Ezact 10 mg tablete

Glavna informacija

  • Trgovački naziv:
  • Ezact 10 mg tablete
  • Doziranje:
  • 10 mg
  • Farmaceutski oblik:
  • tableta
  • Sastav:
  • Urbroj: jedna tableta sadrži 10 mg ezetimiba
  • Tip recepta:
  • na recept, u ljekarni ponovljivi recept
  • Koristi za:
  • Ljudi
  • Vrsta lijekova:
  • alopatski lijek
  • Proizveden od:
  • Pliva Hrvatska d.o.o., Zagreb, Republika Hrvatska; Merckle GmbH, Blaubeuren, Njemačka

Dokument

Lokalizacija

  • Na raspolaganju u:
  • Ezact 10 mg tablete
    Hrvatska
  • Jezik:
  • hrvatski

Terapeutski informacija

  • Proizvod sažetak:
  • Pakiranje: 14 tableta u blisteru, u kutiji [HR-H-624941289-01]; 28 tableta u blisteru, u kutiji [HR-H-624941289-02]; 30 tableta u blisteru, u kutiji [HR-H-624941289-03]; 50 tableta u blisteru, u kutiji [HR-H-624941289-04]; 90 tableta u blisteru, u kutiji [HR-H-624941289-05]; 98 tableta u blisteru, u kutiji [HR-H-624941289-06]; 100 tableta u blisteru, u kutiji [HR-H-624941289-07]; 105 tableta u blisteru, u kutiji [HR-H-624941289-08]; 120 tableta u blisteru, u kutiji [HR-H-624941289-09]; 28 tableta u perforiranom blisteru, u kutiji [HR-H-624941289-10]; 30 tableta u perforiranom blisteru, u kutiji [HR-H-624941289-11]; 90 tableta u perforiranom blisteru, u kutiji [HR-H-624941289-12]; 98 tableta u perforiranom blisteru, u kutiji [HR-H-624941289-13]; 100 tableta u bočici, u kutiji [HR-H-624941289-14]; 105 tableta u bočici, u kutiji [HR-H-624941289-15] Urbroj: 381-12-01/30-16-11

Druge informacije

Status

  • Izvor:
  • HALMED Agencija za lijekove i medicinske proizvode - Agency for medicinal products and medical devices of Croatia
  • Broj odobrenja:
  • HR-H-624941289
  • Datum autorizacije:
  • 05-05-2016
  • Zadnje ažuriranje:
  • 04-06-2018

Uputu o lijeku

Uputa o lijeku: Informacija za korisnika

Ezact 10 mg tablete

ezetimib

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. Pogledajte dio 4.

Što se nalazi u ovoj uputi:

Što je Ezact tablete

i za što se koristi

Što morate znati prije nego počnete uzimati Ezact

Kako uzimati Ezact

Moguće nuspojave

Kako čuvati Ezact

Sadržaj pakiranja i druge informacije

1. Što je Ezact i za što se koristi

Ezact tablete su lijek koji se koristi za snižavanje povišene razine kolesterola.

Ezact snižava razinu ukupnog kolesterola, „lošeg" kolesterola (LDL-kolesterola) i masnih tvari zvanih

trigliceridi u krvi. Ezact također podiže razinu „dobrog“ kolesterola (HDL-kolesterola).

Ezetimib, djelatna tvar Ezact tableta, djeluje tako da smanjuje apsorpciju kolesterola u probavnom

sustavu.

Ezact pridonosi učinku statina, skupine lijekove koji snižavaju razinu kolesterola koju organizam

sam proizvede, na snižavanje kolesterola.

Kolesterol je jedna od nekoliko masnih tvari u krvotoku. Ukupni se kolesterol uglavnom sastoji od

LDL-kolesterola i HDL-kolesterola.

LDL-kolesterol se često naziva „lošim“ kolesterolom jer se može taložiti na stjenkama arterija i

formirati plak. Nakupine plaka mogu dovesti do suženja arterija, što može usporiti ili spriječiti dotok

krvi do vitalnih organa kao što su srce i mozak. To sprječavanje protoka krvi može dovesti do srčanog

ili moždanog udara.

HDL-kolesterol se često naziva „dobrim“ kolesterolom jer pomaže u sprječavanju nakupljanja lošeg

kolesterola u arterijama i jer štiti od srčanih bolesti.

Trigliceridi su jedan od oblika masti u tijelu koje mogu povećati rizik od srčanih bolesti.

Primjenjuju se kod bolesnika kod kojih se razina kolesterola ne može kontrolirati isključivo dijetom.

Za vrijeme uzimanja ovog lijeka morate se pridržavati dijete za snižavanje kolesterola.

Ezact se primjenjuju kao dodatak dijeti za snižavanje kolesterola ako imate:

povišenu razinu kolesterola u tijelu (primarnu hiperkolesterolemiju [heterozigotnu obiteljsku i

H A L M E D

05-05-2016

O D O B R E N O

ne-obiteljsku]):

zajedno sa statinom kada razina kolesterola nije odgovarajuće kontrolirana samo

statinom

samostalno, kada liječenje statinom nije primjereno ili ga bolesnik ne podnosi

nasljednu bolest (homozigotnu obiteljsku hiperkolesterolemiju) koja povećava razinu

kolesterola u krvi. Također će Vam biti propisan statin, a mogli biste primati i druge terapije,

nasljednu bolest (homozigotnu sitosterolemiju, poznatu i kao fitosterolemija) koja povećava

razine biljnih sterola u krvi.

Ako imate srčanu bolest, Ezact u kombinaciji sa statinima (lijekovi za sniženje kolesterola u krvi)

smanjuje rizik od srčanog infarkta, moždanog udara, operativnog zahvata za povećanje protoka krvi

kroz srce ili hospitalizacije zbog bolova u prsima.

Ezact Vam neće pomoći u smanjenju tjelesne težine.

2. Što morate znati prije nego počnete uzimati Ezact

Ako uzimate Ezact zajedno sa statinom, molimo pročitajte uputu o lijeku za taj lijek.

NEMOJTE uzimati Ezact:

ako ste alergični na ezetimib ili na bilo koji drugi sastojak ovog lijeka (naveden u dijelu 6.).

NEMOJTE uzimati Ezact zajedno sa statinom ako:

imate tegobe s jetrom

ste trudni ili dojite.

Upozorenja i mjere opreza

Obratite se svom liječniku ili ljekarniku prije nego uzmete Ezact.

Obavijestite svog liječnika o svim svojim medicinskim stanjima (bolestima), uključujući i o

alergijama.

Prije nego što započnete s uzimanjem Ezacta zajedno sa statinom liječnik treba provesti

pretrage krvi kako bi provjerio rad Vaše jetre.

Pored toga, liječnik Vam može učiniti pretrage krvi kako bi provjerio rad Vaše jetre i nakon

što ste započeli s uzimanjem Ezacta sa statinom.

Ako imate umjerene ili značajne poteškoće s jetrom, ne preporučuje se uzimanje Ezact tableta.

Sigurnost i djelotvornost kombinirane primjene Ezacta i određenih lijekova za snižavanje kolesterola,

odnosno fibrata, nisu utvrđene.

Djeca i adolescenti

Ovaj lijek se ne primjenjuje kod djece i adolescenata u dobi između 6 i 17 godina osim ukoliko to nije

propisao liječnik specijalist jer su dostupni podaci o sigurnosti i djelotvornosti ograničeni.

Ovaj lijek se ne primjenjuje kod djece mlađe od 6 godina jer za tu dobnu skupinu nema informacija.

Drugi lijekovi i Ezact

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

druge lijekove uključujući one koje ste dobili bez recepta.

Posebno je važno da svog liječnika obavijestite ako uzimate lijek (lijekove) s nekom od niže

navedenih djelatnih tvari:

ciklosporin (lijek koji se često koristi kod bolesnika s transplantacijom organa)

lijekove koji sprječavaju zgrušavanje krvi, kao sto su varfarin, fenprokumon, acenokumarol ili

fluindion (antikoagulansi)

H A L M E D

05-05-2016

O D O B R E N O

kolestiramin (lijek za snižavanje kolesterola) jer utječe na način na koji Ezact djeluje

fibrate (lijekovi za snižavanje kolesterola).

Ezact s hranom

Ezact tablete mogu se uzimati s hranom ili bez nje.

Trudnoća i dojenje

Nemojte uzimati Ezact zajedno sa statinom ako ste trudni, pokušavate zatrudnjeti ili mislite da biste

mogli biti trudni. Zatrudnite li dok uzimate Ezact zajedno sa statinom,

odmah

prekinite uzimanje oba

lijeka i obavijestite svog liječnika.

Nema iskustva s primjenom Ezact tableta bez statina u vrijeme trudnoće. Ako ste trudni, posavjetujte

se sa svojim liječnikom prije nego što uzmete Ezact.

Nemojte uzimati ovaj lijek zajedno sa statinom ako dojite jer nije poznato izlučuju li se ti lijekovi u

majčino mlijeko.

Nemojte uzimati ovaj lijek bez statina ako dojite. Posavjetujte se sa svojim liječnikom.

Pitajte liječnika ili ljekarnika za savjet prije uzimanja ovog lijeka.

Upravljanje vozilima i strojevima

Ne očekuje se da bi Ezact mogao omesti Vašu sposobnost upravljanja vozilima ili rukovanja

strojevima. Međutim, potrebno je uzeti u obzir kako pojedine osobe nakon uzimanja Ezacta mogu

imati omaglicu.

Ezact tablete sadrže laktozu

Ezact 10 mg tablete sadrže šećer laktozu. Ako Vam je liječnik rekao da ne podnosite određene šećere,

obratite mu se prije uzimanja ovoga lijeka.

3. Kako uzimati Ezact

Uvijek uzmite ovaj lijek točno onako kako Vam je rekao Vaš liječnik. Nemojte prestati uzimati druge

lijekove za snižavanje kolesterola sve dok Vam to ne kaže Vaš liječnik. Provjerite sa svojim

liječnikom ili ljekarnikom ako niste sigurni.

Prije nego što započnete s uzimanjem Ezacta, trebali biste biti na dijeti za snižavanje

kolesterola.

Tijekom uzimanja Ezacta tableta morate ostati na toj dijeti.

Preporučena doza lijeka je jedna Ezact tableta od 10 mg jedanput na dan, kroz usta.

Ezact tablete možete uzimati u bilo koje doba dana. Možete ih uzeti s hranom ili bez nje.

Ako Vam je liječnik propisao Ezact zajedno sa statinom, oba lijeka možete uzeti u isto vrijeme. U tom

slučaju molimo pročitajte uputu za primjenu tog lijeka u uputi o lijeku.

Ako Vam je liječnik propisao Ezact zajedno s nekim drugim lijekom za snižavanje kolesterola koji

sadržava djelatnu tvar kolestiramin ili neki drugi sekvestrant žučne kiseline, Ezact tablete morate uzeti

najmanje 2 sata prije ili 4 sata nakon uzimanja sekvestranta žučne kiseline.

H A L M E D

05-05-2016

O D O B R E N O

Ako uzmete više Ezact tableta nego što ste trebali

Molimo obavijestite svog liječnika ili ljekarnika.

Ako ste zaboravili uzeti Ezact tablete

Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu dozu, već samo uzmite svoju

normalnu dozu Ezact tableta u uobičajeno vrijeme sljedećeg dana.

Ako ste prestali uzimati Ezact tablete

Obavijestite svog liječnika ili ljekarnika jer bi razina Vašeg kolesterola mogla ponovno narasti.

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 javiti kod svakoga.

Sljedeći se izrazi upotrebljavaju za opis učestalosti nuspojava:

Vrlo česte (mogu se javiti kod više od 1 na 10 bolesnika)

Česte (mogu se javiti u do 1 na 10 bolesnika)

Manje česte (mogu se javiti u do 1 na 100 bolesnika)

Rijetke (mogu se javiti u do 1 na 1 000 bolesnika)

Vrlo rijetke (mogu se javiti u do 1 na 10 000 bolesnika, uključujući izolirane prijave)

Odmah se obratite svom liječniku

ako osjetite bol, osjetljivost ili slabost u mišićima nepoznatog

uzroka jer tegobe s mišićima u rijetkim slučajevima mogu postati ozbiljne i uzrokovati

razgradnju mišićnog tkiva s posljedičnim oštećenjem bubrega, a mogu postati i opasne po život.

Odmah se obratite svom liječniku ako primijetite alergijske reakcije uključujući oticanje lica, usana,

jezika i/ili grla s mogućim otežanim gutanjem ili disanjem. Te su nuspojave prijavljene nakon široke

primjene lijeka.

Kada je lijek primjenjivan sam, prijavljene su sljedeće nuspojave:

Česte

: bol u trbuhu; proljev; nadutost; osjećaj umora.

Manje česte

: povišene vrijednosti nekih laboratorijskih krvnih pretraga funkcije jetre (jetrene

transaminaze) ili mišića (kreatin kinaze); kašalj, probavne smetnje; žgaravica; mučnina; bol u

zglobovima; grčevi u mišićima; bol u vratu; smanjeni tek, bol, bol u prsima, navale vrućine; visoki

krvni tlak.

Osim toga, kada je lijek primjenjivan istodobno sa statinom, prijavljene su sljedeće nuspojave:

Česte

: povišene vrijednosti nekih laboratorijskih krvnih pretraga funkcije jetre (transaminaze);

glavobolja; bol, osjetljivost ili slabost u mišićima.

Manje česte

: trnci; suha usta; svrbež; osip; urtikarija (koprivnjača); bol u leđima; mišićna slabost; bol

u rukama i nogama; neuobičajeni umor ili slabost; oticanje, osobito šaka i stopala

Kada je lijek primjenjivan istovremeno s fenofibratom, sljedeće nuspojave prijavljene su kao

česte

bol u trbuhu.

Osim toga, nakon široke primjene lijeka bile su prijavljene sljedeće nuspojave: omaglica; bolovi u

mišićima; problemi s jetrom; alergijske reakcije uključujući osip i koprivnjaču; crveni osip s

oticanjem, ponekad s točkastim lezijama (multiformni eritem); bol, osjetljivost ili slabost u mišićima;

razgradnja mišića; žučni kamenci ili upala žučnog mjehura (koja može uzrokovati bol u trbuhu,

H A L M E D

05-05-2016

O D O B R E N O

mučninu i povraćanje); upala gušterače često s jakom boli u trbuhu; zatvor; smanjenje broja krvnih

stanica što može uzrokovati modrice/krvarenje (trombocitopenija); trnci; depresija; neuobičajeni umor

ili slabost; zaduha.

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 za prijavu nuspojava navedenog u Dodatku V. Prijavljivanjem nuspojava možete

pridonijeti u procjeni sigurnosti ovog lijeka.

5. Kako čuvati Ezact

Lijek čuvajte izvan pogleda i dohvata djece.

Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji, blisteru i bočici iza

„EXP”/„Rok valjanosti“. 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 Ezact sadrži

Djelatna tvar je ezetimib.

Jedna tableta sadrži 10 mg ezetimiba.

Drugi sastojci su: laktoza hidrat, prethodno geliran škrob, mikrokristalična celuloza, umrežena

karmelozanatrij, povidon K 30, natrijev laurilsulfat, koloidni bezvodni silicijev dioksid,

stearatna kiselina, poloksamer 407.

Kako Ezact izgleda i sadržaj pakiranja

Ezact 10 mg tablete su bijele, bikonveksne tablete u obliku kapsula, s utisnutom oznakom "10" na

jednoj strani tablete.

Veličine pakiranja:

Ezact 10 mg tablete pakirane su u PVC/ACLAR/PVC-Al blistere od 14, 28, 28x1, 30, 30x1, 50, 90,

90x1, 98, 98x1, 100, 105 i 120 tableta ili HDPE bočice s polipropilenskim zatvaračem sigurnim za

djecu, ispod kojeg se nalazi zaštitna folija te spremnik sa silika gelom kao sredstvom za sušenje, koje

sadrže 100 i 105 tableta.

Na tržištu se ne moraju nalaziti sve veličine pakiranja.

Nositelj odobrenja za stavljanje lijeka u promet i proizvođač

Nositelj odobrenja za stavljanje lijeka u promet:

PLIVA HRVATSKA d.o.o.

Prilaz baruna Filipovića 25

10 000 Zagreb

H A L M E D

05-05-2016

O D O B R E N O

Proizvođač:

PLIVA HRVATSKA d.o.o.

Prilaz baruna Filipovića 25

10 000 Zagreb

Merckle GmbH

Ludwig-Merckle-Straße 3, 89143 Blaubeuren, Baden-Wuerttemberg

Njemačka

Ovaj je lijek odobren u državama članicama Europskog gospodarskog prostora (EGP) pod

sljedećim nazivima:

Austrija:

Ezetimib ratiopharm 10 mg Tabletten

Belgija:

Ezetimibe Teva 10 mg Tabletten/comprimés

Češka:

Emtricitabine/Tenofovir disoproxil Teva 200 mg/245 mg

Njemačka:

Ezetimib AbZ 10 mg Tabletten

Danska:

Ezetimibe Teva

Španjolska:

Ezetimiba Teva 10 mg comprimidos EFG

Finska:

Ezetimibe ratiopharm10 mg tabletti

Francuska:

Ezetimibe Teva 10 mg comprimé

Irska:

Ezetimibe Teva 10 mg Tablets

Island:

Ezetimibe ratiopharm 10 mg tafla

Italija:

Ezetimibe Teva

Malta:

Ezetimibe Teva 10 mg Tablets

Nizozemska:

Ezetimibe Teva 10 mg, tabletten

Portugal:

Ezetimiba Teva

Švedska:

Ezetimibe Teva

Slovačka:

Ezetimib Teva 10 mg

Ujedinjeno Kraljevstvo:

Ezetimibe 10 mg Tablets

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

05-05-2016

O D O B R E N O

21-11-2018

Risk for animal and human health related to the presence of dioxins and dioxin-like PCBs in feed and food

Risk for animal and human health related to the presence of dioxins and dioxin-like PCBs in feed and food

Published on: Tue, 20 Nov 2018 The European Commission asked EFSA for a scientific opinion on the risks for animal and human health related to the presence of dioxins (PCDD/Fs) and DL‐PCBs in feed and food. The data from experimental animal and epidemiological studies were reviewed and it was decided to base the human risk assessment on effects observed in humans and to use animal data as supportive evidence. The critical effect was on semen quality, following pre‐ and postnatal exposure. The critical s...

Europe - EFSA - European Food Safety Authority Publications

24-10-2018

Vita Health Products Recall (2018-10-24)

Vita Health Products Recall (2018-10-24)

Health Canada

18-10-2018

Mom Life Market recalls 10" & 16" Personalized Stuffed Plush Bunnies

Mom Life Market recalls 10" & 16" Personalized Stuffed Plush Bunnies

The recalled products may contain phthalate levels that exceed the allowable levels.

Health Canada

18-10-2018

Scientific Opinion on Flavouring Group Evaluation 201 Revision 2 (FGE.201Rev2): 2‐alkylated, aliphatic, acyclic alpha,beta‐unsaturated aldehydes and precursors, with or without additional double‐bonds, from chemical subgroup 1.1.2 of FGE.19

Scientific Opinion on Flavouring Group Evaluation 201 Revision 2 (FGE.201Rev2): 2‐alkylated, aliphatic, acyclic alpha,beta‐unsaturated aldehydes and precursors, with or without additional double‐bonds, from chemical subgroup 1.1.2 of FGE.19

Published on: Wed, 17 Oct 2018 00:00:00 +0200 The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to consider in this revision 2 of Flavouring Group Evaluation 201, the additional data on genotoxicity submitted by the Industry on two substances, 2‐methylpent‐2‐enal [FL‐no: 05.090] and 2 methylcrotonaldehyde [FL‐no: 05.095], from subgroup 1.1.2 of FGE.19. In FGE.201Rev1, the Panel concluded that further data were required in order to clarify the genotoxic poten...

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Applicability of in silico tools for the prediction of dermal absorption for pesticides

Applicability of in silico tools for the prediction of dermal absorption for pesticides

Published on: Tue, 16 Oct 2018 00:00:00 +0200 Based on the “Human in vitro dermal absorption datasets” published as supporting information to the revised EFSA Guidance on Dermal Absorption, in silico models for prediction of absorption across the skin have been evaluated. For this evaluation, a systematic literature search and review was performed, identifying 288 publications describing mathematical models for prediction of dermal absorption. Eleven models potentially relevant to the regulatory assessm...

Europe - EFSA - European Food Safety Authority Publications

11-10-2018

Re‐evaluation of oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (E 479b) as a food additive

Re‐evaluation of oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (E 479b) as a food additive

Published on: Wed, 10 Oct 2018 00:00:00 +0200 The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion re‐evaluating the safety of thermally oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (TOSOM) (E 479b) when used as a food additive. The Scientific Committee on Food (SCF) and the Joint FAO/WHO Expert Committee on Food Additives (JECFA) derived an acceptable daily intake (ADI) of 25 and 30 mg/kg body weight (bw) per day, respectively. There was n...

Europe - EFSA - European Food Safety Authority Publications

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