Glyakt 30 mg tablete

Glavna informacija

  • Trgovački naziv:
  • Glyakt 30 mg tablete s prilagođenim oslobađanjem
  • Doziranje:
  • 30 mg
  • Farmaceutski oblik:
  • tableta s prilagođenim oslobađanjem
  • Sastav:
  • Urbroj: svaka tableta s prilagođenim oslobađanjem sadrži 30 mg gliklazida
  • Tip recepta:
  • na recept, u ljekarni ponovljivi recept
  • Koristi za:
  • Ljudi
  • Vrsta lijekova:
  • alopatski lijek
  • Proizveden od:
  • Balkanpharma - Dupnitsa AD, Dupnitsa, Bugarska; Actavis Group PTC ehf, Hafnarfjordur, Island

Dokument

Lokalizacija

  • Na raspolaganju u:
  • Glyakt 30 mg tablete s prilagođenim oslobađanjem
    Hrvatska
  • Jezik:
  • hrvatski

Terapeutski informacija

  • Proizvod sažetak:
  • Pakiranje: 90 tableta u bočici, u kutiji [HR-H-398480928-01]; 120 tableta u bočici, u kutiji [HR-H-398480928-02]; 180 tableta u bočici, u kutiji [HR-H-398480928-03]; 10 tableta u blisteru, u kutiji [HR-H-398480928-04]; 14 tableta u blisteru, u kutiji [HR-H-398480928-05]; 28 tableta u blisteru, u kutiji [HR-H-398480928-06]; 30 tableta u blisteru, u kutiji [HR-H-398480928-07]; 56 tableta u blisteru, u kutiji [HR-H-398480928-08]; 60 tableta u blisteru, u kutiji [HR-H-398480928-09]; 90 tableta u blisteru, u kutiji [HR-H-398480928-10]; 120 tableta u blisteru, u kutiji [HR-H-398480928-11]; 180 tableta u blisteru, u kutiji [HR-H-398480928-12] Urbroj: 381-12-01/70-15-03

Druge informacije

Status

  • Izvor:
  • HALMED Agencija za lijekove i medicinske proizvode - Agency for medicinal products and medical devices of Croatia
  • Broj odobrenja:
  • HR-H-398480928
  • Datum autorizacije:
  • 26-06-2015
  • Zadnje ažuriranje:
  • 04-06-2018

Uputu o lijeku

Uputa o lijeku: Informacija za bolesnika

Glyakt 30 mg tablete s prilagođenim oslobađanjem

gliklazid

Pažljivo pročitajte cijelu uputu prije nego počnete uzimati lijek jer sadrži Vama važne

podatke.

Sačuvajte ovu uputu. Možda ćete ju trebati ponovo pročitati.

Ako imate dodatnih pitanja, obratite se svom liječniku ili ljekarniku.

Ovaj je lijek propisan 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.

U ovoj uputi:

1. Što je Glyakt i za što se koristi

2. Što morate znati prije nego počnete uzimati Glyakt

3. Kako uzimati Glyakt

4. Moguće nuspojave

5. Kako čuvati Glyakt

6. Sadržaj pakiranja i druge informacije

1.

Što je Glyakt i za što se koristi

Glyakt je lijek koji snižava razine šećera u krvi (antidijabetički lijek koji pripada skupini derivata

sulfonilureje i uzima se kroz usta).

Glyakt se primjenjuje za liječenje određenog oblika šećerne bolesti (šećerna bolest tipa 2) u odraslih,

kada se samo dijetom, tjelesnom aktivnošću i smanjenjem tjelesne težine ne postiže dovoljan učinak u

održavanju šećera (glukoze) u krvi na normalnoj razini.

2.

Što morate znati prije nego počnete uzimati Glyakt

Nemojte uzimati Glyakt:

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

lijekove iz iste skupine (derivati sulfonilureje) ili druge srodne lijekove (hipoglikemijske

sulfonamide)

ako imate šećernu bolest ovisnu o inzulinu (tip 1),

ako imate ketonska tijela i šećer u mokraći (to može značiti da imate dijabetičku ketoacidozu),

dijabetičku pretkomu ili komu,

ako imate teško oštećenje bubrega ili jetre,

ako uzimate lijekove za liječenje gljivičnih infekcija (mikonazol, vidjeti dio ‘Uzimanje drugih

lijekova i Glyakt’),

ako dojite (vidjeti dio ‘Trudnoća i dojenje’).

Upozorenja i mjere opreza

Obratite se svom liječniku ili ljekarniku prije nego uzmete Glyakt.

Za postizanje preporučenih razina šećera u krvi morate slijediti plan liječenja koji je propisao Vaš

liječnik. Ovo znači da osim redovitog uzimanja tableta, morate slijediti i preporuke o dijetalnom

režimu prehrane, provoditi tjelovježbe i ako je potrebno smanjiti težinu.

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Tijekom liječenja gliklazidom potrebno je redovito kontrolirati razine šećera u krvi (i po potrebi u u

mokraći). kao i razinu glikoliziranog hemoglobina (HbA1c). Također bi moglo biti korisno, no samo

po uputama Vašeg liječnika, i da sami kontrolirate svoje razine šećera u krvi.

Tijekom prvih tjedana liječenja moguć je povećani rizik od pojave sniženih razina šećera u krvi

(hipoglikemija). Stoga je potreban osobito pažljiv liječnički nadzor.

Niska razina šećera u krvi (hipoglikemija) može se pojaviti:

ako obroke uzimate neredovito ili ih u potpunosti izostavljate

ako gladujete

ako ste pothranjeni

ako mijenjate prehranu

ako povećate tjelesnu aktivnosti bez odgovarajućeg povećanja unosa ugljikohidrata ako pijete

alkohol, posebno ako pri tom preskačete obroke

ukoliko istovremeno uzimate druge lijekove ili prirodne ljekovite pripravke

ako ste uzeli preveliku dozu gliklazida

ako bolujete od nekih hormonalnih poremećaja (poremećaj rada štitnjače, hipofize ili kore

nadbubrežne žlijezde)

ako Vam je funkcija bubrega ili funkcija jetre jako smanjena

ako ste nedavno prestali uzimati kortikosteroide (lijekovi koji smanjuju upalu) nakon

dugotrajne primjene i/ili primjene u visokim dozama

ako imate teške poremećaje cirkulacije kao što su bolest krvnih žila srca, teško oštećenje

funkcije karotidne arterije ili difuzna bolest krvnih žila.

Ako imate nizak šećer u krvi mogli biste osjetiti sljedeće simptome: glavobolju, pojačanu glad,

mučninu, povraćanje, iznurenost, poremećaje spavanja, nemir, agresivnost, smetnje koncentracije,

smanjenu pozornost i usporenu reakciju, depresiju, smetenost, poremećaje vida i govora, nevoljno

drhtanje, smetnje osjeta, omaglicu te osjećaj nemoći.

Mogu se također javiti i sljedeći znaci i simptomi: znojenje, vlažna koža, tjeskoba, ubrzani ili

nepravilni otkucaji srca, visok krvni tlak te iznenadna jaka bol u prsištu koja se širi u okolna područja

(angina pektoris).

Ako Vam razina šećera u krvi nastavi padati, možete patiti od izrazite smetenosti (delirij), razviti

konvulzije, izgubiti samokontrolu, disanje Vam može postati plitko, a otkucaji srca usporiti, mogli

biste izgubiti svijest.

U većini slučajeva simptomi niskog šećera u krvi brzo nestanu nakon uzimanja nekog oblika šećera

npr. tablete glukoze, kocki šećera, slatkog soka ili zaslađenog čaja. Zbog toga morate uvijek nositi sa

sobom neku vrstu šećera (tablete glukoze, kocke šećera). Upamtite da umjetni zaslađivači nisu

učinkoviti.

Molimo Vas da se javite svom liječniku ili u najbližu bolnicu ako Vam uzimanje šećera ne pomogne

ili ako se simptomi ponove.

Simptomi niske razine šećera u krvi mogu izostati, biti slabije izraženi, postupno se razvijati ili postoji

mogućnost da ih uopće ne primijetite na vrijeme. Ovo se može dogoditi ako ste stariji bolesnik koji

uzima određene lijekove (npr. lijekovi koji djeluju na središnji živčani sustav te beta blokatori).

Ako ste u stresnim situacijama (npr. nesreće, kirurški zahvat, vrućica itd.) Vaš liječnik može

privremeno uvesti terapiju inzulinom.

Simptomi visoke razine šećera u krvi (hiperglikemija) mogu se pojaviti kada gliklazid nije dostatno

smanjio razinu glukoze u krvi, ako se niste pridržavali liječničke upute o načinu uzimanje lijeka ili u

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posebno stresnim situacijama. Simptomi uključuju: žeđ, učestalo mokrenje, suha usta, suhoću i svrbež

kože, kožne infekcije te smanjenu funkcionalnost.

Ukoliko primijetite navedene simptome, morate se odmah javiti svom liječniku li ljekarniku.

Ukoliko Vi ili netko u Vašoj obitelji boluje od nasljedne bolesti nedostatka enzima glukoze-6-

fosfatdehidrogenaze (G6PD) (poremećaj crvenih krvnih stanica), može doći do smanjenja razine

hemoglobina u krvi i razgradnje crvenih krvnih stanica (hemolitička anemija), Obratite se svom

liječniku prije nego počnete uzimati ovaj lijek.

Djeca i adolescenti

Glyakt nije namijenjen za primjenu u djece i adolescenata zbog nedovoljno podataka.

Drugi lijekovi i Glyakt

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

koje druge lijekove.

Prilikom uzimanja nekog od sljedećih lijekova učinak gliklazida na snižavanje šećera u krvi može biti

pojačan, te se mogu pojaviti znakovi niske razine šećera u krvi:

drugi lijekovi za liječenje visoke razine šećera u krvi (oralni antidijabetici ili inzulin)

antibiotici (npr. sulfonamidi ili klaritromicin)

lijekovi za liječenje visokog krvnog tlaka ili zatajenje srca (beta blokatori, ACE inhibitori kao

npr. kaptopril ili enalapril),

lijekovi za liječenje gljivičnih infekcija (mikonazol, flukonazol – pogledajte dio „Nemojte

uzimati Glyakt“),

lijekovi za liječenje vrijeda na želucu ili dvanaesniku (antagonisti H

receptora),

lijekovi za liječenje depresije (inhibitori monoaminooksidaze),

lijekovi za ublažavanje bolova ili antireumatici (fenilbutazon, ibuprofen)

lijekovi koji sadrže alkohol

Prilikom uzimanja nekog od sljedećih lijekova učinak gliklazida na snižavanje šećera u krvi može biti

oslabljen, te se mogu pojaviti znakovi visoke razinemože doći do povećanja vrijednosti šećera u krvi:

lijekovi za liječenje poremećaja središnjeg živčanog sustava (klorpromazin),

lijekovi koji smanjuju upalu (kortikosteroidi ili tetrakosaktrin),

lijekovi za liječenje astme ili lijekovi koji se primjenjuju tijekom poroda (intravenski

salbutamol, ritodrin i terbutallin),

lijekovi za liječenje poremećaja dojke, jakog menstrualnog krvarenja i endometrioze

(danazol).

Glyakt može pojačati učinke lijekova koji smanjuju zgrušavanje krvi (npr. varfarin).

Posavjetujte se sa svojim liječnikom prije nego što počnete uzmete bilo koji drugi lijek. Ako idete u

bolnicu, recite medicinskom osoblju da uzimate Glyakt.

Uzimanje Glyakta s hranom, pićem i alkoholom

Glyakt tablete s prilagođenim oslobađanjem mogu se uzimati s hranom i bezalkoholnim

pićima.

Ne preporučuje se konzumiranje alkohola jer on može narušiti kontrolu Vaše šećerne bolesti na način

koji se ne može predvidjeti.

Trudnoća i dojenje

Trudnoća

Uzimanje lijeka Glyakt se ne preporučuje za vrijeme

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trudnoće. Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, prije nego

uzmete ovaj lijek, obratite se za savjet svom liječniku.

Dojenje

Ako dojite, ne smijete uzimati Glyakt.

Upravljanje vozilima i strojevima

Vaša sposobnost koncentracije ili sposobnost reagiranja može biti oslabljena ako Vam je šećer u krvi

prenizak (hipoglikemija) ili previsok (hiperglikemija) ili ako se kod Vas pojave poteškoće s vidom kao

rezultat takvih stanja. Imajte na umu da biste mogli dovesti u opasnost sebe ili druge (npr. kada

upravljate vozilom ili rukujete strojevima). Molimo upitajte svog liječnika smijete li upravljati

vozilom ako:

imate česte epizode niske razine šećera u krvi (hipoglikemije),

imate mali broj ili uopće nemate upozoravajuće simptome niske razine šećera u krvi

(hipoglikemije).

Glyakt sadrži laktozu.

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

ovaj lijek posavjetujete se sa svojim liječnikom.

3.

Kako uzimati Glyakt

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

liječnikom ili ljekarnikom ukoliko niste sigurni.

Doziranje

Dozu lijeka će odrediti Vaš liječnik, ovisno o razini šećera u krvi i ako je moguće prema razini šećera

u mokraći. Promjene u vanjskim čimbenicima (npr. gubitak tjelesne težine, promjene u načinu života,

stres) ili poboljšanje razine šećera u krvi može zahtjevati prilagođavanje doze gliklazida.

Preporučena početna doza iznosi 30 mg.

Jačina 30 mg: uobičajena doza je jedna do četiri tablete (maksimalno 120 mg) uzete odjednom za

vrijeme doručka. Doza lijeka ovisi o odgovoru na liječenje.

Ukoliko se liječenje Glyakt tabletama kombinira s metforminom, inhibitorom alfa-glukozidaze ili

inzulinom, liječnik će odrediti pravu dozu svakog lijeka prema Vašim individualnim potrebama.

Ako primijetite da Vam Glyakt djeluje prejako ili nedovoljno jako, obavijestite svog liječnika ili

ljekarnika.

Način i put primjene

Za primjenu kroz usta

Progutajte cijelu tabletu u jednom komadu.

Tabletu nemojte žvakati ili drobiti.

Tabletu/e progutajte cijele s čašom vode, tijekom doručka (po mogućnosti u isto vrijeme svaki dan).

Nakon uzimanje lijeka morate uvijek obavezno pojesti obrok.

Ako uzmete više Glyakta nego što ste trebali

Ako uzmete preveliku dozu tableta, odmah obavijestite svog liječnika ili se uputite u hitnu službu

najbliže bolnice.

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Znakovi predoziranja lijekom su isti kao znakovi niske razine šećera u krvi (hipoglikemija) opisani u

odjeljku 2. Simptome je moguće ublažiti ako odmah uzmete šećer (4 do 6 kocki) ili zaslađene napitke

te nakon toga obilnu užinu ili obrok. Ako je bolesnik bez svijesti, odmah obavijestite liječnika i službu

hitne pomoći. Isto treba učiniti ako netko drugi, npr. dijete, slučajno uzme ovaj lijek. Osobama bez

svijesti se ne smije davati hrana ili piće. Uvijek morate nekome reći da ste šećerni bolesnik kako bi ta

osoba mogla pozvati liječnika u slučaju hitnosti.

Ako ste zaboravili uzeti Glyakt

Važno je da uzimate lijek svaki dan jer se redovitim uzimanjem postiže bolji učinak liječenja.

Međutim, ako zaboravite uzeti jednu dozu Glyakta, uzmite sljedeću dozu u uobičajeno vrijeme.

Nemojte uzeti dvostruku dozu da bi nadoknadili zaboravljenu dozu.

Ako Vam liječnik zamijeni tablete gliklazida 80 mg ili neki drugi antidijabetik s Glyaktom

Vaš liječnik će odlučiti o početnoj dozi i neko će vrijeme pažljivo nadgledati Vaše stanje.

Ako prestanete uzimati Glyakt

Budući da je liječenje šećerne bolesti obično doživotno, morate se posavjetovati sa svojim

liječnikom prije nego prestanete uzimati ovaj lijek. Prestanak uzimanja lijeka može uzrokovati visoku

razinu šećera u krvi (hiperglikemija).

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 svakog.

Najčešće zabilježena nuspojava je niska razina šećera u krvi (hipoglikemija). Za simptome i znakove

hipoglikemije, vidjeti „Upozorenja i mjere opreza“ u dijelu 2. Ukoliko se ne liječe, ovi simptomi mogu

napredovati do omamljenosti, gubitka svijesti ili moguće kome. Ako je epizoda niske razine šećera u

krvi teška ili produžena, čak i ako je privremeno kontrolirana unosom šećera, morate odmah potražiti

medicinsku skrb.

Poremećaji jetre

Zabilježeni su izolirani slučajevi poremećene funkcije jetre, što može uzrokovati žutu boju kože i

očiju. Ako se ovo dogodi, odmah se javite svom liječniku. Ovi simptomi obično nestaju nakon

prekida liječenja. Vaš će liječnik odlučiti o prestanku liječenja.

Poremećaji kože i potkožnog tkiva

Zabilježene su kožne promjene poput osipa, crvenila, svrbeži, koprivnjače i angioedema (naglo

oticanje tkiva poput kapaka, lica, usana, usta, jezika ili grla što može rezultirati otežanim disanjem).

Osip može napredovati do proširenog stvaranja mjehurića ili ljuštenja kože.

Poremećaji krvi i limfnog sustava:

Zabilježeni su slučajevi smanjenja broja krvnih stanica (trombocita, crvenih i bijelih krvnih

stanica) što može uzrokovati bljedilo, produljeno krvarenje, pojavu modrica, grlobolje te

vrućice. Ovi simptomi u pravilu nestanu nakon prekida liječenja.

Poremećaji probavnog sustava

Bolovi ili nelagoda u trbuhu, mučnina, povraćanje, loša probava, proljev i zatvor. Ovi učinci su manje

izraženi kada se Glyakt uzima s obrokom kao što je preporučeno u dijelu 3. „Kako uzimati Glyakt“.

Poremećaji oka

Mogli biste imati kratkotrajne smetnje vida, osobito na početku liječenja. Ove smetnje su posljedica

promjena razine šećera u krvi.

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Kao i kod drugih lijekova iz skupine derivata sulfonilureje opisani su sljedeći štetni događaji: slučajevi

teške promjene u broju krvnih stanica te alergijska upala stijenke krvnih žila, smanjenje razine natrija

u krvi (hiponatrijemija), simptomi oštećenja funkcije jetre (npr. žutica) koji su se u većini slučajeva

povukli nakon prekida primjene lijekova iz skupine sulfonilureje, ali u izoliranim slučajevima mogu

dovesti do zatajenja jetre, stanja opasnog po život.

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 Glyakt

Ovaj lijek čuvajte izvan pogleda i dohvata djece.

Ne čuvati na temperaturi iznad 30ºC.

Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na spremniku, kutiji i

blisteru iza „Rok valjanosti", odnosno „EXP“. Rok valjanosti odnosi se na zadnji dan navedenog

mjeseca.

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 Glyakt sadrži:

Djelatna tvar je gliklazid. Jedna tableta sadrži 30 mg gliklazida, u obliku tablete s

prilagođenim oslobađanjem

Pomoćne tvari su: laktoza hidrat, hipromeloza, mikrokristalična celuloza, koloidni, bezvodni

silicijev dioksid, magnezijev stearat

Kako Glyakt i sadržaj pakiranja:

Glyakt 30 mg tablete s prilagođenim oslobađanjem su bijele, ovalne, bikonveksne tablete, veličine

5x11 mm s oznakom „G“ na jednoj strani.

Veličine pakiranja:

Blisteri: 10, 14, 28, 30, 56, 60, 90, 120, 180 tableta s prilagođenim oslobađanjem

Bočice: 90, 120, 180 tableta s prilagođenim oslobađanjem

Na tržištu se ne moraju nalaziti sve veličine pakiranja.

Nositelj odobrenja za stavljanje u promet gotovog lijeka i proizvođač

Nositelj odobrenja za stavljanje lijeka u promet

Actavis Group PTC ehf.

Reykjavíkurvegi 76-78

220 Hafnarfjörður

Island

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O D O B R E N O

Proizvođači:

Actavis ehf.

Reykjavikurvegur 78

IS-220 Hafnarfjörður

Island

Balkanpharma-Dupnitsa AD

3 Samokovsko Shosse Str.,

Dupnitza 2600

Bugarska

Predstavnik nositelja odobrenja za Republiku Hrvatsku

PharmaVigil d.o.o.

VI. Oranički odvojak 2

10 000 Zagreb, Hrvatska

Tel: 01/3890 676

Ovaj lijek je odobren u državama članicama Europskog ekonomskom prostora (EEA) pod

sljedećim nazivima:

Danska Gliclazide Actavis

Bugarska Normodiab MR 30 mg

Normodiab MR 60 mg

Cipar Azildor Actavis Group PTC ehf.

Češka Gliklazid Actavis 30 mg

Gliklazid Actavis 60 mg

Estonija Gliclazide Actavis

Grčka Gliclazide/Actavis

Mađarska Gliclazide Actavis 30 mg, 60 mg módosított hatóanyagleadású tabletta

Island Gliclazide Actavis

Irska Vitile MR 30 mg Modified Release Tablets

Litva Gliclazide Actavis 30,60 mg modifikuoto atpalaidavimo tabletės

Latvija Gliclazide Actavis 30, 60 mg ilgstošās darbības tabletes

Malta Azildor

Poljska Gliclazide Actavis

Rumunjska Gliclazida Actavis 30 mg comprimate cu eliberare modificata

Gliclazida Actavis 60mg comprimate cu eliberare modificata

Slovenija Gliavis 30 mg, 60 mg tablet s prirejenim sproščenjem

Ujedinjeno Kraljevstvo BILXONA 30mg & 60mg modified-release tablets

Način i mjesto izdavanja

Lijek se izdaje na recept, u ljekarni.

Uputa je zadnji puta revidirana u lipnju 2016.

Detaljnije informacije o ovom lijeku dostupne su na internet stranici Agencije za lijekove i medicinske

proizvode Republike Hrvatske www.halmed.hr.

H A L M E D

08-07-2016

O D O B R E N O

15-11-2018

Results from 2018 National Youth Tobacco Survey show dramatic increase in e-cigarette use among youth over past year

Results from 2018 National Youth Tobacco Survey show dramatic increase in e-cigarette use among youth over past year

New findings from the National Youth Tobacco Survey show that more than 3.6 million middle and high school students were current (past 30 day) e-cigarette users in 2018.

FDA - U.S. Food and Drug Administration

7-11-2018

Reactie op berichtgeving over nota Waarborgfonds

Reactie op berichtgeving over nota Waarborgfonds

Op dinsdag 30 oktober heeft minister Bruno Bruins een feitenrelaas rondom het faillissement van de MC Groep naar de Tweede Kamer gestuurd.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

31-10-2018

Outcome of a public consultation on the draft guidance on the scientific requirements for health claims related to muscle function and physical performance

Outcome of a public consultation on the draft guidance on the scientific requirements for health claims related to muscle function and physical performance

Published on: Tue, 30 Oct 2018 00:00:00 +0100 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 guidance on the scientific requirements for health claims related to muscle function and physical performance, prepared by the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA), supported by the Working Group on Claims. The draft guidance was endorsed by the Panel for public consultation ...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Peer review of the pesticide risk assessment of the active substance dimethoate

Peer review of the pesticide risk assessment of the active substance dimethoate

Published on: Tue, 30 Oct 2018 00:00:00 +0100 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Italy and co‐rapporteur Member State Bulgaria for the pesticide active substance dimethoate 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 dimetho...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Updated review of the existing maximum residue levels for imazalil according to Article 12 of Regulation (EC) No 396/2005 following new toxicological information

Updated review of the existing maximum residue levels for imazalil according to Article 12 of Regulation (EC) No 396/2005 following new toxicological information

Published on: Tue, 30 Oct 2018 00:00:00 +0100 In compliance with Article 43 of Regulation (EC) No 396/2005, EFSA received a mandate from the European Commission to provide an update of the reasoned opinion on the review of existing maximum residue levels (MRLs) for imazalil published on 5 September 2017, taking into account the additional information provided on the toxicity of the metabolites R014821, FK‐772 and FK‐284. EFSA did not derive MRL proposals from the post‐harvest uses reported on citrus fru...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos when used as a feed flavouring for all animal species

Safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos when used as a feed flavouring for all animal species

Published on: Tue, 30 Oct 2018 00:00:00 +0100 Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos (hop strobiles) when used as a sensory feed additive for all animal species. The additive is specified to containing 40% beta acids and less than 0.2% alpha acids. Known substances of conce...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Efficacy of Bergazym® P100 (endo‐1,4‐β‐xylanase) as a feed additive for chickens for fattening and weaned piglets

Efficacy of Bergazym® P100 (endo‐1,4‐β‐xylanase) as a feed additive for chickens for fattening and weaned piglets

Published on: Tue, 30 Oct 2018 00:00:00 +0100 The product Bergazym® P100 contains a xylanase which is produced by a non‐genetically modified strain of Trichoderma reesei. The additive is available in a coated granular form and it is intended to be used as a zootechnical additive (functional group: digestibility enhancers) for chickens for fattening, and weaned piglets at the dose of 1,500 EPU/kg feed. The production strain and the additive were fully characterised in a previous assessment of the Panel o...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Guidance on the scientific requirements for health claims related to muscle function and physical performance

Guidance on the scientific requirements for health claims related to muscle function and physical performance

Published on: Tue, 30 Oct 2018 00:00:00 +0100 EFSA has asked the Panel on Nutrition, Novel Foods and Food Allergens (NDA) to update the guidance on the scientific requirements for health claims related to physical performance published in 2012. The update takes into account the experience gained by the NDA Panel with the evaluation of additional health claim applications, changes introduced to the general scientific guidance for stakeholders for health claims applications and information collected from ...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Peer review of the pesticide risk assessment of the active substance methiocarb

Peer review of the pesticide risk assessment of the active substance methiocarb

Published on: Tue, 30 Oct 2018 00:00:00 +0100 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State the United Kingdom and co‐rapporteur Member State Germany for the pesticide active substance methiocarb 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 use...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Safety and efficacy of Lactobacillus hilgardii CNCM I‐4785 and Lactobacillus buchneri CNCM I‐4323/NCIMB 40788 as a silage additive for all animal species

Safety and efficacy of Lactobacillus hilgardii CNCM I‐4785 and Lactobacillus buchneri CNCM I‐4323/NCIMB 40788 as a silage additive for all animal species

Published on: Tue, 30 Oct 2018 00:00:00 +0100 Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed was asked to deliver a scientific opinion on the safety and efficacy of a strain of Lactobacillus hilgardii and of Lactobacillus buchneri when used as a technological additive intended to improve ensiling at a proposed application rate of 3.0 x 108 colony forming units (CFU)/kg fresh material. The two bacterial species are considered by EFS...

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Published on: Fri, 19 Oct 2018 00:00:00 +0200 EFSA was requested to deliver a scientific opinion on the implications for human health of the flavouring substance 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide [FL‐no: 16.133], in the Flavouring Group Evaluation 411 (FGE.411), according to Regulation (EC) No 1331/2008 of the European Parliament and of the Council. The substance has not been reported to occur in natural source materials of botanical or animal origin. It is intende...

Europe - EFSA - European Food Safety Authority Publications

18-10-2018

P. East Trading Corp. Issues Alert on Undeclared Sulfites In Fruits Du Sud Golden Seedless Raisins

P. East Trading Corp. Issues Alert on Undeclared Sulfites In Fruits Du Sud Golden Seedless Raisins

P. EAST TRADING CORP. of Bronx, NY is recalling Fruits Du Sud Golden Seedless Raisins (Lot No. FDS T499/18) 30 lbs Box, because they contain undeclared SULFITES. People who have a severe sensitivity to sulfites run the risk of serious or life-threatening reactions if they consume these products.

FDA - U.S. Food and Drug Administration

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

25-9-2018

Voluntary Recall on Harris Teeter Low Fat Cookies & Cream Frozen Yogurt Due to Undeclared Peanut Product

Voluntary Recall on Harris Teeter Low Fat Cookies & Cream Frozen Yogurt Due to Undeclared Peanut Product

Harris Teeter is notifying shoppers of a voluntarily recall of Harris Teeter Low Fat Frozen Yogurt Cookies & Cream 1.5 qt laminated cartons, UPC 0 72036 98182 0, with all SELL BY DATES up to 07/30/19 due to undeclared peanut product.

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

31-8-2018

Peer review of the pesticide risk assessment of the active substance cypermethrin

Peer review of the pesticide risk assessment of the active substance cypermethrin

Published on: Thu, 30 Aug 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 Germany for the pesticide active substance 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 cype...

Europe - EFSA - European Food Safety Authority Publications

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

6-8-2018

G & C Raw, LLC Recalls Pat's Cat Turkey, and Ground Lamb Pet Food, because of Possible Listeria Monocytogenes Health Risk

G & C Raw, LLC Recalls Pat's Cat Turkey, and Ground Lamb Pet Food, because of Possible Listeria Monocytogenes Health Risk

G & C Raw, of Versailles, OH is recalling 30 1-lb containers of Pat's Cat Turkey Cat Food and 40 2-lb containers of Ground Lamb Dog Food because it has the potential to be contaminated with Listeria monocytogenes. Listeria monocytogenes can cause serious and sometimes fatal infections in animals eating the products.

FDA - U.S. Food and Drug Administration

31-7-2018

July 30, 2018: Two People Guilty of Distributing Tramadol Pills

July 30, 2018: Two People Guilty of Distributing Tramadol Pills

July 30, 2018: Two People Guilty of Distributing Tramadol Pills

FDA - U.S. Food and Drug Administration

17-7-2018

Blokhuis kondigt grootschalige extra vaccinatie aan: Ruim half miljoen kinderen krijgen oproep

Blokhuis kondigt grootschalige extra vaccinatie aan: Ruim half miljoen kinderen krijgen oproep

Volgend jaar worden zo’n 650.000 kinderen extra opgeroepen om zich te laten inenten tegen de zeer ernstige infectieziekte meningokokken. Het gaat om kinderen die zijn geboren na 1 januari 2001 en voor mei 2004. Dat laat staatssecretaris Paul Blokhuis (VWS) weten in een brief aan de Tweede Kamer. Reden voor deze maatregel is dat in de afgelopen jaren een stijging te zien is van het aantal mensen dat de infectie meningokokken type W oploopt. Met deze extra vaccinatieronde moet die groei worden ingedamd. He...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

30-10-2018

EU/3/14/1250 (Akcea Therapeutics UK Ltd)

EU/3/14/1250 (Akcea Therapeutics UK Ltd)

EU/3/14/1250 (Active substance: Phosphorothioate oligonucleotide targeted to transthyretin) - Transfer of orphan designation - Commission Decision (2018)7282 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/098/13/T/01

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2080 (Freeline Therapeutics Ltd)

EU/3/18/2080 (Freeline Therapeutics Ltd)

EU/3/18/2080 (Active substance: Recombinant adeno-associated viral vector serotype S3 containing codon-optimised expression cassette encoding human coagulation factor IX variant) - Orphan designation - Commission Decision (2018)7281 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/127/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2079 (Spark Therapeutics Ireland Ltd)

EU/3/18/2079 (Spark Therapeutics Ireland Ltd)

EU/3/18/2079 (Active substance: Recombinant adeno-associated viral vector containing a bioengineered capsid and a codon-optimised expression cassette to drive the expression of the SQ form of a B-domain deleted human coagulation factor VIII) - Orphan designation - Commission Decision (2018)7280 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/104/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2078 (Sellas Life Sciences Limited)

EU/3/18/2078 (Sellas Life Sciences Limited)

EU/3/18/2078 (Active substance: Peptides YMFPNAPYL, SGQAYMFPNAPYLPSCLES, RSDELVRHHNMHQRNMTKL and PGCNKRYFKLSHLQMHSRKHTG) - Orphan designation - Commission Decision (2018)7279 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/091/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2077 (Worphmed Srl)

EU/3/18/2077 (Worphmed Srl)

EU/3/18/2077 (Active substance: Melatonin) - Orphan designation - Commission Decision (2018)7278 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/077/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2076 (Orphan Europe S.A.R.L.)

EU/3/18/2076 (Orphan Europe S.A.R.L.)

EU/3/18/2076 (Active substance: Glycine, L-alanine, L-arginine, L-aspartic acid, L-cysteine, L-cystine, L-glutamic acid, L-histidine, L-lysine monohydrate, L-methionine, L-phenylalanine, L-proline, L-serine, L-threonine, L-tryptophan, L-tyrosine, taurine) - Orphan designation - Commission Decision (2018)7277 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/100/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2075 (Consorcio Centro de InvestigaciOn BiomEdica en Red M.P.)

EU/3/18/2075 (Consorcio Centro de InvestigaciOn BiomEdica en Red M.P.)

EU/3/18/2075 (Active substance: Gefitinib) - Orphan designation - Commission Decision (2018)7276 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/090/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2074 (PhaRA bvba)

EU/3/18/2074 (PhaRA bvba)

EU/3/18/2074 (Active substance: Avapritinib) - Orphan designation - Commission Decision (2018)7275 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/079/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2073 (Fondazione Telethon)

EU/3/18/2073 (Fondazione Telethon)

EU/3/18/2073 (Active substance: Autologous CD34+ haematopoietic stem and progenitor cells genetically modified with the lentiviral vector IDUA LV, encoding for the alpha-L-iduronidase cDNA) - Orphan designation - Commission Decision (2018)7274 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/113/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2071 (Loxo Oncology Limited)

EU/3/18/2071 (Loxo Oncology Limited)

EU/3/18/2071 (Active substance: 6-(2-hydroxy-2-methylpropoxy)-4-(6-(6-((6-methoxypyridin-3-yl)methyl)-3,6-diazabicyclo[3.1.1]heptan-3-yl)pyridin-3-yl)pyrazolo[1,5-a]pyridine-3-carbonitrile) - Orphan designation - Commission Decision (2018)7272 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/125/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2072 (FGK Representative Service GmbH)

EU/3/18/2072 (FGK Representative Service GmbH)

EU/3/18/2072 (Active substance: 6'-(R)-methyl-5-O-(5-amino-5,6-dideoxy-alpha-L-talofuranosyl)-paromamine sulfate) - Orphan designation - Commission Decision (2018)7273 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/102/18

Europe -DG Health and Food Safety

30-9-2018

Roteas (Daiichi Sankyo Europe GmbH)

Roteas (Daiichi Sankyo Europe GmbH)

Roteas (Active substance: edoxaban) - PSUSA - Modification - Commission Decision (2018)5089 of Sun, 30 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10387/201710

Europe -DG Health and Food Safety

17-9-2018

Reminder: the FDA is accepting applications through Sept. 30, 2018, for the #FDAInnovationChallenge for devices to help combat #opioid addiction.   Submissions will be evaluated based on the feasibility, potential public health impact and novelty of the c

Reminder: the FDA is accepting applications through Sept. 30, 2018, for the #FDAInnovationChallenge for devices to help combat #opioid addiction. Submissions will be evaluated based on the feasibility, potential public health impact and novelty of the c

Reminder: the FDA is accepting applications through Sept. 30, 2018, for the #FDAInnovationChallenge for devices to help combat #opioid addiction. Submissions will be evaluated based on the feasibility, potential public health impact and novelty of the concept.

FDA - U.S. Food and Drug Administration

30-8-2018

Steglatro (Merck Sharp and Dohme B.V.)

Steglatro (Merck Sharp and Dohme B.V.)

Steglatro (Active substance: ertugliflozin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5789 of Thu, 30 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4315/T/2

Europe -DG Health and Food Safety

30-8-2018

Fluenz Tetra (AstraZeneca AB)

Fluenz Tetra (AstraZeneca AB)

Fluenz Tetra (Active substance: influenza vaccine (live attenuated, nasal)) - Centralised - Variation - Commission Decision (2018)5815 of Thu, 30 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2617/II/82

Europe -DG Health and Food Safety

3-8-2018

Scandonest and associated names

Scandonest and associated names

Scandonest and associated names (Active substance: mepivacaine) - Community Referrals - Art 30 - Commission Decision (2018)5380 of Fri, 03 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/A-30/1455

Europe -DG Health and Food Safety

1-8-2018

Bridion (Merck Sharp and Dohme B.V.)

Bridion (Merck Sharp and Dohme B.V.)

Bridion (Active substance: sugammadex) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5213 of Wed, 01 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/885/T/30

Europe -DG Health and Food Safety

30-7-2018

Nityr (Cycle Pharmaceuticals Ltd)

Nityr (Cycle Pharmaceuticals Ltd)

Nityr (Active substance: nitisinone) - Centralised - Authorisation - Commission Decision (2018)5446 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4582

Europe -DG Health and Food Safety

30-7-2018

Esmya (Gedeon Richter Plc.)

Esmya (Gedeon Richter Plc.)

Esmya (Active substance: ulipristal) - Referral - Commission Decision (2018)5101 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2041/A-20

Europe -DG Health and Food Safety

30-7-2018

Aimovig (Novartis Europharm Limited)

Aimovig (Novartis Europharm Limited)

Aimovig (Active substance: erenumab) - Centralised - Authorisation - Commission Decision (2018)5102 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4447

Europe -DG Health and Food Safety

30-7-2018

Besponsa (Pfizer Europe MA EEIG)

Besponsa (Pfizer Europe MA EEIG)

Besponsa (Active substance: inotuzumab ozogamicin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5104 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4119/T/7

Europe -DG Health and Food Safety

30-7-2018

Segluromet (Merck Sharp and Dohme B.V.)

Segluromet (Merck Sharp and Dohme B.V.)

Segluromet (Active substance: ertugliflozin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5103 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4314/T/2

Europe -DG Health and Food Safety

30-7-2018

Invokana (Janssen-Cilag International NV)

Invokana (Janssen-Cilag International NV)

Invokana (Active substance: canagliflozin) - Centralised - Renewal - Commission Decision (2018)5105 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2649/R/37

Europe -DG Health and Food Safety

30-7-2018

NovoEight (Novo Nordisk A/S)

NovoEight (Novo Nordisk A/S)

NovoEight (Active substance: turoctocog alfa) - Centralised - 2-Monthly update - Commission Decision (2018)5093 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2719/II/23

Europe -DG Health and Food Safety

30-7-2018

Hyrimoz (Sandoz GmbH)

Hyrimoz (Sandoz GmbH)

Hyrimoz (Active substance: adalimumab) - Centralised - Authorisation - Commission Decision (2018)5097 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4320

Europe -DG Health and Food Safety

30-7-2018

Halimatoz (Sandoz GmbH)

Halimatoz (Sandoz GmbH)

Halimatoz (Active substance: adalimumab) - Centralised - Authorisation - Commission Decision (2018)5098 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4866

Europe -DG Health and Food Safety

30-7-2018

Rasagiline ratiopharm (Teva B.V.)

Rasagiline ratiopharm (Teva B.V.)

Rasagiline ratiopharm (Active substance: rasagiline) - Centralised - Yearly update - Commission Decision (2018)5108 of Mon, 30 Jul 2018

Europe -DG Health and Food Safety

30-7-2018

Hefiya (Sandoz GmbH)

Hefiya (Sandoz GmbH)

Hefiya (Active substance: adalimumab) - Centralised - Authorisation - Commission Decision (2018)5099 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4865

Europe -DG Health and Food Safety

30-7-2018

Alsitek (AB Science)

Alsitek (AB Science)

Alsitek (Active substance: masitinib) - Refusal of authorisation - Commission Decision (2018)5109 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4398

Europe -DG Health and Food Safety

30-7-2018

UBAC (Laboratorios Hipra, S.A.)

UBAC (Laboratorios Hipra, S.A.)

UBAC (Active substance: Streptococcus uberis vaccine (inactivated)) - Centralised - Authorisation - Commission Decision (2018)5152 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/4595

Europe -DG Health and Food Safety

30-7-2018

Apoquel (Zoetis Belgium S.A.)

Apoquel (Zoetis Belgium S.A.)

Apoquel (Active substance: Oclacitinib maleate) - Centralised - Renewal - Commission Decision (2018)5153 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2688/R/13

Europe -DG Health and Food Safety

30-7-2018

Ofev (Boehringer Ingelheim International GmbH)

Ofev (Boehringer Ingelheim International GmbH)

Ofev (Active substance: Nintedanib) - PSUSA - Modification - Commission Decision (2018)5115 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10319/201710

Europe -DG Health and Food Safety

30-7-2018

Ceplene (Noventia Pharma Srl)

Ceplene (Noventia Pharma Srl)

Ceplene (Active substance: Histamine dihydrochloride) - Centralised - Renewal - Commission Decision (2018)5116 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/796/R/36

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

30-7-2018

Trazimera (Pfizer Europe MA EEIG)

Trazimera (Pfizer Europe MA EEIG)

Trazimera (Active substance: trastuzumab) - Centralised - Authorisation - Commission Decision (2018)5095 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4463

Europe -DG Health and Food Safety

30-7-2018

RXULTI (Otsuka Pharmaceutical Europe Ltd)

RXULTI (Otsuka Pharmaceutical Europe Ltd)

RXULTI (Active substance: brexpiprazole) - Centralised - Authorisation - Commission Decision (2018)5088 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3841

Europe -DG Health and Food Safety

24-7-2018

ACV meeting statement, Meeting 8, 30 May 2018

ACV meeting statement, Meeting 8, 30 May 2018

Advisory Committee on Vaccines meeting statement

Therapeutic Goods Administration - Australia

11-7-2018

Vantavo (Merck Sharp and Dohme B.V.)

Vantavo (Merck Sharp and Dohme B.V.)

Vantavo (Active substance: alendronic acid / colecalciferol) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4511 of Wed, 11 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1180/T/30

Europe -DG Health and Food Safety

11-7-2018

Tovanor Breezhaler (Novartis Europharm Limited)

Tovanor Breezhaler (Novartis Europharm Limited)

Tovanor Breezhaler (Active substance: glycopyrronium bromide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4526 of Wed, 11 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2690/T/30

Europe -DG Health and Food Safety