Humulin

Glavne informacije

  • Zaščiteno ime:
  • Humulin M3 100 i.e./ml suspenzija za injiciranje v vložku
  • Farmacevtska oblika:
  • suspenzija za injiciranje
  • Sestava:
  • insulin, humani 100 i.e. / 1 ml
  • Pot uporabe:
  • Subkutana uporaba
  • Enote v paketu:
  • škatla s 5 vložki s 3 ml suspenzije
  • Tip zastaranja:
  • Rp - Predpisovanje in izdaja zdravila je le na recept
  • Uporabi za:
  • ljudje
  • Vrsta medicine:
  • Alopatska drog

Dokumentov

Lokalizacija

  • Na voljo v:
  • Humulin M3 100 i.e./ml suspenzija za injiciranje v vložku
    Slovenija
  • Jezik:
  • slovenščina

Terapevtski podatki

  • Terapevtska skupina:
  • humani insulin

Drugi podatki

Stanje

  • Source:
  • JAZMP - Javna agencija RS za zdravila in medicinske pripomočke - Slovenia Medicines Agency
  • Status dovoljenje:
  • Zdravilo z dovoljenjem za promet
  • Številka dovoljenja:
  • 10023-139/2015-18
  • Datum dovoljenje:
  • 07-09-2016
  • EAN koda:
  • 3837000166095
  • Zadnja posodobitev:
  • 25-05-2018

Podatki za bolnike

JAZMP – IB/032 – 22.11.2017

Navodilo za uporabo

Humulin M3 100 i.e./ml suspenzija za injiciranje v vložku

humani insulin

Pred začetkom uporabe zdravila natančno preberite navodilo, ker vsebuje za vas

pomembne podatke!

Navodilo shranite. Morda ga boste želeli ponovno prebrati.

Če imate dodatna vprašanja, se posvetujte z zdravnikom, farmacevtom ali medicinsko

sestro.

Zdravilo je bilo predpisano vam osebno in ga ne smete dajati drugim. Njim bi lahko celo

škodovalo, čeprav imajo znake bolezni, podobne vašim.

Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom, farmacevtom ali

medicinsko sestro. Posvetujte se tudi, če opazite katere koli neželene učinke, ki niso

navedeni v tem navodilu. Glejte poglavje 4.

Kaj vsebuje navodilo

Kaj je zdravilo Humulin M3 in za kaj ga uporabljamo

Kaj morate vedeti, preden boste vzeli zdravilo Humulin M3

Kako jemati zdravilo Humulin M3

Možni neželeni učinki

Shranjevanje zdravila Humulin M3

Vsebina pakiranja in dodatne informacije

1.

Kaj je zdravilo Humulin M3 in za kaj ga uporabljamo

Zdravilo Humulin M3 vsebuje zdravilno učinkovino humani insulin in ga uporabljamo za

zdravljenje sladkorne bolezni. Če vaša trebušna slinavka ne izloča dovolj insulina za uravnavanje

ravni glukoze v krvi, se pojavi sladkorna bolezen. Zdravilo Humulin M3 se uporablja za

dolgoročno uravnavanje glukoze. Gre za mešanico kratko in dolgo delujočega insulina.

Podaljšano delovanje je omogočeno z vključitvijo protamin sulfata v suspenzijo.

Zdravnik vam bo morda, poleg zdravila Humulin M3, predpisal tudi insulin s dolgotrajnejšim

delovanjem. Vsaka vrsta insulina ima svoje navodilo za bolnika, kjer si lahko preberete o njem.

Insulina ne smete menjati, razen če vam to predpiše zdravnik. V primeru zamenjave insulina

bodite zelo previdni. Vsaka vrsta insulina ima na ovojnini in vložku drugačno barvo in drugačen

simbol, zato jih je med sabo lahko ločiti.

2.

Kaj morate vedeti, preden boste uporabili zdravilo Humulin M3

Ne uporabljajte zdravila Humulin M3

če mislite, da se začenja hipoglikemija (nizek krvni sladkor).

V nadaljevanju teh

navodil boste našli nasvete za odpravo blage hipoglikemije (glejte razdelek A v poglavju

če ste alergični na humani insulin ali katero koli sestavino tega zdravila (navedeno v

poglavju 6).

Opozorila in previdnostni ukrepi

JAZMP – IB/032 – 22.11.2017

Pred začetkom jemanja zdravila Humulin M3 se posvetujte z zdravnikom, farmacevtom ali

medicinsko sestro.

Če ste z dosedanjim zdravljenjem z insulinom dobro uravnavali ravni sladkorja v krvi,

morda pri čezmernem znižanju krvnega sladkorja ne boste začutili opozorilnih znakov.

Opozorilni znaki so našteti v nadaljevanju teh navodil. Skrbno morate uskladiti čas

obrokov, pogostnost in obseg telesnih naporov. Ves čas natančno spremljajte raven

sladkorja v krvi s pogostim preverjanjem glukoze v krvi.

Nekaj bolnikov, pri katerih se je po prehodu z živalskega insulina na humanega pojavila

hipoglikemija, je poročalo, da so bili pri njih zgodnji opozorilni znaki manj opazni ali pa

drugačni kot prej. Če imate hipoglikemije pogosto, ali če jih le s težavo prepoznate, se o

tem, prosimo, pogovorite s svojim zdravnikom.

Če je vaš odgovor na katerokoli od naslednjih vprašanj DA, morate o tem obvestiti svojega

zdravnika, farmacevta ali medicinsko sestro v diabetološki ambulanti.

Ali ste morda nedavno zboleli?

Imate težave z ledvicami ali jetri?

Ali ste telesno bolj aktivni kot običajno?

Količina potrebnega insulina se lahko spremeni tudi, če pijete alkoholne pijače.

Svojega zdravnika, farmacevta ali medicinsko sestro v diabetološki ambulanti obvestite

tudi, če načrtujete potovanje v tujino. Zaradi časovne razlike med državami boste morda

morali na potovanjih jesti obroke in si injicirati insulin ob drugih urah dneva, kakor če bi

bili doma.

Pri nekaterih bolnikih z dolgotrajno sladkorno boleznijo tipa 2 in boleznijo srca ali

predhodno kapjo, ki so se zdravili s pioglitazonom in insulinom, je prišlo do razvoja

srčnega popuščanja. Če občutite znake srčnega popuščanja, npr. nenavadno kratka sapa,

hitro pridobivanje telesne mase ali lokalizirano otekanje (edem), nemudoma obvestite

svojega zdravnika.

Druga zdravila in zdravilo Humulin M3

Obvestite zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli drugo

zdravilo.

Vaše potrebe po insulinu se lahko spremenijo, če jemljete

steroide,

nadomestno terapijo s ščitničnimi hormoni,

peroralne antidiabetike,

acetilsalicilno kislino,

rastni hormon,

oktreotid, lanreotid,

“stimulatorje receptorjev beta

” (na primer ritodrin, salbutamol ali terbutalin),

beta blokatorje,

tiazide ali nekatere antidepresive (zaviralce monoamin-oksidaze),

danazol,

nekatere zaviralce angiotenzin-konvertaze (ACE) (na primer kaptopril, enalapril) ali

blokatorje receptorjev angiotenzina II

kontracepcijske tablete,

sulfonamide.

Nosečnost in dojenje

JAZMP – IB/032 – 22.11.2017

Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z

zdravnikom ali farmacevtom, preden vzamete to zdravilo.

Količina insulina, ki ga potrebujete običajno v prvih treh mesecih nosečnosti upade, v naslednjih

šestih mesecih pa se poveča. Če dojite, boste morda morali spremeniti svoj odmerek insulina ali

prehrano.

Vpliv na sposobnost upravljanja vozil in strojev

Ob hipoglikemiji (nizkem krvnem sladkorju) lahko upadeta sposobnost koncentracije in reakcijska

sposobnost. Na to možnost ne smete pozabiti v okoliščinah, ko bi lahko ogrozili lastno varnost in

varnost drugih (npr. pri vožnji avtomobila ali pri delu s stroji). Z zdravnikom se morate

pogovoriti, ali je za vas sploh priporočljivo, da vozite motorno vozilo, če imate:

pogoste hipoglikemije,

manj izrazite opozorilne znake hipoglikemije ali če teh sploh ni.

3.

Kako uporabljati zdravilo Humulin M3

3 ml vložek je namenjen samo uporabi v 3 ml injekcijskih peresnikih. Ni namenjen uporabi v

1,5 ml injekcijskih peresnikih.

Ko vam v lekarni izdajo zdravilo, vedno takoj preverite oznake na pakiranju in vložku, da

preverite ime in vrsto insulina. Poskrbite, da dobite zdravilo Humulin M3, ki vam ga je

predpisal zdravnik.

Pri uporabi tega zdravila natančno upoštevajte navodila zdravnika ali farmacevta. Če ste

negotovi, se posvetujte z zdravnikom ali farmacevtom.

Da bi preprečili možen prenos bolezni,

morate vsak vložek uporabljati samo vi, tudi če zamenjate iglo na dostavnem pripomočku.

Odmerjanje

Vaš zdravnik vam bo povedal, natančno koliko zdravila potrebujete, kdaj ga uporabite in

kako pogosto. Ta navodila veljajo izključno za vas. Natančno jih upoštevajte in redno

obiskujte diabetološko ambulanto.

Pri prehodu na drugo vrsto insulina (na primer prehod z živalskega na humani insulin)

boste morda potrebovali več ali manj insulina kot prej. To lahko velja le za prvo injekcijo

ali pa bo šlo za postopno spremembo skozi več tednov ali celo mesecev.

Zdravilo Humulin M3 si injicirajte pod kožo. Zdravila si ne smete dati na drugačen način.

Zdravila Humulin M3 se pod nobenim pogojem ne sme dati v žilo.

Priprava zdravila Humulin M3

Vložke zdravila Humulin M3 je treba tik pred uporabo desetkrat zavrteti med dlanmi rok in

desetkrat obrniti za 180°, da ponovno suspendirate insulin, dokler ni enakomerno motnega

ali mlečnega videza. Če ni takega videza, ponavljajte zgoraj opisani postopek, dokler

sestavine niso zmešane. Vložki vsebujejo majhno stekleno kroglico, ki je v pomoč pri

mešanju. Ne stresajte močno, ker lahko to povzroči penjenje, ki lahko ovira pravilno

odmerjanje odmerka. Vložke morate pogosto pregledovati in jih ne smete uporabiti, če so

navzoči strdki snovi ali se trdni beli delci držijo dna ali stene vložka, kar daje videz

zamrznjenosti. Pred injiciranjem to vsakič preverite.

Priprava injekcijskega peresnika za uporabo

JAZMP – IB/032 – 22.11.2017

Najprej si umijte roke. Razkužite gumijasto opno vložka.

Vložke zdravila Humulin M3 morate uporabljati samo v ustreznih injekcijskih

peresnikih, označenih s CE. Prosimo, preverite, da so vložki zdravila Humulin M3 ali

Lilly omenjeni v navodilih za uporabo, priloženih vašemu injekcijskemu peresniku.

3 ml vložek se prilega samo v 3 ml injekcijski peresnik.

Upoštevajte navodila, priložena injekcijskemu peresniku. Vstavite vložek v injekcijski

peresnik.

Odmerek boste nastavili na 1 ali 2 enoti. Potem držite injekcijski peresnik z iglo, obrnjeno

navzgor, in potrkajte po steni injekcijskega peresnika, da morebitni mehurčki izplavajo na

vrh. Z injekcijskim peresnikom, še vedno obrnjenim navzgor, pritisnite na injekcijski

mehanizem. Pritiskajte, dokler se na konici igle ne pojavi kapljica zdravila Humulin M3.

Nekaj majhnih zračnih mehurčkov lahko ostane v injekcijskem peresniku, saj so

neškodljivi, če pa so preveliki, lahko to spremeni odmerek insulina.

Injiciranje zdravila Humulin M3

Pred injiciranjem kožo očistite v skladu z navodili. Injicirajte pod kožo, kot so vas naučili.

Ne injicirajte neposredno v veno. Po injiciranju pustite iglo v koži še pet sekund, da boste

zagotovo prejeli celoten odmerek zdravila. Mesta injiciranja ne smete drgniti. Pazite na to,

da bo naslednje mesto injiciranja vsaj 1 cm oddaljeno od prejšnjega in da jih boste ves čas

menjavali, v skladu z navodili.

Po injiciranju

Ko končate injiciranje, snemite iglo z injekcijskega peresnika s pomočjo zunanjega

pokrovčka igle. Tako bo insulin ostal sterilen in ne bo uhajal iz injekcijskega peresnika,

preprečili pa boste tudi vstop zraka v injekcijski peresnik in zamašitev igle.

Vaših igel ne

delite z drugimi.

Tudi vašega injekcijskega peresnika ne delite z drugimi. Injekcijski

peresnik pokrijte s pokrovčkom.

Naslednja injiciranja

Vložek pustite v injekcijskem peresniku. Pred vsakim injiciranjem odmerite 1 ali 2 enoti in

pritisnite na injekcijski mehanizem, pri tem naj bo injekcijski peresnik obrnjen navzdol,

dokler se na konici igle ne pojavi kapljica zdravila Humulin M3. Koliko zdravila Humulin

M3 je še ostalo v injekcijskem peresniku, lahko ugotovite tako, da pogledate na merilo na

steni vložka. Razdalja med dvema oznakama na merilu je približno 20 enot. Če to ne

zadostuje za vaš odmerek, zamenjajte vložek.

V vložek zdravila Humulin M3 ne smete primešati kakega drugega insulina. Ko vložek

izpraznite, ga ne smete ponovno uporabiti.

Če ste uporabili večji odmerek zdravila Humulin M3, kot bi smeli

Če ste uporabili večji odmerek zdravila Humulin M3, kot bi smeli, vam lahko krvni sladkor

čezmerno upade. Preverjajte nivo krvnega sladkorja. (glejte razdelek A v poglavju 4)

Če ste pozabili uporabiti zdravilo Humulin M3

Če ste uporabili manjši odmerek zdravila Humulin M3, kot ga potrebujete, vam lahko krvni

sladkor naraste. Preverjajte nivo krvnega sladkorja. Ne injicirajte dvojnega odmerka, če ste

pozabili uporabiti prejšnji odmerek.

Če ste prenehali uporabljati zdravilo Humulin M3

JAZMP – IB/032 – 22.11.2017

Če ste uporabili manjši odmerek zdravila Humulin M3, kot ga potrebujete, vam lahko krvni

sladkor preveč naraste. Ne menjajte svojega insulina, če vam ni tako svetoval vaš zdravnik.

Če imate dodatna vprašanja o uporabi zdravila, se posvetujte z zdravnikom, farmacevtom ali

medicinsko sestro.

4.

Možni neželeni učinki

Kot vsa zdravila ima lahko tudi to zdravilo neželene učinke, ki pa se ne pojavijo pri vseh

bolnikih.

Humani insulin lahko povzroči hipoglikemijo (nizek krvni sladkor). Več informacij o

hipoglikemiji se nahaja v spodnjem podpoglavju »Pogostejše težave zaradi sladkorne

bolezni«.

Možni neželeni učinki

Pogosti neželeni učinki: pojavijo se lahko pri največ 1 od 10 bolnikov

Lokalna alergijska reakcija

Pri nekaterih ljudeh se na mestu injiciranja insulina pojavijo rdečina, oteklina ali srbenje, kar

običajno mine v nekaj dneh do nekaj tednih. Če tako reakcijo opazite pri sebi, povejte svojemu

zdravniku.

Občasni neželeni učinki: pojavijo se lahko pri največ 1 od 100 bolnikov

Lipodistrofija

(zadebelitev ali vdolbina v koži) Če opazite zadebelitev kože ali vdolbino v koži

na mestu injiciranja, na to opozorite svojega zdravnika.

Zelo redki neželeni učinki: pojavijo se lahko pri največ 1 od 10.000 bolnikov

Sistemska alergijska reakcija

Simptomi so naslednji:

padec krvnega tlaka,

izpuščaj po vsem telesu,

težko dihanje,

piskanje v pljučih,

hitro bitje srca,

znojenje.

Če menite, da se je zaradi jemanja zdravila Humulin M3 pri vas pojavila taka alergijska reakcija

na insulin, o tem nemudoma obvestite svojega zdravnika.

Poročali so o edemu (otekanje rok, gležnjev; zastajanje tekočine), predvsem na začetku

zdravljenja z insulinom ali ob spremembi zdravljenja, namenjeni boljšemu nadzoru sladkorja v

krvi.

Pogostejše težave zaradi sladkorne bolezni

A.

Hipoglikemija

JAZMP – IB/032 – 22.11.2017

Hipoglikemija (nizek krvni sladkor) pomeni, da v krvi ni dovolj sladkorja. Do tega lahko pride,

če:

vzamete preveč zdravila Humulin M3 ali insulina kake druge vrste;

izpustite kak obrok, jeste kasneje kot običajno ali spremenite prehrano;

ste telesno preveč aktivni ali preveč delate tik pred obrokom ali po njem;

imate okužbo ali zbolite (še posebej driska ali bruhanje);

se pri vas spremenijo potrebe po insulinu;

imate težave z ledvicami ali jetri in se stanje poslabša.

Na raven sladkorja v vaši krvi lahko vplivajo alkohol in nekatera zdravila.

Prvi simptomi nizkega krvnega sladkorja se običajno pojavijo hitro in vključujejo naslednje:

utrujenost,

hitro bitje srca,

živčnost ali psihično preobčutljivost,

slabost,

glavobol,

hladen znoj.

Če niste prepričani, da boste zagotovo prepoznali opozorilne simptome, se izogibajte

okoliščinam, npr. vožnji avtomobila, v katerih bi zaradi hipoglikemije ogrozili sebe ali druge.

Zdravila Humulin M3 ne uporabite, če mislite, da se začenja hipoglikemija (nizek krvni

sladkor).

Če vam upade krvni sladkor, pojejte nekaj tablet glukoze, malo sladkorja ali popijte sladkano

pijačo. Potem pojejte še sadje, kekse ali sendvič, kot vam je svetoval vaš zdravnik, in počivajte.

Pogosto vam bo tako uspelo odpraviti blago hipoglikemijo ali manjše preveliko odmerjanje

insulina. Če pa se vam počutje poslabša in postane dihanje plitvo in koža bleda, nemudoma

pokličite zdravnika. Z injekcijo glukagona bo lahko odpravil tudi hujšo hipoglikemijo. Po

injekciji glukagona pojejte malo glukoze ali sladkorja. Če vam injiciranje glukagona ni pomagalo,

boste morali v bolnišnico. Zdravnika prosite, naj vam pove kaj več o glukagonu.

B.

Hiperglikemija in diabetična ketoacidoza

Hiperglikemija (previsok krvni sladkor) pomeni, da vaše telo nima dovolj insulina. Vzroki za

hiperglikemijo so lahko naslednji:

niste vzeli zdravila Humulin M3 ali kakega drugega insulina;

vzeli ste manj insulina, kot vam je predpisal vaš zdravnik;

pojedli ste veliko več, kot predpisuje vaša dieta;

imate zvišano telesno temperaturo, okužbo ali čustvene obremenitve.

Hiperglikemija lahko vodi v diabetično ketoacidozo. Prvi simptomi se pojavijo postopoma v več

urah ali celo dnevih. Simptomi so naslednji:

zaspanost,

pomanjkanje apetita,

pordela lica,

vonj po sadju v izdihanem zraku,

žeja,

slabost ali bruhanje.

Hudi simptomi so težko dihanje in hitro bitje srca.

Nemudoma poiščite zdravniško pomoč.

Če hipoglikemije (nizkega krvnega sladkorja) ali hiperglikemije (previsokega krvnega sladkorja)

ne zdravimo, lahko postane ena ali druga zelo huda in povzroči glavobole, slabost, bruhanje,

dehidracijo, nezavest, komo ali celo smrt.

Trije preprosti koraki, kako se izogniti hipoglikemiji in hiperglikemiji:

JAZMP – IB/032 – 22.11.2017

Vedno imejte pri roki rezervne igle in rezerven vložek zdravila Humulin M3.

Vedno nosite s seboj nekaj, kar bo pokazalo, da ste sladkorni bolnik.

S seboj imejte vedno tudi nekaj sladkorja.

C.

Bolezen

Če ste bolni, še posebej, če vam je slabo ali bruhate, se lahko vaše potrebe po insulinu

spremenijo.

Tudi če jeste manj kot običajno, še vedno potrebujete insulin.

Preverjajte kri ali

urin, upoštevajte navodila za primer bolezni in obvestite svojega zdravnika.

Poročanje o neželenih učinkih

Če opazite katerega koli izmed neželenih učinkov, se posvetujte z zdravnikom ali farmacevtom.

Posvetujte se tudi, če opazite neželene učinke, ki niso navedeni v tem navodilu. O neželenih

učinkih lahko poročate tudi neposredno na

Javna agencija Republike Slovenije za zdravila in medicinske pripomočke

Sektor za farmakovigilanco

Nacionalni center za farmakovigilanco

Slovenčeva ulica 22

SI-1000 Ljubljana

Tel: +386 (0)8 2000 500

Faks: +386 (0)8 2000 510

e-pošta: h-farmakovigilanca@jazmp.si

spletna stran: www.jazmp.si

S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti

tega zdravila.

5.

Shranjevanje zdravila Humulin M3

Zdravilo shranjujte nedosegljivo otrokom!

Pred prvo uporabo shranjujte zdravilo Humulin M3 v hladilniku (2 °C - 8 °C).

Ne zamrzujte

Zdravilo Humulin M3, ki ga trenutno uporabljate, shranjujte pri sobni temperaturi (do 30 °C) do

28 dni. Injekcijskega peresnika ali vložkov, ki jih trenutno uporabljate, ne puščajte v bližini virov

toplote ali na soncu. Injekcijskega peresnika z vstavljenim vložkom ne shranjujte s pritrjeno iglo.

Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini.

Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.

Ne uporabljajte tega zdravila, če opazite strdke snovi ali se trdni beli delci držijo dna ali stene

vložka, kar daje videz zamrznjenosti. Pred injiciranjem to vsakič preverite.

Zdravila ne smete odvreči v odpadne vode ali med gospodinjske odpadke. O načinu

odstranjevanja zdravila, ki ga ne potrebujete več, se posvetujte s farmacevtom. Taki ukrepi

pomagajo varovati okolje.

6.

Vsebina pakiranja in dodatne informacije

Kaj vsebuje zdravilo Humulin M3

-

Zdravilna učinkovina

v tem zdravilu je humani insulin. 1 ml suspenzije za injiciranje

vsebuje 100 i.e./ml humanega insulina. 3 ml suspenzije za injiciranje (en vložek) vsebuje

300 i.e. humanega insulina. Humani insulin izdelajo v laboratoriju z uporabo postopka

JAZMP – IB/032 – 22.11.2017

‘tehnologije rekombinantne DNA’. Tako izdelan insulin ima enako sestavo kot humani

insulin, naravni hormon, ki ga izloča trebušna slinavka. Ta insulin je torej drugačen od

živalskega insulina. Zdravilo Humulin M3 je predhodno zmešana suspenzija, ki vsebuje 30

% v vodni raztopljenega insulina in 70 % insulina s protamin sulfatom.

-

Pomožne snovi

so protaminijev sulfat, metakrezol, glicerol, fenol, natrijev hidrogenfosfat,

cinkov oksid voda za injekcije, natrijev hidroksid (za uravnavanje pH) in klorovodikova

kislina (za uravnavanje pH).

Izgled zdravila Humulin M3 in vsebina pakiranja

Zdravilo Humulin M3 je sterilna suspenzija humanega insulina za injiciranje.

Pakiranje: škatla s 5 vložki

Način in režim izdaje zdravila

Predpisovanje in izdaja zdravila je le na recept.

Imetnik dovoljenja za promet z zdravilom in izdelovalec

Imetnik dovoljenja za promet z zdravilom: Eli Lilly farmacevtska družba, d.o.o., Dunajska cesta

167, 1000 Ljubljana, Slovenija

Izdelovalca: Lilly France S.A.S., Rue du Colonel Lilly, 67640 Fegersheim, Francija ali Eli Lilly

Italia S.p.A., Via A. Gramsci, 731-733, 50019 Sesto Fiorentino, Italija

Navodilo je bilo nazadnje revidirano dne 22.11.2017.

21-11-2018

Implementation and verification of PBPK modelling codes of TCDD in rats and humans into Berkeley Madonna

Implementation and verification of PBPK modelling codes of TCDD in rats and humans into Berkeley Madonna

Published on: Tue, 20 Nov 2018 The goal of the current work was to implement and verify previously published rat and human PBPK modelling codes for TCDD into Berkeley Madonna. The US‐EPA has used these PBPK models in the reassessment of TCDD. A procurement contract has been set up to explore the possibilities to adequately run the models and reproduce previously published results. The implementation of the available codes in Berkeley Madonna was carried out at RIKILT‐WUR under the framework agreement wi...

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

Extensive Literature Search, Selection for Relevance and Data Extraction of Studies Related to the Toxicity of PCDD/Fs and DL‐PCBs in Experimental Animals

Extensive Literature Search, Selection for Relevance and Data Extraction of Studies Related to the Toxicity of PCDD/Fs and DL‐PCBs in Experimental Animals

Published on: Tue, 20 Nov 2018 Polychlorinated dibenzodioxins (PCDD), polychlorinated dibenzofurans (PCDFs) and dioxin‐like polychlorinated biphenyls (DL‐PCBs) are detected ubiquitously in the environment, diet and human tissues. The European Food Safety Authority (EFSA) CONTAM Panel received a mandate from the European Commission for a scientific opinion on the risks for human and animal health related to the presence of dioxins and DL‐PCBs in food and feed. To support preparatory work for the hazard i...

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

Extensive literature search, selection for relevance and data extraction of studies related to the toxicity of PCDD/Fs and DL‐PCBs in humans

Extensive literature search, selection for relevance and data extraction of studies related to the toxicity of PCDD/Fs and DL‐PCBs in humans

Published on: Tue, 20 Nov 2018 To enable the hazard identification and characterisation in the risk assessment for humans related to the seventeen 2,3,7,8‐substituted dioxins (PCCDs) and furans (PCDFs) and the twelve dioxin‐like polychlorinated biphenyls (DL‐PCBs), EFSA outsourced an extensive literature search (ELS), followed by selection for relevance and extraction of relevant data for consideration in the risk assessment. Two tailored search strategies for Web of Science (WoS) and PubMed for identif...

Europe - EFSA - European Food Safety Authority Publications

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

15-11-2018

Assessment of genetically modified maize MZHG0JG for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐DE‐2016‐133)

Assessment of genetically modified maize MZHG0JG for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐DE‐2016‐133)

Published on: Wed, 14 Nov 2018 The scope of application EFSA‐GMO‐DE‐2016‐133 is for food and feed uses, import and processing of genetically modified (GM) maize MZHG0JG in the European Union. Maize MZHG0JG was developed to confer tolerance to the herbicidal active substances glyphosate and glufosinate‐ammonium. The molecular characterisation data and bioinformatic analyses do not identify issues requiring food/feed safety assessment. None of the identified differences in the agronomic/phenotypic and com...

Europe - EFSA - European Food Safety Authority Publications

13-11-2018

Questions on antimicrobial resistance

Questions on antimicrobial resistance

Antimicrobial resistance is a major public health issue in France: resistance to antibiotics calls into question the efficacy of treatments for infections occurring in humans and animals alike. At its annual symposium on this issue, ANSES will be presenting the result of its two reports on national trends in resistance in animals (Resapath report) and sales of veterinary antimicrobials.

France - Agence Nationale du Médicament Vétérinaire

13-11-2018

The importance of vector abundance and seasonality

The importance of vector abundance and seasonality

Published on: Mon, 12 Nov 2018 00:00:00 +0100 This joint ECDC‐EFSA report assesses whether vector count data (abundance) and the way these change throughout the year (seasonality) can provide useful information about vector‐borne diseases epidemiological processes of interest, and therefore, whether resources should be devoted to collecting such data. The document also summarises what measures of abundance and seasonality can be collected for each vector group (mosquitoes, sandflies, midges and ticks), ...

Europe - EFSA - European Food Safety Authority Publications

9-11-2018

Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Losartan Potassium and Hydrochlorothiazide Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)

Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Losartan Potassium and Hydrochlorothiazide Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)

Sandoz Inc. is voluntarily recalling one lot of Losartan Potassium Hydrochlorothiazide Tablets, USP 100mg/25mg to the consumer level. This product is being recalled due to the trace amount of an impurity, N-nitrosodiethylamine (NDEA) contained in the API Losartan, USP manufactured by Zhejiang Huahai Pharmaceutical Co. Ltd. Sandoz Inc. Losartan Potassium Hydrochlorothiazide product is manufactured by Lek Pharmaceuticals dd, Ljubljana, Slovenia. This impurity, which is a substance that occurs naturally in ...

FDA - U.S. Food and Drug Administration

5-11-2018

Products containing metam-sodium: ANSES announces the withdrawal of marketing authorisations

Products containing metam-sodium: ANSES announces the withdrawal of marketing authorisations

Plant protection products containing metam-sodium are used in market gardening and horticulture to disinfect the soil. Following the substance's approval at European level, ANSES reassessed the dossiers and notified the industrial companies concerned of its intention to withdraw all marketing authorisations for metam-sodium products. ANSES is also taking this opportunity to reiterate the importance of phytopharmacovigilance and the requirement for professionals to report any adverse effects on humans or ...

France - Agence Nationale du Médicament Vétérinaire

30-10-2018

Sciegen Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Irbesartan Tablets, USP  75 Mg, 150 Mg, and 300 Mg Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in The Active Pharmaceutical Ingredient (API)

Sciegen Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Irbesartan Tablets, USP 75 Mg, 150 Mg, and 300 Mg Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in The Active Pharmaceutical Ingredient (API)

ScieGen Pharmaceuticals, Inc. is voluntarily recalling listed lots, within expiry, of Irbesartan Tablets, USP 75 mg, 150 mg, and 300 mg dosage forms to the consumer level. These products are being recalled due to the presence of an impurity, N-nitrosodiethylamine (NDEA) contained in the API Irbesartan, USP manufactured by Aurobindo Pharma Limited. This impurity, which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, has been classified as a...

FDA - U.S. Food and Drug Administration

29-10-2018

Aurobindo Pharma Limited Issues Voluntary Recall of Irbesartan Drug Substance due to the Detection of Trace Amounts of NDEA (NNitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)

Aurobindo Pharma Limited Issues Voluntary Recall of Irbesartan Drug Substance due to the Detection of Trace Amounts of NDEA (NNitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)

Aurobindo Pharma Limited is voluntarily recalling 22 Batches of the drug substance Irbesartan due to the presence of an impurity, N-nitrosodiethylamine (NDEA). The impurity, which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC).

FDA - U.S. Food and Drug Administration

26-10-2018

Multi-country outbreak of Listeria monocytogenes sequence type 8 infections linked to consumption of salmon products

Multi-country outbreak of Listeria monocytogenes sequence type 8 infections linked to consumption of salmon products

Published on: Thu, 25 Oct 2018 00:00:00 +0200 A multi-country outbreak of 12 listeriosis cases caused by Listeria monocytogenes sequence type (ST) 8 has been identified through whole genome sequencing (WGS) analysis in three EU/EEA countries: Denmark (6 cases), Germany (5) and France (1). Four of these cases have died due to or with the disease. It is likely that the extent of this outbreak has been underestimated since the outbreak was identified through sequencing and only a subset of the EU/EEA count...

Europe - EFSA - European Food Safety Authority Publications

25-10-2018

Xylitol and Your Dog: Danger, Paws Off

Xylitol and Your Dog: Danger, Paws Off

This sugar substitute, found in some human foods and dental products, can be poisonous to your dog.

FDA - U.S. Food and Drug Administration

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

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

Pest categorisation of Thecaphora solani

Pest categorisation of Thecaphora solani

Published on: Tue, 16 Oct 2018 00:00:00 +0200 The Panel on Plant Health performed a pest categorisation of the fungus Thecaphora solani, the causal agent of smut of potato, for the EU. The identity of the pest is well established and reliable methods exist for its detection and identification. T. solaniis present in Bolivia, Chile, Colombia, Ecuador, Mexico, Panama, Peru and Venezuela. The pathogen is not known to occur in the EU and is listed in Annex IAI of Directive 2000/29/EC, meaning its introducti...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Assessment of low pathogenic avian influenza virus transmission via raw poultry meat and raw table eggs

Assessment of low pathogenic avian influenza virus transmission via raw poultry meat and raw table eggs

Published on: Mon, 15 Oct 2018 00:00:00 +0200 A rapid qualitative assessment has been done by performing a theoretical analysis on the transmission of low pathogenic avian influenza (LPAI) via fresh meat from poultry reared or kept in captivity for the production of meat (raw poultry meat) or raw table eggs. A predetermined transmission pathway followed a number of steps from a commercial or non‐commercial poultry establishment within the EU exposed to LPAI virus (LPAIV) to the onward virus transmission...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Pest categorisation of Melampsora farlowii

Pest categorisation of Melampsora farlowii

Published on: Mon, 15 Oct 2018 00:00:00 +0200 Following a request from the European Commission, the EFSA Panel on Plant Health performed a pest categorisation of Melampsora farlowii, a well‐defined and distinguishable fungus of the family Melampsoraceae. M. farlowii is the causal agent of a leaf and twig rust of hemlocks (Tsuga spp.) in eastern North America. The pathogen is regulated in Council Directive 2000/29/EC (Annex IAI) as a harmful organism whose introduction into the EU is banned. M. farlowii ...

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

9-10-2018

Peer review of the pesticide risk assessment for the active substance flumioxazin in light of negligible exposure data submitted

Peer review of the pesticide risk assessment for the active substance flumioxazin in light of negligible exposure data submitted

Published on: Mon, 08 Oct 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessment carried out by the competent authority of the rapporteur Member State, Czech Republic, for the pesticide active substance flumioxazin are reported. The European Commission requested EFSA to conduct a peer review and provide its conclusions on whether exposure of humans to flumioxazin can be considered negligible, taking into account the European Commission's draft guidance on th...

Europe - EFSA - European Food Safety Authority Publications

4-10-2018

Silver Star Brands, Inc. Issues Voluntary Nationwide Recall of Human and Animal Drug Products Due to Microbial Contamination

Silver Star Brands, Inc. Issues Voluntary Nationwide Recall of Human and Animal Drug Products Due to Microbial Contamination

Silver Star Brands, Inc., is initiating a voluntary recall of six products for humans (including four Native Remedies® and two Healthful Naturals™) and two PetAlive® products for pets for a total of eight products with lot numbers, see table below, to the consumer level. The products have been tested and found to contain microbial contamination.

FDA - U.S. Food and Drug Administration

28-9-2018

Avian influenza overview May – August 2018

Avian influenza overview May – August 2018

Published on: Thu, 27 Sep 2018 00:00:00 +0200 Between 16 May and 15 August 2018, three highly pathogenic avian influenza (HPAI) A(H5N8) outbreaks in poultry establishments and three HPAI A(H5N6) outbreaks in wild birds were reported in Europe. Three low pathogenic avian influenza (LPAI) outbreaks were reported in three Member States. Few HPAI and LPAI bird cases have been detected in this period of the year, in accordance with the seasonal expected pattern of LPAI and HPAI. There is no evidence to date ...

Europe - EFSA - European Food Safety Authority Publications

22-9-2018

Risk assessment of new sequencing information on genetically modified carnation FLO‐40689‐6

Risk assessment of new sequencing information on genetically modified carnation FLO‐40689‐6

Published on: Fri, 21 Sep 2018 00:00:00 +0200 The GMO Panel has previously assessed genetically modified (GM) carnation FLO‐40689‐6 and concluded that there is no scientific reason to consider that the import, distribution and retailing in the EU of carnation FLO‐40689‐6 cut flowers for ornamental use will cause any adverse effects on human health or the environment. On 27 October 2017, the European Commission requested EFSA to analyse new nucleic acid sequencing data and updated bioinformatics data for...

Europe - EFSA - European Food Safety Authority Publications

22-9-2018

Risk assessment of new sequencing information for genetically modified soybean BPS‐CV127‐9

Risk assessment of new sequencing information for genetically modified soybean BPS‐CV127‐9

Published on: Fri, 21 Sep 2018 00:00:00 +0200 The GMO Panel has previously assessed genetically modified (GM) soybean BPS‐CV127‐9. This soybean was found to be as safe and nutritious as its conventional counterpart and commercial soybean varieties with respect to potential effects on human and animal health and the environment in the context of its intended uses. On 16 February 2018, European Commission requested EFSA to analyse new nucleic acid sequencing data and updated bioinformatics data for GM soy...

Europe - EFSA - European Food Safety Authority Publications

13-11-2018

EU/3/17/1863 (Celgene Europe B.V.)

EU/3/17/1863 (Celgene Europe B.V.)

EU/3/17/1863 (Active substance: Autologous T lymphocyte-enriched population of cells transduced with a lentiviral vector encoding a chimeric antigen receptor targeting human B cell maturation antigen with 4-1BB and CD3-zeta intracellular signalling domains) - Transfer of orphan designation - Commission Decision (2018)7574 of Tue, 13 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/270/16/02

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

29-10-2018

Replagal (Shire Human Genetic Therapies AB)

Replagal (Shire Human Genetic Therapies AB)

Replagal (Active substance: Agalsidase alfa) - Centralised - Yearly update - Commission Decision (2018)7250 of Mon, 29 Oct 2018

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/3/15/1532 (Sirius Regulatory Consulting EU Limited)

EU/3/15/1532 (Sirius Regulatory Consulting EU Limited)

EU/3/15/1532 (Active substance: Insulin human) - Transfer of orphan designation - Commission Decision (2018)6985 of Mon, 22 Oct 2018

Europe -DG Health and Food Safety

2-10-2018

EU/3/16/1786 (Voisin Consulting S.A.R.L.)

EU/3/16/1786 (Voisin Consulting S.A.R.L.)

EU/3/16/1786 (Active substance: Recombinant adeno-associated viral vector serotype 2 carrying the gene for the human aromatic L-amino acid decarboxylase protein) - Transfer of orphan designation - Commission Decision (2018)6427 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/183/16/T/02

Europe -DG Health and Food Safety

27-9-2018

We want to help patients/caregivers know how to use pen needles correctly. FDA received reports of patients using standard pen needles to inject insulin w/o removing the inner needle cover. The cover stopped patients from getting the right amnt of insulin

We want to help patients/caregivers know how to use pen needles correctly. FDA received reports of patients using standard pen needles to inject insulin w/o removing the inner needle cover. The cover stopped patients from getting the right amnt of insulin

We want to help patients/caregivers know how to use pen needles correctly. FDA received reports of patients using standard pen needles to inject insulin w/o removing the inner needle cover. The cover stopped patients from getting the right amnt of insulin https://go.usa.gov/xPWZq  pic.twitter.com/LT9SptJge1

FDA - U.S. Food and Drug Administration

24-9-2018

Ryzodeg (Novo Nordisk A/S)

Ryzodeg (Novo Nordisk A/S)

Ryzodeg (Active substance: Insulin degludec/insulin aspart) - Centralised - Yearly update - Commission Decision (2018)6242 of Mon, 24 Sep 2018

Europe -DG Health and Food Safety

24-9-2018

Tresiba (Novo Nordisk A/S)

Tresiba (Novo Nordisk A/S)

Tresiba (Active substance: Insulin degludec) - Centralised - Yearly update - Commission Decision (2018)6244 of Mon, 24 Sep 2018

Europe -DG Health and Food Safety

21-9-2018

Scientific guideline:  Reflection paper on the use of aminopenicillins and their beta-lactamase inhibitor combinations in animals in the European Union: development of resistance and impact on human and animal health, draft: consultation open

Scientific guideline: Reflection paper on the use of aminopenicillins and their beta-lactamase inhibitor combinations in animals in the European Union: development of resistance and impact on human and animal health, draft: consultation open

The objective of this document is to review available information on the use of aminopenicillins and their beta-lactamase inhibitor combinations in veterinary medicines in the EU, their effect on the emergence of antimicrobial resistance (AMR) and the potential impact of resistance on human and animal health. The document provides information for the risk profiling, as recommended by the Antimicrobial Advice ad hoc Expert Group (AMEG) of the EMA.

Europe - EMA - European Medicines Agency

17-9-2018

 European Medicines Agency (EMA) Human Scientific Committees' Working Party with Healthcare Professionals’ Organisations (HCPWP), European Medicines Agency, London, UK, From: 26-Sep-2018, To: 26-Sep-2018

European Medicines Agency (EMA) Human Scientific Committees' Working Party with Healthcare Professionals’ Organisations (HCPWP), European Medicines Agency, London, UK, From: 26-Sep-2018, To: 26-Sep-2018

This Healthcare Professionals' Working Party (HCPWP) plenary meeting will include discussions on advances in clinical practice and the scientific and regulatory challenges. Members will also be invited to present how they are including regulatory sciences in fellowships and young researchers’ training. Feedback will be given from the representatives of the Scientific Committees.

Europe - EMA - European Medicines Agency

17-9-2018

 European Medicines Agency (EMA) Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and with Healthcare Professionals’ Organisations (HCPWP), European Medicines Agency, London, UK, From: 25-Sep-2018, To: 25-Sep

European Medicines Agency (EMA) Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and with Healthcare Professionals’ Organisations (HCPWP), European Medicines Agency, London, UK, From: 25-Sep-2018, To: 25-Sep

This joint Patients' and Consumers' Working Party (PCWP) and Healthcare Professionals' Working Party (HCPWP) meeting will include results of the 2017 EMA perception survey. EMA regulatory science to 2025 will be discussed together with updates on Good Pharmacovigilance Practices (GVP). The Topic Group on Digital media and health will feedback to the working parties’ members. Participants will also receive an update on ongoing work on electronic product information and on availability of authorised med...

Europe - EMA - European Medicines Agency