FrancophonIA/ELRC3.0 huggingface dataset:
English: − rare (more than 1 but less than 10 animals in 10,000 animals)
Slovenian: - občasni (pojavijo se pri več kot1živali toda pri manj kot 10 živalih od 1.000 živali) - redki (pojavijo se pri več kot1živali toda pri manj kot 10 živalih od 10.000 živali) - zelo redki (pojavijo se pri manj kot 1 živali od 10.000 živali, vključujoč posamezne primere).
English: For animal treatment only.
Slovenian: Samo na veterinarski recept.
English: Name and address of the manufacturer of the biological active substance Intervet International B.V.
Slovenian: Ime in naslov izdelovalca biološke aktivne učinkovine
English: BATCH NUMBER Lot {number}
Slovenian: IZDELOVALČEVA ŠTEVILKA SERIJE Lot {številka}
English: EXPIRY DATE EXP: {month/year}
Slovenian: DATUM IZTEKA ROKA UPORABNOSTI EXP: {mesec/leto}
English: A slight cloudy discharge commonly occurs from the mucosal injection site at 3 or 4 days post vaccination.
Slovenian: Običajno se 3 do 4 dni po cepljenju na mestu vboda pojavi blag moten izcedek.
English: In addition to the clinical signs given under section 6, vaccination with a ten times overdose may induce an abscess in one of the submandibular lymph nodes.
Slovenian: Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) (če je potrebno) Poleg kliničnih znakov, ki so opisani v poglavju 6, lahko cepljenje z 10-krat prevelikim odmerkom povzroči tudi absces na katerem od submandibularnih limfnih vozlov.
English: NAME OF THE DILUENT
Slovenian: Viala z vehikom
English: SPECIAL STORAGE CONDITIONS Keep out of the sight and reach of children.
Slovenian: Zdravilo shranjujte nedosegljivo otrokom.
English: EXPIRY DATE EXP {month/year}
Slovenian: DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA Exp {mesec/leto}
English: EXPIRY DATE Exp {month/year}
Slovenian: DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA EXP{mesec/leto}
English: 6.1 List of excipients
Slovenian: 6.5 Vrsta ovojnine in vsebina
English: Fimbriae Types 2 and 3 (FIM)
Slovenian: fimbrije tipa 2 in 3 (FIM)
English: 3 micrograms Conjugated to meningococcal protein2 50 micrograms adsorbed on aluminium phosphate (0.17 mg Al adsorbed on amorphous aluminium hydroxyphosphate sulfate (0.15 mg Al 3 produced in yeast (Saccharomyces cerevisiae) cells by recombinant DNA technology 4 produced in Vero cells or equivalent antigenic quantity determined by a suitable immunochemical method.
Slovenian: adsorbiran na aluminijev fosfat (0,17 mg Al adsorbiran na amorfni aluminijev hidroksifosfat sulfat (0,15 mg Al 3 pridobljen v celicah kvasovke (Saccharomyces cerevisiae) s tehnologijo rekombinantne DNA 4 pridobljen v celicah Vero ali enakovredna količina antigenov, določena z ustrezno imunokemijsko metodo.
English: Poliovirus (Inactivated)4: Type 1 (Mahoney)
Slovenian: poliovirus (inaktiviran)4 tip 1 (sev Mahoney)
English: Hepatitis B surface antigen2,3:
Slovenian: površinski antigen hepatitisa B2,3
English: 50 (5x10) pre-filled syringes (multipack)
Slovenian: 50 (5 x 10) napolnjenih injekcijskih brizg (združeno pakiranje)
English: --1 One dose (0.5 ml) contains: Diphtheria Toxoid1:
Slovenian: --1 En odmerek (0,5 ml) vsebuje: toksoid davice1
English: Tetanus Toxoid1:
Slovenian: toksoid tetanusa1
English: Bordetella pertussis antigens1: Pertussis Toxoid (PT)
Slovenian: antigene Bordetella pertussis1 toksoid bakterije oslovskega kašlja (PT)
English: Filamentous Haemagglutinin (FHA) 20 micrograms Pertactin (PRN)
Slovenian: pertaktin (PRN)
English: The European Commission granted a marketing authorisation valid throughout the European Union for Entyvio on 22 May 2014.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Entyvio, veljavno po vsej Evropski uniji, izdala 22. maja 2014.
English: What measures are being taken to ensure the safe and effective use of Entyvio?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Entyvio?
English: What is Entyvio and what is it used for?
Slovenian: Kaj je zdravilo Entyvio in za kaj se uporablja?
English: Furthermore, the risks are considered manageable, despite the lack of long-term safety data, if recommendations in place are followed.
Slovenian: Poleg tega so bila tveganja kljub pomanjkanju podatkov o dolgoročni varnosti ocenjena kot obvladljiva, če se upoštevajo sprejeta priporočila.
English: The full EPAR and risk management plan summary for Entyvio 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) in povzetek načrta obvladovanja tveganj za zdravilo Entyvio sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The recommended dose is 300 mg given at weeks zero, two and six, and then every eight weeks after that in patients who respond.
Slovenian: Priporočeni odmerek je 300 mg, ki se daje na ničti, drugi in šesti teden ter nato pri bolnikih z odzivom na vsakih osem tednov.
English: This is a summary of the European public assessment report (EPAR) for Entyvio.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Entyvio.
English: It is not intended to provide practical advice on how to use Entyvio.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: Entyvio was also shown to be more effective than placebo at improving symptoms of Crohn's disease.
Slovenian: Prav tako se je zdravilo Entyvio izkazalo za učinkovitejše od placeba pri izboljšanju simptomov Crohnove bolezni.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Entyvio's benefits are greater than its risks and recommended that it be approved for use in the EU.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Entyvio večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
English: Entyvio is given as an infusion that lasts 30 minutes.
Slovenian: Zdravilo Entyvio se daje z infuzijo, ki traja najmanj 30 minut.
English: Patients who receive Entyvio must be given a special alert card that summarises the safety information about the medicine.
Slovenian: Bolniki, ki prejemajo zdravilo Entyvio, morajo prejeti posebno opozorilno kartico, na kateri so povzete informacije o varnosti zdravila.
English: The company will also provide educational material to all healthcare professionals expected to prescribe Entyvio to remind them of the need to monitor patients for signs of neurological disease or PML, in particular those treated with certain biological medicines which may potentially cause PML.
Slovenian: Poleg tega bo družba zagotovila izobraževalno gradivo za vse zdravstvene delavce, ki naj bi predpisovali zdravilo Entyvio, da jih bo opozorila na potrebo po spremljanju bolnikov glede znakov nevroloških bolezni in PML, zlasti tistih, ki se zdravijo z določenimi biološkimi zdravili, ki lahko povzročijo PML.
English: Why is Entyvio approved?
Slovenian: Zakaj je bilo zdravilo Entyvio odobreno?
English: A risk management plan has been developed to ensure that Entyvio is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Entyvio je bil pripravljen načrt obvladovanja tveganj.
English: Other information about Entyvio
Slovenian: Druge informacije o zdravilu Entyvio
English: In ulcerative colitis and Crohn's disease these cells are involved in causing inflammation in the gut.
Slovenian: Pri ulceroznem kolitisu in Crohnovi bolezni te celice sodelujejo pri povzročanju vnetja v črevesju.
English: Vedolizumab has been designed to attach to ‘alfa-4-beta-7 integrin', a protein mostly found on the surface of certain white blood cells in the gut.
Slovenian: Vedolizumab je bil zasnovan tako, da se veže na „integrin alfa-4beta-7“, beljakovino, ki je najpogosteje prisotna na površini določenih belih krvnih celic v črevesju.
English: Entyvio must not be used in people with active serious infections such as tuberculosis, sepsis (infection in the blood), listeriosis (infection with bacteria called Listeria) or opportunistic infections (those seen in patients with a weakened immune system) such as progressive multifocal leukoencephalopathy (PML, a rare brain infection that usually leads to severe disability or death).
Slovenian: Zdravilo Entyvio se ne sme uporabljati pri osebah z aktivnimi resnimi okužbami, kot so tuberkuloza, sepsa (okužba krvi), listerioza (okužba z bakterijo, imenovano Listeria) ali oportunistične okužbe (takšne, ki se pojavijo pri bolnikih z oslabljenim imunskim sistemom), kot je progresivna multifokalna levkoencefalopatija (PML, tj. redka okužba možganov, ki običajno povzroči hudo invalidnost ali smrt).
English: What are the risks associated with Entyvio?
Slovenian: Kakšna tveganja so povezana z zdravilom Entyvio?
English: For more information about treatment with Entyvio, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Entyvio preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Patients received either Entyvio or placebo (a dummy treatment) and the main measure of effectiveness was the proportion of patients whose symptoms improved after 6 weeks of treatment.
Slovenian: Bolniki so prejemali bodisi zdravilo Entyvio bodisi placebo (zdravilo brez zdravilne učinkovine), glavno merilo učinkovitosti pa je bilo delež bolnikov, pri katerih so se po 6 tednih zdravljenja simptomi izboljšali.
English: Entyvio is produced by a method known as ‘recombinant DNA technology'; it is made by cells into which a gene (DNA) has been introduced that makes them able to produce vedolizumab.
Slovenian: Zdravilo Entyvio se pridobiva z metodo, imenovano „tehnologija rekombinantne DNA“: izdelajo ga celice, v katere so vstavili gen (DNA), s pomočjo katerega lahko tvorijo vedolizumab.
English: Entyvio was shown to be more effective than placebo: 47% (106 out of 225) of patients who received Entyvio showed an improvement in symptoms, compared with 26% (38 out of 149) of patients who received placebo.
Slovenian: Zdravilo Entyvio se je izkazalo za učinkovitejše od placeba: izboljšanje simptomov so opazili pri 47 % (106 od 225) bolnikov, ki so prejemali zdravilo Entyvio, v primerjavi s 26 % (38 od 149) bolnikov, ki so prejemali placebo.
English: It can only be obtained with a prescription and treatment should be started and supervised by a specialist who has experience in the diagnosis and treatment of ulcerative colitis or Crohn's disease.
Slovenian: Izdaja zdravila je le na recept, zdravljenje z njim pa mora uvesti in nadzorovati zdravnik specialist, ki ima izkušnje z diagnosticiranjem in zdravljenjem ulceroznega kolitisa ali Crohnove bolezni.
English: What benefits of Entyvio have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Entyvio izkazalo v študijah?
English: The most common side effects with Entyvio (which may affect more than 1 in 10 people) are nasopharyngitis (inflammation of the nose and throat such as a cold), headache and arthralgia (joint pain).
Slovenian: Najpogostejši neželeni učinki zdravila Entyvio (ki se lahko pojavijo pri več kot 1 osebi od 10) so nazofaringitis (vnetje nosu in žrela, kot je na primer prehlad), glavobol in artralgija (bolečine v sklepih).
English: By blocking alfa-4-beta-7 integrin, vedolizumab reduces the inflammation in the gut and the symptoms of these diseases.
Slovenian: Vedolizumab z zaviranjem integrina alfa-4-beta-7 zmanjša vnetje v črevesju in simptome teh bolezni.
English: In Crohn's disease, the CHMP considered that although the time required for improvement of symptoms may be longer and the size of the effect limited when compared with anti-TNF-alfa therapy, Entyvio still offers a benefit for patients because of its different mechanism of action and safety profile.
Slovenian: Glede Crohnove bolezni je odbor CHMP menil, da je sicer čas, potreben za izboljšanje simptomov, lahko daljši, obseg učinka pa omejen v primerjavi z zdravljenjem z zaviralci TNF-alfa, vendar ima zdravilo Entyvio zaradi drugačnega mehanizma delovanja ter varnostnega profila kljub temu koristi za bolnike.
English: It is used to treat adult patients with ulcerative colitis (a disease causing inflammation and ulcers in the lining of the gut) or Crohn's disease (a disease causing inflammation of the digestive tract).
Slovenian: Uporablja se za zdravljenje odraslih bolnikov z ulceroznim kolitisom (boleznijo, ki povzroča vnetje in razjede na črevesni sluznici) ali Crohnovo boleznijo (boleznijo, ki povzroča vnetje prebavnega trakta).
English: Entyvio is a medicine that contains the active substance vedolizumab.
Slovenian: Entyvio je zdravilo, ki vsebuje zdravilno učinkovino vedolizumab.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Entyvio, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Entyvio in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: In one main study in adult patients with moderate to severe active Crohn's disease in whom conventional therapy or TNF-alfa antagonists were ineffective or could not be tolerated, 15% (32 out of 220) of patients receiving Entyvio showed improved symptoms after 6 weeks of treatment, compared with 7% (10 out of 148) of patients on placebo.
Slovenian: V eni glavni študiji pri odraslih bolnikih z zmerno do močno aktivno Crohnovo boleznijo, pri katerih konvencionalno zdravljenje ali zdravljenje z zaviralci TNF-alfa ni bilo učinkovito ali pa ga niso prenašali, so izboljšanje simptomov po 6 tednih opazili pri 15 % (32 od 220) bolnikov, ki so prejemali zdravilo Entyvio, v primerjavi s 7 % (10 od 148) bolnikov, ki so prejemali placebo.
English: Similarly, in this study the maintenance of the effect up to 52 weeks with Entyvio was more effective than with placebo.
Slovenian: Podobno je bilo v tej študiji vzdrževanje učinka zdravila Entyvio v obdobju 52 tednov uspešnejše kot pri placebu.
English: In ulcerative colitis, the Committee considered that the benefit of Entyvio has been clearly demonstrated, which is relevant for patients who do not respond to TNF-alfa therapy.
Slovenian: Odbor je menil, da je bila pri ulceroznem kolitisu korist zdravila Entyvio nedvomno dokazana, kar je pomembno za bolnike, ki se ne odzivajo na zdravljenje z zaviralci TNF-alfa.
English: For practical information about using Entyvio, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Entyvio naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: In addition, the study also showed that Entyvio maintained the effect up to 52 weeks more effectively than placebo.
Slovenian: Poleg tega je študija pokazala, da je zdravilo Entyvio uspešneje vzdrževalo učinek v obdobju 52 tednov kot placebo.
English: Vedolizumab is used to treat moderate to severe active disease when conventional therapy or medicines called TNF-alfa antagonists are ineffective, no longer effective, or cannot be tolerated by the patient.
Slovenian: Vedolizumab se uporablja za zdravljenje zmerno do močno aktivne bolezni, kadar konvencionalno zdravljenje ali zdravljenje z zdravili, imenovanimi zaviralci tumorje nekrotizirajočega faktorja alfa (TNF-alfa), ni učinkovito, ni več učinkovito ali pa ga bolnik ne prenaša.
English: For the full list of all side effects reported with Entyvio, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Entyvio, glejte navodilo za uporabo.
English: In ulcerative colitis, Entyvio has been investigated in a main study in patients with moderate to severe active disease in whom conventional therapy or TNF-alfa antagonists were ineffective or could not be tolerated.
Slovenian: Zdravilo Entyvio so pri ulceroznem kolitisu proučili v glavni študiji pri bolnikih z zmerno do močno aktivno boleznijo, pri katerih konvencionalno zdravljenje ali zdravljenje z zaviralci TNF-alfa ni bilo učinkovito ali pa ga niso prenašali.
English: All patients are monitored for any reactions during the infusion and for at least one to two hours after the end of the infusion.
Slovenian: Med infundiranjem in še najmanj eno do dve uri po njem je treba preverjati, ali so se pri bolniku pojavile kakršne koli reakcije.
English: The active substance in Entyvio, vedolizumab, is a monoclonal antibody.
Slovenian: Zdravilna učinkovina v zdravilu Entyvio, vedolizumab, je monoklonsko protitelo.
English: Entyvio is available as a powder to be made up into a solution for infusion (drip) into a vein.
Slovenian: Zdravilo Entyvio je na voljo v obliki praška za pripravo raztopine za infundiranje (kapalno infuzijo) v veno.
English: How is Entyvio used?
Slovenian: Kako se zdravilo Entyvio uporablja?
English: How does Entyvio work?
Slovenian: Kako zdravilo Entyvio deluje?
English: The European Commission issued a decision on 2 September 2011.
Slovenian: Evropska komisija je odločbo izdala 2. septembra 2011.
English: The use in children was further clarified.
Slovenian: Natančneje je bila pojasnjena tudi uporaba pri otrocih.
English: Diflucan is authorised in the EU via national procedures.
Slovenian: Zdravilo Diflucan je v EU odobreno z nacionalnimi postopki.
English: Why was Diflucan reviewed?
Slovenian: Zakaj je bilo zdravilo Diflucan pregledano?
English: The CHMP harmonised the dosing recommendations for the various indications to be in line with international guidelines.
Slovenian: CHMP je uskladil priporočila za odmerjanje za različne indikacije, tako da so usklajena z mednarodnimi smernicami.
English: The European Medicines Agency has completed a review of Diflucan.
Slovenian: Evropska agencija za zdravila je zaključila pregled zdravila Diflucan.
English: The Committee harmonised the wording on the use of the medicine for these conditions, specifying when it is to be used for treatment and prophylaxis (prevention) and introducing restrictions for certain indications.
Slovenian: Odbor je uskladil besedilo za uporabo zdravila pri teh boleznih in opredelil, kdaj je treba zdravilo uporabljati za zdravljenje in profilakso (preprečevanje), ter uvedel omejitve za nekatere indikacije.
English: On 18 February 2010, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Diflucan in the EU.
Slovenian: Evropska komisija je 18. februarja 2010 zadevo napotila na CHMP, da bi uskladila dovoljenja za promet z zdravilom Diflucan v EU.
English: Diflucan is an antifungal medicine that belongs to the triazoles group.
Slovenian: Diflucan je protiglivično zdravilo, ki spada v skupino triazolov.
English: It contains the active substance fluconazole.
Slovenian: Vsebuje zdravilno učinkovino flukonazol.
English: Diflucan is also available in the EU under other trade names: Fluconazole, Fungustatin, Fungata, Triflucan.
Slovenian: Zdravilo Diflucan je v EU na voljo tudi pod drugimi tržnimi imeni: Fluconazole, Fungustatin, Fungata, Triflucan.
English: Medicines known to prolong the QT interval and which are metabolised via the cytochrome P450 (CYP) 3A4 such as cisapride, astemizole, pimozide, quinidine and erythromycin should also not be given to patients receiving Diflucan.
Slovenian: Zdravila, za katera je znano, da podaljšujejo interval QT in ki se presnavljajo prek citokroma P450 (CYP) 3A4, kot so cisaprid, astemizol, pimozid, kinidin in eritromicin, se prav tako ne smejo dajati bolnikom, ki jemljejo zdravilo Diflucan.
English: Diflucan works by preventing the formation of ergosterol, which is an important part of fungal cell walls.
Slovenian: Zdravilo Diflucan deluje tako, da preprečuje nastajanje ergosterola, ki je pomemben del glivičnih celičnih sten.
English: Other sections harmonised by the CHMP include sections on special warnings, side effects, interactions, pharmacological properties and quality.
Slovenian: Druga poglavja, ki jih je uskladil CHMP, so poglavje s posebnimi opozorili, o neželenih učinkih, medsebojnem delovanju, farmakoloških lastnostih ter kakovosti zdravila.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that there is a need to harmonise the prescribing information for Diflucan in the European Union (EU).
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri Agenciji je zaključil, da je treba v Evropski uniji (EU) uskladiti podatke o predpisovanju zdravila Diflucan.
English: Terfenadine must also not be used in patients receiving Diflucan at multiple doses of 400 mg per day or higher.
Slovenian: Pri bolnikih, ki jemljejo zdravilo Diflucan z večkratnimi odmerki v količini 400 mg na dan ali več, se prav tako ne sme uporabljati terfenadin.
English: The CHMP agreed that Diflucan should not be used in patients who are hypersensitive (allergic) to the active substance, to related azole substances, or to any of other ingredient of the medicine.
Slovenian: CHMP je potrdil, da se zdravilo Diflucan ne sme uporabljati pri bolnikih, ki so preobčutljivi za (alergični na) zdravilno učinkovino, na sorodne azolne snovi ali katero koli drugo sestavino zdravila.
English: The CHMP agreed that Diflucan can be used for the following conditions: mucosal and invasive candidiasis, genital candidiasis (trush), crypotococcal meningitis, dermatomycosis, coccidiodomycosis and onychomycosis.
Slovenian: CHMP je potrdil, da se zdravilo Diflucan lahko uporablja za naslednje bolezni: mukozna in invazivna kandidiaza, genitalna kandidiaza (sor), kriptokokni meningitis, dermatomikoze, kokcidiodomikoze in onihomikoze.
English: What is Diflucan?
Slovenian: Kaj je zdravilo Diflucan?
English: Diflucan is used to treat various fungal infections, including candidiasis (thrush) and fungus in the nails.
Slovenian: Zdravilo Diflucan se uporablja za zdravljenje različnih glivičnih okužb, vključno s kandidiazo (sor) in nohtnimi glivicami.
English: Diflucan was identified as needing harmonisation by the Co-ordination Group on the Mutual and Decentralised Procedures - Human (CMD(h)).
Slovenian: Skupina za usklajevanje za postopek z medsebojnim priznavanjem in decentralizirani postopek za zdravila za uporabo v humani medicini CMD(h) je ugotovila, da je za zdravilo Diflucan potrebno usklajevanje.
English: As a result of the following weaknesses identified with this study the results could not be accepted:
Slovenian: Kot posledica naslednjih slabosti, ugotovljenih pri tej študiji, rezultatov niso mogli sprejeti:
English: • The possibility of release into the environment has not been investigated.
Slovenian: • možnost sproščanja v okolje ni bila raziskana.
English: In the first phase the DT50 was calculated to be 4 hours, while it was 12 hours in the second phase.
Slovenian: V prvi fazi je bil izračunani DT50 4 ure, medtem ko je bil v drugi fazi 12 ur.
English: However at the end of the study (27 days), 64% of the dose formed non-extractable residues.
Slovenian: Vendar pa so ob koncu študije (27 dni) 64 % odmerka sestavljali ostanki, ki jih ni bilo mogoče ekstrahirati.
English: The DT50 was further recalculated in accordance with a biphasic model.
Slovenian: DT50 so ponovno izračunali v skladu z bifaznim modelom.
English: Res Vet Sci. 1980 May;28(3):267-74.
Slovenian: Res Vet Sci. 1980 maj;28(3):267-74.
English: Member State Applicant/Marketing Authorisation Holder
Slovenian: Država članica Predlagatelj/imetnik dovoljenja za promet z zdravilom
English: When such specific information is not available the default values given in the guideline are applied.
Slovenian: Kadar tovrstne specifične informacije niso na voljo, se uporabijo privzete vrednosti, podane v smernici.
English: The CVMP therefore considers that the objections raised by Germany and The Netherlands should not prevent the granting of a Marketing Authorisation.
Slovenian: CVMP zato meni, da ugovori Nemčije in Nizozemske ne smejo preprečiti odobritve dovoljenja za promet z zdravilom.