FrancophonIA/ELRC3.0 huggingface dataset:
English: Why is Lutathera approved?
Croatian: Zašto je lijek Lutathera odobren?
English: In a main study of 229 patients with GEP-NETs that contained somatostatin receptors, patients given Lutathera lived for an average of 28 months without their disease getting worse.
Croatian: U glavnoj studiji koja je uključivala 229 bolesnika s GEP-NET-ovima koji su imali somatostatinske receptore, bolesnici kojima se davao lijek Lutathera živjeli su u prosjeku 28 mjeseci bez pogoršavanja bolesti u usporedbi s 9 mjeseci u bolesnika liječenih oktreotidom, lijekom koji je već odobren za liječenje te bolesti.
English: Only a minority of patients with GEP-NETs can be cured with surgery and at the time of diagnosis the tumours would have spread in most patients.
Croatian: Kirurškim zahvatom može se liječiti samo mali broj bolesnika s GEP-NET-ovima i u većine bolesnika tumori su se već proširili u vrijeme postavljanja dijagnoze.
English: Lutathera can help slow down the worsening of GEP-NETs.
Croatian: Lijek Lutathera može pomoći u usporavanju pogoršavanja GEP-NET-ova.
English: For more information about treatment with Lutathera, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Lutathera pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svojem liječniku ili ljekarniku.
English: The active substance in Lutathera, lutetium (177Lu) oxodotreotide, works by attaching to somatostatin receptors, which are found in high numbers in some GEP-NETs.
Croatian: Djelatna tvar u lijeku Lutathera, lutecijev (177Lu) oksodotreotid, djeluje tako da se pričvršćuje za somatostatinske receptore kojih ima u velikom broju u nekim GEP-NET-ovima.
English: Lutathera can help slow the worsening of the condition and its side effects are considered manageable.
Croatian: Lijek Lutathera može pomoći u usporavanju pogoršavanja stanja te se smatra da se njegove nuspojave mogu kontrolirati.
English: The medicine is only for GEP-NETs that have receptors called somatostatin receptors on their cell surfaces.
Croatian: Lijek je namijenjen samo za GEP-NET-ove koji na površini stanica imaju receptore koji se nazivaju somatostatinski receptori.
English: What benefits of Lutathera have been shown in studies?
Croatian: Koje su koristi lijeka Lutathera dokazane u ispitivanjima?
English: Lutathera contains the active substance lutetium (177Lu) oxodotreotide.
Croatian: Lijek Lutathera sadržava djelatnu tvar lutecijev (177Lu) oksodotreotid.
English: For practical information about using Lutathera, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Lutathera bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svojem liječniku ili ljekarniku.
English: How does Lutathera work?
Croatian: Kako djeluje Lutathera?
English: Lutathera is given by infusion (drip) into a vein.
Croatian: Lijek Lutathera daje se intravenskom infuzijom (drip).
English: For the full list of all side effects reported with Lutathera, see the package leaflet.
Croatian: Potpuni popis svih nuspojava zabilježenih pri primjeni lijeka Lutathera potražite u uputi o lijeku.
English: How is Lutathera used?
Croatian: Kako se Lutathera koristi?
English: Annex IV Scientific conclusions and grounds for maintenance of the marketing authorisations or the variation to the terms of the marketing authorisations, as relevant
Croatian: Znanstveni zaključci i razlozi za zadržavanje odobrenja za stavljanje lijeka u promet ili izmjene uvjeta odobrenja za stavljanje lijeka u promet, ovisno o primjenjivosti
English: This summary was last updated in 06-2016.
Croatian: Ovaj je sažetak posljednji put ažuriran u 06.2016.
English: The full EPAR for Reyataz can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Croatian: Cjeloviti EPAR za lijek Reyataz nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This finding was maintained after 96 weeks.
Croatian: Isti je rezultat bio i nakon 96 tjedana.
English: It is available as capsules (100 mg, 150 mg, 200 mg and 300 mg) and oral powder (50 mg).
Croatian: Dostupan je u kapsulama (100 mg, 150 mg, 200 mg i 300 mg) i kao oralni prašak (50 mg).
English: The patients also had improvements in their immune systems.
Croatian: Bolesnicima se poboljšao i imunosni sustav.
English: What measures are being taken to ensure the safe and effective use of Reyataz?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Reyataz?
English: In studies, side effects were similar in younger patients.
Croatian: U ispitivanjima su se slične nuspojave pojavile u mlađih bolesnika.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Reyataz on 2 March 2004.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Reyataz na snazi u Europskoj uniji od 2. ožujka 2004.
English: Reyataz does not cure HIV infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
Croatian: Reyataz ne liječi infekciju HIV-om ni AIDS, no može odgoditi oštećenje imunosnog sustava i razvoj infekcija i bolesti povezanih s AIDS-om.
English: This allows a lower dose of atazanavir to be used for the same antiviral effect.
Croatian: To omogućuje upotrebu niže doze atazanavira za isti antivirusni učinak.
English: For adults (aged 18 years or over), the recommended dose is 300 mg once a day.
Croatian: Preporučena doza za odrasle osobe (u dobi od 18 godina ili više) iznosi 300 mg jedanput na dan.
English: It blocks an enzyme called protease, which is needed for the virus to multiply.
Croatian: Djeluje tako da blokira enzim koji se naziva proteaza, a koji je potreban za reprodukciju virusa.
English: Reyataz is normally given with ritonavir to boost its action but doctors can consider stopping ritonavir in adults in some specific situations.
Croatian: Reyataz se obično daje s ritonavirom za poboljšanje njegova djelovanja, ali liječnici mogu razmotriti prestanak davanja ritonavira odraslim bolesnicima u specifičnim situacijama.
English: In all of the studies, the patients also took two nucleoside or nucleotide reverse transcriptase inhibitors (NRTIs, a type of antiviral medicine).
Croatian: U svim su ispitivanjima bolesnici također uzimali dva nukleozidna ili nukleotidna inhibitora reverzne transkriptaze (NRTI-ovi, vrsta antivirusnog lijeka).
English: For more information about treatment with Reyataz, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Reyataz pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Reyataz.
Croatian: Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet te preporuke o uvjetima za primjenu lijeka Reyataz.
English: In patients who had been treated before, the results of the first study could not be interpreted, as a large number of patients left the study before its planned end.
Croatian: Rezultati prvog ispitivanja za bolesnike koji nisu prethodno bili liječeni nije bilo moguće procijeniti jer je velik broj bolesnika napustio ispitivanje prije njegova predviđenog kraja.
English: This document is a summary of the European Public Assessment Report (EPAR) for Reyataz.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Reyataz.
English: Treatment with Reyataz should be started by a doctor who has experience in the treatment of HIV infection.
Croatian: Liječenje lijekom Reyataz mora započeti liječnik koji je iskusan u liječenju infekcija HIV-om.
English: The main measure of effectiveness was the change in the levels of HIV in the patients' blood (viral load).
Croatian: Glavna mjera djelotvornosti bila je promjena razine HIV-a u krvi bolesnika (virusno opterećenje).
English: A measure of effectiveness was the viral load after treatment for 48 weeks.
Croatian: Mjera djelotvornosti bilo je virusno opterećenje nakon liječenja od 48 tjedana.
English: Reyataz is used together with low-dose ritonavir and other antiviral medicines to treat adults and children aged 3 months and over and weighing at least 5 kg who are infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Croatian: Reyataz se koristi zajedno s niskim dozama ritonavira i drugim antivirusnim lijekovima za liječenje odraslih osoba i djece u dobi od 3 mjeseca i starije koja teže najmanje 5 kg te koja su zaražena virusom humane imunodeficijencije tipa 1 (HIV-1), virusom koji uzrokuje stečeni sindrom imunodeficijencije (AIDS).
English: The medicine is not expected to work in patients in whom many medicines in the same class as Reyataz (protease inhibitors) do not work.
Croatian: Ne očekuje se da će lijek djelovati u bolesnika u kojih ne djeluju brojni lijekovi istog razreda kao Reyataz (inhibitori proteaze).
English: Reyataz, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Croatian: Reyataz primijenjen u kombinaciji s drugim antivirusnim lijekovima smanjuje količinu HIV-a u krvi i održava je niskom.
English: Blocking the enzyme prevents the virus from multiplying, slowing down the spread of infection.
Croatian: Kad je enzim blokiran, virus se ne razmnožava, što usporava širenje infekcije.
English: In addition, Reyataz must not be given to patients taking rifampicin (used to treat tuberculosis), sildenafil (when this medicine is used to treat pulmonary arterial hypertension), St John's wort (a herbal medicine used to treat depression) or medicines that are broken down in the body in the same way as Reyataz and are harmful at high levels in the blood.
Croatian: Usto se Reyataz ne smije davati bolesnicima koji uzimaju rifampicin (za liječenje tuberkuloze), sildenafil (kada se koristi za liječenje plućne arterijske hipertenzije), gospinu travu (biljni pripravak koji se koristi za liječenje depresije) ili lijekove koji se u tijelu razgrađuju na isti način kao Reyataz i koji su štetni u visokim količinama u krvi.
English: More than half of these patients had taken HIV treatment in the past.
Croatian: Više od polovice tih bolesnika već je prethodno uzimalo lijekove za liječenje infekcije HIV-om.
English: Reyataz oral powder with ritonavir has been assessed in two main studies involving 155 children aged from 3 months up to 11 years.
Croatian: Oralni prašak Reyataz s ritonavirom ocijenjen je u dvama glavnim ispitivanjima koja su obuhvatila 155 djece u dobi između 3 mjeseca i 11 godina.
English: In adults, the most common side effects with Reyataz (seen in between 1 and 10 patients in 100) are headache, ocular icterus (yellowing of the eyes), vomiting, diarrhoea, abdominal pain (stomach ache), nausea (feeling sick), dyspepsia (heartburn), rash, fatigue (tiredness) and jaundice (yellowing of the skin and eyes because of liver problems).
Croatian: Najčešće nuspojave lijeka Reyataz u odraslih osoba (uočene u 1 do 10 na 100 bolesnika) jesu glavobolja, očni ikterus (žutilo očiju), povraćanje, proljev, bol u trbuhu (trbobolja), mučnina (osjećaj slabosti), dispepsija (žgaravica), osip, umor (malaksalost) i žutica (žuta boja kože i očiju povezana s problemima jetre).
English: In patients who had not been treated before, ritonavir-boosted Reyataz capsules were as effective as ritonavir-boosted lopinavir.
Croatian: U bolesnika koji nisu prethodno bili liječeni, kapsule lijeka Reyataz ojačanog ritonavirom bile su jednako djelotvorne kao i lopinavir ojačan ritonavirom.
English: Other information about Reyataz:
Croatian: Ostale informacije o lijeku Reyataz:
English: For patients who have received HIV medicines before, doctors should prescribe Reyataz only after they have looked at which medicines the patient has taken and carried out tests to establish that the virus is likely to respond to Reyataz.
Croatian: Bolesnicima koji su već primali lijekove za liječenje infekcije HIV-om liječnici bi trebali propisati Reyataz tek nakon što provjere koje je sve lijekove bolesnik uzimao te nakon što provedu pretrage kojima će se utvrditi postoji li vjerojatnost da će virus reagirati na Reyataz.
English: A small dose of another medicine, ritonavir, is normally given at the same time as a ‘booster'.
Croatian: Niska doza drugog lijeka, ritonavira, uobičajeno se daje u isto vrijeme kad i dodatna doza.
English: Reyataz must not be used in patients who have severe reductions in their liver function; if given with ritonavir it must not be used in patients with moderate reduction in liver function.
Croatian: Reyataz se ne smije primjenjivati u bolesnika kojima je ozbiljno smanjena jetrena funkcija; ako se primjenjuje zajedno s ritonavirom, ne smije se primjenjivati u bolesnika s umjereno smanjenom jetrenom funkcijom.
English: What is Reyataz?
Croatian: Što je Reyataz?
English: Reyataz is an antiviral medicine that contains the active substance atazanavir.
Croatian: Reyataz je antivirusni lijek koji sadrži djelatnu tvar atazanavir.
English: The Committee decided that Reyataz's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: Odbor je odlučio da koristi od lijeka Reyataz nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenja za stavljanje lijeka u promet.
English: In the two studies in children aged from 3 months up to 11 years taking boosted Reyataz oral powder, the viral load was undetectable in about half the children after treatment for 48 weeks.
Croatian: U dvama ispitivanjima u djece u dobi od 3 mjeseca do 11 godina koji su uzimali ojačani lijek Reyataz u obliku oralnog praška, virusno opterećenje bilo je nemjerljivo u otprilike polovice djece nakon liječenja od 48 tjedana.
English: A further main study involved 172 patients who had achieved undetectable viral load (below 50 copies/ml) after treatment with Reyataz capsules and ritonavir.
Croatian: Još jedno glavno ispitivanje provedeno je na 172 bolesnika u kojih je utvrđeno nemjerljivo virusno opterećenje (manje od 50 kopija/ml) nakon liječenja kapsulama Reyataz i ritonavirom.
English: The CHMP considered that Reyataz's effectiveness had been shown in patients aged at least 3 months and weighing at least 5 kg.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) smatrao je da je djelotvornost lijeka Reyataz utvrđena u bolesnika u dobi od barem 3 mjeseca i težine najmanje 5 kg.
English: What is the risk associated with Reyataz?
Croatian: Koji su rizici povezani s lijekom Reyataz?
English: The active substance in Reyataz, atazanavir, is a protease inhibitor.
Croatian: Djelatna tvar u lijeku Reyataz, atazanavir, inhibitor je proteaze.
English: In the patients aged between 6 and 18 years, 81% of those who had not taken HIV treatment in the past (13 out of 16) and 24% of those who had taken it in the past (6 out of 25) had viral loads below 50 copies/ml after 48 weeks.
Croatian: U bolesnika u dobi od 6 do 18 godina virusno opterećenje kod 81 % onih koji prije nisu uzimali lijekove za liječenje infekcije HIV-om (13 od 16) i 24 % onih koji su ih prije uzimali (6 od 25) bilo je manje od 50 kopija/ml nakon 48 tjedana.
English: Reyataz oral powder can be used for children aged at least 3 months and weighing at least 5 kg, and for patients who cannot swallow capsules.
Croatian: Oralni prašak Reyataz može se koristiti u djece starije od 3 mjeseca koja teže najmanje 5 kg te u bolesnika koji ne mogu gutati kapsule.
English: Reyataz capsules boosted with ritonavir have also been studied in 41 patients aged between 6 and 18 years.
Croatian: Kapsule lijeka Reyataz ojačanog ritonavirom ispitivane su i na 41 bolesniku u dobi od 6 do 18 godina.
English: In the study in patients who already had undetectable viral loads with ritonavir-boosted Reyataz capsules, these were maintained in 68 of 87 patients (78%) who continued treatment with a higher dose of Reyataz without ritonavir, and in 64 of 85 (75%) who continued with the boosted combination.
Croatian: U ispitivanju provedenom na bolesnicima koji su već imali nemjerljivo virusno opterećenje s kapsulama lijeka Reyataz ojačanog ritonavirom, te su se vrijednosti održale u 68 od 87 bolesnika (78 %) koji su nastavili liječenje većom dozom lijeka Reyataz bez ritonavira i u 64 od 85 bolesnika (75 %) koji su nastavili liječenje ojačanim lijekom.
English: At the start of the study, the patients' viral loads were around 88,100 copies/ml, but after 48 weeks, 78% of the patients taking Reyataz (343 out of 440) had viral loads below 50 copies/ml, compared with 76% of those taking lopinavir (338 out of 443).
Croatian: Na početku ispitivanja virusno opterećenje bolesnika iznosilo je otprilike 88 100 kopija/ml, ali nakon 48 tjedana virusno opterećenje u 78 % bolesnika koji su uzimali Reyataz (343 od 440) iznosilo je manje od 50 kopija/ml, za razliku od 76 % bolesnika koji su uzimali lopinavir (338 od 443).
English: It compared continued treatment with either a higher dose of Reyataz without ritonavir or the boosted combination.
Croatian: U ispitivanju je uspoređeno kontinuirano liječenje višom dozom lijeka Reyataz bez ritonavira ili ojačanom kombinacijom.
English: One study compared ritonavir-boosted Reyataz with ritonavir-boosted lopinavir (another antiviral medicine) in 883 patients who had not taken treatment for HIV infection before.
Croatian: U jednom je ispitivanju Reyataz ojačan ritonavirom uspoređen s lopinavirom ojačanim ritonavirom (drugi antivirusni lijek) u 883 bolesnika koji dotad nikada nisu dobivali terapiju za liječenje infekcije HIV-om.
English: The study looked at the effect of the medicine on viral load and on the immune system, among other measures.
Croatian: U ispitivanju su se, među ostalim mjerama, proučavali učinci lijeka na virusno opterećenje i imunosni sustav.
English: Reyataz capsules have been assessed in four main studies involving patients aged 16 years and over.
Croatian: Kapsule lijeka Reyataz ocijenjene su u četirima glavnim ispitivanjima provedenima na bolesnicima u dobi od 16 godina i starijima.
English: In younger patients, the dose of Reyataz depends on body weight.
Croatian: Doza lijeka Reyataz za mlađe bolesnike ovisi o njihovoj težini.
English: In the third study, patients taking ritonavir-boosted Reyataz capsules had similar falls in viral load after 24 and 48 weeks as those taking ritonavir-boosted lopinavir: they had fallen by around 99% after 48 weeks.
Croatian: U trećem ispitivanju u bolesnika koji su uzimali kapsule lijeka Reyataz ojačanog ritonavirom nakon 24 tjedna te 48 tjedana došlo je do istog pada virusnog opterećenja kao i u bolesnika koji su uzimali lopinavir ojačan ritonavirom: smanjenje je bilo otprilike 99 % nakon 48 tjedana.
English: Why has Reyataz been approved?
Croatian: Zašto je lijek Reyataz odobren?
English: In the second study, ritonavir-boosted lopinavir caused a greater reduction in viral load than Reyataz capsules taken without ritonavir after 24 weeks.
Croatian: U drugom je ispitivanju lopinavir ojačan ritonavirom nakon 24 tjedna doveo do većeg smanjenja virusnog opterećenja od kapsula lijeka Reyataz primijenjenog bez ritonavira.
English: What is Reyataz used for?
Croatian: Za što se Reyataz koristi?
English: How is Reyataz used?
Croatian: Kako se Reyataz koristi?
English: What benefit has Reyataz shown during the studies?
Croatian: Koje su koristi lijeka Reyataz utvrđene u ispitivanjima?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Reyataz have been included in the summary of product characteristics and the package leaflet.
Croatian: U sažetku opisa svojstava lijeka i u uputi o lijeku nalaze se preporuke i mjere opreza za sigurnu i učinkovitu primjenu lijeka Reyataz kojih se zdravstveni radnici i bolesnici trebaju pridržavati.
English: For the full list of restrictions with Reyataz see the package leaflet.
Croatian: Potpuni popis ograničenja za lijek Reyataz potražite u uputi o lijeku.
English: The other three studies involved a total of 743 patients who had taken treatment for HIV infection before: the first two compared Reyataz, taken with saquinavir (another antiviral medicine) but without ritonavir, with ritonavir-boosted saquinavir or ritonavir-boosted lopinavir.
Croatian: Ostala su tri ispitivanja obuhvatila ukupno 743 bolesnika koji su prethodno primali terapiju za liječenje infekcije HIV-om: u prva dva ispitivanja
English: The final study compared Reyataz plus either ritonavir or saquinavir with ritonavir-boosted lopinavir in 358 patients.
Croatian: Reyataz uz istodobnu primjenu ritonavira ili sakvinavira uspoređen s lopinavirom ojačanim ritonavirom.
English: For the full list of all side effects reported with Reyataz, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Reyataz potražite u uputi o lijeku.
English: How has Reyataz been studied?
Croatian: Kako je Reyataz ispitivan?
English: How does Reyataz work?
Croatian: Kako djeluje Reyataz?
English: de la Industria, 30
Croatian: Avda. de la Industria, 30
English: Portrazza may increase this risk.
Croatian: Portrazza može povećati taj rizik.
English: This corresponds to a half-life of approximately 14 days.
Croatian: To odgovara poluvijeku od približno 14 dana.
English: Eleven of the 12 patients had an unwitnessed death.
Croatian: Jedanaest od tih 12 bolesnika umrlo je bez prisustva svjedoka.
English: The causes of these deaths and their relationship to treatment were not always known.
Croatian: Uzroci tih smrtnih slučajeva i njihova povezanost s liječenjem nisu uvijek bili poznati.
English: What Portrazza is and what it is used for
Croatian: Što je Portrazza i za što se koristi
English: • Monitor patient for worsening of condition.
Croatian: • Nadzirati bolesnika zbog mogućeg pogoršanja stanja.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Do not shake.
Croatian: DRUGO(A) POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO Nemojte tresti.
English: c Based on laboratory assessments.
Croatian: Na temelju laboratorijskih pretraga.
English: The number of infusions that you receive will depend on how and for how long you respond to treatment with Portrazza.
Croatian: Broj infuzija koje ćete primiti ovisit će o tome kako i koliko dugo odgovarate na liječenje lijekom Portrazza.
English: Other medicines and Portrazza
Croatian: Drugi lijekovi i Portrazza
English: Efficacy results are shown in Table 4.
Croatian: Rezultati za djelotvornost prikazani su u Tablici 4.
English: Tell your doctor if you are taking, have recently taken or might take any other medicines.
Croatian: Obavijestite svog liječnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove,
English: Seek medical help immediately if you experience any of the following:
Croatian: Odmah potražite liječničku pomoć ako primijetite nešto od navedenoga:
English: The predicted time to reach steady state was approximately 70 days.
Croatian: Predviđeno vrijeme do postizanja stanja dinamičke ravnoteže iznosilo je približno 70 dana.
English: Immunogenicity As with all therapeutic proteins, there is the potential for immunogenicity.
Croatian: Kao i kod svih terapijskih proteina, postoji mogućnost imunogenosti.
English: The infusion duration should not exceed 2 hours.
Croatian: Infuzija ne smije trajati dulje od 2 sata.
English: Portrazza should not be given to patients under the age of 18 years because there is no information about how it works in this age group.
Croatian: Portrazza se ne smije primjenjivati u bolesnika mlađih od 18 godina jer nema podataka o tome kako lijek djeluje u toj dobnoj skupini.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 15 February 2016
Croatian: Datum prvog odobrenja: 15. veljače 2016.