Etoxib 30 mg filmom obložene

Glavna informacija

  • Trgovački naziv:
  • Etoxib 30 mg filmom obložene tablete
  • Doziranje:
  • 30 mg
  • Farmaceutski oblik:
  • filmom obložena tableta
  • Sastav:
  • Urbroj: jedna filmom obložena tableta sadrži 30 mg etorikoksiba
  • Tip recepta:
  • na recept, u ljekarni neponovljivi recept
  • Koristi za:
  • Ljudi
  • Vrsta lijekova:
  • alopatski lijek
  • Proizveden od:
  • Krka d.d., Novo mesto, Slovenija; TAD Pharma Gmbh, Cuxhaven, Njemačka

Dokument

Lokalizacija

  • Na raspolaganju u:
  • Etoxib 30 mg filmom obložene tablete
    Hrvatska
  • Jezik:
  • hrvatski

Terapeutski informacija

  • Proizvod sažetak:
  • Pakiranje: 7 tableta u blisteru, u kutiji [HR-H-568519667-01]; 14 tableta u blisteru, u kutiji [HR-H-568519667-02]; 28 tableta u blisteru, u kutiji [HR-H-568519667-03]; 30 tableta u blisteru, u kutiji [HR-H-568519667-04]; 56 tableta u blisteru, u kutiji [HR-H-568519667-05]; 60 tableta u blisteru, u kutiji [HR-H-568519667-06]; 84 tablete u blisteru, u kutiji [HR-H-568519667-07]; 98 tableta u blisteru, u kutiji [HR-H-568519667-08]; 100 tableta u blisteru, u kutiji [HR-H-568519667-09] Urbroj: 381-12-01/30-16-04

Druge informacije

Status

  • Izvor:
  • HALMED Agencija za lijekove i medicinske proizvode - Agency for medicinal products and medical devices of Croatia
  • Broj odobrenja:
  • HR-H-568519667
  • Datum autorizacije:
  • 21-10-2016
  • Zadnje ažuriranje:
  • 04-06-2018

Uputu o lijeku

Uputa o lijeku: Informacije za bolesnika

Etoxib 30 mg filmom obložene tablete

Etoxib 60 mg filmom obložene tablete

Etoxib 90 mg filmom obložene tablete

Etoxib 120 mg filmom obložene tablete

etorikoksib

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 liječniku ili ljekarniku.

Ovaj je lijek propisan samo Vama. Nemojte ga davati drugima. Može im naškoditi, čak i ako su

njihovi znakovi bolesti jednaki Vašima.

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

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

Što se nalazi u ovoj uputi

Što je Etoxib i za što se koristi

Što morate znati prije nego počnete uzimati Etoxib

Kako uzimati Etoxib

Moguće nuspojave

Kako čuvati Etoxib

Sadržaj pakiranja i druge informacije

1.

Što je Etoxib i za što se koristi

Što je Etoxib

Etoxib sadrži djelatnu tvar etorikoksib. Etoxib je lijek iz skupine lijekova koji se zovu

selektivni inhibitori ciklooksigenaze-2 (COX-2). Oni pripadaju većoj skupini lijekova koji se

zovu nesteroidni protuupalni lijekovi (NSAIL).

Za što se Etoxib koristi?

Etoxib pomaže smanjiti bolove i oticanje (upalu) u zglobovima i mišićima u osoba u dobi od 16

godina i starijih koje imaju osteoartritis, reumatoidni artritis, ankilozantni spondilitis i giht.

Etoxib se također koristi za kratkotrajno liječenje umjereno jake boli nakon stomatološkog

kirurškog zahvata u osoba u dobi od 16 ili više godina.

Što je osteoartritis?

Osteoartritis je bolest zglobova. Nastaje zbog postupnog trošenja hrskavice koja oblaže krajeve

kostiju. To uzrokuje oticanje (upalu), bol, osjetljivost, ukočenost i tjelesnu nesposobnost.

Što je reumatoidni artritis?

Reumatoidni artritis je kronična upalna bolest zglobova. Uzrokuje bol, ukočenost, oticanje zglobova i

sve veći gubitak pokretljivosti zahvaćenih zglobova. Također može uzrokovati upalu u drugim

organima.

Što je giht?

Giht je bolest koju karakteriziraju iznenadni, ponavljajući napadaji jake boli, vrlo bolne upale i

crvenilo zglobova. Uzrokovan je odlaganjem mineralnih kristala u zglobovima.

Što je ankilozantni spondilitis?

Ankilozantni spondilitis je upalna bolest koja zahvaća kralježnicu i velike zglobove.

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2.

Što morate znati prije nego počnete uzimati Etoxib

Nemojte uzimati Etoxib:

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

ako ste alergični na nesteroidne protuupalne lijekove (NSAIL), uključujući acetilsalicilatnu

kiselinu i COX-2 inhibitore (vidjeti 'Moguće nuspojave', dio 4.)

ako imate aktivan čir na želucu ili krvarenje iz želuca ili crijeva

ako imate ozbiljnu bolest jetre

ako imate ozbiljnu bolest bubrega

ako ste trudni ili mislite da biste mogli biti trudni ili dojite (vidjeti dio 'Trudnoća, dojenje i

plodnost')

ako ste mlađi od 16 godina

ako imate upalnu bolest crijeva kao što je Crohnova bolest, ulcerozni kolitis ili kolitis

ako imate povišen krvni tlak koji nije dobro kontroliran lijekovima koje uzimate (provjerite sa

svojim liječnikom ili medicinskom sestrom ako niste sigurni je li Vaš krvni tlak dobro

kontroliran)

ako Vam je liječnik dijagnosticirao srčane tegobe, uključujući zatajenje srca (umjereni ili teški

oblik), anginu (bolovi u prsima)

ako ste imali srčani udar, operaciju na srcu radi ugradnje premosnice, bolest perifernih arterija

(loša cirkulacija u nogama ili stopalima zbog suženih ili začepljenih arterija)

ako ste imali bilo kakav oblik moždanog udara (uključujući mali moždani udar ili prolazni

ishemijski napadaj (engl.

trenzitorna ishemijska ataka,

TIA). Etorikoksib može blago povećati

rizik od srčanog i moždanog udara, stoga ga ne smiju uzimati bolesnici koji su već imali srčane

tegobe ili moždani udar.

Smatrate li da se bilo što od navedenog odnosi na Vas, nemojte uzimati ovaj lijek dok se ne

posavjetujete sa svojim liječnikom.

Upozorenja i mjere opreza

Obratite se svom liječniku ili ljekarniku prije nego uzmete Etoxib ako:

u povijesti bolesti imate krvarenje ili čir na želucu.

ste izgubili puno tekućine (ako ste dehidrirani), na primjer zbog dugotrajnog povraćanja ili

proljeva.

ste otekli zbog zadržavanja tekućine u tijelu.

u povijesti bolesti imate zatajenje srca ili bilo koju drugu bolest srca.

u povijesti bolesti imate povišen krvni tlak. Etoxib u nekih ljudi može povisiti krvni tlak,

posebno pri uzimanju visokih doza lijeka, stoga će Vam liječnik povremeno provjeravati krvni

tlak.

u povijesti bolesti imate bolesti jetre ili bubrega.

se liječite od neke infekcije. Etoxib može maskirati ili prikriti vrućicu koja je znak infekcije.

imate šećernu bolest, povišen kolesterol ili pušite. Navedeno može povećati rizik od bolesti

srca.

ste žena koja pokušava zatrudnjeti.

imate više od 65 godina.

Ako niste sigurni odnosi li se nešto od navedenog na Vas,

razgovarajte sa svojim liječnikom prije

uzimanja lijeka Etoxib

kako biste provjerili je li ovaj lijek prikladan za Vas.

Djelotvornost lijeka Etoxib slična je u starijih i mlađih odraslih bolesnika. Ako imate više od

65 godina, liječnik će Vas željeti redovito nadzirati. Nije potrebna prilagodba doze u bolesnika starijih

od 65 godina.

Djeca i adolescenti

Ovaj lijek ne smijete dati djeci i adolescentima mlađima od 16 godina.

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Drugi lijekovi i Etoxib

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

druge lijekove.

Nakon što počnete uzimati lijek Etoxib, liječnik će Vas možda željeti nadzirati kako bi provjerio

djeluju li lijekovi koje uzimate ispravno, osobito ako uzimate neki od sljedećih lijekova:

lijekove koji sprječavaju zgrušavanje krvi (antikoagulanse), kao što je varfarin

rifampicin (antibiotik)

metotreksat (lijek koji potiskuje imunološke reakcije i često se primjenjuje u liječenju

reumatoidnog artritisa)

ciklosporin ili takrolimus (lijekove koji potiskuju imunološke reakcije)

litij (lijek koji se koristi u liječenju nekih oblika depresije)

lijekove koji pomažu kontrolirati povišeni krvni tlak i zatajenje srca, a zovu se ACE inhibitori i

blokatori angiotenzinskih receptora, kao što su enalapril i ramipril te losartan i valsartan

diuretike (lijekove za mokrenje)

digoksin (lijek za liječenje zatajenja srca i nepravilnog srčanog ritma)

minoksidil (lijek za liječenje povišenog krvnog tlaka)

salbutamol u tabletama ili oralnoj otopini (lijek za astmu)

tablete za sprječavanje trudnoće (kombinacija bi mogla povećati rizik od nuspojava)

hormonsko nadomjesno liječenje (kombinacija bi mogla povećati rizik od nuspojava)

acetilsalicilatnu kiselinu, pri uzimanju acetilsalicilatne kiseline i lijeka Etoxib povećava se rizik

od nastanka čira na želucu.

acetilsalicilatna kiselina za sprječavanje srčanog ili moždanog udara:

Etoxib se može uzimati s

niskim dozama

acetilsalicilatne kiseline. Uzimate li niske doze

acetilsalicilatne kiseline za sprječavanje srčanog ili moždanog udara, ne smijete prekidati

liječenje acetilsalicilatnom kiselinom dok se ne posavjetujete sa svojim liječnikom.

acetilsalicilatna kiselina i drugi nesteroidni protuupalni lijekovi (NSAIL):

nemojte uzimati

visoke doze

acetilsalicilatne kiseline ili druge protuupalne lijekove dok

uzimate Etoxib.

Etoxib s hranom i pićem

Učinak lijeka Etoxib možda će nastupiti brže kada se uzme bez hrane.

Trudnoća, dojenje i plodnost

Trudnoća

Lijek Etoxib ne smije se uzimati tijekom trudnoće. Ako ste trudni, mislite da biste mogli biti trudni ili

planirate trudnoću, nemojte uzimati ovaj lijek. Zatrudnite li, prestanite uzimati ovaj lijek i posavjetujte

se sa svojim liječnikom. Razgovarajte sa svojim liječnikom ako niste sigurni ili trebate savjet.

Dojenje

Nije poznato izlučuje li se Etoxib u majčino mlijeko u ljudi. Dojite li ili namjeravate dojiti,

posavjetujte sa svojim liječnikom prije nego što počnete uzimati lijek Etoxib. Ako uzimate Etoxib, ne

smijete dojiti.

Plodnost

Ne preporučuje se primjena lijeka Etoxib u žena koje pokušavaju zatrudnjeti.

Upravljanje vozilima i strojevima

U nekih su bolesnika u vrijeme uzimanja lijeka Etoxib prijavljene omaglica i pospanost.

Nemojte voziti ako osjetite omaglicu ili pospanost.

Nemojte rukovati alatima niti strojevima ako osjetite omaglicu ili pospanost.

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3.

Kako uzimati Etoxib

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

ili ljekarnikom ako niste sigurni.

Nemojte uzeti više od preporučene doze za Vaše stanje. Liječnik će povremeno htjeti razgovarati o

Vašem liječenju. Važno je da uzimate najnižu dozu dovoljnu za ublažavanje boli i da lijek Etoxib ne

uzimate dulje nego što je potrebno. Naime, produljenim trajanjem liječenja može se povećati rizik od

srčanoga i moždanog udara, posebno pri uzimanju visokih doza lijeka.

Ovaj je lijek dostupan u različitim jačinama, a ovisno o Vašoj bolesti liječnik će Vam propisati jačinu

lijeka koja je prikladna za Vas.

Preporučena doza je:

Osteoartritis

Preporučena doza je 30 mg jedanput na dan, a ako je potrebno, može se povisiti do najviše doze od

60 mg jedanput na dan.

Reumatoidni artritis

Preporučena doza je 60 mg etorikoksiba jedanput na dan. Doza se može povisiti do najviše doze od

90 mg.

Ankilozantni spondilitis

Preporučena doza je 60 mg etorikoksiba jedanput na dan. Doza se može povisiti do najviše doze od

90 mg jedanput na dan, ako je potrebno.

Liječenje akutne boli

Etoricoxib se smije uzimati samo u vrijeme trajanja akutne boli.

Giht

Preporučena doza je 120 mg jedanput na dan, koja se smije uzeti samo u vrijeme trajanja akutne

boli, najduže 8 dana liječenja.

Bol nakon stomatološkog kirurškog zahvata

Preporučena doza je 90 mg jedanput na dan, najduže 3 dana liječenja.

Osobe koje imaju tegobe s jetrom

Imate li blagu bolest jetre, ne smijete uzimati više od 60 mg na dan.

Imate li

umjerenu

bolest jetre, ne smijete uzimati više od

30 mg na dan

Primjena u djece i adolescenata

Etoxib tablete ne smiju uzimati djeca ili adolescenti mlađi od 16 godina.

Starije osobe

Nije potrebno prilagođavati dozu u starijih bolesnika. Kao i kod primjene drugih lijekova, potreban je

oprez u starijih bolesnika.

Način primjene

Etoxib je namijenjen za primjenu kroz usta. Uzmite tablete jedanput na dan. Etoxib se može uzimati s

hranom ili bez nje.

Ako uzmete više Etoxib nego što ste trebali

Nikad ne smijete uzeti više tableta nego što Vam je preporučio liječnik. Uzmete li previše Etoxib

tableta, odmah potražite liječničku pomoć.

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Ako ste zaboravili uzeti Etoxib

Važno je da lijek Etoxib uvijek uzimate kako Vam je propisao Vaš liječničk. Ako ste zaboravili uzeti

lijek, sutradan samo nastavite uzimati lijek prema uobičajenom rasporedu. Nemojte uzeti dvostruku

dozu kako biste nadoknadili zaboravljenu tabletu.

U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se liječniku ili ljekarniku.

4.

Moguće nuspojave

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

Ako se u Vas pojave neki od navedenih simptoma, odmah prekinite uzimati lijek Etoxib i

razgovarajte sa svojim liječnikom (vidjeti dio 2. Što morate znati prije nego počnete uzimati

lijek Etoxib):

kratkoća daha, bolovi u prsima ili pojava oticanja gležnjeva ili pogoršanje istog

žuta boja kože ili bjeloočnice (žutica) – znakovi koji ukazuju na tegobe s jetrom

jaki ili stalni bolovi u trbuhu ili crna stolica

alergijska reakcija – koja može uključivati kožne reakcije kao što su čirevi ili plikovi, ili

oticanje lica, usana, jezika ili grla koje može uzrokovati otežano disanje

U vrijeme liječenja lijekom Etoxib zabilježene su sljedeće nuspojave:

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

bolovi u trbuhu

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

suha alveola (upala i bol nakon vađenja zuba)

oticanje nogu i/ili stopala zbog zadržavanja tekućine (edem)

omaglica, glavobolja

palpitacije (ubrzani ili nepravilni otkucaji srca), nepravilan srčani ritam (aritmija)

povišen krvni tlak

piskanje pri disanju ili kratkoća daha (bronhospazam)

zatvor, vjetrovi (prekomjerni plinovi), gastritis (upala sluznice želuca), žgaravica, proljev,

probavne smetnje (dispepsija)/nelagoda u trbuhu, mučnina, povraćanje, upala jednjaka, rane

(ulceracije) u ustima

promijenjene vrijednosti pretraga krvi koje se odnose na funkciju jetre

stvaranje modrica (krvnih podljeva)

opća slabost i umor, simptomi nalik gripi

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

gastroenteritis (upala probavnog trakta koja uključuje i želudac i tanko crijevo/želučana viroza),

infekcija gornjeg dijela dišnog sustava, infekcija mokraćnih puteva

promjene laboratorijskih vrijednosti (smanjen broj crvenih krvnih stanica, smanjen broj bijelih

krvnih stanica, smanjen broj krvnih pločica (trombocita)

preosjetljivost (alergijska reakcija uključujući koprivnjaču koja može biti ozbiljna i zahtijevati

hitno liječenje)

povećan ili smanjen tek, porast tjelesne težine

tjeskoba, depresija, smanjena mentalna oštrina; halucinacije (vidite, osjećate ili čujete stvari

koje ne postoje)

promjena osjeta okusa, nesanica, utrnulost ili trnci, pospanost

zamagljen vid, nadražene i crvene oči

zujanje u ušima, vrtoglavica (osjećaj vrtnje tijekom mirovanja)

poremećaj srčanog ritma (atrijska fibrilacija), ubrzan puls, zatajenje srca, osjećaj stezanja,

pritiska ili težine u prsnom košu (angina pektoris), srčani udar

crvenilo uz osjećaj vrućine, moždani udar, mali moždani udar (prolazni ishemijski napadaj),

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jako povišenje krvnog tlaka, upala krvnih žila

kašalj, nedostatak zraka, krvarenje iz nosa

nadutost u trbuhu ili crijevima, promjene u radu crijeva, suha usta, čir na želucu, upala sluznice

želuca koja može postati ozbiljna i prokrvariti, sindrom nadraženog crijeva, upala gušterače

oticanje lica, kožni osip ili svrbež, crvenilo kože

grčevi/stezanje mišića, bolovi/ukočenost u mišićima

povišene vrijednosti kalija u krvi, promjene u vrijednostima pretraga krvi ili mokraće koje se

odnose na funkciju bubrega, teške tegobe s bubrezima

bolovi u prsima

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

angioedem (alergijska reakcija koja uključuje oticanje lica, usana, jezika i/ili grla koje može

uzrokovati otežano disanje ili gutanje, a može biti ozbiljna i zahtijevati hitno

liječenje)/anafilaktične/anafilaktoidne reakcije uključujući šok (ozbiljna alergijska reakcija koja

zahtijeva hitno liječenje)

smetenost, nemir

tegobe s jetrom (hepatitis)

snižene vrijednosti natrija u krvi

zatajenje jetre, žuta boja kože i/ili bjeloočnica (žutica)

teške kožne reakcije

Prijavljivanje nuspojava

Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti 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 Etoxib

Lijek čuvajte izvan pogleda i dohvata djece.

Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji iza oznake EXP.

Rok valjanosti odnosi se na zadnji dan navedenog mjeseca.

Lijek ne zahtijeva posebne uvjete čuvanja.

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

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

6.

Sadržaj pakiranja i druge informacije

Što Etoxib sadrži

Djelatna tvar je etorikoksib.

Jedna filmom obložena tableta sadrži 30 mg, 60 mg, 90 mg ili 120 mg etorikoksiba.

Drugi sastojci su: mikrokristalična celuloza, bezvodni kalcijev hidrogenfosfat, umrežena

karmelozanatrij, natrijev stearilfumarat, bezvodni koloidni silicijev dioksid u jezgri tablete i

poli(vinilni alkohol), titanijev dioksid (E171), makrogol 3000, talk, žuti željezov oksid E172 (

u

tabletama od 60 mg

) i crveni željezov oksid E172 (u tabletama od

90 mg i 120 mg

) u film

ovojnici.

Kako Etoxib izgleda i sadržaj pakiranja

Etoxib filmom obložene tablete dostupne su u četiri jačine:

30 mg filmom obložene tablete su bijele ili gotovo bijele, okrugle (promjer: 6 mm), blago

bikonveksne, filmom obložene tablete s ukošenim rubovima.

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60 mg filmom obložene tablete su svijetlo smeđkasto žute, okrugle (promjer: 8 mm), bikonveksne,

filmom obložene tablete s ukošenim rubovima, s utisnutom oznakom “60” na jednoj strani tablete.

90 mg filmom obložene tablete su ružičaste, okrugle (promjer: 9 mm), bikonveksne, filmom obložene

tablete s ukošenim rubovima, s utisnutom oznakom “90” na jednoj strani tablete.

120 mg filmom obložene tablete su smeđkasto crvene, okrugle (promjer: 10 mm), blago bikonveksne,

filmom obložene tablete s ukošenim rubovima, s razdjelnim urezom na jednoj strani tablete. Razdjelni

urez nije namijenjen za lomljenje tablete.

30 mg filmom obložene tablete

Dostupne su u kutiji sa po 7, 14, 28, 30, 56, 60, 84, 98 ili 100 tableta u blisterima.

60 mg filmom obložene tablete

Dostupne su u kutiji sa po 7, 14, 20, 28, 30, 50, 56, 60, 84, 98 ili 100 tableta u blisterima.

90 mg filmom obložene tablete

Dostupne su u kutiji sa po 5, 7, 14, 20, 28, 30, 50, 56, 60, 84, 98 ili 100 tableta u blisterima.

120 mg filmom obložene tablete

Dostupne su u kutiji sa po 5, 7, 14, 20, 28, 30, 56, 60, 84, 98 ili 100 tableta u blisterima.

Na tržištu se ne moraju nalaziti sve veličine pakiranja.

Nositelj odobrenja za stavljanje lijeka u promet

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

Proizvođač

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

TAD Pharma GmbH, Heinz-Lohmann-Straße 5

,

27472 Cuxhaven

,

Njemačka

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

slijedećim nazivima:

Država

Naziv lijeka

Mađarska, Bugarska, Češka

Republika, Poljska,

Rumunjska, Slovačka, Slovenija

Roticox

Belgija, Danska, Finska, Irska,

Island, Norveška, Portugal,

Španjolska, Švedska,

Ujedinjeno Kraljevstvo

Etoricoxib Krka

Hrvatska, Estonija

Etoxib

Njemačka

Etoriax

Litva, Latvija

Bericox

Način i mjesto izdavanja lijeka

Lijek se izdaje na recept, u ljekarni.

Ova uputa je zadnji puta revidirana u listopadu 2016.

H A L M E D

21-10-2016

O D O B R E N O

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

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