FrancophonIA/ELRC3.0 huggingface dataset:
English: At week 26, Ulunar Breezhaler produced statistically significant improvement in peak FEV1 compared to placebo in the first 4 hours post dose (LS mean treatment difference 330 ml) (p<0.001).
Maltese: Mas-26 ġimgħa, Ulunar Breezhaler ipproduċa titjib sinjifikanti statistikament flogħla FEV1 imqabbel mal-plaċebo fl-ewwel 4 sigħat wara l-għoti tad-doża (differenza fil-medja talkura ta' LS ta' 330 ml) (p<0.
English: Ulunar Breezhaler - placebo
Maltese: Ulunar Breezhaler - plaċebo
English: At 26 weeks (primary endpoint), Ulunar Breezhaler increased trough FEV1 by 80 ml in patients (Ulunar Breezhaler n=82; placebo n=42) with the lowest degree of reversibility (<5%) (p=0.053) and by 220 ml in those patients (Ulunar Breezhaler n=392, placebo n=190) with a higher degree of reversibility at baseline (≥5%) compared to placebo (p<0.001).
Maltese: Fis-26 ġimgħa (endpoint primarju), Ulunar Breezhaler żied l-anqas FEV1 bi 80 ml f'pazjenti (Ulunar Breezhaler n=82; plaċebo n=42) bl-anqas grad ta' riversibbiltà (<5%) (p=0.053) u b'220 ml f'dawk il-pazjenti (Ulunar Breezhaler n=392, plaċebo n=190) b'livell ogħla ta' riversibbiltà fil-linja bażi (≥5%) imqabbel mal-plaċebo (p<0.
English: 6 or 10 Ultibro Breezhaler capsules to be used in the inhaler
Maltese: 10 kapsuli Ulunar Breezhaler biex jintużaw mal inhaler
English: In the 52-week study comparing Ulunar Breezhaler (n=1,675) and fluticasone/salmeterol (n=1,679), Ulunar Breezhaler met the primary study objective of non-inferiority in rate of all COPD exacerbations (mild, moderate or severe) compared to fluticasone/salmeterol.
Maltese: Fl-istudju ta' 52 ġimgħa li qabbel Ulunar Breezhaler (n=1,675) u fluticasone/salmeterol (n=1,679), Ulunar Breezhaler laħaq l-objettiv primarju tal-istudju ta' non-inferjorità fir-rata ta' kull taħrix ta' COPD (ħafif, moderat jew sever) meta mqabbel ma' fluticasone/salmeterol.
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Maltese: Pazjenti li għandhom problemi ereditarji rari ta' intolleranza għall-galactose, nuqqas totali ta' lactase jew malassorbiment tal-glucose-galactose m'għandhomx jieħdu dan il- prodott mediċinali.
English: There were no relevant effects of Ulunar Breezhaler on mean heart rate over 24 h and heart rate assessed after 30 minutes, 4 h and 24 h.
Maltese: Ma kienx hemm effetti relevanti ta' Ulunar Breezhaler fuq il-medja tar-rata tal-qalb fuq medda ta' 24 siegħa u r-rata tal-qalb evalwata wara 30 minuta, 4 sigħat u 24 siegħa.
English: What Ulunar Breezhaler contains - The active substances are indacaterol (as maleate) and glycopyrronium bromide.
Maltese: X'fih Ulunar Breezhaler - Is-sustanzi attivi huma indacaterol (bħala maleate) u glycopyrronium bromide.
English: Ulunar Breezhaler further showed superiority in reducing the annualised rate of all exacerbations by 11% versus fluticasone/salmeterol (p=0.003).
Maltese: Ulunar Breezhaler wera wkoll superjorità fit-tnaqqis tarrata anwalizzata ta' kull taħrix bi 11% meta mqabbel ma' fluticasone/salmeterol (p=0.003).
English: In COPD patients both systemic exposure and total urinary excretion of glycopyrronium at pharmacokinetic steady state increased about dose-proportionally over the (delivered) dose range of 44 to 176 micrograms.
Maltese: F'pazjenti b'COPD kemm l-espożizzjoni sistemika u l-eskrezzjoni totali mal-awrina ta' glycopyrronium fi stat farmakokinetiku fiss żdiedet proporzjonalment skont id-doża (meħuda) fuq il medda tad-dożi mogħtija minn 44 sa 176 mikrogramma.
English: Immediate hypersensitivity reactions have been reported after administration of indacaterol or glycopyrronium, which are the active substances of Ulunar Breezhaler.
Maltese: Reazzjonijiet immedjati ta' sensittività eċċessiva ġew irrappurtati wara l-għoti ta' indacaterol jew glycopyrronium, li huma s-sustanzi attivi ta' Ulunar Breezhaler.
English: Ulunar Breezhaler has also shown a statistically significant effect on health-related quality of life measured using the St. George's Respiratory Questionnaire (SGRQ) as indicated by a reduction in SGRQ total score at 26 weeks compared to placebo (LS mean treatment difference -3.01, p=0.002) and tiotropium (LS mean treatment difference -2.13, p=0.009) and reductions versus indacaterol and glycopyrronium were -1.09 and -1.18, respectively.
Maltese: George's Respiratory Questionnaire (SGRQ) kif indikat bi tnaqqis fl-iskor totali ta' SGRQ mas-26 ġimgħa mqabbel mal-plaċebo (differenza fil-medja tal-kura ta' LS ta' -3.01, p=0.002) u tiotropium (differenza fil-medja tal-kura ta' LS ta' -2.13, p=0.009) u tnaqqis kontra indacaterol u glycopyrronium kienu ta' -1.09% u -1.18, rispettivament.
English: Ulunar Breezhaler 85 micrograms/43 micrograms inhalation powder, hard capsules indacaterol/glycopyrronium
Maltese: Ulunar Breezhaler 85 mikrogramma/43 mikrogramma trab li jittieħed man-nifs, kapsuli iebsa indacaterol/glycopyrronium
English: The largest time-matched difference versus placebo was 4.62 ms (90% CI 0.40, 8.85 ms), the largest time-matched decrease was -2.71 ms (90% CI -6.97, 1.54 ms), indicating that Ulunar Breezhaler had no relevant impact on the QT interval, as was expected by the properties of its components.
Maltese: L-akbar differenza fil-ħin mqabbel malplaċebo kien ta' 4.62 ms (90% CO 0.40, 8.85 ms), l-akbar tnaqqis fil-ħin imqabbel kien ta' -2.71 ms (90% CI -6.97, 1.54 ms), li juri li Ulunar Breezhaler ma kellu l-ebda impatt relevanti fuq l-intervall tal-QT, kif kien mistenni minħabba l-proprjetajiet tal-komponenti tiegħu.
English: Apontis Pharma GmbH & Co. KG Tel: +49 2173 8955 4949
Maltese: KG Tel: +49 2173 8955 4949
English: The capsules must be administered only using the Ulunar Breezhaler inhaler (see section 6.6).
Maltese: Il-kapsuli għandhom jittieħdu biss billi jintuża l-inhaler Ulunar Breezhaler (ara sezzjoni 6.6).
English: When to inhale Ulunar Breezhaler
Maltese: • Inhaler wieħed Ulunar Breezhaler
English: Ulunar Breezhaler should not be administered concomitantly with medicinal products containing other long-acting beta-adrenergic agonists or long-acting muscarinic antagonists, the pharmacotherapeutic groups to which the components of Ulunar Breezhaler belong (see section 4.5).
Maltese: Ulunar Breezhaler m'għandux jingħata flimkien ma' prodotti mediċinali li fihom agonisti betaadrenerġiċi oħrajn b'azzjoni fit-tul jew antagonisti muskariniċi b'azzjoni fit-tul, il-gruppi farmakoterapewtiċi li jagħmlu parti minnhom il-komponenti ta' Ulunar Breezhaler (ara sezzjoni 4.5).
English: The incidence of pneumonia was 3.2% in the Ulunar Breezhaler arm compared to 4.8% in the fluticasone/salmeterol arm (p=0.017).
Maltese: L-inċidenza ta' pnewmonja kienet ta' 3.2% fil-fergħa ta' Ulunar Breezhaler meta mqabbel ma' 4.8% fil-fergħa ta' fluticasone/salmeterol (p = 0.017).
English: Ulunar Breezhaler prolonged time to first moderate or severe exacerbation with a 22% reduction in risk of an exacerbation (p<0.001) and prolonged time to first severe exacerbation with a 19% reduction in risk of an exacerbation (p=0.046).
Maltese: Ulunar Breezhaler tawwal il-ħin sal-ewwel taħrix moderat jew sever bi tnaqqis ta' 22% fir-riskju ta' taħrix (p<0.001) u tawwal il-ħin sal-ewwel taħrix sever bi tnaqqis ta' 19% fir-riskju ta' taħrix (p=0.046).
English: Ulunar Breezhaler demonstrated a statistically superior improvement versus tiotropium in the percentage of “days able to perform usual daily activities” over 26 weeks (LS mean treatment difference 8.45%, p<0.001).
Maltese: Ulunar Breezhaler wera titjib superjuri statistikament kontra tiotropium fil-perċentwali ta' “jiem li fihom tkun kapaċi twettaq attivitajiet ta' kuljum” tul medda ta' 26 ġimgħa (differenza fil-medja talkura ta' LS ta' 8.45%, p<0.001).
English: Ulunar Breezhaler 85 micrograms/43 micrograms inhalation powder, hard capsules are transparent and yellow and contain a white to almost white powder.
Maltese: Ulunar Breezhaler 85 mikrogramma/43 mikrogramma trab li jittieħed man-nifs, kapsuli iebsa trasparenti u sofor u fihom trab minn abjad għal kważi abjad.
English: In another study comparing Ulunar Breezhaler (n=258) and fluticasone/salmeterol (n=264), for 26 weeks , the number of moderate or severe COPD exacerbations/patient-years was 0.15 versus 0.18 (18 events versus 22 events), respectively (p=0.512), and the number of all COPD exacerbations/patients-years (mild, moderate or severe) was 0.72 versus 0.94 (86 events versus 113 events), respectively (p=0.098).
Maltese: Fi studju ieħor li qabbel Ulunar Breezhaler (n=258) u fluticasone/salmeterol (n=264) għal 26 ġimgħa, l-għadd ta' taħrixiet ta' COPD ħfief jew moderat/snin ta' pazjent kien ta' 0.15 kontra 0.18 (18il avveniment kontra 22 avveniment), rispettivament (p=0.512), u n-numru ta' kull taħrix tasCOPD/snin ta' pazjent (ħafif, moderat jew sever) kien ta' 0.
English: Ulunar Breezhaler 85 micrograms/43 micrograms inhalation powder hard capsules
Maltese: Ulunar Breezhaler 85 mikrogramma/43 mikrogramma trab li jittieħed man-nifs, kapsuli iebsa
English: Ulunar Breezhaler also statistically significantly reduced the annualised rate of all COPD exacerbations (mild, moderate or severe) by 15% as compared to glycopyrronium (p=0.001) and 14% as compared to tiotropium (p=0.002).
Maltese: Ulunar Breezhaler naqqas ukoll b'mod statistikament sinifikanti ir-rata anwalizzata ta' kull taħrix ta' COPD (ħafif, moderat jew sever) b'15% meta mqabbel ma' glycopyrronium (p=0.001) u b'14% meta mqabbel ma' tiotropium (p=0.002).
English: Each delivered dose (the dose that leaves the mouthpiece of the inhaler) contains 110 micrograms of indacaterol maleate equivalent to 85 micrograms of indacaterol and 54 micrograms of glycopyrronium bromide equivalent to 43 micrograms of glycopyrronium.
Maltese: Kull doża meħuda (id-doża li tħalli l-bokkin tal-inhaler) fiha 110 mikrogramma ta' indacaterol maleate ekwivalenti għal 85 mikrogramma ta' indacaterol u 54 mikrogramma ta' glycopyrronium bromide ekwivalenti għal 43 mikrogramma ta' glycopyrronium.
English: The mean pre-dose FEV1 (average of the values taken at -45 and -15 minutes prior to the morning dose of study medication) was statistically significant in favour of Ulunar Breezhaler at week 26 compared to fluticasone/salmeterol (least squares [LS] mean treatment difference 100 ml, p<0.001), at week 52 compared to placebo (LS mean treatment difference 189 ml, p<0.001) and at all visits up to week 64 compared to glycopyrronium (LS mean treatment difference 70-80 ml, p<0.001) and tiotropium (LS mean treatment difference 60-80 ml, p<0.001).
Maltese: Il-medja tal-FEV1 wara l-għoti tad-doża (il-medja tal-valuri ttieħdet -45 u -15-il minuta qabel ma ngħatat id-doża tal-mediċina mogħtija waqt l-istudju għal filgħodu) kienet sinjifikanti statistikament favur Ulunar Breezhaler fis-26 ġimgħa mqabbel ma' fluticasone/salmeterol (differenza fil-medja talkura tal-anqas kwadri [LS] 100 ml, p<0.001), fit-52 ġimgħa mqabbel ma' plaċebo (differenza filmedja tal-kura ta' LS ta' 189 ml, p<0.001) u waqt il-viżti kollha sal-64 ġimgħa mqabbel ma' glycopyrronium (differenza fil-medja tal-kura ta' LS ta' 70-80 ml, p <0.
English: Compared to fluticasone/salmeterol, Ulunar Breezhaler reduced the annualised rate of both moderate or severe exacerbations by 17% (p<0.001), and of severe exacerbations (requiring hospitalisation) by 13% (not statistically significant, p=0.231).
Maltese: Meta mqabbel ma' fluticasone/salmeterol, Ulunar Breezhaler naqqas ir-rata anwalizzata kemm tattaħrix moderat kif ukoll dak sever bi 17% (p<0.001), u ta' taħrix sever (li jeħtieġ rikoveru l-isptar) bi 13% (mhux statistikament sinifikanti, p=0.231).
English: - The other ingredients of the inhalation powder are lactose monohydrate and magnesium stearate (see section 2 under “Ulunar Breezhaler contains lactose”).
Maltese: - Is-sustanzi l-oħra tat-trab li jittieħed man-nifs huma l-lactose monohydrate u magnesium stearate (ara sezzjoni 2 taħt “Ulunar Breezhaler fih il-lactose”).
English: Time to first pneumonia was prolonged with Ulunar Breezhaler compared to fluticasone/salmeterol (p=0.013).
Maltese: Il-ħin sal-ewwel avveniment ta' pnewmonja ttawwal b'Ulunar Breezhaler meta mqabbel ma' fluticasone/salmeterol (p=0.013).
English: A statistically significantly higher percentage of patients receiving Ulunar Breezhaler responded with a 1 point or greater improvement in the TDI focal score at week 26 compared to placebo (68.1% and 57.5% respectively, p=0.004).
Maltese: Persentaġġ ogħla u sinjifikanti statistikament ta' pazjenti mogħtija Ulunar Breezhaler irrispondew b'titjib ta' punt 1 jew akbar fl-iskor fokali tat-TDI fis-26 ġimgħa mqabbel mal-plaċebo (68.1% u 57.5% rispettivament, p=0.004).
English: The presentation of the safety profile is based on the experience with Ulunar Breezhaler and the individual active substances.
Maltese: Il-preżentazzjoni tal-profil ta' sigurtà tissejjes fuq l-esperjenza ta' Ulunar Breezhaler u s-sustanzi attivi individwali.
English: Based on the clinical pharmacokinetic characteristics of its monotherapy components, Ulunar Breezhaler can be used at the recommended dose in patients with mild to moderate renal impairment.
Maltese: Skont karatteristiċi farmakokinetiċi kliniċi tal-komponenti monoterapewtiċi tiegħu, Ulunar Breezhaler jista' jintuża skont id-doża rrakkomandata f'pazjenti b'indeboliment tal-fwied minn ħafif sa moderat.
English: Ulunar Breezhaler can be used at the recommended dose in elderly patients (75 years of age and older).
Maltese: Ulunar Breezhaler jista' jintuża skont id-doża rrakkomandata f'pazjenti anzjani (minn 75 sena 'l fuq).
English: Based on the in vitro performance data, the dose of indacaterol delivered to the lung is expected to be similar for Ulunar Breezhaler and indacaterol monotherapy product.
Maltese: Skont id-dejta ta' wirja in vitro, id-doża ta' indacaterol imwassla fil-pulmun hi mistennija li tkun tixbah lil dik ta' Ulunar Breezhaler u l-prodott monoterapewtiku b'indacaterol.
English: Show the pack of Ulunar Breezhaler.
Maltese: Uri l-pakkett ta' Ulunar Breezhaler.
English: The effects of Ulunar Breezhaler on QTc interval were investigated in healthy volunteers after inhalation of Ulunar Breezhaler up to 4 times the recommended therapeutic dose in four dose steps each separated by one hour.
Maltese: L-effetti ta' Ulunar Breezhaler fuq l-intervall tal-QTc kien mistħarreġ fost voluntiera b'saħħithom wara li ħadu man-nifs Ulunar Breezhaler sa 4 darbiet aktar id-doża terapewtika rrakkomandata mqassma f'4 stadji kull wieħed imbiegħed mill-ieħor b'siegħa.
English: In healthy volunteers, after the administration of 4 times the recommended therapeutic dose of Ulunar Breezhaler, the effect on serum potassium was very small (maximal difference -0.14 mmol/l when compared to placebo).
Maltese: L-effett fuq il-potassju fis-serum fost voluntiera b'saħħithom, wara l-għoti ta' 4 darbiet aktar mid-doża terapewtika rrakkomandata ta' Ulunar Breezhaler, kien żgħir ħafna (id-differenza massima ta'0.14 mmol/l meta mqabbel mal-plaċebo).
English: Ulunar Breezhaler is used as an ongoing treatment for your COPD.
Maltese: Ulunar Breezhaler jintuża bħala trattament kontinwu għas-COPD.
English: A population pharmacokinetic analysis of data in COPD patients after inhalation of Ulunar Breezhaler indicated no significant effect of age, gender and (lean body) weight on the systemic exposure to indacaterol and glycopyrronium.
Maltese: Analiżi farmakokinetika tal-popolazzjoni tad-dejta fost pazjenti b'COPD wara li ħadu Ulunar Breezhaler man-nifs uriet li ma hemmx effett sinjifikanti tal-età, is-sess u (ġisem immejjel) l-piż fuq lespożizzjoni sistemika ta' indicaterol u glycopyrronium.
English: Heart rate effects in healthy volunteers were investigated after a single dose of 4 times the recommended therapeutic dose of Ulunar Breezhaler administered in four dose steps each separated by one hour and compared to the effects of placebo, indacaterol, glycopyrronium and salmeterol.
Maltese: L-effetti fuq ir-rata tal-qalb f'voluntiera b'saħħithom kienu investigati wara doża singola ta' 4 darbiet id-doża terapewtika rrakkomandata ta' Ulunar Breezhaler mogħti f'doża mqassma f'4 stadji kull wieħed imbiegħed mill-ieħor b'siegħa u mqabbel mal-effetti tal-plaċebo, indacaterol, glycopyrronium u salmeterol.
English: Ulunar Breezhaler can be used at the recommended dose in patients with mild to moderate renal impairment.
Maltese: Ulunar Breezhaler jista' jintuża skont id-doża rrakkomandata f'pazjenti b'indeboliment tal-kliewi bejn ħafif u moderat.
English: In the 52-week active-controlled study, the mean pre-dose FEV1 was statistically significant in favour of Ulunar Breezhaler at all visits up to week 52 compared to fluticasone/salmeterol (LS mean treatment difference 62-86 ml, p<0.001).
Maltese: 001). Fl-istudju ta' 52 ġimgħa kkontrollat bl-attiv, il-medja tal-FEV1 ta' qabel id-doża kienet statistikament sinifikanti favur Ulunar Breezhaler waqt il-viżti kollha sat-52 ġimgħa, meta mqabbel ma' fluticasone/salmeterol (differenza fil-medja tal-kura ta' LS ta' 62-86 ml, p<0.001).
English: The co-administration of Ulunar Breezhaler with other anticholinergic-containing medicinal products has not been studied and is therefore not recommended (see section 4.4).
Maltese: L-għoti flimkien ta' Ulunar Breezhaler ma' prodotti mediċinali oħrajn li fihom antikolinerġiċi ma ġiex studjat u għalhekk mhuwiex irrakkomandat (ara sezzjoni 4.4).
English: • One Ulunar Breezhaler inhaler
Maltese: • Tużax il-kapsuli Ulunar Breezhaler ma' xi inhaler ieħor.
English: Over 52 weeks, Ulunar Breezhaler reduced the use of rescue medication by 0.25 puffs per day compared to fluticasone/salmeterol (p<0.001).
Maltese: Matul 52 ġimgħa, Ulunar Breezhaler naqqas l-użu ta' medikazzjoni ta' riskju b'0.25 sprejjaturi kuljum meta mqabbel ma' fluticasone/salmeterol (p<0.
English: During long-term clinical studies, more patients on Ulunar Breezhaler experienced clinically notable changes in blood glucose (4.9%) at the recommended dose than on placebo (2.7%).
Maltese: Waqt studji kliniċi fit-tul, aktar pazjenti mogħtija Ulunar Breezhaler kellhom tibdil notevoli klinikament fil-livell tal-glukosju (4.9%) fid-demm skont id-doża rrakkomandata milli meta ngħata lplaċebo (2.7%).
English: (December 2008)
Maltese: (Diċembru 2008)
English: In 2008:
Maltese: Fl-2008:
English: Revenue increased by 10.7%
Maltese: Id-dħul żdied b'10.7%
English: Reporting in EudraVigilance Veterinary
Maltese: Ir-rappurtar fl-EudraVigilance Veterinary
English: ‘Regulatory and procedural guidance': http://www.emea.europa.eu/htms/human/raguidelines/intro.htm 13 ‘Medicines for the elderly': http://www.emea.europa.eu/htms/human/elderly/introduction.htm
Maltese: Dokumenti tal-Bord Maniġerjali: http://www.emea.europa.eu/htms/general/manage/MB/MB_documents.html Websajt tal-ENCePP: http://www.encepp.eu ‘Gwida regolatorja u proċedurali': http://www.emea.europa.eu/htms/human/raguidelines/intro.htm 13 ‘Mediċini għall-Anzjani': http://www.emea.europa.eu/htms/human/elderly/introduction.htm
English: 2009 (forecast)
Maltese: 2009 (tbassir)
English: 9 Regulation (EC) No 1394/2007 on advanced therapy medicinal products.
Maltese: 9 Regolament (KE) Nru 1394/2007 dwar il-prodotti mediċinali b'terapija avvanzata.
English: the COMP adopted 86 positive opinions and 1 negative opinion;
Maltese: il-COMP adotta 86 opinjoni pożittiva u opinjoni negattiva waħda;
English: received 85 requests for administrative assistance.
Maltese: irċieva 85 talba għal għajnuna amministrattiva.
English: Fees
Maltese: Werrej
English: further contributions to a series of activities with partners of the tri-partite (EU-USA-Japan) International Conference on Harmonisation (ICH) and its veterinary equivalent (VICH);
Maltese: aktar kontribuzzjonijiet għal sensiela ta' attivitajiet ma' msieħba tal-Konferenza Internazzjonali tripartitika dwar l-Armonizzazzjoni (UE-Stati Uniti-Ġappun) (ICH) u l-ekwivalent veterinarju (VICH);
English: Implementing the European Risk Management Strategy
Maltese: European Medicines Agency
English: One draft entry was released for public consultation.
Maltese: Inħareġ abbozz wieħed ta' inklużjoni għal konsultazzjoni pubblika.
English: In 2008, the HMPC: finalised 17 Community herbal monographs4 for traditional and well-established herbal medicines;
Maltese: Fl-2008, l-HMPC: iffinalizza 17-il monografija Komunitarja ta' mediċini erbali4 għal mediċini magħmulin minn ħxejjex tradizzjonali u stabbiliti sew;
English: General EU contribution Special EU contribution for orphan medicines Contribution from EEA Community programmes Other
Maltese: Kontribuzzjoni ġenerali tal-UE Kontribuzzjoni speċjali tal-UE għall-mediċini orfni Kontribuzzjoni miż-ŻEE
English: adopted 5 entries to the ‘Community list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products'5.
Maltese: adotta 5 inklużjonijiet għal ‘lista Komunitarja ta' sustanzi, preparazzjonijiet u taħlitiet mill-ħxejjex għall-użu fi prodotti mediċinali tradizzjonali erbali'5.
English: Belgium Bulgaria Czech Republic Denmark Germany Estonia Ireland Greece Spain France Italy Cyprus Latvia Lithuania Luxembourg Hungary Malta Netherlands Austria Poland Portugal Romania Slovenia Slovakia Finland Sweden United Kingdom Other
Maltese: L-Olanda L-Awstrija Il-Polonja Il-Portugall Ir-Rumanija Is-Slovenja Is-Slovakja Il-Finlandja L-Isvezja
English: The COMP's opinion is forwarded to the European Commission, which takes the final decision on orphan designation.
Maltese: L-opinjoni tal-COMP tintbagħat lillKummissjoni Ewropea, li tieħu d-deċiżjoni finali fuq in-nominazzjoni orfni.
English: processed 337 applications for qualification or renewal of SME status;
Maltese: ipproċessa 337 applikazzjoni għall-kwalifikazzjoni jew għat-tiġdid ta' stejtus ta' SME;
English: reviewed and approved 84 applications from SMEs for the reduction or deferment of fees;
Maltese: irreveda u approva 84 applikazzjoni minn SMEs għat-tnaqqis jew id-differiment ta' ħlasijiet;
English: A total of 104 applications for post-authorisation evaluation of veterinary medicines were received in 2008 - just slightly fewer than the 109 received in 2007.
Maltese: Fl-2008 kien hemm total ta' 104 applikazzjoni għal evalwazzjoni ta' wara l-awtorizzazzjoni ta' mediċini veterinarji - ftit biss inqas mill-109 li daħlu fl-2007.
English: In 2008, a total of 459,485 reports of adverse drug reactions (ADRs) associated with the use of medicines in humans were entered into EudraVigilance.
Maltese: Fl-2008, total ta' 459,485 rapport ta' reazzjonijiet avversi għal mediċini (ADRs) assoċjati mal-użu ta' mediċini fil-bnedmin iddaħħlu fl-EudraVigilance.
English: In 2008, the total number of post-authorisation procedures finalised was 2,157, or some 13% higher than in the previous year.
Maltese: Fl-2008, in-numru totali ta' proċeduri ta' wara l-awtorizzazzjoni finalizzati kien ta' 2,157, jew madwar 13% ogħla mis-sena ta' qabel.
English: Applications for new medicinal products Generic applications
Maltese: Applikazzjonijiet għal prodotti mediċinali ġodda Applikazzjonijiet ġeneriċi
English: An equivalent system, called EudraVigilance Veterinary, exists to receive reports of adverse reactions occurring through the use of authorised veterinary medicines.
Maltese: Teżisti sistema ekwivalenti, imsejħa EudraVigilance Veterinary, li tirċievi rapporti ta' reazzjonijiet avversi li jseħħu permezz tal-użu ta' mediċini veterinarji awtorizzati.
English: Orphan medicinal product designation procedures (2006-2008)
Maltese: Proċeduri ta' nominazzjoni ta' prodotti mediċinali orfni (2006
English: Generics, hybrid products, etc.
Maltese: Prodotti mediċinali ġodda (mhux orfni) Prodotti mediċinali orfni Prodotti bijoloġiċi simili Prodotti ġeneriċi, ibridi, eċċ.
English: Interacting with patients, consumers and healthcare professionals
Maltese: L-interazzjoni mal-pazjenti, mal-konsumaturi u mal-professjonisti fil-kura tas-saħħa
English: the first pre-pandemic vaccine for use in adults against the H5N1 subtype of the influenza-A virus, which may cause avian influenza in humans.
Maltese: l-ewwel vaċċin pre-pandemiku għall-użu fl-adulti kontra s-sotto tip ta' H5N1 tal-virus-A talinfluwenza, li jista' jikkawża l-influwenza avjarja fil-bnedmin.