FrancophonIA/ELRC3.0 huggingface dataset:
English: Pegylated bovine granulocyte colony stimulating factor
Croatian: Pegilirani goveđi faktor stimulacije granulocitnih kolonija
English: CONTRAINDICATIONS Do not use in case of hypersensitivity to the active substance or to any of the excipients.
Croatian: Ne primjenjivati u slučaju preosjetljivosti na djelatnu tvar ili na bilo koju od pomoćnih tvari.
English: There is no information available about the pharmacokinetics of pegbovigrastim in cattle.
Croatian: Ne postoje dostupni podaci o farmakokinetici pegbovigrastima u goveda.
English: UK-L24 2LN
Croatian: UK-L24 2LN Ujedinjeno Kraljevstvo
English: The product should only be used on the basis of a positive benefit: risk assessment performed at the herd level by the responsible veterinarian.
Croatian: Proizvod treba koristiti samo onda kada odgovorni veterinar napravivši procjenu omjera koristi i rizika na razini stada zaključi da će njegovo korištenje biti korisno.
English: Concurrent administration of substances which alter immune function (e.g. corticosteroids or non steroidal anti-inflammatory drugs) may reduce the efficacy of the product.
Croatian: Istodobna primjena tvari koje mijenjaju imunosni sustav (npr. kortikosteroidi ili nesteroidni protuupalni lijekovi) mogu smanjiti djelotvornost proizvoda.
English: There may also be other effects including nausea and a skin rash, hypersensitivity reactions (breathing difficulties, hypotension, urticaria and angioedema).
Croatian: Također se mogu se javiti i druge reakcije uključujući mučninu i osip kože, reakcije preosjetljivosti (poteškoće s disanjem, hipotenzija, urtikarija i angioedem).
English: bG-CSF presents additional functions beyond its action on neutrophils and these may be direct or indirect functions on other cells/receptors and cytokine pathways.
Croatian: Također je dokazano da pojačava mikrobiocidne sposobnosti neutrofila koje su posredovane mijeloperoksidaza vodik peroksid halidom. bG-CSF ima dodatna djelovanja pored svog djelovanja na neutrofile, a to mogu biti izravna ili neizravna djelovanja na druge stanice/receptore i puteve citokina.
English: 10 syringes.
Croatian: 10 štrcaljki.
English: Meat and offal: zero days.
Croatian: Meso i jestive iznutrice: nula dana.
English: Disposal: read package leaflet
Croatian: Odlaganje: pročitati uputu o VMP
English: The efficacy was tested alongside normal dairy herd management practices.
Croatian: Djelotvornost je ispitana zajedno s korištenjem uobičajenog programa upravljanja stadom.
English: Evidence from similar active substances in humans suggests that accidental administration of more than the authorised dose could result in adverse reactions, which are related to the activity of pegbovigrastim.
Croatian: Dokaz o primjeni sličnih djelatnih tvari kod ljudi ukazuje da slučajna primjena doze veće od odobrene može dovesti do nuspojava, koje su povezane s djelovanjem pegbovigrastima.
English: Evidence from similar active substances in humans suggests that accidental administration to cattle of more than the authorised dose could result in adverse reactions, which are related to the activity of pegbovigrastim.
Croatian: Dokaz o primjeni sličnih djelatnih tvari kod ljudi ukazuje da slučajna primjena doze veće od odobrene na govedima može dovesti do nuspojava, koje su povezane s djelovanjem pegbovigrastima.
English: 100 syringes.
Croatian: 100 štrcaljki.
English: In the clinical studies, non-typical anaphylactoid reactions were uncommonly observed.
Croatian: U kliničkim ispitivanjima, manje često su uočene netipične anafilaktičke reakcije.
English: During the clinical field studies, non typical anaphylactoid type reactions were uncommonly observed.
Croatian: Tijekom kliničkih terenskih ispitivanja, manje često su uočene netipične anafilaktičke reakcije.
English: 50 syringes.
Croatian: 50 štrcaljki.
English: United Kingdom
Croatian: Ujedinjeno Kraljevstvo ili
English: Seek medical advice immediately and show the package leaflet to the physician.
Croatian: Odmah potražiti pomoć liječnika i pokažite mu uputu o VMP.
English: The immunoregulatory activities of granulocyte colony stimulating factor concerns notably cells of the neutrophilic granulocyte lineage which bear cell surface receptors for the protein.
Croatian: Imunoregulacijske aktivnosti faktora stimulacije granulocitnih kolonija u značajnoj mjeri se odnose na stanice porijeklom od neutrofilnih granulocita koje nose stanične površinske receptore za bjelančevinu.
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) The product is a clear, colourless to pale yellow solution for injection containing 15 mg pegbovigrastim (pegylated bovine colony stimulating factor) in a pre-filled syringe.
Croatian: Proizvod je bistra, bezbojna do blijedo žuta otopina za injekciju koja sadrži 15 mg pegbovigrastima (pegilirani goveđi faktor stimulacije granulocitnih kolonija) u napunjenoj štrcaljki.
English: Subcutaneous administration.
Croatian: Primijeniti potkožno.
English: In one safety study in Jersey cows the margin of safety of this product was 1.5x the highest recommended dose (an overdose of 60µg/kg was administered on three occasions) (see also section 4.10).
Croatian: U jednom ispitivanju neškodljivosti kod Jersey krava, granica neškodljivosti ovog proizvoda bila je 1,5 x od najviše preporučene doze (u tri slučaja primijenjeno je predoziranje od 60µg/kg) (također vidi dio 4.10).
English: In one safety study in Jersey cows, at overdose of 60 µg/kg, administered on three occasions (1.5x the highest recommended dose), abomasal ulcers were observed.
Croatian: U jednom ispitivanju neškodljivosti kod Jersey krava, pri predoziranju od 60 µg/kg koje je primijenjeno u tri slučaja (1,5 x više od najviše preporučene doze), uočeni su ulkusi u sirištu.
English: Only for subcutaneous administration.
Croatian: Samo za potkožnu primjenu.
English: MRL Target tissues
Croatian: MRL Ciljna tkiva Ostale odredbe Terapijska klasifikacija
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Imrestor 15 mg solution for injection for cattle
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA Imrestor 15 mg otopina za injekciju za goveda
English: In one safety study in Jersey cows the margin of safety of this product was 1.5x the highest recommended dose (an overdose of 60µg/kg was administered on three occasions).
Croatian: U jednom ispitivanju neškodljivosti kod Jersey krava, granica neškodljivosti ovog proizvoda bila je 1,5x od najviše preporučene doze (u tri slučaja primijenjeno je predoziranje od 60 µg/kg ).
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Imrestor 15 mg solution for injection for cattle pegbovigrastim
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA Imrestor 15 mg otopina za injekciju za goveda pegbovigrastim
English: Manufacturer for the batch release: Elanco Speke Operations Fleming Road
Croatian: Nositelj odobrenja za proizvodnju odgovoran za puštanje serije u promet: Elanco Speke Operations
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 2.7 ml pre-filled syringe
Croatian: OSNOVNI PODACI KOJI SE MORAJU NALAZITI NA MALIM UNUTARNJIM PAKOVANJIMA
English: PACKAGE LEAFLET Imrestor 15 mg solution for injection for cattle
Croatian: UPUTA O VMP ZA Imrestor 15 mg otopina za injekciju za goveda
English: NO ENTRY
Croatian: NIJE
English: EXPIRY DATE
Croatian: PRIMJENJI VO
English: PHARMACOLOGICAL PROPERTIES
Croatian: Farmakološki djelatna tvar
English: NOT APPLIA BLE
Croatian: NEMA UNOSA
English: Further information on Revinty Ellipta can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Više informacija o lijeku Revinty Ellipta možete naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This overview was last updated in 02-2018.
Croatian: Ovaj pregled informacija posljednji je put ažuriran: 02.2018.
English: Revinty Ellipta (fluticasone furoate / vilanterol)
Croatian: Revinty Ellipta (flutikazonfuroat/vilanterol)
English: Relvar Ellipta is available as an inhaler in two strengths (92/22 micrograms and 184/22 micrograms).
Croatian: Lijek Revinty Ellipta dostupan je kao inhalator u dvije različite jačine (92/22 mikrograma i 184/22 mikrograma).
English: This medicine is the same as Relvar Ellipta, which is already authorised in the EU.
Croatian: Ovaj lijek isti je kao i lijek Relvar Ellipta, koji je već odobren u EU-u.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Revinty Ellipta have also been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Revinty Ellipta nalaze se također u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: In COPD, it is used in adults who have flare-ups of the disease despite regular bronchodilator treatment (treatment to widen the airways).
Croatian: Kad je u pitanju KOPB, primjenjuje se u odraslih u kojih je došlo do pogoršanja bolesti usprkos redovitom liječenju bronhodilatatorima (lijekovi koji šire dišne putove).
English: Side effects reported with Revinty Ellipta are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Revinty Ellipta pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: These patients were already well controlled with the comparator medicine and Revinty Ellipta treatment was able to maintain their FEV1.
Croatian: Ti su bolesnici već bili dobro kontrolirani usporednim lijekom, a primjenom lijeka Revinty Ellipta bilo je moguće održavati njihov FEV1.
English: For more information about using Revinty Ellipta, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Revinty Ellipta pogledajte uputu o lijeku ili se obratite liječniku ili ljekarniku.
English: What measures are being taken to ensure the safe and effective use of Revinty Ellipta?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Revinty Ellipta?
English: The company that makes Relvar Ellipta has agreed that its scientific data can be used for Revinty Ellipta (‘informed consent').
Croatian: Proizvođač lijeka Relvar Ellipta pristao je da se njegovi znanstveni podatci upotrijebe za lijek Revinity Ellipta (tzv. „informirani pristanak”).
English: Revinty Ellipta received a marketing authorisation valid throughout the EU on 2 May 2014.
Croatian: Lijek Revinty Ellipta dobio je odobrenje za stavljanje lijeka u promet koje je na snazi u Europskoj uniji od 2. svibnja 2014.
English: More serious side effects include pneumonia and fractures (seen in up to 1 in 10 people), which were reported more often in patients with COPD than those with asthma.
Croatian: U ozbiljnije nuspojave ubrajaju se upala pluća i frakture (mogu se pojaviti u do 1 na 10 osoba), a prijavljivane su češće u bolesnika s KOPB-om nego u bolesnika s astmom.
English: It attaches to beta-2 receptors in the airways and causes the muscles of the airways to relax and widen, allowing the patient to breathe more easily.
Croatian: Veže se na beta-2 receptore i uzrokuje opuštanje i širenje mišića u dišnim putovima zbog čega bolesnik može lakše disati.
English: The most common side effects with Revinty Ellipta (which may affect more than 1 in 10 people) are headache and nasopharyngitis (inflammation of the nose and throat).
Croatian: Najčešće su nuspojave lijeka Revinty Ellipta (koje se mogu pojaviti u više od 1 na 10 osoba) glavobolja i nazofaringitis (upala nosa i grla).
English: What is Revinty Ellipta and what is it used for?
Croatian: Što je Revinty Ellipta i za što se koristi?
English: As for all medicines, data on the use of Revinty Ellipta are continuously monitored.
Croatian: Kao za sve lijekove, podatci o primjeni lijeka Revinty Ellipta kontinuirano se prate.
English: A fourth study in 1,522 patients showed that Revinty Ellipta was as effective as another medicine containing a corticosteroid (fluticasone propionate) and a long-acting beta-2 agonist (salmeterol).
Croatian: Četvrtim ispitivanjem provedenim na 1 522 bolesnika dokazano je da je lijek Revinty Ellipta jednako djelotvoran kao drugi lijek koji sadrži kortikosteroid (flutikazonpropionat) i dugodjelujući beta-2 agonist (salmeterol).
English: The European Medicines Agency concluded that Revinty Ellipta's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove zaključila je da koristi lijeka Revinty Ellipta nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
English: This reduces inflammation in the airways and improves the patient's breathing.
Croatian: Time se smanjuje upala dišnih putova i poboljšava bolesnikovo disanje.
English: Other information about Revinty Ellipta
Croatian: Ostale informacije o lijeku Revinty Ellipta
English: Revinty Ellipta is an inhaler for treating asthma and chronic obstructive pulmonary disease (COPD).
Croatian: Revinty Ellipta je inhalator za liječenje astme i kronične opstruktivne plućne bolesti (KOPB).
English: Revinty Ellipta contains two active substances that work in different ways to improve breathing in patients with asthma and COPD.
Croatian: Revinty Ellipta sadrži dvije djelatne tvari koje djeluju na različite načine kako bi poboljšale disanje bolesnika s astmom i KOPB-om.
English: In two further studies, Revinty Ellipta reduced the number of flare-ups by between 13 and 34% more than vilanterol alone
Croatian: U dvama daljnjim ispitivanjima primjenom lijeka Revinty Ellipta broj pogoršanja smanjen je za između 13 % i 34 % više nego primjenom samo vilanterola.
English: An overview of Revinty Ellipta and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Revinty Ellipta i zašto je odobren u EU-u
English: Why is Revinty Ellipta authorised in the EU?
Croatian: Zašto je lijek Revinty Ellipta odobren u EU-u?
English: Revinty Ellipta 184/22 also improved FEV1 by 193 ml more than fluticasone furoate and 210 ml more than another inhaler containing fluticasone propionate.
Croatian: Primjenom lijeka Revinty Ellipta 184/22 također je poboljšan FEV1, i to za 193 ml više nego primjenom flutikazonfuroata i za 210 ml više nego primjenom drugog inhalatora koji sadrži flutikazonpropionat.
English: Revinty Ellipta can only be obtained with a prescription.
Croatian: Revinty Ellipta izdaje se samo na liječnički recept.
English: The first study showed that Revinty Ellipta 92/22 improved average FEV1 by 115 ml more than placebo, and a second study showed that Revinty Ellipta 184/22 improved average FEV1 by 131 ml more than placebo.
Croatian: U prvom je ispitivanju utvrđeno da se primjenom lijeka Revinty Ellipta 92/22 prosječni FEV1 poboljšao za 115 ml više nego primjenom placeba, a u drugom ispitivanju dokazano je da se primjenom lijeka Revinty Ellipta 184/22 prosječni FEV1 poboljšao za 131 ml više nego primjenom placeba.
English: In a third study, fewer patients taking Revinty Ellipta 92/22 had at least one severe flare-up after a year of treatment than those taking fluticasone furoate alone (13% versus 16%).
Croatian: U trećem je ispitivanju broj bolesnika liječenih lijekom Revinty Ellipta 92/22 koji su imali najmanje jedno pogoršanje nakon godinu dana liječenja bio manji od broja takvih bolesnika liječenih samo flutikazonfuroatom (13 % u odnosu na 16 %).
English: In two of the studies, Revinty Ellipta 92/22 increased the volume of air a patient could breathe out in one second (FEV1) by 36 ml more than fluticasone furoate alone and 172 ml more than placebo (a dummy treatment).
Croatian: U dvama ispitivanjima od njih tri primjenom lijeka Revinty Ellipta 92/22 volumen zraka koji je bolesnik mogao izdahnuti u jednoj sekundi (FEV1) povećan je za 36 ml više nego primjenom samo flutikazonfuroata i za 172 ml više nego uz primjenu placeba (prividno liječenje).
English: What are the risks associated with Revinty Ellipta?
Croatian: Koji su rizici povezani s lijekom Revinty Ellipta?
English: Revinty Ellipta contains the active substances fluticasone furoate and vilanterol.
Croatian: Revinty Ellipta sadrži djelatne tvari flutikazonfuroat i vilanterol.
English: Regarding its safety, the most frequent side effects reported with Revinty Ellipta were similar to those seen with other COPD and asthma treatments; an increased incidence of pneumonia was observed in patients with COPD.
Croatian: Kad je riječ o sigurnosti, najčešće nuspojave prijavljene za lijek Revinty Ellipta bile su slične nuspojavama zapaženima prilikom liječenja drugim lijekovima protiv KOPB-a i astme.
English: Four studies in over 5,500 patients showed that Revinty Ellipta improves breathing and reduces flare ups of symptoms in patients with COPD.
Croatian: U četiri ispitivanja provedena na više od 5 500 bolesnika utvrđeno je da lijek Revinty Ellipta poboljšava disanje i umanjuje pogoršanje simptoma u bolesnika s KOPB-om.
English: Three studies in over 3,200 patients showed that Revinty Ellipta improves breathing and reduces flareups in patients with persistent asthma.
Croatian: U trima ispitivanjima provedenima na više od 3 200 bolesnika utvrđeno je da Revinty Ellipta poboljšava disanje i umanjuje pogoršanja u bolesnika s trajnom astmom.
English: Revinty Ellipta improves breathing and reduces flare ups of symptoms in patients with asthma and COPD.
Croatian: Primjenom lijeka Revinty Ellipta poboljšava se disanje i umanjuje pogoršanje simptoma u bolesnika s astmom i KOPB-om.
English: How is Revinty Ellipta used?
Croatian: Kako se Revinty Ellipta koristi?
English: How does Revinty Ellipta work?
Croatian: Kako djeluje Revinty Ellipta?
English: What benefits of Revinty Ellipta have been shown in studies?
Croatian: Koje su koristi lijeka Revinty Ellipta utvrđene u ispitivanjima?
English: For the full list of side effects of Revinty Ellipta, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Revinty Ellipta potražite u uputi o lijeku.
English: It is given twice a day.
Croatian: Uzima se dvaput na dan.
English: Without ergosterol, the fungus cannot spread or dies.
Croatian: Bez ergosterola gljivice se ne mogu širiti ili odumru.
English: Patients need to receive an initial higher dose (loading dose) on the first day.
Croatian: Bolesnici moraju primiti početnu veću dozu (udarnu dozu) prvoga dana.
English: The dose may be increased or decreased according to how the patient responds.
Croatian: Doza se može povećati ili smanjiti, ovisno o tome kako bolesnik reagira na liječenje.
English: The full EPAR and risk management plan summary for Voriconazole Hikma can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR i plan upravljanja rizikom za lijek Voriconazole Hikma nalaze se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Therefore, the CHMP's view was that, as for Vfend, the benefit outweighs the identified risk.
Croatian: Stoga je stav CHMP-a da u pogledu lijeka Vfend koristi nadmašuju identificirane rizike.
English: It works by disrupting the formation of ergosterol, which is an important part of fungal cell membranes.
Croatian: Djeluje tako da sprečava stvaranje ergosterola, koji je važan sastavni dio staničnih stijenki gljivica.
English: As for every medicine, the company provided studies on the quality of voriconazole.
Croatian: Kao i za svaki lijek, tvrtka je dostavila ispitivanja o kvaliteti vorikonazola.
English: • invasive aspergillosis (a type of fungal infection due to Aspergillus);
Croatian: • invazivne aspergiloze (vrste gljivične infekcije uzrokovane gljivicom Aspergillus);
English: Because Voriconazole Hikma is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Croatian: Budući da je Voriconazole Hikma generički lijek, smatra se da su njegove koristi i rizici isti kao i oni referentnog lijeka.
English: • serious fungal infections caused by Scedosporium or Fusarium (two different types of fungus).
Croatian: • ozbiljnih gljivičnih infekcija uzrokovanih gljivicama Scedosporium ili Fusarium (dva različita tipa gljivica).
English: There was no need for ‘bioequivalence' studies to investigate whether voriconazole is absorbed similarly to the reference medicine, Vfend, to produce the same level of the active substance in the blood.
Croatian: Nije bilo potrebe za ispitivanjima bioekvivalencije da bi se istražilo apsorbira li se vorikonazol na sličan način kao referentni lijek, Vfend, radi proizvodnje jednake razine djelatne tvari u krvi.
English: Both the loading and the maintenance doses are given by infusion, but once patients improve prescribers should consider switching patients to a voriconazole medicine that can be given by mouth.
Croatian: Udarna doza i doza održavanja daju se infuzijom, no jednom kada se stanje bolesnika poboljša, liječnici koji propisuju terapiju trebaju razmotriti mogućnost prelaska bolesnika na lijek koji sadrži varikonazol koji se primjenjuje kroz usta.
English: • candidaemia (a type of fungal infection due to Candida) in patients with a normal white blood cell count;
Croatian: • kandidemije (vrste gljivične infekcije uzrokovane gljivicom Candida) u bolesnika s normalnim brojem bijelih krvnih stanica;
English: Voriconazole Hikma is also used to prevent fungal infections in patients who have had haematopoietic (blood) stem-cell transplantation (a transplant of a type of stem cells that can develop into blood cells) and are at high risk of infection.
Croatian: Voriconazole Hikma također se primjenjuje u prevenciji gljivičnih infekcija u bolesnika koji su imali hematopoetsku transplantaciju (krvnih) matičnih stanica (transplantacija vrste matičnih stanica koje se mogu razviti u krvne stanice) s visokim rizikom od infekcije.
English: The aim of the loading dose is to attain effective blood levels quickly.
Croatian: Udarna se doza daje radi brzog postizanja djelotvornih razina koncentracije u krvi.
English: Voriconazole Hikma is an antifungal medicine used for the treatment of adults and children over the age of two years who have the following infections caused by a fungus:
Croatian: Hikma je antifungalni lijek koji se koristi za liječenje odraslih osoba i djece starije od 2 godine koji boluju od sljedećih infekcija uzrokovanih gljivicama:
English: The loading dose is then followed by a maintenance dose that can be adjusted according to the patient's response.
Croatian: Nakon udarne doze daje se doza održavanja koja se može prilagoditi ovisno o odgovoru bolesnika na liječenje.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Voriconazole Hikma has been shown to be comparable to Vfend.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) zaključio je kako je u skladu sa zahtjevima EU-a potvrđeno da je lijek Voriconazole Hikma usporediv s lijekom Vfend.
English: When used for treating fungal infections, Voriconazole Hikma is intended mainly for patients with infections that are worsening and possibly life-threatening.
Croatian: Kada se primjenjuje za liječenje gljivičnih infekcija, lijek Voriconazole Hikma uglavnom je namijenjen bolesnicima s gljivičnim infekcijama koje se pogoršavaju i mogu biti opasne po život.
English: • other serious invasive Candida infections when the fungus is resistant to fluconazole (another antifungal medicine);
Croatian: • drugih ozbiljnih invanzivnih infekcija uzrokovanih gljivicom Candida kada su gljivice rezistentne na flukonazol (drugi antifungalni lijek);
English: This is a summary of the European public assessment report (EPAR) for Voriconazole Hikma.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) lijeka Voriconazole Hikma.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Voriconazole Hikma on 27 May 2015.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Voriconazole Hikma na snazi u Europskoj uniji od 27. svibnja 2015.