FrancophonIA/ELRC3.0 huggingface dataset:
English: • Peginterferon alfa-2b + ribavirin for 4 weeks followed by Victrelis 800 mg three times daily + peginterferon alfa-2b + ribavirin for 32 weeks.
Maltese: • Peginterferon alfa-2b + ribavirin għal 4 ġimgħat segwit minn Victrelis 800 mg tliet darbiet kuljum + peginterferon alfa-2b + ribavirin għal 32 ġimgħa.
English: • Peginterferon alfa-2b + ribavirin for 4 weeks followed by Victrelis 800 mg three times daily + peginterferon alfa-2b + ribavirin for 24 weeks.
Maltese: • Peginterferon alfa-2b + ribavirin għal 4 ġimgħat segwit minn Victrelis 800 mg tliet darbiet kuljum + peginterferon alfa-2b + ribavirin għal 24 ġimgħa.
English: Dose modifications due to anaemia/haemolytic anaemia occurred twice as often in patients treated with the combination of Victrelis with peginterferon alfa-2b and ribavirin (26%) compared to peginterferon alfa-2b and ribavirin alone (13%).
Maltese: Victrelis ma' peginterferon alfa-2b u ribavirin (26%) meta mqabbla ma' peginterferon alfa-2b u ribavirin biss (13%).
English: The transfusion rate was 4% (10/249) in subjects randomized to receive ribavirin dose reduction and 2% (5/251) in subjects randomized to receive erythropoietin.
Maltese: Ir-rata ta' trasfużjoni kienet ta' 4% (10/249) f'individwi li ntgħażlu b'mod każwali biex jirċievu tnaqqis fid-doża ta' ribavirin u ta' 2% (5/251) f'individwi li ntgħażlu b'mod każwali biex jirċievu erythropoietin.
English: The median times for the most relevant boceprevir-resistant variants observed in genotype 1b patients (> 10%) to become undetectable were as follows: I/V170A, 0.46 years; T54A, 0.47 years; V55A, 0.83 years; A156S, 0.89 years; and T54S, 1.11 years.
Maltese: I/V170A, 0.46 sena; T54A, 0.47 sena; V55A, 0.83 sena; A156S,
English: In comparison, 79% (66/84) of genotype 1b subjects no longer had any RAVs detected at the boceprevir-resistance associated loci by population sequencing.
Maltese: Meta mqabbel ma' dan, 79% (66/84) tal-individwi bil-ġenotip 1b ma kienx għad fadlilhom RAVs li setgħu jitkejlu fil-postijiet assoċjati ma' reżistenza għal boceprevir permezz ta' sekwenzar tal-popolazzjoni.
English: Boceprevir concentrations are not likely to be affected by maraviroc co-administration (based on elimination pathway of boceprevir).
Maltese: Il-konċentrazzjonijiet ta' boceprevir mhumiex probabbli li jkunu affettwati b'amministrazzjoni flistess ħin ta' maraviroc (abbażi tal-mogħdija ta' eliminazzjoni ta' boceprevir).
English: Co-administration of Victrelis with an oral contraceptive containing ethinyl estradiol and at least 1 mg of norethindrone is unlikely to alter the contraceptive effectiveness.
Maltese: L-għoti ta' Victrelis flimkien ma' kontraċettiv orali li fih l-ethinyl estradiol u tal-anqas 1 mg ta' norethindrone x'aktarx li mhuwiex se jibdel leffettività tal-kontraċettiv.
English: Whether on treatment early viral response and/or IL28B genotype could reliably identify those patients who are unlikely to retrieve significant benefit of boceprevir (higher SVR rates or short course treatment duration) on top of the bitherapy is currently under investigation.
Maltese: Esperjenza klinika oħra ma identifikatx differenzi fir-risponsi bejn il-pazjenti akbar u l-pazjenti iżgħar fl-età (ara
English: Please refer to the Summary of Product Characteristics for peginterferon alfa.
Maltese: Jekk jogħġbok irreferi għas-Sommarju tal-Karatteristiċi tal-Prodott ta' peginterferon alfa.
English: Method of administration
Maltese: MSD France
English: However, among poorly interferon-responsive patients to peginterferon alfa-2b/ribavirin during the 4-week lead-in period, the efficacy of boceprevir appeared to be reduced for those who had variants V36M, T54S, V55A or R155K detected at baseline.
Maltese: Madankollu, fost pazjenti li wrew rispons dgħajjef għal interferon għal peginterferon alfa-2b/ribavirin waqt il-perijodu ta' kura ta' introduzzjoni ta' 4 ġimgħat, l-effikaċja ta' boceprevir dehret imnaqqsa f'dawk li kellhom varjanti V36M, T54S, V55A jew R155K osservati fil-linja bażi.
English: Dry eye, retinal exudates, vision blurred, visual impairment
Maltese: Għajn xotta, tnixxija mir-retina, vista mċajpra, indeboliment fil-vista
English: It is not recommended to co-administer darunavir/ritonavir and Victrelis.
Maltese: Mhux irrakkomandat li tagħti darunavir/ritonavir flimkien ma' Victrelis.
English: Boceprevir/medicine derived material was shown to be transferred into the milk of lactating rats.
Maltese: Boceprevir/materjal miksub mill-mediċina ntwerew li jiġu ttrasferiti fil-ħalib ta' firien li jkunu qed ireddgħu.
English: Table 2 provides dosing recommendations as a result of drug interactions with Victrelis.
Maltese: Tabella 2 tipprovdi rakkomandazzjonijiet tad-dożaġġ bħala riżultat tal-interazzjonijiet tal-mediċina ma' Victrelis.
English: Sexual: missing menstrual period; heavy or prolonged menstrual period; uterine bleeding (i.e., prolonged >7 days or excessive bleeding at irregular or more frequent than normal intervals, bleeding occurring in menopausal women at least 6 months to 1 year after cessation of cycles) Mental illness: anger; hostile attitude or behaviour; threatening behaviour; substance abuse problems, abnormal behaviour; feeling of confusion; thoughts of suicide; sudden intense fear or apprehension; feeling you are being persecuted; difficulty solving problems Muscles: pain in your bones; local or widespread pain
Maltese: Rektum jew anus: ħakk fl-anus; ma tkunx tista' tipporga jew bidla fil-kulur tal-ippurgar; ippurgar aktar ta' spiss; ħruġ ta' demm mill-anus Sess: tinqabeż il-menstrwazzjoni (pirjid); menstrwazzjoni qawwija jew li tieħu fit-tul; ħruġ ta' demm mill-utru (i.e., ħruġ ta' demm li jdum >7 ijiem jew li jkun eċċessiv f'intervalli irregolari jew aktar frekwenti minn dawk normali, ħruġ ta' demm li jseħħ f'nisa li kellhom il-menopawsa mill-inqas 6 xhur jew sena wara li jkunu waqfulhom iċ-ċikli) Mard mentali: rabja; attitudni jew imġiba ostili; komportament ta' theddid; problemi ta' abbuż ta' sustanzi, imġieba mhux normali; sens ta' konfużjoni; ħsibijiet ta' suwiċidju; f'daqqa waħda tħoss biża kbir jew tħossok anzjuż/a; tħoss li qed tiġi ppersegwitat/a; tbatija biex issolvi l
English: Previous Partial Responder = subject who failed to achieve SVR after at least 12 weeks of previous treatment with peginterferon alfa and ribavirin, but demonstrated a ≥ 2 log10 reduction in HCV-RNA by Week 12 and had detectable HCV-RNA at End of Treatment (EOT).
Maltese: Persuna li Qabel Kellha Rispons Parzjali għall-Kura = individwu li ma kisibx SVR wara mill-inqas 12-il ġimgħa ta' kura li ngħatat qabel b'peginterferon alfa u ribavirin, iżda wera tnaqqis ta' ≥ 2 log10 flRNA ta' HCV sa Ġimgħa 12 u kellu HCV-RNA rilevabbli fit-Tmiem tal-Kura (EOT).
English: • Hypersensitivity to the active substance or any of the excipients listed in section 6.1.
Maltese: • Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe wieћed mill-eċċipjenti elenkati
English: Overall, the presence of baseline RAVs did not appear to have a notable association with treatment response in subjects receiving the combination of boceprevir with peginterferon alfa-2b and ribavirin.
Maltese: Globalment, ilpreżenza ta' RAVs fil-linja bażi ma dehritx li kellha assoċjazzjoni notevoli mar-rispons għall-kura f'individwi li kienu qed jirċievu taħlita ta' boceprevir ma' peginterferon alfa-2b u ribavirin.
English: Pregnancy must be avoided due to the use of Victrelis with ribavirin.
Maltese: Tqala għandha tiġi evitata minħabba l-użu ta' Victrelis ma' ribavirin.
English: Victrelis must be administered in combination with peginterferon alfa and ribavirin.
Maltese: Victrelis għandu jingħata flimkien ma' peginterferon alfa u ribavirin.
English: Available pharmacodynamic/toxicological data in rats have shown effects of boceprevir/metabolites on fertility, which in females have been shown to
Maltese: Dejta farmakodinamika/tossikoloġika disponibbli mill-firien uriet effetti ta' boceprevir/tal-metaboliti fuq il-fertilità, li fin-nisa intwerew li huma riversibbli (ara sezzjoni 5.3).
English: Achievement of SVR was associated with the subject's response to peginterferon alfa-2b and ribavirin therapy, whether defined by classification of response to previous treatment, or by a decrease in HCVRNA at TW 4 (see Table 7).
Maltese: Il-kisba ta' SVR kienet assoċjata mar-rispons tal-individwu għat-terpija b'peginterferon alfa-2b u ribavirin, kemm jekk iddefinita permezz ta' klassifikazzjoni tar-rispons għall-kura li ngħatat qabel, kif ukoll permezz ta' tnaqqis fl-RNA ta' HCV fi TW 4 (ara Tabella 7).
English: Storage by the pharmacist Store in a refrigerator.
Maltese: Żieda filmonitoraġġ kliniku u tallaboratorju hija neċessarja.
English: Hepatobiliary disorders Uncommon:
Maltese: Disturbi fil-fwied u fil-marrara Mhux komuni:
English: Victrelis may be co-administered with AKR inhibitors.
Maltese: Pazjenti li jirċievu prednisone u Victrelis għandhom jiġu mmonitorjati kif xieraq.
English: Cases of pancytopenia have been reported in patients receiving Victrelis in combination with peginterferon alfa and ribavirin.
Maltese: Każijiet ta' panċitopenija kienu rrappurtati f'pazjenti li kienu qed jirċievu Victrelis flimkien ma' peginterferon alfa u ribavirin.
English: The last available value in the period at and after FW 24.
Maltese: 1 fil-Ġimgħa ta' Segwitu (FW) 24.
English: See package leaflet for further information.
Maltese: Jista' jkun li mhux il-pakketti tad-daqsijiet kollha jkunu fis-suq.
English: * The Full Analysis Set (FAS) consisted of all subjects who became anaemic (serum haemoglobin of approximately ≤10 g/dL within the treatment period) and were randomized to using either ribavirin dose reduction or erythropoietin (N=500).
Maltese: * Is-Sett Sħiħ ta' Analiżi (FAS - Full Analysis Set) kien jikkonsisti fl-individwi kollha li saru anemiċi (emoglobina tas-serum madwar ≤10 g/dL fi żmien il-perjodu ta' kura) u ntgħażlu b'mod każwali biex jew jużaw tnaqqis fid-doża ta' ribavirin jew inkella erythropoietin (N=500).
English: Boceprevir was absorbed following oral administration with a median Tmax of 2 hours.
Maltese: Boceprevir ma jitneħħiex bid-dijalisi.
English: Tel: 0800 673 673 673 (+49 (0) 89 4561 2612)
Maltese: SVR %, (n/N) 96.3 (156/162 ) 96.3 (155/161 ) 0.0
English: Pleural fibrosis*, orthopnoea, respiratory failure
Maltese: Truxija*, skonfort fil-widnejn, indeboliment fis-smigħ
English: Each capsule has a yellowish-brown, opaque cap with an "MSD" logo imprinted in red ink and offwhite, opaque body with the code "314" imprinted in red ink.
Maltese: Kull kapsula għadha għatu kannella jagħti fl-isfar, opak bil-lowgo "MSD" stampat b'linka ħamra u korp ofwajt, opak bil-kodiċi "314" stampat b'linka ħamra.
English: Subjects were randomized in a 1:1:1 ratio in two cohorts (Cohort 1 N=
Maltese: Tul tal-kura = 28 ġimgħa 1.
English: boceprevir AUC ↓ 6%** boceprevir Cmax ↓ 2% boceprevir C8h ↑ 4%
Maltese: L-AUC ta' boceprevir ↓9% Is-Cmax ta' boceprevir ↑ 2%
English: SVR § % (n/N) EOT % (n/N) Relapse
Maltese: SVR § % (n/N)
English: Hyperbilirubinaemia
Maltese: J05AE12
English: If the patient has confirmed, detectable HCV-RNA at TW 24; then discontinue three-medicine
Maltese: TWISSIJA SPEĊJALI LI L-PRODOTT MEDIĊINALI GĦANDU JINŻAMM
English: Relapser: subject who failed to achieve SVR after at least 12 weeks of previous treatment with peginterferon alfa-2b and ribavirin, but had undetectable HCV-RNA at the end of treatment.
Maltese: Individwu li Rkada: individwu li naqas li jilħaq SVR wara mill-inqas 12-il ġimgħa ta' kura preċedenti b'peginterferon alfa-2b u ribavirin, iżda kellu RNA ta' HCV fit-tmiem tal-kura.
English: General: shaking; fainting; difficulty breathing; feeling thirsty; trouble sleeping; throbbing headache; generally feeling unwell; feeling like you are spinning Eyes or ears: dry eyes; ringing in the ears; changes in your vision Mouth, nose or throat: mouth pain, tooth ache; pain when swallowing; nose bleed, stuffy nose; a change in how things smell; sore and raised patches in the mouth; feeling very thirsty with a dry mouth or dry skin; swelling of the thyroid gland, neck or voicebox; underactive thyroid gland; sores or swelling in the mouth, burning feeling on the tongue; feeling of tension or fullness in the nose, cheeks and behind the eyes - sometimes with a throbbing ache, fever or
Maltese: Mard mentali: tħossok anzjuż/a; tħoss diqa kbira jew li m'inti tajjeb/tajba għal xejn (depressjoni); tħossok irritabbli, jkollok tensjoni jew irrikwitezza Demm: għadd baxx ta' ċelluli ħomor tad-demm (anemija), tnaqqis fin-numru ta' ċelluli ħomor tad-demm - is-sinjali jistgħu jinkludu tħossok għajjien/a, uġigħ ta' ras, ikollok qtugħ ta' nifs meta tagħmel l-eżerċizzju; għadd baxx ta' newtrofili (newtropenija), numru baxx ta' ċelluli bojod tad-demm - is-sinjali jistgħu jinkludu li tieħu aktar infezzjonijiet mis-soltu - inkluż deni, tkexkix kbir ta' bard, ġriżmejn misluħin jew ulċeri fil-ħalq
English: The SVR rates for those who received at least one dose of Victrelis (i.e. excluding patients who discontinued during PR lead-in) are 41% for null responders, 67% for partial responders and 96% for relapsers.
Maltese: Ir-rati ta' SVR għal dawk li ngħataw mill-inqas doża waħda ta' Victrelis (i.e. minbarra l-pazjenti li waqfu waqt il-perjodu ta' introduzzjoni ta' PR) huma 41% għal dawk li ma rrispondew assolutament xejn, 67% għal dawk li rrispondew b'mod parzjali u 96% għal dawk li rkadew.
English: HIV Non-nucleoside Reverse Transcriptase Inhibitors (NNRTI)
Maltese: Inibitur ta' Reverse Transcriptase Mhux Nucleoside (NNRTI) tal-HIV L-AUC ta' boceprevir ↓ 19%**
English: At Treatment Week 8
Maltese: Fil-Ġimgħa ta' Kura 8
English: Tel: +353 (0)1 299 8700 medinfo_ireland@merck.com
Maltese: Τηλ: +30 210 98 97 300 dpoc_greece@merck.com
English: No dose adjustment of digoxin or Victrelis is recommended.
Maltese: Ma hu rakkomandat lebda aġġustament fid-doża ta' digoxin jew Victrelis.
English: Eleven subjects were missing TW 4 assessment (HCV-RNA) and were not included in the Lead-In
Maltese: Ħdax-il individwu kellhom stima nieqsa ta' TW 4 (RNA ta' HCV) u ma ġewx inklużi fir-riżultati ta'
English: Some cases have also been reported in patients coinfected with hepatitis B and C viruses treated with interferon (refer to the Summary of Product Characteristics for peginterferon alfa for more information on HBV reactivation in patients coinfected with HBV and HCV treated with interferon).
Maltese: Ġew ukoll irrappurtati xi każijiet f'pazjenti ko-infettati bil-virusis tal-epatite B u Ċ ikkurati b'interferon (irreferi għas-Sommarju tal-Karatteristiċi tal-Prodott għal peginterferon alfa għal aktar informazzjoni dwar irriattivazzjoni tal-HBV f'pazjenti ko-infettati bl-HBV u bl-HCV ikkurati b'interferon).
English: It is not recommended to co-administer lopinavir/ritonavir and Victrelis.
Maltese: Mhux irrakkomandat li tagħti lopinavir/ritonavir flimkien ma' Victrelis.
English: Stomach and gut: pain in stomach and in the upper right side of the stomach or back; a burning feeling in the stomach, upset stomach; feeling bloated, burping (belching) Anus: wind (flatulence); piles (haemorrhoids); difficulty passing stools (constipation) Urinary: going to the toilet to urinate more often than usual Sexual: a decrease in sex drive; difficulty getting or keeping an erection Mental illness: changes in mood, feeling agitated; memory loss, trouble concentrating Chest: difficulty breathing; chest discomfort, chest pain; heavy feeling in the chest, with
Maltese: Ġilda u xagħar: ġilda tiħmar; infezzjoni fil-ġilda kkawżata minn batterja Stonku u msaren: problemi biex tiddiġerixxi l-ikel; tirremetti d-demm; rimettar, dijarea, u uġigħ qawwi fin-naħa l-leminija ta' fuq tal-istonku (addome) Sess: tnaqqis fil-livelli tal-isperma
English: Respiratory, thoracic and mediastinal disorders Cough*, dyspnoea*
Maltese: Disturbi respiratorji, toraċiċi u medjastinali Sogħla*, qtugħ ta' nifs*
English: The combination of boceprevir with these medicines is not recommended (see section 4.4).
Maltese: Il-kombinazzjoni ta' boceprevir ma' dawn il-mediċini mhijiex rakkomandata (ara sezzjoni 4.4).
English: • have another liver problem in addition to hepatitis C infection • have HIV (human immunodeficiency virus) or have ever had any other problems with your
Maltese: • għandek problema oħra fil-fwied minbarra infezzjoni bl-epatite Ċ • għandek l-HIV (virus tal-immunodefiċjenza umana) jew qatt kellek xi problemi oħra bis
English: In poorly interferon responsive patients (defined as < 1-log10 decline in HCV-RNA at TW 4) the use of triple therapy should be considered on a case by case basis, as the likelihood of achieving sustained virologic response (SVR) with triple therapy is lower in these patients (see section 5.1).
Maltese: Din l-iskeda kienet eżaminata biss f'individwi li ma ħadmitx fuqhom terapija li ngħataw qabel u li kellhom rispons ittardjat (ara sezzjoni 5.1).
English: How to store Victrelis
Maltese: † flistudju ewlieni
English: Slovenská republika Merck Sharp & Dohme, s. r. o. Tel.: +421 2 58282010 dpoc_czechslovak@merck.com
Maltese: Tel.: +421 2 58282010 dpoc_czechslovak@merck.com
English: HIV Nucleoside Reverse Transcriptase Inhibitor (NRTI)
Maltese: Inibitur ta' Nucleoside Reverse Transcriptase (NRTI) tal-HIV L-AUC ta' boceprevir ↑ 8%**
English: All subjects with detectable HCV-RNA in plasma at TW 24 were discontinued from treatment.
Maltese: Hija rakkomandata żieda filmonitoraġġ kliniku u tallaboratorju għassoppressjoni tal-HIV u lHCV.
English: %(n/N) * The Intent-to-Treat (ITT) population consisted of all subjects (N=168) who received at least one dose of any study medicine (peginterferon alfa-2b, ribavirin, or Victrelis).
Maltese: Il-popolazzjoni b'Intenzjoni li tiġi Kkurata (ITT - Intent-to-Treat) għall-analiżi tal-SVR kienet tikkonsisti fl-individwi kollha (N=168) li ngħataw mill-inqas doża waħda ta' kwalunkwe mediċina talistudju (peginterferon alfa-2b, ribavirin, jew Victrelis).
English: Very common (may affect more than 1 in 10 people) General: headache; chills, fever; feeling sick (nausea); flu-like symptoms; feeling dizzy, low energy; not being able to sleep; low appetite, weight loss; shortness of breath Mouth, nose or throat: cough; dry mouth; funny taste Skin and hair: dry skin, itching, rash; hair loss or thinning of hair Joints and muscles: unusual weakness; painful, swollen joints; muscle ache not caused by exercise
Maltese: Komuni ħafna (jistgħu jaffettwaw aktar minm persuna waħda minn kull 10) Ġenerali: uġigħ ta' ras; tkexkix ta' bard, deni; dardir (nawsja); sintomi bħal tal-influwenza; tħossok stordut, nuqqas ta' enerġija; ma tkunx tista' torqod; ma tantx ikollok aptit, telf ta' piż;
English: Subjects with these baseline variants and reduced response to peginterferon alfa-2b/ribavirin represented approximately 1% of the total number of
Maltese: Individwi b'dawn il-varjanti fil-linja bażi u rispons imnaqqas għal peginterferon alfa-2b/ribavirin irrappreżentaw madwar 1% tan-numru totali ta' individwi ikkurati b'boceprevir.
English: This is due to liver function changes during treatment with Victrelis.
Maltese: Mhuwiex irrakkomandat tnaqqis fid-doża ta' Victrelis.
English: The treatment discontinuation rate due to anaemia was 2% (5/249) in subjects randomized to receive ribavirin dose reduction and 2% (6/251) in subjects randomized to receive erythropoietin.
Maltese: Ir-rata ta' twaqqif tal-kura minħabba anemija kienet ta' 2% (5/249) f'individwi li ntgħażlu b'mod każwali biex jirċievu tnaqqis fid-doża ta' ribavirin u ta' 2% (6/251) f'individwi li ntgħażlu b'mod każwali biex jirċievu erythropoietin.
English: P05411 was a phase II randomized, double-blind, placebo-controlled study comparing Victrelis 800 mg orally three times daily in combination with PR [peginterferon alfa-2b 1.5 µg/kg/week subcutaneously and weight-based dosing with ribavirin (600-1,400 mg/day orally)] to PR alone in subjects co-infected with HIV and HCV genotype 1 who were previously untreated for chronic HCV infection.
Maltese: II, ikkontrollat bil-plaċebo li qabbel Victrelis 800 mg b'mod orali tliet darbiet kuljum f'kombinazzjoni ma' PR [peginterferon alfa-2b 1.5 µg/kg/ġimgħa mogħti taħt il-ġilda u dożaġġ ibbażat fuq il-piż ma' ribavirin (600-1,400 mg/jum b'mor orali)] ma' PR waħdu f'individwi ko-infettati bl-HIV u l-ġenotip 1 tal-HCV li ma kinux ingħataw kura qabel għal infezzjoni kronika tal-HCV.
English: In a study of patients with varying degrees of stable chronic liver impairment (mild, moderate and severe), no clinically significant differences in pharmacokinetic parameters were found, and no dose adjustment is recommended.
Maltese: Fi studju ta' pazjenti bi gradi varji ta' indeboliment kroniku stabbli tal-fwied (ħafif, moderat u qawwi), ma nstabu l-ebda differenzi sinifikanti b'mod kliniku fil-parametri farmakokinetiċi, u ma huwa rrakkomandat l-ebda aġġustament fid-doża.
English: • CYP3A4 inducer medicines (such as antibiotic medicine - rifampicin, and anticonvulsant medicines - carbamazepine, phenobarbital, phenytoin)
Maltese: (bħal mediċina antibijotika - rifampiċina, mediċini kontra l-aċċessjonijiet
English: Rilpivirine* (rilpivirine 25 mg every 24 hours + Victrelis 800 mg three times daily)
Maltese: Etravirine* (etravirine 200 mg kull 12-il siegħa + Victrelis 800 mg tliet darbiet kuljum)
English: Article 33(4) of Directive 2001/82/EC, as amended.
Maltese: Artikolu 33(4) tad-Direttiva 2001/82/KE, kid emendat.
English: The application was submitted in the framework of Article 32 of Directive 2001/82/EC, where the Reference Member State was the United Kingdom and the Concerned Member States were Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, the Netherlands, Norway, Poland, Portugal, Slovakia, Spain and Sweden.
Maltese: L-applikazzjoni ġiet sottomessa fil-qafas tal-Artikolu 32 tad-Direttiva 2001/82/KE, fejn l-Istat Membru ta' Referenza kien ir-Renju Unit u l-Istati Membri Konċernati kienu l-Awstrija, il-Belġju, Ċipru, ir-Repubblika Ċeka, idDanimarka, il-Finlandja, Franza, il-Ġermanja, il-Greċja, l-Ungerija, l-Islanda, l-Irlanda, l-Italja, ilLussemburgu, l-Olanda, in-Norveġja, il-Polonja, il-Portugall, is-Slovakkja, Spanja u l-Isvezja.
English: The Rapporteur and Co-Rapporteur appointed were: Prof. Christian Friis and Dr Valda Sejane, respectively.
Maltese: Christian Friis u Dr. Valda Sejane, rispettivament.
English: The Mutual Recognition Procedure UK/V/0321/001/MR started on 1 May 2008.
Maltese: IlProċedura ta' Rikonoxximent Reċiproku UK/V/0321/MR inbdiet fl-1 ta' Mejju 2008.
English: The proposal was rejected by the majority of CVMP members.
Maltese: Il-proposta ġiet irrifjutata mill-maġġoranza tal-membri tas-CVMP.
English: referral for TILDREN 500 mg, lyophilisate for solution for infusion
Maltese: TILDREN 500 mg, lyophilisate għal soluzzjoni għal infużjoni
English: Page 2/2
Maltese: II.
English: Opinion following an Article 33(4)
Maltese: Opinjoni b'segwitu ta' referenza għall-Artikolu 33(4)
English: Opinion following an Article 33(4) referral for TILDREN 500 mg, lyophilisate for solution for infusion
Maltese: Opinjoni b'segwitu ta' referenza għall-Artikolu 33(4) għal TILDREN 500 mg, lyophilisate għal soluzzjoni għal infużjoni EMA/552841/2010
English: During its 15-17 September 2009 meeting, the CVMP appointed Dr David Murphy as rapporteur and Dr Jiří Bureš as co-rapporteur for the re-examination of the above mentioned opinion.
Maltese: Matul il-laqgħa tiegħu tal-15-17 ta' Settembru 2009, is-CVMP, ħatar lil Dr David Murphy bħala relatur u lill-Dr Jiří Bureš bħala korelatur għar-rieżami tal-opinjoni msemmija hawn fuq.
English: Based on the evaluation of the rapporteurs' assessment of the detailed grounds for the re-examination, on 11 November 2009, the CVMP considered the rapporteurs' proposal for amending the opinion adopted on 15 July 2009.
Maltese: Abbażi tal-evalwazzjoni tal-valutazzjoni tar-relaturi tar-raġunijiet dettaljati għar-rieżami, fil-11 ta' Novembru 2009, is-CVMP qies il-proposta tar-relaturi biex tiġi emendata l-opinjoni adottata fil-15 ta' Lulju 2009.
English: Oral explanations were given on 16 June 2009.
Maltese: Spjegazzjonijiet orali ngħataw fis-16 ta' Ġunju 2009.