FrancophonIA/ELRC3.0 huggingface dataset:
English: The added value of retesting for this feature in inactivated viral vaccines is extremely small.
Slovenian: Dodana vrednost ponovnega testiranja zaradi tega pojava v inaktiviranih virusnih cepivih je izredno majhna.
English: Foot and Mouth virus is virtually exotic to Western Europe and Bluetongue, although of a recent change in status, is not ubiquitous or endemic in the majority of the EU, so for these 2 agents the practical risks should be lower.
Slovenian: Virus slinavke in parkljevke je za zahodno Evropo skorajda eksotičen, bolezen modrikastega jezika pa kljub nedavnim spremembam v statusu ni vseprisotna ali endemična v večini EU, tako da bi moralo biti praktično tveganje v primeru teh dveh snovi nižje.
English: Intervet International Podruznica
Slovenian: Intervet International Podružnica
English: The extra testing (which requires the use of animals) would therefore be a disproportionate measure when balanced against the positive effects which can be obtained for this vaccine.
Slovenian: Dodatno testiranje (kjer je treba uporabiti živali) bi bilo tako nesorazmeren ukrep, če bi ga primerjali s pozitivnimi učinki, ki bi jih lahko imelo to cepivo.
English: ES-37080 Salamanca Spain
Slovenian: ES-37080 Salamanca Španija
English: Based on the current requirements and the relevant safeguards (e.g., GMP) the CVMP concludes that the Applicant has taken adequate measures to guarantee the quality and safety of Bovilis BVD.
Slovenian: Na osnovi trenutnih zahtev in ustreznih zaščitnih ukrepov (npr. DPP - dobra proizvodna praksa), je CVMP zaključil, da je vlagatelj izvedel ustrezne ukrepe, s katerimi lahko zagotavlja kakovost in varnost zdravila Bovilis BVD.
English: Consequently Germany notified the EMEA, on 31 October 2006, that the CMD(v) failed to reach an agreement regarding Bovilis BVD.
Slovenian: Dne 31. oktobra je Nemčija obvestila agencijo EMEA, da CMD(v) ni uspel doseči soglasja glede zdravila Bovilis BVD.
English: The CMD(v) could not reach an agreement by day 60 of this procedure, as to where Denmark maintained their concerns.
Slovenian: CMD(v) do 60. dne tega postopka ni mogel doseči soglasja glede dejstva, ker je imela Danska še vedno iste zadržke.
English: Bovilis BVD was first authorised in Germany on 6 May 1998 (as Bovilis BVD-MD).
Slovenian: Zdravilo Bovilis BVD je bilo najprej odobreno v Nemčiji dne 6. maja 1998 (pod imenom Bovilis BVD-MD).
English: The probability that any such contamination would be identified in the test proposed by the Danish Medicines Agency is even smaller.
Slovenian: Možnost, da bi s testi lahko odkrili tako kontaminacijo, kot je predlagala Danska agencija za zdravila, je še manjša.
English: Wybrzeze Gdynskie 6c PL-01-531 Warszawa Poland
Slovenian: Wybrzeze Gdynskie 6c PL-01-531 Warszawa Poljska
English: DE-85716 Unterschleissheim Germany
Slovenian: DE-85716 Unterschleissheim Nemčija
English: At day 90 of the MRP, 2 August 2006, Denmark could not agree to the granting of a marketing authorization as they considered the product to present a potential serious risk for animal health.
Slovenian: Na 90. dan postopka medsebojnega priznavanja, dne 2. avgusta 2006, Danska ni mogla privoliti v odobritev dovoljenja za promet, ker je zdravilo štela za morebitno nevarno za zdravje živali.
English: 3, Paparigopoulou Street GR-152 32 Halandri Athens Greece
Slovenian: 3, Paparigopoulou Street GR-152 32 Halandri Athens Grčija
English: Intervet Portuguesa Ltd. Estrada Nacional 249, Km 14,2 PT-2725-397 Mem Martins Codes
Slovenian: Portugalska Intervet Portuguesa Ltd. Estrada Nacional 249, Km 14,2 PT-2725-397 Mem Martins Codes
English: The Marketing Authorisation Holder should provide all supporting data to justify a positive benefit-risk ratio for the treated animal.
Slovenian: Imetnik dovoljenja za promet z zdravilom bi moral priskrbeti vse podatke, ki govorijo v prid pozitivnemu razmerju med koristmi in tveganji pri zdravljenih živalih.
English: The matter was referred to the Co-ordination Group for Mutual Recognition and Decentralised Procedures, CMD(v), for a 60 day procedure in accordance with Article 33(1) of Directive 2001/82/EC, as amended.
Slovenian: Zadeva je bila posredovana koordinacijski skupini za medsebojno priznavanje in decentralizirane postopke, CMD(v), v 60 dni dolg postopek v skladu s členom 33(1) Direktive 2001/82/ES z vsemi spremembami.
English: With regard to the potential benefit or otherwise from conducting additional tests, it is known that the efficiency of final batch testing in revealing defects is highly variable, depending on the type of defect, and that it is preferable to build quality into the whole process rather than rely on end product testing.
Slovenian: Kar se tiče morebitnih koristi in ostalega glede izvajanja dodatnih testov pa je znano, da je učinkovitost testiranja končnih serij z namenom odkrivanja okvar zelo spremenljiva in odvisna od vrste okvar in da je bolje napraviti kakovost za sestavni del celotnega postopka, kot pa se zanašati na testiranje končnega proizvoda.
English: Intervet Bulgaria EOOD 7, Iskarsko shoes blvd BG-1528 Sofia Bulgaria
Slovenian: Intervet Bulgaria EOOD 7, Iskarsko shoes blvd BG-1528 Sofia Bolgarija
English: FR-49071 Beaucouzé Cedex France
Slovenian: FR-49071 Beaucouzé Cedex Francija
English: 50 ELISA units, inducing ≥ 4.6 log2 VN units
Slovenian: 50 enot ELISA, vključno z ≥ 4.6 log2 enot NT
English: Member State Applicant or Marketing Authorisation Holder
Slovenian: Vlagatelj ali imetnik dovoljenja za promet z zdravilom
English: Considering all the measures taken, it is very unlikely that any contamination of Bovilis BVD could firstly occur, and secondly that such contamination would eventually lead to seroconversion, even in a small number of vaccinated animals.
Slovenian: Glede na vsa privzeta merila je zelo malo verjetno, da bi najprej prišlo do kontaminacije zdravila Bovilis BVD in da bi nato taka kontaminacija nazadnje privedla do serokonverzije, celo pri majhnem številu cepljenih živali.
English: There are many years of experience with the use of this vaccine, and there are no known adverse reactions associated with the vaccine.
Slovenian: Kljub mnogoletnim izkušnjam z uporabo tega cepiva ni znanih neželenih učinkov, ki bi jih povezovali s tem cepivom.
English: As the likelihood of contamination of Bovilis BVD vaccine, and the subsequent probability of seroconversion by such contaminants is extremely low, the advantage of additional final product testing for extraneous agents (serological method) is considered to be negligible.
Slovenian: Ker je verjetnost kontaminacije cepiva Bovilis BVD in posledična verjetnost serokonverzije zaradi takih kontaminantov izjemno nizka, se štejejo koristi dodatnega testiranja končnih proizvodov na prisotnost tujih snovi (serološka metoda) za zanemarljive.
English: The CVMP has concluded that the risk/benefit for Bovilis BVD is favourable.
Slovenian: CVMP je zaključil, da je razmerje med koristmi in tveganji za zdravilo Bovilis BVD ugodno.
English: Therefore the Danish testing requirement is considered to be unjustified.
Slovenian: Zaradi tega šteje Odbor zahtevo Danske glede dodatnih testiranj za neutemeljeno.
English: Luxembourg Intervet Belgium Bedrijvenlaan 7
Slovenian: Luksemburg Intervet Belgium Bedrijvenlaan 7
English: The risk of accidental contamination with FMDV, IBRV, BLV and BTV is concluded to be low; consequently the risk of seroconversion against the listed agents is also concluded to be low.
Slovenian: Tveganje za nenamerno kontaminacijo s FMDV, IBRV, BLV in BTV je bilo ocenjeno kot nizko; posledično se sklepa, da je tveganje serokonverzije v prisotnosti navedenih snovi prav tako nizko.
English: Belgium Intervet Belgium Bedrijvenlaan 7
Slovenian: Intervet Belgium Bedrijvenlaan 7
English: Denmark considers that the proposed testing regime to demonstrate freedom from extraneous agents is insufficient to ensure that Bovilis BVD would not interfere with their national eradication campaigns for certain animal diseases and that therefore the benefit: risk assessment for Bovilis BVD is negative and authorisation of the product would represent a potential serious risk to animal health.
Slovenian: Danska je bila mnenja, da predlagan režim testiranj za dokazovanje odsotnosti tujih snovi ne zadostuje za zagotavljanje, da zdravilo Bovilis BVD ne bo motilo njenih nacionalnih eradikacijskih programov proti določenim živalskim boleznim, zaradi česar je bila ocena razmerja med koristmi in tveganji v primeru zdravila Bovilis BVD negativna, odobritev dovoljenja za promet z zdravilom pa bi predstavljala morebitno resno tveganje za zdravje živali.
English: • the production of Bovilis BVD vaccine is in compliance with GMP requirements
Slovenian: • da je proizvodnja cepiva Bovilis BVD v skladu z zahtevami smernic DPP,
English: Therefore the requested additional specified extraneous testing requirement is scientifically not justified for Bovilis BVD.
Slovenian: Zato zahteva po dodatnem specificiranem testiranju na vsebnost tujih snovi v primeru zdravila Bovilis BVD znanstveno ni utemeljena.
English: No scientific arguments are available concerning how the additional testing would minimise the risk of possible seroconversion induced by the vaccine.
Slovenian: kako naj bi dodatno testiranje zmanjšalo tveganje za morebitno serokonverzijo, ki bi jo sprožilo cepivo.
English: Krizna 10
Slovenian: Križna 10
English: Although the consequences of an accidental seroconversion against the listed extraneous agents would damage the animal health status of a country free from the four specified diseases, the benefit: risk evaluation remains positive due to the low risk of contamination of the product.
Slovenian: Čeprav bi bile posledice nenamerne serokonverzije zaradi prisotnosti navedenih tujih snovi poslabšanje zdravstvenega stanja živali v državi, kjer ni prisotnih omenjenih štirih vrst bolezni, pa bi ostala ocena razmerja med koristmi in tveganji pozitivna zaradi nizkega tveganja za kontaminacijo proizvoda.
English: SK-040 01 Kosice Slovak Republic Tel: +421 (55) 676 9405 Fax: +421 (55) 676 9873
Slovenian: SK-040 01 Kosice Slovaška republika Tel: +421 (55) 676 9405 Faks: +421 (55) 676 9873
English: During its meeting of November 2006, the CVMP started a referral procedure under Article 33(4) of Directive 2001/82/EC as amended for Bovilis BVD.
Slovenian: Med srečanjem novembra 2006 je odbor CVMP začel z napotitvenim postopkom glede zdravila Bovilis BVD v skladu s členom 33(4) Direktive 2001/82/ES z vsemi spremembami.
English: The application was made in accordance with Article 12.3 of Directive 2001/82/EC as a stand alone application.
Slovenian: Vloga je bila izdelana v skladu s členom 12(3) Direktive 2001/82/ES za samostojno zdravilo.
English: Czech Republic Tel: +420 (2) 333 440 25 Fax: +420 (2) 333 440 22
Slovenian: Češka republika Tel: +420 (2) 333 440 25 Faks: +420 (2) 333 440 22
English: Pursuant to Article 33(4) of Council Directive 2001/82/EC, as amended, the matter has been referred to CVMP.
Slovenian: Zadeva je bila v skladu s členom 33(4) Direktive Sveta 2001/82/ES z vsemi spremembami, predana Odboru za zdravila za uporabo v veterinarski medicini (CVMP).
English: Fax: + 31 485 587 653
Slovenian: Faks: + 31 485 587 653
English: The benefits of Bovilis BVD vaccine are accepted.
Slovenian: Koristi zdravila Bovilis BVD so priznani.
English: Fax: +39 (02) 516 866 87
Slovenian: Faks: +39 (02) 516 866 87
English: • extraneous agents testing of finished batches of Bovilis BVD for FMDV, BLV, BTV and IBRV is not required in the relevant monographs
Slovenian: • da zahtev po testiranju končnih serij zdravila Bovilis BVD na prisotnost virusa slinavke in parkljevke, virusa goveje levkemije, virusa bolezni modrikastega jezika in virusa infekcioznega bovinega rinotraheitisa glede na ustrezne monografkse publikacije ni potrebno.
English: BLV and IBRV are more ubiquitous but the measures summarised below have generally been accepted in the majority of member states to be adequate to ensure negligible risk.
Slovenian: Virus goveje levkemije (BLV) in virus infekcioznega bovinega rinotraheitisa (IBRV) sta bolj vseprisotna, vendar pa je večina članic, kot zadostne za zagotovitev zanemarljivo majhnega tveganja, sprejela spodaj navedena merila: V splošnem je mogoče odsotnost tujih snovi v cepivih zagotoviti z:
English: Fax: +32 (15) 436 733
Slovenian: Faks: +32 (15) 436 733
English: monographs for inactivated bovine vaccines and have written to the EDQM and asked them to address this.
Slovenian: Odbor CVMP je ugotovil neskladnosti (pri testiranju na prisotnost tujih snovi) v monografijah evropske farmakopeje v primeru neaktiviranih cepiv za govedo, o katerih je EDQM (Evropskemu direktoratu za kakovost zdravil) podal pisno prošnjo za odgovor na vprašanje.
English: Intervet International B.V. Wim de Korverstraat 35 NL-5831 AN Boxmeer The Netherlands Tel: + 31 485 587 652
Slovenian: NL-5831 AN Boxmeer Nizozemska
English: In general, the absence of extraneous agents in vaccines can be ensured by: GMP compliance of the production system Extraneous agents testing of raw materials Extraneous agents testing of batches of finished product, if required.
Slovenian: testiranjem serij končnih proizvodov na prisotnost tujih snovi, če je potrebno.
English: It is available as tablets (20 mg; 40 and 80 mg).
Slovenian: Na voljo je v obliki tablet (20, 40 in 80 mg).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Telmisartan Actavis on 30 September 2010.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Telmisartan Actavis, veljavno po vsej Evropski uniji, izdala 30. septembra 2010.
English: pressure is not reached, the dose can be increased to 80 mg, or another medicine for hypertension can be added, such as hydrochlorothiazide.
Slovenian: se ciljni krvni tlak ne doseže, se lahko odmerek zviša na 80 mg ali pa doda še eno zdravilo proti hipertenziji, kot je hidroklorotiazid.
English: For more information about treatment with Telmisartan Actavis, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Telmisartan Actavis preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: This means that Telmisartan Actavis is similar to a ‘reference medicine' already authorised in the European Union (EU) called Micardis.
Slovenian: To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Micardis.
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 Telmisartan Actavis.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: This allows the blood pressure to drop, reducing the risks associated with high blood pressure, such as having a heart attack or stroke.
Slovenian: To povzroči padec krvnega tlaka in zmanjšanje tveganja, ki je povezano z visokim krvnim tlakom, kot sta srčni infarkt ali kap.
English: The doctor should monitor the patient's blood pressure closely when starting Telmisartan Actavis, and may decide to adjust the patient's blood pressure-lowering medication.
Slovenian: Zdravnik mora med uvajanjem zdravila Telmisartan Actavis skrbno spremljati bolnikov krvni tlak in se lahko odloči za prilagoditev odmerka zdravila za zniževanje bolnikovega krvnega tlaka.
English: Telmisartan Actavis is used to treat essential hypertension (high blood pressure) in adults.
Slovenian: Zdravilo Telmisartan Actavis se uporablja za zdravljenje esencialne hipertenzije (visokega krvnega tlaka) pri odraslih.
English: Because Telmisartan Actavis is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Slovenian: Ker je Telmisartan Actavis generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
English: This is a summary of the European public assessment report (EPAR) for Telmisartan Actavis.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Telmisartan Actavis.
English: The full EPAR for Telmisartan Actavis can be found on the Agency's website EMA website/Find medicine/Human medicines/European Public Assessment Reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Telmisartan Actavis je na voljo na spletni strani agencije EMA website/Find medicine/Human medicines/European Public Assessment Reports.
English: It also allows the heart to pump blood more easily, which can help to reduce the risk of future cardiovascular problems.
Slovenian: Hkrati srcu olajša črpanje krvi, kar pripomore k zmanjšanju tveganja za pojav srčno-žilnih težav v prihodnosti.
English: What are the benefits and risks of Telmisartan Actavis?
Slovenian: Kakšne so koristi in tveganja, povezani z zdravilom Telmisartan Actavis?
English: The active substance in Telmisartan Actavis, telmisartan, is an ‘angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II.
Slovenian: Zdravilna učinkovina v zdravilu Telmisartan Actavis, telmisartan, je antagonist receptorja angiotenzina II, kar pomeni, da preprečuje delovanje hormona v telesu, ki mu pravimo angiotenzin II.
English: For the treatment of essential hypertension, the usual recommended dose of Telmisartan Actavis is 40 mg once a day, but some patients may benefit from using 20 mg once a day.
Slovenian: Za zdravljenje esencialne hipertenzije znaša običajni priporočeni odmerek zdravila Telmisartan Actavis 40 mg enkrat dnevno, vendar pa lahko nekaterim bolnikom zadostuje že 20-miligramski odmerek.
English: The CHMP concluded that, in accordance with EU requirements, Telmisartan Actavis has been shown to have comparable quality and to be bioequivalent to Micardis.
Slovenian: CHMP je zaključil, da je bilo za zdravilo Telmisartan Actavis v skladu z zahtevami EU dokazano, da ima primerljivo raven kakovosti kot zdravilo Micardis ter da mu je biološko enakovredno.
English: Telmisartan Actavis is also used to prevent cardiovascular problems (problems with the heart and blood vessels) such as heart attacks or strokes.
Slovenian: Zdravilo Telmisartan Actavis se uporablja tudi za preprečevanje srčno-žilnih težav (težav s srcem in ožiljem), kot sta srčni infarkt in možganska kap.
English: Telmisartan Actavis is a ‘generic medicine'.
Slovenian: Zdravilo Telmisartan Actavis je „generično zdravilo“.
English: Because Telmisartan Actavis is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Micardis.
Slovenian: Ker je Telmisartan Actavis generično zdravilo, so bile študije pri bolnikih omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Micardis.
English: By blocking the receptors to which angiotensin II normally attaches, telmisartan stops the hormone having an effect, allowing the blood vessels to widen.
Slovenian: Telmisartan z zaviranjem receptorjev, na katere se angiotenzin II običajno veže, prepreči učinek hormona, kar privede do razširitve žil.
English: The Committee recommended that Telmisartan Actavis be given marketing authorisation.
Slovenian: Priporočil je, da se za zdravilo Telmisartan Actavis izda dovoljenje za promet.
English: Telmisartan Actavis is a medicine that contains the active substance telmisartan.
Slovenian: Telmisartan Actavis je zdravilo, ki vsebuje zdravilno učinkovino telmisartan.
English: Other information about Telmisartan Actavis:
Slovenian: Druge informacije o zdravilu Telmisartan Actavis
English: Why has Telmisartan Actavis been approved?
Slovenian: Zakaj je bilo zdravilo Telmisartan Actavis odobreno?
English: What is Telmisartan Actavis?
Slovenian: Kaj je zdravilo Telmisartan Actavis?
English: How has Telmisartan Actavis been studied?
Slovenian: Kako je bilo zdravilo Telmisartan Actavis raziskano?
English: How is Telmisartan Actavis used?
Slovenian: Kako se zdravilo Telmisartan Actavis uporablja?
English: What is Telmisartan Actavis used for?
Slovenian: Za kaj se zdravilo Telmisartan Actavis uporablja?
English: How does Telmisartan Actavis work?
Slovenian: Kako zdravilo Telmisartan Actavis deluje?
English: MA (EU) Number (Invented) name Strength Pharmaceutical Form Route of Administration
Slovenian: (Izmišljeno) ime Jakost Farmacevtska oblika Pot uporabe
English: MA (EU) Number
Slovenian: Številka EU
English: 0.6 ml (10 mg/ml) 1 pre-filled syringe
Slovenian: 0,6 ml (10 mg/ml) 1 napolnjena uporaba
English: Content (concentration)
Slovenian: (koncentracija) pakiranja
English: (Invented) name
Slovenian: Velikost ime
English: Strength Pharmaceutical Form
Slovenian: (Izmišljeno) Jakost Farmacevtska oblika Pot uporabe Stična ovojnina Vsebina
English: Subcutaneous use pre-filled syringe (glass)
Slovenian: 6 mg raztopina za injiciranje subkutana napolnjena
English: This overview was last updated in March 2019.
Slovenian: Ta povzetek je bil nazadnje posodobljen marca 2019.
English: In the future if the animals are exposed to similar proteins the immune system will be able to respond more quickly.
Slovenian: Ob ponovni izpostavitvi živali podobnim beljakovinam v prihodnosti se bo imunski sistem tako hitreje odzval.
English: Safety studies have shown that the strain is safe for turkeys, however, precautionary measures must be followed to avoid direct or indirect contact between vaccinated chickens and turkeys.
Slovenian: V študijah varnosti so dokazali, da je sev varen za purane, vendar je treba upoštevati previdnostne ukrepe, da ne pride do neposrednega ali posrednega stika med cepljenimi piščanci in purani.
English: It can make birds more prone to other diseases and can interfere with effective vaccination.
Slovenian: Zaradi nje so ptice lahko dovzetnejše za druge bolezni in lahko vpliva na učinkovitost cepljenja.
English: Vaccinated birds had a protection level of between 81% and 95% against disease signs.
Slovenian: Pri cepljenih pticah je bila raven zaščite pred znaki bolezni med 81 % in 95 %.
English: Innovax-ND-IBD received a marketing authorisation valid throughout the EU on 22 August 2017.
Slovenian: Zdravilo Innovax-ND-IBD je pridobilo dovoljenje za promet, veljavno po vsej Evropski uniji, 22. avgusta 2017.
English: The full EPAR for Innovax-ND-IBD can be found on the Agency's website: ema.europa.eu/medicines/veterinary/EPAR/innovax-nd-ibd.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Innovax-ND-IBD je na voljo na spletni strani agencije: ema.europa.eu/medicines/veterinary/EPAR/innovax-nd-ibd.
English: Similar challenges were carried out after hatching to show the effects of vaccination of chicken eggs.
Slovenian: Podobni provokacijski testi so bili izvedeni po izvalitvi, da bi dokazali učinke cepljenja kokošjih jajc.
English: The vaccine can be given to one-day-old chicks as a single injection under the skin in the neck or directly into 18 - 19-day-old chicken eggs containing embryos (unhatched developing chicks).
Slovenian: Cepivo se lahko uporablja pri en dan starih piščancih v obliki enkratnega injiciranja pod kožo na vratu ali neposrednega injiciranja v 18-19 dni stara jajca, ki vsebujejo zarodke (še ne izvaljene piščance v razvoju).
English: The European Medicines Agency decided that Innovax-ND-IBD's benefits are greater than its risks and recommended it can be authorised for use in the EU.
Slovenian: Evropska agencija za zdravila je zaključila, da so koristi zdravila Innovax-ND-IBD večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.