Ultop 10 mg želučanootporne

Glavna informacija

  • Trgovački naziv:
  • Ultop 10 mg želučanootporne tvrde kapsule
  • Doziranje:
  • 10 mg
  • Farmaceutski oblik:
  • želučanootporna kapsula, tvrda
  • Sastav:
  • Urbroj: svaka kapsula sadrži 10 mg omeprazola
  • Tip recepta:
  • na recept, u ljekarni ponovljivi recept
  • Koristi za:
  • Ljudi
  • Vrsta lijekova:
  • alopatski lijek
  • Proizveden od:
  • Krka d.d., Novo Mesto, Slovenija

Dokument

Lokalizacija

  • Na raspolaganju u:
  • Ultop 10 mg želučanootporne tvrde kapsule
    Hrvatska
  • Jezik:
  • hrvatski

Terapeutski informacija

  • Proizvod sažetak:
  • Pakiranje: 28 kapsula u bočici, u kutiji [HR-H-946593019-01] Urbroj: 381-12-01/70-15-07

Druge informacije

Status

  • Izvor:
  • HALMED Agencija za lijekove i medicinske proizvode - Agency for medicinal products and medical devices of Croatia
  • Broj odobrenja:
  • HR-H-946593019
  • Datum autorizacije:
  • 29-07-2015
  • Zadnje ažuriranje:
  • 05-06-2018

Uputu o lijeku

Uputa o lijeku: Informacije za korisnika

Ultop 10 mg želučanootporne tvrde kapsule

Ultop 20 mg želučanootporne tvrde kapsule

Ultop 40 mg želučanootporne tvrde kapsule

omeprazol

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

Sačuvajte ovu uputu. Možda ćete je trebati ponovno pročitati.

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

Ovaj je lijek propisan samo Vama. Nemojte ga davati drugima. Može im 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, vidjeti dio 4.

Što se nalazi u ovoj uputi:

Što je Ultop i za što se koristi?

Što morate znati prije nego počnete uzimati Ultop?

.

Kako uzimati Ultop?

Moguće nuspojave

Kako čuvati Ultop?

Sadržaj pakiranja i druge informacije

1.

Što je Ultop i za što se koristi?

Ultop kapsule sadrže lijek pod nazivom omeprazol. Omeprazol pripada skupini lijekova koja se zove

„inhibitori protonske pumpe“. Inhibitori protonske pumpe smanjuju količinu kiseline koja se stvara u želucu.

Ultop kapsule se primjenjuju za liječenje sljedećih stanja:

Odrasli:

gastroezofagealna refluksna bolest (GERB) tj. vraćanje kiselog želučanog sadržaja u jednjak (cijev

koja povezuje ždrijelo sa želucem), uzrokujući bol, upalu i žgaravicu.

čirevi (vrijed) u gornjem dijelu crijeva (čir na dvanaesniku) ili želucu.

čirevi koji nastaju zbog infekcije bakterijom

Helicobacter pylori

. U tom slučaju, liječnik će Vam

možda propisati i antibiotike za liječenje infekcije i lakše zacjeljivanje čira.

čirevi koji nastaju zbog primjene lijekova koji se nazivaju nesteroidni protuupalni lijekovi (NSAID).

Ultop kapsule se mogu koristiti i za sprječavanje pojave čireva tijekom primjene nesteroidnih

protuupalnih lijekova.

pojačano izlučivanje želučane kiseline zbog izrasline u gušterači (Zollinger-Ellisonov sindrom).

Djeca:

Djeca starija od 1 godine i težine ≥ 10 kg

gastroezofagealna refluksna bolest (GERB) tj vraćanje kiselog želučanog sadržaja u jednjak (cijev

koja povezuje ždrijelo sa želucem), uzrokujući bol u želucu upalu i žgaravicu.

U djece, simptomi mogu uključivati vraćanje želučanog sadržaja u usta (regurgitacija), povraćanje i slabiji

porast tjelesne težine.

Djeca starija od 4 godine i adolescenti

čirevi koji nastaju zbog infekcije bakterijom Helicobacter pylori. Ako Vaše dijete boluje od takvog

čira, liječnik će mu, možda, propisati i antibiotike za liječenje infekcije i lakše zacjeljivanje čira.

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2.

Što morate znati prije nego počnete uzimati Ultop?

Nemojte uzimati Ultop

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

ako ste alergični na lijekove koji sadrže druge inhibitore protonske pumpe (primjerice pantoprazol,

lanzoprazol, rabeprazol, esomeprazol).

ako uzimate lijek pod nazivom

nelfinavir

(koristi se za liječenje infekcije HIV virusom).

Nemojte uzeti Ultop kapsule ako se bilo što od gore navedenog odnosi na Vas. Ako niste sigurni,

posavjetujte se sa svojim liječnikom.

Upozorenja i mjere opreza

Ultop može prikriti simptome drugih bolesti. Stoga, ako Vam se dogodi nešto od sljedećeg prije početka

uzimanja Ultopa ili dok ih koristite, odmah se posavjetujte sa svojim liječnikom ako:

značajno gubite na tjelesnoj masi bez jasnog razloga ili imate poteškoće s gutanjem.

imate bol u želucu ili problema s probavom.

povraćate hranu ili krv.

imate crnu stolicu (krv u stolici).

imate težak ili dugotrajan proljev, jer je omeprazol povezan s nešto češćom pojavom proljeva

uzrokovanih infekcijom.

imate teške probleme s jetrom.

ako ste ikad imali kožnu reakciju nakon terapije s lijekom sličnim Ultopu koji smanjuje želučanu

kiselinu.

Ako dobijete osip na koži, posebice na područjima izloženima suncu obavijestite svojeg liječnika što je prije

moguće, jer ćete možda morati prekinuti liječenje Ultopom. Sjetite se spomenuti i bilo koje druge štetne

učinke poput boli u zglobovima.

Ako dugotrajno uzimate Ultop (dulje od 1 godine), Vaš liječnik će Vas vjerojatno redovito kontrolirati.

Morate prijaviti sve nove i izražene simptome i okolnosti kad god posjetite liječnika.

Uzimanje inhibitora protonske pumpe poput Ultopa, posebno dulje od godinu dana, može blago povećati

rizik od prijeloma kuka, ručnog zgloba ili kralježnice. Obavijestite svog liječnika ako imate osteoporozu ili

uzimate kortikosteroide (koji mogu povećati rizik od osteoporoze).

Drugi lijekovi i Ultop

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

lijekove.

To je zbog toga što Ultop i može utjecati na učinak drugih lijekova i obrnuto.

Ne uzimajte Ultop tablete ako uzimate lijekove koji sadrže

nelfinavir

(lijek za liječenje infekcije HIV

virusom).

Obavijestite svog liječnika ili ljekarnika ako uzimate bilo koji od sljedećih lijekova:

ketokonazol, itrakonazol, posakonazol

vorikonazol

, koji se koriste za liječenje gljivičnih

infekcija.

digoksin

, koji se primjenjuje za liječenje bolesti srca.

diazepam,

koji se koristi za liječenje tjeskobe, opuštanje mišića ili epilepsije.

fenitoin

, koji se koristi za liječenje epilepsije. Ako uzimate fenitoin, liječnik će Vas promatrati kada

počnete ili kada prestanete uzimati Ultop.

lijekove koji se koriste za sprječavanje zgrušavanja krvi, kao što su

varfarin

ili drugi

blokatori

vitamina K

. Liječnik će Vas promatrati kada počnete ili kada prestanete uzimati Ultop.

rifampicin

, koji se koristi za liječenje tuberkuloze.

atazanavir

, koji se koristi za liječenje infekcije HIV-om.

takrolimus

, koji se primjenjuje kod transplantacije organa.

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pripravke gospine trave

Hypericum perforatum

), koji se koriste za liječenje blage depresije.

cilostazol

, koji se koristi za liječenje jake boli u mišićima nogu kod hodanja.

sakvinavir

, koji se koristi za liječenje infekcije HIV-om.

klopidogrel

, koji se koristi za sprječavanje stvaranja krvnih ugrušaka/tromba.

erlotinib

, koji se koristi za liječenje raka.

metotreksat

(kemoterapeutik koja se primjenjuje u velikim dozama za liječenje raka) – ako uzimate

velike doze metotreksata, Vaš liječnik može privremeno obustaviti primjenu Ultopa.

Ako Vam je liječnik uz Ultop propisao antibiotike amoksicilin i klaritromicin za liječenje čira uzrokovanog

bakterijom

Helicobacter pylori

, vrlo je važno da liječnika obavijestite ako uzimate bilo koje druge lijekove.

Ultop s hranom i pićem

Možete uzeti kapsulu s hranom ili na prazan želudac.

Molimo pogledajte dio 3. ove upute za informacije o načinu uzimanja ovog lijeka.

Trudnoća i dojenje

Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate trudnoću, obratite se svom liječniku ili

ljekarniku za savjet prije nego uzmete ovaj lijek.

Omeprazol se izlučuje u majčino mlijeko, ali nije vjerojatno da će utjecati na novorođenče ako se

primjenjuju terapijske doze.

Vaš će liječnik odlučiti možete li uzimati Ultop ako dojite.

Upravljanje vozilima i strojevima

Ultop ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima. Postoji

mogućnost nastanka nuspojava kao što su omaglica i smetnje vida (vidjeti dio 4). U tom slučaju ne smijete

upravljati vozilom niti raditi sa strojevima.

Ultop sadrži saharozu

Ako Vam je liječnik rekao da ne podnosite neke šećere, savjetujete se s liječnikom prije uzimanja ovog lijeka.

3.

Kako uzimati Ultop?

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

liječnikom ili ljekarnikom ako niste sigurni.

Vaš liječnik će Vam reći koliko kapsula trebate uzeti i koliko dugo ih uzimati. To će ovisiti o Vašem stanju,

o tome koje ste dobi i kako radi Vaša jetra.

Uobičajene doze su navedene u nastavku.

Odrasli:

Liječenje simptoma gastroezofagealne refluksne bolesti (GERB), kao što su

žgaravica

vraćanje želučane

kiseline

Ako je Vaš liječnik ustanovio da Vam je sluznica jednjaka blago oštećena, uobičajena doza je 20 mg

jedanput dnevno tijekom 4-8 tjedana. Ako jednjak još nije zacijelio, liječnik Vam može povećati dozu

na 40 mg tijekom sljedećih 8 tjedana.

Nakon zacjeljivanja jednjaka, uobičajena doza je 10 mg jedanput dnevno.

Ako jednjak nije oštećen, uobičajena doza je 10 mg jedanput dnevno.

Liječenje

čira u gornjem dijelu tankog crijeva

(čir na dvanaesniku):

Uobičajena doza je 20 mg jedanput dnevno tijekom 2 tjedna. Ako čir još nije zacijelio, Vaš liječnik će

Vam možda propisati istu dozu još sljedeća 2 tjedna.

Ako čir nije u potpunosti zacijelio, doza se može povećati na 40 mg jedanput dnevno tijekom 4 tjedna.

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Liječenje

čira na želucu

Uobičajena doza je 20 mg jedanput dnevno tijekom 4 tjedna. Ako čir još nije zacijelio, Vaš liječnik će

Vam možda propisati da uzimate istu dozu još sljedeća 4 tjedna.

Ako čir nije u potpunosti zacijelio, doza se može povećati na 40 mg jednom dnevno tijekom 8 tjedana.

Sprječavanje

ponovnog nastanka ulkusa na dvanaesniku i želucu

Uobičajena doza je 10 mg ili 20 mg jednom dnevno. Vaš liječnik će možda povećati dozu na 40 mg

jedanput dnevno.

Liječenje

čira na dvanaesniku i želucu uzrokovanog primjenom nesteroidnih protuupalnih lijekova

Uobičajena doza je 20 mg jedanput dnevno tijekom 4–8 tjedana.

Sprječavanje

nastanka

ulkusa na dvanaesniku i želucu tijekom uzimanja nesteroidnih protuupalnih

lijekova:

Uobičajena doza je 20 mg jednom dnevno.

Liječenje

ulkusa uzrokovanih infekcijom bakterijom Helicobacter pylori

i sprječavanje njihovog

ponovnog nastanka:

Uobičajena doza je 20 mg Ultopa dvaput dnevno tijekom jednog tjedna.

Vaš liječnik će Vam također propisati dva antibiotika (amoksicilin, klaritromicina ili metronidazol).

Liječenje pojačanog izlučivanja želučane kiseline zbog

izrasline

u gušterači

(Zollinger-Ellison sindrom)

Uobičajena doza je 60 mg dnevno.

Vaš liječnik će prilagoditi dozu ovisno o Vašim potrebama te također odlučiti koliko dugo će trajati

liječenje.

Primjena u djece i adolescenata

Liječenje simptoma gastroezofagealne refluksne bolesti (GERB), kao što su

žgaravica

vraćanje želučane

kiseline

Djeca starija od 1 godine i tjelesne mase veće od 10 kg mogu uzimati Ultop. Doza za djecu ovisi o

tjelesnoj masi djeteta i liječnik će odlučiti koja je doza potrebna.

Liječenje

ulkusa uzrokovanih infekcijom bakterijom Helicobacter pylori

i sprječavanje njihovog

ponovnog nastanka:

Djeca starija od 4 godine mogu uzimati Ultop. Dozu će odrediti liječnik na temelju djetetove tjelesne

mase.

Vaš liječnik će također Vašem djetetu propisati dva antibiotika, amoksicilin i klaritromicin.

Način primjene

Ovaj lijek se uzima kroz usta. Možete ga uzeti uz hranu ili natašte. Preporučuje se uzimati ga ujutro.

Progutajte cijelu kapsulu s pola čaše vode. Nemojte žvakati niti drobiti kapsule jer kapsule sadrže

mikrogranule (pelete) koje sprječavaju da želučana kiselina razgradi lijek u želucu. Važno je da se granule

(pelete) ne oštete.

Što učiniti ako Vi ili Vaše dijete imate problema s gutanjem kapsula

Ako Vi ili Vaše dijete imate problema s gutanjem kapsula:

otvorite kapsulu i progutajte sadržaj s pola čaše vode ili pomiješajte sadržaj s malom količinom

jogurta, bilo kojim kiselim voćnim sokom (npr. jabuka, naranča ili ananas) ili kašici od jabuka.

uvijek promiješajte mješavinu prije nego što je popijete (mješavina ne smije biti bistra). Popijte ovu

mješavinu odmah ili unutar 30 minuta.

kako biste bili sigurni da ste popili sav lijek, dobro isperite čašu s pola čaše vode i popijte. Čvrsti

dijelovi sadrže lijek – nemojte ih žvakati niti drobiti.

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Ako uzmete više Ultopa nego što ste trebali

Ako ste uzeli više lijeka nego što Vam je propisao Vaš liječnik, odmah se posavjetujte sa svojim liječnikom

ili ljekarnikom.

Ako ste zaboravili uzeti Ultop

Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu dozu.

Ako ste zaboravili uzeti dozu, uzmite je čim se sjetite. Međutim, ako je uskoro vrijeme za Vašu sljedeću

dozu, preskočite propuštenu dozu.

Ako prestanete uzimati Ultop

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

ljekarniku

.

4.

Moguće nuspojave

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

Ako primijetite bilo koju od sljedećih ozbiljnih nuspojava, prestanite uzimati Ultop kapsule i odmah

obavijestite liječnika:

iznenadno piskutavo disanje, oticanje usana, jezika, grla ili tijela, osip, nesvjestica ili poteškoće s

gutanjem. To mogu biti simptomi teške alergijske reakcije pod nazivom angioedem.

crvenilo kože s mjehurima ili ljuštenjem. Može doći do stvaranja velikih mjehura i krvarenja u

području usana, očiju, usta, nosa i spolovila. To mogu biti simptomi bolesti koje se nazivaju Stevens-

Johnsonov sindrom ili toksična epidermalna nekroliza.

žuta koža, tamna boja mokraće i umor koji ukazuju na probleme s jetrom.

Ostale nuspojave:

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

glavobolja

bol u trbuhu, zatvor, proljev, vjetrovi (flatulencija)

mučnina, povraćanje

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

oticanje stopala i gležnjeva

nesanica

omaglica, trnci i bockanje, izrazita pospanost

vrtoglavica

osip, koprivnjača i svrbež kože

promjene rezultata krvnih pretraga rada jetre

prijelom kuka, ručnog zgloba i kralježnice

opća slabost

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

promjene u krvi kao što su smanjeni broj bijelih krvnih stanica ili trombocita. To može dovesti do

slabosti, lakog nastajanja modrica ili povećati mogućnost nastanka infekcija

alergijske reakcije

snižene razine natrija u krvi. To može uzrokovati slabost, povraćanje i grčeve

uznemirenost, smetenost ili depresija

promjene osjeta okusa

problemi s vidom, poput zamućenog vida

iznenadno piskanje ili osjećaj nedostatka zraka (bronhospazam)

suha usta ili upala s unutrašnje strane usta

gljivična infekcija kandidom

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upala jetre, koja može dovesti do žute obojenosti kože (žutice), tamne boje mokraće i umora

osip kože koji se javlja nakon izlaganja sunčevoj svjetlosti

ispadanje kose (alopecija)

bolni otečeni zglobovi

bol u mišićima

pojačano znojenje

problemi s bubrezima (intersticijski nefritis)

Vrlo rijetke (mogu se javiti u manje od 1 na 10 000 osoba)

promjene u krvnoj slici, uključujući manjak bijelih krvnih stanica (agranulocitozu)

agresija

priviđenja (halucinacije)

teški problemi s jetrom koji dovode do zatajenja jetre i upale mozga

mišićna slabost

povećanje dojki u muškaraca

Nepoznato (učestalost se ne može procijeniti iz dostupnih podataka)

upala crijeva (koja uzrokuje proljev)

ako Ultop uzimate dulje od tri mjeseca, razina magnezija u krvi može pasti. Niska razina magnezija

može se očitovati kao umor, nevoljno stezanje mišića, dezorijentacija, grčevi, omaglica ili ubrzan

srčani ritam. Ako primijetite neki od tih simptoma, odmah obavijestite svog liječnika. Niske razine

magnezija također mogu dovesti do pada razine kalija ili kalcija u krvi. Vaš liječnik Vas može

redovito upućivati na krvne pretrage radi kontrole razine magnezija

osip, moguće praćen boli u zglobovima

Ultop može u vrlo rijetkim slučajevima utjecati na bijele krvne stanice dovodeći do slabljenja imuniteta. Ako

imate infekciju sa simptomima kao što je vrućica s teškim

općim stanjem ili vrućicu sa simptomima lokalne

infekcije poput bolova u vratu, ždrijelu ili ustima ili otežano mokrenje, morate se što prije javiti svom

liječniku, kako bi se krvnim pretragama isključio manjak bijelih krvnih stanica (agranulocitoza). Važno je da

tada kažete da uzimate ovaj lijek.

Prijavljivanje nuspojava

Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili ljekarnika. Ovo uključuje i svaku

moguću nuspojavu koja nije navedena u ovoj uputi. Nuspojave možete prijaviti izravno putem nacionalnog

sustava za prijavu nuspojava navedenog u Dodatku V.

Prijavljivanjem nuspojava možete pridonijeti u procjeni sigurnosti ovog lijeka.

5.

Kako čuvati Ultop?

Ovaj lijek čuvajte izvan pogleda i dohvata djece.

Čuvati na temperaturi ispod 25

Čuvati u originalnom pakiranju radi zaštite od vlage.

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

odnosi se na zadnji dan navedenog mjeseca.

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

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

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6.

Sadržaj pakiranja i druge informacije

Što Ultop sadrži?

Djelatna tvar je omeprazol. Svaka kapsula sadrži 10 mg, 20 mg ili 40 mg omeprazola.

Drugi sastojci su: hidroksipropilceluloza; teški magnezijev subkarbonat; saharoza, kukuruzni škrob,

natrijev laurilsulfat; metakrilatna kiselina/etilakrilat kopolimer 1:1, 30 postotna raspršina; talk,

makrogol 6000 i titanijev dioksid (E171) u jezgri, te želatina, titanijev dioksid (E171) i crveni željezov

oksid (E172) u kapsuli.

Kako Ultop izgleda i sadržaj pakiranja?

Ultop 10 mg

: tijelo kapsule je svijetlo ružičaste boje, a kapa bijele boje; kapsule su punjene bijelim do lagano

žutim ili lagano ružičastim peletama.

Ultop 20 mg: tijelo kapsule je svijetlo ružičaste boje, a kapa smeđe-ružičaste boje; kapsule su punjene bijelim do

lagano žutim ili lagano ružičastim peletama.

Ultop 40 mg: tijelo kapsule je smeđe-ružičaste boje, a kapa svijetlo ružičaste boje; kapsule su punjene

bijelim do lagano žutim ili lagano ružičastim peletama.

Ultop 10 mg je dostupan u plastičnoj bočici s plastičnim zatvaračem s integriranim sredstvom za sušenje, a

svaka kutija sadrži ukupno 28 kapsula.

Ultop 20 mg je dostupan u plastičnoj bočici s plastičnim zatvaračem s integriranim sredstvom za sušenje, a

svaka kutija sadrži ukupno 14 ili 28 kapsula.

Ultop 40 mg je dostupan u:

plastičnoj bočici s plastičnim zatvaračem s integriranim sredstvom za sušenje, a svaka kutija sadrži

ukupno 14 kapsula,

plastičnoj bočici s plastičnim zatvaračem s integriranim sredstvom za sušenje i valjkom sa sredstvom

za sušenje, a svaka kutija sadrži ukupno 28 kapsula.

Na tržištu se ne moraju nalaziti sve veličine pakiranja.

Nositelj odobrenja za stavljanje lijeka u promet i proizvođač

Nositelj odobrenja

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

Proizvođač

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

Način i mjesto izdavanja lijeka

Lijek se izdaje na recept, u ljekarni.

Ova uputa je zadnji puta revidirana u lipnju 2016.

H A L M E D

03-06-2016

O D O B R E N O

21-11-2018

Fresenius Kabi Issues Voluntary Nationwide Recall of Sodium Chloride Injection, USP, 0.9% Due to Product Labeling Incorrectly Stating Stoppers Do Not Contain Latex

Fresenius Kabi Issues Voluntary Nationwide Recall of Sodium Chloride Injection, USP, 0.9% Due to Product Labeling Incorrectly Stating Stoppers Do Not Contain Latex

Fresenius Kabi USA is voluntarily recalling 163 lots of Sodium Chloride Injection, USP, 0.9%, 10 mL fill in a 10 mL vial and Sodium Chloride Injection, USP, 0.9%, 20 mL fill in a 20 mL vial to the user level. The product insert states that stoppers for both the 10mL and the 20mL vials do not contain natural rubber latex; the tray label for the two vial sizes and the vial label for the 20mL vial also state that the stoppers do not contain latex. The product is being recalled because the stoppers contain n...

FDA - U.S. Food and Drug Administration

21-11-2018

Mylan Initiates Voluntary Nationwide Recall of 15 Lots of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Fou

Mylan Initiates Voluntary Nationwide Recall of 15 Lots of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Fou

Mylan N.V. (NASDAQ: MYL) today announced that its U.S. based Mylan Pharmaceuticals business is conducting a voluntary nationwide recall to the consumer level of select lots of Valsartan-containing products, including six lots of Amlodipine and Valsartan Tablets, USP (including the 5mg/160mg, 10mg/160mg, and 10mg/320mg strengths), seven lots of Valsartan Tablets, USP (including 40 mg, 80 mg, 160 mg, and 320 mg strengths), and two lots of Valsartan and Hydrochlorothiazide Tablets, USP 320mg/25mg strength. ...

FDA - U.S. Food and Drug Administration

21-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

24-10-2018

Vita Health Products Recall (2018-10-24)

Vita Health Products Recall (2018-10-24)

Health Canada

18-10-2018

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

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

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

Health Canada

18-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

11-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

11-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

10-10-2018

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

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

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

FDA - U.S. Food and Drug Administration

10-10-2018

Enforcement Report for the Week of October 10, 2018

Enforcement Report for the Week of October 10, 2018

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

FDA - U.S. Food and Drug Administration

24-9-2018

FDA Announces Availability of Resources for Animal Drug Sponsors

FDA Announces Availability of Resources for Animal Drug Sponsors

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

FDA - U.S. Food and Drug Administration

19-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

13-9-2018

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

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

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

FDA - U.S. Food and Drug Administration

11-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Update of the Xylella spp. host plant database

Update of the Xylella spp. host plant database

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

Europe - EFSA - European Food Safety Authority Publications

10-9-2018

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

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

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

FDA - U.S. Food and Drug Administration

7-9-2018

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

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

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

FDA - U.S. Food and Drug Administration

1-9-2018

Spodoptera frugiperda partial risk assessment

Spodoptera frugiperda partial risk assessment

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

22-8-2018

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

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

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

FDA - U.S. Food and Drug Administration

10-8-2018

Enforcement Report for the Week of July 25, 2018

Enforcement Report for the Week of July 25, 2018

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

FDA - U.S. Food and Drug Administration

12-11-2018

Spinraza (Biogen Netherlands B.V.)

Spinraza (Biogen Netherlands B.V.)

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

Europe -DG Health and Food Safety

23-10-2018

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

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

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

Europe -DG Health and Food Safety

22-10-2018

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

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

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

Europe -DG Health and Food Safety

19-10-2018

Recocam (Bimeda Animal Health Limited)

Recocam (Bimeda Animal Health Limited)

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

Europe -DG Health and Food Safety

26-9-2018

Kexxtone (Elanco GmbH)

Kexxtone (Elanco GmbH)

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

Europe -DG Health and Food Safety

19-9-2018

Lartruvo (Eli Lilly Nederland B.V.)

Lartruvo (Eli Lilly Nederland B.V.)

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

Europe -DG Health and Food Safety

19-9-2018

Pregabalin Mylan (Mylan S.A.S.)

Pregabalin Mylan (Mylan S.A.S.)

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

Europe -DG Health and Food Safety

10-9-2018

Akynzeo (Helsinn Birex Pharmaceuticals Ltd)

Akynzeo (Helsinn Birex Pharmaceuticals Ltd)

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

Europe -DG Health and Food Safety

10-9-2018

Alkindi (Diurnal Limited)

Alkindi (Diurnal Limited)

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

Europe -DG Health and Food Safety

10-9-2018

Retacrit (Hospira UK Limited)

Retacrit (Hospira UK Limited)

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

Europe -DG Health and Food Safety

10-9-2018

Silapo (STADA Arzneimittel AG)

Silapo (STADA Arzneimittel AG)

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

Europe -DG Health and Food Safety

4-9-2018

ACM meeting statement, Meeting 10, 2 August 2018

ACM meeting statement, Meeting 10, 2 August 2018

The Advisory Committee on Medicines meeting statement is now available

Therapeutic Goods Administration - Australia

22-8-2018

BTVPUR (Merial)

BTVPUR (Merial)

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

Europe -DG Health and Food Safety

10-8-2018

Torisel (Pfizer Europe MA EEIG)

Torisel (Pfizer Europe MA EEIG)

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

Europe -DG Health and Food Safety

10-8-2018

Brinavess (Correvio)

Brinavess (Correvio)

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

Europe -DG Health and Food Safety

10-8-2018

Lymphoseek (Norgine B.V.)

Lymphoseek (Norgine B.V.)

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

Europe -DG Health and Food Safety

10-8-2018

Sivextro (Merck Sharp and Dohme B.V.)

Sivextro (Merck Sharp and Dohme B.V.)

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

Europe -DG Health and Food Safety

10-8-2018

Cubicin (Merck Sharp and Dohme B.V.)

Cubicin (Merck Sharp and Dohme B.V.)

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

Europe -DG Health and Food Safety

10-8-2018

Thalidomide Celgene (Celgene Europe B.V.)

Thalidomide Celgene (Celgene Europe B.V.)

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

Europe -DG Health and Food Safety

10-8-2018

CANCIDAS (Merck Sharp and Dohme B.V.)

CANCIDAS (Merck Sharp and Dohme B.V.)

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

Europe -DG Health and Food Safety

10-8-2018

Tesavel (Merck Sharp and Dohme B.V.)

Tesavel (Merck Sharp and Dohme B.V.)

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

Europe -DG Health and Food Safety

10-8-2018

Januvia (Merck Sharp and Dohme B.V.)

Januvia (Merck Sharp and Dohme B.V.)

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

Europe -DG Health and Food Safety

10-8-2018

Bortezomib Hospira (Pfizer Europe MA EEIG)

Bortezomib Hospira (Pfizer Europe MA EEIG)

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

Europe -DG Health and Food Safety

7-8-2018

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

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

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

FDA - U.S. Food and Drug Administration

7-8-2018

Memantine Accord (Accord Healthcare Limited)

Memantine Accord (Accord Healthcare Limited)

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

Europe -DG Health and Food Safety

30-7-2018

Zalmoxis (MolMed S.p.A.)

Zalmoxis (MolMed S.p.A.)

Zalmoxis (Active substance: Allogeneic T cells genetically modified with a retroviral vector encoding for a truncated form of the human low affinity nerve growth factor receptor (?LNGFR) and the herpes simplex I virus thymidine kinase (HSV-TK Mut2)) - Centralised - Renewal - Commission Decision (2018)5118 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2801/R/10

Europe -DG Health and Food Safety