Darob mite

Glavne informacije

  • Zaščiteno ime:
  • Darob mite 80 mg tablete
  • Farmacevtska oblika:
  • tableta
  • Sestava:
  • sotalol 70,54 mg / 1 tableta
  • Pot uporabe:
  • Peroralna uporaba
  • Enote v paketu:
  • škatla s 50 tabletami (5 x 10 tablet v pretisnem omotu)
  • Tip zastaranja:
  • Rp - Predpisovanje in izdaja zdravila je le na recept
  • Uporabi za:
  • ljudje
  • Vrsta medicine:
  • Alopatska drog

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  • Na voljo v:
  • Darob mite 80 mg tablete
    Slovenija
  • Jezik:
  • slovenščina

Terapevtski podatki

  • Terapevtska skupina:
  • sotalol

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:
  • 103-187/2014-2
  • Datum dovoljenje:
  • 25-08-2015
  • EAN koda:
  • 3837000000771
  • Zadnja posodobitev:
  • 18-01-2018

Podatki za bolnike

Darob mite 80 mg tablete

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NAVODILO ZA UPORABO

Darob mite 80 mg tablete

sotalolijev klorid

Pred uporabo natančno preberite navodilo!

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 katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni

učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.

Navodilo vsebuje:

Kaj je zdravilo Darob mite in za kaj ga uporabljamo

Kaj morate vedeti, preden boste vzeli zdravilo Darob mite

Kako jemati zdravilo Darob mite

Možni neželeni učinki

Shranjevanje zdravila Darob mite

Dodatne informacije

1.

Kaj je zdravilo Darob mite in zakaj ga uporabljamo

Zdravilo Darob mite je zdravilo za zdravljenje motenj srčnega ritma (antiaritmik).

Zdravilo Darob mite je antiaritmik iz III. skupine antiaritmikov in izrazito zavira receptorje

beta.

Zdravilo Darob mite uporabljamo za zdravljenje srčnih aritmij in sicer za:

hudo simptomatsko ventrikularno tahikardijo (hitro utripanje srca, pri katerem

nastajajo impulzi v prekatih srca),

simptomatsko supraventrikularno tahikardijo, ki zahteva zdravljenje, npr.

preprečevanje kronične atrijske fibrilacije (kroničnega preddvornega

migetanja) po elektrokonverziji,

preprečevanje paroksizmalne atrijske fibrilacije (preddvornega migetanja).

2.

Kaj morate vedeti, preden boste vzeli zdravilo Darob mite

Ne uporabljajte zdravila Darob mite

če ste alergični (preobčutljivi) na zdravilno učinkovino sotalolijev klorid,

sulfonamide ali katerokoli sestavino zdravila Darob mite.

če imate kongestivno srčno popuščanje (NYHA IV),

če ste preboleli nenadno srčno kap (akutni miokardni infarkt),

če ste v šoku,

pri visokostopenjskih motnjah prevajanja med srčnimi preddvori in prekati

(atrioventrikularni blok II. in III. stopnje),

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pri bloku prevajanja med sinusnim vozlom in preddvorom,

če imate bolezen sinusnega vozla, za katero je značilno počasno bitje srca (pod

60 utripov na minuto), ki je pogosto prekinjeno z epizodami hitrega in nerednega

srčnega utripa ali obdobji sinusnega zastoja,

pri srčnem utripu, ki je nižji od 50 udarcev na minuto (to je pri bradikardiji),

pri obstoječem podaljšanju intervala QT (določena sprememba v EKG),

če imate zmanjšano vrednost kalija v krvi (hipokaliemijo),

če imate nizek krvni tlak (hipotenzijo),

če imate pozno fazo poapnitve arterij udov (periferne arterijske okluzivne bolezni),

če imate kronično obolenje dihal, za katerega so značilni kronično zmanjšan

pretok zraka, kratka sapa, kašelj, piskanje in povečano nastajanje sluzi, kar

otežuje dihanje (kronična obstruktivna pljučna bolezen (KOPB)),

če imate zvečano kislost krvi (metabolično acidozo).

Bodite posebno pozorni pri jemanju zdravila Darob mite

Če ste bolnik z okvarjenim delovanjem ledvic (glejte poglavje 3) vam bo zdravnik

prilagodil odmerek zdravila Darob mite.

Zdravljenje z zdravilom Darob mite lahko prikrije znake prenizkega krvnega sladkorja

(hipoglikemije), zlasti pospešen srčni utrip in drhtenje prstov. Na to je treba paziti

predvsem, če ste bolnik s sladkorno boleznijo, ki jim krvni sladkor zelo niha, ter če se

strogo postite.

Če imate tumor nadledvične žleze (feokromocitom), vam bo zdravnik lahko predpisal

zdravilo Darob mite le v primeru, če boste sočasno prejemali terapijo z zaviralci

alfa-receptorjev.

Če imate osebno ali družinsko anamnezo luskavice (psoriaze), vam bo zdravnik zdravilo

z antagonističnim beta delovanjem (kot je npr. zdravilo Darob mite) predpisal le po

skrbnem pretehtanju koristi in tveganj.

Če imate ishemično bolezen srca in želite po dolgotrajni uporabi prenehati uporabljati

zdravilo Darob mite se posvetujte z zdravnikom. V takih primerih je potrebna posebna

previdnost.

Če boste imeli operacijo ali boste prejeli anestetike morate povedati zdravniku, da

jemljete zdravilo Darob mite.

Antagonistično beta delovanje zdravila Darob mite lahko poveča vašo občutljivost za

alergene in stopnjuje takojšnje preobčutljivostne reakcije (anafilaktične reakcije). Če ste

v preteklosti imeli hude preobčutljivostne reakcije, ali če prejemate zdravljenje za

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ublažitev oz. odpravo alergijskih reakcij (desenzibilizacijsko zdravljenje), vas bolj

ogrožajo zelo močne anafilaktične reakcije. Zato vam bo zdravnik predpisal zdravilo

Darob mite le po skrbnem pretehtanju koristi in tveganj.

Če ste v preteklosti doživeli srčni infarkt ali imate slabo delovanje prekatov, vas posebno

ogroža poslabšanje motenj srčnega ritma.

Uporaba drugih zdravil

Sočasna peroralna uporaba zdravila Darob mite in zaviralcev kalcijevih kanalčkov

verapamilskega in diltiazemskega tipa (zdravila za zdravljenje visokega krvnega tlaka)

lahko povzroči izrazit padec krvnega tlaka ter počasno bitje srca in visokostopenjske

motnje prevajanja med preddvorom in prekatom zaradi dodatnega učinka na sinusni in

atrioventrikularni vozel.

Če dobivate zdravilo Darob mite, je kontraindicirana intravenska uporaba zaviralcev

kalcijevih kanalčkov verapamilskega in diltiazemskega tipa (razen na intenzivnih

oddelkih).

Kombinirano zdravljenje z antiaritmiki (zdravila za zdravljenje motenj srčnega ritma) iz I.

skupine (zlasti s kinidinu podobnimi snovmi) in drugimi antiaritmiki iz III. skupine lahko

čezmerno podaljša interval QT (določena sprememba v EKG), to pa spremlja večje

tveganje za prekatne motnje srčnega ritma. Da bi preprečili čezmerno podaljšanje

intervala QT, se morate izogniti tudi uporabi drugih antiaritmikov iz III. skupine.

Sočasna uporaba zdravila Darob mite in zdravil, pri katerih je verjetno podaljšanje

intervala QT (npr. tricikličnih ali tetracikličnih antidepresivov (kot sta imipramin in

maprotilin), antihistaminikov (kot sta astemizol in terfenadin), makrolidnih antibiotikov

(eritromicin), probukola, haloperidola, halofantrina in terodilina, je povezana z večjim

tveganjem za poslabšanje motenj srčnega ritma (torsades de pointes).

Sočasna uporaba zaviralcev kalcijevih kanalčkov nifedipinskega tipa (zdravila za

zdravljenje visokega krvnega tlaka) lahko stopnjuje padec krvnega tlaka.

Sočasna uporaba zdravila Darob mite in noradrenalina ali zaviralcev MAO (zdravila za

zdravljenje depresij) ter nenadna prekinitev sočasnega zdravljenja s klonidinom (zdravilo

za zdravljenje visokega krvnega tlaka) lahko izzovejo čezmeren porast krvnega tlaka.

Sočasna uporaba zdravila Darob mite in tricikličnih antidepresivov (zdravil za zdravljenje

psihičnih bolezni), barbituratov (zdravil za zdravljenje epilepsije), fenotiazinov (zdravil, ki

se uporabljajo kot antihistraminiki ali antipsihotiki), narkotikov (zdravil, ki povzročajo

splošno anestezijo ali delujejo močno protibolečinsko) in zdravil za zniževanje krvnega

tlaka, diuretikov (zdravil, ki povečajo izločanje urina) ali vazodilatatorjev (zdravil, ki širijo

žile) lahko povzroči čezmeren padec krvnega tlaka.

Učinek zmanjšanja moči kontrakcije srca (negativni inotropni učinek) zdravila Darob mite

in narkotikov ali zdravil za zdravljenje motenj srčnega ritma se lahko sešteva.

Sočasna uporaba učinkovin, kot so reserpin, klonidin, alfa-metildopa, gvanfacin ali srčni

glikozidi (zdravila proti šibkosti srčne mišice) lahko stopnjuje učinek zmanjšanja števila

udarcev srca na minuto in hitrosti prevajanja impulzov v srcu (negativni kronotropni in

negativni dromotropni učinek) zdravila Darob mite.

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Živčnomišična blokada (blokada povezave živcev in mišic) s tubokurarinom (zdravilo za

mišično relaksacijo) se lahko okrepi z zdravilom Darob mite.

Sočasna uporaba zdravila Darob mite in insulina ali peroralnih zdravil za zdravljenje

sladkorne bolezni lahko povzroči nenormalno znižanje koncentracije glukoze v krvi, še

zlasti ob telesnem naporu. Ti simptomi so lahko prekriti.

Sočasna uporaba diuretičnih zdravil, ki izpljavljajo kalij (npr. furosemida ali

hidroklorotiazida) lahko spremlja večje tveganje za motnje srčnega ritma zaradi znižane

količine kalija v krvi.

Hkrati z zdravilom Darob mite naj ne bi uporabljali tricikličnih antidepresivov (zdravila za

zdravljenje depresij) ali uživali alkohola, ker to lahko poveča tveganje za prekatne

motnje srčnega ritma.

Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali

katerokoli zdravilo, tudi če ste ga dobili brez recepta.

Jemanje zdravila Darob mite skupaj s hrano in pijačo

Med zdravljenjem z zdravilom Darob mite se izogibajte pitju alkoholnih pijač, ker lahko

izzovejo motnje srčnega ritma.

Zdravila Darob mite ne jemljite istočasno z mlekom in mlečnimi izdelki, ker lahko hkratno

zaužitje zmanjša absorpcijo zdravilne učinkovine.

Nosečnost in dojenje

Posvetujte se z zdravnikom ali s farmacevtom, preden vzamete katerokoli zdravilo.

Nosečnost

Če ste noseči, smete sotalolijev klorid, zdravilno učinkovino zdravila Darob mite,

uporabljati le po skrbnem pretehtanju koristi in tveganja, ker o uporabi pri nosečnicah ni

dovolj podatkov. Ugotovljeno pa je bilo, da sotalolijev klorid prehaja posteljico.

Dojenje

Sotalolijev klorid, zdravilna učinkovina zdravila Darob mite, se izloča v materinem mleku.

Dojenje med zdravljenjem z zdravilom Darob mite ni priporočljivo.

Vpliv na sposobnost upravljanja vozil in strojev

To zdravilo lahko vpliva na posameznikovo zmožnost za vožnjo, upravljanje strojev oz.

varno delo v nevarnih pogojih. To še posebno velja na začetku zdravljenja, po povečanju

odmerka ali po prehodu na drugo zdravilo, pa tudi po sočasnem pitju alkohola.

Pomembne informacije o nekaterih sestavinah zdravila Darob mite

To zdravilo vsebuje laktozo. Če vam je zdravnik povedal, da imate intoleranco za

nekatere sladkorje, se pred uporabo tega zdravila posvetujte s svojim zdravnikom.

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3.

Kako jemati zdravilo Darob mite

Pri jemanju zdravila Darob mite natančno upoštevajte zdravnikova navodila. Če ste

negotovi, se posvetujte z zdravnikom ali s farmacevtom.

Huda simptomatska ventrikularna tahikardija (hitro utripanje srca, pri katerem nastajajo

impulzi v prekatih srca)

Začetni odmerek je 1 tableta zdravila Darob mite dvakrat na dan (kar ustreza 1 x 80 mg

sotalolijevega klorida dvakrat na dan). Če učinek ni zadosten, vam zdravnik dnevni

odmerek lahko poveča na 1 tableto zdravila Darob mite trikrat na dan (kar ustreza 1 x

80 mg sotalolijevega klorida trikrat na dan) ali na 2 tableti zdravila Darob mite dvakrat na

dan (kar ustreza 2 x 80 mg sotalolijevega klorida dvakrat na dan).

V primeru smrtno nevarne motnje srčnega ritma in nezadostne učinkovitosti vam

zdravnik odmerek lahko poveča na 6 tablet zdravila Darob mite (kar ustreza

480 mg/dan) v dveh ali treh posamičnih odmerkih. V takšnih primerih vam bo zdravnik

odmerek povečal le, če možne koristi odtehtajo večje tveganje za hude neželene učinke

(zlasti učinke, ki pospešujejo nastanek motenj srčnega ritma).

Zdravnik vam odmerek lahko zviša šele po 2 do 3 dneh prejemanja terapije.

Preddvorno migetanje:

Začetni odmerek je 1 tableta zdravila Darob mite dvakrat na dan (kar ustreza 1 x 80 mg

sotalolijevega klorida dvakrat na dan). Če boste odmerek dobro prenašali, učinek pa ne

bo zadosten, vam zdravnik odmerek lahko poveča na 1 tableto zdravila Darob mite

trikrat na dan (kar ustreza 1 x 80 mg sotalolijevega klorida trikrat na dan). Če imate

napade preddvornega migetanja, se tega odmerka ne sme preseči.

Če začetni odmerek ni dovolj učinkovit, vendar ga dobro prenašate in imate kronično

preddvorno migetanje, vam zdravnik odmerek lahko poveča na največ 2 tableti zdravila

Darob mite dvakrat na dan (kar ustreza 2 x 80 mg sotalolijevega klorida dvakrat na dan).

Zdravnik vam lahko odmerek zviša šele po 2 do 3 dneh prejemanja terapije.

Priporočeni odmerek za bolnike z okvarjenim delovanjem ledvic:

Če imate okvarjeno delovanje ledvic se zdravilo Darob mite po večkratni uporabi kopiči.

Zato vam bo zdravnik odmerek prilagodil vaši hitrosti izločanja skozi ledvice (ledvičnemu

očistku) ter hkrati spremljal srčno frekvenco (ta ne sme biti manj kot 50 utripov/minuto) in

klinični odziv. Če imate hudo odpoved ledvic, vam bo zdravnik lahko predpisal zdravilo

Darob mite le ob pogostem spremljanju EKG in koncentracije v serumu.

Če imate očistek kreatinina nad 60 ml/min (to je nad 1 ml/s), je začetni odmerek zdravila

Darob mite 80 mg vsakih 12 ur, nato pa vam bo odmerek določil zdravnik glede na vaš

klinični odziv.

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Če imate očistek kreatinina med 30 in 59 ml/min (to je med 0,5 in 1 ml/s), je začetni

odmerek zdravila Darob mite 80 mg vsakih 24 ur, nato pa vam bo odmerek določil

zdravnik glede na vaš klinični odziv.

Če imate očistek kreatinina med 10 in 29 ml/min (to je med 0,17 in 0,5 ml/s), je začetni

odmerek zdravila Darob mite 80 mg vsakih 36 do 48 ur, nato pa vam bo odmerek

določil zdravnik glede na vaš klinični odziv.

Če imate očistek kreatinina pod 10 ml/min (to je pod 0,17 ml/s), se uporaba zdravila

Darob mite odsvetuje.

Otroci

Ker ni dovolj terapevtskih izkušenj, zdravila Darob mite pri otrocih ne smete uporabljati.

Starejši bolniki

Pri zdravljenju starejših bolnikov bo zdravnik upošteval možnost okvarjenega delovanja

ledvic.

Če ste preboleli srčni infarkt ali imate hudo srčno popuščanje, vas bo zdravnik med

obdobjem povečevanja odmerka tega antiaritmičnega zdravila posebno natančno

nadziral.

Če ste preboleli srčni infarkt in/ali imate motnje srčnega ritma ter če ste terapijo

prejemali dolgo časa, morate zdravilo opustiti postopoma skladno z navodili zdravnika,

saj lahko nenadna prekinitev škodljivo vpliva na klinično stanje.

Tablete pogoltnite cele, z nekaj tekočine (npr. z enim kozarcem vode).

Če ste vzeli večji odmerek zdravila Darob mite, kot bi smeli

Če ste vzeli večji odmerek zdravila Darob mite, kot bi smeli, se takoj posvetujte s svojim

zdravnikom, v primeru če bo potrebno sprejeti nujne ukrepe. Znaki prevelikega

odmerjanja so odvisni od tega, v kakšnem stanju je bilo vaše srce (delovanje levega

prekata, motnje srčnega ritma). Odvisno od tega, kako izrazito je preveliko odmerjanje,

so možni sledeči znaki: utrujenost, izguba zavesti, razširjene zenice, napadi krčev,

padec krvnega tlaka, počasno bitje srca vse do srčnega zastoja ter neznačilne prekatne

tahikardije (Torsades de pointes) in simptomi kardiovaskularnega šoka.

Če opazite takšne znake, se takoj posvetujte s svojim zdravnikom. Če ne morete

kontaktirati svojega zdravnika, pojdite v bolnišnico. Za zdravljenje prevelikega odmerka

potrebujete intenzivno zdravniško pomoč.

Če ste pozabili vzeti zdravilo Darob mite

Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek, temveč nadaljujte

zdravljenje s predpisanim odmerkom.

Če motnje srčnega ritma ponovno nastopijo, se takoj posvetujte s svojim zdravnikom.

Če ste prenehali jemati zdravilo Darob mite

Zdravljenja z zdravilom Darob mite ne smete prekinjati ali končati brez predhodnega

posveta z vašim zdravnikom.

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Če ste doživeli srčni infarkt in/ali imate motnje srčnega ritma ali ste se z zdravilom Darob

mite zdravili dalj časa, morate zdravilo opustiti postopoma, saj lahko ob nenadni

prekinitvi pride do poslabšanja stanja bolezni.

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

farmacevtom.

4.

Možni neželeni učinki

Kot vsa zdravila ima lahko tudi zdravilo Darob mite neželene učinke, ki pa se ne pojavijo

pri vseh bolnikih.

Pogostnost neželenih učinkov je opredeljena takole:

Zelo pogosti: pojavijo se pri več kot 1 od 10 bolnikov

Pogosti: pojavijo se pri 1 do 10 bolnikih od 100 bolnikov

Občasni: pojavijo se pri 1 do 10 bolnikih od 1.000 bolnikov

Redki: pojavijo se pri 1 do 10 bolnikih od 10.000 bolnikov

Zelo redki: pojavijo se pri manj kot 1 bolniku od 10.000 bolnikov

Neznana pogostnost: pogostnosti iz razpoložljivih podatkov ni mogoče oceniti

Pogosti neželeni učinki:

srčno popuščanje, počasno bitje srca, motnje prevajanja;

mravljinčenje, omedlevica, vrtoglavica, omotica, glavobol;

občutek siljenja na bruhanje, bruhanje, driska, suha usta;

pordelost, srbenje, izpuščaj;

utrujenost, hladni udi;

zmedenost, halucinacije, nenormalne sanje, motnje spanja, depresivno

razpoloženje;

znižanje krvnega tlaka.

Občasni neželeni učinki:

vnetje veznice;

oteženo dihanje pri bolnikih z obstruktivnimi boleznimi dihal (astma, bronhitis,

kronična obstruktivna pljučna bolezen);

plešavost.

Redki neželeni učinki:

luskavica.

Zelo redki neželeni učinki:

angina pektoris;

vnetje roženice in veznice, zmanjšanje solzenja;

poapnitev arterij udov;

alergijsko vnetje sluznice bronhusov, ki ga spremlja fibroza (razraščanje

vezivnega tkiva).

Neznana pogostnost:

motnje srčnega ritma (zlasti pri bolnikih s smrtno nevarnimi motnjami srčnega

ritma in okvarjenim delovanjem levega prekata);

zamegljen vid;

krči v mišicah, šibkost mišic;

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JAZMP-IA/028-21.06.2013

znižana koncentracija krvnega sladkorja; Pri bolnikih, ki se strogo postijo, ter pri

sladkornih bolnikih , pri katerih vrednosti krvnega sladkorja občutno nihajo, se

lahko zgodi, da znaki nizkega krvnega sladkorja niso vidni (zlasti hitro utripanje

srca).

težave s potenco;

Tako kot pri drugih antagonistih adrenergičnih receptorjev beta, se lahko tudi pri

uporabi sotalolijevega klorida pojavijo motnje v presnovi maščob: zvišanje

celotnega holesterola, zvišanje trigliceridov, znižanje HDL holesterola.

Pojavi se lahko prehitro utripanje srca, ki se začne v prekatih srca (vključno s

torsades de pointes). Pojavijo se lahko proaritmični učinki (motnje srčnega ritma),

celo življenjsko nevarne aritmije.

Če katerikoli neželen učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni

omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.

5. Shranjevanje zdravila Darob mite

Zdravilo shranjujte nedosegljivo otrokom!

Za shranjevanje zdravila niso potrebna posebna navodila.

Zdravila Darob mite ne smete uporabljati po datumu izteka roka uporabnosti, ki je

naveden na ovojnini. Datum izteka roka uporabnosti se nanaša na zadnji dan

navedenega meseca.

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

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

ukrepi pomagajo varovati okolje.

6. Dodatne informacije

Kaj vsebuje zdravilo Darob mite

- Zdravilna učinkovina je sotalolijev klorid. Ena tableta vsebuje 80 mg sotalolijevega

klorida, kar ustreza 70,54 mg sotalola.

- Pomožne snovi so: laktoza monohidrat, koruzni škrob, hidroksipropilceluloza, natrijev

karboksimetilškrob (tip A), brezvodni koloidni silicijev dioksid, magnezijev stearat.

Izgled zdravila Darob mite in vsebina pakiranja:

Bela do skoraj bela, okrogla, izbočena tableta z odtisnjenim “80” na eni strani in široko

zarezo na drugi strani.

Razdelilna zareza ni namenjena delitvi tablete na enaka odmerka.

Škatla s 50 tabletami (5 x 10 tablet v pretisnem omotu).

Način in režim izdajanja zdravila Darob mite

Predpisovanje in izdaja zdravila je le na recept.

Darob mite 80 mg tablete

JAZMP-IA/028-21.06.2013

Imetnik dovoljenja za promet z zdravilom

ABBOTT LABORATORIES d.o.o., Dolenjska cesta 242c, 1000 Ljubljana, Slovenija

Izdelovalec

AbbVie Deutchland GmbH&Co.KG, Knollstrasse, 67061 Ludwigshafen, Nemčija

Navodilo je bilo odobreno: 21. 06. 2013.

15-11-2018

Vanpak Limited recalls various Cosmetic products in pressurised containers.

Vanpak Limited recalls various Cosmetic products in pressurised containers.

The recalled products do not have mandatory hazard labelling as required by the Cosmetics Regulations under the Food and Drugs Act. Improper labelling could result in misuse of the product and lead to serious injury.

Health Canada

5-11-2018

STIHL Limited recalls STIHL MSA 161 T Battery Operated Arborist Chain Saw

STIHL Limited recalls STIHL MSA 161 T Battery Operated Arborist Chain Saw

The side inter-lock button may stick when gripping the machine, which could cause the throttle trigger to remain depressed and the chain to continue to run even after releasing the throttle trigger. This can pose a risk of laceration to the user or bystander.

Health Canada

5-11-2018

Vanpak Limited recalls David Ross Extra purified Butane gas

Vanpak Limited recalls David Ross Extra purified Butane gas

The recalled products do not have proper hazard labelling as required by the Consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act. Improper labelling could result in unintentional exposure to these products and lead to serious illness, injury or death.

Health Canada

30-10-2018

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

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

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

FDA - U.S. Food and Drug Administration

30-10-2018

Mountain Warehouse Limited recalls BPA-Free Printed Kids' Water Bottles

Mountain Warehouse Limited recalls BPA-Free Printed Kids' Water Bottles

If the spout of the water bottle becomes detached during use, a small ring can be exposed and both the spout and the ring may pose a choking hazard.

Health Canada

29-10-2018

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

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

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

FDA - U.S. Food and Drug Administration

17-10-2018

Faribault Foods, Inc. Announces Voluntary Recall of a Limited Quantity of S&W Brand White Beans Due to the Presence of Undeclared (Sulfites)

Faribault Foods, Inc. Announces Voluntary Recall of a Limited Quantity of S&W Brand White Beans Due to the Presence of Undeclared (Sulfites)

Faribault Foods, Inc. of Faribault, MN is recalling its 15 ounce S&W White Beans because it contains undeclared sulfites. People who have an allergy or severe sensitivity to sulfites run the risk of serious or life-threatening allergic reaction if they consume this product.

FDA - U.S. Food and Drug Administration

16-10-2018

Pest categorisation of Cronartium harknessii, Cronartium kurilense and Cronartium sahoanum

Pest categorisation of Cronartium harknessii, Cronartium kurilense and Cronartium sahoanum

Published on: Mon, 15 Oct 2018 00:00:00 +0200 Following a request from the European Commission, the EFSA Panel on Plant Health performed a pest categorisation of Cronartium harknessii, Cronartium kurilense and Cronartium sahoanum, which are well‐defined and distinguishable tree fungal pathogens of the family Cronartiaceae. In 2018, these species were moved from the genus Endocronartium to the genus Cronartium. These pathogens are not known to be present in the EU and are regulated in Council Directive 2...

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

12-10-2018

Voluntary Recall of Limited Amounts of Nuts & Vanilla Protein Plant Shake

Voluntary Recall of Limited Amounts of Nuts & Vanilla Protein Plant Shake

Forager Project is recalling three dates of Nuts and Vanilla – Organic Plant Protein Shake because the product contains almond flour which is not declared on the label.

FDA - U.S. Food and Drug Administration

11-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

28-9-2018

FDA approves a new antibacterial drug to treat a serious lung disease using a novel pathway to spur innovation

FDA approves a new antibacterial drug to treat a serious lung disease using a novel pathway to spur innovation

The FDA approved the first antibacterial drug under the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD). LPAD was created by Congress to spur development of drugs targeting serious infections in limited patient populations with unmet need.

FDA - U.S. Food and Drug Administration

13-9-2018

Use of next‐generation sequencing in microbial risk assessment

Use of next‐generation sequencing in microbial risk assessment

Published on: Mon, 27 Aug 2018 00:00:00 +0200 Despite the ever increase in rigorous control and monitoring measures to assure safe food along the entire farm‐to‐fork chain, the past decade has also witnessed an increase in microbial food alerts. Hence, research on food safety and quality remain of utmost importance. Complementary, and at least as important, is the necessity to be able to assess the potential microbial risks along the food chain. Risk assessment relies on sound scientific data. Unfortuna...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Emerson Electric Canada Limited recalls RIDGID NXT 6 Gallon and 9 Gallon Wet/Dry Vacuum Cleaners

Emerson Electric Canada Limited recalls RIDGID NXT 6 Gallon and 9 Gallon Wet/Dry Vacuum Cleaners

The on/off switch can be dislodged or pulled out from the vacuum motor cover. Doing so while the vacuum is plugged in could expose the user to energised wiring connectors and pose a potential shock hazard.

Health Canada

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

11-9-2018

Risk assessment of white willow (Salix alba) in food

Risk assessment of white willow (Salix alba) in food

Published on: Tue, 28 Aug 2018 00:00:00 +0200 This Technical Report contains a description of the activities within the work programme of the EU‐FORA Fellowship on the risk assessment of white willow in food. The bark of different varieties of willow has had a long history of medical use as a means to reduce fever and as a painkiller. Willow bark is also used in weight loss and sports performance food supplements. The labelling of these products usually does not mention any restrictions to the length of...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Risk assessment of antimicrobial resistance along the food chain through culture‐independent methodologies

Risk assessment of antimicrobial resistance along the food chain through culture‐independent methodologies

Published on: Mon, 27 Aug 2018 00:00:00 +0200 Antimicrobial resistance (AMR) represents a major challenge for Public Health and the scientific community, and requires immediate and drastic solutions. Acquired resistance to certain antimicrobials is already widespread to such an extent that their efficacy in the treatment of certain life‐threatening infections is already compromised. To date, the emergence and spread of AMR has been attributed to the use, misuse or indiscriminate use of antibiotics as th...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Scientific Opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) effect models for regulatory risk assessment of pesticides for aquatic organisms

Scientific Opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) effect models for regulatory risk assessment of pesticides for aquatic organisms

Published on: Thu, 23 Aug 2018 00:00:00 +0200 Following a request from EFSA, the Panel on Plant Protection Products and their Residues (PPR) developed an opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) models and their use in prospective environmental risk assessment (ERA) for pesticides and aquatic organisms. TKTD models are species‐ and compound‐specific and can be used to predict (sub)lethal effects of pesticides under untested (time‐variable) exposure conditions. Three differen...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Risk to human and animal health related to the presence of 4,15‐diacetoxyscirpenol in food and feed

Risk to human and animal health related to the presence of 4,15‐diacetoxyscirpenol in food and feed

Published on: Thu, 16 Aug 2018 00:00:00 +0200 4,15‐Diacetoxyscirpenol (DAS) is a mycotoxin primarily produced by Fusarium fungi and occurring predominantly in cereal grains. As requested by the European Commission, the EFSA Panel on Contaminants in the Food Chain (CONTAM) assessed the risk of DAS to human and animal health related to its presence in food and feed. Very limited information was available on toxicity and on toxicokinetics in experimental and farm animals. Due to the limitations in the avai...

Europe - EFSA - European Food Safety Authority Publications

22-8-2018

UPDATED: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan/Amlodipine/HCTZ, Valsartan/Amlodipine and Valsartan Tablets

UPDATED: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan/Amlodipine/HCTZ, Valsartan/Amlodipine and Valsartan Tablets

Torrent Pharmaceuticals Limited is voluntarily recalling ALL LOTS within expiry of Valsartan/Amlodipine/HCTZ, Valsartan/Amlodipine and Valsartan tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals. The impurity detected in the API is N-nitrosodimethylamine (NDMA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industr...

FDA - U.S. Food and Drug Administration

16-11-2018

Daptomycin Hospira (Hospira UK Limited)

Daptomycin Hospira (Hospira UK Limited)

Daptomycin Hospira (Active substance: daptomycin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7678 of Fri, 16 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/004310/T/0008

Europe -DG Health and Food Safety

9-11-2018

Recent Ebola outbreaks in remote areas with limited resources can benefit from rapid diagnostic tools, and the issuance of today’s EUA is an important step in addressing these outbreaks.  http://go.usa.gov/xPvs4 pic.twitter.com/o2I1dYUQCx

Recent Ebola outbreaks in remote areas with limited resources can benefit from rapid diagnostic tools, and the issuance of today’s EUA is an important step in addressing these outbreaks. http://go.usa.gov/xPvs4 pic.twitter.com/o2I1dYUQCx

Recent Ebola outbreaks in remote areas with limited resources can benefit from rapid diagnostic tools, and the issuance of today’s EUA is an important step in addressing these outbreaks. http://go.usa.gov/xPvs4  pic.twitter.com/o2I1dYUQCx

FDA - U.S. Food and Drug Administration

6-11-2018

Symkevi (Vertex Pharmaceuticals (Europe) Limited)

Symkevi (Vertex Pharmaceuticals (Europe) Limited)

Symkevi (Active substance: tezacaftor/ivacaftor) - Centralised - Authorisation - Commission Decision (2018)7415 of Tue, 06 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4682

Europe -DG Health and Food Safety

6-11-2018

Trelegy Ellipta (GlaxoSmithKline Trading Services Limited)

Trelegy Ellipta (GlaxoSmithKline Trading Services Limited)

Trelegy Ellipta (Active substance: fluticasone furoate/umeclidinium/vilanterol) - Centralised - 2-Monthly update - Commission Decision (2018)7416 of Tue, 06 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4363/WS/1369

Europe -DG Health and Food Safety

6-11-2018

Elebrato Ellipta (GlaxoSmithKline Trading Services Limited)

Elebrato Ellipta (GlaxoSmithKline Trading Services Limited)

Elebrato Ellipta (Active substance: fluticasone furoate/umeclidinium/vilanterol) - Centralised - 2-Monthly update - Commission Decision (2018)7417 of Tue, 06 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4781/WS/1369

Europe -DG Health and Food Safety

1-11-2018

Taxespira (Hospira UK Limited)

Taxespira (Hospira UK Limited)

Taxespira (Active substance: docetaxel) - Centralised - Withdrawal - Commission Decision (2018)7368 of Thu, 01 Nov 2018

Europe -DG Health and Food Safety

31-10-2018

Integrilin (GlaxoSmithKline (Ireland) Limited)

Integrilin (GlaxoSmithKline (Ireland) Limited)

Integrilin (Active substance: Eptifibatide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7340 of Wed, 31 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/230/T/79

Europe -DG Health and Food Safety

31-10-2018

Volibris (GlaxoSmithKline (Ireland) Limited)

Volibris (GlaxoSmithKline (Ireland) Limited)

Volibris (Active substance: Ambrisentan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7339 of Wed, 31 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/839/T/56

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2078 (Sellas Life Sciences Limited)

EU/3/18/2078 (Sellas Life Sciences Limited)

EU/3/18/2078 (Active substance: Peptides YMFPNAPYL, SGQAYMFPNAPYLPSCLES, RSDELVRHHNMHQRNMTKL and PGCNKRYFKLSHLQMHSRKHTG) - Orphan designation - Commission Decision (2018)7279 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/091/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2071 (Loxo Oncology Limited)

EU/3/18/2071 (Loxo Oncology Limited)

EU/3/18/2071 (Active substance: 6-(2-hydroxy-2-methylpropoxy)-4-(6-(6-((6-methoxypyridin-3-yl)methyl)-3,6-diazabicyclo[3.1.1]heptan-3-yl)pyridin-3-yl)pyrazolo[1,5-a]pyridine-3-carbonitrile) - Orphan designation - Commission Decision (2018)7272 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/125/18

Europe -DG Health and Food Safety

22-10-2018

EU/3/17/1966 (Sirius Regulatory Consulting EU Limited)

EU/3/17/1966 (Sirius Regulatory Consulting EU Limited)

EU/3/17/1966 (Active substance: N-(bromoacetyl)-3,3-dinitroazetidine) - Transfer of orphan designation - Commission Decision (2018)6986 of Mon, 22 Oct 2018

Europe -DG Health and Food Safety

22-10-2018

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

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

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

Europe -DG Health and Food Safety

19-10-2018

Recocam (Bimeda Animal Health Limited)

Recocam (Bimeda Animal Health Limited)

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

Europe -DG Health and Food Safety

16-10-2018

Dexxience (Portola Pharma UK Limited)

Dexxience (Portola Pharma UK Limited)

Dexxience (Active substance: betrixaban) - Refusal of authorisation - Commission Decision (2018)6226 of Tue, 16 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4309

Europe -DG Health and Food Safety

2-10-2018

Imraldi (Samsung Bioepis UK Limited)

Imraldi (Samsung Bioepis UK Limited)

Imraldi (Active substance: adalimumab) - Centralised - 2-Monthly update - Commission Decision (2018)6458 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4279/IB/14

Europe -DG Health and Food Safety

2-10-2018

Intuniv (Shire Pharmaceuticals Ireland Limited)

Intuniv (Shire Pharmaceuticals Ireland Limited)

Intuniv (Active substance: guanfacine) - Centralised - Yearly update - Commission Decision (2018)6473 of Tue, 02 Oct 2018

Europe -DG Health and Food Safety

2-10-2018

Vimizim (BioMarin International Limited)

Vimizim (BioMarin International Limited)

Vimizim (Active substance: elosulfase alfa) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6491 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/002779/T/0026

Europe -DG Health and Food Safety

25-9-2018

Slenyto (RAD Neurim Pharmaceuticals EEC Limited)

Slenyto (RAD Neurim Pharmaceuticals EEC Limited)

Slenyto (Active substance: melatonin) - Centralised - Authorisation - Commission Decision (2018)6223 of Tue, 25 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4425

Europe -DG Health and Food Safety

25-9-2018

Pelgraz (Accord Healthcare Limited)

Pelgraz (Accord Healthcare Limited)

Pelgraz (Active substance: pegfilgrastim) - Centralised - Authorisation - Commission Decision (2018)6288 of Tue, 25 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/003961/0000

Europe -DG Health and Food Safety

24-9-2018

Lenalidomide Accord (Accord Healthcare Limited)

Lenalidomide Accord (Accord Healthcare Limited)

Lenalidomide Accord (Active substance: lenalidomide) - Centralised - Authorisation - Commission Decision (2018)6237 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4857

Europe -DG Health and Food Safety

24-9-2018

Nitisinone MDK (MendeliKABS Europe Limited)

Nitisinone MDK (MendeliKABS Europe Limited)

Nitisinone MDK (Active substance: nitisinone) - Centralised - Yearly update - Commission Decision (2018)6241 of Mon, 24 Sep 2018

Europe -DG Health and Food Safety

24-9-2018

Xerava (Tetraphase Pharmaceuticals Ireland Limited)

Xerava (Tetraphase Pharmaceuticals Ireland Limited)

Xerava (Active substance: Eravacycline) - Centralised - Authorisation - Commission Decision (2018)6231 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4237

Europe -DG Health and Food Safety

24-9-2018

Cosentyx (Novartis Europharm Limited)

Cosentyx (Novartis Europharm Limited)

Cosentyx (Active substance: secukinumab) - PSUSA - Modification - Commission Decision (2018)6213 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/00010341/201712

Europe -DG Health and Food Safety

10-9-2018

Alkindi (Diurnal Limited)

Alkindi (Diurnal Limited)

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

Europe -DG Health and Food Safety

10-9-2018

Retacrit (Hospira UK Limited)

Retacrit (Hospira UK Limited)

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

Europe -DG Health and Food Safety

4-9-2018

Spinraza (Biogen Idec Limited)

Spinraza (Biogen Idec Limited)

Spinraza (Active substance: nusinersen) - Centralised - 2-Monthly update - Commission Decision (2018)5862 of Tue, 04 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4312/II/4

Europe -DG Health and Food Safety

29-8-2018

Mekinist (Novartis Europharm Limited)

Mekinist (Novartis Europharm Limited)

Mekinist (Active substance: trametinib) - Centralised - 2-Monthly update - Commission Decision (2018)5778 of Wed, 29 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2643/WS/1274

Europe -DG Health and Food Safety

29-8-2018

Nucala (GlaxoSmithKline Trading Services Limited)

Nucala (GlaxoSmithKline Trading Services Limited)

Nucala (Active substance: mepolizumab) - Centralised - 2-Monthly update - Commission Decision (2018)5770 of Wed, 29 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3860/II/13/G

Europe -DG Health and Food Safety

29-8-2018

Varuby (TESARO U.K. Limited)

Varuby (TESARO U.K. Limited)

Varuby (Active substance: rolapitant) - Centralised - Yearly update - Commission Decision (2018)5765 of Wed, 29 Aug 2018

Europe -DG Health and Food Safety

28-8-2018

Kalydeco (Vertex Pharmaceuticals (Europe) Limited)

Kalydeco (Vertex Pharmaceuticals (Europe) Limited)

Kalydeco (Active substance: ivacaftor) - PASS - Modification - Commission Decision (2018)5693 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2494/RSR/S/14

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2062 (IQVIA RDS Ireland Limited)

EU/3/18/2062 (IQVIA RDS Ireland Limited)

EU/3/18/2062 (Active substance: Bertilimumab) - Orphan designation - Commission Decision (2018)5740 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/098/18

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2060 (Biogen Idec Limited)

EU/3/18/2060 (Biogen Idec Limited)

EU/3/18/2060 (Active substance: Adeno-associated viral vector serotype hu68 containing the human SMN1 gene) - Orphan designation - Commission Decision (2018)5732 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/065/18

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2058 (IQVIA RDS Ireland Limited)

EU/3/18/2058 (IQVIA RDS Ireland Limited)

EU/3/18/2058 (Active substance: 1-(3-methylbutanoyl)-L-aspartyl-L-threonyl-L-histidyl-L-phenylalanyl-L-prolyl-(L-cystinyl-L-isoleucyl-[(N6-(S)-4-carboxy-4-palmitamidobutanoyl)-L-lysinyl]-L-phenylalanyl-L-glutamyl-L-prolyl-L-arginyl-L-serinyl-L-lysinyl-L-glycinyl-L-cystinyl)-L-lysinamide, disulfide, acetate) - Orphan designation - Commission Decision (2018)5730 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/099/18

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2063 (IQVIA RDS Ireland Limited)

EU/3/18/2063 (IQVIA RDS Ireland Limited)

EU/3/18/2063 (Active substance: CD34+ haematopoietic stem and progenitor cells with CD3+ T-cells) - Orphan designation - Commission Decision (2018)5733 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/088/18

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2057 (Pharm Research Associates (UK) Limited)

EU/3/18/2057 (Pharm Research Associates (UK) Limited)

EU/3/18/2057 (Active substance: 1-(2-hydroxyethyl)-8-{[5-(4-methylpiperazin-1-yl)-2-(trifluoromethoxy) phenyl]amino}-4,5-dihydro-1H-pyrazolo[4,3-h]quinazoline-3-carboxamide fumarate salt) - Orphan designation - Commission Decision (2018)5729 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/051/18

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2056 (Nogra Pharma Limited)

EU/3/18/2056 (Nogra Pharma Limited)

EU/3/18/2056 (Active substance: (S)-(-)-3-(4-aminophenyl)-2-methoxypropanoic acid) - Orphan designation - Commission Decision (2018)5728 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/075/18

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2055 (IQVIA RDS Ireland Limited)

EU/3/18/2055 (IQVIA RDS Ireland Limited)

EU/3/18/2055 (Active substance: (3R,3aS,9R,9aS,9bS)-3-((dimethylamino)methyl)-9-hydroxy-6,9-dimethyl-3,3a,4,5,7,8,9,9a-octahydroazuleno[4,5-b]furan-2(9bH)-one fumarate) - Orphan designation - Commission Decision (2018)5727 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/060/18

Europe -DG Health and Food Safety

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

28-8-2018

Orkambi (Vertex Pharmaceuticals (Europe) Limited)

Orkambi (Vertex Pharmaceuticals (Europe) Limited)

Orkambi (Active substance: Lumacaftor/Ivacaftor) - PSUSA - Modification - Commission Decision (2018)5710 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10455/201711

Europe -DG Health and Food Safety

27-8-2018

Firazyr (Shire Pharmaceuticals Ireland Limited)

Firazyr (Shire Pharmaceuticals Ireland Limited)

Firazyr (Active substance: icatibant) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5697 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/899T/41

Europe -DG Health and Food Safety

27-8-2018

Kymriah (Novartis Europharm Limited)

Kymriah (Novartis Europharm Limited)

Kymriah (Active substance: tisagenlecleucel) - Centralised - Authorisation - Commission Decision (2018)5717 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4090

Europe -DG Health and Food Safety

27-8-2018

Arixtra (Aspen Pharma Trading Limited)

Arixtra (Aspen Pharma Trading Limited)

Arixtra (Active substance: Fondaparinux sodium) - PSUSA - Modification - Commission Decision (2018)5708 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/403/PSUSA/1467-201712

Europe -DG Health and Food Safety

25-8-2018

Xagrid (Shire Pharmaceuticals Ireland Limited)

Xagrid (Shire Pharmaceuticals Ireland Limited)

Xagrid (Active substance: anagrelide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5682 of Sat, 25 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/480/T/82

Europe -DG Health and Food Safety

22-8-2018

Lenvima (Eisai Europe Limited)

Lenvima (Eisai Europe Limited)

Lenvima (Active substance: lenvatinib) - Centralised - 2-Monthly update - Commission Decision (2018)5627 of Wed, 22 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3727/II/11/G

Europe -DG Health and Food Safety