Evicel

Glavna informacija

  • Trgovački naziv:
  • Evicel
  • Koristi za:
  • Ljudi
  • Vrsta lijekova:
  • alopatski lijek

Dokument

Lokalizacija

  • Na raspolaganju u:
  • Evicel
    Europska Unija
  • Jezik:
  • hrvatski

Terapeutski informacija

  • Terapijska grupa:
  • Antihaemorrhagics
  • Područje terapije:
  • Hemostaza, Kirurški
  • Terapijske indikacije:
  • Evicel se koristi kao potporno liječenje u kirurgiji gdje su standardne kirurške tehnike nedovoljne za poboljšanje hemostaze. Evicel također je istaknuo kao шовного podrška гемостаз u oblasti vaskularne kirurgije.
  • Proizvod sažetak:
  • Revision: 14

Druge informacije

Status

  • Izvor:
  • EMA - European Medicines Agency
  • Status autorizacije:
  • odobren
  • Broj odobrenja:
  • EMEA/H/C/000898
  • Datum autorizacije:
  • 05-10-2008
  • EMEA koda:
  • EMEA/H/C/000898
  • Zadnje ažuriranje:
  • 20-12-2018

Uputu o lijeku: sastav, indikacije, doziranje, nuspojave, interakcija, trudnoća, dojenje

B. UPUTA O LIJEKU

Uputa o lijeku: Informacija za bolesnika

EVICEL otopine za tkivno ljepilo

humani fibrinogen

humani trombin

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

Sačuvajte ovu uputu. Možda ćete je trebati ponovno pročitati.

Ako imate dodatnih pitanja, obratite se liječniku.

Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika, ljekarnika ili medicinsku

sestru. To uključuje i svaku moguću nuspojavu koja nije navedena u ovoj uputi. Pogledajte dio

Što se nalazi u ovoj uputi:

Što je EVICEL i za što se koristi

Što morate znati prije nego primite EVICEL

Kako primjenjivati EVICEL

Moguće nuspojave

Kako čuvati EVICEL

Sadržaj pakiranja i druge informacije

1.

Što je EVICEL i za što se koristi

EVICEL je humano fibrinsko tkivno ljepilo koje se isporučuje u kutiji s dvije odvojene bočice, od

kojih svaka sadrži 1 ml, 2 ml ili 5 ml otopine (humanog fibrinogena odnosno humanog trombina).

Aplikator za primjenu lijeka i odgovarajući dodatni nastavci isporučuju se zasebno.

Fibrinogen je koncetrat proteina sa sposobnošću zgrušavanja, a trombin je enzim koji uzrokuje

sljepljivanje proteina sa sposobnošću zgrušavanja. Stoga, kada se te dvije komponente pomiješaju,

odmah stvaraju ugrušak.

EVICEL se primjenjuje u odraslih tijekom kirurških zahvata za smanjivanje krvarenja i iscjetka iz rane

za vrijeme i nakon operacije.

EVICEL se može koristiti u kirurgiji krvnih žila te u kirurškim zahvatima na stražnjoj trbušnoj

stijenci. EVICEL se također može koristiti kao potpora za nepropusno zatvaranje moždanih ovojnica

(dura mater) pri neurokirurškim operacijama kada su ostale kirurške tehnike nedostatne.

Lijek se kapa ili raspršuje po rezu tkiva gdje stvara tanak sloj koji zatvara tkivo i/ili zaustavlja

krvarenje.

2.

Što morate znati prije nego primite EVICEL

Nemojte primiti EVICEL

ako ste preosjetljivi (alergični) na lijekove dobivene iz ljudske krvi ili neki drugi sastojak lijeka

EVICEL (naveden u dijelu 6.). Znakovi alergijskih reakcija uključuju koprivnjaču, osip, stezanje

u prsnom košu, piskanje pri disanju, pad krvnog tlaka i otežano disanje. U slučaju pojave tih

simptoma odmah se mora prekinuti primjenu lijeka.

EVICEL se ne smije primjenjivati intravaskularno.

EVICEL nije za uporabu u endoskopskoj kirurgiji. Za laparoskopiju, pogledajte preporuke u

nastavku.

EVICEL se ne smije primjenjivati za lijepljenje linije šava dure mater ako nakon postavljenih

šavova zaostane razmak između rubova širi od 2 mm.

EVICEL se ne smije primjenjivati kao ljepilo za učvršćivanje duralnih zakrpa.

EVICEL se ne smije primjenjivati kao tkivno ljepilo kada se dura mater ne može zašiti.

Upozorenja i mjere opreza

Kako bi se izbjegao rizik od potencijalno smrtonosne zračne ili plinske embolije, pri nanošenju

lijeka EVICEL raspršivačem, smije se upotrebljavati isključivo stlačeni CO

Prije nanošenja lijeka EVICEL, površinu rane treba osušiti standardnim tehnikama (npr.

uzastopnim prislanjanjem kompresa, tupferima ili napravama za sukciju).

Kad se EVICEL primjenjuje tijekom kirurškog zahvata, kirurg mora osigurati da se primijeni

samo na površinu tkiva. EVICEL se ne smije injicirati u tkivo ili krvne žile jer bi uzrokovao

stvaranje ugrušaka koji mogu biti smrtonosni.

Primjena lijeka EVICEL nije ispitana u sljedećim postupcima te stoga nema podataka koji bi

ukazivali na njegovu djelotvornost kod sljedećih postupaka:

spajanja tkiva lijepljenjem

kirurških zahvata na mozgu ili leđnoj moždini osim potpore nepropusnom zatvaranju

moždanih ovojnica (dura mater)

kontrole krvarenja u želucu ili crijevima primjenom kroz endoskop (cjevčicu)

lijepljenja kod kirurških popravaka na crijevima.

lijepljenja kod transsfenoidalnih i otoneurokirurških postupaka

Nije poznato utječe li radioterapija na djelotvornost fibrinskog ljepila kada se primjenjuje za

lijepljenje linije šava u neurokirurškim postupcima.

Primjena lijeka EVICEL u neurokirurškim postupcima kod bolesnika kod kojih su ugrađeni

implantati ili postavljene duralne zakrpe nije ocijenjena u kliničkim ispitivanjima.

Kada se EVICEL primjenjuje za zatvaranje linije šava dure mater, potrebno je zaustaviti

krvarenje prije primjene lijeka.

Primijenite EVICEL u tankom sloju. Prekomjerna debljina ugruška može negativno interferirati

s djelotvornošću lijeka i procesom cijeljenja rane.

Kod primjene lijeka EVICEL putem raspršivača koji koriste regulator tlaka došlo je do po život

opasne zračne ili plinske embolije. Čini se da je ovaj događaj povezan s uporabom raspršivača pri

tlakovima višima od preporučenih i/ili u neposrednoj blizini površine tkiva. EVICEL se smije

primijeniti raspršivanjem samo kada je moguće točno odrediti udaljenost raspršivanja, posebice u

laparoskopskim postupcima. Udaljenost raspršivača od tkiva i tlak moraju biti unutar raspona koje

preporučuje proizvođač raspršivača (pogledajte tablicu u dijelu Upute za uporabu). Kada se EVICEL

raspršuje, moraju se pratiti promjene krvnog tlaka, pulsa, saturacije kisikom i CO

na kraju izdaha

zbog moguće pojave zračne ili plinske embolije. Kada se s ovim lijekom koriste dodatni nastavci,

potrebno je pažljivo se pridržavati uputa za uporabu i tamo preporučenih raspona tlaka i udaljenosti od

površine tkiva.

Okolna područja potrebno je zaštititi kako bi se osiguralo da se EVICEL primijeni samo na

površinu koju treba tretirati.

Kao i kod svakog lijeka koji sadrži proteine, moguće su alergijske reakcije preosjetljivosti.

Znakovi takvih reakcija uključuju koprivnjaču, osip, stezanje u prsnom košu, piskanje pri

disanju, pad krvnog tlaka i anafilaksiju. U slučaju pojave tih simptoma mora se odmah

prekinuti primjena lijeka.

Kada se lijekovi dobivaju iz ljudske krvi ili plazme, primjenjuju se određene mjere za

sprečavanje prijenosa zaraznih bolesti na bolesnike. One obuhvaćaju pažljiv odabir darivatelja

krvi i plazme kako bi se osiguralo isključivanje darivatelja koji su rizični za prijenos infekcije,

kao i testiranje svake darovane doze i “pulova” (objedinjenih doza) plazme na prisutnost

virusa/infekcije. Proizvođači ovih lijekova također tijekom obrade krvi i plazme primjenjuju

postupke koji mogu inaktivirati ili ukloniti viruse. Usprkos tim mjerama, kada se primjenjuju

lijekovi pripremljeni iz ljudske krvi ili plazme, ne može se potpuno isključiti mogućnost

prijenosa infekcije. To vrijedi i za nepoznate viruse, ili one koji se tek pojavljuju te za druge

vrste infekcija.

Mjere koje se poduzimaju u proizvodnji fibrinogena i trombina smatraju se učinkovitima protiv virusa

s lipidnom ovojnicom, poput virusa humane imunodeficijencije (HIV), virusa hepatitisa B i

hepatitisa C te za viruse bez ovojnice, poput virusa hepatitisa A. Poduzete mjere mogu imati

ograničenu djelotvornost protiv parvovirusa B19. Infekcija parvovirusom B19 može biti opasna za

trudnice (infekcija ploda), za osobe s oslabljenim imunološkim sustavom ili osobe koje boluju od

nekih vrsta anemije (npr. anemije srpastih stanica ili hemolitičke anemije).

Zdravstveni radnici će u povijest bolesti zabilježiti naziv i broj serije lijeka kako bi se mogao pratiti

trag eventualnog izvora infekcije.

Djeca i adolescenti

Premalo je podataka da bi se mogla poduprijeti sigurnost i učinkovitost lijeka EVICEL u djece i

adolescenata.

Drugi lijekovi i Evicel

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

druge lijekove, uključujući i one koji Vam nisu propisani.

Trudnoća i dojenje

Nema dovoljno podataka da bi se znalo postoji li neki poseban rizik povezan s primjenom lijeka

EVICEL tijekom trudnoće ili dojenja. Međutim, s obzirom da se EVICEL primjenjuje tijekom

kirurškog zahvata, ako ste trudni ili dojite, obratite se svom liječniku za savjet prije nego primite ovaj

lijek i raspravite s njim ukupan rizik od kirurškog zahvata.

3.

Kako primjenjivati EVICEL

Liječnik koji Vas liječi primijenit će EVICEL tijekom kirurškog zahvata.

Za vrijeme operacije liječnik će pomoću aplikatora nakapati ili raspršiti lijek EVICEL na otvoreno

tkivo. Aplikator omogućuje istodobnu primjenu jednakih količina obiju komponenti lijeka EVICEL i

njihovo ujednačeno miješanje, što je važno za postizanje optimalnog učinka tkivnog ljepila.

Količina lijeka EVICEL koja će se primijeniti ovisi o površini tkiva koja će se tretirati tijekom

operacije. Lijek se nakapava na tkivo u kratkim štrcajima ili se raspršuje u vrlo malim količinama

(0,1-0,2 ml) kako bi se stvorio tanak, ujednačen sloj. Ako primjena jednog sloja lijeka EVICEL ne

zaustavi krvarenje u potpunosti, može se primijeniti drugi sloj.

4.

Moguće nuspojave

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

sljedeće nuspojave koje su se pojavile tijekom kliničkih ispitivanja, smatra se da su povezane s

primjenom lijeka EVICEL:

Najozbiljnije nuspojave

vodenasti iscjedak iz rane ili iz nosa (istjecanje likvora, rinoreja likvora)

glavobolja, mučnina i povraćanje (uzrokovano subduralnim higromom, to jest nakupljanjem

cerebrospinalnog likvora u subduralnom prostoru)

vrućica ili dugotrajan zatvor, vjetrovi (uzrokovani abdominalnim apscesom)

Gore navedene nuspojave bile su česte (mogu se pojaviti u do 1 na 10 osoba).

utrnulost ili bol u udovima, promjena boje kože (uzrokovane okluzijom grafta ili trombozom)

Ove su nuspojave bile manje česte (mogu se pojaviti u do 1 na 100 osoba).

Primijetite li bilo koji od gore navedenih simptoma, ili bilo koje druge simptome vezane za Vaš

kirurški zahvat, odmah se obratite svom liječniku ili kirurgu. Ako se ne osjećate dobro, odmah o tome

obavijestite svog liječnika, čak i ako su vaši simptomi različiti od gore opisanih.

Ostale nuspojave

Ostale nuspojave prijavljene kao česte tijekom kliničkih ispitivanja lijeka EVICEL (mogu se pojaviti u

do 1 na 10 osoba) uključuju, meningitis i nakupljanje cerebrospinalnog likvora u moždanim

komorama (hidrocefalus). Sve ove nuspojave bile su česte.

Manje česte nuspojave tijekom kliničkih ispitivanja lijeka EVICEL (mogu se pojaviti u 1 na 100

osoba), uključuju infekciju, nakupljanje krvi (hematome), oticanje, smanjenje koncentracije

hemoglobina, te postoperativne komplikacije rane (uključujući krvarenje ili infekciju).

EVICEL je fibrinsko tkivno ljepilo. Fibrinska tkivna ljepila općenito mogu u rijetkim slučajevima (u

do 1 na 1000 osoba) uzrokovati alergijske reakcije. Ako razvijete alergijsku reakciju, možete imati

jedan ili više od sljedećih simptoma: kožni osip, koprivnjaču, stezanje u prsnom košu, zimicu, navale

crvenila, glavobolju, nizak krvni tlak, bezvoljnost, mučninu, osjećaj nemira, ubrzani puls, trnce,

povraćanje ili piskanje pri disanju. Do sada nisu prijavljene alergijske reakcije u bolesnika liječenih

lijekom EVICEL.

Postoji također teoretska mogućnost da razvijete protutijela na proteine u lijeku EVICEL, što bi

potencijalno moglo ometati zgrušavanje krvi. Učestalost ove vrste događaja nije poznata (ne može se

procijeniti iz dostupnih podataka).

Prijavljivanje nuspojava

Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika, ljekarnika ili medicinsku sestru.

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 EVICEL

Lijek čuvajte izvan pogleda i dohvata djece.

Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici i pakiranju iza

oznake „Rok valjanosti” / „EXP“. Rok valjanosti odnosi se na zadnji dan navedenog mjeseca.

Bočice se moraju čuvati u uspravnom položaju.

Čuvati u zamrzivaču na temperaturi od -18°C ili nižoj. Bočice čuvati u vanjskom pakiranju radi zaštite

od svjetlosti. Ne ponovno zamrzavati.

Nakon odmrzavanja, neotvorene bočice mogu se čuvati na temperaturi od 2°C - 8°C i zaštićene od

svjetlosti najdulje 30 dana, bez ponovnog zamrzavanja tijekom tog razdoblja. Novi datum roka

valjanosti na temperaturi od 2°C - 8 °C potrebno je zabilježiti na kutiji, ali on ne smije prelaziti rok

valjanosti koji je proizvođač otisnuo na kutiju i naljepnicu. Na kraju tog razdoblja lijek se mora

primjeniti ili zbrinuti u otpad.

Komponente fibrinogen i trombin stabilne su na sobnoj temperaturi do 24 sata. Nakon što je postigao

sobnu temperaturu, EVICEL nemojte odlagati u hladnjak. Nakon što se navuče u aplikator, mora se

odmah upotrijebiti. Zbrinite u otpad neupotrijebljeni lijek nakon 24 sata na sobnoj temperaturi.

6.

Sadržaj pakiranja i druge informacije

Što EVICEL sadrži

Djelatne tvari navedene su u nastavku:

Komponenta 1: Humani protein sa sposobnošću zgrušavanja koji sadrži većinom fibrinogen i

fibronektin (50-90 mg/ml)

Komponenta 2: Humani trombin (800-1200 IU/ml)

Drugi sastojci su:

Komponenta 1: argininklorid, glicin, natrijev klorid, natrijev citrat, kalcijev klorid, voda za injekcije.

Komponenta 2: kalcijev klorid, humani albumin, manitol, natrijev acetat i voda za injekcije.

Kako EVICEL izgleda i sadržaj pakiranja

Veličine pakiranja

EVICEL je humano fibrinsko tkivno ljepilo koje se isporučuje u kutiji s dvije odvojene staklene

bočice. Svaka sadrži 1 ml, 2 ml ili 5 ml otopine humanog fibrinogena odnosno humanog trombina.

EVICEL je dostupan u sljedećim veličinama pakiranja: 2 x 1 ml, 2 x 2 ml i 2 x 5 ml. Na tržištu svih

zemalja se ne moraju nalaziti sve veličine pakiranja.

Aplikator za primjenu lijeka i odgovarajući dodatni nastavci isporučuju se zasebno.

Nositelj odobrenja za stavljanje lijeka u promet:

Omrix Biopharmaceuticals N.V.

Leonardo Da Vinci Laan 15

B-1831 Diegem

Belgija

Tel: + 32 2 746 30 00

Fax: + 32 2 746 30 01

Proizvođač

Omrix Biopharmaceuticals Ltd.

Plasma Fractionation Institute

Sheba Hospital, Tel Hashomer

Ramat Gan 5262000, Izrael

Tel:

+972-3-5316512

Fax:

+972-3-5316590

Ova uputa je zadnji puta revidirana u

Ostali izvori informacija

Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za

lijekove: http://www.ema.europa.eu.

Ova uputa o lijeku dostupna je na svim jezicima EU-a/EGP-a na internetskim stranicama Europske

agencije za lijekove.

Sljedeće informacije namijenjene su samo zdravstvenim radnicima.

UPUTE ZA UPORABU

Pročitajte ove upute prije nego otvorite pakiranje

EVICEL se isporučuje u sterilnim pakiranjima te je stoga važno da upotrijebite

samo

neoštećena

pakiranja koja nisu otvarana (naknadna sterilizacija nije moguća).

Čuvanje

Odobreni rok valjanosti lijeka EVICEL je 2-godišnje čuvanje na temperaturi od ≤18°C. Lijek se ne

smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji.

Unutar 2-godišnjeg roka valjanosti, nakon odmrzavanja, neotvorene bočice mogu se čuvati na

temperaturi od 2°C - 8°C (u hladnjaku) i zaštićene od svjetlosti najdulje 30 dana. Datum početka

čuvanja lijeka u hladnjaku treba naznačiti na kutiji u za to predviđenom prostoru. Ne ponovno

zamrzavati.

Komponente fibrinogen i trombin su stabilni na sobnoj temperaturi do 24 sata, ali nakon što se navuku

u aplikator, moraju se odmah upotrijebiti.

Bočice se moraju čuvati u uspravnom položaju.

Lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i naljepnici.

Čuvati izvan pogleda i dohvata djece.

Aplikator za primjenu lijeka se treba čuvati na sobnoj temperaturi, odvojeno od fibrinogena i

trombina.

Odmrzavanje

Bočice je potrebno odmrznuti na jedan od sljedećih načina:

temperaturi od

2°C

8°C

(u hladnjaku): bočice će se odmrznuti za jedan dan,

na temperaturi od

20°C

25°C

(sobna temperatura): bočice će se odmrznuti za jedan sat

na temperaturi od

37°C

(npr. vodena kupelj, primjenom aseptičke tehnike ili zagrijavanjem bočice u

ruci): bočice je potrebno odmrznuti u roku od 10 minuta te ih se ne smije ostaviti na toj temperaturi

dulje od 10 minuta ili dok se potpuno ne odmrznu. Temperatura ne smije premašiti 37°C.

Prije primjene lijek mora dostići temperaturu od 20°C

30°C.

Priprema

EVICEL se primjenjuje isključivo pomoću aplikatora lijeka EVICEL koji ima oznaku CE, uz koji se

po izboru mogu koristiti dodatni nastavci. U pakiranjima aplikatora i dodatnog pribora nalaze se

detaljne upute za primjenu lijeka EVICEL pomoću aplikatora i dodatnog pribora po izboru.

Dodatne nastavke smiju koristiti samo osobe koje su na odgovarajući način obučene za laparoskopske,

laparoskopijom potpomognute ili otvorene kirurške zahvate. Lijek treba rekonstituirati i primijeniti

samo u skladu s uputama i s napravama koje se preporučuju za ovaj lijek.

Kako biste izbjegli rizik od moguće po život opasne zračne ili plinske embolije, Evicel treba

raspršivati samo pomoću stlačenog CO

Otopine trebaju biti bistre ili blago opalescentne. Ne smiju se upotrijebiti otopine koje su zamućene ili

imaju talog. Navucite sadržaj dviju bočica u aplikator slijedeći upute za uporabu priložene u pakiranju

aplikatora. Obje štrcaljke potrebno je napuniti jednakim volumenom otopina, a nijedna ne smije

sadržavati mjehuriće zraka. Za pripravu lijeka EVICEL za primjenu ne koriste se igle.

Prije primjene EVICEL-a površinsko područje rane treba osušiti standardnim tehnikama (primjerice,

povremenom primjenom kompresa, tupfera, uređaja za sukciju).

Primjena kapanjem

Držeći nastavak aplikatora što bliže površini tkiva, ali ne dodirujući tkivo tijekom primjene, nanesite

pojedinačne kapi na područje koje se tretira. Ako se nastavak aplikatora začepi, vršak katetera može se

svaki puta odrezati za 0,5 cm.

Primjena raspršivanjem

EVICEL se smije primijeniti samo raspršivanjem pomoću stlačenog CO

Spojite kratku cijev na aplikatoru na muški kraj luer-nastavka duge plinske cijevi. Spojite ženski luer-

nastavak plinske cijevi (s bakteriostatskim filtrom veličine pora 0,2 μm) na regulator tlaka. Regulator

tlaka potrebno je koristiti u skladu s uputama proizvođača.

Kada EVICEL primjenjujete raspršivačem, pazite da su upotrijebljeni tlak i udaljenost od tkiva unutar

raspona koji preporučuje proizvođač raspršivača.

Kirurški

zahvat

Komplet za

raspršivanje

koji se

koristi

Nastavci

aplikatora koji se

koriste

Regulator

tlaka koji

se koristi

Udaljenost

od ciljnog

tkiva

Tlak

raspršivanja

Otvoreni

kirurški

zahvat

Aplikator

lijeka

EVICEL

savitljivi nastavak

duljine 6 cm

Regulator

tlaka

Omrix

10 – 15 cm

20 – 25 psi

(1,4 – 1,7 bar)

kruti nastavak

duljine 35 cm

savitljivi nastavak

duljine 45 cm

Laparoskopski

postupci

kruti nastavak

duljine 35 cm

4 – 10 cm

15 – 20 psi

(1,0 – 1,4 bar)

savitljivi nastavak

duljine 45 cm

20 psi

(1,4 bar)

Lijek je potrebno raspršiti na površinu tkiva u kratkim štrcajima (0,1-0,2 ml) kako bi se formirao

tanak, ujednačen sloj. EVICEL stvara proziran film preko područja primjene.

Kada raspršujete EVICEL, moraju se pratiti promjene krvnog tlaka, pulsa, saturacije kisikom i CO

kraju izdaha zbog moguće pojave plinske embolije.

Zbrinjavanje

Neiskorišteni lijek ili otpadni materijal potrebno je zbrinuti sukladno nacionalnim propisima.

19-3-2019

ANSES and University of Rennes 1 strengthen their scientific cooperation dedicated to "One Health"

ANSES and University of Rennes 1 strengthen their scientific cooperation dedicated to "One Health"

Roger Genet, Director General of ANSES, and David Alis, President of the University of Rennes 1, today signed a scientific framework agreement aimed at strengthening their cooperation on environmental health, focused primarily on the "One Health" concept covering human, animal and plant health for the benefit of all. To mark this occasion, a conference and round table were organised on the theme of the exposome, one of the key issues at the heart of this new partnership between the two institutions.  

France - Agence Nationale du Médicament Vétérinaire

13-3-2019

Pest categorisation of Phymatotrichopsis omnivora

Pest categorisation of Phymatotrichopsis omnivora

Published on: Tue, 12 Mar 2019 The Panel on Plant Health performed a pest categorisation of Phymatotrichopsis omnivora, the causal agent of Phymatotrichum root rot of more than 2,000 dicotyledonous plant species, for the EU. The pest is listed as Trechispora brinkmannii in Annex IAI of Directive 2000/29/EC. P. omnivora is a well‐defined fungal species and reliable methods exist for its detection and identification. It is present in south‐western USA, northern Mexico, Libya and Venezuela. The pest is not...

Europe - EFSA - European Food Safety Authority EFSA Journal

13-3-2019

Safety and efficacy of Probion forte® (Bacillus subtilis KCCM 10941P and Bacillus coagulans KCCM 11093P) for chickens for fattening

Safety and efficacy of Probion forte® (Bacillus subtilis KCCM 10941P and Bacillus coagulans KCCM 11093P) for chickens for fattening

Published on: Tue, 12 Mar 2019 In 2017, the EFSA Panel on Additive and Products or Substances used in Animal Feed (FEEDAP) delivered a scientific opinion on the safety and efficacy of Probion Forte®(Bacillus subtilis KCCM 10941P and Bacillus coagulans KCCM 11093P) as a feed additive for chickens for fattening. The two bacterial species are considered suitable for the qualified presumption of safety (QPS) approach to safety assessment provided that the identity of the strains is established and the lack ...

Europe - EFSA - European Food Safety Authority EFSA Journal

7-3-2019

American Health Packaging Issues Voluntary Nationwide Recall of Valsartan Tablets Due to the Detection of NDEA (N-Nitrosodiethylamine) Impurity

American Health Packaging Issues Voluntary Nationwide Recall of Valsartan Tablets Due to the Detection of NDEA (N-Nitrosodiethylamine) Impurity

American Health Packaging is voluntarily recalling one lot of Valsartan Tablets, USP, 160 mg to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug product. The impurity detected in the finished drug product is N-Nitrosodiethylamine (NDEA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Resea...

FDA - U.S. Food and Drug Administration

7-3-2019

USDA and FDA Announce a Formal Agreement to Regulate Cell-Cultured Food Products from Cell Lines of Livestock and Poultry

USDA and FDA Announce a Formal Agreement to Regulate Cell-Cultured Food Products from Cell Lines of Livestock and Poultry

USDA’s Food Safety and Inspection Service and FDA announce a formal agreement to jointly oversee the production of human food products derived from the cells of livestock and poultry

FDA - U.S. Food and Drug Administration

7-3-2019

Safety and efficacy of Robenz® 66G (robenidine hydrochloride) for chickens for fattening and turkeys for fattening

Safety and efficacy of Robenz® 66G (robenidine hydrochloride) for chickens for fattening and turkeys for fattening

Published on: Tue, 05 Mar 2019 Following a request from European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of Robenz® 66G (robenidine hydrochloride (HCl)) when used as a feed additive for chickens for fattening and turkeys for fattening. The coccidiostat Robenz®66G is considered safe for chickens for fattening at the highest proposed level of 36 mg robenidine HCl/kg complete feed with a ...

Europe - EFSA - European Food Safety Authority EFSA Journal

1-3-2019

AurobindoPharma USA, Inc. Initiates a Voluntary Nationwide Consumer Level Recall Expansion of 38 Lots of Amlodipine Valsartan Tablets USP and Valsartan Tablets, USP due to the detection of NDEA (N-Nitrosodiethylamine) Impurity.

AurobindoPharma USA, Inc. Initiates a Voluntary Nationwide Consumer Level Recall Expansion of 38 Lots of Amlodipine Valsartan Tablets USP and Valsartan Tablets, USP due to the detection of NDEA (N-Nitrosodiethylamine) Impurity.

AurobindoPharma USA, Inc. is conducting a voluntary recall expansion of 38 lots of Valsartan and Amlodipine and Valsartan tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug product. This recall is an expansion of the recall initiated 12/31/18 The impurity detected in the finished drug product is N-nitrosodiethylamine (NDEA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial proc...

FDA - U.S. Food and Drug Administration

27-2-2019

The European Union summary report on antimicrobial resistance in zoonotic and indicator bacteria from humans, animals and food in 2017

The European Union summary report on antimicrobial resistance in zoonotic and indicator bacteria from humans, animals and food in 2017

Published on: Tue, 26 Feb 2019 The data on antimicrobial resistance in zoonotic and indicator bacteria in 2017, submitted by 28 EU Member States (MSs), were jointly analysed by EFSA and ECDC. Resistance in zoonotic Salmonella and Campylobacter from humans, animals and food, and resistance in indicator Escherichia coli as well as meticillin-resistant Staphylococcus aureus in animals and food were addressed, and temporal trends assessed. ‘Microbiological’ resistance was assessed using epidemiological cut-...

Europe - EFSA - European Food Safety Authority EFSA Journal

26-2-2019

Giant hogweed: limit its proliferation in order to reduce risks to human health and the environment

Giant hogweed: limit its proliferation in order to reduce risks to human health and the environment

Placed on the European Union's list of invasive species of concern, giant hogweed presents risks both to the flora of the environments it colonises and to human health. In response to this observation, ANSES was asked to summarise knowledge regarding this plant and make risk management recommendations. With its expert assessment work completed, the Agency recommends the creation of a monitoring system and the use of available control methods to eradicate giant hogweed populations in high-priority areas.

France - Agence Nationale du Médicament Vétérinaire

26-2-2019

Safety and efficacy of TYFER™ (ferric tyrosine chelate) as a zootechnical feed additive for chickens, turkeys and minor poultry species for fattening or reared for laying/breading

Safety and efficacy of TYFER™ (ferric tyrosine chelate) as a zootechnical feed additive for chickens, turkeys and minor poultry species for fattening or reared for laying/breading

Published on: Mon, 25 Feb 2019 Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the product TYFER™ (ferric tyrosine chelate) as zootechnical feed additive for chickens, turkeys and minor poultry species for fattening or reared for laying/breeding. The additive is safe for chickens for fattening at the maximum expected level of 200 mg TYFER™/kg complete feed; this conclusion can be extended to chickens reared for laying/breedin...

Europe - EFSA - European Food Safety Authority EFSA Journal

20-2-2019

Salmonella control in poultry flocks and its public health impact

Salmonella control in poultry flocks and its public health impact

Published on: Mon, 18 Feb 2019 An increase in confirmed human salmonellosis cases in the EU after 2014 triggered investigation of contributory factors and control options in poultry production. Reconsideration of the five current target serovars for breeding hens showed that there is justification for retaining Salmonella Enteritidis, Salmonella Typhimurium (including monophasic variants) and Salmonella Infantis, while Salmonella Virchow and Salmonella Hadar could be replaced by Salmonella Kentucky and ...

Europe - EFSA - European Food Safety Authority EFSA Journal

19-3-2019


Human medicines European public assessment report (EPAR): Erleada, apalutamide, Prostatic Neoplasms, Date of authorisation: 14/01/2019, Status: Authorised

Human medicines European public assessment report (EPAR): Erleada, apalutamide, Prostatic Neoplasms, Date of authorisation: 14/01/2019, Status: Authorised

Human medicines European public assessment report (EPAR): Erleada, apalutamide, Prostatic Neoplasms, Date of authorisation: 14/01/2019, Status: Authorised

Europe - EMA - European Medicines Agency

18-3-2019


Orphan designation: Autologous CD34+ haematopoietic stem cells transduced with lentiviral vector encoding the human betaA-T87Q-globin gene, Treatment of beta thalassaemia intermedia and major, 24/01/2013, Positive

Orphan designation: Autologous CD34+ haematopoietic stem cells transduced with lentiviral vector encoding the human betaA-T87Q-globin gene, Treatment of beta thalassaemia intermedia and major, 24/01/2013, Positive

Orphan designation: Autologous CD34+ haematopoietic stem cells transduced with lentiviral vector encoding the human betaA-T87Q-globin gene, Treatment of beta thalassaemia intermedia and major, 24/01/2013, Positive

Europe - EMA - European Medicines Agency

18-3-2019


Orphan designation: Human haptoglobin, Treatment of sickle cell disease, 09/12/2011, Positive

Orphan designation: Human haptoglobin, Treatment of sickle cell disease, 09/12/2011, Positive

Orphan designation: Human haptoglobin, Treatment of sickle cell disease, 09/12/2011, Positive

Europe - EMA - European Medicines Agency

14-3-2019


Human medicines European public assessment report (EPAR): Lusutrombopag Shionogi, lusutrombopag, Thrombocytopenia, Date of authorisation: 18/02/2019, Status: Authorised

Human medicines European public assessment report (EPAR): Lusutrombopag Shionogi, lusutrombopag, Thrombocytopenia, Date of authorisation: 18/02/2019, Status: Authorised

Human medicines European public assessment report (EPAR): Lusutrombopag Shionogi, lusutrombopag, Thrombocytopenia, Date of authorisation: 18/02/2019, Status: Authorised

Europe - EMA - European Medicines Agency

14-3-2019


Orphan designation: recombinant human interleukin-3 truncated diphtheria toxin fusion protein, Treatment of acute myeloid leukaemia, 09/10/2015, Positive

Orphan designation: recombinant human interleukin-3 truncated diphtheria toxin fusion protein, Treatment of acute myeloid leukaemia, 09/10/2015, Positive

Orphan designation: recombinant human interleukin-3 truncated diphtheria toxin fusion protein, Treatment of acute myeloid leukaemia, 09/10/2015, Positive

Europe - EMA - European Medicines Agency

13-3-2019

Actrapid (Novo Nordisk A/S)

Actrapid (Novo Nordisk A/S)

Actrapid (Active substance: Insulin human (rDNA)) - Centralised - Yearly update - Commission Decision (2019)2070 of Wed, 13 Mar 2019

Europe -DG Health and Food Safety

12-3-2019


Orphan designation: C1 esterase inhibitor (human), Treatment in solid organ transplantation, 14/12/2018, Positive

Orphan designation: C1 esterase inhibitor (human), Treatment in solid organ transplantation, 14/12/2018, Positive

Orphan designation: C1 esterase inhibitor (human), Treatment in solid organ transplantation, 14/12/2018, Positive

Europe - EMA - European Medicines Agency

11-3-2019


Orphan designation: Bifunctional fusion protein composed of two extracellular domains of transforming growth factor beta receptor II fused with a human immunoglobulin G1 monoclonal antibody against programmed death ligand 1, Treatment of biliary tract ca

Orphan designation: Bifunctional fusion protein composed of two extracellular domains of transforming growth factor beta receptor II fused with a human immunoglobulin G1 monoclonal antibody against programmed death ligand 1, Treatment of biliary tract ca

Orphan designation: Bifunctional fusion protein composed of two extracellular domains of transforming growth factor beta receptor II fused with a human immunoglobulin G1 monoclonal antibody against programmed death ligand 1, Treatment of biliary tract cancer, 14/12/2018, Positive

Europe - EMA - European Medicines Agency

8-3-2019

EU/3/12/968 (Clinical Network Services (NL) B.V.)

EU/3/12/968 (Clinical Network Services (NL) B.V.)

EU/3/12/968 (Active substance: Human monoclonal antibody targeting Staphylococcus aureus alpha-toxin) - Transfer of orphan designation - Commission Decision (2019)1940 of Fri, 08 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004447

Europe -DG Health and Food Safety

8-3-2019

EU/3/17/1894 (Granzer Regulatory Consulting and Services)

EU/3/17/1894 (Granzer Regulatory Consulting and Services)

EU/3/17/1894 (Active substance: Recombinant human antibody directed against misfolded human superoxide dismutase 1) - Transfer of orphan designation - Commission Decision (2019)1943 of Fri, 08 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004025

Europe -DG Health and Food Safety

8-3-2019

EU/3/06/381 (Clinical Network Services (NL) B.V.)

EU/3/06/381 (Clinical Network Services (NL) B.V.)

EU/3/06/381 (Active substance: Human monoclonal antibody against Pseudomonas aeruginosa serotype O11) - Transfer of orphan designation - Commission Decision (2019)1941 of Fri, 08 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004486

Europe -DG Health and Food Safety

8-3-2019


Orphan designation: Adeno-associated virus serotype HSC15 expressing human phenylalanine hydroxylase, Treatment of phenylalanine hydroxylase deficiency, 14/12/2018, Positive

Orphan designation: Adeno-associated virus serotype HSC15 expressing human phenylalanine hydroxylase, Treatment of phenylalanine hydroxylase deficiency, 14/12/2018, Positive

Orphan designation: Adeno-associated virus serotype HSC15 expressing human phenylalanine hydroxylase, Treatment of phenylalanine hydroxylase deficiency, 14/12/2018, Positive

Europe - EMA - European Medicines Agency

7-3-2019

Kiovig (Baxter AG)

Kiovig (Baxter AG)

Kiovig (Active substance: Human normal immunoglobulin (IVIg)) - Centralised - 2-Monthly update - Commission Decision (2019)1909 of Thu, 07 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/628/IB/88

Europe -DG Health and Food Safety

7-3-2019


Orphan designation: Adeno-associated viral vector expressing human 21- hydroxylase, Treatment of congenital adrenal hyperplasia, 14/12/2018, Positive

Orphan designation: Adeno-associated viral vector expressing human 21- hydroxylase, Treatment of congenital adrenal hyperplasia, 14/12/2018, Positive

Orphan designation: Adeno-associated viral vector expressing human 21- hydroxylase, Treatment of congenital adrenal hyperplasia, 14/12/2018, Positive

Europe - EMA - European Medicines Agency

7-3-2019


Orphan designation: Human anti-promyostatin monoclonal antibody, Treatment of spinal muscular atrophy, 14/12/2018, Positive

Orphan designation: Human anti-promyostatin monoclonal antibody, Treatment of spinal muscular atrophy, 14/12/2018, Positive

Orphan designation: Human anti-promyostatin monoclonal antibody, Treatment of spinal muscular atrophy, 14/12/2018, Positive

Europe - EMA - European Medicines Agency

6-3-2019


Human medicines highlights - March 2019

Human medicines highlights - March 2019

Human medicines highlights - March 2019

Europe - EMA - European Medicines Agency

6-3-2019

Consultation: Proposed medical device classification for human cells, tissues and organs storage solutions and IVF media

Consultation: Proposed medical device classification for human cells, tissues and organs storage solutions and IVF media

This consultation paper considers the EU regulatory framework as an input into the review and reform of the Australian regulatory requirements for medical devices classification. Closing date: 29 April 2019

Therapeutic Goods Administration - Australia

4-3-2019


Orphan designation: Autologous haematopoietic stem cells transduced with lentiviral vector Lenti-D encoding the human ABCD1 cDNA, Treatment of adrenoleukodystrophy, 06/06/2012, Positive

Orphan designation: Autologous haematopoietic stem cells transduced with lentiviral vector Lenti-D encoding the human ABCD1 cDNA, Treatment of adrenoleukodystrophy, 06/06/2012, Positive

Orphan designation: Autologous haematopoietic stem cells transduced with lentiviral vector Lenti-D encoding the human ABCD1 cDNA, Treatment of adrenoleukodystrophy, 06/06/2012, Positive

Europe - EMA - European Medicines Agency

1-3-2019


Human medicines European public assessment report (EPAR): Rizmoic, naldemedine, Constipation, Date of authorisation: 18/02/2019, Status: Authorised

Human medicines European public assessment report (EPAR): Rizmoic, naldemedine, Constipation, Date of authorisation: 18/02/2019, Status: Authorised

Human medicines European public assessment report (EPAR): Rizmoic, naldemedine, Constipation, Date of authorisation: 18/02/2019, Status: Authorised

Europe - EMA - European Medicines Agency

1-3-2019

EU/3/15/1563 (TMC Pharma (EU) Limited)

EU/3/15/1563 (TMC Pharma (EU) Limited)

EU/3/15/1563 (Active substance: Recombinant human interleukin-3 truncated diphtheria toxin fusion protein) - Transfer of orphan designation - Commission Decision (2019)1751 of Fri, 01 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003921

Europe -DG Health and Food Safety

1-3-2019


Referral: Syner-Kinase and associated names, urokinase, Article 29(4) referrals, Opinion provided by Committee for Medicinal Products for Human Use, 28/02/2019

Referral: Syner-Kinase and associated names, urokinase, Article 29(4) referrals, Opinion provided by Committee for Medicinal Products for Human Use, 28/02/2019

Referral: Syner-Kinase and associated names, urokinase, Article 29(4) referrals, Opinion provided by Committee for Medicinal Products for Human Use, 28/02/2019

Europe - EMA - European Medicines Agency

28-2-2019

EU/3/19/2141 (Fondazione Telethon)

EU/3/19/2141 (Fondazione Telethon)

EU/3/19/2141 (Active substance: Lentiviral vector encoding human coagulation factor IX) - Orphan designation - Commission Decision (2019)1733 of Thu, 28 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000002293

Europe -DG Health and Food Safety

28-2-2019

EU/3/19/2140 (Artemida Pharma Europe Limited)

EU/3/19/2140 (Artemida Pharma Europe Limited)

EU/3/19/2140 (Active substance: Humanised IGg1 monoclonal antibody targeting human transferrin receptor conjugated to human iduronate-2-sulfatase) - Orphan designation - Commission Decision (2019)1732 of Thu, 28 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000001793

Europe -DG Health and Food Safety

26-2-2019


Human medicines European public assessment report (EPAR): Macimorelin Aeterna Zentaris, macimorelin, Diagnostic Techniques, Endocrine, Date of authorisation: 11/01/2019, Status: Authorised

Human medicines European public assessment report (EPAR): Macimorelin Aeterna Zentaris, macimorelin, Diagnostic Techniques, Endocrine, Date of authorisation: 11/01/2019, Status: Authorised

Human medicines European public assessment report (EPAR): Macimorelin Aeterna Zentaris, macimorelin, Diagnostic Techniques, Endocrine, Date of authorisation: 11/01/2019, Status: Authorised

Europe - EMA - European Medicines Agency

26-2-2019

Survey of human insulin products

Survey of human insulin products

The TGA has tested a range of human insulin products and all met the applicable quality standards

Therapeutic Goods Administration - Australia

25-2-2019


Orphan designation: Ex vivo fused normal allogeneic human myoblast with another normal allogeneic human myoblast, Treatment of Duchenne muscular dystrophy, 19/11/2018, Positive

Orphan designation: Ex vivo fused normal allogeneic human myoblast with another normal allogeneic human myoblast, Treatment of Duchenne muscular dystrophy, 19/11/2018, Positive

Orphan designation: Ex vivo fused normal allogeneic human myoblast with another normal allogeneic human myoblast, Treatment of Duchenne muscular dystrophy, 19/11/2018, Positive

Europe - EMA - European Medicines Agency

25-2-2019

EU/3/12/1091 (bluebird bio (Netherlands) B.V.)

EU/3/12/1091 (bluebird bio (Netherlands) B.V.)

EU/3/12/1091 (Active substance: Autologous CD34+ haematopoietic stem cells transduced with lentiviral vector encoding the human betaA-T87Q-globin gene) - Transfer of orphan designation - Commission Decision (2019)1626 of Mon, 25 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003556

Europe -DG Health and Food Safety

25-2-2019

EU/3/12/1003 (bluebird bio (Netherlands) B.V.)

EU/3/12/1003 (bluebird bio (Netherlands) B.V.)

EU/3/12/1003 (Active substance: Autologous haematopoietic stem cells transduced with lentiviral vector Lenti-D encoding the human ABCD1 cDNA) - Transfer of orphan designation - Commission Decision (2019)1634 of Mon, 25 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003636

Europe -DG Health and Food Safety

25-2-2019

EU/3/15/1518 (Novartis Europharm Limited)

EU/3/15/1518 (Novartis Europharm Limited)

EU/3/15/1518 (Active substance: Adenovirus-associated viral vector serotype 2 containing the human RPE65 gene) - Transfer of orphan designation - Commission Decision (2019)1628 of Mon, 25 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003549

Europe -DG Health and Food Safety

25-2-2019

EU/3/12/981 (Novartis Europharm Limited)

EU/3/12/981 (Novartis Europharm Limited)

EU/3/12/981 (Active substance: Adenovirus associated viral vector serotype 2 containing the human RPE65 gene) - Transfer of orphan designation - Commission Decision (2019)1627 of Mon, 25 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003485

Europe -DG Health and Food Safety

25-2-2019


Orphan designation: Ex vivo fused normal allogeneic human myoblast with autologous human myoblast derived from Duchenne muscular dystrophy affected donor, Treatment of Duchenne muscular dystrophy, 19/11/2019, Positive

Orphan designation: Ex vivo fused normal allogeneic human myoblast with autologous human myoblast derived from Duchenne muscular dystrophy affected donor, Treatment of Duchenne muscular dystrophy, 19/11/2019, Positive

Orphan designation: Ex vivo fused normal allogeneic human myoblast with autologous human myoblast derived from Duchenne muscular dystrophy affected donor, Treatment of Duchenne muscular dystrophy, 19/11/2019, Positive

Europe - EMA - European Medicines Agency

25-2-2019


Orphan designation: Anti-GD2 monoclonal antibody 3F8 humanised, Treatment of neuroblastoma, 19/11/2018, Positive

Orphan designation: Anti-GD2 monoclonal antibody 3F8 humanised, Treatment of neuroblastoma, 19/11/2018, Positive

Orphan designation: Anti-GD2 monoclonal antibody 3F8 humanised, Treatment of neuroblastoma, 19/11/2018, Positive

Europe - EMA - European Medicines Agency

22-2-2019


Orphan designation: Adult human bone-marrow-derived, ex-vivo-expanded, pooled allogeneic mesenchymal stromal cells, Treatment of thromboangiitis obliterans (Buerger's disease), 21/05/2015, Positive

Orphan designation: Adult human bone-marrow-derived, ex-vivo-expanded, pooled allogeneic mesenchymal stromal cells, Treatment of thromboangiitis obliterans (Buerger's disease), 21/05/2015, Positive

Orphan designation: Adult human bone-marrow-derived, ex-vivo-expanded, pooled allogeneic mesenchymal stromal cells, Treatment of thromboangiitis obliterans (Buerger's disease), 21/05/2015, Positive

Europe - EMA - European Medicines Agency

22-2-2019


Orphan designation: Modified recombinant human C-type natriuretic peptide (Vosoritide), Treatment of achondroplasia, 24/01/2013, Positive

Orphan designation: Modified recombinant human C-type natriuretic peptide (Vosoritide), Treatment of achondroplasia, 24/01/2013, Positive

Orphan designation: Modified recombinant human C-type natriuretic peptide (Vosoritide), Treatment of achondroplasia, 24/01/2013, Positive

Europe - EMA - European Medicines Agency

22-2-2019


Orphan designation: Pegylated recombinant human hyaluronidase PH20(pegvorhyaluronidase alfa), Treatment of pancreatic cancer, 16/12/2014, Positive

Orphan designation: Pegylated recombinant human hyaluronidase PH20(pegvorhyaluronidase alfa), Treatment of pancreatic cancer, 16/12/2014, Positive

Orphan designation: Pegylated recombinant human hyaluronidase PH20(pegvorhyaluronidase alfa), Treatment of pancreatic cancer, 16/12/2014, Positive

Europe - EMA - European Medicines Agency

21-2-2019


Orphan designation: Recombinant human growth hormone modified by fusion with two hydrophilic polypeptide chains (somavaratan), Treatment of growth-hormone deficiency, 05/08/2013, Withdrawn

Orphan designation: Recombinant human growth hormone modified by fusion with two hydrophilic polypeptide chains (somavaratan), Treatment of growth-hormone deficiency, 05/08/2013, Withdrawn

Orphan designation: Recombinant human growth hormone modified by fusion with two hydrophilic polypeptide chains (somavaratan), Treatment of growth-hormone deficiency, 05/08/2013, Withdrawn

Europe - EMA - European Medicines Agency

20-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Nanobody directed towards the fusion protein of human respiratory syncytial virus (ALX-0171), decision type: , therapeutic area: , PIP number: P/0367/2018

Opinion/decision on a Paediatric investigation plan (PIP): Nanobody directed towards the fusion protein of human respiratory syncytial virus (ALX-0171), decision type: , therapeutic area: , PIP number: P/0367/2018

Opinion/decision on a Paediatric investigation plan (PIP): Nanobody directed towards the fusion protein of human respiratory syncytial virus (ALX-0171), decision type: , therapeutic area: , PIP number: P/0367/2018

Europe - EMA - European Medicines Agency

20-2-2019

Silgard (Merck Sharp and Dohme Limited)

Silgard (Merck Sharp and Dohme Limited)

Silgard (Active substance: Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed)) - Centralised - Withdrawal - Commission Decision (2019)1516 of Wed, 20 Feb 2019

Europe -DG Health and Food Safety

20-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Autologous CD34+ hematopoietic stem cells transduced ex vivo with EFS lentiviral vector encoding for the human adenosine deaminase gene, decision type: , therapeutic area: , PIP number: P/0400/20

Opinion/decision on a Paediatric investigation plan (PIP): Autologous CD34+ hematopoietic stem cells transduced ex vivo with EFS lentiviral vector encoding for the human adenosine deaminase gene, decision type: , therapeutic area: , PIP number: P/0400/20

Opinion/decision on a Paediatric investigation plan (PIP): Autologous CD34+ hematopoietic stem cells transduced ex vivo with EFS lentiviral vector encoding for the human adenosine deaminase gene, decision type: , therapeutic area: , PIP number: P/0400/2018

Europe - EMA - European Medicines Agency

20-2-2019


Orphan designation: autologous human adipose perivascular stromal cells genetically modified to secrete soluble tumour necrosis factor-related apoptosis-inducing ligand, The treatment of pancreatic cancer, 19/11/2018, Positive

Orphan designation: autologous human adipose perivascular stromal cells genetically modified to secrete soluble tumour necrosis factor-related apoptosis-inducing ligand, The treatment of pancreatic cancer, 19/11/2018, Positive

Orphan designation: autologous human adipose perivascular stromal cells genetically modified to secrete soluble tumour necrosis factor-related apoptosis-inducing ligand, The treatment of pancreatic cancer, 19/11/2018, Positive

Europe - EMA - European Medicines Agency

19-2-2019


Orphan designation: human apotransferrin, Treatment of beta-thalassaemia intermedia and major, 19/11/2018, Positive

Orphan designation: human apotransferrin, Treatment of beta-thalassaemia intermedia and major, 19/11/2018, Positive

Orphan designation: human apotransferrin, Treatment of beta-thalassaemia intermedia and major, 19/11/2018, Positive

Europe - EMA - European Medicines Agency

19-2-2019


Orphan designation: Salmonella typhi Ty21a strain transfected with a plasmid vector encoding the human vascular endothelial growth factor receptor 2, Treatment of glioma, 23/08/2017, Positive

Orphan designation: Salmonella typhi Ty21a strain transfected with a plasmid vector encoding the human vascular endothelial growth factor receptor 2, Treatment of glioma, 23/08/2017, Positive

Orphan designation: Salmonella typhi Ty21a strain transfected with a plasmid vector encoding the human vascular endothelial growth factor receptor 2, Treatment of glioma, 23/08/2017, Positive

Europe - EMA - European Medicines Agency

18-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Holoclar,Ex-vivo expanded human autologous epithelium containing stem cells, decision type: , therapeutic area: , PIP number: P/0370/2018

Opinion/decision on a Paediatric investigation plan (PIP): Holoclar,Ex-vivo expanded human autologous epithelium containing stem cells, decision type: , therapeutic area: , PIP number: P/0370/2018

Opinion/decision on a Paediatric investigation plan (PIP): Holoclar,Ex-vivo expanded human autologous epithelium containing stem cells, decision type: , therapeutic area: , PIP number: P/0370/2018

Europe - EMA - European Medicines Agency

18-2-2019

EU/3/17/1956 (TxCell S.A.)

EU/3/17/1956 (TxCell S.A.)

EU/3/17/1956 (Active substance: Adeno-associated viral vector serotype 2/6 encoding zinc-finger nucleases and the human iduronate 2-sulfatase gene) - Transfer of orphan designation - Commission Decision (2019)1371 of Mon, 18 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003578

Europe -DG Health and Food Safety

18-2-2019

EU/3/17/1955 (TxCell S.A.)

EU/3/17/1955 (TxCell S.A.)

EU/3/17/1955 (Active substance: Adeno-associated viral vector serotype 2/6 encoding zinc-finger nucleases and the human alpha L-iduronidase gene) - Transfer of orphan designation - Commission Decision (2019)1370 of Mon, 18 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003576

Europe -DG Health and Food Safety

14-2-2019

EU/3/18/1975 (Nightstar Europa Limited)

EU/3/18/1975 (Nightstar Europa Limited)

EU/3/18/1975 (Active substance: Adenovirus-associated viral vector serotype 8 containing the human RPGR gene) - Transfer of orphan designation - Commission Decision (2019)1376 of Thu, 14 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003405

Europe -DG Health and Food Safety

14-2-2019

EU/3/12/1051 (AstraZeneca AB)

EU/3/12/1051 (AstraZeneca AB)

EU/3/12/1051 (Active substance: Recombinant human lecithin cholesterol acyltransferase) - Transfer of orphan designation - Commission Decision (2019)1365 of Thu, 14 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003174

Europe -DG Health and Food Safety

14-2-2019

EU/3/12/1094 (BioMarin International Limited)

EU/3/12/1094 (BioMarin International Limited)

EU/3/12/1094 (Active substance: Modified recombinant human C-type natriuretic peptide) - Transfer of orphan designation - Commission Decision (2019)1348 of Thu, 14 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003587

Europe -DG Health and Food Safety

14-2-2019

EU/3/17/1969 (Maria Livadiotis)

EU/3/17/1969 (Maria Livadiotis)

EU/3/17/1969 (Active substance: Recombinant adeno-associated viral vector serotype 2/1 encoding human beta-hexosaminidase alpha and beta subunits) - Transfer of orphan designation - Commission Decision (2019)1357 of Thu, 14 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003568

Europe -DG Health and Food Safety

14-2-2019

EU/3/16/1702 (Clinical Network Services (NL) B.V.)

EU/3/16/1702 (Clinical Network Services (NL) B.V.)

EU/3/16/1702 (Active substance: Recombinant human monoclonal antibody to insulin receptor) - Transfer of orphan designation - Commission Decision (2019)1372 of Thu, 14 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003601

Europe -DG Health and Food Safety

14-2-2019

EU/3/15/1499 (Voisin Consulting S.A.R.L.)

EU/3/15/1499 (Voisin Consulting S.A.R.L.)

EU/3/15/1499 (Active substance: Adult human bone-marrow-derived, ex-vivo-expanded, pooled allogeneic mesenchymal stromal cells) - Transfer of orphan designation - Commission Decision (2019)1375 of Thu, 14 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003671

Europe -DG Health and Food Safety

14-2-2019

EU/3/14/1394 (Pharma Gateway AB)

EU/3/14/1394 (Pharma Gateway AB)

EU/3/14/1394 (Active substance: Pegylated recombinant human hyaluronidase PH20) - Transfer of orphan designation - Commission Decision (2019)1343 of Thu, 14 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000002720

Europe -DG Health and Food Safety