Glika 30 mg tablete

Glavna informacija

  • Trgovački naziv:
  • Glika 30 mg tablete s prilagođenim oslobađanjem
  • Doziranje:
  • 30 mg
  • Farmaceutski oblik:
  • tableta s prilagođenim oslobađanjem
  • Sastav:
  • Urbroj: jedna 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:
  • Belupo lijekovi i kozmetika d.d., Koprivnica, Republika Hrvatska

Dokument

Lokalizacija

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

Terapeutski informacija

  • Proizvod sažetak:
  • Pakiranje: 60 tableta u blisteru, u kutiji [HR-H-059594135-01] Urbroj: 381-12-01/38-17-06

Druge informacije

Status

  • Izvor:
  • HALMED Agencija za lijekove i medicinske proizvode - Agency for medicinal products and medical devices of Croatia
  • Broj odobrenja:
  • HR-H-059594135
  • Datum autorizacije:
  • 01-12-2017
  • Zadnje ažuriranje:
  • 04-06-2018

Uputu o lijeku

Uputa o lijeku: Informacije za bolesnika

GLIKA 30 mg tablete s prilagođenim oslobađanjem

gliklazid

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 Vašeg 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 GLIKA i za što se koristi?

Što morate znati prije nego počnete uzimati lijek GLIKA?

Kako uzimati lijek GLIKA?

Moguće nuspojave

Kako čuvati lijek GLIKA?

Sadržaj pakiranja i druge informacije

1.

Što je GLIKA i za što se koristi?

GLIKA je lijek koji smanjuje razinu šećera u krvi (oralni antidijabetik koji spada u skupinu lijekova

derivata sulfonilureje).

Lijek GLIKA je predviđen za liječenje odraslih bolesnika sa šećernom bolešću neovisnom o inzulinu (tip

2), u kojih se bolest, odnosno normalna razina šećera u krvi, ne može regulirati samo prehranom,

tjelovježbom ili mršavljenjem.

2.

Što morate znati prije nego počnete uzimati lijek GLIKA?

Nemojte uzimati lijek GLIKA:

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

lijekove iz ove skupine (derivati sulfonilureje), odnosno druge srodne lijekove (sulfonamidi)

ako imate šećernu bolest ovisnu o inzulinu (tip 1)

ako imate ketonska tijela ili šećer u mokraći (to može značiti da imate ketoacidozu), ili u slučaju

dijabetičke pretkome ili kome

ako bolujete od teške bolesti bubrega ili jetre

ako uzimate lijekove za

liječenje gljivičnih infekcija (mikonazol; vidjeti dio

Drugi lijekovi i

GLIKA)

ako dojite (vidjeti dio Trudnoća i dojenje).

Upozorenja i mjere opreza

Obratite se Vašem liječniku ili ljekarniku prije nego uzmete lijek GLIKA.

Da biste postigli normalne vrijednosti šećera u krvi morate se pridržavati načina liječenja koje je propisao

Vaš liječnik. Pored redovitog uzimanja lijeka, to podrazumijeva promjenu režima prehrane, tjelovježbu te

prema potrebi smanjenje tjelesne mase.

Tijekom uzimanja ovog lijeka potrebno je redovito kontrolirati razinu šećera u krvi (prema potrebi u

urinu), a ukoliko je to nužno i razinu glikoziliranog hemoglobina (HbA1c).

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Tijekom prvih tjedana liječenja postoji povećan rizik od nastanka hipoglikemije (niske vrijednosti šećera

u krvi), stoga je potrebno pažljivo praćenje razine šećera u krvi.

Niska razina šećera u krvi može se pojaviti:

ako ne jedete redovito ili preskačete obroke

ako gladujete

ako ste pothranjeni

ako mijenjate prehranu

ako ste pojačali fizičku aktivnost a pri tome niste prilagodili unos ugljikohidrata

ako konzumirate alkohol, osobito ako pri tome preskačete obroke

ako istovremeno uzimate druge lijekove ili prirodna ljekovita sredstva

ako uzmete preveliku dozu gliklazida

ako bolujete od nekih poremećaja žlijezda s unutrašnjim izlučivanjem (poremećaj rada štitnjače ili

hipofize (pituitarne žlijezde))

ako imate teško oštećenje funkcije bubrega ili jetre.

Ako imate nisku razinu šećera u krvi možete imati sljedeće simptome: glavobolja, teška glad, mučnina,

povraćanje, umor, poremećaj spavanja, nemir, agresivnost, slaba koncentracija, smanjena budnost i

usporene

reakcije,

depresija,

smetenost,

poremećaj

vida

govora,

tremor

(drhtavica),

osjetilni

poremećaji, omaglica i osjećaj nemoći.

Mogu se pojaviti i sljedeći znakovi i simptomi: znojenje, vlažna i ljepljiva koža, tjeskoba, brz ili

nepravilan rad srca, visoki krvni tlak, iznenadna i oštra bol u prsima koja se može širiti u okolna područja

(angina pektoris).

Ako Vam se razina šećera u krvi nastavi smanjivati, možete patiti od jake smetenosti (delirij), pojave

grčeva (konvulzije), gubitka samokontrole, plitkog disanja, usporenog rada srca i gubitka svijesti.

U većini slučajeva simptomi niske razine glukoze u krvi brzo nestanu kada uzmete neki oblik šećera (npr.

tablete glukoze, kocke šećera, slatki sok ili zaslađeni čaj).

Shodno tome, preporučljivo je da uza sebe uvijek imate neki oblik šećera (tablete glukoze ili kocku

šećera). Imajte na umu da Vam umjetna sladila ne mogu pomoći. Obavezno se javite svom liječniku ili

najbližoj zdravstvenoj ustanovi u slučaju da Vam uzimanje šećera ne pomogne ili ukoliko se simptomi

ponove.

Ponekad su simptomi niske razine šećera u krvi slabo izraženi, pojavljuju se vrlo sporo ili ih uopće nema,

odnosno niste svjesni njihova postojanja. To se može dogoditi u starijih bolesnika koji koriste određene

lijekove (npr. lijekovi koji djeluju na središnji živčani sustav i beta blokatori).

Ukoliko se nalazite u stanju stresa zbog nekih iznimnih napora (npr. nesreća, kirurški zahvat, vrućica),

liječnik Vam može privremeno propisati terapiju inzulinom.

Simptomi visoke razine šećera u krvi (hiperglikemija) mogu se javiti u slučaju da gliklazid nije dostatno

smanjio razinu šećera, da se niste pridržavali uputa koje Vam je liječnik propisao ili u slučaju iznimno

stresnih situacija. Simptomi koji se pri tome mogu javiti su žeđ, učestalo mokrenje, suhoća usta, svrbež i

suhoća kože, kožne infekcije i pojačan umor.

Ukoliko primijetite navedene simptome, obavezo kontaktirajte Vašeg liječnika ili ljekarnika.

Postoji mogućnost

poremećaja

glukoze

u krvi,

uključujući

hipoglikemiju

i hiperglikemiju,

istovremeno liječite s fluorokinolonima (vrsta antibiotika) osobito u starijih osoba.

Preporučuje se pažljiva kontrola šećera u krvi kod svih bolesnika koji istovremeno uzimaju Glika 30 mg

tablete s prilagođenim oslobađanjem i fluorokinolone.

Ukoliko Vi ili netko od članova Vaše obitelji bolujete od nasljedne bolesti nedostatka enzima glukoza-6-

fosfat dehidrogenaze (G6PD) (poremećaj crvenih krvnih stanica), koja može uzrokovati smanjenje razine

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hemoglobina u krvi i razgradnju crvenih krvnih stanica (hemolitička anemija), pitajte Vašeg liječnika za

savjet prije nego počnete koristiti ovaj lijek.

Lijek

GLIKA

nije

namijenjen

primjenu

djece

zbog

nedostatnih

podataka

učinkovitosti

neškodljivosti lijeka u toj dobnoj skupini.

Drugi lijekovi i GLIKA

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

druge lijekove, uključujući i one koje ste kupili bez recepta. Učinci GLIKA tableta na sniženje razine

šećera u krvi mogu biti pojačani, a znakovi niske razine šećera izraženi, ukoliko se istovremeno uzimaju

sa sljedećim lijekovima:

drugi lijekovi za liječenje visoke razine šećera u krvi (oralni antidijabetici, agonisti GLP-1 receptora

ili inzulin)

antibiotici (npr. sulfonamidi, klaritromicin)

lijekovi za liječenje visokog krvnog tlaka ili slabosti srca (beta-blokatori, ACE inhibitori kao što su

kaptopril ili enapril)

lijekovi za liječenje gljivičnih infekcija (mikonazol, flukonazol)

lijekovi za liječenje vrijeda želuca ili početnog dijela tankog crijeva (antagonisti H

receptora)

lijekovi za liječenje depresije (inhibitori monoaminooksidaze)

lijekovi protiv bolova ili antireumatici (fenilbutazon, ibuprofen)

lijekovi koji sadrže alkohol.

Učinci lijeka GLIKA na sniženje razine šećera u krvi mogu biti smanjeni, a znakovi visoke razine šećera

u krvi izraženi, ukoliko se istovremeno uzimaju sa sljedećim lijekovima:

lijekovi za liječenje poremećaja središnjeg živčanog sustava (klorpromazin)

lijekovi protiv upale (kortikosteroidi)

lijekovi za liječenje astme ili lijekovi koji se primjenjuju tijekom poroda (intravenozni salbutamol,

ritodrin i terbutalin)

lijekovi za liječenje bolesti dojke, teškog krvarenja za vrijeme menstrualnog ciklusa i endometrioze

(danazol).

lijekovi koji sadrže Gospinu travu

Poremećaji

razini

šećera

(hiperglikemija

hipoglikemija)

mogući

istovremene

primjene

fluorokinolona (vrsta antiobiotika) osobito u starijih osoba.

Lijek GLIKA može pojačati učinke lijekova koji se koriste protiv zgrušavanja krvi (npr. varfarin).

Posavjetujte se s Vašim liječnikom ili ljekarnikom prije nego počnete koristiti bilo koji lijek. Ukoliko ste

zaprimljeni u bolnicu, obavijestite nadležnog liječnika da uzimate lijek GLIKA.

GLIKA s hranom i pićem

GLIKA se može uzimati s hranom i bezalkoholnim pićima.

Uzimanje alkoholnih pića se ne preporučuje obzirom da mogu nepredvidivo remetiti kontrolu šećerne

bolesti.

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 bilo koji lijek.

Primjena lijeka GLIKA za vrijeme trudnoće se ne preporučuje.

Lijek GLIKA ne smijete uzimati ako dojite.

Upravljanje vozilima i strojevima

Vaša koncentracija može biti oslabljena, a reakcije usporene u slučaju niske (hipoglikemija) ili visoke

(hiperglikemija) razine šećera u krvi, odnosno možete imati smetnje vida kao posljedicu oba stanja.

Imajte na umu da možete ugroziti sebe i druge ukoliko vozite auto ili upravljate strojevima.

Pitajte Vašeg liječnika smijete li voziti auto ako:

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imate česte epizode pada šećera u krvi (hipoglikemija)

imate slabo izražene upozoravajuće znakove niske razine šećera u krvi (hipoglikemija) ili ih uopće

nemate.

3.

Kako uzimati lijek GLIKA?

Doziranje

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

liječnikom ili ljekarnikom ako niste sigurni.

Dozu lijeka će odrediti Vaš liječnik ovisno o razini šećera u krvi i prema potrebi u mokraći.

Promjene vanjskih čimbenika

(npr. gubitak tjelesne mase, promjene u načinu života, stres) mogu

zahtijevati promjenu doze gliklazida.

Ovisno o odgovoru na liječenje, uobičajena doza iznosi od jedne do četiri tablete (najviše 120 mg),

jednokratno za vrijeme doručka.

Ukoliko

lijek

GLIKA primjenjuju

u kombinaciji

metforminom, inhibitorom

alfa-glukozidaze,

tiazolidindioninom,

inhibitorima

enzima

dipeptidil

peptidaze

agonistima

GLP-1

receptora

inzulinom, liječnik će za Vas odrediti dozu svakog pojedinačnog lijeka.

Ukoliko imate dojam da Vam je razina šećera u krvi previsoka iako uzimate lijek kako Vam je propisano,

razgovarajte s Vašim liječnikom ili ljekarnikom.

Način primjene

Za primjenu kroz usta.

Tabletu treba progutati cijelu. Tabletu nemojte žvakati.

Tabletu progutajte s čašom vode za vrijeme doručka (po mogućnosti u isto vrijeme svaki dan).

Nakon uzimanja lijeka obavezno uzmite obrok.

Ako uzmete više lijeka GLIKA nego što ste trebali

Ako uzmete previše GLIKA tableta, odmah se obratite Vašem liječniku ili u najbližu zdravstvenu

ustanovu. Znakovi predoziranja odgovaraju znakovima niske razine glukoze u krvi (hipoglikemija),

opisanim u dijelu 2. Što morate znati prije nego počnete uzimati lijek GLIKA. Simptomi se mogu

ublažiti uzimanjem šećera (4 do 6 kocke) ili nekog slatkog pića, nakon čega treba uzeti obrok. Ukoliko je

bolesnik bez svijesti odmah obavijestite liječnika i službu hitne pomoći. Na isti način treba postupati u

slučaju da je netko (npr. dijete) uzeo lijek nenamjerno. Bolesniku bez svijesti zabranjeno je davati hranu

ili piće.

Poželjna je prisutnost osobe upoznate s mogućim komplikacijama bolesti koja će u slučaju hitnog stanja

moći pozvati liječnika.

Ako ste zaboravili uzeti lijek GLIKA

Kako bi liječenje bilo učinkovito važno je lijek uzimati redovito. Ukoliko ste propustili uzeti dozu

GLIKA tableta, uzmite sljedeću dozu u uobičajeno vrijeme. Nemojte uzeti dvostruku dozu kako biste

nadoknadili zaboravljenu dozu.

Ako prestanete uzimati lijek GLIKA

Prije nego što prestanete uzimati lijek razgovarajte s Vašim liječnikom obzirom da je liječenje šećerne

bolesti u pravilu doživotno. Prekid liječenja može uzrokovati porast razine šećera u krvi (hiperglikemija)

što povećava rizik nastanka komplikacija šećerne bolesti.

Ako imate bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se Vašem liječniku ili ljekarniku.

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4.

Moguće nuspojave

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

Najčešća nuspojava je niska razina šećera u krvi (hipoglikemija). Znakovi i simptomi hipoglikemije

opisani su u dijelu 2. Što morate znati prije nego počnete uzimati lijek GLIKA; Upozorenja i mjere

opreza.

Ukoliko se ne poduzme liječenje, simptomi mogu napredovati do pojave pospanosti, gubitka svijesti čak i

kome. Ako je hipoglikemijska epizoda teška ili dugotrajna, čak i ako se stanje privremeno poboljša

uzimanjem šećera, trebate zatražiti hitnu medicinsku pomoć.

Poremećaji krvi i limfnog sustava

Primijećeno je smanjenje broja krvnih stanica (npr. krvne pločice, crvene i bijele

krvne stanice).

Posljedično se može pojaviti:

bljedilo

produljeno vrijeme krvarenja

modrice

upala grla

groznica.

Ovi simptomi obično nestanu nakon što se liječenje prekine.

Poremećaji jetre i žuči

Zabilježeni su pojedinačni slučajevi poremećene funkcije jetre s posljedičnim žutilom kože i očiju.

Ukoliko primijetite ove simptome odmah se javite Vašem liječniku. Simptomi se u pravilu povuku nakon

prestanka liječenja. O prestanku liječenja odlučit će Vaš liječnik.

Poremećaji kože i potkožnog tkiva

Primijećene su promjene na koži kao što su:

osip

crvenilo

svrbež

koprivnjača

angioedem (brzo oticanje očnih vjeđa, lica, usana, jezika i ždrijela koje može rezultirati otežanim

disanjem). Osip se može proširiti po cijelome tijelu ili uzrokovati ljuštenje kože.

iznimno, znakovi teške reakcije preosjetljivosti (DRESS): u početku sa simptomima sličnima gripi i

osipom na licu, a zatim s generaliziranim osipom po cijelom tijelu

i s povišenom tjelesnom

temperaturom.

Također se mogu javiti i teže kožne reakcije.

Poremećaji probavnog sustava

bol ili nelagoda u želucu

mučnina

poremećaji probave

proljev

zatvor.

Pojava ovih simptoma može se ublažiti primjenom lijeka GLIKA zajedno s obrokom, kako je to

preporučeno i navedeno u dijelu 3. Kako uzimati lijek GLIKA; Način primjene.

Poremećaji oka

Možete imati kratkotrajne smetnje vida, osobito na početku liječenja. Te smetnje su posljedica promjena

u razini šećera u krvi.

Ostali učinci koji su uočeni pri primjeni lijekova iste skupine kojoj pripada GLIKA

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Prilikom primjene ostalih preparata sulfonilureje primijećeni su slučajevi ozbiljnog smanjenja broja

krvnih stanica, alergijske upale stijenki krvnih žila te smanjena koncentracija soli u krvi (hiponatrijemija).

Simptomi poremećene funkcije jetre (npr. žutica) koji se također mogu pojaviti, povuku se u većini

slučajeva nakon prestanka uzimanja sulfonilureje, premda u ponekim slučajevima mogu dovesti do po

život opasnog zatajenja jetre.

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 GLIKA tablete?

Lijek ne zahtijeva posebne uvjete čuvanja.

Ovaj lijek čuvajte izvan pogleda i dohvata djece.

Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji. Rok valjanosti odnosi

se na zadnji dan navedenog mjeseca.

Nikada nemojte nikakve lijekove bacati u otpadne vode ili kućni otpad. Pitajte Vašeg ljekarnika kako

baciti lijekove koje više ne koristite. Ove će mjere pomoći u očuvanju okoliša.

6.

Sadržaj pakiranja i druge informacije

Što GLIKA sadrži?

Djelatna tvar je gliklazid.

Jedna tableta s prilagođenim oslobađanjem sadrži 30 mg gliklazida.

Pomoćne tvari su: hipromeloza; kalcijev hidrogenfosfat, bezvodni; magnezijev stearat.

Kako GLIKA izgleda i sadržaj pakiranja?

GLIKA 30 mg tableta s prilagođenim oslobađanjem je bijela do gotovo bijela, neobložena tableta oblika

kapsule, duljine 10.5 mm, širine 4.3 mm i bez oznaka na obje strane.

60 tableta u PVC/PVDC//Al blisteru, u kutiji.

Nositelj odobrenja za stavljanje lijeka u promet i proizvođač

BELUPO lijekovi i kozmetika d.d.

Ulica Danica 5

48 000 Koprivnica

Način i mjesto izdavanja lijeka

Lijek se izdaje na recept, u ljekarni.

Ova uputa je posljednji put revidirana u prosincu 2017.

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01 - 12 - 2017

O D O B R E N O

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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

6-7-2018

TGA presentation: National Medicines Symposium, 30 May 2018

TGA presentation: National Medicines Symposium, 30 May 2018

This presentation covers the revised requirements for advertisements for medicines containing Schedule 3 substances

Therapeutic Goods Administration - Australia