FrancophonIA/ELRC3.0 huggingface dataset:
English: • looking at the results of the two studies of complicated abdominal infections taken together, 85% of the patients receiving Doribax were cured (275 out of 325), compared with 84% of the patients receiving meropenem (260 out of 309);
Slovenian: • skupni rezultati obeh študij, pri katerih so sodelovali bolniki z zapletenimi trebušnimi okužbami, so pokazali, da je ozdravelo 85 % bolnikov (275 od 325), ki so prejemali zdravilo Doribax, v primerjavi s 84 % bolnikov (260 od 309), ki so prejemali meropenem;
English: • looking at the results of the two studies in nosocomial pneumonia taken together, 75% of the patients receiving Doribax were cured (195 out of 260), compared with 72% of the patients taking piperacillin/tazobactam or imipenem (174 out of 241);
Slovenian: • skupni rezultati obeh študij, pri katerih so sodelovali bolniki z nozokomialno pljučnico, so pokazali, da je ozdravelo 75 % bolnikov (195 od 260), ki so prejemali zdravilo Doribax, v primerjavi z 72 % bolnikov (174 od 241), ki so prejemali piperacilin/tazobaktam ali imipenem;
English: Doribax has been studied in five main studies that compared Doribax with other antibiotics: • two studies compared Doribax with piperacillin/tazobactam or imipenem in a total of 979 patients
Slovenian: • v dveh študijah so zdravilo Doribax primerjali z piperacilinom/tazobaktamom ali imipenemom pri skupaj 979 bolnikih z nozokomialno pljučnico;
English: It has been authorised in the European Union since 4 April 2008.
Slovenian: V Evropski uniji je odobreno od 4. aprila 2008.
English: The full European Public Assessment Report for Effentora can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Effentora je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: It is a well-known substance, which has been used to control pain for many years.
Slovenian: To je dobro znana učinkovina, ki se že mnogo let uporablja za obvladovanje bolečine.
English: The duration of treatment was determined by the time needed by each patient to control 9 episodes of breakthrough pain within a 21-day period.
Slovenian: Trajanje zdravljenja je bilo odvisno od časa, ki ga je posamezen bolnik potreboval za nadzor 9 epizod prebijajoče bolečine v obdobju 21 dni.
English: Each patient ranked their pain intensity on a scale of 0 to 10.
Slovenian: Vsak bolnik je ocenil intenzivnost svoje bolečine z oceno od 0 do 10.
English: In all of the studies, the main measure of effectiveness was the change in pain intensity in the 60 minutes after taking the tablet.
Slovenian: Glavno merilo učinkovitosti v vseh študijah je bila sprememba intenzivnosti bolečine v 60 minutah po zaužitju tablete.
English: Effentora is available as ‘buccal tablets' (tablets that dissolve in the mouth).
Slovenian: Zdravilo Effentora je na voljo v obliki „bukalnih tablet“ (tablet, ki se raztopijo v ustih).
English: The application was withdrawn after the CHMP had evaluated the documentation provided by the company and formulated lists of questions.
Slovenian: Vlogo so umaknili potem, ko je CHMP ocenil dokumentacijo, ki jo je predložila družba, in oblikoval sezname vprašanj.
English: In its official letter, the company stated that it decided to withdraw the application after the CHMP indicated that the data submitted were not sufficient to address the Committee's concerns.
Slovenian: Družba je v uradnem dopisu navedla, da se je za umik vloge odločila, potem ko je CHMP izrazil mnenje, da predloženi podatki niso bili zadostni, da bi odpravili zadržke Odbora.
English: The applicant presented data from 3 main studies in adults with breakthrough pain already using opioids.
Slovenian: Družba je predložila podatke iz 3 glavnih študij pri odraslih bolnikih s prebijajočo bolečino, ki so že uporabljali opioide.
English: The third study, which lasted for 12 weeks, looked at the effects of Effentora in 148 patients with non-cancer-related longterm pain.
Slovenian: V tretji študiji, ki je trajala 12 tednov, so preučevali učinke zdravila Effentora pri 148 bolnikih z dolgotrajno bolečino, ki ni bila povezana z rakom.
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials with Effentora.
Slovenian: Družba je obvestila CHMP, da umik nima nobenih posledic za bolnike, ki trenutno sodelujejo v kliničnih preskušanjih zdravila Effentora.
English: Once absorbed, fentanyl acts on receptors in the brain and spinal cord to control pain.
Slovenian: Po absorpciji začne fentanil delovati na receptorje v možganih in hrbtenjači ter tako preprečuje bolečino.
English: The effects of Effentora were compared with those of placebo (a dummy treatment) in 79 patients with neuropathic pain (pain due to nerve damage) in one study, and in 77 patients with lowback pain in a second study.
Slovenian: V prvi študiji so učinke zdravila Effentora primerjali z učinki placeba (zdravila brez zdravilne učinkovine) pri 79 bolnikih z nevropatsko bolečino (bolečino zaradi poškodbe živca), v drugi študiji pa pri 77 bolnikih z bolečino v križu.
English: On 11 July 2013, Teva Pharma B.V. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a new indication for Effentora, to extend the treatment for breakthrough pain to adult patients with chronic (long-term) persistent pain from causes other than cancer.
Slovenian: je 11. julija 2013 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za novo indikacijo za zdravilo Effentora, s katero bi razširili zdravljenje prebijajoče bolečine na odrasle bolnike s kronično (dolgotrajno) trdovratno bolečino, ki ni posledica raka.
English: There are no consequences on the use of Effentora in its authorised indication.
Slovenian: Umik nima nobenih posledic za uporabo zdravila Effentora pri odobreni indikaciji.
English: The Committee also had concerns that the patients in the studies had high levels of background pain and might not have been representative of the intended treatment group, which consists of patients with breakthrough pain but whose background pain is otherwise well controlled by regular opioid treatment.
Slovenian: Prav tako je bil zaskrbljen zaradi dejstva, da so imeli bolniki v študijah visoke stopnje osnovne bolečine in zato morda niso bili značilni predstavniki ciljne skupine, ki naj bi uporabljala zdravilo in jo sestavljajo bolniki, ki doživljajo prebijajočo bolečino, vendar pa osnovno bolečino dobro nadzorujejo z običajnimi opioidi.
English: It is already used to treat ‘breakthrough' pain in adults with cancer who are using opioid painkillers to control long-term cancer pain.
Slovenian: Zdravilo se že uporablja za zdravljenje „prebijajoče“ bolečine pri odraslih bolnikih z rakom, ki uporabljajo opioide za nadzor dolgotrajne bolečine zaradi raka.
English: The CHMP considered that, although the use of Effentora is accepted in cancer patients who have limited survival, further data were needed to support its safe use in adults with non-cancer-related pain, who have normal life expectancy and may need long-term treatment.
Slovenian: CHMP je menil, da so kljub dejstvu, da je uporaba zdravila Effentora sprejemljiva pri bolnikih z rakom, ki imajo omejene možnosti preživetja, potrebni dodatni podatki, ki bi podprli varno uporabo zdravila pri odraslih bolnikih z bolečino, ki ni povezana z rakom, pri katerih se pričakuje običajna življenjska doba in bi lahko potrebovali dolgoročno zdravljenje.
English: The Committee noted that several cases of misuse or abuse of the medicine had been reported in the studies, and was concerned about the risk of addiction in non-cancer patients when using Effentora in the long term.
Slovenian: Odbor je ugotovil, da so v študijah poročali o več primerih napačne uporabe ali zlorabe zdravila, zato je bil zaskrbljen glede tveganja za odvisnost bolnikov brez raka pri dolgoročni uporabi zdravila Effentora.
English: Breakthrough pain is when a patient experiences additional, sudden pain in spite of ongoing treatment with painkillers.
Slovenian: O prebijajoči bolečini govorimo, ko bolnik občuti nenadno dodatno bolečino, čeprav uporablja zdravila proti bolečinam.
English: Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had concerns and was of the provisional opinion that Effentora could not have been approved for the treatment of breakthrough pain in adults with long-term pain other than cancer pain.
Slovenian: Na podlagi pregleda podatkov in odgovorov družbe na sezname vprašanj, ki jih je zastavil CHMP, je Odbor v času umika izrazil zadržke in je začasno menil, da zdravila Effentora ni mogoče odobriti za zdravljenje prebijajoče bolečine pri odraslih bolnikih z dolgotrajno bolečino, ki ni posledica raka.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Effentora in patients with non-cancer-related long-term pain did not outweigh its risks.
Slovenian: Zato je CHMP v času umika menil, da koristi zdravila Effentora pri bolnikih z dolgotrajno bolečino, ki ni povezana z rakom, ne odtehtajo z njim povezanih tveganj.
English: What was Effentora expected to be used for?
Slovenian: Za kaj naj bi se zdravilo Effentora uporabljalo?
English: Effentora was also expected to be used to treat breakthrough pain in adults with long-term persistent pain from causes other than cancer, who were already receiving regular treatment with opioids to control their persistent pain.
Slovenian: Zdravilo Effentora naj bi se uporabljalo tudi za zdravljenje prebijajoče bolečine pri odraslih bolnikih z dolgotrajno trdovratno bolečino, ki ni posledica raka, ki so za nadzor trdovratne bolečine že prejemali običajno zdravljenje z opioidi.
English: In Effentora, it is given as a buccal tablet, so that fentanyl is absorbed through the lining of the mouth.
Slovenian: Zdravilo Effentora se daje v obliki bukalnih tablet, tako da se fentanil absorbira skozi ustno sluznico.
English: In adults with long-term pain due to causes other than cancer, Effentora was expected to work in the same way as it does in adults with cancer pain.
Slovenian: Zdravilo Effentora naj bi pri odraslih bolnikih z dolgotrajno bolečino, ki ni posledica raka, delovalo na enak način kot pri odraslih bolnikih z bolečinami zaradi raka.
English: How was Effentora expected to work?
Slovenian: Kako naj bi zdravilo Effentora delovalo?
English: What is happening with Effentora for the treatment ‘breakthrough' pain in adults with cancer?
Slovenian: „prebijajoče“ bolečine pri odraslih bolnikih z rakom?
English: Content Package size Withdrawal Period
Slovenian: Vsebina Velikost pakiranja
English: The main studies lasted for two to four weeks.
Slovenian: Glavne študije so trajale dva do štiri tedne.
English: The marketing authorisation was renewed on 12 March 2004 and on 12 March 2009.
Slovenian: Dovoljenje za promet z zdravilom je bilo obnovljeno 12. marca 2004 in 12. marca 2009.
English: It is available as capsules (white and brown: 5 mg; white: 10 mg).
Slovenian: Na voljo je v obliki kapsul (bele in rjave: 5 mg; bele: 10 mg).
English: Sonata has been studied in a total of 14 studies, involving nearly 3,500 adults and elderly patients.
Slovenian: Zdravilo Sonata so proučevali v skupaj 14 študijah, v katerih je sodelovalo skoraj 3 500 odraslih in starejših bolnikov.
English: Other information about Sonata:
Slovenian: Druge informacije o zdravilu Sonata:
English: Treatment with Sonata should be as short as possible and should last for no more than two weeks.
Slovenian: Zdravljenje z zdravilom Sonata mora biti čim krajše in naj ne traja več kot dva tedna.
English: Neurotransmitters such as GABA are chemicals that allow nerve cells to communicate with each other.
Slovenian: Živčni prenašalci, kot je GABA, so kemijske snovi, ki omogočajo živčnim celicam medsebojno komunikacijo.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) SONATA EPAR summary for the public
Slovenian: EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR) SONATA Povzetek EPAR za javnost
English: Zaleplon is chemically different from the benzodiazepines, but it acts on the same receptors in the brain.
Slovenian: Zaleplon se kemijsko razlikuje od benzodiazepinov, vendar učinkuje na iste receptorje v možganih.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Sonata on 12 March 1999.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Sonata, veljavno po celotni Evropski uniji, odobrila dne 12. marca 1999.
English: The main measure of effectiveness was the time taken to fall asleep.
Slovenian: Glavno merilo učinkovitosti je bil čas, potreben, da je bolnik zaspal.
English: The recommended dose is 10 mg, except for the elderly or patients with mild or moderate liver disease, who should take 5 mg.
Slovenian: Priporočeni odmerek je 10 mg, razen pri starejših ali osebah z blagim ali zmernim obolenjem jeter, ki naj vzamejo 5-miligramski odmerek.
English: The Committee recommended that Sonata be given marketing authorisation.
Slovenian: Odbor je priporočil, da se za zdravilo Sonata odobri dovoljenje za promet.
English: It is a gamma-amino butyric acid (GABA) receptor agonist, which means that it attaches to the receptors for the neurotransmitter GABA and activates them.
Slovenian: Je agonist receptorjev gama-aminomaslene kisline (GABA), kar pomeni, da se veže na receptorje za živčne prenašalce GABA in jih aktivira.
English: By activating its receptors, zaleplon increases GABA's effects, which encourages sleep.
Slovenian: Zaleplon z aktiviranjem receptorjev poveča učinke GABA, kar spodbuja spanec.
English: For more information, see the Package Leaflet.
Slovenian: Za več informacij glejte navodilo za uporabo.
English: It is used only when the insomnia is severe, disabling or causing extreme distress.
Slovenian: Uporablja se samo, kadar je nespečnost huda in osebo onesposobi ali ji povzroča izjemno neugodje.
English: What benefit has Sonata shown during the studies?
Slovenian: Kakšne koristi je zdravilo Sonata izkazalo med študijami?
English: No food should be eaten with or shortly before taking Sonata, because it can reduce the medicine's effects.
Slovenian: Uživanje hrane hkrati z zdravilom Sonata ali tik pred tem ni priporočljivo, saj lahko zmanjša učinke zdravila.
English: Some studies also looked at the time spent asleep and sleeping patterns.
Slovenian: Nekatere študije so merile tudi trajanje spanja in vzorce spanja.
English: It must not be used in patients with severe liver or kidney problems, sleep apnoea syndrome (frequent interruption of breathing during sleep), myasthenia gravis (a disease causing muscle weakness) or severe respiratory insufficiency (breathing disorders), or in patients under 18 years of age.
Slovenian: Ne sme se uporabljati pri bolnikih s hudimi obolenji jeter ali ledvic, bolnikih s sindromom apneje v spanju (pogoste prekinitve dihanja v spanju), miastenijo gravis (boleznijo, ki povzroča šibkost mišic), bolnikih s hudimi težavami z dihanjem ali pri bolnikih, mlajših od 18 let.
English: The most common side effects with Sonata (seen in between 1 and 10 patients in 100) are amnesia (memory problems), paraesthesia (unusual sensations like pins and needles), somnolence (sleepiness) and dysmenorrhoea (painful menstruation).
Slovenian: Najpogostejši neželeni učinki zdravila Sonata (opaženi pri 1 do 10 bolnikih izmed 100) so amnezija (motnja spomina), parestezija (nenormalni občutki zbadanja), somnolenca (zaspanost) in dismenoreja (boleča menstruacija).
English: The powder in Sonata capsules is coloured with an intense dark blue dye, to prevent it being given to someone without their knowledge.
Slovenian: Prašek v kapsulah Sonata je obarvan z intenzivnim temnomodrim barvilom, kar preprečuje, da bi posamezna oseba zdravilo prejela brez svoje vednosti.
English: In the brain, GABA is involved in bringing about sleep.
Slovenian: GABA v možganih sodeluje pri tem, da človek zaspi.
English: Five of these studies were comparative: Sonata was compared with placebo (a dummy treatment) or with zolpidem or triazolam (other medicines used in insomnia).
Slovenian: Pet študij je bilo primerjalnih: zdravilo Sonata so primerjali s placebom (zdravilom brez zdravilne učinkovine) ali zolpidemom ali triazolamom (drugima zdraviloma za zdravljenje nespečnosti).
English: What is the risk associated with Sonata?
Slovenian: Kakšna tveganja so povezana z zdravilom Sonata?
English: Sonata is a medicine that contains the active substance zaleplon.
Slovenian: Sonata je zdravilo, ki vsebuje zdravilno učinkovino zaleplon.
English: Sonata is used for the treatment of adults with insomnia who have difficulty falling asleep.
Slovenian: Zdravilo Sonata se uporablja za zdravljenje odraslih z nespečnostjo, ki težko zaspijo.
English: The active substance in Sonata, zaleplon, belongs to a group of medicines that are related to the benzodiazepines.
Slovenian: Zdravilna učinkovina v zdravilu Sonata, zaleplon, spada v skupino zdravil, ki so podobne benzodiazepinom.
English: For the full list of all side effects reported with Sonata, see the Package Leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Sonata, glejte navodilo za uporabo.
English: Sonata should not be used in people who may be hypersensitive (allergic) to zaleplon or any of the other ingredients.
Slovenian: Zdravila Sonata ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) zaleplon ali katero koli drugo sestavino zdravila.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Sonata's benefits are greater than its risks for the treatment of patients with insomnia who have difficulty falling asleep, when the disorder is severe, disabling or subjecting the individual to extreme distress.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila Sonata pri zdravljenju hude nespečnosti, ki težko zaspijo, kadar je motnja huda, ki osebo onesposobi ali ji povzroča izjemno neugodje, večje od z njim povezanih tveganj.
English: Sonata 10 mg was more effective than placebo in decreasing the time taken to fall asleep and increasing time spent asleep during the first half of the night.
Slovenian: Zdravilo Sonata v odmerku 10 mg je bilo učinkovitejše od placeba pri skrajševanju časa, potrebnega, da je bolnik zaspal, in pri podaljševanju trajanja spanca v prvi polovici noči.
English: Why has Sonata been approved?
Slovenian: Zakaj je bilo zdravilo Sonata odobreno?
English: Sonata must not be taken by children or by patients who have severe liver or kidney problems.
Slovenian: Zdravila Sonata ne smejo jemati otroci ali bolniki s hudim obolenjem jeter ali ledvic.
English: Sonata is taken immediately before going to bed, or after the patient has gone to bed and is having difficulty falling asleep.
Slovenian: Zdravilo Sonata bolnik vzame tik preden gre v posteljo ali potem, ko je že v postelji in ne more zaspati.
English: The full EPAR for Sonata is available here.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Sonata je na voljo tukaj.
English: The time taken to fall asleep was reduced in adults taking Sonata 10 mg, and the effects were maintained for up to four weeks.
Slovenian: Pri odraslih, ki so vzeli 10 mg zdravila Sonata, se je skrajšal čas, potreben, da so zaspali, učinki pa so trajali do štiri tedne.
English: What is Sonata used for?
Slovenian: Za kaj se zdravilo Sonata uporablja?
English: What is Sonata?
Slovenian: Kaj je zdravilo Sonata?
English: How has Sonata been studied?
Slovenian: Kako je bilo zdravilo Sonata raziskano?
English: How does Sonata work?
Slovenian: Kako zdravilo Sonata deluje?
English: In elderly patients, the time taken to fall asleep was often decreased with Sonata 5 mg and was always decreased with Sonata 10 mg, when they were compared with placebo in the two-week studies.
Slovenian: V primerjavi s placebom je bil v dvotedenskih študijah pri starejših bolnikih, ki so jemali zdravilo Sonata v odmerku 5 mg, čas, potreben, da so zaspali, pogosto krajši, pri jemanju 10-miligramskih odmerkov pa je bil vedno krajši.
English: How is Sonata used?
Slovenian: Kako se zdravilo Sonata uporablja?
English: The maximum total daily dose of Sonata is 10 mg.
Slovenian: Največji celotni dnevni odmerek zdravila Sonata je 10 mg. Bolniki ne smejo vzeti drugega odmerka v isti noči.
English: Sonata also preserved sleep patterns in the studies that measured the time spent in different stages of sleep.
Slovenian: V študijah, v katerih so merili čas trajanja različnih faz spanja, se je izkazalo, da zdravilo Sonata ohrani vzorce spanja.
English: Adopted at the 5-8 October 2015 PRAC
Slovenian: Sprejeto na seji odbora PRAC med 5. in 8. oktobrom 2015
English: Anakinra - Thrombocytopenia (EPITT no 18337)
Slovenian: Anakinra - trombocitopenija (EPITT št. 18337)
English: In clinical studies in RA and CAPS patients, thrombocytopenia has been reported in 1.9% of treated patients compared to 0.3% in the placebo group.
Slovenian: V kliničnih študijah bolnikov z revmatoidnim artritisom (RA) in s kriopirinom povezanim periodičnim sindromom (CAPS) so o trombocitopeniji poročali pri 1,9 % zdravljenih bolnikov v primerjavi z 0,3 % v skupini s placebom.
English: Thrombocytopenia
Slovenian: Trombocitopenija
English: New product information wording - Extracts from PRAC recommendations on signals EMA/PRAC/661880/2015
Slovenian: Novo besedilo informacij o zdravilu - izvlečki iz priporočil odbora PRAC o signalih EMA/PRAC/680927/2015
English: Common side effects (may affect up to 1 in 10 people): - Thrombocytopenia (low level of blood platelets).
Slovenian: Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov): - trombocitopenija (nizko število trombocitov v krvi).
English: The thrombocytopenias have been mild, i.e. platelet counts have been >75 x109/l.
Slovenian: Trombocitopenija je bila blaga, tj. število trombocitov je bilo večje od 75 x109/l.
English: During post-marketing use of Kineret, thrombocytopenia has been reported, including occasional case reports indicating severe thrombocytopenia (i.e. platelet counts <10 x109/l).
Slovenian: O trombocitopeniji so poročali tudi pri uporabi zdravila Kineret v obdobju trženja, vključno z občasnimi poročili o primerih hude trombocitopenije (tj. število trombocitov manjše od 10 x109/l).
English: Summary of Product Characteristics: Section 4.8 - Undesirable effects:
Slovenian: Povzetek glavnih značilnosti zdravila: Poglavje 4.8 - Neželeni učinki: bolezni krvi in limfatičnega sistema Pogostnost „pogosti“: trombocitopenija
English: EU Number Invented Name
Slovenian: EU številka Izmišljeno ime
English: Horses Intramuscular Vials (Type I glass) closed with a halogenobutyl rubber stopper and aluminium cap.
Slovenian: Karenca intramuskularno viale (steklo tipa I), zaprte z zamaški iz halogenobutilne gume in zatesnjene z aluminijastimi zaporkami
English: Horses Intramuscular Pre-filled syringes (Type I glass) with a plunger and cap tip of halogenobutyl rubber
Slovenian: 10 steklenih vial intramuskularno napolnjene brizge (steklo tipa I) z batom z nastavkom iz halogenobutila
English: 1 dose 10 pre-filled syringes
Slovenian: 10 napolnjenih brizg
English: 1 bag
Slovenian: 1 vreča
English: Immediate Packaging Content Pack size
Slovenian: Vsebina Velikost pakiranja
English: ml
Slovenian: Jakost
English: Intravenous use Ethylen-vinyl-acetate cryo bag (EVA)
Slovenian: 5-20 x 106 celic/ml disperzija za infundiranje intravenska uporaba zamrzovalna vreča iz etilen-vinil-acetata
English: 5-20 x 106 cells/mL
Slovenian: 10-100 ml
English: Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, Marketing Authorisation Holders in the Member States
Slovenian: Priloga I Seznam imen, farmacevtskih oblik, jakosti zdravila, poti uporabe zdravila in imetnikov dovoljenja za promet z zdravilom v državah članicah
English: AstraZeneca Kft. 1113 Budapest Bocskai út 134-146.
Slovenian: Bocskai út 134-146.