Inegy 10 mg 80 mg tablete

Glavna informacija

  • Trgovački naziv:
  • Inegy 10 mg/80 mg tablete
  • Doziranje:
  • 10 mg + 80 mg
  • Farmaceutski oblik:
  • tableta
  • Sastav:
  • Urbroj: jedna tableta sadrži 10 mg ezetimiba i 80 mg simvastatina
  • Tip recepta:
  • na recept, u ljekarni ponovljivi recept
  • Koristi za:
  • Ljudi
  • Vrsta lijekova:
  • alopatski lijek
  • Proizveden od:
  • Merck Sharp & Dohme B.V., Haarlem, Nizozemska

Dokument

Lokalizacija

  • Na raspolaganju u:
  • Inegy 10 mg/80 mg tablete
    Hrvatska
  • Jezik:
  • hrvatski

Terapeutski informacija

  • Proizvod sažetak:
  • Pakiranje: 28 tableta u blisteru, u kutiji [HR-H-988367136-01] Urbroj: 381-12-01/14-17-03

Druge informacije

Status

  • Izvor:
  • HALMED Agencija za lijekove i medicinske proizvode - Agency for medicinal products and medical devices of Croatia
  • Broj odobrenja:
  • HR-H-988367136
  • Datum autorizacije:
  • 28-04-2017
  • Zadnje ažuriranje:
  • 04-06-2018

Uputu o lijeku

Uputa o lijeku: Informacije za bolesnika

INEGY 10 mg/10 mg tablete

INEGY 10 mg/20 mg tablete

INEGY 10 mg/40 mg tablete

INEGY 10 mg/80 mg tablete

ezetimib/simvastatin

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 INEGY i za što se koristi?

Što morate znati prije nego počnete uzimati INEGY?

Kako uzimati INEGY?

Moguće nuspojave

Kako čuvati INEGY?

Sadržaj pakiranja i druge informacije

1.

Što je INEGY i za što se koristi?

INEGY sadrži djelatne tvari ezetimib i simvastatin. INEGY je lijek koji snižava razinu ukupnog

kolesterola, "štetnog" kolesterola (LDL kolesterol) i masnih tvari zvanih trigliceridi u krvi. INEGY

takoĎer povisuje vrijednosti "korisnog" kolesterola (HDL kolesterol).

INEGY snižava razinu kolesterola na dva načina. Djelatna tvar ezetimib smanjuje apsorpciju

kolesterola u probavnom traktu. Djelatna tvar simvastatin pripada klasi "statina" i inhibira

proizvodnju kolesterola koji tijelo stvara samo.

Kolesterol je jedna od nekoliko masnih tvari koje se nalaze u krvotoku. Vaš ukupni kolesterol sastoji

se uglavnom od LDL i HDL kolesterola.

LDL kolesterol često se naziva "štetnim" kolesterolom zato što se može nakupljati u stijenkama

arterija i stvarati plak. Nakupljeni plak naposlijetku može dovesti do suženja arterija. Suženje arterija

može usporiti ili prekinuti protok krvi do vitalnih organa, kao što su srce i mozak. Takav prekid

protoka krvi može rezultirati srčanim ili moždanim udarom.

HDL kolesterol često se naziva "korisnim" kolesterolom, zato što pomaže u sprječavanju nakupljanja

štetnog kolesterola u arterijama i štiti od srčane bolesti.

Trigliceridi su još jedan oblik masti u krvi koji mogu povećati Vaš rizik od srčane bolesti.

INEGY je namijenjen bolesnicima koji ne mogu regulirati razinu kolesterola samo dijetom. Za

vrijeme uzimanja ovog lijeka nužno je da nastavite s dijetom za snižavanje kolesterola.

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O D O B R E N O

INEGY se uzima kao dodatak dijeti za snižavanje kolesterola ako imate:

povišene vrijednosti kolesterola u krvi (primarna hiperkolesterolemija [heterozigotna obiteljska i

nenasljedna]) ili povišene vrijednosti masnoća u krvi (miješana hiperlipidemija):

koje nisu dobro kontrolirane samim statinom,

koje su već liječene statinom i ezetimibom u odvojenim tabletama.

nasljednu bolest (homozigotnu obiteljsku hiperkolesterolemiju) koja povisuje vrijednosti

kolesterola u Vašoj krvi. Možda ćete primati i drugi oblik liječenja.

bolest srca, INEGY smanjuje rizik od srčanog udara, moždanog udara, kirurškog zahvata za

poboljšanje srčanog krvotoka ili hospitalizacije zbog boli u prsištu.

INEGY Vam ne pomaže u smanjivanju tjelesne težine.

2.

Što morate znati prije nego počnete uzimati INEGY?

Nemojte uzimati INEGY:

ako ste alergični na ezetimib, simvastatin ili neki drugi sastojak ovog lijeka (naveden u

dijelu 6.),

ako trenutno imate tegobe s jetrom,

ako ste trudni ili dojite,

ako uzimate lijek (lijekove) s jednom ili više sljedećih djelatnih tvari:

itrakonazol, ketokonazol, posakonazol ili vorikonazol (primjenjuju se za liječenje

gljivičnih infekcija),

eritromicin, klaritromicin ili telitromicin (primjenjuju se za liječenje infekcija),

inhibitore HIV proteaze kao što su indinavir, nelfinavir, ritonavir i sakvinavir

(inhibitori HIV proteaze primjenjuju se za liječenje HIV infekcije),

boceprevir ili telaprevir (primjenjuju se za liječenje infekcija virusom hepatitisa C),

nefazodon (primjenjuje se za liječenje depresije),

kobicistat,

gemfibrozil (primjenjuje se za snižavanje vrijednosti kolesterola),

ciklosporin (često ga uzimaju bolesnici s presaĎenim organom),

danazol (sintetski hormon za liječenje endometrioze, stanja kod kojeg sluznica

maternice raste izvan maternice).

ako uzimate ili ste u proteklih 7 dana uzeli lijek koji se zove fusidatna kiselina (lijek za

liječenje bakterijske infekcije) kroz usta ili primijenjeno injekcijom. Kombinacija fusidatne

kiseline i lijeka INEGY može dovesti do ozbiljnih problema s mišićima (rabdomioliza).

Nemojte uzimati INEGY u dozi višoj od 10/40 mg na dan ako uzimate lomitapid (primjenjuje se za

liječenje ozbiljne i rijetke nasljedne bolesti kolesterola).

Ako niste sigurni uzimate li koji od gore navedenih lijekova, upitajte Vašeg liječnika.

Upozorenja i mjere opreza

Obavijestite Vašeg liječnika:

o svim zdravstvenim poteškoćama koje imate uključujući alergije,

ako pijete znatne količine alkohola ili ste imali bolest jetre. INEGY možda i nije odgovarajući

lijek za Vas,

ako planirate operativni zahvat. Možda ćete nakratko trebati prekinuti uzimanje lijeka INEGY,

ako ste azijskog porijekla, jer bi za Vas mogle vrijediti drugačije doze.

Prije uzimanja lijeka INEGY Vaš liječnik treba napraviti krvne pretrage te, ako imate simptome

tegoba s jetrom, i za vrijeme uzimanja lijeka INEGY. Na ovaj način će provjeriti kako radi Vaša jetra.

Vaš će liječnik možda ponoviti krvne pretrage nakon što počnete uzimati INEGY kako bi provjerio

kako radi Vaša jetra.

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Ako imate šećernu bolest ili rizik od razvoja šećerne bolesti, Vaš liječnik će Vas pažljivo nadzirati

dok uzimate ovaj lijek. Ako imate visoke razine šećera i masnoća u krvi, prekomjernu tjelesnu težinu i

visok krvni tlak, vjerojatno ste pod rizikom od razvoja šećerne bolesti.

Obavijestite Vašeg liječnika ako imate tešku bolest pluća.

Kombinirana primjena lijeka INEGY i fibrata (odreĎeni lijekovi za snižavanje kolesterola) mora se

izbjegavati, jer kombinirana primjena lijeka INEGY i fibrata nije ispitana.

Osjetite li bol, osjetljivost ili slabost u mišićima nepoznatog uzroka, odmah se obratite Vašem

liječniku. Tegobe s mišićima u rijetkim slučajevima mogu postati ozbiljne te mogu uzrokovati i

razgradnju mišićnog tkiva s posljedičnim oštećenjem bubrega; a vrlo rijetko su bili zabilježeni i

smrtni ishodi.

Rizik od razgradnje mišićnog tkiva povećava se povišenjem doze lijeka INEGY osobito pri primjeni

doze od 10/80 mg, a povećan rizik postoji i u odreĎenih bolesnika. Obavijestite Vašeg liječnika ako se

nešto od navedenog odnosi na Vas:

imate tegobe s bubrezima,

imate tegobe sa štitnjačom,

imate 65 ili više godina,

ženskog ste spola,

imali ste tegobe s mišićima tijekom liječenja drugim lijekovima za snižavanje kolesterola koji se

zovu "statini" (kao što su simvastatin, atorvastatin i rozuvastatin) ili fibrati (kao što su gemfibrozil

i bezafibrat),

Vi ili član Vaše uže obitelji imate nasljedni mišićni poremećaj.

TakoĎer obavijestite Vašeg liječnika ili ljekarnika ako imate konstantnu mišićnu slabost. Možda će

biti potrebni dodatni testovi i lijekovi kako bi se to dijagnosticiralo i liječilo.

Djeca i adolescenti

INEGY se ne preporučuje u djece mlaĎe od 10 godina.

Drugi lijekovi i INEGY

Posebno je važno da obavijestite Vašeg liječnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti

neki od niže navedenih lijekova s nekom od sljedećih djelatnih tvari. Uzimanje lijeka INEGY s bilo

kojim od tih lijekova može povećati rizik od tegoba s mišićima (neki od ovih lijekova već su

spomenuti u dijelu "Nemojte uzimati INEGY"):

ako morate uzeti fusidatnu kiselinu kroz usta zbog liječenja bakterijske infekcije morat

ćete privremeno prekinuti primjenu ovog lijeka. Vaš liječnik će Vam reći kada je

sigurno ponovno započeti uzimati INEGY. Uzimanje lijeka INEGY s fusidatnom

kiselinom može u rijetkim slučajevima dovesti do slabosti, osjetljivosti ili boli u

mišićima (rabdomioliza). Vidjeti dio 4. za više informacija o rabdomiolizi.

ciklosporin (često ga uzimaju bolesnici s presaĎenim organom),

danazol (sintetski hormon za liječenje endometrioze, stanja kod kojeg sluznica maternice

raste izvan maternice),

lijekovi s djelatnom tvari kao što je itrakonazol, ketokonazol, flukonazol, posakonazol ili

vorikonazol (primjenjuju se za liječenje gljivičnih infekcija),

fibrati s djelatnim tvarima kao što su gemfibrozil i bezafibrat (primjenjuju se za snižavanje

kolesterola),

eritromicin, klaritromicin ili telitromicin (primjenjuju se za liječenje bakterijskih infekcija),

inhibitori HIV proteaze kao što su indinavir, nelfinavir, ritonavir i sakvinavir (primjenjuju se

za liječenje HIV infekcije),

protuvirusni lijekovi za liječenje hepatitisa C, kao što su boceprevir, telaprevir, elbasvir ili

grazoprevir (primjenjuju se za liječenje infekcije virusom hepatitisa C),

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nefazodon (primjenjuje se za liječenje depresije),

lijekovi koji sadrže djelatnu tvar kobicistat,

amiodaron (primjenjuje se za liječenje nepravilnih otkucaja srca),

verapamil, diltiazem ili amlodipin (primjenjuju se za liječenje visokog krvnog tlaka, boli u

prsima povezane s bolešću srca ili drugih srčanih tegoba),

lomitapid (primjenjuje se za liječenje ozbiljnog i rijetkog nasljednog poremećaja kolesterola),

visoke doze (1 g ili više svaki dan) niacina ili nikotinatne kiseline (primjenjuju se za

snižavanje kolesterola),

kolhicin (primjenjuje se za liječenje gihta).

Osim o spomenutim lijekovima obavijestite Vašeg liječnika ili ljekarnika ako uzimate, nedavno ste

uzeli ili biste mogli uzeti bilo koje druge lijekove. Posebno je važno da obavijestite Vašeg liječnika

ako uzimate:

lijekove s djelatnom tvari koja sprječava zgrušavanje krvi kao što su varfarin, fluindion,

fenprokumon ili acenokumarol (antikoagulansi),

kolestiramin (takoĎer se primjenjuje za snižavanje kolesterola), jer on mijenja učinak lijeka

INEGY,

fenofibrat (takoĎer se primjenjuje za snižavanje kolesterola),

rifampicin (primjenjuje se za liječenje tuberkuloze).

TakoĎer, svakom liječniku koji Vam propisuje novi lijek morate reći da uzimate INEGY.

INEGY s hranom i pićem

Sok od grejpa sadrži jedan ili više sastojaka koji utječu na metabolizam nekih lijekova, uključujući i

INEGY. Trebate izbjegavati uzimanje soka od grejpa, jer on može povećati rizik za razvoj mišićnih

tegoba.

Trudnoća i dojenje

Nemojte uzimati INEGY ako ste trudni, mislite da biste mogli biti trudni ili planirate trudnoću.

Zatrudnite li dok uzimate INEGY, odmah ga prestanite uzimati i obavijestite Vašeg liječnika.

Nemojte uzimati INEGY ako dojite, jer nije poznato izlučuje li se lijek u majčino mlijeko.

Obratite se Vašem liječniku ili ljekarniku za savjet prije nego uzmete bilo koji lijek.

Upravljanje vozilima i strojevima

INEGY ne bi trebao utjecati na Vašu sposobnost upravljanja vozilima ili rada sa strojevima. Ipak,

vodite računa o tome da je nakon uzimanja lijeka INEGY u nekih osoba bila prijavljena omaglica.

INEGY sadrži laktozu

INEGY tablete sadrže šećer koji se zove laktoza. Ako Vam je liječnik rekao da ne podnosite neke

vrste šećera, savjetujte se s liječnikom prije uzimanja ovog lijeka.

3.

Kako uzimati INEGY?

Vaš će liječnik odrediti koja je odgovarajuća doza lijeka za Vas, ovisno o Vašem trenutnom liječenju

i osobnom riziku.

Tablete nemaju razdjelni urez i ne smiju se lomiti.

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

liječnikom ili ljekarnikom ako niste sigurni.

Prije nego započnete liječenje lijekom INEGY, morate biti na odgovarajućoj dijeti za

snižavanje kolesterola.

U vrijeme liječenja INEGY tabletama nužno je nastaviti s dijetom za snižavanje kolesterola.

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Odrasli: Doza lijeka je 1 INEGY tableta jedanput na dan, kroz usta.

Primjena u adolescenata (u dobi od 10 do 17 godina): Doza lijeka je 1 INEGY tableta jedanput na

dan, kroz usta (ne smije se prekoračiti maksimalna doza od 10 mg/40 mg jedanput na dan).

Doza lijeka INEGY od 10 mg/80 mg preporučuje se samo odraslim bolesnicima s vrlo visokim

vrijednostima kolesterola i s visokim rizikom za razvoj bolesti srca, koji nisu postigli ciljnu vrijednost

kolesterola uzimajući niže doze.

INEGY uzimajte navečer. Možete ga uzimati s hranom ili bez nje.

Ako Vam je liječnik propisao INEGY zajedno s drugim lijekom za snižavanje kolesterola koji sadrži

djelatnu tvar kolestiramin ili neki drugi sekvestrant žučnih kiselina, INEGY morate uzimati najmanje

2 sata prije ili 4 sata nakon uzimanja sekvestranta žučnih kiselina.

Ako uzmete više INEGY tableta nego što ste trebali

Molimo Vas obratite se Vašem liječniku ili ljekarniku.

Ako ste zaboravili uzeti INEGY

Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu dozu, samo sutradan uzmite

uobičajenu dozu lijeka INEGY prema uobičajenom rasporedu.

Ako prestanete uzimati INEGY

Obratite se Vašem liječniku ili ljekarniku, jer Vam se vrijednost kolesterola opet može povisiti.

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

ljekarniku.

4.

Moguće nuspojave

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

dio 2. Što morate znati prije nego počnete uzimati INEGY).

Prijavljene su sljedeće česte nuspojave (mogu se javiti u do 1 na 10 osoba):

bolovi u mišićima,

povišene vrijednosti laboratorijskih krvnih pretraga jetrenih proba (transaminaze) i/ili mišićne

funkcije (kreatin kinaza).

Prijavljene su sljedeće manje česte nuspojave (mogu se javiti u do 1 na 100 osoba):

povišene vrijednosti krvnih pretraga funkcije jetre; povišene vrijednosti mokraćne kiseline u

krvi; produljeno vrijeme zgrušavanja krvi; proteini u mokraći; smanjenje tjelesne težine,

omaglica; glavobolja; trnci,

bol u trbuhu; probavne smetnje; vjetrovi; mučnina; povraćanje; nadutost trbuha; proljev; suha

usta; žgaravica,

osip; svrbež; koprivnjača,

bol u zglobovima; bol, osjetljivost, slabost ili grčevi u mišićima; bol u vratu; bol u rukama i

nogama; bol u leĎima,

neuobičajeni umor ili slabost; osjećaj umora; bol u prsima; oticanje, osobito šaka i stopala,

poremećaj spavanja; poteškoće sa spavanjem.

Sljedeće nuspojave takoĎer su prijavljene u osoba koje uzimaju tablete INEGY ili lijekove koji sadrže

djelatne tvari ezetimib ili simvastatin:

smanjen broj crvenih krvnih stanica (anemija); smanjen broj krvnih stanica, što može

uzrokovati stvaranje modrica/krvarenje (trombocitopenija),

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utrnulost ili slabost ruku i nogu; slabo pamćenje, gubitak pamćenja, smetenost,

poteškoće s disanjem uključujući uporan kašalj i/ili nedostatak zraka ili vrućicu,

zatvor,

upala gušterače često praćena jakim bolovima u trbuhu,

upala jetre sa sljedećim simptomima: žućkasta boja kože i bjeloočnica; svrbež, tamna boja

mokraće ili jako svijetla boja stolice, umor ili slabost, gubitak apetita; zatajenje jetre; žučni

kamenci ili upala žučnog mjehura (koja može uzrokovati bol u trbuhu, mučninu i povraćanje),

gubitak kose; odignuti crveni osip, ponekad u obliku mete (multiformni eritem),

reakcije preosjetljivosti uključujući sljedeće: alergijske reakcije uključujući oticanje lica,

usana, jezika i/ili grla, što može uzrokovati otežano disanje ili gutanje i zahtijeva hitno

liječenje, bol ili upala zglobova, upala krvnih žila, neuobičajeno stvaranje modrica, burne

kožne reakcije i oticanje, koprivnjača, osjetljivost kože na sunce, vrućica, crvenilo uz osjećaj

vrućine, nedostatak zraka i loše osjećanje, simptomi bolesti slične lupusu (uključujući osip,

tegobe sa zglobovima i promjene na bijelim krvnim stanicama),

bol, osjetljivost, slabost ili grčevi u mišićima; razgradnja mišićnog tkiva; tegobe s tetivama,

ponekad komplicirane rupturom tetive,

smanjen tek,

navale vrućine; visoki krvni tlak,

bol,

poremećaj erektilne funkcije,

depresija,

promjene nekih laboratorijskih krvnih pretraga funkcije jetre.

Dodatne moguće nuspojave prijavljene kod primjene nekih statina:

poremećaj spavanja, uključujući noćne more,

poremećaji spolne funkcije,

šećerna bolest. Vjerojatnost šećerne bolesti veća je ako imate povišene razine šećera i masti u

krvi, prekomjernu tjelesnu težinu i visok krvni tlak. Vaš će Vas liječnik nadzirati dok uzimate

ovaj lijek,

bol, osjetljivost ili slabost mišića koja je konstantna i ne prestaje nakon prestanka primjene

lijeka INEGY (nepoznata učestalost).

Osjetite li bol, osjetljivost ili slabost u mišićima nepoznatog uzroka, odmah se obratite Vašem

liječniku. Tegobe s mišićima u rijetkim slučajevima mogu postati ozbiljne te mogu uzrokovati i

razgradnju mišićnog tkiva s posljedičnim oštećenjem bubrega; a vrlo rijetko su bili zabilježeni i

smrtni ishodi.

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 INEGY?

Ovaj lijek čuvajte izvan pogleda i dohvata djece.

Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji ili blisteru iza

oznake "EXP".

Ne čuvati na temperaturi iznad 30°C.

Čuvati u originalnom pakiranju radi zaštite od vlage i svjetlosti.

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O D O B R E N O

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 INEGY sadrži?

Djelatne tvari su ezetimib i simvastatin. Jedna tableta sadrži 10 mg ezetimiba i 10 mg, 20 mg, 40 mg

ili 80 mg simvastatina.

Drugi sastojci su: butilhidroksianizol, citratna kiselina hidrat, umrežena karmelozanatrij, hipromeloza,

laktoza hidrat, magnezijev stearat, mikrokristalična celuloza i propilgalat.

Kako INEGY izgleda i sadržaj pakiranja?

INEGY tablete su bijele do bjelkaste tablete, u obliku kapsule.

INEGY 10 mg/10 mg tablete: “311” utisnuto na jednoj strani, dimenzija tablete 8,5 mm x 4,2 mm.

INEGY 10 mg/20 mg tablete: “312” utisnuto na jednoj strani, dimenzija tablete 10,7 mm x 5,3 mm.

INEGY 10 mg/40 mg tablete: “313” utisnuto na jednoj strani, dimenzija tablete 13,9 mm x 6,0 mm.

INEGY 10 mg/80 mg tablete: “315” utisnuto na jednoj strani, dimenzija tablete 17,5 mm x 7,5 mm.

Tablete nemaju razdjelni urez i ne smiju se lomiti.

INEGY je dostupan u blister pakiranju sa 28 tableta, u kutiji.

Nositelj odobrenja za stavljanje lijeka u promet

Merck Sharp & Dohme d.o.o.

Ivana Lučića 2a, 10 000 Zagreb

Proizvođač

Merck Sharp & Dohme B. V.

Waarderweg 39, Postbus 581, 2003 PC Haarlem

Nizozemska

Način i mjesto izdavanja lijeka

Lijek se izdaje na recept, u ljekarni.

Ova uputa je posljednji put revidirana u ožujku 2018.

H A L M E D

08 - 03 - 2018

O D O B R E N O

24-10-2018

Vita Health Products Recall (2018-10-24)

Vita Health Products Recall (2018-10-24)

Health Canada

18-10-2018

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

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

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

Health Canada

18-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Pest categorisation of Stagonosporopsis andigena

Pest categorisation of Stagonosporopsis andigena

Published on: Tue, 16 Oct 2018 00:00:00 +0200 The Panel on Plant Health performed a pest categorisation of Stagonosporopsis andigena, the causal agent of black blight of potato, for the EU. The pest is a well‐defined fungal species and reliable methods exist for its detection and identification. S. andigena is present in Bolivia and Peru. The pest is not known to occur in the EU and is listed in Annex IAI of Directive 2000/29/EC as Phoma andina, meaning its introduction into the EU is prohibited. The ma...

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Lumpy skin disease: scientific and technical assistance on control and surveillance activities

Lumpy skin disease: scientific and technical assistance on control and surveillance activities

Published on: Tue, 16 Oct 2018 00:00:00 +0200 The duration of the vaccination campaign sufficient to eliminate lumpy skin disease (LSD) mainly depends on the vaccination effectiveness and coverage achieved. By using a spread epidemiological model, assuming a vaccination effectiveness of 65%, with 50% and 90% coverage, 3 and 4 years campaigns, respectively, are needed to eliminate LSD. When vaccination effectiveness is 80% to 95%, 2 years of vaccination at coverage of 90% is sufficient to eliminate LSD vir...

Europe - EFSA - European Food Safety Authority Publications

11-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

11-10-2018

Wild boar in focus: Review of existing models on spatial distribution and density of wild boar and proposal for next steps

Wild boar in focus: Review of existing models on spatial distribution and density of wild boar and proposal for next steps

Published on: Wed, 10 Oct 2018 00:00:00 +0200 This report provides a review of existing models for predicting the spatial distribution and abundance of wild boar at various scales (global, continental, national and regional) in order to inform the development of a new model to produce estimates of wild boar abundance at European level. The review identifies and discusses a range of models based on a wide variety of data types, corresponding to those targeted by the data collection model set by ENETwild,...

Europe - EFSA - European Food Safety Authority Publications

10-10-2018

Sprayology Issues Voluntary Nationwide Recall of Homeopathic Aqueous-Based Medicines Due to Microbial Contamination

Sprayology Issues Voluntary Nationwide Recall of Homeopathic Aqueous-Based Medicines Due to Microbial Contamination

Eight and Company LLC, d/b/a Sprayology is voluntarily recalling all lots within expiry from 10/18-7/22 of its aqueous-based homeopathic product line for human use. All products manufactured by the contract manufacturer, King Bio, have been recalled due to possible microbial contamination.

FDA - U.S. Food and Drug Administration

10-10-2018

Enforcement Report for the Week of October 10, 2018

Enforcement Report for the Week of October 10, 2018

Recently Updated Records for the Week of October 10, 2018 Last Modified Date: Tuesday, October 09, 2018

FDA - U.S. Food and Drug Administration

24-9-2018

FDA Announces Availability of Resources for Animal Drug Sponsors

FDA Announces Availability of Resources for Animal Drug Sponsors

The FDA is making available two pre-recorded webinars and a slide presentation to help drug sponsors understand recent changes to the submission process for new animal drug applications and related submissions. The changes take effect 10/1/2018.

FDA - U.S. Food and Drug Administration

19-9-2018

National dietary survey in 2012‐2016 on the general population aged 1‐79 years in the Netherlands

National dietary survey in 2012‐2016 on the general population aged 1‐79 years in the Netherlands

Published on: Tue, 18 Sep 2018 00:00:00 +0200 During the years 2012‐2016, the Dutch National Food Consumption survey was conducted in the Netherlands. For the survey, a random sample was drawn from consumer panels stratified by age and gender and maintained representative to the population with regard to region, address density and educational level. Complete results were obtained for 4,313 persons (response rate 65%); including toddlers, children, adolescents, adults and elderly. Pregnant or lactating ...

Europe - EFSA - European Food Safety Authority Publications

13-9-2018

October 10, 2018: Meeting of the Oncologic Drugs Advisory Committee

October 10, 2018: Meeting of the Oncologic Drugs Advisory Committee

October 10, 2018: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement

FDA - U.S. Food and Drug Administration

11-9-2018

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

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

Published on: Mon, 10 Sep 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Belgium and co‐rapporteur Member State Greece for the pesticide active substance alpha‐cypermethrin are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Update of the Xylella spp. host plant database

Update of the Xylella spp. host plant database

Published on: Mon, 10 Sep 2018 00:00:00 +0200 Following a request from the European Commission, EFSA periodically updates the database on the host plants of Xylella spp. While previous editions of the database (2015 and 2016) dealt with the species Xylella fastidiosa only, this database version addresses the whole genus Xylella, including therefore both species X. fastidiosa and Xylella taiwanensis. The database now includes information on host plants of Xylella spp. retrieved from scientific literature...

Europe - EFSA - European Food Safety Authority Publications

10-9-2018

USDA and FDA announce joint public meeting on use of animal cell culture technology to develop products derived from livestock and poultry

USDA and FDA announce joint public meeting on use of animal cell culture technology to develop products derived from livestock and poultry

WASHINGTON, Sept. 10, 2018 – U.S. Secretary of Agriculture Sonny Perdue, DVM and U.S. Food and Drug Administration Commissioner Scott Gottlieb, M.D. today announced a joint public meeting to be held on Oct. 23-24, 2018 to discuss the use of cell culture technology to develop products derived from livestock and poultry.

FDA - U.S. Food and Drug Administration

7-9-2018

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

Camber Pharmaceuticals, Inc. is voluntarily recalling one single lot of Montelukast Sodium Tablets, USP 10mg, to the consumer level. This recall of one batch of Montelukast Sodium Tablets, USP 10mg, lot# MON17384 Exp. 12/31/2019, was prompted because a complaint of a sealed bottle labeled as Montelukast 10mg 30 ct found to contain 90 tablets of Losartan Potassium Tablets, USP 50mg

FDA - U.S. Food and Drug Administration

1-9-2018

Spodoptera frugiperda partial risk assessment

Spodoptera frugiperda partial risk assessment

Published on: Fri, 31 Aug 2018 00:00:00 +0200 EFSA was asked for a partial risk assessment of Spodoptera frugiperda for the territory of the EU focussing on the main pathways for entry, factors affecting establishment, risk reduction options and pest management. As a polyphagous pest, five commodity pathways were examined in detail. Aggregating across these and other pathways, we estimate that tens of thousands to over a million individual larvae could enter the EU annually on host commodities. Instigat...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Outcome of the public consultation on a draft protocol for the Scientific Opinion on dietary sugars

Outcome of the public consultation on a draft protocol for the Scientific Opinion on dietary sugars

Published on: Fri, 10 Aug 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) carried out a public consultation to receive input from the scientific community and all interested parties on a draft protocol for the Scientific Opinion on free sugars from all dietary sources, prepared by the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA Panel), supported by the ad‐hoc Working Group on Sugars. The draft protocol was endorsed by the Panel for public consultation at its plenary meeti...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Safety assessment of the process ‘General Plastic’, based on Starlinger Decon technology, used to recycle post‐consumer PET into food contact materials

Safety assessment of the process ‘General Plastic’, based on Starlinger Decon technology, used to recycle post‐consumer PET into food contact materials

Published on: Fri, 10 Aug 2018 00:00:00 +0200 This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety evaluation of the recycling process General Plastic (EU register No RECYC153), which is based on the Starlinger Decon technology. The decontamination efficiency of the process was demonstrated by a challenge test. The input of this process is hot caustic washed and dried poly(ethylene terephthalate) (PET) flakes orig...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Protocol for the scientific opinion on the Tolerable Upper Intake Level of dietary sugars

Protocol for the scientific opinion on the Tolerable Upper Intake Level of dietary sugars

Published on: Fri, 10 Aug 2018 00:00:00 +0200 In June 2016, EFSA received a mandate from the national food competent authorities of five European countries (Denmark, Finland, Iceland, Norway and Sweden) to provide a dietary reference value (DRV) for sugars, with particular attention to added sugars. A draft protocol was developed with the aim of defining as much as possible beforehand the strategy that will be applied for collecting data, appraising the relevant evidence, and analysing and integrating t...

Europe - EFSA - European Food Safety Authority Publications

22-8-2018

Radagast Pet Food Voluntarily Expands Recall to Include Rad Cat Raw Diet Products With Best By Dates of 10/19/18 Through 12/3/19 Due to Potential Health Risk

Radagast Pet Food Voluntarily Expands Recall to Include Rad Cat Raw Diet Products With Best By Dates of 10/19/18 Through 12/3/19 Due to Potential Health Risk

Radagast Pet Food, Inc. of Portland, OR is expanding its voluntary recall to include an additional quantity of Rad Cat Raw Diet across all varieties with Best By dates of 10/19/18 through 12/3/19 because it has the potential to be contaminated with Listeria monocytogenes. Radagast Pet Food is conducting this voluntary recall out of an abundance of caution because of its strong commitment to food safety and quality.

FDA - U.S. Food and Drug Administration

10-8-2018

Enforcement Report for the Week of July 25, 2018

Enforcement Report for the Week of July 25, 2018

Recently Updated Records for the Week of July 25, 2018 Last Modified Date: Friday, August 10, 2018

FDA - U.S. Food and Drug Administration

9-8-2018

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mg Due to The Detection of Trace Amounts of N-Nitrosodimethylamine (NDMA) Impurity, Found in an Active Pharmaceutical Ingredient (API)

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mg Due to The Detection of Trace Amounts of N-Nitrosodimethylamine (NDMA) Impurity, Found in an Active Pharmaceutical Ingredient (API)

As a precautionary measure, Camber Pharmaceuticals, Inc. is voluntarily recalling all unexpired lots of Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mg to the hospital, retail and consumer level. This recall of multiple batches of Valsartan Tablets was prompted due to the detection of trace amounts of N-Nitrosodimethylamine (NDMA), a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, Unit – I (API manufacturer).

FDA - U.S. Food and Drug Administration

12-11-2018

Spinraza (Biogen Netherlands B.V.)

Spinraza (Biogen Netherlands B.V.)

Spinraza (Active substance: nusinersen) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7550 of Mon, 12 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4312/T/10

Europe -DG Health and Food Safety

23-10-2018

EU/3/16/1804 (Eli Lilly Nederland B.V.)

EU/3/16/1804 (Eli Lilly Nederland B.V.)

EU/3/16/1804 (Active substance: Pegylated recombinant human interleukin-10) - Transfer of orphan designation - Commission Decision (2018)6994 of Tue, 23 Oct 2018

Europe -DG Health and Food Safety

22-10-2018

EU/3/10/815 (Pfizer Europe MA EEIG)

EU/3/10/815 (Pfizer Europe MA EEIG)

EU/3/10/815 (Active substance: Sildenafil citrate) - Transfer of orphan designation - Commission Decision (2018)6993 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/068/10/T/01

Europe -DG Health and Food Safety

19-10-2018

Recocam (Bimeda Animal Health Limited)

Recocam (Bimeda Animal Health Limited)

Recocam (Active substance: Meloxicam) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6954 of Fri, 19 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2247/T/10

Europe -DG Health and Food Safety

26-9-2018

Kexxtone (Elanco GmbH)

Kexxtone (Elanco GmbH)

Kexxtone (Active substance: Monensin sodium) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6324 of Wed, 26 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2235/T/10

Europe -DG Health and Food Safety

19-9-2018

Lartruvo (Eli Lilly Nederland B.V.)

Lartruvo (Eli Lilly Nederland B.V.)

Lartruvo (Active substance: olaratumab) - Centralised - Annual renewal - Commission Decision (2018)6105 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4216/R/10

Europe -DG Health and Food Safety

19-9-2018

Pregabalin Mylan (Mylan S.A.S.)

Pregabalin Mylan (Mylan S.A.S.)

Pregabalin Mylan (Active substance: pregabalin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 5971 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4078/T/10

Europe -DG Health and Food Safety

10-9-2018

Akynzeo (Helsinn Birex Pharmaceuticals Ltd)

Akynzeo (Helsinn Birex Pharmaceuticals Ltd)

Akynzeo (Active substance: netupitant / palonosetron) - Centralised - Yearly update - Commission Decision (2018)5947 of Mon, 10 Sep 2018

Europe -DG Health and Food Safety

10-9-2018

Alkindi (Diurnal Limited)

Alkindi (Diurnal Limited)

Alkindi (Active substance: hydrocortisone) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5945 of Mon, 10 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4416/T/03

Europe -DG Health and Food Safety

10-9-2018

Retacrit (Hospira UK Limited)

Retacrit (Hospira UK Limited)

Retacrit (Active substance: epoetin zeta) - Centralised - Yearly update - Commission Decision (2018)5946 of Mon, 10 Sep 2018

Europe -DG Health and Food Safety

10-9-2018

Silapo (STADA Arzneimittel AG)

Silapo (STADA Arzneimittel AG)

Silapo (Active substance: epoetin zeta) - Centralised - Yearly update - Commission Decision (2018)5944 of Mon, 10 Sep 2018

Europe -DG Health and Food Safety

4-9-2018

ACM meeting statement, Meeting 10, 2 August 2018

ACM meeting statement, Meeting 10, 2 August 2018

The Advisory Committee on Medicines meeting statement is now available

Therapeutic Goods Administration - Australia

22-8-2018

BTVPUR (Merial)

BTVPUR (Merial)

BTVPUR (Active substance: Bluetongue virus vaccine (inactivated) (multistrain: 1-2 strains out of a set of 4)) - Centralised - 2-Monthly update - Commission Decision (2018)5630 of Wed, 22 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2231/II/10

Europe -DG Health and Food Safety

10-8-2018

Torisel (Pfizer Europe MA EEIG)

Torisel (Pfizer Europe MA EEIG)

Torisel (Active substance: Temsirolimus) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5521 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/799/T/71

Europe -DG Health and Food Safety

10-8-2018

Brinavess (Correvio)

Brinavess (Correvio)

Brinavess (Active substance: vernakalant hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5523 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1215/T/31

Europe -DG Health and Food Safety

10-8-2018

Lymphoseek (Norgine B.V.)

Lymphoseek (Norgine B.V.)

Lymphoseek (Active substance: tilmanocept) - Centralised - Yearly update - Commission Decision (2018)5520 of Fri, 10 Aug 2018

Europe -DG Health and Food Safety

10-8-2018

Sivextro (Merck Sharp and Dohme B.V.)

Sivextro (Merck Sharp and Dohme B.V.)

Sivextro (Active substance: tedizolid phosphate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5522 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2846/T/28

Europe -DG Health and Food Safety

10-8-2018

Cubicin (Merck Sharp and Dohme B.V.)

Cubicin (Merck Sharp and Dohme B.V.)

Cubicin (Active substance: Daptomycin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5519 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/637/T/69

Europe -DG Health and Food Safety

10-8-2018

Thalidomide Celgene (Celgene Europe B.V.)

Thalidomide Celgene (Celgene Europe B.V.)

Thalidomide Celgene (Active substance: Thalidomide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5524 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/823/T/57

Europe -DG Health and Food Safety

10-8-2018

CANCIDAS (Merck Sharp and Dohme B.V.)

CANCIDAS (Merck Sharp and Dohme B.V.)

CANCIDAS (Active substance: caspofungin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5517 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/379/T/67

Europe -DG Health and Food Safety

10-8-2018

Tesavel (Merck Sharp and Dohme B.V.)

Tesavel (Merck Sharp and Dohme B.V.)

Tesavel (Active substance: sitagliptin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5518 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/910/T/65

Europe -DG Health and Food Safety

10-8-2018

Januvia (Merck Sharp and Dohme B.V.)

Januvia (Merck Sharp and Dohme B.V.)

Januvia (Active substance: sitagliptin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4511 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/722/T/65

Europe -DG Health and Food Safety

10-8-2018

Bortezomib Hospira (Pfizer Europe MA EEIG)

Bortezomib Hospira (Pfizer Europe MA EEIG)

Bortezomib Hospira (Active substance: bortezomib) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5515 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4207/T/10

Europe -DG Health and Food Safety

7-8-2018

By Aug. 10, all packages and advertisements for “covered” tobacco products (except for cigars and pipe tobacco) and roll-your-own/cigarette tobacco products must have the required nicotine warning statement. https://cards.twitter.com/cards/2m2m96/5xn98 …

By Aug. 10, all packages and advertisements for “covered” tobacco products (except for cigars and pipe tobacco) and roll-your-own/cigarette tobacco products must have the required nicotine warning statement. https://cards.twitter.com/cards/2m2m96/5xn98 …

By Aug. 10, all packages and advertisements for “covered” tobacco products (except for cigars and pipe tobacco) and roll-your-own/cigarette tobacco products must have the required nicotine warning statement. https://cards.twitter.com/cards/2m2m96/5xn98 …

FDA - U.S. Food and Drug Administration

7-8-2018

Memantine Accord (Accord Healthcare Limited)

Memantine Accord (Accord Healthcare Limited)

Memantine Accord (Active substance: memantine) - Centralised - Renewal - Commission Decision (2018)5421 of Tue, 07 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2766/R/10

Europe -DG Health and Food Safety

1-8-2018

Nimenrix (Pfizer Europe MA EEIG)

Nimenrix (Pfizer Europe MA EEIG)

Nimenrix (Active substance: Meningococcal group A, C, W-135 and Y conjugate vaccine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5220 of Wed, 01 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2226/T/80

Europe -DG Health and Food Safety