PREXANIL COMBI

Glavne informacije

  • Zaščiteno ime:
  • PREXANIL COMBI 4 mg/1,25 mg tablete
  • Farmacevtska oblika:
  • tableta
  • Sestava:
  • indapamid 1,25 mg / 1 tableta; perindopril 3,34 mg / 1 tableta
  • Pot uporabe:
  • Peroralna uporaba
  • Enote v paketu:
  • škatla s 30 tabletami (1 x 30 tablet v pretisnem omotu)
  • Tip zastaranja:
  • Rp - Predpisovanje in izdaja zdravila je le na recept
  • Uporabi za:
  • ljudje
  • Vrsta medicine:
  • Alopatska drog

Dokumentov

Lokalizacija

  • Na voljo v:
  • PREXANIL COMBI 4 mg/1,25 mg tablete
    Slovenija
  • Jezik:
  • slovenščina

Terapevtski podatki

  • Terapevtska skupina:
  • perindopril in diuretiki

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:
  • 10123-455/2015-9
  • Datum dovoljenje:
  • 18-04-2016
  • EAN koda:
  • 3837000098549
  • Zadnja posodobitev:
  • 19-01-2018

Podatki za bolnike

JAZMP-II/085/G-12. 8. 2016

NAVODILO ZA UPORABO

JAZMP-II/085/G-12. 8. 2016

Navodilo za uporabo

Prexanil Combi 4 mg/1,25 mg tablete

terc-butilaminijev perindoprilat/indapamid

Pred začetkom jemanja 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 ali s farmacevtom.

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 ali s farmacevtom. Posvetujte

se tudi, če opazite katere koli neželene učinke, ki niso navedeni v tem navodilu. Glejte poglavje 4.

Kaj vsebuje navodilo:

Kaj je zdravilo Prexanil Combi in za kaj ga uporabljamo

Kaj morate vedeti, preden boste vzeli zdravilo Prexanil Combi

Kako jemati zdravilo Prexanil Combi

Možni neželeni učinki

Shranjevanje zdravila Prexanil Combi

Vsebina pakiranja in dodatne informacije

1.

Kaj je zdravilo Prexanil Combi in za kaj ga uporabljamo

Prexanil Combi je kombinacija dveh učinkovin, perindoprila in indapamida. Sodi med antihipertenzive

in je namenjen zdravljenju odraslih bolnikov z zvišanim krvnim tlakom (hipertenzijo).

Perindopril uvrščamo v razred zdravil, imenovanih zaviralci angiotenzinske konvertaze (ACE).

Tovrstna zdravila delujejo tako, da širijo žile, zaradi česar srce po njih lažje črpa kri. Indapamid je

diuretik. Diuretiki povečujejo količino urina, ki ga tvorijo ledvice, vendar se indapamid od drugih

diuretikov razlikuje, saj količino nastalega urina poveča le blago. Vsaka od obeh zdravilnih učinkovin

znižuje krvni tlak, pri urejanju krvnega tlaka pa delujeta skupaj.

2.

Kaj morate vedeti, preden boste vzeli zdravilo Prexanil Combi

Ne jemljite zdravila Prexanil Combi

če ste alergični na perindopril ali kateri koli drug zaviralec ACE, indapamid ali kateri koli drug

sulfonamid, ali katero koli sestavino tega zdravila (navedeno v poglavju 6),

če ste opažali simptome, kot so sopenje, otekanje obraza ali jezika, močno srbenje ali hudi kožni

izpuščaji med predhodnim zdravljenjem z zaviralci ACE, ali če ste vi ali člani vaše družine imeli

tovrstne simptome v kakršnih koli drugih okoliščinah (stanje, imenovano angioedem),

če imate sladkorno bolezen ali okvarjeno delovanje ledvic in se zdravite z zdravilom za znižanje

krvnega tlaka, ki vsebuje aliskiren,

če imate hudo bolezen jeter ali stanje, imenovano jetrna encefalopatija (degenerativna bolezen

možganov),

če imate hudo ledvično bolezen ali potrebujete dializo,

če imate nizko vrednost kalija v krvi,

če sumijo, da imate nezdravljeno dekompenzirano srčno popuščanje (hudo zadrževanje tekočine,

težave z dihanjem),

če ste noseči več kot 3 mesece (jemanju zdravila Prexanil Combi se je bolje izogniti tudi v

zgodnji nosečnosti - glejte poglavje »Nosečnost in dojenje«),

če dojite.

JAZMP-II/085/G-12. 8. 2016

Opozorila in previdnostni ukrepi

Pred začetkom jemanja zdravila Prexanil Combi se posvetujte z zdravnikom ali s farmacevtom:

če imate zožitev aorte (glavne žile, ki vodi iz srca), hipertrofično kardiomiopatijo (bolezen srčne

mišice) ali stenozo ledvične arterije (zožitev arterije, ki ledvice oskrbuje s krvjo),

če imate srčno popuščanje ali kakršne koli druge težave s srcem,

če imate težave z ledvicami,

če imate težave z jetri,

če imate kolagensko bolezen (bolezen kože), kot sta sistemski eritematozni lupus ali skleroderma,

če imate aterosklerozo (togost arterij),

če imate hiperparatiroidizem (preveliko delovanje obščitnične žleze),

če imate protin,

če imate sladkorno bolezen,

če ste na dieti z omejitvijo soli ali uporabljate nadomestke soli, ki vsebujejo kalij,

če jemljete litij ali zdravila, ki varčujejo s kalijem (spironolakton, triamteren), ali dodatke kalija,

se morate izogibati sočasni uporabi z zdravilom Prexanil Combi (glejte poglavje »Jemanje drugih

zdravil«),

če ste starejši,

če ste kdaj doživeli fotosenzitivne reakcije (preobčutljivost za svetlobo),

če doživite hudo alergično reakcijo z otekanjem obraza, ustnic, ust, jezika ali grla, ki jo spremljata

težko požiranje ali dihanje (angioedem). Pojavi se lahko kadar koli med zdravljenjem. Če se pri

vas pojavijo takšni simptomi, takoj prenehajte z jemanjem zdravila in nemudoma obiščite

zdravnika.

če jemljete katero od naslednjih zdravil, ki se uporabljajo za zdravljenje visokega krvnega tlaka:

antagonist receptorjev angiotenzina II (ta zdravila imenujemo tudi "sartani" – mednje

spadajo na primer valsartan, telmisartan in irbesartan), še zlasti če imate kakšne težave z

ledvicami, ki so povezane s sladkorno boleznijo,

aliskiren.

Zdravnik vam bo morda v rednih presledkih kontroliral delovanje ledvic, krvni tlak in količino

elektrolitov (npr. kalija) v krvi.

Glejte tudi informacije pod naslovom »Ne jemljite zdravila Prexanil Combi«.

če ste pripadnik črne rase, ker imate morda večje tveganje za angioedem, in bo to zdravilo pri vas

morda manj učinkovito znižalo krvni tlak kot pri bolnikih drugih ras.

če ste bolnik na hemodializi in prestajate dializo z visokopretočnimi membranami.

Angioedem

Pri bolnikih, ki so jemali zaviralce angiotenzinske konvertaze, vključno z zdravilom Prexanil Combi, so

poročali o angioedemu (huda alergična reakcija z otekanjem obraza, ustnic, jezika ali grla, ki jo

spremljata težko požiranje ali dihanje). Pojavi se lahko kadar koli med zdravljenjem. Če se pri vas

pojavijo takšni simptomi, takoj prenehajte z jemanjem zdravila Prexanil Combi in nemudoma obiščite

zdravnika. Glejte tudi poglavje 4.

Če mislite, da ste noseči (ali nameravate zanositi), o tem obvestite svojega zdravnika. Uporaba zdravila

Prexanil Combi ni priporočljiva v zgodnjem obdobju nosečnosti, po tretjem mesecu nosečnosti pa ga ne

smete jemati, ker lahko povzroči resno škodo vašemu otroku (glejte poglavje »Nosečnost in dojenje«).

Svojega zdravnika ali medicinsko osebje morate obvestiti, da jemljete zdravilo Prexanil Combi tudi:

če imate predvideno anestezijo in/ali operacijo,

če ste pred kratkim imeli drisko, ste bruhali ali ste dehidrirani,

če imate predvideno dializo ali aferezo lipoproteinov majhne gostote (LDL) (odstranjevanje

holesterola iz krvi s pomočjo aparata),

če imate predvideno desenzibilizacijsko zdravljenje za zmanjšanje učinkov alergije na pike čebel

ali os,

če imate predvideno zdravstveno preiskavo, pri kateri je potrebno injiciranje jodiranega

kontrastnega sredstva (snovi, ki omogoči, da so organi, kot so ledvice ali želodec, vidni na

JAZMP-II/085/G-12. 8. 2016

rentgenskih posnetkih),

če med jemanjem zdravila Prexanil Combi doživite spremembe vida ali bolečino v enem ali obeh

očesih. To je lahko znak razvoja glavkoma, zvišanega pritiska v očesu (očeh). Prenehajte z

zdravljenjem z zdravilom Prexanil Combi in obiščite zdravnika.

Športniki morajo vedeti, da zdravilo Prexanil Combi vsebuje učinkovino (indapamid), ki lahko povzroči

pozitiven izvid testov za doping.

Otroci in mladostniki

Zdravila Prexanil Combi ne smete dajati otrokom in mladostnikom

Druga zdravila in zdravilo Prexanil Combi

Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati

katero koli drugo zdravilo.

Jemanju zdravila Prexanil Combi se morate izogibati skupaj z:

litijem (za zdravljenje bolnikov z manijo ali depresijo),

aliskirenom (zdravilom za zdravljenje hipertenzije), če nimate sladkorne bolezni ali težav z

ledvicami,

diuretiki, ki varčujejo s kalijem (npr. triamterenom, amiloridom), kalijevimi solmi,

estramustinom (za zdravljenje raka).

drugimi zdravili za zdravljenje visokega krvnega tlaka: zaviralci encima angiotenzinske

konvertaze in antagonisti angiotenzinskih receptorjev.

Na zdravljenje z zdravilom Prexanil Combi lahko vplivajo druga zdravila. Zdravnik vam bo morda

moral spremeniti odmerek in/ali upoštevati druge previdnostne ukrepe. Vedno obvestite svojega

zdravnika, če jemljete katero od naslednjih zdravil, saj je lahko potrebna posebna previdnost:

druga zdravila za zdravljenje zvišanega krvnega tlaka, vključno z antagonisti receptorjev

angiotenzina II ali aliskirenom (glejte tudi informacije pod naslovoma »Ne jemljite zdravila

Prexanil Combi« in »Opozorila in previdnostni ukrepi«) ali diuretiki (zdravila, ki povečujejo

količino urina, ki ga tvorijo ledvice),

zdravila, ki varčujejo s kalijem in se uporabljajo pri zdravljenju srčnega popuščanja: eplerenon in

spironolakton v odmerkih od 12,5 mg do 50 mg na dan,

anestetike,

jodirana kontrastna sredstva,

moksifloksacin, sparfloksacin (antibiotika za zdravljenje okužb),

metadon (uporablja se pri zdravljenju odvisnosti),

prokainamid (za zdravljenje nerednega srčnega utripa),

alopurinol (za zdravljenje protina),

mizolastin, terfenadin ali astemizol (antihistaminiki za zdravljenje senenega nahoda ali alergij),

kortikosteroide za zdravljenje različnih stanj, vključno s hudo astmo in revmatoidnim artritisom,

imunosupresive za zdravljenje avtoimunskih motenj ali po operacijah presaditve organov za

preprečitev zavrnitve (npr. ciklosporin, takrolimus),

eritromicin z injekcijo (antibiotik),

halofantrin (za zdravljenje določenih vrst malarije),

pentamidin (za zdravljenje pljučnice),

injekcije zlata (za zdravljenje revmatoidnega poliartritisa),

vinkamin (za starejše bolnike s simptomatičnimi kognitivnimi motnjami, vključno z izgubo

spomina),

bepridil (za zdravljenje angine pektoris),

zdravila proti motnjam srčnega ritma (npr. kinidin, hidrokinidin, dizopiramid, amiodaron,

sotalol),

cisaprid, difemanil (uporabljata se za zdravljenje želodčnih in prebavnih težav),

digoksin ali druge srčne glikozide (za zdravljenje težav s srcem),

baklofen (za zdravljenje bolnikov s togostjo mišic, ki nastaja pri boleznih, kot je multipla

JAZMP-II/085/G-12. 8. 2016

skleroza),

zdravila za zdravljenje sladkorne bolezni, kot so insulin, metformin ali gliptini,

kalcij, vključno z dodatki kalcija,

stimulantna odvajala (npr. sena),

nesteroidna protivnetna zdravila (npr. ibuprofen) ali salicilate v velikih odmerkih (npr.

acetilsalicilna kislina),

amfotericin B z injekcijo (za zdravljenje hudih glivičnih bolezni),

zdravila za zdravljenje duševnih motenj, kot so depresija, anksioznost, shizofrenija... (npr.

triciklični antidepresivi, nevroleptiki (kot so amisulprid, sulpirid, sultoprid, tiaprid, haloperidol,

droperidol)),

tetrakosaktid (za zdravljenje Crohnove bolezni),

trimetoprim (za zdravljenje okužb),

vazodilatatorje vključno z nitrati (zdravila, ki širijo krvne žile),

heparin (zdravila za redčenje krvi),

zdravila za zdravljenje nizkega krvnega tlaka, šoka ali astme (npr. efedrin, noradrenalin ali

adrenalin).

Zdravilo Prexanil Combi skupaj s hrano in pijačo

Najbolje je, da zdravilo Prexanil Combi jemljete pred obrokom.

Nosečnost in dojenje

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

zdravnikom ali farmacevtom, preden vzamete to zdravilo.

Nosečnost

Zdravniku morate povedati, če mislite, da ste noseči ali če načrtujete nosečnost. Zdravnik vam bo

praviloma svetoval prenehanje jemanja zdravila Prexanil Combi, preden ali takoj ko zanosite in vam

namesto zdravila Prexanil Combi svetoval jemanje drugega zdravila. Zdravilo Prexanil Combi v

zgodnjem obdobju nosečnosti ni priporočljivo, če ste noseči več kot 3 mesece, pa ga ne smete jemati, saj

lahko po tretjem mesecu nosečnosti povzroči resno škodo vašemu otroku.

Dojenje

Če dojite, zdravila Prexanil Combi ne smete jemati.

Če dojite ali nameravate začeti z dojenjem, o tem nemudoma obvestite svojega zdravnika.

Takoj obiščite svojega zdravnika.

Vpliv na sposobnost upravljanja vozil in strojev

Prexanil Combi običajno ne vpliva na pozornost, toda nizek krvni tlak lahko pri nekaterih bolnikih

povzroča različne reakcije, kot sta omotica ali šibkost. Če to velja za vas, se lahko zmanjša vaša

sposobnost upravljanja vozil in strojev.

Zdravilo Prexanil Combi vsebuje laktozo monohidrat.

Če vam je zdravnik povedal, da ne prenašate določenih vrst sladkorja, se posvetujte z njim, preden

vzamete to zdravilo.

3.

Kako jemati zdravilo Prexanil Combi

Pri jemanju tega zdravila natančno upoštevajte navodila zdravnika ali farmacevta. Če ste negotovi, se

posvetujte z zdravnikom ali s farmacevtom.

Priporočeni odmerek je ena tableta enkrat na dan. Zdravnik se lahko odloči, da vam spremeni režim

odmerjanja, če imate ledvično okvaro. Najbolje je, da tableto vzamete zjutraj in pred obrokom. Tableto

pogoltnite s kozarcem vode.

JAZMP-II/085/G-12. 8. 2016

Če ste vzeli večji odmerek zdravila Prexanil Combi, kot bi smeli

Če ste vzeli preveč tablet, se takoj posvetujte z zdravnikom ali urgentnim oddelkom najbližje bolnišnice.

Najverjetnejši pojav pri prevelikem odmerjanju je nizek krvni tlak. Če je znižanje krvnega tlaka izrazito

(in je povezano s slabostjo, bruhanjem, krči, omotico, zaspanostjo, duševno zmedenostjo, spremembami

v količini urina, ki ga izločajo ledvice), pomaga, če se uležete z dvignjenimi nogami.

Če ste pozabili vzeti zdravilo Prexanil Combi

Pomembno je, da zdravilo jemljete vsak dan, saj je redno zdravljenje učinkovitejše. Če ste pozabili vzeti

odmerek zdravila Prexanil Combi, vzemite naslednjega ob običajnem času. Ne vzemite dvojnega

odmerka, da bi nadomestili izpuščenega.

Če ste prenehali jemati zdravilo Prexanil Combi

Ker je zdravljenje povišanega krvnega tlaka običajno doživljenjsko, se posvetujte z zdravnikom, preden

prenehate jemati to zdravilo.

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

4.

Možni neželeni učinki

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

Prenehajte jemati zdravilo in nemudoma obiščite zdravnika, če opazite katerega koli od

naslednjih neželenih učinkov, ki je lahko resen:

huda omotica in omedlevanje zaradi nizkega krvnega tlaka (pogosti) (pojavijo se lahko pri največ

1 od 10 bolnikov),

bronhospazem (stiskanje v prsih, sopenje in zasoplost) (občasni) (pojavijo se lahko pri največ 1

od 100 bolnikov),

otekanje obraza, ustnic, ust, jezika ali grla, težave pri dihanju (angioedem) (glejte poglavje 2

»Opozorila in previdnostni ukrepi«) (občasni) (pojavijo se lahko pri največ 1 od 100 bolnikov),

hude kožne reakcije, vključno z multiformnim eritemom (kožni izpuščaj, ki se pogosto začne z

rdečimi srbečimi površinami na obrazu, rokah ali nogah) ali intenzivnim kožnim izpuščajem,

koprivnico,

pordelostjo

kože

celega

telesa,

močnim

srbenjem,

pojavom

mehurjev

koži,

luščenjem

otekanjem

kože,

vnetjem

sluznic

(Stevens

Johnsonov

sindrom)

drugimi

alergijskimi reakcijami (zelo redki) (pojavijo se lahko pri največ 1 od 10.000 bolnikov),

srčno-žilne motnje (nereden srčni utrip, angina pektoris (bolečina v prsih, čeljusti in hrbtu ob

fizičnem naporu), srčni infarkt) (zelo redki) (pojavijo se lahko pri največ 1 od 10.000 bolnikov),

šibkost v rokah in nogah ali težave z govorom, kar je lahko znak možganske kapi (zelo redki)

(pojavijo se lahko pri največ 1 od 10.000 bolnikov),

vnetje trebušne slinavke, ki lahko povzroči hude bolečine v trebuhu in hrbtu, ki jih spremlja zelo

slabo počutje (zelo redki) (pojavijo se lahko pri največ 1 od 10.000 bolnikov),

porumenelost kože ali oči (zlatenica), ki je lahko znak za hepatitis (zelo redki) (pojavijo se lahko

pri največ 1 od 10.000 bolnikov),

življenje ogrožajoč nereden srčni utrip (neznana pogostnost),

bolezen možganov, ki je posledica bolezni jeter (jetrna encefalopatija) (neznana pogostnost).

Možni neželeni učinki so našteti po padajoči pogostnosti:

Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov): kožne reakcije pri bolnikih nagnjenih k

alergijskim in astmatičnim reakcijam, glavobol, omotica, vrtoglavica, mravljinčenje, motnje vida,

tinitus (občutek šumenja v ušesu), kašelj, zasoplost (dispneja), prebavne motnje (slabost,

bruhanje, bolečine v trebuhu, motnje okušanja, dispepsija ali slaba prebava, driska, zaprtje),

alergijske reakcije (npr. kožni izpuščaji, srbenje), mišični krči, občutek utrujenosti.

JAZMP-II/085/G-12. 8. 2016

Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov): hitre spremembe razpoloženja, motnje

spanja, koprivnica, purpura (rdeče pike na koži), skupki mehurjev, težave z ledvicami, impotenca,

potenje, povečano število eozinofilcev (vrsta belih krvnih celic), spremembe laboratorijskih

parametrov: visoke vrednosti kalija v krvi, kar je reverzibilno po ukinitvi zdravila, nizke vrednosti

natrija v krvi, zaspanost, omedlevica, palpitacije (zavedanje lastnega srčnega utripa), tahikardija

(hiter srčni utrip), hipoglikemija (zelo nizka vrednost sladkorja v krvi) pri sladkornih bolnikih,

vaskulitis (vnetje krvnih žil), suha usta, fotosenzitivne reakcije (povečana občutljivost kože na

sonce), artralgija (bolečine v sklepih), mialgija (bolečine v mišicah), bolečina v prsih, slabo

počutje, periferni edem, zvišana telesna temperatura, povišana vrednost sečnine v krvi in povišana

vrednost kreatinina v krvi, padec.

Redki (pojavijo se lahko pri največ 1 od 1.000 bolnikov): spremembe laboratorijskih parametrov:

povišane vrednosti jetrnih encimov, visoke vrednosti bilirubina v serumu, utrujenost.

Zelo redki (pojavijo se lahko pri največ 1 od 10.000 bolnikov): zmedenost, eozinofilna pljučnica

(redka vrsta pljučnice), rinitis (zamašen nos ali izcedek iz nosu), hude težave z ledvicami,

spremembe krvnih parametrov, kot je zmanjšano število belih in rdečih krvnih celic, znižane

vrednosti hemoglobina, znižane vrednosti trombocitov, visoke vrednosti kalcija v krvi, okvara

delovanja jeter.

Neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti): nenormalni zapis

EKG srca, spremembe laboratorijskih parametrov: nizke vrednosti kalija, visoke vrednosti sečne

kisline in visoke vrednosti glukoze v krvi, kratkovidnost (miopija), zamegljen vid, okvara vida.

Če prestajate sistemski eritematozni lupus (vrsta kolagenske bolezni), se stanje lahko poslabša.

Lahko se pojavijo bolezni krvi, ledvic, jeter ali trebušne slinavke in spremembe laboratorijskih vrednosti

(testi krvi). Zdravnik vam bo mogoče predpisal krvne preiskave, da bi spremljal vaše stanje.

Poročanje o neželenih učinkih

Če opazite kateri koli neželeni učinek, 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 Univerzitetni klinični center Ljubljana, Interna klinika, Center za zastrupitve, Zaloška

cesta 2, SI-1000 Ljubljana, Faks: + 386 (0)1 434 76 46, e-pošta: farmakovigilanca@kclj.si. S tem, ko

poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega zdravila.

5.

Shranjevanje zdravila Prexanil Combi

Zdravilo shranjujte nedosegljivo otrokom!

Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli. Rok

uporabnosti zdravila se izteče na zadnji dan navedenega meseca. Shranjujte pri temperaturi do 30 ºC.

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

zdravila, ki ga ne uporabljate več, se posvetujte s farmacevtom. Taki ukrepi pomagajo varovati okolje.

6.

Vsebina pakiranja in dodatne informacije

Kaj vsebuje zdravilo Prexanil Combi

Zdravilni učinkovini sta terc-butilaminijev perindoprilat in indapamid. Ena tableta vsebuje 4 mg

terc-butilaminijevega perindoprilata (kar ustreza 3,338 mg perindoprila) in 1,25 mg indapamida.

Pomožne snovi v tableti so: laktoza monohidrat, magnezijev stearat (E470B), hidrofoben koloidni

silicijev dioksid in mikrokristalna celuloza.

JAZMP-II/085/G-12. 8. 2016

Izgled zdravila Prexanil Combi in vsebina pakiranja

Prexanil Combi je v obliki belih, paličastih tablet. Ena tableta vsebuje 4 mg terc-butilaminijevega

perindoprilata in 1,25 mg indapamida.

Tablete so na voljo v pretisnih omotih po 14, 20, 28, 30, 50, 56, 60, 90, 100 ali 500 tablet.

Na trgu morda ni vseh navedenih pakiranj.

Način in režim predpisovanja in izdaje zdravila

Predpisovanje in izdaja zdravila je le na recept.

Imetnik dovoljenja za promet z zdravilom in izdelovalec

Imetnik dovoljenja za promet z zdravilom

Servier Pharma d.o.o.

Podmilščakova ulica 24

1000 Ljubljana

Slovenija

Telefon: 01 563 48 11

Izdelovalec

Les Laboratoires Servier Industrie

905, route de Saran

45520 Gidy

Francija

Servier (Ireland) Industries Ltd

Gorey Road

Arklow – Co. Wicklow

Irska

Zdravilo je v državah članicah EGP pridobilo dovoljenje za promet z naslednjimi imeni:

Avstrija

BI PREDONIUM

Francija

Perindopril/Indapamide Biogaran 4 mg/1.25 mg comprime

Irska

COVERSYL PLUS 4 MG/1.25MG TABLETS

Slovenija

Prexanil Combi 4 mg/1,25 mg tablete

Navodilo je bilo nazadnje revidirano dne 12. 08. 2016.

21-11-2018

FDA approves new treatment for patients with acute myeloid leukemia

FDA approves new treatment for patients with acute myeloid leukemia

The FDA approved Daurismo (glasdegib) tablets to be used in combination with low-dose cytarabine (LDAC), a type of chemotherapy, for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults who are 75 years of age or older or who have other chronic health conditions or diseases (comorbidities) that may preclude the use of intensive chemotherapy.

FDA - U.S. Food and Drug Administration

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

17-11-2018

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Aspergillus oryzae (strain NZYM‐FA)

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Aspergillus oryzae (strain NZYM‐FA)

Published on: Fri, 16 Nov 2018 The food enzyme is an endo‐1,4‐β‐xylanase (EC 3.2.1.8) produced with a genetically modified strain of Aspergillus oryzae by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This xylanase is intended to be used in baking and cereal‐based processes. Based on the proposed maximum use levels, dietary exposure to the food enzyme–total organic solids (TOS) was e...

Europe - EFSA - European Food Safety Authority Publications

16-11-2018

FDA approves first-line treatment for peripheral T-cell lymphoma under new review pilot

FDA approves first-line treatment for peripheral T-cell lymphoma under new review pilot

The FDA expanded the approved use of Adcetris (brentuximab vedotin) injection in combination with chemotherapy for adult patients with certain types of peripheral T-cell lymphoma (PTCL). This is the first FDA approval for treatment of newly diagnosed PTCL, and the agency used a new review program to complete the approval more quickly.

FDA - U.S. Food and Drug Administration

15-11-2018

Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM‐OC)

Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM‐OC)

Published on: Wed, 14 Nov 2018 The food enzyme maltogenic amylase (glucan 1,4‐a‐maltohydrolase; EC 3.2.1.133) is produced with a genetically modified Bacillus subtilis strain NZYM‐OC by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production microorganism and recombinant DNA. This maltogenic amylase is intended to be used in baking processes. Based on the maximum use levels recommended, dietary exposure to the food enzyme–...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM‐SO)

Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM‐SO)

Published on: Wed, 14 Nov 2018 The food enzyme maltogenic amylase (glucan 1,4‐α‐maltohydrolase; EC 3.2.1.133) is produced with a genetically modified Bacillus subtilis strain NZYM‐SO by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production microorganism and recombinant DNA. This maltogenic amylase is intended to be used in baking processes. Based on the maximum use levels, dietary exposure to the food enzyme–total organi...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Safety evaluation of the food enzyme acetolactate decarboxylase from a genetically modified Bacillus licheniformis (strain NZYM‐JB)

Safety evaluation of the food enzyme acetolactate decarboxylase from a genetically modified Bacillus licheniformis (strain NZYM‐JB)

Published on: Wed, 14 Nov 2018 The food enzyme acetolactate decarboxylase (α‐acetolactate decarboxylase; EC 4.1.1.5) is produced with a genetically modified Bacillus licheniformis strain NZYM‐JB by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This acetolactate decarboxylase is intended to be used in distilled alcohol production and brewing processes. Residual amounts of total organi...

Europe - EFSA - European Food Safety Authority Publications

9-11-2018

Safety assessment of the substance Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials

Safety assessment of the substance Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials

Published on: Wed, 07 Nov 2018 00:00:00 +0100 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP Panel) assessed the safety of the additive Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials. It is a family of mixtures combining the four lanthanides lanthanum (La), europium (Eu), gadolinium (Gd) and/or terbium (Tb) in different proportions as their 1,4‐benzene dicarboxylate complexes, used as a taggant in plastics for authentication and ...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Bacillus subtilis (strain LMG S‐24584)

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Bacillus subtilis (strain LMG S‐24584)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme endo‐1,4‐β‐xylanase (EC 3.2.1.8) is produced with the genetically modified Bacillus subtilis strain LMG S‐24584 by Puratos N. V. The genetic modifications do not give rise to safety concerns. The Panel noted that, although the production strain was not detected in the food enzyme, recombinant DNA was present in all batches of the food enzyme tested. The food enzyme is intended to be used in baking processes. Based on the maximum use levels re...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Safety evaluation of the food enzyme glucan 1,4‐α‐glucosidase from a genetically modified Aspergillus niger (strain NZYM‐BW)

Safety evaluation of the food enzyme glucan 1,4‐α‐glucosidase from a genetically modified Aspergillus niger (strain NZYM‐BW)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme glucan 1,4‐α‐glucosidase (EC 3.2.1.3) is produced with the genetically modified Aspergillus niger strain NZYM‐BW by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. The glucan 1,4‐α‐glucosidase food enzyme is intended to be used in distilled alcohol production and starch processing for the production of glucose syrups. Residu...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Safety of the food enzyme glucoamylase from a genetically modified Aspergillus niger (strain NZYM‐BF)

Safety of the food enzyme glucoamylase from a genetically modified Aspergillus niger (strain NZYM‐BF)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme glucoamylase (glucan 1,4‐α‐glucosidase; EC 3.2.1.3) is produced with the genetically modified strain of Aspergillus niger by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This glucoamylase is intended to be used in brewing processes and in starch processing for glucose syrups production. Residual amounts of total organic s...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Safety evaluation of the food enzyme α‐amylase from a genetically modified Aspergillus niger (strain NZYM‐MC)

Safety evaluation of the food enzyme α‐amylase from a genetically modified Aspergillus niger (strain NZYM‐MC)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme alpha‐amylase (4‐α‐d‐glucan glucanohydrolase; EC 3.2.1.1) is produced with the genetically modified strain of Aspergillus niger by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This α‐amylase is intended to be used in starch processing for glucose syrups production, beverage alcohol (distilling) processes and baking proces...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Safety and efficacy of Lactobacillus hilgardii CNCM I‐4785 and Lactobacillus buchneri CNCM I‐4323/NCIMB 40788 as a silage additive for all animal species

Safety and efficacy of Lactobacillus hilgardii CNCM I‐4785 and Lactobacillus buchneri CNCM I‐4323/NCIMB 40788 as a silage additive for all animal species

Published on: Tue, 30 Oct 2018 00:00:00 +0100 Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed was asked to deliver a scientific opinion on the safety and efficacy of a strain of Lactobacillus hilgardii and of Lactobacillus buchneri when used as a technological additive intended to improve ensiling at a proposed application rate of 3.0 x 108 colony forming units (CFU)/kg fresh material. The two bacterial species are considered by EFS...

Europe - EFSA - European Food Safety Authority Publications

26-10-2018

Safety and efficacy of l‐threonine produced by fermentation using Escherichia coli CGMCC 7.232 for all animal species

Safety and efficacy of l‐threonine produced by fermentation using Escherichia coli CGMCC 7.232 for all animal species

Published on: Thu, 25 Oct 2018 00:00:00 +0200 The product subject of this assessment is l‐threonine produced by fermentation with a genetically modified strain of Escherichia coli (CGMCC 7.232). It is intended to be used in feed and water for drinking for all animal species and categories. The production strain and its recombinant DNA were not detected in the additive. The product l‐threonine, manufactured by fermentation with E. coli CGMCC 7.232, does not raise any safety concern with regard to the gen...

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

Scientific Opinion on Flavouring Group Evaluation 200, Revision 1 (FGE.200 Rev.1): 74 α,β‐unsaturated aliphatic aldehydes and precursors from chemical subgroup 1.1.1 of FGE.19

Scientific Opinion on Flavouring Group Evaluation 200, Revision 1 (FGE.200 Rev.1): 74 α,β‐unsaturated aliphatic aldehydes and precursors from chemical subgroup 1.1.1 of FGE.19

Published on: Fri, 19 Oct 2018 00:00:00 +0200 The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to evaluate the genotoxic potential of 74 flavouring substances from subgroup 1.1.1 of FGE.19 in the Flavouring Group Evaluation 200 Revision 1 (FGE.200 Rev1). In FGE.200, genotoxicity studies were provided for one representative substance, namely hex‐2(trans)‐enal [FL‐no: 05.073], and for other two substances in the same subgroup, namely 2‐dodecenal [FL‐no: 05.03...

Europe - EFSA - European Food Safety Authority Publications

18-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

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

11-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

19-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

12-9-2018

Kabinet investeert in eerste 1000 dagen kind

Kabinet investeert in eerste 1000 dagen kind

Van kinderwens tot 2-jarige peuter: de ontwikkeling die we in de eerste 1000 dagen als kind meemaken is cruciaal voor zowel een gezonde groei als de ontplooiing en kansen op latere leeftijd. Verreweg de meeste kinderen in Nederland groeien veilig en gezond op. Toch heeft ongeveer 14% van de kinderen in Nederland een ‘valse’ start door vroeggeboorte, een te laag geboortegewicht of een combinatie van beide. Minister Hugo de Jonge (VWS), gemeenten, partijen uit de geboortezorg en de jeugdgezondheidszorg (JG...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

11-9-2018

Risk assessment of substances used in food supplements: the example of the botanical Gymnema sylvestre

Risk assessment of substances used in food supplements: the example of the botanical Gymnema sylvestre

Published on: Tue, 28 Aug 2018 00:00:00 +0200 Botanicals and preparations derived from these are among the substances frequently added to foods and food supplements, yet the safety of many botanicals has not been systematically assessed. In the context of the EU‐FORA fellowship programme, the fellow performed an assessment on the safety of the botanical Gymnema sylvestre, in accordance with EFSA's guidance on the assessment of safety of botanicals. Although preparations of G. sylvestre are marketed as f...

Europe - EFSA - European Food Safety Authority Publications

7-9-2018

Orphan designation:  Recombinant human beta-glucuronidase (vestronidase alfa),  for the: Treatment of mucopolysaccharidosis type VII (Sly syndrome)

Orphan designation: Recombinant human beta-glucuronidase (vestronidase alfa), for the: Treatment of mucopolysaccharidosis type VII (Sly syndrome)

On 21 March 2012, orphan designation (EU/3/12/973) was granted by the European Commission to NDA Regulatory Science Ltd, United Kingdom, for recombinant human beta-glucuronidase for the treatment of mucopolysaccharidosis type VII (Sly syndrome).

Europe - EMA - European Medicines Agency

29-8-2018

Scientific Opinion about the Guidance of the Chemical Regulation Directorate (UK) on how aged sorption studies for pesticides should be conducted, analysed and used in regulatory assessments

Scientific Opinion about the Guidance of the Chemical Regulation Directorate (UK) on how aged sorption studies for pesticides should be conducted, analysed and used in regulatory assessments

Published on: Mon, 27 Aug 2018 00:00:00 +0200 The EFSA Panel on Plant Protection Products and their Residues reviewed the guidance on how aged sorption studies for pesticides should be conducted, analysed and used in regulatory assessment. The inclusion of aged sorption is a higher tier in the groundwater leaching assessment. The Panel based its review on a test with three substances taken from a data set provided by the European Crop Protection Association. Particular points of attention were the quali...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Joint EFSA and ECDC 2018 workshop on preparedness for a multi‐national food safety/public health incident

Joint EFSA and ECDC 2018 workshop on preparedness for a multi‐national food safety/public health incident

Published on: Tue, 21 Aug 2018 00:00:00 +0200 Abstract In May 2018, EFSA and ECDC co‐facilitated a workshop on preparedness for a multi‐national food safety/public health incident. The workshop, hosted at AGES in Vienna, was conceived to closely align with EFSA's Strategy 2020 commitment to prepare for future risk assessment challenges. EFSA, ECDC, AGES and BfR worked together closely to develop a workshop and associated training materials to be delivered over a 2.5‐day agenda. The workshop was attended...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Evaluation of data concerning the necessity of bromoxynil as herbicide to control a serious danger to plant health which cannot be contained by other available means, including non‐chemical methods

Evaluation of data concerning the necessity of bromoxynil as herbicide to control a serious danger to plant health which cannot be contained by other available means, including non‐chemical methods

Published on: Mon, 13 Aug 2018 00:00:00 +0200 EFSA was requested by the European Commission to provide scientific assistance under Article 31 of Regulation (EC) No 178/2002 regarding the evaluation of data concerning the necessity of bromoxynil as a herbicide to control a serious danger to plant health which cannot be contained by other available means including non‐chemical methods, in accordance with Article 4(7) of Regulation (EC) No 1107/2009. In this context, EFSA organised a commenting phase with ...

Europe - EFSA - European Food Safety Authority Publications

17-8-2018

Middel tegen ziekte van Kahler in basispakket na succesvolle prijsonderhandelingen

Middel tegen ziekte van Kahler in basispakket na succesvolle prijsonderhandelingen

Minister Bruno Bruins (Medische Zorg) heeft met succes onderhandeld over de prijs van het middel daratumumab in twee verschillende combinatietherapieën voor de vervolgbehandeling van de ziekte van Kahler (multipel myeloom). Bij deze ziekte is er sprake van kwaadaardige woekering van plasmacellen in het beenmerg. Daratumumab was al beschikbaar als zogenaamde monotherapie voor patiënten die al eerder zijn behandeld. Door de prijsafspraken wordt het middel vanaf 1 september voor deze patiënten ook vergoed u...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

10-8-2018

FDA approves new vaginal ring for one year of birth control

FDA approves new vaginal ring for one year of birth control

FDA approved Annovera (segesterone acetate and ethinyl estradiol vaginal system), a combined hormonal contraceptive for women of reproductive age used to prevent pregnancy and is the first vaginal ring contraceptive that can be used for an entire year.

FDA - U.S. Food and Drug Administration

30-7-2018

ANSES recommends that certain populations avoid the consumption of food supplements containing melatonin

ANSES recommends that certain populations avoid the consumption of food supplements containing melatonin

Under the national nutrivigilance scheme, reports of adverse effects likely to be associated with the consumption of food supplements containing melatonin have been brought to the attention of ANSES. A retrospective analysis of these reports, combined with the considerable level of consumption of this type of supplement, led ANSES to conduct an assessment of the potential health risks. In its Opinion of February 2018, the Agency highlighted the existence of populations and situations at risk, for which t...

France - Agence Nationale du Médicament Vétérinaire

18-7-2018

Orphan designation:  Recombinant humanised anti-human interleukin-1 beta monoclonal antibody,  for the: Treatment of Behçet’s disease

Orphan designation: Recombinant humanised anti-human interleukin-1 beta monoclonal antibody, for the: Treatment of Behçet’s disease

On 1 October 2010, orphan designation (EU/3/10/796) was granted by the European Commission to XOMA Ireland Ltd, Ireland, for recombinant humanised anti-human interleukin-1 beta monoclonal antibody for the treatment of Behçet’s disease.

Europe - EMA - European Medicines Agency

17-7-2018

Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall of Valsartan and Valsartan Hydrochlorothiazide Tablets

Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall of Valsartan and Valsartan Hydrochlorothiazide Tablets

Teva Pharmaceuticals USA today confirmed a voluntary recall to the consumer / user level of 29 lots of single and 51 lots of combination valsartan medicines distributed under the Actavis label in the U.S. due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceutical. The impurity detected in the API is N- nitrosodimethylamine (NDMA), which is a substance that occurs naturally in certain foods, drinking wat...

FDA - U.S. Food and Drug Administration

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

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

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

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

19-9-2018

#FDA issues final guidance with recommendations for labeling and safety testing of #heparin  containing medical devices and device-led combination products to help  reduce the risk of patient injury. To read the guidance, click here:  https://go.usa.gov/x

#FDA issues final guidance with recommendations for labeling and safety testing of #heparin containing medical devices and device-led combination products to help reduce the risk of patient injury. To read the guidance, click here: https://go.usa.gov/x

#FDA issues final guidance with recommendations for labeling and safety testing of #heparin containing medical devices and device-led combination products to help reduce the risk of patient injury. To read the guidance, click here: https://go.usa.gov/xP2VB  #MedicalDevice pic.twitter.com/hsdX5ylKPu

FDA - U.S. Food and Drug Administration

28-8-2018

EU/3/18/2067 (Omeros London Limited)

EU/3/18/2067 (Omeros London Limited)

EU/3/18/2067 (Active substance: Recombinant human monoclonal antibody against mannan-binding lectin-associated serine protease-2) - Orphan designation - Commission Decision (2018)5737 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/044/18

Europe -DG Health and Food Safety

22-8-2018

CLYNAV (Elanco GmbH)

CLYNAV (Elanco GmbH)

CLYNAV (Active substance: Salmon pancreas disease vaccine (recombinant DNA plasmid)) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5624 of Wed, 22 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2390/T/02

Europe -DG Health and Food Safety

15-8-2018

Scientific guideline:  Draft guideline on similar biological medicinal products containing recombinant granulocyte-colony stimulating factor (rG-CSF) - Revision 1, draft: consultation open

Scientific guideline: Draft guideline on similar biological medicinal products containing recombinant granulocyte-colony stimulating factor (rG-CSF) - Revision 1, draft: consultation open

The proposed guideline will replace annex to guideline on similar medicinal products containing biotechnology-derived proteins as active substance: Non-Clinical and Clinical Issues - Guidance on similar medicinal products containing recombinant granulocyte-colony stimulating factor, EMEA/CHMP/BMWP/31329/2005

Europe - EMA - European Medicines Agency

7-8-2018

EU/3/18/2049 (Inozyme Pharma Ireland Ltd)

EU/3/18/2049 (Inozyme Pharma Ireland Ltd)

EU/3/18/2049 (Active substance: Recombinant human ectonucleotide pyrophosphatase/phosphodiesterase 1 fused to the Fc fragment of IgG1) - Orphan designation - Commission Decision (2018)5281 of Tue, 07 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/053/18

Europe -DG Health and Food Safety

7-8-2018

LETIFEND (Laboratorios LETI, S.L.unipersonal)

LETIFEND (Laboratorios LETI, S.L.unipersonal)

LETIFEND (Active substance: Recombinant Protein Q from L. infantum MON-1) - Centralised - Yearly update - Commission Decision (2018)5415 of Tue, 07 Aug 2018

Europe -DG Health and Food Safety

2-8-2018

EU/3/18/2043 (Dr Ulrich Granzer)

EU/3/18/2043 (Dr Ulrich Granzer)

EU/3/18/2043 (Active substance: Combination of carboplatin and sodium valproate) - Orphan designation - Commission Decision (2018)5275 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/036/18

Europe -DG Health and Food Safety

2-8-2018

EU/3/14/1351 (Kyowa Kirin Holdings B.V.)

EU/3/14/1351 (Kyowa Kirin Holdings B.V.)

EU/3/14/1351 (Active substance: Recombinant human monoclonal IgG1 antibody for fibroblast growth factor 23) - Transfer of orphan designation - Commission Decision (2018)5289 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/133/14/T/02

Europe -DG Health and Food Safety

27-7-2018

EU/3/14/1410 (Chiesi Farmaceutici S.p.A.)

EU/3/14/1410 (Chiesi Farmaceutici S.p.A.)

EU/3/14/1410 (Active substance: Recombinant human aspartylglucosaminidase) - Transfer of orphan designation - Commission Decision (2018)5051 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/172/14/T/01

Europe -DG Health and Food Safety

27-7-2018

EU/3/11/911 (Chiesi Farmaceutici S.p.A.)

EU/3/11/911 (Chiesi Farmaceutici S.p.A.)

EU/3/11/911 (Active substance: Recombinant human galactocerebrosidase) - Transfer of orphan designation - Commission Decision (2018)5050 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/042/11/T/01

Europe -DG Health and Food Safety

27-7-2018

EU/3/02/103 (Chiesi Farmaceutici S.p.A.)

EU/3/02/103 (Chiesi Farmaceutici S.p.A.)

EU/3/02/103 (Active substance: Recombinant Human Porphobilinogen Deaminase) - Transfer of orphan designation - Commission Decision (2018)5048 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/OD/083/01/T/01

Europe -DG Health and Food Safety

18-7-2018

EU/3/16/1686 (Mereo Biopharma Ireland Ltd)

EU/3/16/1686 (Mereo Biopharma Ireland Ltd)

EU/3/16/1686 (Active substance: Recombinant humanised monoclonal IgG2 lambda antibody against human sclerostin) - Transfer of orphan designation - Commission Decision (2018)4809 of Wed, 18 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/052/16/T/02

Europe -DG Health and Food Safety