FrancophonIA/ELRC3.0 huggingface dataset:
English: They work by reducing the activity of an enzyme called plasmin that is responsible for breaking up the fibres in blood clots.
Slovenian: Delujejo tako, da zmanjšajo delovanje encima, imenovanega plazmin, ki razgrajuje vlakna v krvnih strdkih.
English: Furthermore, the CHMP advised that careful consideration be given to benefits and risks of aprotinin, and the availability of alternative treatments.
Slovenian: Poleg tega je opozoril, da je treba skrbno pretehtati koristi in tveganja aprotinina ter možnost uporabe drugih zdravil.
English: The CHMP set out conditions for the reintroduction of aprotinin medicines onto the market and also made recommendations on the use of aminocaproic acid and tranexamic acid.
Slovenian: CHMP je določil pogoje, pod katerimi se lahko zdravila, ki vsebujejo aprotinin, ponovno dajo na trg, in izdal priporočila glede uporabe aminokaprojske kisline in traneksamične kisline.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of these medicines outweigh their risks and recommended that the EU-wide suspension of the marketing authorisation for aprotinin-containing medicines that has been in place since 2008 be lifted.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi teh zdravil večje od z njimi povezanih tveganj, in priporočil preklic začasnega umika dovoljenj za promet z zdravili, ki vsebujejo aprotinin, ki je po vsej EU veljal od leta 2008.
English: On 14 February 2012, the European Medicines Agency completed a review of the antifibrinolytic medicines aprotinin, aminocaproic acid and tranexamic acid.
Slovenian: Evropska agencija za zdravila je 14. februarja 2012 zaključila pregled antifibrinolitikov aprotinina, aminokaprojske kisline in traneksamične kisline.
English: The CHMP therefore concluded that the benefits of aprotinin outweigh its risk in appropriately managed patients undergoing isolated heart bypass surgery (not combined with other heart surgery), and recommended that the suspension of aprotinin medicines in the EU be lifted for this revised indication.
Slovenian: CHMP je zato zaključil, da so koristi aprotinina večje od z njim povezanega tveganja pri ustrezno zdravljenih bolnikih, ki so prestali izolirano obvodno operacijo na srcu (tj. operacijo, ki ni kombinirana z drugim kirurškim posegom na srcu), in priporočil preklic začasnega umika zdravil, ki vsebujejo aprotinin, s trgov EU za to spremenjeno indikacijo.
English: The current CHMP review was initiated at the request of the German medicines agency to take into account further data and analyses from the BART study and other sources that have become available since 2007.
Slovenian: Ta pregled je CHMP začel na zahtevo nemške agencije za zdravila, ki je želela, da se upoštevajo dodatni podatki in analize iz študije BART ter drugih virov, ki so postali na voljo po letu 2007.
English: Antifibrinolytics work by preventing fibrinolysis, the natural process by which blood clots are broken down.
Slovenian: Antifibrinolitiki delujejo tako, da preprečujejo fibrinolizo, tj. naravni proces raztapljanja krvnih strdkov.
English: The European Commission issued a decision for aminocaproic acid on 10 October 2012.
Slovenian: Evropska komisija je sklep o aminokaprojski kislini izdala 10. oktobra 2012.
English: The amended information for tranexamic acid can be found here.
Slovenian: Spremenjene informacije o traneksamični kislini so na voljo tukaj.
English: The European Commission issued a decision for tranexamic acid on 10 October 2012.
Slovenian: Evropska komisija je sklep o traneksamični kislini izdala 10. oktobra 2012.
English: The amended prescribing information on aprotinin medicines for doctors can be found here.
Slovenian: Spremenjena navodila za zdravnike za predpisovanje zdravil, ki vsebujejo aprotinin, so na voljo tukaj.
English: The suspension in Germany led to an EU-wide review by the CHMP which recommended the suspension of aprotinin throughout the EU on 21 November 2007.
Slovenian: Zaradi začasnega umika dovoljenj v Nemčiji je CHMP opravil pregled na ravni EU in 21. novembra 2007 priporočil začasen umik aprotinina s trgov po vsej EU.1 V času izdaje priporočila je CHMP predvidel nadaljnji pregled, ko bodo na voljo končni podatki iz študije BART.
English: The amended prescribing information on aminocaproic acid for doctors can be found here.
Slovenian: Spremenjena navodila za zdravnike za predpisovanje zdravil, ki vsebujejo aminokaprojsko kislino, so na voljo tukaj.
English: New analyses showed flaws in the way the study was carried out, which cast doubt on the previous conclusions.
Slovenian: CHMP je ponovno proučil prejšnje priporočilo v zvezi z aprotininom in pri tem upošteval nove informacije iz študije BART. Nove analize so razkrile napake v načinu izvedbe študije, zaradi česar so prejšnji zaključki postali vprašljivi.
English: INJECTION
Slovenian: INJEKCIJA
English: Via Valosa di Sopra, 9 20052 Monza - Italy
Slovenian: Via Valosa di Sopra, 9 20052 Monza - Italija
English: Tranexamic acid containing medicinal products with Marketing Authorisation in the European Union
Slovenian: Zdravila, ki vsebujejo traneksaminsko kislino in imajo dovoljenje za promet v Evropski uniji
English: HU - Hungary sanofi-aventis Zrt.
Slovenian: HU - Madžarska sanofi-aventis Zrt.
English: Kennedy L-1855 Luxembourg
Slovenian: Kennedy L-1855 Luksemburg
English: Diagonal 67-69 08019 Barcelona España
Slovenian: Diagonal 67-69 08019 Barcelona Španija
English: List of the invented names, pharmaceutical forms, strengths of the medicinal products, route of administration, marketing authorisation holders in the member states
Slovenian: Seznam imen, farmacevtskih oblik, jakosti zdravila, načina uporabe in imetnikov dovoljenja za promet v državah članicah
English: Bioindutria Laboratorio Italiano Medicinali spa Via De Ambrosiis, 2 15067 Novi Ligure Alessandria Italy
Slovenian: Bioindutria Laboratorio Italiano Medicinali spa Via De Ambrosiis, 2 15067 Novi Ligure Alessandria
English: 1045 Budapest, Hungary
Slovenian: 1045 Budapest,
English: Pfizer ApS, Lautrupvang 8, DK-2750 Ballerup, Denmark
Slovenian: Pfizer ApS, Lautrupvang 8, DK-2750 Ballerup, Danska
English: AT - Austria
Slovenian: AT - Avstrija
English: NO - Norway
Slovenian: NO - Norveška
English: Pharmacia Ireland Ltd, 9 Riverwalk, National Digital Park,
Slovenian: Pharmacia Ireland Ltd, 9 Riverwalk, National Digital Park, Citywest Business Campus,
English: DK - Denmark
Slovenian: DK - Danska
English: FI - Finland
Slovenian: FI - Finska
English: ET - Estonia
Slovenian: ET - Estonija
English: CONSTANTINOUPOLEOS STREET, P.O.BOX 51409, 3505 LEMESOS, CYPRUS
Slovenian: MEDOCHEMIE LTD, 1-10 CONSTANTINOUPOLEOS STREET, P.O.BOX 51409, 3505 LEMESOS, CIPER
English: A. NIKOLAKOPOULOS A.E. GALATSIOU AVENUE 115, Athens 11146
Slovenian: GALATSIOU AVENUE 115, Athens 11146
English: CZ - Czech Republic Sanofi-Aventis, s.r.o., Evropská 846/176a, 160 00
Slovenian: Sanofi-Aventis, s.r.o., Evropská 846/176a, 160 00 Praha 6, Češka republika
English: LU - Luxembourg PFIZER S.A.N.V.
Slovenian: LU - Luksemburg PFIZER S.A.N.V.
English: Rivium Westlaan 142 2909 LD, Capelle a/d Ijssel
Slovenian: NL - Nizozemska Pfizer B.V., Rivium Westlaan 142, 2909 LD, Capelle a/d Ijssel
English: PL - Poland
Slovenian: PL - Poljska
English: FR - France
Slovenian: FR - Francija
English: EL - Greece
Slovenian: EL - Grčija
English: 191 90 Sollentuna Sweden
Slovenian: Pfizer AB , 191 90 Sollentuna, Švedska
English: CY - Cyprus
Slovenian: CY - Ciper
English: SE - Sweden
Slovenian: SE - Švedska
English: UK - United Kingdom Pharmacia Limited Walton Oaks, Dorking Road, Tadworth
Slovenian: Pharmacia Limited, Walton Oaks, Dorking Road, Tadworth, Surrey KT20 7NS
English: IS - Iceland
Slovenian: IS - Islandija
English: DE - Germany
Slovenian: DE - Nemčija
English: Sanofi-Aventis France Boulevard Romain Rolland 113, F-75014 Paris, France solution for infusion intravenous use
Slovenian: Sanofi-Aventis France boulevard Romain Rolland 1-13, F-75014 Paris, Francija
English: IE - Ireland
Slovenian: IE - Irska
English: Floridsdorfer Hauptstraße 1 A-1210 Wien
Slovenian: Floridsdorfer Hauptstraße
English: LU - Luxembourg Eumedica SA 67, Avenue Winston Churchill B- 1180 Bruxelles
Slovenian: LU - Luksemburg Eumedica SA 67, Avenue Winston Churchill
English: 1180 Brussels
Slovenian: B- 1180 Bruxelles
English: Warszawskie Zakłady Farmaceutyczne POLFA S.A. 22/24 karolkowa st.
Slovenian: Warszawskie Zakłady Farmaceutyczne POLFA S.A.
English: ES - Spain
Slovenian: ES - Španija
English: 1324 Lysaker Norway
Slovenian: Pfizer AS, Postboks 3, 1324 Lysaker Norveška
English: Pfizer B.V.
Slovenian: PFIZER S.A.N.V.
English: Praha 6, Czech Republic
Slovenian: CZ - Češka republika
English: 01-207 Warsaw, Poland solution for infusion intravenous use
Slovenian: 22/24 karolkowa st. 01-207 Warsaw, Poljska
English: This summary was last updated in 09-2017.
Slovenian: Povzetek je bil nazadnje posodobljen 09-2017.
English: The two studies together involved a total of 614 patients.
Slovenian: Študiji sta skupaj vključevali 614 bolnikov.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Invega on 25 June 2007.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Invega, veljavno po vsej Evropski uniji, izdala 25. junija 2007.
English: What measures are being taken to ensure the safe and effective use of Invega?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Invega?
English: Schizophrenia
Slovenian: Shizofrenija
English: Invega paliperidone
Slovenian: Invega paliperidon
English: It is not intended to provide practical advice on how to use Invega.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: The full EPAR for Invega 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 Invega je na voljo na spletni strani agencije ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: What is Invega and what is it used for?
Slovenian: Kaj je zdravilo Invega in za kaj se uporablja?
English: It is available as prolonged-release tablets (3, 6, 9 and 12 mg).
Slovenian: Na voljo je v obliki tablet s podaljšanim sproščanjem (3 mg, 6 mg, 9 mg in 12 mg).
English: The European Medicines Agency decided that Invega's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: Evropska agencija za zdravila je sklenila, da so koristi zdravila Invega večje od z njim povezanih tveganj, in priporočila, da se zanj izda dovoljenje za promet.
English: This is a summary of the European public assessment report (EPAR) for Invega.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Invega.
English: ‘Prolonged release' means that paliperidone is released slowly from the tablet over a few hours.
Slovenian: „Podaljšano sproščanje“ pomeni, da se paliperidon iz tablete sprošča počasi več ur.
English: Side effects in adolescents are similar to those in adults, although some side effects may occur more frequently.
Slovenian: Neželeni učinki pri mladostnikih so podobni tistim pri odraslih, čeprav se lahko nekateri pojavijo pogosteje.
English: What benefits of Invega have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Invega izkazalo v študijah?
English: This disrupts signals sent between brain cells by ‘neurotransmitters', substances that nerve cells use to communicate with neighbouring cells.
Slovenian: S tem prekine signale, ki jih med možganskimi celicami pošiljajo „živčni prenašalci“, tj. snovi, ki jih živčne celice uporabljajo za komunikacijo z bližnjimi celicami.
English: By blocking these receptors, paliperidone helps to normalise the activity of the brain and reduce symptoms.
Slovenian: Z zaviranjem teh receptorjev paliperidon pripomore k normalizaciji dejavnosti možganov in olajša simptome.
English: Similar results were seen in the other two short-term studies, with higher doses of Invega being more effective than lower doses.
Slovenian: Podobne rezultate so opazili v drugih dveh kratkotrajnih študijah, pri čemer so bili večji odmerki zdravila Invega učinkovitejši kot manjši.
English: Schizoaffective disorder
Slovenian: Shizoafektivna motnja
English: Studies in adolescents have shown similar results with Invega to those seen in adults.
Slovenian: Študije pri mladostnikih so pokazale podobne rezultate kot študije pri odraslih.
English: Why is Invega approved?
Slovenian: Zakaj je bilo zdravilo Invega odobreno?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Invega have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Invega upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: What are the risks associated with Invega?
Slovenian: Kakšna tveganja so povezana z zdravilom Invega?
English: Paliperidone acts mainly by blocking the receptors for the neurotransmitters dopamine and 5-hydroxytryptamine (also called serotonin), which are involved in schizophrenia.
Slovenian: Paliperidon v glavnem zavira receptorje za živčna prenašalca dopamin in 5-hidroksitriptamin (imenovan tudi serotonin), ki sta dejavna pri shizofreniji.
English: In a third study of 334 previously treated patients, symptoms of depression came back in 15% (25 out of 164) of patients given paliperidone compared with 34% (57 out of 170) of patients given placebo.
Slovenian: V tretji študiji s 334 predhodno zdravljenimi bolniki so se simptomi depresije znova pojavili pri 15 % (25 od 164) bolnikov, ki so prejemali paliperidon, in pri 34 % (57 od 170) bolnikov, ki so prejemali placebo.
English: For more information about treatment with Invega, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Invega preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: In the brain, paliperidone attaches to several different receptors (targets) on nerve cells.
Slovenian: Paliperidon se v možganih veže na različne receptorje (prijemališča) na živčnih celicah.
English: Invega must not be taken by people who are hypersensitive (allergic) to paliperidone or any of the other ingredients, or to risperidone.
Slovenian: Zdravila Invega ne smejo jemati osebe, ki so preobčutljive za (alergične na) paliperidon ali katero koli drugo sestavino zdravila ali risperidon.
English: The most frequent side effects with Invega in adults are headache, insomnia (difficulty sleeping), sleepiness, parkinsonism (effects similar to Parkinson's disease such as shaking, muscle stiffness and slow movement), dystonia (involuntary muscle contractions), tremor (shaking), dizziness, akathisia (restlessness), agitation, anxiety, depression, increased weight, nausea, vomiting, constipation, dyspepsia (heartburn), diarrhoea, dry mouth, tiredness, toothache, muscle and bone pain, back pain, asthenia (weakness), tachycardia (increased heart rate), high blood pressure, prolonged QT interval (an alteration of the electrical activity of the heart), upper respiratory tract infection (nose and throat infections) and cough.
Slovenian: agitacija, tesnobnost, depresija, povečana telesna masa, navzea, bruhanje, zaprtost, dispepsija (zgaga), driska, suha usta, utrujenost, zobobol, bolečine v mišicah in kosteh, bolečine v hrbtu, astenija (oslabelost), tahikardija (pospešen srčni utrip), visok krvni tlak, podaljšan interval QT (spremenjena električna aktivnost srca), okužba zgornjih dihal (okužbe nosu in grla) in kašelj.
English: For practical information about using Invega, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Invega naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: How is Invega used?
Slovenian: Kako se zdravilo Invega uporablja?
English: Invega is also used to treat adults with schizoaffective disorder.
Slovenian: Uporablja se tudi za zdravljenje odraslih s shizoafektivno motnjo.
English: This is a condition in which the patient has episodes of elevated mood (mania) or low mood (depression) in addition to symptoms of schizophrenia.
Slovenian: To je stanje, v katerem ima bolnik poleg simptomov shizofrenije še epizode privzdignjenega razpoloženja (manije) ali potrtosti (depresije).
English: After assessing the symptoms, the doctor may adjust the dose to between 3 and 12 mg once a day in adults with schizophrenia and to between 6 and 12 mg once a day in patients with schizoaffective disorder.
Slovenian: Po oceni simptomov lahko zdravnik odmerek pri odraslih bolnikih s shizofrenijo prilagodi v razponu od 3 do 12 mg enkrat na dan, pri bolnikih s shizoafektivno motnjo pa v razponu med 6 in 12 mg enkrat na dan.
English: Symptom scores fell by 19.9 points in those taking olanzapine.
Slovenian: Ocene simptomov so se pri bolnikih, ki so jemali olanzapin, znižale za 19,9 točke.
English: In an additional longer-term study involving 207 adults with schizophrenia who had initially been treated over 14 weeks, Invega was more effective than placebo in preventing new symptoms for up to 35 weeks.
Slovenian: V dodatni dolgotrajni študiji, ki je vključevala 207 odraslih bolnikov s shizofrenijo, ki so se na začetku zdravili 14 tednov, je bilo zdravilo Invega pri preprečevanju pojava novih simptomov v 35-tedenskem obdobju učinkovitejše od placeba.
English: Three short-term studies innvolving 1,692 adults showed that Invega is more effective than placebo (a dummy treatment) and as effective as another antipsychotic medicine olanzapine at reducing symptoms of schizophrenia (as measured by a standard rating scale).
Slovenian: Tri kratkotrajne študije, ki so vključevale 1 692 odraslih, so pokazale, da je zdravilo Invega pri zmanjševanju simptomov shizofrenije (merjenih s standardno ocenjevalno lestvico) učinkovitejše od placeba (zdravila brez zdravilne učinkovine) in enako učinkovito kot drugo antipsihotično zdravilo, olanzapin.
English: Invega is an antipsychotic medicine used in adults and adolescents from 15 years of age to treat schizophrenia, a mental illness with symptoms such as disorganised thinking and speech, hallucinations (hearing or seeing things that are not there), suspiciousness and delusions (false beliefs).
Slovenian: Invega je antipsihotično zdravilo, ki se uporablja pri odraslih in mladostnikih, starejših od 15 let, za zdravljenje shizofrenije, tj. duševne bolezni s simptomi, kot so nepovezano razmišljanje in govor, halucinacije (prisluhi ali prividi), sumničavost in blodnje (zmotna prepričanja).
English: Invega contains the active substance paliperidone.
Slovenian: Zdravilo Invega vsebuje zdravilno učinkovino paliperidon.
English: Paliperidone is an active breakdown product (metabolite) of risperidone, another atypical antipsychotic medicine that has been used in the treatment of schizophrenia since the 1990s.
Slovenian: Paliperidon je aktivni presnovek (metabolit) risperidona, drugega atipičnega antipsihotika, ki se za zdravljenje shizofrenije uporablja od devetdesetih let prejšnjega stoletja.
English: The active substance in Invega, paliperidone, is known as an ‘atypical' antipsychotic because it is different from the older antipsychotic medicines that have been available since the 1950s.
Slovenian: Zdravilna učinkovina v zdravilu Invega, paliperidon, spada med netipična antipsihotična zdravila, ker se razlikuje od starejših antipsihotikov, ki so na voljo od petdesetih let prejšnjega stoletja dalje.
English: Invega can only be obtained with a prescription.
Slovenian: Predpisovanje in izdaja zdravila Invega je le na recept.
English: For the full list of all side effects reported with Invega, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Invega, glejte navodilo za uporabo.
English: Studies have shown that Invega can reduce symptoms scores and prevent symptoms in patients with schizoaffective disorder.
Slovenian: Študije so pokazale, da zdravilo Invega pri bolnikih s shizoafektivno motnjo lahko izboljša ocene simptomov in simptome prepreči.
English: Other information about Invega
Slovenian: Druge informacije o zdravilu Invega
English: In one study, patients who were given Invega had a fall in their symptom score for mania of between 27.4 and 30.6 after 6 weeks compared with 21.7 in patients who were given placebo.
Slovenian: V eni študiji se je pri bolnikih, ki so prejemali zdravilo Invega, po šestih tednih ocena simptomov glede manije znižala za 27,4 do 30,6 točke, medtem ko se je pri bolnikih, ki so prejemali placebo, znižala za 21,7 točke.
English: In one of these studies, average symptom scores fell by between 17.9 and 23.3 points after 6 weeks in those taking Invega compared with a fall of 4.1 points with placebo.
Slovenian: V eni od teh študij so se povprečne ocene simptomov po šestih tednih pri bolnikih, ki so jemali zdravilo Invega, znižale za 17,9 do 23,3 točke , pri bolnikih, ki so jemali placebo, pa za 4,1 točke.
English: In adolescents with schizophrenia the maximum daily dose depends on the patient's body weight and should not be more than 6 mg in those who weigh less than 51 kg. For more information on the use of Invega, including the adjustment of doses in those with kidney disease and the elderly, see the summary of product characteristics (also part of the EPAR).
Slovenian: Pri mladostnikih s shizofrenijo je največji dnevni odmerek odvisen od telesne mase bolnika in ne sme presegati 6 mg pri tistih bolnikih, ki tehtajo manj kot 51 kg. Za več informacij o uporabi zdravila
English: How does Invega work?
Slovenian: Kako zdravilo Invega deluje?
English: In another study, the fall in symptom score for mania after 6 weeks was 20.0 in the Invega group and 10.8 in the placebo group.
Slovenian: V drugi študiji se je ocena simptomov glede manije po šestih tednih pri skupini, ki je jemala zdravilo Invega, znižala za 20,0 točke, pri skupini, ki je jemala placebo, pa za 10,8 točke.
English: The recommended starting dose of Invega in adults is 6 mg once a day, taken in the morning; the starting dose in adolescents is 3 mg daily.
Slovenian: Priporočeni začetni odmerek zdravila Invega pri odraslih je 6 mg enkrat na dan, ki se jemlje zjutraj, začetni odmerek za mladostnike pa je 3 mg na dan. Bolniki lahko jemljejo zdravilo Invega s hrano ali med obroki, vendar vsak dan enako, tj. ne smejo ga jemati enkrat s hrano, naslednji dan pa brez nje.
English: It is given once daily for up to two weeks.
Slovenian: Daje se enkrat na dan do 14 dni.
English: This summary was last updated in July 2015.
Slovenian: Povzetek je bil nazadnje posodobljen julija 2015.
English: It is either given with food or directly into the mouth at a dosage of 0.6 mg/kg bodyweight.
Slovenian: Zdravilo se daje pomešano s hrano ali neposredno v gobec v odmerkih po 0,6 mg/kg telesne mase.
English: The full EPAR for Novaquin can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila Novaquin je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: The European Commission granted a marketing authorisation valid throughout the EU for Novaquin on 8 September 2015.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Novaquin, veljavno po vsej Evropski uniji, izdala 8. septembra 2015.
English: This is a summary of the European public assessment report (EPAR) for Novaquin.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Novaquin.
English: What are the benefits and risks of Novaquin?
Slovenian: Kakšne so koristi in tveganja, povezani z zdravilom Novaquin?