Yasnal Q-Tab 10 mg raspadljive

Glavna informacija

  • Trgovački naziv:
  • Yasnal Q-Tab 10 mg raspadljive tablete za usta
  • Doziranje:
  • 10 mg
  • Farmaceutski oblik:
  • raspadljiva tableta za usta
  • Sastav:
  • Urbroj: svaka raspadljiva tableta za usta sadrži 10 mg donepezilklorida u obliku donepezilklorid hidrata
  • Tip recepta:
  • na recept, u ljekarni ponovljivi recept
  • Koristi za:
  • Ljudi
  • Vrsta lijekova:
  • alopatski lijek
  • Proizveden od:
  • Krka d.d., Novo mesto, Slovenija

Dokument

Lokalizacija

  • Na raspolaganju u:
  • Yasnal Q-Tab 10 mg raspadljive tablete za usta
    Hrvatska
  • Jezik:
  • hrvatski

Terapeutski informacija

  • Proizvod sažetak:
  • Pakiranje: 10 tableta u blisteru, u kutiji [HR-H-700070026-01]; 28 tableta u blisteru, u kutiji [HR-H-700070026-02]; 30 tableta u blisteru, u kutiji [HR-H-700070026-03]; 50 tableta u blisteru, u kutiji [HR-H-700070026-04]; 56 tableta u blisteru, u kutiji [HR-H-700070026-05]; 60 tableta u blisteru, u kutiji [HR-H-700070026-06]; 84 tablete u blisteru, u kutiji [HR-H-700070026-07]; 90 tableta u blisteru, u kutiji [HR-H-700070026-08]; 98 tableta u blisteru, u kutiji [HR-H-700070026-09]; 100 tableta u blisteru, u kutiji [HR-H-700070026-10] Urbroj: 381-12-01/30-17-03

Druge informacije

Status

  • Izvor:
  • HALMED Agencija za lijekove i medicinske proizvode - Agency for medicinal products and medical devices of Croatia
  • Broj odobrenja:
  • HR-H-700070026
  • Datum autorizacije:
  • 23-05-2017
  • Zadnje ažuriranje:
  • 05-06-2018

Uputu o lijeku

Uputa o lijeku: Informacije za bolesnika

Yasnal Q-Tab 5 mg raspadljive tablete za usta

Yasnal Q-Tab 10 mg raspadljive tablete za usta

donepezilklorid

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 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 Yasnal Q-Tab i za što se koristi?

Što morate znati prije nego počnete uzimati Yasnal Q-Tab?

Kako uzimati Yasnal Q-Tab?

Moguće nuspojave

Kako čuvati Yasnal Q-Tab?

Sadržaj pakiranja i druge informacije

1.

Što je Yasnal Q-Tab i za što se koristi?

Yasnal Q-Tab sadrži djelatnu tvar donepezilklorid koja pripada skupini lijekova pod nazivom

inhibitori acetilkolinesteraze. Donepezil povisuje razinu acetilkolina, tvari u mozgu koja je povezana

uz funkciju pamćenja tako da usporava pad razine acetilkolina.

Yasnal Q-Tab se koristi za liječenje simptoma demencije u bolesnika kojima je postavljena dijagnoza

blage do srednje teške Alzheimerove bolesti.

Simptomi uključuju porast gubitka pamćenja, konfuziju i promjene u ponašanju što dovodi do toga da

se oboljeli od Alzheimerove bolesti sve teže i teže nose sa svakodnevnim aktivnostima.

Yasnal Q-Tab se primjenjuje samo u odraslih bolesnika.

2.

Što morate znati prije nego počnete uzimati Yasnal Q-Tab?

Nemojte uzimati Yasnal Q-Tab

ako ste alergični na donepezilklorid, na derivate piperidina ili neki drugi sastojak ovog lijeka

(naveden u dijelu 6.).

Upozorenja i mjere opreza

Obratite se Vašem liječniku ili ljekarniku prije nego uzmete Yasnal Q-Tab.

Obavijestite svog liječnika ili ljekarnika prije nego počnete uzimati Yasnal Q-Tab ako imate ili ste

imali:

čir na želucu ili dvanaesniku

napadaje ili konvulzije

problem sa srcem (osobito nepravilan ili vrlo usporen rad srca)

astmu ili drugu dugotrajnu plućnu bolest

probleme s jetrom ili hepatitis

poteškoće s mokrenjem ili blagu bolest bubrega.

Recite Vašem liječniku ako ste trudni ili mislite da biste mogli biti trudni.

H A L M E D

23 - 05 - 2017

O D O B R E N O

Drugi lijekovi i Yasnal Q-Tab

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

druge lijekove, uključujući i one koje ste nabavili bez liječničkog recepta. To se odnosi i na lijekove

koje biste mogli uzimati istodobno ubuduće ako nastavite uzimati Yasnal Q-Tab. Nekolicina lijekova

može promijeniti djelovanje lijeka Yasnal Q-Tab, odnosno i Yasnal Q-Tab može utjecati na djelovanje

drugog lijeka.

Posebno naglasite svom liječniku ako uzimate bilo koji od sljedećih vrsta lijekova:

druge lijekove za liječenje Alzheimerove bolesti, npr. galantamin,

lijekove protiv boli ili artritisa, npr. acetilsalicilatnu kiselinu, nesteroidne protuupalne lijekove

(NSAIL) poput ibuprofena ili diklofenaka,

antikolinergičke lijekove, npr. tolterodin,

antibiotike, npr. eritromicin, rifampicin,

lijekove protiv gljivičnih infekcija, npr. itrakonazol ili ketokonazol,

antidepresive, npr. fluoksetin,

antikonvulzive (antiepileptike, protiv napadaja, grčeva), npr. fenitoin, karbamazepin,

lijekove za liječenje poteškoća sa srcem, npr. kinidin, beta blokatore (propanolol ili atenolol),

mišićne relaksanse, npr. sukcinilkolin,

lijekove koji se mogu nabaviti bez recepta npr. biljne lijekove.

Ako idete na operaciju koja zahtijeva primjenu anestezije, recite svom liječniku ili anesteziologu da

uzimate Yasnal Q-Tab. Razlog je što Vaš lijek može utjecati na količinu anestetika koja će biti

potrebna.

Yasnal Q-Tab mogu koristiti bolesnici s bolešću bubrega ili blagom do umjerenom bolešću jetre. Ako

imate bolest bubrega ili jetre o tome prvo obavijestite svog liječnika. Bolesnici s teškom bolesti jetre

ne smiju uzimati Yasnal Q-Tab.

Recite liječniku ili ljekarniku ime svog njegovatelja. Njegovatelj će vam pomoći da pravilno uzimate

lijek.

Yasnal Q-Tab s hranom, pićem i alkoholom

Hrana neće utjecati na učinak Yasnala Q-Tab.

Nemojte piti alkohol tijekom uzimanja Yasnala Q-Tab jer alkohol može smanjiti njegovu učinkovitost.

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.

Yasnal Q-Tab se ne smije primjenjivati tijekom trudnoće osim ako nije neophodno.

Nemojte dojiti dok uzimate Yasnal Q-Tab.

Upravljanje vozilima i strojevima

Alzheimerova bolest može smanjiti Vašu sposobnost upravljanja vozilima ili strojevima te ne smijete

izvoditi ove aktivnosti ako Vam liječnik nije rekao da su za Vas sigurne.

TakoĎer, Vaš lijek može uzrokovati umor, omaglicu i grč mišića. Ako Vam se pojavi nešto od

navedenoga, ne smijete upravljati vozilima ili strojevima.

Yasnal Q-Tab sadrži aspartam (E951), glukozu, saharozu i sorbitol (E420)

Aspartam je izvor fenilalanina. Može biti štetan u osoba s fenilketonurijom.

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

uzimati ovaj lijek posavjetujete se sa svojim liječnikom.

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O D O B R E N O

3.

Kako uzimati Yasnal Q-Tab?

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

liječnikom ili ljekarnikom ako niste sigurni.

Recite svom liječniku ili ljekarniku ime osobe koja se za Vas brine. Osoba koja se za Vas brine

pomoći će Vam uzimati Vaš lijek na način kako je propisano.

Obično ćete početi uzimati 5 mg svaku večer prije odlaska na spavanje.

Nakon mjesec dana Vaš liječnik Vam može reći da uzimate 10 mg svaku večer prije odlaska na

spavanje.

Yasnal Q-Tab raspadljive tablete za usta su krhke. Ne smiju se gurati kroz foliju blistera jer će to

oštetiti tabletu. Nemojte rukovati tabletom s mokrim rukama jer bi se tableta mogla slomiti. Na

sljedeći način izvadite tabletu iz pakiranja:

Primite blister za rubove i odvojite jedan odjeljak blistera od ostatka, lagano trgajući duž

perforacija koje je okružuju.

Povucite rub folije i potpuno odvojite foliju.

Istresite tabletu na ruku.

Stavite tabletu na jezik čim ste je izvadili iz pakiranja.

Za nekoliko će se sekundi početi otapati u ustima te ju možete progutati i bez vode. Prije stavljanja

tablete na jezik, usta trebaju biti prazna.

Jačina tablete koju ćete uzimati može se mijenjati ovisno o tome koliko dugo uzimate lijek te o

preporukama Vašeg liječnika. Maksimalna preporučena doza je 10 mg svaku večer.

Nije potrebna prilagodba doze ako imate poteškoće s bubrezima.

Ako imate poteškoće s jetrom, možda će biti potrebno da Vaš liječnik prilagodi Vašu dozu prema

Vašim potrebama (vidjeti dio 2 „Što morate znati prije nego počnete uzimati Yasnal Q-Tab“).

Nemojte prestati uzimati tablete osim ako Vam tako nije odredio Vaš liječnik.

Povremeno ćete trebati posjetiti svojeg liječnika da ocijeni Vaše liječenje i procijeni Vaše simptome.

Primjena u djece i adolescenata

Yasnal Q-Tab se ne preporučuje za primjenu u djece i adolescenata (mlaĎih od 18 godina).

Ako uzmete više Yasnala Q-Tab nego što ste trebali

NEMOJTE uzimati više od jedne tablete dnevno. Odmah obavijestite svog liječnika ako uzmete više

nego što biste trebali. Ako ne možete kontaktirati svog liječnika, javite se hitnoj medicinskoj službi.

Uvijek ponesite sa sobom tablete i povijest bolesti kako bi liječnik mogao vidjeti što ste uzimali.

Simptomi predoziranja uključuju slabost i mučninu, slinjenje, znojenje, usporen rad srca, niski krvni

tlak (nesvjesticu ili omaglicu prilikom ustajanja), probleme s disanjem, gubitak svijesti i napadaje

(trzanje) ili konvulzije.

Ako ste zaboravili uzeti Yasnal Q-Tab

Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu dozu. Ako ste zaboravili uzeti

tabletu, samo uzmite jednu tabletu u uobičajeno vrijeme idući dan.

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O D O B R E N O

Ako zaboravite uzimati lijek dulje od tjedan dana, obratite se liječniku prije nastavka uzimanja tableta.

Ako prestanete uzimati Yasnal Q-Tab

Nemojte prestati uzimati tablete osim ako Vam Vaš liječnik nije tako rekao. Ako prestanete uzimati

Yasnal Q-Tab, učinak Vašeg liječenja postupno će nestati.

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 u svakoga.

Morate odmah obavijestiti svojeg liječnika ako primijetite ovdje navedene ozbiljne nuspojave. Možda

će Vam biti potrebno hitno medicinsko liječenje.

vrućica praćena ukočenošću mišića, znojenjem ili sniženom razinom svijesti (poremećaj koji se

naziva “neuroleptički maligni sindrom”) (može se javiti u manje od 1 na 10 000 osoba).

mišićna slabost, osjetljivost ili bol, a posebice ako se istovremeno ne osjećate dobro, imate

visoku temperaturu ili tamnu mokraću. To može biti uzrokovano abnormalnom razgradnjom

mišića koja može biti opasna po život i dovesti do problema s bubrezima (stanje koje se zove

rabdomioliza) (može se javiti u manje od 1 na 10 000 osoba).

oštećenje jetre, npr. hepatitis. Simptomi hepatitisa su osjećaj mučnine ili slabosti, gubitak

apetita, loše opće stanje, vrućica, svrbež, žutilo kože i očiju te tamno obojena mokraća (može se

javiti u manje od 1 na 1000 osoba).

čir na želucu i dvanaesniku. Simptomi pojave čireva su bol i nelagoda u želucu (loša probava)

koja se osjeća izmeĎu pupka i prsne kosti (može se javiti u manje od 1 na 100 osoba).

krvarenje u želucu ili crijevima. To može dovesti do pojave stolice crne poput katrana ili

vidljivih tragova krvi iz rektuma (završnog dijela debelog crijeva) (može se javiti u manje od 1

na 100 osoba).

napadaji ili konvulzije (mogu se javiti u manje od 1 na 100 osoba).

Vrlo česte (mogu se javiti u više od 1 na 10 osoba):

proljev

mučnina (osjećaj mučnine)

glavobolja

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

prehlada

gubitak apetita

halucinacije (pričinjavanje da vidite ili čujete stvari kojih zapravo nema)

neobični snovi uključujući noćne more

uznemirenost

agresivno ponašanje

nesvjestica

omaglica

problemi sa spavanjem (nesanica)

povraćanje

nelagoda u želucu

kožni osip

svrbež

grč mišića

nekontrolirano mokrenje (inkontinencija)

umor

bolovi

sklonost padovima i ozljedama

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23 - 05 - 2017

O D O B R E N O

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

usporeni rad srca

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

ukočenost, drhtanje ili nekontrolirani pokreti, osobito lica i jezika, ali i udova (ekstrapiramidalni

simptomi)

poremećaji srčanog sustava za provoĎenje električnih impulsa (sinus-atrijski blok,

atrioventrikularni blok)

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 Yasnal Q-Tab?

Ovaj lijek čuvajte izvan pogleda i dohvata djece.

Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na pakiranju. 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 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 Yasnal Q-Tab sadrži?

Djelatna tvar je donepezilklorid. Svaka raspadljiva tableta za usta sadrži 5 mg ili 10 mg

donepezilklorida u obliku donepezilklorid hidrata.

Drugi sastojci su: manitol (E421); mikrokristalična celuloza; nisko supstituirana

hidroksipropilceluloza; maltodekstrin; glukoza; saharoza; arapska guma; sorbitol (E420);

aroma, banana; aspartam (E951); kalcijev silikat i magnezijev stearat.

Kako Yasnal Q-Tab izgleda i sadržaj pakiranja?

5 mg raspadljive tablete za usta: bijele, okrugle raspadljive tablete za usta, s kosim rubovima,

promjera 5,5 mm.

10 mg raspadljive tablete za usta: bijele, okrugle raspadljive tablete za usta, s kosim rubovima,

promjera 7 mm.

Yasnal Q-Tab je dostupan u pakiranjima od 10, 28, 30, 50, 56, 60, 84, 90, 98 i 100 raspadljivih tableta

za usta u blisterima, u kutiji.

Na tržištu se ne moraju nalaziti sve veličine pakiranja.

Nositelj odobrenja za stavljanje lijeka u promet i proizvođač

Nositelj odobrenja:

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

Proizvođač:

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

H A L M E D

23 - 05 - 2017

O D O B R E N O

Način i mjesto izdavanja lijeka

Lijek se izdaje na recept, u ljekarni.

Ova uputa je posljednji puta revidirana u svibnju 2017.

H A L M E D

23 - 05 - 2017

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

6-10-2018

Nederland organiseert volgende wereldwijde WHO conferentie tegen tabak

Nederland organiseert volgende wereldwijde WHO conferentie tegen tabak

In 2020 organiseert Nederland de volgende wereldwijde conferentie van de Wereldgezondheidsorganisatie tegen tabak. Het gaat om de negende editie van de zogenaamde Conference of the Parties (COP) van het WHO FCTC verdrag. Dat is vandaag bekendgemaakt in Genève tijdens de sluitingsceremonie van de achtste COP. Staatssecretaris Paul Blokhuis (VWS) heeft het initiatief genomen om de conferentie naar Nederland te halen en was op 1 oktober in Genève om de Nederlandse kandidatuur kracht bij te zetten.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

24-9-2018

Bezoek Staatssecretaris Blokhuis aan VN in teken van strijd tegen roken

Bezoek Staatssecretaris Blokhuis aan VN in teken van strijd tegen roken

Staatssecretaris Paul Blokhuis is van dinsdag 25 t/m donderdag 27 september in New York voor een bezoek aan de Algemene Vergadering van de Verenigde Naties. Voor Blokhuis staat tijdens zijn bezoek het tabaksontmoedigingsbeleid centraal.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

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

Scientific Opinion about the Guidance of the Chemical Regulation Directorate (UK) on how aged sorption studies for pesticides should be conducted, analysed and used in regulatory assessments

Scientific Opinion about the Guidance of the Chemical Regulation Directorate (UK) on how aged sorption studies for pesticides should be conducted, analysed and used in regulatory assessments

Published on: Mon, 27 Aug 2018 00:00:00 +0200 The EFSA Panel on Plant Protection Products and their Residues reviewed the guidance on how aged sorption studies for pesticides should be conducted, analysed and used in regulatory assessment. The inclusion of aged sorption is a higher tier in the groundwater leaching assessment. The Panel based its review on a test with three substances taken from a data set provided by the European Crop Protection Association. Particular points of attention were the quali...

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

21-9-2018

Regulatory and procedural guideline:  Draft qualification opinion on stride velocity 95th centile as a secondary endpoint in Duchenne Muscular Dystrophy measured by a valid and suitable wearable device, draft: consultation open

Regulatory and procedural guideline: Draft qualification opinion on stride velocity 95th centile as a secondary endpoint in Duchenne Muscular Dystrophy measured by a valid and suitable wearable device, draft: consultation open

This report provides a final agreed draft Context of Use for public consultation describing where Stride Velocity measured at the ankle 95th Centile is deemed by CHMP as an appropriate endpoint in studies to support regulatory decision making on medicines for the treatment of Duchenne Muscular Dystrophy (DMD), together with CHMP’s scientific consideration of the submission leading to the draft opinion. The document also includes the questions posed by the applicant and also raised by CHMP to the Applic...

Europe - EMA - European Medicines Agency

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

13-9-2018

 European Medicines Agency stakeholder interaction on the development of medicinal products for chronic non-infectious liver diseases (PBC, PSC, NASH), European Medicines Agency, London, UK, From: 03-Dec-2018, To: 03-Dec-2018

European Medicines Agency stakeholder interaction on the development of medicinal products for chronic non-infectious liver diseases (PBC, PSC, NASH), European Medicines Agency, London, UK, From: 03-Dec-2018, To: 03-Dec-2018

This workshop on the development of medicines for chronic non-infectious liver diseases, including primary biliary cholangitis, primary sclerosing cholangitis and nonalcoholic steatohepatitis, provides a platform for discussion on appropriate endpoints including validation of surrogate endpoints/biomarkers, suitable study populations, potentially adequate trial designs and the specific challenges with paediatric medicine development. The workshop will support the drafting of a reflection paper on regul...

Europe - EMA - European Medicines Agency

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

17-8-2018

#FDA issues FR notice on proposed list of #MedicalDevice accessories suitable for class I. Comments open for 60 days. View the list here:  https://go.usa.gov/xUe37  #FDARA

#FDA issues FR notice on proposed list of #MedicalDevice accessories suitable for class I. Comments open for 60 days. View the list here: https://go.usa.gov/xUe37  #FDARA

#FDA issues FR notice on proposed list of #MedicalDevice accessories suitable for class I. Comments open for 60 days. View the list here: https://go.usa.gov/xUe37  #FDARA

FDA - U.S. Food and Drug Administration

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