FrancophonIA/ELRC3.0 huggingface dataset:
English: MARKETING AUTHORISATION NUMBERS EU/1/11/729/002 (28 tablets)
Slovenian: ŠTEVILKE DOVOLJENJ ZA PROMET Z ZDRAVILOM EU/1/11/729/002 (28 tablet)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER LABEL ON MULTIPACKS OF 360 (4 PACKS OF 90 x 1 TABLETS) BUNDLEDINCLUDING THE BLUE BOX - 80 mg/5 mg
Slovenian: ZUNANJE OZNAČEVANJE PRI SKUPINSKEM PAKIRANJU PO 360 TABLET (4 PAKIRANJA PO 90 x 1 TABLETO) - Z MODRIM OKENCEM - 80 mg/5 mg
English: Blue and white oval shaped two layer tablets engraved with the product code A1 and the company logo on the other side.
Slovenian: Modra in bela dvoslojna tableta ovalne oblike z oznako A1 na eni strani in znak podjetja na drugi strani.
English: Activated charcoal may be useful in the treatment of overdose of both telmisartan and amlodipine.
Slovenian: Po zaužitju prevelikega odmerka telmisartana in amlodipina je lahko koristno dajanje aktivnega oglja.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/729/005 (28 tablets)
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/11/729/005 (28 tablet)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/729/003 (28 tablets)
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/11/729/003 (28 tablet)
English: What Onduarp looks like and contents of the pack Onduarp 80 mg/5 mg tablets are blue and white oval shaped two layer tablets engraved with the product code A3 and the company logo on the other side.
Slovenian: Tablete Onduarp po 80 mg/5 mg so modre in bele dvoslojne tablete ovalne oblike z oznako A3 na eni strani in znak podjetja na drugi strani.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/729/001 (28 tablets)
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/11/729/001 (28 tablet)
English: Blue and white oval shaped two layer tablets engraved with the product code A3 and the company logo on the other side.
Slovenian: Modra in bela dvoslojna tableta ovalne oblike z oznako A3 na eni strani in znak podjetja na drugi strani.
English: What Onduarp looks like and contents of the pack Onduarp 80 mg/10 mg tablets are blue and white oval shaped two layer tablets engraved with the product code A4 and the company logo on the other side.
Slovenian: Tablete Onduarp po 80 mg/10 mg so modre in bele dvoslojne tablete ovalne oblike z oznako A4 na eni strani in znak podjetja na drugi strani.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/729/002 (28 tablets)
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/11/729/002 (28 tablet)
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 40 mg telmisartan and 5 mg amlodipine (as amlodipine besilate).
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena tableta vsebuje 40 mg telmisartana in 5 mg amlodipina (v obliki amlodipinijevega besilata).
English: Blue and white oval shaped two layer tablets engraved with the product code A4 and the company logo on the other side.
Slovenian: Modra in bela dvoslojna tableta ovalne oblike z oznako A4 na eni strani in znak podjetja na drugi strani.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 40 mg telmisartan and 10 mg amlodipine (as amlodipine besilate).
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena tableta vsebuje 40 mg telmisartana in 10 mg amlodipina (v obliki amlodipinijevega besilata).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 80 mg telmisartan and 5 mg amlodipine (as amlodipine besilate).
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena tableta vsebuje 80 mg telmisartana in 5 mg amlodipina (v obliki amlodipinijevega besilata).
English: Renal impairment including acute renal failure General disorders and administration site conditions Rare:
Slovenian: Ušesne bolezni, vključno z motnjami labirinta Občasni:
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 80 mg telmisartan and 10 mg amlodipine (as amlodipine besilate).
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena tableta vsebuje 80 mg telmisartana in 10 mg amlodipina (v obliki amlodipinijevega besilata).
English: This study population is considered representative of the patients in the EU.
Slovenian: Populacija študije se šteje za reprezentativno za bolnike v EU.
English: Therefore, these results do not provide robust evidence of efficacy.
Slovenian: Zato ti rezultati ne zagotavljajo robustnih dokazov učinkovitosti.
English: This study did not raise any concern in terms of safety.
Slovenian: Študija ni vzbudila zadržkov v zvezi z varnostjo.
English: To be used in dental offices only by dental professionals.'
Slovenian: Uporabljajo ga lahko le zobozdravniki v zobozdravniških ordinacijah.“
English: The study population consisted of 983 adults ranging in age from 18 and 80 years and with a mean age of 43 years.
Slovenian: Populacija študije je obsegala 983 odraslih oseb, starih od 18 do 80 let, s povprečno starostjo 43 let.
English: The following indication was agreed by the CHMP:
Slovenian: CHMP je potrdil naslednjo indikacijo:
English: The positive results seen in this study relate only in the female subgroup which was not based on a pre-defined subgroup analysis but a post-hoc analysis.
Slovenian: Pozitivni rezultati v tej študiji se nanašajo samo na žensko podskupino, ki ni temeljila na vnaprej opredeljeni analizi podskupin, ampak na post-hoc analizi.
English: Prevention of Adult Caries Study (PACS)
Slovenian: Študija preprečevanja kariesa pri odraslih (PACS)
English: Although the results may not be statistically significant, there was no evidence of an interaction, and thus there are sufficient statistical evidence to grant an indication for all surfaces in the high-risk population, and not just root surfaces.
Slovenian: Čeprav rezultati morda niso statistično pomembni, ni bilo dokazov o interakciji, zato je dovolj statističnih dokazov, da se odobri indikacija za vse površine v populaciji z visokim tveganjem, ne le za površine korenin.
English: The objecting Member State was of the view that the evidence provided was not considered compelling enough even in the high-risk adult population.
Slovenian: Ugovarjajoča država članica je menila, da se predloženi dokazi tudi pri odraslih z velikim tveganjem ne štejejo za dovolj pomembne.
English: It is intended to be applied to the surface of permanent teeth in four weekly applications in the first month of treatment, followed by a single application at month six.
Slovenian: Zdravilo se nanaša na površino trajnih zob vsake štiri tedne v prvem mesecu zdravljenja in nato še enkrat v šestem mesecu.
English: Overall summary of the scientific evaluation of Prevora
Slovenian: Splošni povzetek znanstvenega vrednotenja zdravila Prevora
English: Therefore, when considered in addition to the previously submitted data, there is now sufficient evidence to conclude that the risk-benefit is positive in the proposed indication.
Slovenian: Zato je zdaj ob upoštevanju predhodno predloženih podatkov dovolj dokazov za zaključek, da je razmerje med koristmi in tveganji za predlagano indikacijo pozitivno.
English: The two clinical studies initially submitted by the MAH to support the proposed indication were:
Slovenian: Klinični študiji, ki ju je imetnik dovoljenja za promet z zdravilom prvotno predložil za podporo predlagani indikaciji, sta bili:
English: The MAH, CHX Technologies Europe Ltd submitted to CHMP for consideration the results of another study, the Prevention of Adult Caries Study (PACS), to confirm the results seen to date.
Slovenian: Imetnik dovoljenja za promet z zdravilom, družba CHX Technologies Europe Ltd, je CHMP v presojo predložila rezultate druge študije, študije preprečevanja kariesa pri odraslih (Prevention of Adult Caries Study, PACS), da bi potrdili do zdaj zbrane rezultate.
English: The significance of this preventive effect increases for high risk participants, for both all tooth surfaces and for coronal surfaces.
Slovenian: Pomen tega preventivnega učinka se povečuje pri preiskovancih z velikim tveganjem, tako za vse zobne površine kot za površine krone.
English: It was concluded that the indication in patients at high-risk should be maintained and that the result seen with coronal surfaces should also be reflected.
Slovenian: Zaključili so, da je treba indikacijo pri bolnikih z visokim tveganjem ohraniti in da je treba upoštevati rezultat za površine krone.
English: • and scientific discussion within the Committee the CHMP has recommended the granting of the marketing authorisation for which the summary of product characteristics and package leaflet are set out in Annex III for Prevora
Slovenian: • in znanstvene razprave znotraj Odbora je CHMP priporočil odobritev dovoljenja za promet z zdravilom Prevora, katerega povzetek glavnih značilnosti zdravila in navodilo za uporabo sta navedena v Dodatku III.
English: However, when the result in high-risk patients is considered, a significant difference is seen between active and placebo.
Slovenian: Če pa se upošteva rezultat pri bolnikih z visokim tveganjem, je vidna pomembna razlika med zdravilno učinkovino in placebom.
English: Therefore, Prevora appears to have a negative effect, resulting in more cavities in the at lowrisk population.
Slovenian: Zato je videti, da ima zdravilo Prevora negativen učinek, kar povzroči več kavitet v populaciji z majhnim tveganjem.
English: The pivotal study included a total of 79 subjects on active.
Slovenian: V ključno študijo je bilo vključenih skupno 79 preiskovancev.
English: In addition, the new trial also suggests a benefit for coronal surfaces, and no apparent differences between root and coronal surfaces.
Slovenian: Poleg tega novo preskušanje nakazuje tudi koristi za površine krone ter nobene jasne razlike med površinami korenine in krone.
English: Dental caries is a bacterial based chronic disease.
Slovenian: Zobna gniloba je kronična bolezen, ki jo povzročajo bakterije.
English: When risk (as measured by the number of cavities at screening) is added to the ANOVA model to account for the bimodal distribution of disease in this study population at both screening and during the study, an overall clinical effect of 36.8% at p = 0.04 is observed.
Slovenian: Če se tveganje (izmerjeno s številom kavitet v fazi presejanja) doda v model ANOVA, da se upošteva bimodalna porazdelitev bolezni v populaciji te študije v fazi presejanja in med študijo, ugotovimo skupni klinični učinek 36,8 odstotka z vrednostjo p = 0,04.
English: Benefit-risk assessment
Slovenian: Ocena koristi in tveganj
English: A 24.5% reduction for all tooth surfaces (root plus coronal surfaces) was seen with a p-value of 0.0322 [95% confidence interval (CI) of 0.62 - 0.98].
Slovenian: Ugotovili so 24,5-odstotno zmanjšanje na vseh zobnih površinah (površine korenine in krone) z vrednostjo p 0,0322 [95-odstotni interval zaupanja (IZ): 0,62-0,98].
English: There is no evidence of a difference in the point estimates for coronal and all surfaces which suggest that the results for root surfaces should be of a similar magnitude.
Slovenian: Ni dokazov o razliki med točkovnimi ocenami za površine krone in vse površine, kar nakazuje, da bi morali biti rezultati za površine korenine enakega reda velikosti.
English: Clinical Study #002 (Dundee Adolescent Study)
Slovenian: Klinična študija št. 2 (študija pri mladostnikih, Dundee)
English: SCIENTIFIC CONCLUSIONS AND GROUNDS FOR POSITIVE OPINION AND AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EUROPEAN MEDICINES AGENCY
Slovenian: PRILOGA II ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA POZITIVNO MNENJE IN DOPOLNITEV POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJA IN NAVODILA ZA UPORABO, KI JIH JE PREDSTAVILA EVROPSKA AGENCIJA ZA ZDRAVILA
English: This is a Phase III, multi-centre, placebo-controlled, double-blinded, prospective study.
Slovenian: Ta študija je multicentrična, s placebom nadzorovana, dvojno slepa, prospektivna študija III. faze.
English: The primary endpoint was the number of new cavities (coronal plus root surfaces) per participant, as measured at the end-of-study visit.
Slovenian: Primarni cilj študije je bilo število novih kavitet (na površinah krone in korenine) na preiskovanca, izmerjeno ob zadnjem kontrolnem obisku v študiji.
English: A double-blind, randomised, multi-centred, controlled trial conducted in adults at risk of dental caries.
Slovenian: Dvojno slepo, randomizirano, multicentrično, kontrolirano preskušanje pri odraslih s tveganjem zobne gnilobe.
English: The medicinal product, Prevora 100 mg/ml is a 10% w/v chlorhexidine dental solution indicated to reduce dental caries in permanent teeth of adolescents and adults.
Slovenian: Zdravilo Prevora 100 mg/ml je 10-odstotna (w/v) dentalna raztopina klorheksidina, ki se uporablja za zmanjšanje zobne gnilobe na stalnih zobeh mladostnikov in odraslih.
English: These were patients between the ages of 11 and 13 years with evidence of past or current caries experience and elevated levels of salivary Streptococcus mutants.
Slovenian: To so bili bolniki, stari od 11 do 13 let, z dokazano zobno gnilobo v preteklosti ali v času preskušanja ter zvišanimi ravnmi Streptococcus mutants v slini.
English: The CHMP assessing the apparent “reverse” treatment effect for at low-risk population explained this issue by the relative absence of high risk participants (those with 3+ cavities at screening) in the placebo groups where as the high-risk population (at risk population) had a higher baseline rate of cavities.
Slovenian: CHMP je po vrednotenju navideznega „nasprotnega“ učinka zdravljenja v populaciji z majhnim tveganjem to vprašanje razložil z relativno odsotnostjo preiskovancev z visokim tveganjem (osebe s tremi kavitetami ali več v fazi presejanja) v skupini, ki je prejemala placebo, medtem ko je imela populacija z velikim tveganjem (populacija s tveganjem) višjo izhodiščno stopnjo kavitet.
English: ‘Prevora 100mg/ml Dental Solution is an antiseptic solution which is applied topically to the dentition of patients for the prevention of coronal and root caries in adult patients at high-risk of dental caries (e.g. xerostomia sufferers or those with 3 or more caries at the start of the treatment plan).
Slovenian: „Zdravilo Prevora 100 mg/ml dentalna raztopina je antiseptična raztopina, ki se nanese topično na zobovje bolnikov za preprečevanje zobne gnilobe na kroni in koreninah pri odraslih bolnikih z visokim tveganjem zobne gnilobe (npr. bolniki s kserostomijo ali 3 ali več karioznimi lezijami na začetku načrta zdravljenja).
English: It consists of a chlorhexidine coating solution (Stage 1) and an inert sealant coating (Stage 2) which is applied after the application of the chlorhexidine solution.
Slovenian: Sestavlja ga raztopina klorheksidina za oblogo (1. stopnja) in inertna tesnilna obloga (2. stopnja), ki se nanese po nanosu raztopine klorheksidina.
English: A 3-year randomised double-blind trial in at-risk adolescent patients to evaluate the efficacy and safety of Prevora 100mg/ml Dental Solution in reducing caries increment.
Slovenian: Triletno randomizirano, dvojno slepo preskušanje pri mladostnikih s tveganjem za razvoj bolezni, s katerim so ocenjevali učinkovitost in varnost zdravila Prevora 100 mg/ml dentalna raztopina pri zmanjševanju napredovanja zobne gnilobe.
English: The results were considered not compelling enough due to the unsupportive nature of the adolescent study (below).
Slovenian: Rezultati se niso šteli za dovolj pomembne, ker študija na mladostnikih ne podpira zdravila (v nadaljevanju).
English: The study enrolled 983 at-risk adults and the study objectives were: determine the efficacy of Prevora in reducing cavities in at-risk adults, evaluate its safety, and evaluate the emergence if any, of chlorhexidineresistant Streptococcus mutans post treatment in study participants, and the emergence, if any, of opportunistic infections in the form of Candida albicans post treatment in study participants.
Slovenian: V študijo so vključili 983 odraslih oseb s tveganjem za razvoj bolezni, cilji študije pa so bili: ugotoviti učinkovitost zdravila Prevora pri zmanjševanju kavitet pri odraslih osebah s tveganjem za razvoj bolezni, oceniti njegovo varnost ter oceniti morebiten pojav Streptococcus mutans, odpornega proti klorheksidinu, pri preiskovancih po zdravljenju in oportunističnih okužb s Candida albicans pri preiskovancih po zdravljenju.
English: The secondary endpoints were new coronal cavities and root cavities per participant.
Slovenian: Sekundarna cilja študije sta bila nove kavitete na kroni in korenini na preiskovanca.
English: Clinical Study #001 (Adult Xerostomia Study)
Slovenian: Klinična študija št. 1 (študija kserostomije pri odraslih)
English: This study was submitted as supportive data since it was a failed study, as no significant difference was found between placebo and Prevora as measured by the primary outcome variable.
Slovenian: Ta študija je bila predložena kot podporni podatek, ker ni bila uspešna, saj z merjenjem s spremenljivko primarnega izida niso ugotovili pomembne razlike med placebom in zdravilom Prevora.
English: The PACS study failed on the primary endpoint as there was no difference between active and placebo in the number of caries per patient.
Slovenian: Študija PACS je bila neuspešna glede primarnega cilja, saj ni bilo razlike med zdravilno učinkovino in placebom pri obsegu zobne gnilobe na bolnika.
English: The product is a topical two-stage chlorhexidine solution.
Slovenian: Zdravilo je topična dvostopenjska raztopina klorheksidina.
English: For root surfaces, a 40.8% reduction with a p-value 0.0206 (95% CI of 0.23 - 0.78) and for coronal surfaces, no significant difference was seen between placebo and Prevora (p-value
Slovenian: Na površinah korenine so ugotovili 40,8-odstotno zmanjšanje z vrednostjo p 0,0206 [95-odstotni interval zaupanja (IZ): 0,23-0,78], na površinah krone pa ni bilo pomembne razlike med placebom in zdravilom Prevora (vrednost p 0,0644).
English: Subsequent applications being based upon clinical judgment of caries risk by the dental professional.
Slovenian: O nadaljnjih nanosih presodi zobozdravnik glede na klinični pregled tveganja zobne gnilobe.
English: Furthermore, it was agreed that the product information should also be amended to reflect that no significant resistance to Streptococcus mutans or opportunistic infections with Candida albicans were observed after treatment with Prevora over one year in adult patients.
Slovenian: Poleg tega je bilo dogovorjeno, da se informacije o zdravilu spremenijo tako, da vsebujejo podatek, da v enem letu po zdravljenju z zdravilom Prevora pri odraslih bolnikih niso opazili pomembne odpornosti proti Streptococcus mutans ali oportunističnih okužb s Candida albicans.
English: Grounds for positive opinion and amendment of the summary of product characteristics and package leaflet
Slovenian: Podlaga za pozitivno mnenje in dopolnilo povzetka glavnih značilnosti zdravila in navodila za uporabo
English: in high risk patients;
Slovenian: zlasti rezultata študije PACS pri bolnikih z visokim tveganjem,
English: Prevora has been evaluated in two randomised, double-blinded, placebo-controlled clinical trials (RCTs) conducted according to GCP.
Slovenian: Zdravilo Prevora so ocenili v dveh randomiziranih, dvojno slepih, s placebom nadzorovanih kliničnih preskušanjih, izvedenih skladno z dobro klinično prakso.
English: As defined by the primary endpoint, this study showed no significant difference between active and placebo.
Slovenian: Glede na primarni cilj študija ni pokazala pomembne razlike med zdravilno učinkovino in placebom.
English: Considering the resistant and opportunistic infections, this study showed no significant resistance to Streptococcus mutans or opportunistic infections with Candida albicans after treatment with Prevora over one year in adult patients.
Slovenian: V študiji so v zvezi z odpornimi in oportunističnimi okužbami dokazali, da v enem letu po zdravljenju z zdravilom Prevora pri odraslih bolnikih ni bilo pomembne odpornosti proti Streptococcus mutans ali oportunističnih okužb s Candida albicans.
English: • the assessment of all available data submitted by the MAH in particular the result from the PACS
Slovenian: • vrednotenja razpoložljivih podatkov, ki jih je predložil imetnik dovoljenja za promet z zdravilom,
English: The comparison of caries increment was active versus placebo.
Slovenian: Opravili so primerjavo napredovanja zobne gnilobe pri uporabnikih zdravilne učinkovine in uporabnikih placeba.
English: In its letter notifying the Agency of the withdrawal of the application, the company stated that the withdrawal was due to initial concerns expressed by the CAT that the data from the main study would not be sufficient to support the approval of the medicine.
Slovenian: Družba je v dopisu, s katerim je agencijo obvestila o umiku vloge, navedla, da je umik posledica začetnih zadržkov, ki jih je izrazil odbor CAT, da podatki iz glavne študije ne bodo zadoščali za podporo odobritvi zdravila.
English: On 10 July 2018, FGK Representative Service GmbH officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Raligize, for the treatment of cancer of the cervix (the neck of the womb).
Slovenian: Podjetje FGK Representative Service GmbH je 10. julija 2018 uradno obvestilo Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Raligize, namenjenim zdravljenju raka cerviksa (materničnega vratu).
English: The company provided data from one main study involving 50 women with advanced cervical cancer, including cancer that had come back after other treatment or had spread elsewhere in the body.
Slovenian: Družba je predložila podatke iz glavne študije, ki je vključevala 50 žensk z napredovalim rakom materničnega vratu, vključno z rakom, ki se je po zdravljenju z drugim zdravilom ponovil ali se je razširil drugam po telesu.
English: As the CAT was still evaluating the initial documentation provided by the company on behalf of the CHMP, it had not yet made any recommendations.
Slovenian: Ker je odbor CAT v imenu odbora CHMP še vedno ocenjeval začetno dokumentacijo, ki jo je predložila družba, še ni podal nobenih priporočil.
English: The application was withdrawn while the CAT was still evaluating the initial documentation provided by the company.
Slovenian: Vlogo so umaknili, ko je odbor CAT še vedno ocenjeval začetno dokumentacijo, ki jo je predložila družba.
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials using Raligize.
Slovenian: Družba je odbor CHMP obvestila, da umik nima nobenih posledic za bolnike, ki trenutno sodelujejo v kliničnih preskušanjih zdravila Raligize.
English: Results of treatment with Raligize were compared with results previously seen in similar women given other treatments for cervical cancer.
Slovenian: Rezultate zdravljenja z zdravilom Raligize so primerjali z rezultati, ki so jih predhodno opazili pri ženskah s podobnimi značilnostmi, ki so prejemale druga zdravila za zdravljenje raka materničnega vratu.
English: It was to be available as a concentrate for making up an infusion (drip) to be given into a vein.
Slovenian: Na voljo naj bi bilo v obliki koncentrata za pripravo infuzije (kapalne infuzije) za dajanje v veno.
English: Because Raligize is an advanced therapy medicine, it was assessed on behalf of the CHMP by the Committee for Advanced Therapies (CAT).
Slovenian: Zdravilo Raligize je zdravilo za napredno zdravljenje, zato ga je v imenu odbora CHMP ocenjeval Odbor za napredno zdravljenje (CAT).
English: Raligize was developed as a type of advanced therapy medicine called a ‘gene therapy product'.
Slovenian: Zdravilo Raligize je bilo razvito kot vrsta zdravila za napredno zdravljenje, ki se imenuje „zdravilo za gensko zdravljenje“.
English: What is Raligize?
Slovenian: Kaj je zdravilo Raligize?
English: Raligize is a cancer medicine containing the active substance axalimogene filolisbac.
Slovenian: Raligize je zdravilo za zdravljenje raka, ki vsebuje učinkovino aksalimogen filolisbak.