FrancophonIA/ELRC3.0 huggingface dataset:
English: Take special care with [product name]”
Slovenian: Bodite posebno pozorni pri uporabi [ime zdravila]
English: At each visit, the risk benefit profile of cabergoline treatment for the patient should be reassessed to determine the suitability of continued treatment with cabergoline.
Slovenian: Ob vsakem pregledu je potrebno ovrednotiti razmerje koristi in tveganj za bolnika, da določimo, ali je še primerno nadaljevanje zdravljenja s kabergolinom.
English: Section 2 “Before you take [product name]”: Do not take [product name] if you:
Slovenian: Poglavje 2 “Kaj morate vedeti, preden boste vzeli zdravilo [ime zdravila]”: Ne jemljite zdravila [ime zdravila], če:
English: Fibrotic disorders can have an insidious onset and patients should be regularly monitored for possible manifestations of progressive fibrosis.
Slovenian: Fibrotične bolezni lahko nastopijo prikrito, zato je potrebno bolnike redno spremljati, za primer da bi se pojavili znaki progresivne fibroze.
English: “For long-term treatment: Evidence of cardiac valvulopathy as determined by pre-treatment echocardiography.”
Slovenian: „Za dolgoročno zdravljenje: Dokazi srčne valvulopatije, določeni z ehokardiografijo pred zdravljenjem.“
English: He/she will also have an echocardiogram (an ultrasound test of the heart) taken before treatment is started and at regular intervals during treatment.
Slovenian: Naredil bo tudi ehokardiogram /ultrazvočni pregled srca pred začetkom zdravljenja in nato tudi v rednih časovnih presledkih med zdravljenjem.
English: The following should be included under Pregnancy and breast feeding (for cabergoline-containing medicinal products authorised in the indication of anovulation and infertility only):
Slovenian: Naslednje besedilo je potrebno vključiti pod Nosečnost in dojenje (samo za zdravila, ki vsebujejo kabergolin in so registrirana za indikacijo anovulacije (izostanka ovulacije) in neplodnosti):
English: The following should be included under Cardiac disorders: “Very common: cardiac valvulopathy (including regurgitation) and related disorders (pericarditis and pericardial effusion).”
Slovenian: Pod Srčne bolezni je potrebno vključiti naslednje besedilo: “Zelo pogosto: srčna valvulopatija (vključno z regurgitacijo) in z njo povezane bolezni (perikarditis in perikardialni izliv."
English: Before initiating long-term treatment:
Slovenian: Pred začetkom dolgoročnega zdravljenja:
English: In some cases, symptoms or manifestations of cardiac valvulopathy improved after discontinuation of pergolide.
Slovenian: V nekaterih primerih so se simptomi ali manifestacije srčne valvulopatije po prenehanju dajanja pergolida izboljšali.
English: In patients with valvular regurgitation, it is not known whether pergolide treatment might worsen the underlying disease.
Slovenian: Pri bolnikih z valvularno regurgitacijo ni znano, ali bi utegnilo zdravljenje s pergolidom poslabšati že obstoječo bolezen.
English: Chest x-ray examination is recommended in cases of unexplained ESR increases to abnormal values.
Slovenian: V primerih nepojasnjenih povečanj ESR na nenormalne vrednosti priporočajo rentgenski pregled prsnega koša.
English: Cardiac failure; cases of valvular and pericardial fibrosis have often manifested as cardiac failure.
Slovenian: srčno popuščanje; primeri valvularne in perikardialne fibroze se pogosto izrazijo v obliki srčnega popuščanja.
English: In patients with valvular regurgitation, it is not known whether cabergoline treatment might worsen the underlying disease.
Slovenian: Pri bolnikih z valvularno regurgitacijo ni znano, ali bi utegnilo zdravljenje s kabergolinom poslabšati že obstoječo bolezen.
English: In some cases, symptoms or manifestations of cardiac valvulopathy improved after discontinuation of cabergoline.
Slovenian: V nekaterih primerih so se simptomi ali manifestacije srčne valvulopatije po prenehanju dajanja kabergolina izboljšali.
English: During long-term treatment:
Slovenian: Med dolgoročnim zdravljenjem:
English: The need for other clinical monitoring (e.g. physical examination including, cardiac auscultation, Xray, CT scan) should be determined on an individual basis.
Slovenian: fizični pregled vključno s kardialno avskultacijo, rentgensko slikanje, CT) je potrebno določiti za vsakega bolnika posebej.
English: Before initiating treatment:
Slovenian: Pred začetkom zdravljenja:
English: “Before administration of cabergoline pregnancy should be excluded.
Slovenian: “Preden uvedemo kabergolin, je potrebno izključiti morebitno nosečnost.
English: Cabergoline should be discontinued if an echocardiogram reveals new or worsened valvular regurgitation, valvular restriction or valve leaflet thickening (see Section 4.3).
Slovenian: Zdravljenje s kabergolinom je treba prekiniti, če ehokardiogram pokaže novo ali poslabšano valvularno regurgitacijo, valvularno restrikcijo ali zadebelitev lističa zaklopke (glejte Poglavje 4.3).
English: During treatment:
Slovenian: Med zdravljenjem:
English: Pergolide should be discontinued if an echocardiogram reveals new or worsened valvular regurgitation, valvular restriction or valve leaflet thickening (see Section 4.3).
Slovenian: Zdravljenje s pergolidom je treba prekiniti, če ehokardiogram pokaže novo ali poslabšano valvularno regurgitacijo, valvularno restrikcijo ali zadebelitev lističa zaklopke (glejte Poglavje 4.3).
English: If fibrotic valvular disease is detected, the patient should not be treated with pergolide (see section 4.3).
Slovenian: Če odkrijemo fibrotično valvularno bolezen, zdravljenje s pergolidom ni dovoljeno (glejte poglavje 4.3).
English: Renal insufficiency or ureteral/abdominal vascular obstruction that may occur with pain in the loin/flank and lower limb oedema as well as any possible abdominal masses or tenderness that may indicate retroperitoneal fibrosis.
Slovenian: ledvične insuficience ali uretralne/abdominalne vaskularne obstrukcije, ki se lahko začne z bolečino v ledjih in v bočnem predelu ter z edemi spodnjih okončin, lahko pa tudi z nastankom gmot v abdomnu ali občutljivostjo, kar je lahko znak retroperitonealne fibroze.
English: Therefore, valvular fibrosis (and constrictive pericarditis) should be excluded if such symptoms occur.
Slovenian: Zato je potrebno, v primeru da se pokažejo tovrstni simptomi, izključiti valvularno fibrozo (in konstrikcijski perikarditis).
English: It is also appropriate to perform baseline investigations of erythrocyte sedimentation rate or other inflammatory markers, lung function/chest X-ray and renal function prior to initiation of therapy.
Slovenian: Primerno je tudi, da se pred začetkom zdravljenja opravijo osnovne preiskave hitrosti sedinmentacije eritrocitov ali drugih kazalcev vnetja, rentgenski pregled pljučnega delovanja/prsnega koša in ledvičnega delovanja.
English: “Very common side effect (affecting more than one person in ten): heart valve and related disorders e.g. inflammation (pericarditis) or leaking of fluid in the pericardium (pericardial effusion).
Slovenian: “Zelo pogosti neželeni učinki (ki jih izkusi več kot ena oseba od desetih): obolenja srčne zaklopke in druga sorodna obolenja, npr. vnetje (perikarditis, t.j.
English: If fibrotic valvular disease is detected, the patient should not be treated with cabergoline (see section 4.3).
Slovenian: Če odkrijemo fibrotično valvularno bolezen, zdravljenje s kabergolinom ni dovoljeno (glejte poglavje 4.3).
English: “- have or had fibrotic reactions (scar tissue) affecting your heart.”
Slovenian: “- imate ali ste imeli fibrotične reakcije (brazgotinasto tkivo), ki so prizadele vaše srce.”
English: ANNEX III AMENDMENTS TO THE SUMMARIES OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLETS
Slovenian: ANEKS III SPREMEMBE POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA IN NAVODILA ZA UPORABO
English: “Evidence of cardiac valvulopathy as determined by pre-treatment echocardiography.”
Slovenian: “Znaki srčne valvulopatije, ugotovljene z ehokardiografijo pred začetkom zdravljenja..”
English: Additional appropriate investigations such as erythrocyte sedimentation rate, and serum creatinine measurements should be performed if necessary to support a diagnosis of a fibrotic disorder.”
Slovenian: Po potrebi je zaradi dokazovanja diagnoze fibrotičnega obolenja treba opraviti ustrezne dodatne preiskave, kot sta hitrost sedimentacije eritrocitov in serumski kreatinin."
English: “If you have or had fibrotic reactions (scar tissue) affecting your heart, lungs or abdomen.
Slovenian: “Če imate ali ste ste imeli fibrotične reakcije (brazgotinasto tkivo), ki so prizadele vaše srce, pljuča ali trebuh.
English: Section 2 “Before you take [product name]”.
Slovenian: Poglavje 2 “Kaj morate vedeti, preden boste vzeli zdravilo [ime zdravila]”:
English: “-will be treated with [product name] for a long period and have or had fibrotic reactions (scar tissue) affecting your heart.”
Slovenian: „- se boste z zdravilom [ime zdravila] zdravili dolgo časa in imate oziroma ste imeli fibrozne reakcije (brazgotinsko tkivo), ki so vplivale na vaše srce.“
English: Fibrotic and serosal inflammatory disorders such as pleuritis, pleural effusion, pleural fibrosis, pulmonary fibrosis, pericarditis, pericardial effusion, cardiac valvulopathy involving one or more valves (aortic, mitral and tricuspid) or retroperitoneal fibrosis have occurred after prolonged usage of ergot derivatives with agonist activity at the serotonin 5HT2B receptor, such as pergolide.
Slovenian: Po dolgotrajnejši uporabi ergot derivatov z delovanjem na serotoninske receptorje 5HT2B, kakršen je pergolid, so se pojavila fibrotična in serozna vnetna obolenja, kot so plevritis, plevralni izliv, plevralna fibroza, pljučna fibroza, perikarditis, perikardialni izliv, srčna valvulopatija, ki prizadene eno ali več zaklopk (aortno, mitralno in trikuspidalno) ali retroperitonealna fibroza.
English: Fibrotic and serosal inflammatory disorders such as pleuritis, pleural effusion, pleural fibrosis, pulmonary fibrosis, pericarditis, pericardial effusion, cardiac valvulopathy involving one or more valves (aortic, mitral and tricuspid) or retroperitoneal fibrosis have occurred after prolonged usage of ergot derivatives with agonist activity at the serotonin 5HT2B receptor, such as cabergoline.
Slovenian: Po dolgotrajnejši uporabi ergot derivatov z delovanjem na serotoninske receptorje 5HT2B, kakršen je kabergolin, so se pojavila fibrotična in serozna vnetna obolenja, kot so plevritis, plevralni izliv, plevralna fibroza, pljučna fibroza, perikarditis, perikardialni izliv, srčna valvulopatija, ki prizadene eno ali več zaklopk (aortno, mitralno in trikuspidalno) ali retroperitonealna fibroza.
English: Clinical diagnostic monitoring for development of valvular disease or fibrosis, as appropriate, is essential.
Slovenian: Nujno potrebno je klinično diagnostično spremljanje, skladno s potrebami, zaradi možnosti nastanka valvularne bolezni ali fibroze.
English: 4.2 Posology and method of administration The following should be reflected as appropriate: Restriction of the maximum dose to 3 mg/day
Slovenian: Najvišji dnevni odmerek je omejen na 3 mg/dan
English: AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE SUMMARY OF PRODUCT CHARACTERISTICS FOR PERGOLIDE CONTAINING MEDICINAL PRODUCTS
Slovenian: SPREMEMBE, KI JIH JE POTREBNO VKLJUČITI V USTREZNA POGLAVJA POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA ZA VSA ZDRAVILA, KI VSEBUJEJO PERGOLID
English: AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE SUMMARY OF PRODUCT CHARACTERISTICS FOR CABERGOLINE CONTAINING MEDICINAL PRODUCTS
Slovenian: SPREMEMBE, KI JIH JE POTREBNO VKLJUČITI V USTREZNA POGLAVJA POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA ZA VSA ZDRAVILA, KI VSEBUJEJO KABERGOLIN
English: Clinical diagnostic monitoring for development of fibrotic disorders, as appropriate, is essential.
Slovenian: Nujno potrebno je klinično diagnostično spremljanje, skladno s potrebami, zaradi možnosti nastanka fibrotičnih obolenj.
English: Therefore, during treatment, attention should be paid to the signs and symptoms of: Pleuro-pulmonary disease such as dyspnoea, shortness of breath, persistent cough or chest pain.
Slovenian: plevro-pljučne bolezni, kot je dispneja, kratka sapa, vztrajen kašelj ali bolečine v prsnem košu.
English: AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE PACKAGE LEAFLET FOR PERGOLIDE CONTAINING MEDICINAL PRODUCTS
Slovenian: POPRAVKI, KI JIH JE POTREBNO VKLJUČITI V USTREZNA POGLAVJA NAVODILA ZA UPORABO PRI VSEH ZDRAVILIH, KI VSEBUJEJO PERGOLID
English: AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE PACKAGE LEAFLET FOR CABERGOLINE CONTAINING MEDICINAL PRODUCTS
Slovenian: POPRAVKI, KI JIH JE POTREBNO VKLJUČITI V USTREZNA POGLAVJA NAVODILA ZA UPORABO PRI VSEH ZDRAVILIH, KI VSEBUJEJO KABERGOLIN
English: Ref. EMEA/CHMP/494914/2008
Slovenian: EMEA/CHMP/494934/2008
English: The procedure started on 22 March 2007.
Slovenian: Postopek se je začel 22. marca 2007.
English: London, 3 September 2008 Doc.
Slovenian: London, 3. september 2008 Ref. dok.
English: A Decision was issued by the European Commission on 3 September 2008.
Slovenian: Odločbo je Evropska komisija izdala 3. septembra 2008.
English: The Marketing Authorisation Holder provided supplementary information on 23 July 2007.
Slovenian: Imetnik dovoljenja za promet z zdravilom je posredoval dodatne informacije 23. julija 2007.
English: Cozaar Comp and associated names, 50/12.5 mg; 100/12.5 mg; 100/25 mg, film coated tablets is a fixed dose combination of losartan and hydrochlorothiazide.
Slovenian: Zdravilo Cozaar Comp in povezana imena, 50/12,5 mg; 100/12,5 mg; 100/25 mg, filmsko obložene tablete, je kombinacija fiksnih odmerkov losartana in hidroklorotiazida.
English: Losartan is an orally active angiotensin II (Ang- II) receptor antagonist acting on the AT1 receptor subtype, thus blocking the effect of Ang-II in the renin angiotensin system (RAS) cascade.
Slovenian: Losartan je peroralno aktivni antagonist receptorjev angiotenzina II (Ang- II), ki deluje na receptorje podtipa AT1 in tako blokira učinek Ang-II v kaskadi renin-angiotenzinskega sistema (RAS).
English: Hydrochlorothiazide (HCTZ) is a thiazide diuretic which has also been used as an antihypertensive agent.
Slovenian: Hidroklorotiazid (HCTZ) je tiazidni diuretik, ki se uporablja tudi kot antihipertenziv.
English: The basis for referral was that there were divergences in the Summaries of Product Characteristics (SPC) of Cozaar Comp. and associated names approved across EU Member States, with respect to the following indications: Treatment of hypertension in patients whose blood pressure is not adequately controlled on losartan or hydrochlorothiazide; As first step treatment in patients with moderate to severe hypertension and in patients with high or very high cardiovascular risk; Reduction of cardiovascular morbidity and mortality in hypertensive patients with left ventricular hypertrophy.
Slovenian: Podlaga za napotitev so bile ugotovljene razlike v odobrenih povzetkih glavnih značilnosti zdravila za zdravilo Cozaar Comp in povezana imena v različnih državah članicah EU v zvezi z indikacijami: zdravljenje hipertenzije pri bolnikih, pri katerih krvnega tlaka ni mogoče ustrezno nadzorovati samo z losartanom ali hidroklortiazidom; prva stopnja zdravljenja bolnikov z zmerno do resno hipertenzijo in bolnikov z visokim ali zelo visokim srčnožilnim tveganjem; zmanjšanje kardiovaskularne obolevnosti in smrtnosti pri hipertenzivnih bolnikih s hipertrofijo levega prekata.
English: On 23 February 2007, Denmark presented to the EMEA a referral under Article 30 of Directive 2001/83/EC, as amended, in order to harmonise the nationally authorised summaries of product characteristics, package leaflet and labelling of the medicinal product Cozaar Comp. and associated names.
Slovenian: Dne 23. februarja 2007 je Danska agenciji EMEA predložila napotitev v skladu s členom 30 Direktive 2001/83/ES, kakor je bila spremenjena, da bi tako uskladili nacionalno odobrene povzetke glavnih značilnosti zdravila, navodila za uporabo in označevanje za zdravilo Cozaar Comp in povezana imena.
English: The losartan/hydrochlorothiazide combination is indicated for the treatment of hypertension in patients whose blood pressure is not adequately controlled on losartan or hydrochlorothiazide.
Slovenian: Kombinacija losartan/hidroklorotiazid je namenjena za zdravljenje hipertenzije pri bolnikih, pri katerih samo z losartanom ali hidroklortiazidom ni mogoče ustrezno uravnavati krvnega tlaka.
English: The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II together with the amended SPC, labelling and package leaflet in Annex III.
Slovenian: Seznam zadevnih imen izdelkov je naveden v Dodatku I. Znanstveni zaključki so na voljo v Dodatku II, spremenjeni povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo pa v Dodatku III.
English: During its 21 - 24 April 2008 meeting, the CHMP, in the light of the overall submitted data and the scientific discussion within the Committee, was of the opinion that the proposal for the harmonisation of the SPC, Labelling and Package leaflet was acceptable and that they should be amended.
Slovenian: Med zasedanjem od 21. do 24. aprila 2008 je CHMP na podlagi vseh posredovanih podatkov in znanstvene razprave v okviru Odbora, sprejel mnenje, da je predlog za uskladitev povzetkov glavnih značilnosti zdravila, označevanja in navodila za uporabo sprejemljiv ter da jih je treba ustrezno spremeniti.
English: The CHMP gave a positive opinion on 24 April 2008 recommending the harmonisation of the SPC, labelling and package leaflet for Cozaar Comp. and associated names.
Slovenian: CHMP je 24. aprila 2008 izdal pozitivno mnenje, s katerim priporoča uskladitev povzetkov glavnih značilnosti zdravila, označevanja in navodila za uporabo za Cozaar Comp. in povezana imena.
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 30 REFERRAL FOR Cozaar Comp and associated names International Non-Proprietary Name (INN): losartan + hydrochlorothiazide
Slovenian: Mednarodno nelastniško ime (INN): losartan + hidroklorotiazid
English: The European Commission issued a decision on 7 July 2010.
Slovenian: Evropska komisija je odločbo izdala dne 7. julija 2010.
English: Harald Enzmann (Germany)
Slovenian: Harald Enzmann (Nemčija)
English: It is used to treat the following types of cancer:
Slovenian: Uporablja se za zdravljenje naslednjih vrst raka:
English: Jean-François Baurain (Belgium)
Slovenian: Jean-François Baurain (Belgija)
English: Bendamustine has been used in anticancer medicines in Germany since the early 1970s.
Slovenian: Bendamustin se v Nemčiji v zdravilih proti raku uporablja od začetka sedemdesetih let prejšnjega stoletja.
English: What are the conclusions of the CHMP?
Slovenian: Do kakšnih zaključkov je prišel CHMP?
English: Why was Levact reviewed?
Slovenian: Zakaj je bilo zdravilo Levact pregledano?
English: As a result, the cancer cells cannot divide and the growth of tumours slows down.
Slovenian: Celice raka se tako ne morejo deliti in rast tumorjev se upočasni.
English: The European Medicines Agency has completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Levact and associated names.
Slovenian: Evropska agencija za zdravila je končala postopek arbitraže, do katerega je prišlo po nesoglasju med državami članicami Evropske unije (EU) glede odobritve zdravila Levact in povezanih imen.
English: Co-Rapporteur:
Slovenian: Soporočevalec:
English: It binds to the DNA of cells while they are reproducing, which stops cell division.
Slovenian: Veže se na DNK celic med njihovim razmnoževanjem, kar preprečuje delitev celic.
English: However, the Member States were not able to reach an agreement and the German medicines regulatory agency referred the matter to the CHMP for arbitration on 2 October 2009.
Slovenian: Vendar države članice niso mogle doseči soglasja in nemška regulativna agencija za zdravila je dne 2. oktobra 2009 zadevo napotila na CHMP v arbitražo.
English: 14 January 2010 and 17 February 2010
Slovenian: 14. januarja 2010 in 17. februarja 2010
English: The grounds for the referral were that one Member State, the United Kingdom, could not approve the indication non-Hodgkin's lymphoma, and two Member States, Belgium and France, could not approve the indication multiple myeloma because not enough data on the effectiveness of this medicine were available to support these indications.
Slovenian: Podlaga za napotitev je bila, da ena država članica, Združeno kraljestvo, ni mogla odobriti indikacije ne-Hodgkinov limfom, dve državi članici, Belgija in Francija, pa nista mogli odobriti indikacije multipli mielom, saj ni bilo dovolj podatkov glede učinkovitosti tega zdravila pri teh indikacijah.
English: The Committee therefore recommended that Levact be granted marketing authorisation in Germany and all concerned Member States for all the indications that were applied for.
Slovenian: Odbor je tako priporočil odobritev dovoljenja za promet z zdravilom Levact v Nemčiji in v vseh zadevnih državah članicah za vse indikacije, za katere je bila vložena vloga.
English: This is a procedure where one Member State (the ‘reference Member State', in this instance Germany) assesses a medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other Member States (the ‘concerned Member States', in this instance Belgium, Denmark, Finland, France, Ireland, Italy, Luxembourg, Norway, Poland, Spain and the United Kingdom).
Slovenian: To je postopek, v katerem ena država članica („referenčna država članica“, v tem primeru Nemčija) oceni zdravilo z namenom odobritve dovoljenja za promet z njim, ki bo veljavno v tej državi in v drugih državah članicah („zadevne države članice“, v tem primeru Avstrija, Belgija, Danska, Finska, Francija, Irska, Italija, Luksemburg, Norveška, Poljska, Španija in Združeno kraljestvo).
English: Astellas Pharma GmbH submitted Levact to the German medicines regulatory agency for a decentralised procedure.
Slovenian: Družba Astellas Pharma GmbH je nemški regulativni agenciji predložila zdravilo Levact v decentralizirani postopek.
English: 22 October 2009
Slovenian: 22. oktober 2009
English: Based on the evaluation of these data and the scientific discussion within the Committee, the CHMP concluded that the benefits of Levact outweigh its risks for the two indications for which objections were raised.
Slovenian: Na podlagi ocene teh podatkov in znanstvene razprave v Odboru je CHMP menil, da koristi zdravila Levact odtehtajo njegova tveganja pri obeh indikacijah, pri katerih so se pojavili zadržki.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Levact outweigh its risks, and that the marketing authorisation can be granted in Germany and in the following Member States: Austria, Belgium, Denmark, Finland, France, Ireland, Italy, Luxembourg, Norway, Poland, Spain and the United Kingdom.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da koristi zdravila Levact odtehtajo njegova tveganja in da se lahko dovoljenje za promet z zdravilom odobri v Nemčiji ter v navedenih državah članicah: Avstrija, Belgija, Danska, Finska, Francija, Irska, Italija, Luksemburg, Norveška, Poljska, Španija in Združeno kraljestvo.
English: The CHMP assessed the two clinical studies presented by the company to support the multiple myeloma and non-Hodgkin's lymphoma indications.
Slovenian: CHMP je ocenil dve klinični študiji, ki ju je družba predložila v podporo indikacijama multipli mielom in ne-Hodgkinov limfom.
English: Levact is an anticancer medicine.
Slovenian: Levact je zdravilo proti raku.
English: Questions and answers on Levact and associated names (bendamustine hydrochloride, 2.5 mg/ml, powder for concentrate for solution for infusion) EMA/CHMP/735863/2009
Slovenian: Vprašanja in odgovori v zvezi z zdravilom Levact in povezanimi imeni (bendamustin hidroklorid, 2,5 mg/ml, prašek za koncentrat za raztopino za infundiranje) EMA/CHMP/735863/2009
English: Company responses provided on:
Slovenian: Odgovori družbe, poslani dne:
English: 18 March 2010
Slovenian: 18. marec 2010
English: 7 July 2010
Slovenian: 7. julij 2010