse budget van de organisatie gaat daarmee fors omhoog, van 3,4 miljoen naar 5,4 miljoen euro. Daarnaast zijn er extra middelen voor andere lopende activiteiten zoals de lokale aanpakken suïcidepreventie en onderzoek. In totaal is daar 15 miljoen mee gemoeid.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

17-7-2018

July 17, 2018: Former President of Cumberland Distribution, Inc. Sentenced to 15 Years in Federal Prison for $50 Million Drug Diversion Scheme

July 17, 2018: Former President of Cumberland Distribution, Inc. Sentenced to 15 Years in Federal Prison for $50 Million Drug Diversion Scheme

July 17, 2018: Former President of Cumberland Distribution, Inc. Sentenced to 15 Years in Federal Prison for $50 Million Drug Diversion Scheme

FDA - U.S. Food and Drug Administration

29-6-2018

Wish Bone Salad Dressing Issues Allergy Alert On Undeclared Milk and Egg in 15 oz. Wish-Bone House Italian Salad Dressing

Wish Bone Salad Dressing Issues Allergy Alert On Undeclared Milk and Egg in 15 oz. Wish-Bone House Italian Salad Dressing

Pinnacle Foods Inc. is voluntarily recalling a limited quantity of Wish Bone House Italian Salad Dressing 15 oz. with the health and safety of our consumers as our top priority. The recall was initiated after learning from a retail customer that a limited number of bottles were mislabeled. The product contains milk and egg, known allergens not declared on the bottle. People who have an allergy or severe sensitivity to milk or egg may run the risk of a serious or life-threatening allergic reaction if t...

FDA - U.S. Food and Drug Administration

8-11-2018

There's only 1 week until the 2018 Patient Engagement Advisory Committee meeting. Join the @US_FDA on Nov 15 to discuss patient-generated health data from sources like social media, activity trackers, and patient-driven registries.pic.twitter.com/WkDNnXqm

There's only 1 week until the 2018 Patient Engagement Advisory Committee meeting. Join the @US_FDA on Nov 15 to discuss patient-generated health data from sources like social media, activity trackers, and patient-driven registries.pic.twitter.com/WkDNnXqm

There's only 1 week until the 2018 Patient Engagement Advisory Committee meeting. Join the @US_FDA on Nov 15 to discuss patient-generated health data from sources like social media, activity trackers, and patient-driven registries. pic.twitter.com/WkDNnXqmbw

FDA - U.S. Food and Drug Administration

31-10-2018

Imraldi (Samsung Bioepis NL B.V.)

Imraldi (Samsung Bioepis NL B.V.)

Imraldi (Active substance: adalimumab) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7344 of Wed, 31 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4279/T/15

Europe -DG Health and Food Safety

22-10-2018

EU/3/16/1640 (Celgene Europe B.V.)

EU/3/16/1640 (Celgene Europe B.V.)

EU/3/16/1640 (Active substance: 2-methyl-1-[(4-[6-(trifluoromethyl)pyridin-2-yl]-6-{[2-(trifluoromethyl)pyridin-4-yl]amino}-1,3,5-triazin-2-yl)amino]propan-2-ol methanesulfonate) - Transfer of orphan designation - Commission Decision (2018)6989 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/253/15/T/01

Europe -DG Health and Food Safety

22-10-2018

EU/3/15/1495 (Ultragenyx Netherlands B.V.)

EU/3/15/1495 (Ultragenyx Netherlands B.V.)

EU/3/15/1495 (Active substance: Triheptanoin) - Transfer of orphan designation - Commission Decision (2018)6992 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/007/15/T/02

Europe -DG Health and Food Safety

22-10-2018

EU/3/15/1532 (Sirius Regulatory Consulting EU Limited)

EU/3/15/1532 (Sirius Regulatory Consulting EU Limited)

EU/3/15/1532 (Active substance: Insulin human) - Transfer of orphan designation - Commission Decision (2018)6985 of Mon, 22 Oct 2018

Europe -DG Health and Food Safety

17-10-2018

Interact with experts from CDER, CBER & CDRH to learn what’s important when conducting clinical trials & preparing submissions for FDA review.

Register for FDA #CDERSBIA Clinical Investigator Training Course – November 13-15 in Silver Spring, MD.  https:

Interact with experts from CDER, CBER & CDRH to learn what’s important when conducting clinical trials & preparing submissions for FDA review. Register for FDA #CDERSBIA Clinical Investigator Training Course – November 13-15 in Silver Spring, MD. https:

Interact with experts from CDER, CBER & CDRH to learn what’s important when conducting clinical trials & preparing submissions for FDA review. Register for FDA #CDERSBIA Clinical Investigator Training Course – November 13-15 in Silver Spring, MD. https://go.usa.gov/xPqku  pic.twitter.com/EYNZANlgr9

FDA - U.S. Food and Drug Administration

15-10-2018

Riximyo (Sandoz GmbH)

Riximyo (Sandoz GmbH)

Riximyo (Active substance: rituximab) - Centralised - Yearly update - Commission Decision (2018)6811 of Mon, 15 Oct 2018

Europe -DG Health and Food Safety

1-10-2018

EU/3/16/1762 (Pharma Gateway AB)

EU/3/16/1762 (Pharma Gateway AB)

EU/3/16/1762 (Active substance: Synthetic 15-amino-acid macrocyclic peptide acylated with a polyethyleneglycol palmitoylated linker) - Transfer of orphan designation - Commission Decision (2018)6399 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/107/16/T/01

Europe -DG Health and Food Safety

25-9-2018

Conducting clinical trials & preparing a submission for #FDA review?

Register for #CDERSBIA’s Clinical Investigator Training Course: November 13-15 to learn about FDA regulations, scientific principles for conducting clinical trials, & more!  https://go.

Conducting clinical trials & preparing a submission for #FDA review? Register for #CDERSBIA’s Clinical Investigator Training Course: November 13-15 to learn about FDA regulations, scientific principles for conducting clinical trials, & more! https://go.

Conducting clinical trials & preparing a submission for #FDA review? Register for #CDERSBIA’s Clinical Investigator Training Course: November 13-15 to learn about FDA regulations, scientific principles for conducting clinical trials, & more! https://go.usa.gov/xPqku . pic.twitter.com/Ktqq9Slx0y

FDA - U.S. Food and Drug Administration

24-9-2018

Tomorrow, September 25th at 9:15 AM, join the #FDA for a session at #MedTechCon about our #DigitalHealth Software Precertification #FDAPrecert Pilot Program...

Tomorrow, September 25th at 9:15 AM, join the #FDA for a session at #MedTechCon about our #DigitalHealth Software Precertification #FDAPrecert Pilot Program...

Tomorrow, September 25th at 9:15 AM, join the #FDA for a session at #MedTechCon about our #DigitalHealth Software Precertification #FDAPrecert Pilot Program...

FDA - U.S. Food and Drug Administration

18-8-2018

EU/3/16/1645 (Salzman Group Ltd)

EU/3/16/1645 (Salzman Group Ltd)

EU/3/16/1645 (Active substance: Cannabidiol) - Transfer of orphan designation - Commission Decision (2018)4806 of Sat, 18 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/248/15/T/01

Europe -DG Health and Food Safety

15-8-2018

EU/3/18/1994 (Quality Regulatory Clinical Ireland Limited)

EU/3/18/1994 (Quality Regulatory Clinical Ireland Limited)

EU/3/18/1994 (Active substance: Ivosidenib) - Transfer of orphan designation - Commission Decision (2018)5555 of Wed, 15 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/172/17/T/01

Europe -DG Health and Food Safety

15-8-2018

Orbactiv (Rempex London Ltd)

Orbactiv (Rempex London Ltd)

Orbactiv (Active substance: oritavancin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5556 of Wed, 15 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3785/T/20

Europe -DG Health and Food Safety

15-8-2018

Komboglyze (AstraZeneca AB)

Komboglyze (AstraZeneca AB)

Komboglyze (Active substance: saxagliptin / metformin) - Centralised - 2-Monthly update - Commission Decision (2018)5559 of Wed, 15 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2059/WS/1289

Europe -DG Health and Food Safety

15-8-2018

Ivabradine Zentiva (Zentiva, k.s.)

Ivabradine Zentiva (Zentiva, k.s.)

Ivabradine Zentiva (Active substance: ivabradine) - Centralised - Yearly update - Commission Decision (2018)5558 of Wed, 15 Aug 2018

Europe -DG Health and Food Safety

27-7-2018

EU/3/15/1473 (Celgene Europe B.V.)

EU/3/15/1473 (Celgene Europe B.V.)

EU/3/15/1473 (Active substance: Lenalidomide) - Transfer of orphan designation - Commission Decision (2018)5042 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/284/14/T/01

Europe -DG Health and Food Safety

27-7-2018

EU/3/16/1635 (Leadiant GmbH)

EU/3/16/1635 (Leadiant GmbH)

EU/3/16/1635 (Active substance: N-acetyl-D-mannosamine monohydrate) - Transfer of orphan designation - Commission Decision (2018)5053 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/228/15/T/01

Europe -DG Health and Food Safety

10-7-2018

Corbilta (Orion Corporation)

Corbilta (Orion Corporation)

Corbilta (Active substance: levodopa / carbidopa / entacapone) - Centralised - Renewal - Commission Decision (2018)4468 of Tue, 10 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2785/R/15

Europe -DG Health and Food Safety

27-6-2018

EU/3/15/1606 (Bayer AG)

EU/3/15/1606 (Bayer AG)

EU/3/15/1606 (Active substance: (S)-N-(5-((R)-2-(2,5-difluorophenyl)pyrrolidin-1-yl)pyrazolo[1,5-a]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide hydrogen sulfate) - Transfer of orphan designation - Commission Decision (2018)4094 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/184/15/T/02

Europe -DG Health and Food Safety

27-6-2018

EU/3/15/1460 (Eisai GmbH)

EU/3/15/1460 (Eisai GmbH)

EU/3/15/1460 (Active substance: Lenvatinib) - Transfer of orphan designation - Commission Decision (2018)4080 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/287/14/T/01

Europe -DG Health and Food Safety

27-6-2018

EU/3/15/1590 (Merck Europe B.V.)

EU/3/15/1590 (Merck Europe B.V.)

EU/3/15/1590 (Active substance: Recombinant human monoclonal IgG1 antibody against programmed death ligand-1) - Transfer of orphan designation - Commission Decision (2018)4088 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/150/15/T/02

Europe -DG Health and Food Safety

19-6-2018

Zepatier (Merck Sharp and Dohme B.V.)

Zepatier (Merck Sharp and Dohme B.V.)

Zepatier (Active substance: elbasvir / grazoprevir) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3917 of Tue, 19 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4126/T/15

Europe -DG Health and Food Safety