Co-Nebilet

Glavne informacije

  • Zaščiteno ime:
  • Co-Nebilet 5 mg/12,5 mg filmsko obložene tablete
  • Farmacevtska oblika:
  • filmsko obložena tableta
  • Sestava:
  • hidroklorotiazid 12,5 mg / 1 tableta; nebivolol 5 mg / 1 tableta
  • Pot uporabe:
  • Peroralna uporaba
  • Enote v paketu:
  • škatla z 28 tabletami (2 x 14 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:
  • Co-Nebilet 5 mg/12,5 mg filmsko obložene tablete
    Slovenija
  • Jezik:
  • slovenščina

Terapevtski podatki

  • Terapevtska skupina:
  • nebivolol in tiazidi

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:
  • 5363-I-481/13
  • Datum dovoljenje:
  • 21-02-2013
  • EAN koda:
  • 3837000121278
  • Zadnja posodobitev:
  • 18-01-2018

Podatki za bolnike

Navodilo za uporabo

CO-NEBILET 5 mg/12,5 mg filmsko obložene tablete

nebivolol/hidroklorotiazid

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

podatke!

Navodilo shranite. Morda ga boste želeli ponovno prebrati.

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

sestro. Posvetujte se tudi, če opazite katere koli neželene učinke, ki niso navedeni v tem navodilu.

Glejte poglavje 4.

Kaj vsebuje navodilo

Kaj je zdravilo Co-Nebilet in za kaj ga uporabljamo

Kaj morate vedeti, preden boste vzeli zdravilo Co-Nebilet

Kako jemati zdravilo Co-Nebilet

Možni neželeni učinki

Shranjevanje zdravila Co-Nebilet

Vsebina pakiranja in dodatne informacije

1.

Kaj je zdravilo Co-Nebilet in za kaj ga uporabljamo

Zdravilo Co-Nebilet kot zdravilni učinkovini vsebuje nebivolol in hidroklorotiazid.

Nebivolol je zdravilo za srce in ožilje. Spada v skupino selektivnih blokatorjev beta receptorjev

(tj. selektivno deluje na srce in ožilje). Preprečuje pospešen srčni utrip in obvladuje črpalno moč

srca. Širi tudi žile in tako pomaga znižati krvni tlak.

Hidroklorotiazid je diuretik: deluje tako, da poveča količino nastalega urina.

Zdravilo Co-Nebilet je kombinacija nebivolola in hidroklorotiazida v eni tableti. Uporablja se za

zdravljenje zvišanega krvnega tlaka (hipertenzije). Uporablja se namesto obeh ločenih zdravil pri

bolnikih, ki ti zdravili že jemljejo skupaj.

2.

Kaj morate vedeti, preden boste vzeli zdravilo Co-Nebilet

Ne uporabljajte zdravila Co-Nebilet

če ste alergični na nebivolol ali na hidroklorotiazid ali katero koli sestavino tega zdravila

(navedeno v poglavju 6).

alergični

(preobčutljivi)

druge

sulfonamidne

snovi

(kot

hidroklorotiazid,

sulfonamidno zdravilo)

če imate eno ali več od naslednjih motenj:

zelo počasno bitje srca (manj kot 60 utripov na minuto)

določene druge resne motnje srčnega ritma (npr. bolezen sinusnega vozla, sinoatrijski blok,

atrioventrikularni blok 2. ali 3. stopnje)

srčno popuščanje, ki se je pravkar pojavilo ali se je v zadnjem času poslabšalo, ali če zaradi

cirkulacijskega šoka, ki je posledica akutnega srčnega popuščanja, z intravensko infuzijo

dobivate zdravila, ki pomagajo delovanju srca

nizek krvni tlak

resne težave s pretokom krvi v rokah ali nogah

nezdravljen feokromocitom, to je tumor, ki se nahaja nad ledvicami (tumor nadledvičnih žlez)

JAZMP – IB/012/G – 27.02.2015

hude težave z ledvicami, popolno prenehanje nastajanja urina (anurija)

presnovno motnjo (metabolično acidozo), npr. diabetično ketoacidozo.

astmo ali piskajoče dihanje (zdaj ali kdaj v preteklosti)

moteno delovanje jeter

visoko koncentracijo kalcija v krvi, nizko koncentracijo kalija v krvi, nizko koncentracijo

natrija v krvi, ki trajajo in so odporni proti zdravljenju

visoko koncentracijo sečne kisline s simptomi protina

Opozorila in previdnostni ukrepi

Pred začetkom jemanja zdravila Co-Nebilet se posvetujte s svojim zdravnikom ali s farmacevtom.

Zdravnika morate obvestiti, če imate katero od naslednjih težav ali se vam takšna težava pojavi:

vrsta bolečine v prsnem košu, ki nastane zaradi spontanega krča srčnih žil; imenujemo jo

Prinzmetalova angina pektoris

srčni blok 1. stopnje (vrsta blage prevodne motnje v srcu, ki vpliva na srčni ritem)

nenormalno počasno bitje srca

nezdravljeno kronično srčno popuščanje

eritematozni lupus (motnjo imunskega sistema, tj. obrambnega sistema telesa)

luskavico (kožno bolezen, za katero so značilne luskaste, rožnate kožne spremembe) ali ste kdaj

imeli luskavico

čezmerno dejavno žlezo ščitnico: to zdravilo lahko prikrije znake nenormalno hitrega bitja srca,

ki se pojavi zaradi te

motnje

slabo prekrvitev v rokah in nogah, npr. Raynaudovo bolezen ali sindrom, krčem podobne

bolečine med hojo

alergijo: to zdravilo lahko povzroči močnejšo reakcijo na pelod ali druge snovi, na katere ste

alergični

dolgotrajne težave z dihanjem

sladkorno bolezen: to zdravilo lahko prikrije opozorilne znake nizkega krvnega sladkorja (npr.

razbijanje srca, hitro bitje srca); zdravnik vam bo tudi naročil, da si med jemanjem zdravila

Co-Nebilet pogosteje merite krvni sladkor, ker utegne biti potrebna prilagoditev odmerka zdravil

proti sladkorni bolezni

težave z ledvicami: zdravnik vam bo preveril delovanje ledvic in se tako prepričal, da se ne

slabša. Ne jemljite zdravila Co-Nebilet, če imate resne težave z ledvicami (glejte poglavje "Ne

uporabljajte zdravila Co-Nebilet")

če ste nagnjeni k nizki koncentraciji kalija v krvi in še zlasti, če imate sindrom podaljšanega QT

(vrsta nepravilnosti na EKG) ali jemljete digitalis (kot pomoč črpalnemu delovanju srca);

verjetnost za nizko koncentracijo kalija v krvi je večja, če imate cirozo jeter, če ste prehitro

izgubili veliko vode iz telesa zaradi močnega diuretičnega zdravljenja, ali če vaše uživanje kalija

s hrano in pijačo ni zadostno

če imate predvideno operacijo, morate anesteziologu povedati, da jemljete zdravilo Co-Nebilet,

preden dobite anestezijo.

Zdravilo Co-Nebilet lahko poveča koncentracijo maščob in sečne kisline v krvi. Vpliva lahko na

koncentracijo določenih sestavin krvi, ki jih imenujemo elektroliti: zdravnik vam bo elektrolite od

časa do časa kontroliral s preiskavo krvi.

Hidroklorotiazid v zdravilu Co-Nebilet lahko povzroči preobčutljivost kože za sončno svetlobo ali

umetno UV-svetlobo. Če se vam med zdravljenjem pojavi izpuščaj, srbeče pege ali občutljivost

kože, nehajte jemati zdravilo Co-Nebilet in obvestite zdravnika (glejte tudi poglavje 4).

Protidopinški test: zdravilo Co-Nebilet lahko povzroči pozitiven antidopinški test.

Otroci in mladostniki

Zaradi nezadostnih podatkov o uporabi pri otrocih in mladostnikih zdravila Co-Nebilet pri njih

ni

priporočljivo uporabljati.

JAZMP – IB/012/G – 27.02.2015

Druga zdravila in zdravilo Co-Nebilet

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

začeli jemati katero koli drugo zdravilo.

Zdravniku morate povedati, če poleg zdravila Co-Nebilet jemljete ali dobivate katero od naslednjih

zdravil:

Zdravila, ki lahko – tako kot zdravilo Co-Nebilet – vplivajo na krvni tlak in/ali delovanje srca:

zdravila

uravnavanje krvnega

tlaka

zdravila

težave

srcem

(npr.

amiodaron,

amlodipin,

cibenzolin,

klonidin,

digoksin,

diltiazem,

dizopiramid,

dofetilid,

felodipin,

flekainid,

guanfacin,

hidrokinidin,

ibutilid,

lacidipin,

lidokain,

meksiletin,

metildopa,

moksonidin, nikardipin, nifedipin, nimodipin, nitrendipin, propafenon, kinidin, rilmenidin,

sotalol, verapamil)

pomirjevala (sedative) ali zdravila za psihozo (duševno motnjo), npr. amisulpirid, barbiturate

(ki se uporabljajo tudi pri epilepsiji), klorpromazin, ciamemazin, droperidol, haloperidol,

levomepromazin, narkotična zdravila, fenotiazin (ki se uporablja tudi pri bruhanju in slabosti),

pimozid, sulpirid, sultoprid, tioridazin, tiaprid, trifluoperazin

zdravila za depresijo, npr. amitriptilin, fluoksetin, paroksetin

zdravila, ki se uporabljajo za anestezijo med operacijo

zdravila za astmo, zamašenost nosu ali določene bolezni oči, npr. glavkom (zvišan očesni

tlak), ali za širjenje zenice

baklofen (zdravilo za preprečevanje krčev)

amifostin (podporno zdravilo pri zdravljenju raka).

Zdravila, katerih učinek ali toksične učinke lahko zdravilo Co-Nebilet poveča:

litij, ki se uporablja kot stabilizator razpoloženja

cisaprid (uporablja se za prebavne težave)

bepridil (uporablja se za angino pektoris)

difemanil (uporablja se za čezmerno znojenje)

zdravila

proti okužbam:

eritromicin

infuziji ali injekciji,

pentamidin in

sparfloksacin,

amfotericin in natrijev penicillin G, halofantrin (uporablja se za malarijo)

vinkamin (uporablja se za težave s krvnim pretokom v možganih)

mizolastin in terfenadin (uporabljata se za alergije)

diuretiki in odvajala

zdravila

zdravljenje

akutnega

vnetja:

steroidi

(npr.

kortizon

prednizon),

ACTH

(adrenokortikotropni hormon) in zdravila, pridobljena iz salicilne kisline (npr. acetilsalicilna

kislina/Aspirin in drugi salicilati)

karbenoksolon (uporablja se za zgago in razjede na želodcu)

kalcijeve soli, uporabljene kot dodatek za zdravje kosti

zdravila za sproščanje mišic (npr. tubokurarin)

diazoksid, ki se uporablja za zdravljenje nizkega krvnega sladkorja in visokega krvnega tlaka.

amantadin, ki je protivirusno zdravilo

ciklosporin, ki se uporablja za zaviranje telesnega imunskega odziva

kontrastna sredstva z jodom, ki se uporabljajo pri kontrastnih rentgenskih slikanjih

zdravila proti raku (npr. ciklofosfamid, fluorouracil, metotreksat)

Zdravila, katerih učinek lahko zdravilo Co-Nebilet zmanjša:

zdravila za znižanje sladkorja v krvi (insulin in peroralna antidiabetična zdravila, metformin)

zdravila za protin (npr. alopurinol, probenecid in sulfinpirazon)

zdravila, kot je noradrenalin, ki se uporabljajo za zdravljenje nizkega krvnega tlaka ali

počasnega bitja srca

Zdravila proti bolečinam in vnetju (nesteroidna protivnetna zdravila), ker lahko zmanjšajo učinek

zdravila Co-Nebilet na znižanje krvnega tlaka

Zdravila za zdravljenje čezmerne želodčne kisline ali razjed (antacidi), npr. cimetidin: zdravilo

Co-Nebilet morate vzeti med jedjo, antacid pa med enim in drugim obrokom.

JAZMP – IB/012/G – 27.02.2015

Zdravilo Co-Nebilet skupaj z alkoholom

jemanjem

zdravila

Co-Nebilet

bodite

previdni

pitju

alkoholnih

pijač,

lahko

povzročijo omedlevico ali omotico. Če se vam to zgodi, ne pijte nobenih alkoholnih pijač: to velja tudi

za vino, pivo in napitke z dodanim alkoholom.

Nosečnost in dojenje

Svojemu zdravniku morate povedati, če ste noseči ali če mislite, da ste. Praviloma vam bo zdravnik

svetoval, da vzamete drugo zdravilo namesto zdravila Co-Nebilet, saj se zdravilo Co-Nebilet med

nosečnostjo

priporoča.

zato,

zdravilna

učinkovina

hidroklorotiazid

prehaja

skozi

posteljico. Uporaba zdravila Co-Nebilet lahko povzroči škodljive učinke za plod in novorojenčka

.

Povejte zdravniku, če dojite ali boste začeli dojiti. Zdravljenje z zdravilom Co-Nebilet ni priporočljivo

za matere, ki dojijo.

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

zdravnikom ali farmacevtom, preden vzamete to zdravilo.

Vpliv na sposobnost upravljanja vozil in strojev

To zdravilo lahko povzroči omotico ali utrujenost. Če se vam to zgodi,

ne upravljajte

vozil in strojev.

Zdravilo Co-Nebilet vsebuje laktozo

To zdravilo vsebuje

laktozo

. Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev,

se z

njim posvetujte

, preden vzamete to zdravilo.

3.

Kako jemati zdravilo Co-Nebilet

Pri jemanju tega zdravila natančno upoštevajte zdravnikova navodila. Če ste negotovi, se posvetujte z

zdravnikom.

Jemljite po eno tableto na dan z nekaj vode, po možnosti vsak dan ob istem času.

Zdravilo Co-Nebilet lahko vzamete pred jedjo, med jedjo ali po jedi, lahko pa ga jemljete neodvisno

od obrokov.

Uporaba pri otrocih in mladostnikih

Ne dajajte zdravila Co-Nebilet otrokom ali mladostnikom.

Razdelilna zareza je namenjena le delitvi tablete za lažje požiranje in ne delitvi na enaka odmerka.

Če ste vzeli večji odmerek zdravila Co-Nebilet, kot bi smeli

Če pomotoma vzamete prevelik odmerek tega zdravila, se

nemudoma

posvetujte z zdravnikom ali s

farmacevtom.

Najpogostejši simptomi in znaki prevelikega odmerjanja so zelo počasno bitje srca

(bradikardija), nizek krvni tlak z možno omedlevico, težko dihanje (kot pri astmi), akutno srčno

popuščanje

,

čezmerno odvajanje vode s posledično izsušenostjo, slabost in zaspanost, mišični krči,

motnje srčnega ritma (zlasti če jemljete tudi digitalis ali zdravila zaradi motenj srčnega ritma).

Če ste pozabili vzeti zdravilo Co-Nebilet

Če pozabite vzeti odmerek zdravila Co-Nebilet, pa se nekaj pozneje spomnite, da bi ga morali vzeti,

vzemite odmerek tistega dne kot po navadi. Če pa je zamuda velika (npr. več ur) in je že blizu čas za

naslednji odmerek, izpustite pozabljeni odmerek in vzemite naslednji, običajni odmerek ob običajnem

času. Ne vzemite dvojnega odmerka. Pazite, da ne boste zdravila pozabljali vzeti večkrat.

Če ste prenehali jemati zdravilo Co-Nebilet

Pred prenehanjem jemanja zdravila Co-Nebilet se vedno posvetujte z zdravnikom.

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

JAZMP – IB/012/G – 27.02.2015

4. Možni neželeni učinki

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

Med uporabo nebivolola so bili opisani naslednji neželeni učinki:

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

glavobol

omotica

utrujenost

nenavaden pekoč, zbadajoč, srbeč ali ščemeč občutek

driska

zaprtje

slabost

kratka sapa

otekle dlani ali stopala.

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

počasen srčni utrip ali druge težave s srcem

nizek krvni tlak

krčem podobne bolečine v nogah med hojo

nenormalen vid

impotenca

depresivni občutki

prebavne težave, plin v želodcu ali črevesju, bruhanje

izpuščaj na koži, srbenje

težko dihanje, podobno kot pri astmi, ki se pojavi zaradi nenadnega skrčenja mišic v dihalih

(bronhospazem)

nočne more.

Zelo redki neželeni učinki

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

omedlevica

poslabšanje luskavice (kožne bolezni, za katero so značilne luskaste, rožnate kožne spremembe).

Naslednji neželeni učinki so bili opisani samo v nekaterih posameznih primerih:

alergijske reakcije, ki zajamejo vse telo, z razširjenimi izpuščajem po koži (preobčutljivostne

reakcije);

hitro nastala oteklina, zlasti okrog ustnic, oči, ali oteklina jezika, ki jo lahko spremlja nenadno

težko dihanje (angioedem);

vrsta kožnih izpuščajev, za katere je značilno, da so bledo rdeči, izbokli, srbeči in so alergijskega

ali nealergijskega izvora (koprivnica).

Med uporabo hidroklorotiazida so bili opisani naslednji neželeni učinki:

Alergijske reakcije

alergijska reakcija, ki zajame vse telo (anafilaktična reakcija)

Srce in ožilje

motnje srčnega ritma, razbijanje srca (palpitacije)

spremembe na elektrokardiogramu

nenadna omedlevica po vstajanju v pokončen položaj, nastanek krvnih strdkov v venah (tromboza)

in embolija, odpoved obtočil (šok)

spremenjeno število krvnih celic, npr.: zmanjšanje števila belih krvnih celic, zmanjšanje števila

krvnih ploščic, zmanjšanje števila rdečih krvnih celic; okvarjeno nastajanje novih krvnih celic v

kostnem mozgu

JAZMP – IB/012/G – 27.02.2015

spremenjena količina tekočine v telesu (izsušitev) in kemičnih sestavin krvi, zlasti znižanje kalija,

znižanje natrija, znižanje magnezija, znižanje klorida in zvišanje kalcija

povečanje

koncentracije

sečne

kisline,

protin,

zvišanje

glukoze

krvi,

sladkorna

bolezen,

metabolična alkaloza (presnovna motnja), zvišanje holesterola in/ali trigliceridov v krvi

Želodec in črevo

pomanjkanje teka, suha usta, slabost, bruhanje, nelagodje v želodcu, bolečine v trebuhu, driska,

redkejše iztrebljanje (zaprtje), odsotnost iztrebljanja (paralitični ileus), vetrovi

vnetje žlez, ki izločajo slino, vnetje trebušne slinavke, zvišanje amilaze (encima trebušne slinavke)

v krvi

porumenelost kože (zlatenica), vnetje žolčnika

Prsni koš

dihalna stiska, vnetje pljuč (pnevmonitis), nastajanje vezivnega tkiva v pljučih (intersticijska

bolezen pljuč), kopičenje tekočine v pljučih (pljučni edem)

Živčevje

vrtoglavica (občutek vrtenja)

napadi krčev, poslabšanje zavesti, koma, glavobol, omotica

apatija, zmedenost, depresija, živčnost, nemir, motnje spanja

nenavaden pekoč, zbadajoč, srbeč ali ščemeč občutek na koži

mišična šibkost (pareza)

Koža in lasje

srbenje, vijolične pege/lise na koži (purpura), urtikarija (koprivnica), večja občutljivost kože za

sončno

svetlobo,

izpuščaj,

izpuščaj

obrazu

in/ali

lisasta

pordelost,

lahko

povzroči

brazgotinjenje (kožni eritematozni lupus), vnetje žil s posledičnim odmrtjem tkiva (nekrotizirajoči

vaskulitis), lupljenje, pordelost, odstopanje, in mehurji na koži (toksična epidermalna nekroliza)

Oči in ušesa

rumen vid, zamegljen vid, poslabšanje kratkovidnosti, zmanjšano nastajanje solz

Sklepi in mišice

mišični krči, mišične bolečine

Sečila

moteno

delovanje

ledvic,

akutna

odpoved

ledvic

(zmanjšano

nastajanje

urina

kopičenje

tekočine in odpadnih snovi v telesu), vnetje vezivnega tkiva v ledvicah (intersticijski nefritis),

sladkor v urinu.

Spolne motnje

erekcijske motnje

Splošno/drugo

splošna šibkost, utrujenost, povišana telesna temperatura, žeja

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 Co-Nebilet

Zdravilo shranjujte nedosegljivo otrokom!

JAZMP – IB/012/G – 27.02.2015

Za shranjevanje zdravila niso potrebna posebna navodila.

Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti , ki je naveden na škatli in

pretisnem omotu poleg oznake »EXP«. 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 uporabljate več, se posvetujte s farmacevtom. Taki ukrepi pomagajo varovati okolje.

6.

Vsebina pakiranja in dodatne informacije

Kaj vsebuje zdravilo Co-Nebilet

Zdravilni učinkovini sta nebivolol in hidroklorotiazid. Ena tableta vsebuje 5 mg nebivolola (kot

nebivololijevega

klorida:

2,5 mg

d-nebivolola

2,5 mg

l-nebivolola)

12,5 mg

hidroklorotiazida.

Druge sestavine zdravila so:

jedro tablete: laktoza monohidrat, polisorbat 80 (E433), hipromeloza (E464), koruzni škrob,

premreženi natrijev karmelozat (E468), mikrokristalna celuloza (E460), brezvodni koloidni

silicijev dioksid (E551), magnezijev stearat (E572)

obloga: makrogol 40 stearat tip I, titanov dioksid (E171), karmini (karminska kislina, E120),

hipromeloza (E464), mikrokristalna celuloza (E460).

Izgled zdravila Co-Nebilet in vsebina pakiranja

Zdravilo Co-Nebilet je na voljo v skoraj rožnatih, okroglih, rahlo bikonveksnih filmsko obloženih

tabletah, ki imajo na eni strani reliefno oznako "5/12.5" in na drugi strani razdelilno zarezo in so na

voljo v pakiranjih s 7, 14, 28, 30, 56 in 90 filmsko obloženimi tabletami.

Tablete so na voljo v pretisnih omotih (pretisni omot iz PP/COC/PP/aluminija).

(Na trgu morda ni vseh navedenih pakiranj.)

Način in režim izdaje zdravila

Predpisovanje in izdaja zdravila je le na recept.

Imetnik dovoljenja za promet z zdravilom in izdelovalec

Menarini International O.L.S.A.

1, Avenue de la Gare L-1611 Luksemburg

Izdelovalec

Berlin-Chemie AG

Glienicker Weg 125, 12489 Berlin, Nemčija

Menarini – Von Heyden GmbH

Leipziger strasse 7-13, 01097 Dresden, Nemčija

A. Menarini Manufacturing Logistics and Services S.r.l.

Via Sette Santi 3, 50131 Firence, Italija

To zdravilo je odobreno v državah članicah EGP pod naslednjimi imeni

Avstrija: Hypoloc plus HCT

Belgija: Nobiretic

Bolgarija: Nebilet Plus

Ciper: Lobivon-plus

JAZMP – IB/012/G – 27.02.2015

Češka: Nebilet Plus

Danska: Hypoloc Comp

Estonija: Nebilet Plus

Finska: Hypoloc Comp

Francija: TEMERITDUO

Grčija: Lobivon-plus

Madžarska: Nebilet Plus

Islandija: Hypoloc Comp

Irska: Hypoloc Plus

Italija: Aloneb

Latvija: Nebilet Plus

Litva: Nebilet Plus

Luksemburg: Nobiten plus

Malta: Nebilet Plus

Norveška: Hypoloc Comp

Poljska: Nebilet HCT

Portugalska: Nebilet Plus

Romunija: Co-Nebilet 5 mg / 12.5 mg

Slovaška: Nebilet HCTZ

Slovenija: Co-Nebilet

Španija:Lobivon plus

Švedska: Hypoloc Comp

Nizozemska: Nebiretic

Velika Britanija: Nebivolol / Hydrochlorothiazide

Navodilo je bilo nazadnje revidirano dne 27.02.2015

JAZMP – IB/012/G – 27.02.2015

17-11-2018

Peer review of the pesticide risk assessment of the active substance clodinafop (variant evaluated clodinafop‐propargyl)

Peer review of the pesticide risk assessment of the active substance clodinafop (variant evaluated clodinafop‐propargyl)

Published on: Fri, 16 Nov 2018 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Greece and co‐rapporteur Member State Germany for the pesticide active substance clodinafop‐propargyl are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of clodinafop‐p...

Europe - EFSA - European Food Safety Authority Publications

9-11-2018

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

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

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

FDA - U.S. Food and Drug Administration

31-10-2018

Peer review of the pesticide risk assessment of the active substance dimethoate

Peer review of the pesticide risk assessment of the active substance dimethoate

Published on: Tue, 30 Oct 2018 00:00:00 +0100 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Italy and co‐rapporteur Member State Bulgaria for the pesticide active substance dimethoate are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of dimetho...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Peer review of the pesticide risk assessment of the active substance methiocarb

Peer review of the pesticide risk assessment of the active substance methiocarb

Published on: Tue, 30 Oct 2018 00:00:00 +0100 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State the United Kingdom and co‐rapporteur Member State Germany for the pesticide active substance methiocarb are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative use...

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

Evaluation of confirmatory data following the Article 12 MRL review for pyraflufen‐ethyl

Evaluation of confirmatory data following the Article 12 MRL review for pyraflufen‐ethyl

Published on: Fri, 19 Oct 2018 00:00:00 +0200 The applicant, Nichino Europe Co. Ltd., submitted application request to the competent national authority in the Netherlands to evaluate confirmatory data that were identified for pyraflufen‐ethyl in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. The submitted data were sufficient to confirm the MRLs for citrus fruits, tree nuts, pome fruits, stone fruits, table and wine grapes, curra...

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

4-10-2018

Peer review of the pesticide risk assessment of the active substance ethoprophos

Peer review of the pesticide risk assessment of the active substance ethoprophos

Published on: Wed, 03 Oct 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Italy and co‐rapporteur Member State Ireland for the pesticide active substance ethoprophos are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of ethopro...

Europe - EFSA - European Food Safety Authority Publications

26-9-2018

Technical Report on the notification of syrup from Sorghum bicolor (L.) Moench as a traditional food from a third country pursuant to Article 14 of Regulation (EU) 2015/2283

Technical Report on the notification of syrup from Sorghum bicolor (L.) Moench as a traditional food from a third country pursuant to Article 14 of Regulation (EU) 2015/2283

Published on: Tue, 25 Sep 2018 00:00:00 +0200 Abstract Following a notification from Sorghum Zrt., submitted to the European Commission under Article 14 of Regulation (EU) 2015/2283 to place on the market syrup from Sorghum bicolor (L.) Moench as a traditional food from a third country (TF), and in line with Article 15(2) of that Regulation, EFSA was asked by the European Commission whether there are duly reasoned safety objections to the placing on the market of the TF within the European Union. The ap...

Europe - EFSA - European Food Safety Authority Publications

21-9-2018

Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for sulfoxaflor in light of confirmatory data

Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for sulfoxaflor in light of confirmatory data

Published on: Thu, 20 Sep 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the risk assessment for an active substance in light of confirmatory data requested following approval in accordance with Article 6(1) of Directive 91/414/EEC and Article 6(f) of Regulation (EC) No 1107/2009. In this context EFSA's scientific views on the specific points raised during the commenting phase conducted with Member State...

Europe - EFSA - European Food Safety Authority Publications

18-9-2018

Peer review of the pesticide risk assessment of the active substance beta‐cyfluthrin

Peer review of the pesticide risk assessment of the active substance beta‐cyfluthrin

Published on: Fri, 14 Sep 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Germany and co‐rapporteur Member State Hungary for the pesticide active substance beta‐cyfluthrin are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of b...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

31-8-2018

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

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

Published on: Thu, 30 Aug 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Belgium and co‐rapporteur Member State Germany for the pesticide active substance cypermethrin are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of cype...

Europe - EFSA - European Food Safety Authority Publications

30-8-2018

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Cyprus and EFSA – Final report

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Cyprus and EFSA – Final report

Published on: Tue, 07 Aug 2018 00:00:00 +0200 Cyprus alongside with another 4 countries has participated successfully in the Grant Agreement GP/EFSA/DATA/2016/01‐GA 02, entitled: “Strategic Partnership with Cyprus on Data Quality”. The project was co‐financed by EFSA, aiming to help both EFSA and data providers from Member States to possess data of high quality in a quantitatively manageable way. The main objective of the grant agreement was the establishment of the data governance, coordination and imp...

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

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

29-8-2018

Peer review of the pesticide risk assessment of the active substance carvone (substance evaluated d‐carvone)

Peer review of the pesticide risk assessment of the active substance carvone (substance evaluated d‐carvone)

Published on: Tue, 07 Aug 2018 00:00:00 +0200 The conclusions of the EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, the Netherlands and co‐rapporteur Member State, Sweden, for the pesticide active substance carvone are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative use...

Europe - EFSA - European Food Safety Authority Publications

10-8-2018

Westminster Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Levothyroxine and Liothyronine (Thyroid Tablets, USP) Due to Risk of Adulteration

Westminster Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Levothyroxine and Liothyronine (Thyroid Tablets, USP) Due to Risk of Adulteration

Westminster Pharmaceuticals, LLC is voluntarily recalling all lots, within expiry, of Levothyroxine and Liothyronine (Thyroid Tablets, USP) 15 mg, 30 mg, 60 mg, 90 mg, & 120 mg to the wholesale level. These products are being recalled as a precaution because they were manufactured using active pharmaceutical ingredients that were sourced prior to the FDA’s Import Alert of Sichuan Friendly Pharmaceutical Co., Ltd., which as a result of a 2017 inspection were found to have deficiencies with Current Good Ma...

FDA - U.S. Food and Drug Administration

18-7-2018

Sodium glucose co-transporter 2 inhibitors

Sodium glucose co-transporter 2 inhibitors

Safety advisory - diabetic ketoacidosis and surgical procedures

Therapeutic Goods Administration - Australia

13-7-2018

Prinston Pharmaceutical Inc Issues Voluntary Nationwide Recall of Valsartan and Valsartan HCTZ Tablets Due to Detection of a Trace Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA) in The Products

Prinston Pharmaceutical Inc Issues Voluntary Nationwide Recall of Valsartan and Valsartan HCTZ Tablets Due to Detection of a Trace Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA) in The Products

Prinston Pharmaceutical Inc. dba Solco Healthcare LLC. is recalling all lots of Valsartan Tablets, 40 mg, 80mg, 160mg, and 320mg; and Valsartan-Hydrochlorothiazide Tablets, 80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg, and 320mg/25mg to the retail level. This product recall is due to the detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA), made by the manufacturer – Zhejiang Huahai Pharmaceutical Co. Ltd. -- that is used in the manufacture of the subject product ...

FDA - U.S. Food and Drug Administration

17-5-2018

BLM Issues Allergy Alert On Undeclared Egg and Milk

BLM Issues Allergy Alert On Undeclared Egg and Milk

BLM Prod.-u. Vertriebsges. mbH & Co. KG, is voluntarily recalling Priano Rosso Pesto Sauce as it may contain undeclared milk and egg. People who have an allergy or severe sensitivity to milk and egg run the risk of serious or life-threatening allergic reaction if they consume this product.

FDA - U.S. Food and Drug Administration

16-5-2018

Mas Food Services Co. Issues Allergy Alert on Undeclared Sulfites in The Peruchef Dry Potato

Mas Food Services Co. Issues Allergy Alert on Undeclared Sulfites in The Peruchef Dry Potato

Mas Food Services Co. of Oakland Park, FL is recalling its 15 ounce packages of The Peruchef brand dry potato because it may contain 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 these products.

FDA - U.S. Food and Drug Administration

8-5-2018

Neurovascular Stents Used for Stent-Assisted Coiling (SAC): Letter to Health Care Providers - Recommendations Associated With the Use of These Devices in the Treatment of Unruptured Brain Aneurysms

Neurovascular Stents Used for Stent-Assisted Coiling (SAC): Letter to Health Care Providers - Recommendations Associated With the Use of These Devices in the Treatment of Unruptured Brain Aneurysms

The FDA has received reports associated with the use of these devices in the treatment of unruptured brain aneurysms that suggest some events of peri-procedural stroke and/or death may have been related to procedural risks or patient selection related factors. These factors include patients who had serious co-morbidities resulting in a reduced life expectancy, or who were intolerant to required anticoagulation or anti-platelet therapy.

FDA - U.S. Food and Drug Administration

15-10-2018

We have created a rumor control page for Hurricane #Michael that will be updated regularly. Help us share this info and remember to always check with official sources like @FLSERT, @GeorgiaEMA and @femaregion4.

 http://fema.gov/hurricane-michael-rumor-co

We have created a rumor control page for Hurricane #Michael that will be updated regularly. Help us share this info and remember to always check with official sources like @FLSERT, @GeorgiaEMA and @femaregion4. http://fema.gov/hurricane-michael-rumor-co

We have created a rumor control page for Hurricane #Michael that will be updated regularly. Help us share this info and remember to always check with official sources like @FLSERT, @GeorgiaEMA and @femaregion4. http://fema.gov/hurricane-michael-rumor-control … pic.twitter.com/T3h7ZiFUrZ

FDA - U.S. Food and Drug Administration

15-10-2018

National Cybersecurity Awareness Month is in its 3rd week. This week's theme: “Strengthening the Cybersecurity Workforce Across All Sectors”. Go to  https://www.dhs.gov/stopthinkconnect … to see what #NCSAM is all about. #FDA #MedicalDevicespic.twitter.co

National Cybersecurity Awareness Month is in its 3rd week. This week's theme: “Strengthening the Cybersecurity Workforce Across All Sectors”. Go to https://www.dhs.gov/stopthinkconnect … to see what #NCSAM is all about. #FDA #MedicalDevicespic.twitter.co

National Cybersecurity Awareness Month is in its 3rd week. This week's theme: “Strengthening the Cybersecurity Workforce Across All Sectors”. Go to https://www.dhs.gov/stopthinkconnect … to see what #NCSAM is all about. #FDA #MedicalDevices pic.twitter.com/KBLIxo9CiV

FDA - U.S. Food and Drug Administration

18-9-2018

 Third industry stakeholder platform on research and development support, European Medicines Agency, London, UK, From: 18-May-2018, To: 18-May-2018

Third industry stakeholder platform on research and development support, European Medicines Agency, London, UK, From: 18-May-2018, To: 18-May-2018

This third meeting between regulators and representatives of industry stakeholder organisations addresses all areas of product-development support, including scientific advice, specifics for paediatric and orphan medicines and support for innovation. The meeting focuses on the implementation of the orphan notice, ‘histology-independent indications’ in the context of orphan designations, the upcoming rollout of a new tool for orphan designation applications, digital technology proposals in medicine develo...

Europe - EMA - European Medicines Agency

4-9-2018

Abseamed (Medice Arzneimittel PUtter GmbH and Co KG)

Abseamed (Medice Arzneimittel PUtter GmbH and Co KG)

Abseamed (Active substance: epoetin alfa) - Centralised - 2-Monthly update - Commission Decision (2018)5860 of Tue, 04 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/727/WS/1406

Europe -DG Health and Food Safety

19-6-2018

Maviret (AbbVie Deutschland GmbH and Co. KG)

Maviret (AbbVie Deutschland GmbH and Co. KG)

Maviret (Active substance: glecaprevir / pibrentasvir) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3916 of Tue, 19 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4430/T/11

Europe -DG Health and Food Safety

11-6-2018

Viekirax (AbbVie Deutschland GmbH and Co. KG)

Viekirax (AbbVie Deutschland GmbH and Co. KG)

Viekirax (Active substance: ombitasvir / paritaprevir / ritonavir) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3766 of Mon, 11 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3839/T/45

Europe -DG Health and Food Safety

4-6-2018

Venclyxto (AbbVie Deutschland GmbH and Co. KG)

Venclyxto (AbbVie Deutschland GmbH and Co. KG)

Venclyxto (Active substance: venetoclax) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3633 of Mon, 04 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4106/T/12

Europe -DG Health and Food Safety

4-6-2018

Exviera (AbbVie Deutschland GmbH and Co. KG)

Exviera (AbbVie Deutschland GmbH and Co. KG)

Exviera (Active substance: dasabuvir) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3628 of Mon, 04 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3837/T/38

Europe -DG Health and Food Safety

29-5-2018

Norvir (AbbVie Deutschland GmbH and Co. KG)

Norvir (AbbVie Deutschland GmbH and Co. KG)

Norvir (Active substance: Ritonavir) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3340 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/127/T/149

Europe -DG Health and Food Safety

25-5-2018

Kaletra (AbbVie Deutschland GmbH and Co. KG)

Kaletra (AbbVie Deutschland GmbH and Co. KG)

Kaletra (Active substance: lopinavir / Ritonavir) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3282 of Fri, 25 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/368/T/169

Europe -DG Health and Food Safety

16-5-2018

EU/3/14/1305 (AbbVie Deutschland GmbH and Co. KG)

EU/3/14/1305 (AbbVie Deutschland GmbH and Co. KG)

EU/3/14/1305 (Active substance: Humanised recombinant monoclonal antibody against epidermal growth factor receptor conjugated to maleimidocaproyl monomethylauristatin F) - Transfer of orphan designation - Commission Decision (2018)3022 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/065/14/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/17/1954 (AbbVie Deutschland GmbH and Co. KG)

EU/3/17/1954 (AbbVie Deutschland GmbH and Co. KG)

EU/3/17/1954 (Active substance: Venetoclax) - Transfer of orphan designation - Commission Decision (2018)3028 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/131/17/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/16/1767 (AbbVie Deutschland GmbH and Co. KG)

EU/3/16/1767 (AbbVie Deutschland GmbH and Co. KG)

EU/3/16/1767 (Active substance: Venetoclax) - Transfer of orphan designation - Commission Decision (2018)3027 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/121/16/T01

Europe -DG Health and Food Safety

16-5-2018

EU/3/16/1766 (AbbVie Deutschland GmbH and Co. KG)

EU/3/16/1766 (AbbVie Deutschland GmbH and Co. KG)

EU/3/16/1766 (Active substance: Venetoclax) - Transfer of orphan designation - Commission Decision (2018)3026 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/122/16/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/16/1667 (AbbVie Deutschland GmbH and Co. KG)

EU/3/16/1667 (AbbVie Deutschland GmbH and Co. KG)

EU/3/16/1667 (Active substance: Rovalpituzumab tesirine) - Transfer of orphan designation - Commission Decision (2018)3025 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/015/16/T02

Europe -DG Health and Food Safety

16-5-2018

EU/3/16/1649 (AbbVie Deutschland GmbH and Co. KG)

EU/3/16/1649 (AbbVie Deutschland GmbH and Co. KG)

EU/3/16/1649 (Active substance: Humanised recombinant IgG4 anti-human tau antibody) - Transfer of orphan designation - Commission Decision (2018)3024 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/239/15/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/16/1617 (AbbVie Deutschland GmbH and Co. KG)

EU/3/16/1617 (AbbVie Deutschland GmbH and Co. KG)

EU/3/16/1617 (Active substance: Venetoclax) - Transfer of orphan designation - Commission Decision (2018)3023 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/205/15/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/10/830 (AbbVie Deutschland GmbH and Co. KG)

EU/3/10/830 (AbbVie Deutschland GmbH and Co. KG)

EU/3/10/830 (Active substance: Veliparib) - Transfer of orphan designation - Commission Decision (2018)3021 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/110/10/T/02

Europe -DG Health and Food Safety

15-5-2018

Synagis (AbbVie Deutschland GmbH and Co. KG)

Synagis (AbbVie Deutschland GmbH and Co. KG)

Synagis (Active substance: palivizumab) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3064 of Tue, 15 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/257/T/116

Europe -DG Health and Food Safety

3-4-2018

EU/3/12/1080 (AbbVie Deutschland GmbH and Co. KG)

EU/3/12/1080 (AbbVie Deutschland GmbH and Co. KG)

EU/3/12/1080 (Active substance: 4-(4-{[2-(4-chlorophenyl)-4,4-dimethylcyclohex-1-en-1-yl]methyl}piperazin-1-yl)-N-({3-nitro-4-[(tetrahydro-2H-pyran-4-ylmethyl)amino]phenyl}sulfonyl)-2-(1H-pyrrolo[2,3-b]pyridin-5-yloxy)benzamide) - Transfer of orphan designation - Commission Decision (2018)2056 of Tue, 03 Apr 2018 European Medicines Agency (EMA) procedure number: EMA/OD/124/12/T/01

Europe -DG Health and Food Safety