FrancophonIA/ELRC3.0 huggingface dataset:
English: For the patients who received > 1 prior cancer-related treatment, a best overall response of CR was reported for 6 patients (12%); PR was reported for 19 patients (39%).
Maltese: Għallpazjenti li kienu rċivew > 1 kura relatata mal-kanċer fil-passat, l-aħjar rispons globali ta' CR ġie rrappurtat għal 6 pazjenti (12%); PR kien irrappurtat għal 19-il pazjent (39%).
English: In patients receiving ADCETRIS combination therapy, serious adverse reactions occurred in 36% of patients.
Maltese: F'pazjenti li jirċievu terapija kombinata b'ADCETRIS, kien hemm reazzjonijiet avversi serji f'36% tal-pazjenti.
English: Table 16: Sample calculations for patients receiving the recommended dose of 1.2 mg/kg of ADCETRIS for weights ranging from 60 kg to 120 kg as combination therapy or when a reduced dose is required
Maltese: Kalkoli tal-kampjun għall-pazjenti li jirċievu d-doża rakkomandata ta' 1.2 mg/kg ta' ADCETRIS għall-piżijiet bejn 60 kg sa 120 kg bħala terapija kombinata jew meta doża mnaqqsa hija meħtieġa
English: These data suggest that efficacy and safety can be extrapolated to other CTCL CD30+ subtypes.
Maltese: Din id-dejta tissuġġerixxi li l-effikaċja u sigurtà jistgħu jiġu estrapolati għal sottotipi oħrajn ta' CTCL CD30+.
English: = Number of ADCETRIS vials needed
Maltese: = Numru ta' kunjetti ta' ADCETRIS meħtieġa
English: - Stevens-Johnson syndrome and toxic epidermal necrolysis - a rare, serious disorder in which you may experience flu-like symptoms followed by a painful red or purplish rash that spreads and blisters including extensive detachment of the skin - decreased level of white blood cells with a fever - damage to the nerves and nerve coverings (demyelinating polyneuropathy)
Maltese: jkollok sintomi li jixbħu l-influwenza segwiti minn raxx aħmar jew fil-vjola li juġgħa, jinfirex u jifforma nfafet inkluż distakkament estensiv tal-ġilda - tnaqqis fil-livell ta' ċelluli bojod tad-demm b' deni - ħsara lin-nervaturi u lill-kisjiet tan-nervaturi (polinewropatija demyelinating)
English: Table 7: Efficacy results in HL patients at increased risk of relapse or progression following ASCT treated with 1.8 mg/kg of ADCETRIS every 3 weeks
Maltese: Riżultati ta' Effikaċja f'Pazjenti b'HL b'Riskju Ogħla ta' Rikaduta jew Progressjoni wara ASCT Ittrattat b'1.8 mg/kg ta' ADECTRIS Kull 3 Ġimgħat
English: Binding of MMAE to tubulin disrupts the microtubule network within the cell, induces cell cycle arrest and results in apoptotic death of the CD30-expressing tumour cell.
Maltese: It-twaħħil ta' MMAE ma' tubulin jfixkel in-netwerk ta' mikrotubuli fiċ-ċellula, jinduċi t-twaqqif taċ-ċiklu taċ-ċellula u jwassal għall-mewt apoptotiku taċ-ċellula tat-tumur li jkollha CD30.
English: Prior chemotherapy Regimens Time from ASCT to first post-transplant relapse
Maltese: KONDIZZJONIJIET JEW RESTRIZZJONIJIET FIRRIGWARD TAL-UŻU SIGUR U EFFIKAĊI TAL-PRODOTT MEDIĊINALI
English: Patient characteristics n = 102
Maltese: N = 102
English: Data were also collected from patients (n = 15) in phase 1 dose escalation and clinical pharmacology studies, and from patients (n = 26) in a NPP, with relapsed or refractory HL who had not received an ASCT, and who were treated with 1.8 mg/kg of ADCETRIS every 3 weeks.
Maltese: Dejta ġiet miġbura wkoll mill-pazjenti (n = 15) mill-fażi 1 ta' studji dwar żieda fid- doza u farmakoloġija klinika u mill-pazjenti (n = 26) f' NPP, b'HL li reġgħet ħarget jew li ma rrispondietx għall-kura, li ma kienux rċevew ASCT, u kienu trattati bid-doża rakkomandata ta' 1.8 mg/kg ta' ADCETRIS kull 3 ġimgħat.
English: Due date
Maltese: N Avvenimenti
English: Number of vials needed = total volume to be diluted divided by total volume per vial [10 mL/vial])
Maltese: Numru ta' kunjetti meħtieġa = volum totali li għandu jiġi dilwit diviż bil-volum totali għal kull kunjett [10 ml/kunjett])
English: Adcetris is also used to lower the likelihood of classical Hodgkin Lymphoma coming back after an autologous stem cell transplant in patients with certain risk factors.
Maltese: Adcetris jintuża wkoll biex inaqqas il-probabilità ta' Limfoma klassika ta' Hodgkin li terġa' titfaċċa wara trapjant ta' ċelluli staminali f'pazjenti b'ċertu fatturi ta' riskju.
English: ADCETRIS may have a moderate influence on the ability to drive and use machines (e.g. dizziness), see section 4.8.
Maltese: ADCETRIS jista' jkollu effett moderat fuq il-ħila biex issuq u tħaddem magni (eż. sturdament), ara sezzjoni 4.8.
English: Sodium content in excipients
Maltese: Kontenut ta' sodium fl-eċċipjenti
English: Early (IA-IIA)
Maltese: Waqqaf il-kura
English: (range, 1 to 6 cycles).
Maltese: L/jum u 4-6 tijiem rispettivament.
English: The significance of this finding in stage IV HL patients with no extranodal disease is not established due to small patient numbers and low event rates (14 events).
Maltese: L-importanza ta' din is-sejba f'pazjenti HL ta' stadju IV mingħajr marda ekstranodali mhux stabbilita minħabba numru żgħir ta' pazjenti u rati baxxi ta' avvenimenti (14il avveniment).
English: Extranodal involvement at time of pre-ASCT relapse
Maltese: Involviment ekstranodali fiż-żmien ta' rikaduta qabel ASCT
English: While the presence of antibodies to brentuximab vedotin does not necessarily predict the development of an IRR, there was a higher incidence of IRRs observed in patients with persistently positive anti-drug antibodies (ADA) relative to patients with transiently positive ADA and never positive ADA.
Maltese: Filwaqt li l-preżenza ta' antikorpi għal brentuximab vedotin mhux bilfors tbassar l-iżvilupp ta' IRR, kienet osservata inċidenza ogħla ta' IRRs f'pazjenti pożittivi b'mod persistenti għal antikorpi kontra l-mediċina (ADA, anti-drug antibodies) meta mqabbel ma' pazjenti pożittivi għal ADA b'mod transitorju u dawk li qatt ma kieneu pożittivi għal ADA.
English: MMAE were observed approximately 2 days after the end of infusion, and exhibited a mono-exponential decline with a t1/2z of approximately 3 to 4 days.
Maltese: Il-konċentrazzjonijiet massimi tal-plażma ta' MMAE kienu osservati madwar jumejn wara t-tmiem tal-infużjoni, u kienu juru tnaqqis mono-esponenzjali b't1/2z ta' madwar 3 sa 4 ijiem.
English: b. To be diluted in 150 mL of diluent and administered by intravenous infusion over 30 minutes every 3 weeks.
Maltese: b. Għandu jiġi dilwit f'150 mL ta' dilwent u jingħata b'infużjoni ġol-vini għal 30 minuta kull 3 ġimgħat.
English: The safety profile of ADCETRIS is based on available clinical trial data, the Named Patient Program (NPP), and post-marketing experience to date.
Maltese: Il-profil tas-sigurtà ta' ADCETRIS hija bbażata fuq dejta disponibbli minn provi kliniċi, il-Programm Pazjent Imsemmi (NPP), u esperjenza wara li l-prodott tqiegħed fis-suq sal-lum.
English: Adjusted p-value
Maltese: Valur p aġġustat
English: Co-administration of brentuximab vedotin did not affect the plasma exposure of AVD.
Maltese: It-tabib jew infermier se jarmu din il-mediċina.
English: B symptoms a n (%)
Maltese: a n (%)
English: For more detailed information, see “Infusion reactions” in section 4. have any problems with a change in the sensitivity of the skin, especially in the hands or feet, such as numbness, tingling, a burning sensation, pain, discomfort or weakness (neuropathy) have headaches, feel tired, experience dizziness, look pale (anaemia), or have unusual bleeding or bruising under the skin, longer than usual bleeding after your blood has been drawn, or bleeding from your gums (thrombocytopenia) develop chills or shivering, or feel warm; you should take your temperature as you may have a fever.
Maltese: Għal aktar informazzjoni dettaljata, ara “Reazzjonijiet għall-infużjoni” f'sezzjoni 4. - għandek xi problemi b'bidla fis-sensittività tal-ġilda, speċjalment fl-idejn jew saqajn, bħal tnemnim, tingiż, sensazzjoni ta' ħruq, uġigħ, skomdu jew dgħjufija (newropatija) - għandek uġigħ ta' ras, tħossok għajjien, ikollok esperjenza ta' sturdament, tidher pallidu/a (anemija), jew ikollok fsada mhux tas-soltu jew tbenġil taħt il-ġilda, fsada itwal mis-soltu wara li jiħdulek id-demm, jew fsada mill-ħanek tiegħek (tromboċitopenija) - ikollok tkexkix jew tregħid, jew tħoss is-sħana; għandek tieħu t-temperatura tiegħek għax jista' jkollok id-deni.
English: Treatment response was assessed by spiral CT of chest, neck, abdomen and pelvis; PET scans and clinical data.
Maltese: Rispons għall-kura kien evalwata permezz ta' CT spirali tas-sider, għonq, addome u pelvi; skans PET u dejta klinika.
English: This being a conditional marketing authorisation and pursuant to Article 14(7) of Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following measures:
Maltese: Peress li din hi Awtorizzazzjoni għat-Tqegħid fis-Suq b' approvazzjoni kondizzjonali skont lArtikolu 14 (7) tar-Regolament (KE) 726/2004, l-MAH għandu jtemm, fiż-żmien stipulat, il-miżuri li gejjin:
English: Testicular atrophy and degeneration were partially reversible following a 16-week treatment-free period.
Maltese: Atrofija u deġenerazzjoni testikulari kienu parzjalment riversibbli wara perijodu ta' 16-il ġimgħa mingħajr kura.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Maltese: F'kullSistema tal-Klassifika Tal-Organi, r-reazzjonijiet avversi huma elenkati taħt il-kategoriji ta' frekwenza ta':
English: In non-clinical studies, brentuximab vedotin treatment has resulted in testicular toxicity, and may alter male fertility.
Maltese: Fi studji mhux kliniċi, kura b'brentuximab vedotin wasslet għall-effett tossiku fuq it-testikoli, u tista' tbiddel il-fertilità maskili.
English: In clinical trials, patients were periodically tested for antibodies to brentuximab vedotin using a sensitive electrochemiluminescent immunoassay.
Maltese: Fil-provi kliniċi, il-pazjenti ġew ittestjati perjodikament għall-antikorpi għal brentuximab vedotin permezz ta' immunoassaj elektrokemiluminixxenti sensittiv.
English: Breastfeeding
Maltese: FARMAĊEWTIKU
English: Relapsed or refractory HL
Maltese: HL rikaduta jew refrattorja
English: Very common side effects (may affect more than 1 in 10 people) decreased level of white blood cells decreased level of blood platelets decreased level of white blood cells with a fever upper respiratory tract infection decrease in weight infection nausea abdominal pain unusual hair loss or thinning muscle pain joint pain or painful, swollen joints dizziness increased liver enzyme levels decreased appetite not being able to sleep bone pain sore or inflammation in the mouth
Maltese: Effetti sekondarji komuni ħafna (jistgħu jaffettwaw aktar minn persuna waħda minn kull 10) - livell imnaqqas ta' ċelluli bojod tad-demm - infezzjoni fil-passaġġ respiratorju ta' fuq - tnaqqis fil-piż - infezzjoni - tqalligħ - uġigħ addominali - ħakk - uġigħ fil-muskoli - uġigħ fil-ġogi jew ġogi bl-uġigħ u minfuħin
English: General
Maltese: Generu
English: 4.3 Contraindication:
Maltese: 4.3 Kontra-indikazzjonijiet:
English: “Fibrosis and cardiac valvulopathy and possibly related clinical phenomena:
Maltese: “Fibrożi u valvulopatija kardijaka, u fenomeni kliniċi possibilment relatati:
English: “Do not take more than 3 <if relevant include colour of the tablet> tablets (3 x 1000 microgram tablets) per day.”
Maltese: “Tieħux iktar minn 3 <jekk huwa relevanti inkludi il-kulur tal-pillola> pilloli (3 x 1000 microgramma pilloli) kuljum.
English: Section 4 “Possible side effects”:
Maltese: Sezzjoni 4 “Effetti sekondarji li jista' jkollu”:
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.
Maltese: Kundizzjonijiet fibrotiċi u serosali infjammatorji, bħall-plewrite, effużjoni plewrali, fibrożi plewrali, fibrożi pulmonari, perikardite, effużjoni perikardjali, valvulopatija kardijaka li tinvolvi valvula waħda jew iktar (aortic, mitral u tricuspid) jew fibrożi retroperitonali, ħarġu wara użu għal tul ta' żmien ta' derivattivi ta' ergot b'effect agonist għar-riċettur tas- serotonina 5HT2B,, bħal pergolide.
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.
Maltese: Kundizzjonijiet fibrotiċi u serosali infjammatorji, bħall-plewrite, effużjoni plewrali, fibrożi plewrali, fibrożi pulmonari, perikardite, effużjoni perikardjali, valvulopatija kardijaka li tinvolvi valvula waħda jew iktar (aortic, mitral u tricuspid) jew fibrożi retroperitonali, ħarġu wara użu għal tul ta' żmien ta' derivattivi ta' ergot b'effett agonist għar-riċettur tas-serotonina 5HT2B,, bħal cabergoline.
English: During treatment:
Maltese: Matul trattament fit-tul:
English: 4.8 Undesirable effects:
Maltese: .8 Effetti mhux mixtieqa:
English: “Evidence of cardiac valvulopathy as determined by pre-treatment echocardiography.”
Maltese: “Evidenza ta' valvulopatija kardijaka hekk kif determinata minn ekokardjografija magħmula qabel ittrattament.”
English: Fibrotic disorders can have an insidious onset and patients should be regularly monitored for possible manifestations of progressive fibrosis.
Maltese: Kundizzjonijiet fibrotiċi jistgħu jiżviluppaw mingħajr ma jkunu evidenti, pazjenti għandhom ikunu mmonitorati regolarment għal manifestazzjonijiet possibli ta' fibrożi progressiva.
English: The need for other clinical monitoring (e.g. physical examination including, cardiac auscultation, Xray, CT scan) should be determined on an individual basis.
Maltese: Eżaminazzjoni fiżika inkluża askultazzjoni kardijaka, Xray, CT scan) għandhom jiġu determinati fuq bażi individwali.
English: Take special care with [product name]”
Maltese: Oqgħod attent ħafna bi [isem il-prodott]”
English: The following should be included under Cardiac disorders: “Very common: cardiac valvulopathy (including regurgitation) and related disorders (pericarditis and pericardial effusion).”
Maltese: Dawn għandhom ikunu inklużi taħt kundizzjonijiet kardijaċi: “Komuni ħafna: valvulopatija kardijaka (inkluż irrigurġitar) u kundizzjonijiet oħra relatati (perikardite u effużjoni pericardjali).”
English: 4.2 Posology and method of administration The following should be reflected as appropriate: Restriction of the maximum dose to 3 mg/day.
Maltese: Restrizzjoni tad-doża massima għal 3 mg/jum.
English: 4.2 Posology and method of administration The following should be reflected as appropriate: Restriction of the maximum dose to 3 mg/day
Maltese: Restrizzjoni tad-doża massima għal 3 mg/jum
English: Before initiating treatment:
Maltese: Waqt it-trattament:
English: Cardiac failure; cases of valvular and pericardial fibrosis have often manifested as cardiac failure.
Maltese: Insuffiċjenza kardijaka; każijiet ta' fibrożi valvulari u perikardjali ta' spiss immanifestaw ruħhom bħala insuffiċjenza kardijaka.
English: ANNEX III AMENDMENTS TO THE SUMMARIES OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLETS
Maltese: GĦALL-PRODOTTI LI FIHOM CABERGOLINE
English: Section 3 How to take [product name]
Maltese: Oqgħod attent ħafna b' [isem il-prodott]
English: In some cases, symptoms or manifestations of cardiac valvulopathy improved after discontinuation of pergolide.
Maltese: F'xi każijiet, is-sintomi jew manifestazzjonijiet ta' valvulopatija kardijaka tjiebu wara li twaqqaf pergolide.
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.
Maltese: Huwa/hija ssirlu/ssirilha ekokardjogramma (test ultrasound tal-qalb) qabel it-trattament u f'intervalli regolari matul it-trattament.
English: Because clinical experience is still limited and the product has a long half-life, as a precautionary measure it is recommended that once regular ovulatory cycles have been achieved women seeking pregnancy discontinue product name] one month before intended conception.”
Maltese: Minħabba li l-esperjenza klinika għadha limitata, u l-prodott għandu half-life twila, bħala mezz ta' prekawzjoni huwa rakomandat li malli iċ-ċikli ovulatorji ikunu stabillizzati, nisa li qed jippjanaw xi tqala għandhom iwaqqfu [isem ilprodott] xahar qabel id-data pjanata ta' konċepiment.
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.
Maltese: Huwa wkoll tajjeb li jsiru investigazzjonijiet bażiċi tar-rata tas-sedimentazzjoni ta' l-eritroċiti, jew marki oħra ta' infjammazzjoni, funzjoni tal-pulmun/x-ray tas-sider u funzjoni tal-kliewi qabel ma tinbeda it-terapija.
English: If fibrotic reactions occur treatment will have to be discontinued.”
Maltese: Jekk iseħħu reazzjonijiet fibrotiċi, it-trattamemt jkollu jitwaqqaf.
English: Erythrocyte sedimentation rate (ESR) has been found to be abnormally increased in association with pleural effusion/fibrosis.
Maltese: Ir-rata tas-sedimentazzjoni ta' l-eritroċiti (ESR) nstabet li tkun żdiedet b'mod mhux normali meta assoċjata ma' effużjoni/fibrożi plewrali.
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):
Maltese: Dawn ta' hawn taħt għandhom ikunu inklużi taħt Tqala u Treddigħ (għall-prodotti li fihom ilcabergoline li huma awtorizzati għall-indikazzjoni ta' infertilita' u nuqqas ta' ovulazzjoni biss):
English: Following treatment initiation, the first echocardiogram must occur within 3-6 months, thereafter, the frequency of echocardiographic monitoring should be determined by appropriate individual clinical assessment with particular emphasis on the above-mentioned signs and symptoms, but must occur at least every 6 to 12 months.
Maltese: Wara li jinbeda t-trattament, l-ewwel ekokardjogramma għandu jsir fl-ewwel 3-6 xhur, wara liema, il-frekwenza tal-monitoraġġ bl-ekokardjogrammi għandu jkun determinat minn eżamijiet kliniċi b'emfażi fuq is-sintomi u sinjali ta' hawn fuq, imma iridu jsiru mill-inqas kull 6 jew 12-il xahar.
English: In some cases, symptoms or manifestations of cardiac valvulopathy improved after discontinuation of cabergoline.
Maltese: F'xi każijiet, is-sintomi jew manifestazzjonijiet ta' valvulopatija kardijaka tjiebu wara li twaqqaf cabergoline.
English: Ref. EMEA/CHMP/494914/2008
Maltese: EMEA/CHMP/494928/2008
English: London, 3 September 2008 Doc.
Maltese: Londra, 3 ta' Settembru 2008 Dok. Ref.
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.
Maltese: Cozaar Comp u ismijiet assoċjati, 50/12.5 mg; 100/12.5 mg; 100/25 mg, pilloli miksijin b'rita hija kombinazzjoni ta' doża fissa ta' losartan u hydrochlorothiazide.
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
Maltese: GĦALL-UŻU MILL-BNIEDEM (CHMP) OPINJONI WARA RIFERIMENT SKOND L-ARTIKOLU 30 GĦAL Cozaar Comp u ismijiet assoċjati Denominazzjoni Komuni Internazzjonali (DKI): losartan + hydrochlorothiazide
English: The Marketing Authorisation Holder provided supplementary information on 23 July 2007.
Maltese: Id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq ta informazzjoni supplimentari fit-23 ta' Lulju 2007.
English: Hydrochlorothiazide (HCTZ) is a thiazide diuretic which has also been used as an antihypertensive agent.
Maltese: Hydrochlorothiazide (HCTZ) huwa dijuretiku b'thiazide li ntuża wkoll bħala sustanza kontra l-pressjoni għolja.
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.
Maltese: Fit-23 ta' Frar 2007, id-Danimarka ippreżentat lill-EMEA riferment skont l-Artikolu 30 tad-Direttiva 2001/83/KE, kif emendata, sabiex jiġu armonizzati s-sommarji tal-karatteristiċi tal-prodott, il-fuljett ta' tagħrif u t-tikketta awtorizzati fuq livell nazzjonali tal-prodott mediċinali Cozaar Comp. u l-ismijiet assoċjati.
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.
Maltese: Losartan huwa antagonista riċettur tat-tip angiotensin II (Ang- II) attiv oralment, li jaġixxi fuq is-subtip tar-riċettur AT1, b'hekk jimblokka l-effett ta' Ang-II fil-kaskada tas-sistema ta' anġjotensin tar-renin (RAS).
English: The procedure started on 22 March 2007.
Maltese: Il-proċedura bdiet fit-22 ta' Marzu 2007.
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.
Maltese: Il-kombinazzjoni losartan/hydrochlorothiazide hija indikata għall-kura tal-pressjoni għolja f'pazjenti li l-pressjoni tad-demm tagħhom mhijiex ikkontrollata b'mod adegwat b'losartan jew b'hydrochlorothiazide.
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.
Maltese: Matul il-laqgħa tiegħu tal-21 - 24 ta' April 2008, is-CHMP, fid-dawl tad-dejta ġenerali ippreżentata u taddiskussjoni xjentifika fi ħdan il-Kumitat, kien tal-opinjoni li l-proposta għall-armonizzazzjoni tal-SPC, Tikketta u Fuljett ta' Tagħrif kienet waħda aċċettabbli u li dawn għandhom jiġu emendati.
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.
Maltese: Is-CHMP ta opinjoni pożittiva fl-24 ta' April 2008 u rrakkomanda l-armonizzazzjoni tal-SPC, tikketta u fuljett ta' tagħrif għal Cozaar Comp. u l-ismijiet assoċjati.
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.
Maltese: Il-bażi tar-riferiment kien li kien hemm diverġenzi fis-Sommarji tal-Karatteristiċi tal-Prodott (SPC) ta' Cozaar Comp. u l-ismijiet assoċjati approvati madwar l-Istati Membri tal-UE fir-rigward tal-indikazzjonijiet li ġejjin:
English: Co-Rapporteur:
Maltese: Ko-Rapporteur:
English: 18 March 2010
Maltese: 18 ta' Marzu 2010
English: Jean-François Baurain (Belgium)
Maltese: Jean-François Baurain (il-Belġju)
English: 22 October 2009
Maltese: 22 ta' Ottubru 2009
English: Harald Enzmann (Germany)
Maltese: Harald Enzmann (il-Ġermanja)
English: Outcome of a procedure under Article 29 of Directive 2001/83/EC as amended
Maltese: Riżultat ta' proċedura skont l-Artikolu 29 ta' Direttiva 2001/83/KE kif emendata
English: Referral start date:
Maltese: Data tal-bidu tar-referenza:
English: EMA/CHMP/735863/2009 Rev. 1 EMEA/H/A-29/1238
Maltese: EMA/CHMP/735863/2009 rev.