FrancophonIA/ELRC3.0 huggingface dataset:
English: • Urinary tract infections o Urinary tract infections o Complicated and uncomplicated upper and lower urinary tract infections: cystitis, pyelitis, cystopyelitis o Upper and lower urinary tract infections, including cystitis, pyelitis and cystopyelitis caused by norfloxacin susceptible bacteria o Complicated and uncomplicated urinary tract infections o Acute urinary tract infections in men o Other lower urinary tract infections, including prostatic infections, and upper urinary tract infections with susceptible bacteria, in adults (i.e. other than uncomplicated acute cystitis) o Acute (except acute pyelonephritis) and chronic (except chronic complicated pyelonephritis) infections of urinary tract caused by sensitive microorganisms o Acute and chronic urinary tract infections, uncomplicated (cystitis, pyelitis) and complicated, excluding complicated pyelonephritis, acute or chronic o Acute infection of lower urinary tract infections in men o Acute lower urinary tract infection in men
Slovenian: Priporočeno besedilo pielitis, cistopielitis o Okužbe zgornjih in spodnjih sečil, vključno s cistitisom, pielitisom in cistopielitisom, ki jih povzročajo bakterije, občutljive za norfloksacin o Zapletene in nezapletene okužbe sečil o Akutne okužbe sečil pri moških o Druge okužbe spodnjih sečil, vključno z okužbami prostate in okužbami zgornjih sečil z občutljivimi bakterijami pri odraslih (tj. razen nezapletenega akutnega cistitisa) o Akutne (razen akutnega pielonefritisa) in kronične (razen kroničnega zapletenega pielonefritisa) okužbe sečil, ki jih povzročajo občutljivi mikroorganizmi o Akutne in kronične okužbe sečil, nezapletene (cistitis, pielitis) in zapletene, akutne ali kronične, razen zapletenega pielonefritisa o Akutne okužbe spodnjih sečil pri moških o Akutne okužbe spodnjih sečil pri moških okužb, ni primerna.
English: Uncomplicated cystitis
Slovenian: Nezapleteni cistitis
English: • Acute exacerbation of chronic bacterial sinusitis.
Slovenian: • Akutno poslabšanje koničnega bakterijskega sinusitisa.
English: • Treatment of bacterial infections in neutropenic patients
Slovenian: • Zdravljenje bakterijskih okužb pri nevtropeničnih bolnikih
English: Norfloxacin
Slovenian: Norfloksacin
English: • Cholangitis
Slovenian: • Kolangitis
English: • Uncomplicated acute cystitis.
Slovenian: • Nezapleteni akutni cistitis.
English: • Acute uncomplicated cystitis.
Slovenian: • Akutni nezapleteni cistitis.
English: Moxifloxacin
Slovenian: Moksifloksacin
English: • Serious gastro-intestinal bacterial infections
Slovenian: • Resne bakterijske okužbe prebavil
English: Pefloxacin Current indications included in product information for pefloxacin containing products
Slovenian: Pefloksacin Trenutne indikacije v informacijah o zdravilu za zdravila, ki vsebujejo pefloksacin
English: • Pyelonephritis and complicated urinary tract infections
Slovenian: • Pielonefritis in zapletene okužbe sečil
English: • Ear, nose and throat infections o Ear, nose and throat infections o Ear, nose and throat infectionsevere infections caused by gramnegative bacilli and susceptible staphylococci o Ear, nose and throat (ENT) infections (such as: chronic sinusitis, external otitis) o Ear nose and throat infections (such as chronic sinusitis, malignant otitis externa)
Slovenian: • Okužbe ušes, nosu in žrela o Okužbe ušes, nosu in žrela o Okužbe ušes, nosu in žrela - hude okužbe, ki jih povzročajo gramnegativni bacili in občutljivi stafilokoki o Okužbe ušes, nosu in žrela (ORL) (kot so: kronični sinusitis, vnetje zunanjega ušesa) o Okužbe ušes, nosu in žrela (kot so: kronični sinusitis, maligno vnetje zunanjega ušesa)
English: • Complicated urinary tract infections and acute pyelonephritis
Slovenian: • Zapletene okužbe sečil in akutni pielonefritis
English: *Very rare cases of prolonged (up to months or years), disabling and potentially irreversible serious drug reactions affecting several, sometimes multiple, system organ classes and senses (including reactions such as tendonitis, tendon rupture, arthralgia, pain in extremities, gait disturbance, neuropathies associated with paraesthesia, depression, fatigue, memory impairment, sleep disorders, and impairment of hearing, vision, taste and smell) have been reported in association with the use of quinolones and fluoroquinolones in some cases irrespective of pre-existing risk factors (see Section 4.4).
Slovenian: *V povezavi z uporabo kinolonov ali fluorokinolonov, v nekaterih primerih neodvisno od obstoječih dejavnikov tveganja, poročali o zelo redkih primerih dolgotrajnih (več mesecev ali let trajajočih), onesposabljajočih in potencialno ireverzibilnih resnih neželenih učinkov zdravila, ki so vplivali na različne organske sisteme in čutila, včasih na več hkrati (vključno z učinki, kot so tendonitis, ruptura kite, artralgija, bolečine v okončinah, težave pri hoji, nevropatije, povezane s parestezijo, depresija, utrujenost, motnje spomina, motnje spanja ter okvara sluha, vida, okusa in vonja) (glejte poglavje 4.4).
English: • Long term prophylaxis of recurrent urinary infections
Slovenian: • Dolgotrajna profilaksa ponavljajočih se okužb sečil
English: • Prevention of systemic urinary tract infections
Slovenian: • Preprečevanje sistemskih okužb sečil
English: • Acute pyelonephritis and complicated urinary tract infections
Slovenian: • Akutni pielonefritis in zapletene okužbe sečil
English: Prulifloxacin Current indications included in product information for prulifloxacin containing products
Slovenian: Prulifloksacin Trenutne indikacije v informacijah o zdravilu za zdravila, ki vsebujejo prulifloksacin
English: • Complicated acute cystitis
Slovenian: • Zapleteni akutni cistitis
English: • Broncho-pulmonary infections due to Pseudomonas aeruginosa in patients with cystic fibrosis
Slovenian: • Bronhopulmonalne okužbe pri bolnikih s cistično fibrozo, ki jih povzroča Pseudomonas aeruginosa
English: • Bacterial prostatitis, epididymoorchitis including cases due to susceptible Neisseria gonorrhoeae
Slovenian: • Bakterijski prostatitis, epididimo-orhitis, vključno s primeri, ki jih povzroča občutljiva Neisseria gonorrhoeae
English: • Prophylaxis of bacterial infections in neutropenic patients
Slovenian: • Profilaksa bakterijskih okužb pri nevtropeničnih bolnikih
English: • Urinary infections o Urinary tract infections o Urinary infection - severe infections caused by gramnegative bacilli and susceptible staphylococci o Urinary tract infections (including prostatitis) o Infections of urinary tract (inclusive of prostatitis)
Slovenian: • Okužbe sečil o Okužbe sečil o Okužbe sečil - hude okužbe, ki jih povzročajo gramnegativni bacili in občutljivi stafilokoki o Okužbe sečil (vključno s prostatitisom) o Okužbe sečil (vključno s prostatitisom)
English: • Acute bacterial sinusitis Otitis media acute
Slovenian: • Akutni bakterijski sinusitis Akutno vnetje srednjega ušesa
English: Very rare cases of prolonged (continuing months or years), disabling and potentially irreversible serious adverse drug reactions affecting different, sometimes multiple, body systems (musculoskeletal, nervous, psychiatric and senses) have been reported in patients receiving quinolones and fluoroquinolones irrespective of their age and pre-existing risk factors.
Slovenian: Pri bolnikih, ki so prejemali kinolone in fluorokinolone, so, neodvisno od njihove starosti in obstoječih dejavnikov tveganja, poročali o zelo redkih primerih dolgotrajnih (več mesecev ali let trajajočih), onesposabljajočih in potencialno ireverzibilnih neželenih učinkov, ki so vplivali na različne organske sisteme, včasih na več hkrati (mišično-skeletni sistem, živčevje, duševno zdravje in čutila).
English: Current indications included in product information for norfloxacin containing products
Slovenian: Trenutne indikacije v informacijah o zdravilu za zdravila, ki vsebujejo norfloksacin
English: • Non-gonococcal urethritis and cervicitis trachomatis o combination therapy for the treatment of cervical infections Gonorrhoea o Gonorrhoea o Gonococcal and non-gonococcal urethritis and cervicitis (complicated or uncomplicated) o Uncomplicated urethral and cervical gonorrhoea.
Slovenian: • Gonoreja o Gonoreja o Gonokokni in negonokokni uretritis in cervicitis (zapleteni ali nezapleteni) o Nezapletena gonoreja sečnice in materničnega vratu.
English: Current indications included in product information for pefloxacin containing products
Slovenian: Trenutne indikacije v informacijah o zdravilu za zdravila, ki vsebujejo pefloksacin
English: Acute exacerbations of chronic obstructive pulmonary disease including chronic bronchitis.
Slovenian: Akutno poslabšanje kronične obstruktivne pljučne bolezni, vključno s kroničnim bronhitisom.
English: • Urinary tract infections o Urinary tract infection o Upper and lower urinary tract infections o Upper and lower urinary tract infections, complicated or not o Infections of the upper and lower urinary tract o Upper and lower, acute and chronic urinary tract infections o Complicated and uncomplicated urinary tract infections (cystitis and pyelonephritis) o Upper and lower urinary tract infections coming from bacteria such as E. coli, K. pneumoniae, Proteus, P. aeruginosa
Slovenian: • Akutni pielonefritis • Zapletene okužbe sečil o Zapletene in nezapletene okužbe sečil (cistitis in pielonefritis) o Okužbe zgornjih in spodnjih sečil zaradi bakterij, kot so E. coli, K. pneumoniae, Proteus, P. aeruginosa
English: • Pyelonephritis and complicated urinary tract infections (see section
Slovenian: • Pielonefritis in zapletene okužbe sečil (glejte poglavje 4.4)
English: • Epididymo-orchitis including cases due to susceptible Neisseria gonorrhoeae
Slovenian: • Epididimo-orhitis, vključno s primeri, ki jih povzroča občutljiva Neisseria gonorrhoeae
English: o Urethritis (XX should only be used if antibacterial treatment considered as first choice of treatment is deemed unfit/inappropriate
Slovenian: • Uretritis (zadnja izbira) o Uretritis (uporablja se lahko samo, če uporaba drugih protibakterijskih zdravil, ki se pogosto priporočajo za začetno zdravljenje teh okužb, ni ustrezna) o Uretritis (zdravilo XX se lahko uporabi samo, če je protibakterijsko zdravljenje, ki je zdravljenje prve izbire, neprimerno/neustrezno)
English: • Pulmonary infections o Pulmonary infections [such as: acute exacerbation of chronic bronchitis, exacerbation of cystic fibrosis, nosocomial pneumonia, pulmonary tuberculosis by resistant mycobacteria, especially in immunocompromised patients (minor anti-tuberculosis medicine)]
Slovenian: • Pljučne okužbe o Pljučne okužbe [kot so: akutno poslabšanje kroničnega bronhitisa, poslabšanje cistične fibroze, nozokomialna pljučnica, pljučna tuberkuloza
English: • Simple uncomplicated acute cystitis
Slovenian: • Nezapleteni akutni cistitis
English: Recommended wording infections caused by gramnegative bacilli and susceptible staphylococci o Infection of respiratory tract (acute exacerbation of chronic bronchitis, exacerbation in cystic fibrosis, nosocomial pneumonia)
Slovenian: • Okužbe dihal o Okužbe dihal o Okužbe dihal - hude okužbe, ki jih povzročajo gramnegativni bacili in občutljivi stafilokoki o Okužbe dihal (akutno poslabšanje kroničnega bronhitisa, poslabšanje cistične fibroze, nozokomialna pljučnica)
English: o Uncomplicated cystitis (XX should only be used if antibacterial treatment considered as first choice of treatment is deemed unfit/inappropriate)
Slovenian: • Nezapleteni cistitis (zadnja izbira) o Nezapleteni cistitis o Nezapleteni cistitis (uporabi se lahko samo, če uporaba drugih protibakterijskih zdravil, ki se pogosto priporočajo za začetno zdravljenje teh okužb, ni ustrezna) o Nezapleteni cistitis (zdravilo XX se lahko uporabi samo, če je protibakterijsko zdravljenje, ki je zdravljenje prve izbire, neprimerno/neustrezno)
English: • Acute exacerbation of chronic obstructive pulmonary disease including chronic bronchitis
Slovenian: • Akutno poslabšanje kronične obstruktivne pljučne bolezni, vključno s kroničnim bronhitisom
English: Very rare cases of long lasting ( up to months or years) or permanent adverse drug reactions, such as tendon inflammations, tendon rupture, joint pain, pain in the limbs, difficulty in walking, abnormal sensations such as pins and needles, tingling, tickling, burning, numbness or pain (neuropathy), depression, fatigue, sleep disorders, memory impairment, as well as impairment of hearing, vision, and taste and smell have been associated with administration of quinolone and fluoroquinolone antibiotics, in some cases irrespective of pre-existing risk factors.
Slovenian: Z uporabo kinolonskih in fluorokinolonskih antibiotikov, v nekaterih primerih ne glede na obstoječe dejavnike tveganja, so povezani zelo redki primeri dolgotrajnih (več mesecev ali let trajajočih) ali trajnih neželenih učinkov, kot so vnetje kit, pretrganje kit, bolečine v sklepih, bolečine v okončinah, težave pri hoji, nenormalna občutenja, kot so mravljinčenje, ščemenje, ščegetanje, žarenje, odrevenelost ali bolečina (nevropatija), depresija, utrujenost, motnje spanja, motnje spomina, pa tudi okvara sluha, vida, okusa in vonja.
English: • Acute exacerbations of chronic obstructive pulmonary disease including chronic bronchitis.
Slovenian: • Akutno poslabšanje kronične obstruktivne pljučne bolezni, vključno s kroničnim bronhitisom.
English: • Urethritis including cases due to susceptible Neisseria gonorrhoeae
Slovenian: • Uretritis, vključno s primeri, ki jih povzroča občutljiva Neisseria gonorrhoeae
English: 1.1.2 Additional deletions of indication(s) for specific quinolones/fluoroquinolones
Slovenian: 1.1.2 Dodatni izbrisi indikacij(e) pri specifičnih kinolonih/fluorokinolonih Dodatno je treba za spodaj navedeno učinkovino izbrisati še naslednje indikacije: Pefloksacin
English: “In [indication] [name of product] should be used only when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the treatment of these infections.”
Slovenian: »[Ime zdravila] se lahko uporablja za [indikacijo] samo, če uporaba drugih protibakterijskih zdravil, ki se običajno priporočajo za zdravljenje teh okužb, ni primerna.«
English: epididymitis and those urinary tract infections associated with urological surgery, neurogenic bladder or nephrolithiasis caused by bacteria susceptible to [name of product]
Slovenian: pielocistitis, pielonefritis, kronični prostatitis, epididimitis in okužbe sečil, povezane z urološko operacijo, nevrogeni mehur ali nefrolitiazo, ki jo povzročajo bakterije, občutljive za [ime zdravila]
English: o Community acquired pneumonia o Community acquired pneumonia (ofloxacin should be used only when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of these infections)
Slovenian: • Zunajbolnišnična okužba s pljučnico (zadnja izbira) o Zunajbolnišnična pljučnica o Zunajbolnišnična pljučnica (ofloksacin se lahko uporablja samo, če uporaba drugih protibakterijskih zdravil, ki se pogosto priporočajo za začetno zdravljenje teh okužb, ni ustrezna)
English: • Acute exacerbations of chronic obstructive pulmonary disease including chronic bronchitis In [indication] [name of product] should be used only when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the treatment of these infections.
Slovenian: • Akutno poslabšanje kronične obstruktivne pljučne bolezni, vključno s kroničnim bronhitisom [Ime zdravila] se lahko uporablja za [indikacijo] samo, če uporaba drugih protibakterijskih zdravil, ki se običajno priporočajo za zdravljenje teh okužb, ni primerna.
English: These infections include cystitis, pyelitis, chronic prostatitis and those urinary infections associated with urological surgery, neurogenic bladder or nephrolithiasis caused by bacteria susceptible to [name of product] o Upper and lower, complicated and uncomplicated, acute and chronic urinary tract infections.
Slovenian: Priporočeno besedilo sečil, povezane z urološko operacijo, nevrogeni mehur ali nefrolitiazo, ki jo povzročajo bakterije, občutljive za [ime zdravila] o Zapletene in nezapletene, akutne in kronične okužbe zgornjih in spodnjih sečil
English: • Urethritis and cervicitis including cases due to susceptible Neisseria gonorrhoeae
Slovenian: • Uretritis in cervicitis, vključno s primeri, ki jih povzroča občutljiva Neisseria gonorrhoeae
English: • Acute exacerbation of chronic obstructive pulmonary disease including bronchitis In [indication] [name of product] should be used only when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the treatment of these infections.
Slovenian: • Akutno poslabšanje kronične obstruktivne pljučne bolezni, vključno z bronhitisom [Ime zdravila] se lahko uporablja za [indikacijo] samo, če uporaba drugih protibakterijskih zdravil, ki se običajno priporočajo za zdravljenje teh okužb, ni primerna.
English: • Abdominal and hepato-biliary infections o Abdominal infections o Abdominal infections - severe infections caused by gramnegative bacilli and susceptible staphylococci o Hepatobiliary infections o Hepatobiliary infection - severe infections caused by gramnegative bacilli and susceptible staphylococci o Infections of bile ducts
Slovenian: • Abdominalne okužbe in okužbe jeter, žolčnika in žolčevodov o Abdominalne okužbe o Abdominalne okužbe - hude okužbe, ki jih povzročajo gramnegativni bacili in občutljivi stafilokoki o Okužbe jeter, žolčnika in žolčevodov o Okužbe jeter, žolčnika in žolčevodov - hude okužbe, ki jih povzročajo gramnegativni bacili in občutljivi stafilokoki o Okužbe žolčevodov
English: • Prophylaxis of frequently repeating infections of urinary tract infections
Slovenian: • Profilaksa pogosto ponavljajočih se okužb sečil
English: • Non-gonococcal urethritis and cervicitis o Non-gonococcal urethritis and cervicitis o Acute non-gonococcal urethritis and cervicitis caused by Chlamydia
Slovenian: • Negonokokni uretritis in cervicitis o Negonokokni uretritis in cervicitis o Akutni negonokokni uretritis in cervicitis, ki ga povzroča Chlamydia trachomatis o Kombinirana terapija za zdravljenje okužb materničnega vratu
English: Ofloxacin Current indications in product information of ofloxacin containing products
Slovenian: Trenutne indikacije v informacijah o zdravilu za zdravila, ki vsebujejo ofloksacin
English: • Complicated urinary tract infections and pyelonephritis
Slovenian: • Zapletene okužbe sečil in pielonefritis
English: • Complicated infections of lower urinary tract
Slovenian: • Zapletene okužbe spodnjih sečil
English: • Gonococcal urethritis and cervicitis including cases due to susceptible Neisseria gonorrhoeae
Slovenian: • Gonokokni uretritis in cervicitis, vključno s primeri, ki jih povzroča občutljiva Neisseria gonorrhoeae
English: These infections include: cystitis, pyelitis, chronic prostatitis and infections related to urological surgical procedures, neurogenic bladder or nephrolithiasis (except acute and chronic complicated pyelonephritis) caused by bacteria sensitive to norfloxacin o Upper and lower, complicated and uncomplicated, acute and chronic urinary tract infections.
Slovenian: kronični prostatitis in okužbe, povezane z urološkimi kirurškimi postopki, nevrogeni mehur ali nefrolitiazo (razen akutnega in kroničnega zapletenega pielonefritisa), ki jih povzročajo bakterije,
English: • Prophylaxis of systemic urinary tract infections
Slovenian: • Profilaksa sistemskih okužb sečil
English: Current category indications included in product information for rufloxacin containing products
Slovenian: Trenutne kategorije indikacij v informacijah o zdravilu za zdravila, ki vsebujejo rufloksacin
English: • Complicated intra-abdmonial infections o intra-abdominal infection o intra-abdominal and bile-ducts infections o Infections of abdominal cavity, including pelvic area o Abdominal cavity infections including of the pelvic bone o Infections of the abdomen and the lesser pelvis
Slovenian: • Abdominalna okužba in okužba jeter, žolčnika in žolčevodov o Abdominalna okužba in okužba jeter, žolčnika in žolčevodov o Intraabdominalna okužba o Intraabdominalne okužbe in okužbe žolčevodov o Okužbe trebušne votline, vključno z medeničnim predelom o Okužbe trebušne votline, vključno z medenično kostjo o Okužbe trebuha in majhne medenice
English: • Complicated urinary tract infections
Slovenian: • Zapletene intraabdominalne okužbe
English: o gonococcal urethritis without signs of pelvic dissemination, in men o cervical gonorrhoea without signs of pelvic
Slovenian: o Gonokokni uretritis brez znakov širjenja v medenici, pri moških o Gonoreja materničnega vratu brez znakov širjenja v medenici o Gonoreja sečnice in materničnega vratu o Gonoreja (uretritis in cervicitis)
English: • Acute bacterial sinusitis In [indication] [name of product] should be used only when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the treatment of these infections.
Slovenian: • Akutni bakterijski sinusitis [Ime zdravila] se lahko uporablja za [indikacijo] samo, če uporaba drugih protibakterijskih zdravil, ki se običajno priporočajo za zdravljenje teh okužb, ni primerna.
English: • Simple uncomplicated cystitis.
Slovenian: • Nezapleteni cistitis.
English: • Pelvic inflammatory disease including cases due to susceptible Neisseria gonorrhoeae
Slovenian: • Medenična vnetna bolezen, vključno s primeri, ki jih povzroča občutljiva Neisseria gonorrhoeae
English: In [indication] [name of product] should be used only when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the treatment of these infections.
Slovenian: [Ime zdravila] se lahko uporablja za [indikacijo] samo, če uporaba drugih protibakterijskih zdravil, ki se običajno priporočajo za zdravljenje teh okužb, ni primerna.
English: • Gonoccocal urethritis and cervicitis due to susceptible Neisseria gonorrhoea
Slovenian: • Gonokokni uretritis in cervicitis, ki jih povzroča občutljiva Neisseria gonorrhoea
English: • Urethritis
Slovenian: • Klamidija
English: • Gonococcal urethritis and cervicitis due to susceptible Neisseria gonorrhoeae
Slovenian: • Gonokokni uretritis in cervicitis, ki ju povzroča občutljiva Neisseria gonorrhoeae
English: In [indication] [name of product] should be used only when it is considered inappropriate to use antibacterial agents that are commonly recommended for the treatment of these infections.
Slovenian: [Ime zdravila] se lahko uporablja za [indikacijo] samo, če uporaba protibakterijskih zdravil, ki se običajno priporočajo za zdravljenje teh okužb, ni primerna.
English: • Uncomplicated acute cystitis In [indication] [name of product] should be used only when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the treatment of these infections.
Slovenian: • Nezapleteni akutni cistitis [Ime zdravila] se lahko uporablja za [indikacijo] samo, če uporaba drugih protibakterijskih zdravil, ki se običajno priporočajo za zdravljenje teh okužb, ni primerna.
English: • Acute otitis media In [indication] [name of product] should be used only when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the treatment of these infections.
Slovenian: • Akutno vnetje srednjega ušesa [Ime zdravila] se lahko uporablja za [indikacijo] samo, če uporaba drugih protibakterijskih zdravil, ki se običajno priporočajo za zdravljenje teh okužb, ni primerna.
English: Chlamydia
Slovenian: Rufloksacin
English: • Community-acquired pneumonia In [indication] [name of product] should be used only when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the treatment of these infections.
Slovenian: • Nezapleteni cistitis [Ime zdravila] se lahko uporablja za [indikacijo] samo, če uporaba drugih protibakterijskih zdravil, ki se običajno priporočajo za zdravljenje teh okužb, ni primerna.
English: This summary was last updated in 08-2017.
Slovenian: Povzetek je bil nazadnje posodobljen 08-2017.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Gazyvaro on 23 July 2014.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Gazyvaro, veljavno po vsej Evropski uniji, izdala 23. julija 2014.