FrancophonIA/ELRC3.0 huggingface dataset:
English: Point estimates in all nine trials favoured cilostazol 100mg bid over placebo and the analysis demonstrated statistical superiority of cilostazol over placebo in six of the nine trials.
Maltese: L-istimi tal-punti fid-disa' provi kollha kemm huma kienu favur il-kilostażolu 100mg darbtejn kuljum meta mqabbel mal-plaċebo u l-analiżi wriet superjorità statistika tal-kilostażolu fuq il-plaċebo f'sitta mid-disa' provi kliniċi.
English: However, they recognised that there is a risk of bleeding with triple therapy and that triple therapy should be avoided (cilostazol and two antiplatelet drugs).
Maltese: Madankollu, jirrikonoxxu li hemm riskju ta' fsada b'terapija trippla u li t-terapija trippla għandha tiġi evitata (ilkilostażolu u żewġ mediċini antipjastrini).
English: These included eight double-blind controlled phase III trials, two of which compared the efficacy of cilostazol with an active comparator (pentoxifylline) and placebo over 24 weeks.
Maltese: Dawn inkludew tmien provi kliniċi double-blind ikkontrollati talfażi III, u tnejn minnhom qabblu l-effikaċja tal-kilostażolu ma' paragunatur attiv (il-pentossifillina) u plaċebo tul 24 ġimgħa.
English: The experts considered that the included patients were a reasonable representation of real-life and it was hard to argue that the study was not reassuring and agreed that cilostazol has shown a consistent trend for being as safe as placebo across the major cardiovascular endpoints.
Maltese: L-esperti qiesu li lpazjenti inklużi kienu rappreżentazzjoni raġonevoli tal-ħajja reali u diffiċli seta' jiġi argumentat li listudju ma kienx rassikuranti u qabel li l-kilostażolu wera xejra konsistenti bħal plaċebo sikur fost il-punti aħħarin kardjovaskulari ewlenin kollha.
English: Other adverse events of interest such as myocardial ischemia (myocardial infarction, angina pectoris, coronary artery disease), congestive heart failure and hypotension, were also identified during the mid-term efficacy clinical trials, with a higher incidence in the cilostazol group compared to placebo.
Maltese: Matul il-provi kliniċi dwar l-effikaċja fuq perjodu ta' żmien medju ġew identifikati wkoll avvenimenti avversi oħrajn ta' interess bħall-iskemija mijokardijaka (infart mijokardijaku, anġina pektoris, mard tal-arterji koronarji), insuffiċjenza kardijaka konġestiva u pressjoni baxxa, b'inċidenza ogħla filgrupp tal-kilostażolu meta mqabbel mal-plaċebo.
English: It was recognised that less adverse events than expected had been reported.
Maltese: Ġie rikonoxxut li kienu ġew irrapportati inqas avvenimenti avversi minn dak li kien mistenni.
English: A greater proportion of ‘completers' treated with cilostazol were classified as ‘responders' than those treated with placebo (39.6%, vs. 26.3% ) with ‘responders' defined as those patients whose walking distance had improved by 50% or more from baseline.
Maltese: Sehem ikbar ta' ‘pazjenti li lestew' ikkurati bil-kilostażolu ġew ikklassifikati bħala ‘pazjenti li kellhom rispons' meta mqabbla ma' dawk ikkurati bil-plaċebo (39.6%, vs. 26.
English: In the CASTLE trial, a lower bleeding event rate was observed in the cilostazol arm than in the placebo arm and the use of concomitant aspirin did not increase the frequency of bleeding in the sub-group treated with cilostazol.
Maltese: Filprova CASTLE, ġiet osservata rata inqas ta' avvenimenti ta' fsada fil-grupp tal-kilostażolu meta mqabbel mal-grupp tal-plaċebo u l-użu tal-aspirina konkomittanti ma żiedx il-frekwenza tal-fsad fis-sottogrupp ikkurat bil-tal-kilostażolu.
English: Given the increase in exposure to cilostazol resulting from concomitant use of CYP3A4 and CYP2C19 inhibitors (such as erythromycin, ketoconazole and omeprazole), the CHMP considered that there is a high potential for interactions with other medicinal products that could increase the risks associated with cilostazol and therefore considered that the SmPC wording in section 4.5 should be strengthened.
Maltese: Minħabba ż-żieda fl-espożizzjoni għall-kilostażolu li rriżultat mill-użu konkomittanti tal-inibituri CYP3A4 u CYP2C19 (bħal erythromycin, ketoconazole u omeprazole), is-CHMP qies li hemm potenzjal għoli għal interazzjonijiet ma' prodotti mediċinali oħrajn li jista' jżid ir-riskji assoċjati mal-kilostażolu u għaldaqstant qies li d-deskrizzjoni tas-SmPC fis-sezzjoni 4.5 għandha tissaħħaħ.
English: Cilostazol is a dihydroquinolinone derivative that inhibits cyclic adenosine monophosphate (cAMP) phosphodiesterase, suppressing cAMP degradation and thereby increasing cAMP levels in platelets and blood vessels.
Maltese: Dan iwassal għal inibizzjoni tal-attivazzjoni u l-aggregazzjoni tal-pjastrini u jipprevjeni r-rilaxx ta' sustanzi vasoattivi u inflammatorji protrombotiċi.
English: The Committee concluded that the benefit-risk balance of cilostazol products for the improvement of the maximal walking distance and maximal pain-free walking distances in patients with intermittent claudication (IC), who do not have rest pain and who do not have evidence of peripheral tissue necrosis (peripheral arterial disease Fontaine stage II) remains positive under normal conditions of use, subject to restrictions, warning, changes to the product information and risk minimisation measures agreed.
Maltese: Il-Kumitat ikkonkluda li l-bilanċ bejn il-benefiċċji u r-riskju tal-prodotti bil-kilostażolu għat-titjib tad-distanza massimali ta' mixi u d-distanzi ta' mixi massimali bla uġigħ f'pazjenti bi klawdikazzjoni intermittenti (IC), li ma għandhomx uġigħ meta jkunu mistrieħa u li ma għandhomx evidenza ta' nekrożi fit-tessut periferiku (mard arterjali periferiku fl-istadju Fontaine II) għadu pożittiv f'kundizzjonijiet normali ta' użu, soġġett għal restrizzjonijiet, twissija, bidliet fit-tagħrif dwar ilprodott u miżuri ta' minimizzazzjoni tar-riskji miftiehma.
English: Overall summary of the scientific evaluation of cilostazol containing medicinal products (see Annex I)
Maltese: Sommarju ġenerali tal-valutazzjoni xjentifika ta' prodotti mediċinali li fihom ilkilostażolu (ara l-Anness I)
English: At the request of the CHMP, an ad-hoc expert advisory group meeting was convened in February 2013.
Maltese: Fuq talba tas-CHMP, saret laqgħa tal-grupp konsultattiv ta' esperti ad-hoc fi Frar 2012.
English: The CHMP was therefore of the opinion that cilostazol has a statistically significant, albeit modest effect on walking distances in patients with IC and that some patients may benefit to a clinically relevant degree.
Maltese: Għaldaqstant is-CHMP kien tal-fehma li l-kilostażolu kellha effett statistikament importanti, għad li modest, fuq id-distanzi ta' mixi f'pazjenti b'IC u li uħud mill-pazjenti jistgħu jibbenefikaw sa ċertu punt klinikament relevanti.
English: Spain therefore referred cilostazol to the CHMP/EMA, requesting that it gives its opinion under Article 31 of Directive 2001/83/EC, on whether the marketing authorisations for medicinal products containing cilostazol should be maintained, varied, suspended or withdrawn.
Maltese: Għaldaqstant Spanja rreferiet il-kilostażolu lis-CHMP/EMA u talbitu jagħti l-fehma tiegħu skont l-Artikolu 31 tadDirettiva 2001/83/KE, dwar jekk l-awtorizzazzjonijiet għat-tqegħid fis-suq għal prodotti mediċinali li fihom il-kilostażolu għandhomx jinżammu, jiġu varjati, sospiżi jew irtirati.
English: The Spanish authority's main concerns centred on reports received of cardiovascular reactions (including fatal cases of MI, angina pectoris and arrhythmias) and haemorrhagic reactions as well as drug interactions.
Maltese: It-tħassib ewlieni tal-awtorità Spanjola kien iffokat fuq rapporti dwar reazzjonijiet kardjovaskulari (inklużi każi fatali ta' MI, anġina pektoris u arritmiji) u reazzjonijiet emorraġiċi kif ukoll interazzjonijiet bejn mediċini.
English: • The Committee has reviewed all adverse drug reaction data and clinical trial data associated with Cilostazol; in particular the cardiovascular events and bleeding reactions.
Maltese: • Il-Kumitat analizza d-dejta kollha dwar ir-reazzjonijiet avversi tal-mediċina u d-dejta tal-provi kliniċi assoċjati mal-kilostażolu; b'mod partikolari l-avvenimenti kardjovaskulari u r reazzjonijiet tal-fsad.
English: • In view of the above safety concerns, the Committee agreed on a number of risk minimisation measures, including changes to the product information to strengthen the wording of the PI to reduce the risk of haemorrhagic events, cardiac events and potential drug-drug interactions (contra-indication in at-risk patients, recommendation of adjustment of the dose, strengthening of the warning to ensure suitability of the treatment with cilostazol).
Maltese: biex jonqos ir-riskju ta' avvenimenti emorraġiċi, avvenimenti kardijaċi u interazzjonijiet potenzjali bejn il-mediċini (kontraindikazzjoni f'pazjenti f'riskju, rakkomandazzjoni ta'
English: Although clinical trial data did not substantiate safety concerns raised from spontaneous ADR reporting, the CHMP concluded that the risk of bleeding and some cardiovascular events including tachyarrhythmias cannot be excluded in at-risk patients.
Maltese: Għad li d-dejta tal-provi kliniċi ma kkonfermtx tħassib dwar is-sigurtà li daħal mir-rapportar spontanju tal-ADR, is-CHMP ikkonkluda li r-riskju ta' fsad u xi avvenimenti kardjovaskulari inklużi takiarritmiji ma jistax jiġi eskluż f'pazjenti f'riskju.
English: The experts were first asked to discuss the current standard approach to the clinical management of peripheral arterial occlusive disease (PAOD), the characteristics of the patients treated with cilostazol and the clinical relevance of the benefits of cilostazol.
Maltese: L-ewwel lesperti ntalbu jiddiskutu l-approċċ standard attwali għall-ġestjoni klinika tal-mard okklużiv arterjali periferiku (PAOD), il-karatteristiċi tal-pazjenti kkurati bil-tal-kilostażolu u r-relevanza klinika talbenefiċċji tal-kilostażolu.
English: In addition, a phase IV double-blind placebo-controlled efficacy study (PACE study), was performed also with pentoxifylline as active comparator.
Maltese: IV dwar l-effikaċja (l-istudju PACE) sar ukoll bil-pentossifillina bħala paragunatur attiv.
English: Results for secondary efficacy endpoints were consistent with the results for ACD.
Maltese: Ir-riżultati għal punti aħħarin sekondarji tal-effikaċja kienu konsistenti marriżultati għall-ACD.
English: 5 x 1 bottle (unit pack)
Maltese: 5 x flixkun 1 (pakkett b'wieħed)
English: Packaging Content
Maltese: Il-Pakkett
English: Cilazapril Teva is available as 0.5 mg, 1 mg and 2.5 mg and 5 mg tablets.
Maltese: Cilazapril Teva jiġi bħala pilloli ta' 0.5 mg, 1 mg u 2.5 mg u 5 mg.
English: In all three media, both products released more than 85% or close to 85% of the drug substance within 15 minutes and more than 95% in 20 minutes.
Maltese: Fit-tliet mezzi kollha, iż-żewġ prodotti rħew aktar minn 85% jew qrib il-85% tas-sustanza mediċinali fi ħdan 15-il minuta u aktar minn 95% f'20 minuta.
English: The MAH also referred to comparative dissolution data for the Cilazapril Teva tablets and the reference product, using three different dissolution media (0.1 N HCl, pH 4.5 acetate buffer and pH 6.8 phosphate buffer).
Maltese: L-MAH irrefera wkoll għad-dejta ta' dissoluzzjoni komparattiva għall-pilloli ta' Cilazapril Teva u l-prodott ta' referenza, bl-użu ta' tliet mezzi ta' dissoluzzjoni (0.1 N HCl, pH 4.5 acetate buffer u pH 6.8 phosphate buffer).
English: • The Committee considered the procedure under Article 31 of Directive 2001/83/EC for Cilazapril Teva and associated names.
Maltese: • Il-Kumitat ikkunsidra l-proċedura skont l-Artikolu 31 tad-Direttiva 2001/83/KE għal Cilazapril Teva u ismijiet assoċjati.
English: Only minor deficiencies were identified, which were not considered to influence the outcome of the clinical bioequivalence (e.g. exact EDTA matrix not specified, validated batch size not given, no influence of haemolytic or lipidaemic plasma shown, matrix effect in 4 different plasma batches shown).
Maltese: EDTA eżatta mhux speċifikata, daqs tal-lott ivvalidat mhux mogħti, ebda influwenza ta' plasma emolitika jew lipidemika murija, effett matriċi f'4 lottijiet tal-plasma differenti murija).
English: The initial marketing authorisations applications for the Cilazapril Teva tablets were supported by a single pivotal bioequivalence study (Study 2005-980), comparing Cilazapril Teva with the EU reference product Vascace, for which samples were analysed by BA Research International (now Cetero Research) between May 26th 2005 and December 20th 2005.
Maltese: L-applikazzjonijiet tal-awtorizzazzjonijiet għat-tqegħid fis-suq inizjali għall-pilloli ta' Cilazapril Teva ġew appoġġati minn studju ta' bijoekwivalenza pivotali uniku (Studju 2005-980), li qabbel Cilazapril Teva mal-prodott ta' referenza tal-UE Vascace, li għalih, kampjuni ġew analizzati minn BA Research International (issa Cetero Research) bejn is-26 ta' Mejju 2005 u l-20 ta' Diċembru 2005.
English: The CHMP also noted the MAH review of study 2005-980 and the quality of the bio-analytical report and the reported similarity between the results generated by Cetero Research and those found from repeated studies/analysis for other drug products.
Maltese: Is-CHMP innota wkoll ir-reviżjoni mill-MAH tal-istudju 2005-980 u l-kwalità tar-rapport bijo-analitiku u s-similarità rrapportata bejn ir-riżultati ġġenerati minn Cetero Research u dawk misjuba minn studji/analiżi ripetuti għal prodotti mediċinali oħrajn.
English: The highly soluble nature of the drug substance over the physiological pH range and the dissolution similarity between Cilazapril Teva and the reference product was also acknowledged.
Maltese: In-natura ferm solubbli tas-sustanza mediċinali fuq il-medda tal-pH fiżjoloġika u s-similarità fid-dissoluzzjoni bejn Cilazapril Teva u l-prodott ta' referenza ġiet rikonoxxuta wkoll.
English: The quality of the bio-analytical report was checked internally by the MAH and was considered to be of good quality, based on the guideline applicable at that time (“Guideline for Industry - Bioanalytical Method Validation”, May 2001).
Maltese: Il-kwalità tar-rapport bijoanalitiku ġiet iċċekkjata internament mill-MAH u ġiet ikkunsidrata li hija ta' kwalità tajba, abbażi tal-linja gwida applikabbli dak il-ħin (“Guideline for IndustryBioanalytical Method Validation”, Mejju 2001).
English: The CHMP was requested to assess whether the deficiencies in conduct of bio-analytical studies performed by the Cetero Research facilities in Houston (Texas, USA) have impact on the benefit/risk of the concerned medicinal products and to give its opinion on whether the marketing authorisations for authorised medicinal products for which studies have been carried out or samples analysed by Cetero Research, during the identified time period, should be maintained, varied, suspended or withdrawn.
Maltese: Is-CHMP intalab jevalwa jekk in-nuqqasijiet fit-twettiq ta' studji bijoanalitiċi li saru mill-faċilitajiet ta' Cetero Research fi Houston (Texas, USA) kellhomx impatt fuq il-benefiċċju/riskju tal-prodotti mediċinali kkonċernati u biex jagħti l-opinjoni tiegħu dwar jekk l-awtorizzazzjonijiet għat-tqegħid fis-suq għal prodotti mediċinali awtorizzati li għalihom kienu saru studji jew li ġew analizzati l-kampjuni minn Cetero Research, matul il-perjodu ta' żmien identifikat, għandhomx jinżammu, jiġu varjati, jiġu sospiżi jew irtirati.
English: The Committee, as a consequence, recommended the suspension of the marketing authorisations for Cilazapril Teva and associated names, pursuant to Article 116 of Directive 2001/83/EC; as a. the risk-benefit balance cannot be considered favourable and b. the particulars supporting the application as provided in Article 10 of Directive 2001/83/EC cannot be considered correct
Maltese: B'konsegwenza ta' dan, il-Kumitat irrakkomanda s-sospensjoni tal-awtorizzazzjonijiet għat-tqegħid fis-suq għal Cilazapril Teva u ismijiet assoċjati skont l-Artikolu 116 tad-Direttiva 2001/83/KE; minħabba li a. il-bilanċ tal-benefiċċju-riskju ma jistax jitqies bħala favorevoli u b. id-dettalji li jappoġġjaw l-applikazzjoni kif previst fl-Artikolu 10 tad-Direttiva 2001/83/KE ma jistgħux jitqiesu bħala korretti
English: Annex II Scientific conclusions and grounds for suspension of the marketing authorisations
Maltese: Anness II Konklużjonijiet xjentifiċi u r-raġunijiet għas-sospensjoni talawtorizzazzjonijiet għat-tqegħid fis-suq
English: Grounds for suspension of the marketing authorisations
Maltese: Raġunijiet għas-sospensjoni tal-awtorizzazzjonijiet għat-tqegħid fis-suq
English: The MAH considered that the satisfactory results of these re-analyses suggest that the final outcome of the Cilazapril Teva study was not influenced by the bioanalytical analyses carried out at Cetero Research, Houston.
Maltese: L-MAH qies li r-riżultati sodisfaċenti ta' dawn l-analiżi mill-ġdid jissuġġerixxu li r-riżultat finali tal-istudju Cilazapril Teva ma ġiex influwenzat mill-analiżi bijo-analitika mwettqa f'Cetero Research, Houston.
English: Finally the MAH noted that the periodic safety update report (PSUR) no. 383/01/12, dated February 13th 2012, reported no increased number of safety concerns with cilazapril.
Maltese: Fl-aħħar nett, l-MAH innota li r-rapport perjodiku għall-aġġornament dwar is-sigurta (PSUR) Nru 383/01/12, datat it-13 ta' Frar 2012, ma rrapporta ebda numru miżjud ta' tħassib dwar is-sigurtà b'cilazapril.
English: The MAH stated that the calculated f2 values indicated dissolution similarity between the drug products in all three media, and therefore considered the probability of the drug being released in the stomach to be high.
Maltese: L-MAH iddikjara li l-valuri f2 kkalkolati indikaw similarità fid-dissoluzzjoni bejn il-prodotti mediċinali fit-tliet mezzi kollha, u għaldaqstant qies li lprobabilità li l-mediċina tiġi rilaxxata fl-istonku tkun waħda għolja.
English: The CHMP considered that these results could not be extrapolated to confirm the reliability of the pivotal bioequivalence study 2005-980.
Maltese: Is-CHMP qies li dawn ir-riżultati ma jistgħux jiġu estrapolati sabiex jikkonfermaw l-affidabilità tal-istudju ta' bijoekwivalenza pivotali 2005-980.
English: The report covers the period 1st January 2009 to 31st December 2011 and identified two case reports, both of which were medically confirmed reports describing non-serious adverse reactions.
Maltese: Ir-rapport ikopri l-perjodu mill-1 ta' Jannar 2009 sal-31 ta' Diċembru 2011 u identifika żewġ rapporti ta' każijiet, li t-tnejn li huma kienu rapporti ikkonfermati medikament li jiddeskrivu reazzjonijiet avversi mhux serji.
English: Cilazapril Teva contains cilazapril, a pyridazine angiotensin-converting enzyme inhibitor (ACE inhibitor) used for the treatment of hypertension and congestive heart failure.
Maltese: Cilazapril Teva fih cilazapril, inibitur tal-enzima li taqleb l-anġjotensin pyridazine (inibitur tal-ACE) użat għall-kura tal-pressjoni għolja u ta' kollass konġestiv tal-qalb.
English: In response to the CHMP list of questions, the MAH stated that the pivotal bioequivalence study 2005980 conducted for Cilazapril Teva met the bioequivalence criteria (point estimates of 93.4% and 100% for AUC0-4h and Cmax, respectively) with respect to the Guideline on the Investigation of Bioequivalence.
Maltese: Bi tweġiba għal-lista ta' mistoqsijiet tas-CHMP, l-MAH iddikjara li l-istudju ta' bijoekwivalenza pivotali 2005980, imwettaq għal Cilazapril Teva issodisfa l-kriterji ta' bijoekwivalenza (estimi tal-punti ta' 93.4% u 100% għal AUC0-4h u Cmax, rispettivament) fir-rigward tal-Linja gwida dwar l-Investigazzjoni talBijoekwivalenza.
English: The CHMP also noted that due to the lack of availability of samples, it was not possible to reanalyse the samples from the clinical study in order to check the validity of the original findings, but the CHMP acknowledged the MAH intention to repeat the study, with final results expected to be available by the end of June 2013.
Maltese: Is-CHMP innota wkoll li minħabba n-nuqqas ta' disponibilità ta' kampjuni, ma kienx possibbli li l-kampjuni mill-istudju kliniku jiġu analizzati mill-ġdid sabiex tiġi ċċekkjata l-validità tas-sejbiet oriġinali, iżda s-CHMP għaraf l-intenzjoni tal-MAH li jirrepeti l-istudju, bir-riżultati finali mistennija li jkunu disponibbli sa tmiem Ġunju 2013.
English: The MAH was therefore of the view that the formulation of this immediate-release product will have only little influence on the bioavailability, which is supported by good point estimates for AUC and Cmax in study 2005-980.
Maltese: Għaldaqstant, l-MAH kien tal-fehma li l-formolazzjoni ta' dan il-prodott b'rilaxx immedjat se jkollha biss ftit influwenza fuq il-bijodisponibilità, li hija appoġġata minn stimi ta' punti tajbin għall-AUC u Cmax fl-istudju 2005-980.
English: Having assessed the available data, the CHMP retained serious doubts due to the findings of the inspection of the Cetero Research facilities in Houston (Texas, USA), regarding the reliability and the correctness of the data from the critical pivotal bioequivalence study submitted in support of the marketing authorisation.
Maltese: Wara li vvaluta d-dejta disponibbli, is-CHMP kien għad fadallu dubji serji minħabba s-sejbiet tal-ispezzjoni tal-faċilitajiet ta' Cetero Research fi Houston (Texas, USA), dwar l-affidabbiltà u l-korrettezza tad-dejta millistudju pivotali kritiku ta' bijoekwivalenza sottomessa b'appoġġ tal-awtorizzazzjoni għat-tqegħid fis-suq.
English: The study will therefore be repeated, with the final results expected to be ready by the end of June 2013.
Maltese: Għaldaqstant, l-istudju sejjer jiġi ripetut, bir-riżultati finali mistennija li jkunu lesti sa tmiem Ġunju 2013.
English: However, for Cilazapril Teva, the MAH stated that no study samples were available for study 2005-980 and that there is therefore no possibility to reanalyse the data.
Maltese: Madankollu, għal Cilazapril Teva, l-MAH iddikjara li ma kien hemm disponibbli ebda kampjun tal-istudju għall-istudju 2005-980 u għaldaqstant, ma hemm ebda possibilità li ddejta tiġi analizzata mill-ġdid.
English: 44 mg;100 mg 1 vial
Maltese: 44 mg;100 mg kunjett 1
English: MA (EU) Number
Maltese: Numru tal-MA
English: Ref. EMEA/321164/2007
Maltese: EMEA/321164/2007
English: 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 86 68 E-mail: mail@emea.europa.eu http://www.emea.europa.eu©EMEA 2007 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged
Maltese: (44-20) 74 18 84 00 Fax (44-20) 74 18 86 68 E-mail: mail@emea.europa.eu http://www.emea.europa.eu©EMEA 2007 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged
English: International non-proprietary name (INN): oblimersen
Maltese: Mhux Patentat (INN): oblimersen
English: London, 19 July 2007 Doc.
Maltese: Londra, 19 ta' Lulju 2007 Dok. Ref.
English: Oblimersen is an ‘anti-sense oligonucleotide' medicine.
Maltese: Oblimersen hija mediċina ‘anti-sense oligonucleotide'.
English: The company that applied for authorisation is Genta Development Limited.
Maltese: Il-kumpanija li applikat għall-awtorizzazzjoni hija Genta Development Limited.
English: The active substance in Genasense, oblimersen, is an antineoplastic medicine.
Maltese: Is-sustanza attiva f'Genasense, oblimersen, hija mediċina antineoplastika.
English: On 26 April 2007, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Genasense 30 mg/ml concentrate for solution for infusion, intended for the treatment of advanced or metastatic melanoma.
Maltese: Fis-26 ta' April 2007, il-Kumitat għall-prodotti Mediċinali għal Użu mill-Bniedem (CHMP) adotta opinjoni negattiva, li tirrakkomanda r-rifjut ta' l-awtorizzazzjoni għat-tqegħid fis-suq għall-prodott mediċinali Genasense 30 mg/ml, konċentrat għal soluzzjoni għall-infużjoni, intiż għal-kura ta' melanoma avvanzata jew metastatika.
English: Genasense has also been studied in 771 patients with advanced or metastatic melanoma.
Maltese: Genasense ġie studjat ukoll f'771-il pazjent b'melanoma avvanzata jew metastatika.