FrancophonIA/ELRC3.0 huggingface dataset:
English: Molecular interactions occur between corticosteroids and LABAs, whereby steroids activate the beta2receptor gene, increasing receptor number and sensitivity and LABAs prime the glucocorticoid receptor for steroid-dependent activation and enhance cell nuclear translocation.
Maltese: Iseħħu interazzjonijiet molekulari bejn il-kortikosterojdi u l-LABAs, fejn l-isterojdi jattivaw il-ġene tar riċetturi beta2, u b'hekk iżidu n-numru tar-riċetturi u s-sensittività u l-LABAs iħejju r-riċettur talglukokortikojdi għal attivazzjoni dipendenti fuq l-isterojdi u jżidu t-traslokazzjoni nukleari taċ-ċelloli.
English: This represents a 25% reduction in the rate of severe asthma exacerbations for subjects treated with fluticasone furoate/vilanterol 92/22 micrograms compared with FF 92 (p=0.014).
Maltese: Dan jirrappreżenta tnaqqis ta' 25% firrata ta' taħrix sever tal-ażżma għall-pazjenti mogħtija Relvar Ellipta 92/22 mikrogramma meta mqabbel ma' FF 92 (p=0.014).
English: If you are using this medicine for COPD you may be at an increased risk of developing an infection of the lungs known as pneumonia.
Maltese: Jekk qed tuża din il-mediċina għal COPD, inti tista' tkun f'riskju akbar li tiżviluppa infezzjoni fil-pulmuni magħrufa bħala pulmonite.
English: The effects of age on the pharmacokinetics of fluticasone furoate and vilanterol were determined in phase III studies in COPD and asthma.
Maltese: L-effetti tal-età fuq il-farmakokinetika ta' fluticasone furoate u vilanterol kienu determinati fi studji ta' fażi
English: Carton
Maltese: TIKKETTAR
English: Following oral administration, vilanterol was eliminated mainly by metabolism followed by excretion of metabolites in urine and faeces approximately 70% and 30% of the radioactive dose respectively in a human radiolabel study conducted by the oral route.
Maltese: Wara għoti orali, vilanterol ġie eliminat prinċipalment permezz tal-metaboliżmu segwit mit-tneħħija tal metaboliti fl-awrina u l-ippurgar ta' madwar 70% u 30% rispettivament tad-doża radjuattiva fi studju radjutikkettat fil-bniedem bir-rotta orali.
English: Concomitant administration of other sympathomimetic medicinal products (alone or as part of combination therapy) may potentiate the adverse reactions of fluticasone furoate/vilanterol.
Maltese: L-għoti fl-istess ħin ta' prodotti mediċinali simpatomimetiċi oħra (waħedhom jew bħala parti minn terapija kombinata) jista' jqawwi r-reazzjonijiet avversi ta' fluticasone furoate/vilanterol.
English: In peripheral blood mononuclear cells from subjects with COPD, a larger anti-inflammatory effect was seen in the presence of the combination of fluticasone furoate/vilanterol compared with fluticasone furoate alone at concentrations achieved with clinical doses.
Maltese: F'ċelloli mononukleari tad-demm periferali minn individwi b'COPD, deher effett anti-infjammatorju akbar filpreżenza tal-kombinazzjoni ta' fluticasone furoate/vilanterol imqabbel ma' fluticasone furoate waħdu f'konċentrazzjonijiet miksuba f'dożi kliniċi.
English: The increase in vilanterol exposure was not associated with an increase in beta2-agonist related systemic effects on heart rate, blood potassium or QTcF interval.
Maltese: Iż-żieda fl-esponiment għal vilanterol ma kinitx assoċjata ma' żieda fl-effetti sistemiċi relatati mal-agonisti beta2 fuq ir-rata tal-qalb, il-potassju fid-demm jew l-intervall QTcF.
English: Fluticasone furoate was not genotoxic in a standard battery of studies and was not carcinogenic in lifetime inhalation studies in rats or mice at exposures similar to those at the maximum recommended human dose, based on AUC.
Maltese: Fluticasone furoate ma kienx ġenotossiku f'batterija standard ta' studji u ma kienx karċinoġeniku fi studji tal-inalazzjoni tul il-ħajja fil-firien jew fil-ġrieden b'esponimenti simili għal dawk bid-doża massima rakkomandata fil-bniedem, fuq il-bażi tal-AUC.
English: Nasopharyngitis Paradoxical bronchospasm Oropharyngeal pain Sinusitis
Maltese: Jista' jkun hemm bronkospażmu paradossali b'żieda immedjata fit-tħarħir wara t-teħid tad-doża.
English: PHARMACEUTICAL FORM Inhalation powder, pre-dispensed (Inhalation powder).
Maltese: Pulmonite (infezzjoni fil-pulmun) (effett sekondarju komuni, jista' jaffettwa sa persuna 1 minn 10)
English: How to use Relvar Ellipta See ‘Step-by-step instructions' after section 6 of this leaflet for full information.
Maltese: Ara l-‘Istruzzjonijiet pass pass' wara sezzjoni 6 ta' dan il-fuljett għal informazzjoni sħiħa.
English: Based on in vitro data, the major routes of metabolism of both fluticasone furoate and vilanterol in human are mediated primarily by CYP3A4.
Maltese: Abbażi ta' dejta in vitro, ir-rotot tal-metaboliżmu kemm ta' fluticasone furoate kif ukoll ta' vilanterol filbniedem huma medjati prinċipalment permezz ta' CYP3A4.
English: In adolescents (12 years or older), there are no recommended dose modifications.
Maltese: Fl-adolexxenti (12-il sena jew aktar), ma hemm l-ebda modifika rakkomandata fid-doża.
English: Relvar Ellipta should be discontinued immediately, the patient assessed and alternative therapy instituted if necessary.
Maltese: Relvar Ellipta għandu jitwaqqaf immedjatament, il-pazjent jiġi eżaminat u jekk ikun meħtieġ, tinbeda terapija alternattiva.
English: In HZA106837 patients were randomised to receive either fluticasone furoate/vilanterol 92/22 micrograms [n=1009] or FF 92 micrograms [n=1010] both administered once daily.
Maltese: Fl-istudju HZA106837, il-pazjenti ġew randomizzati biex jirċievu jew Relvar Ellipta 92/22 mikrogramma [n=1009] jew FF 92 mikrogramma
English: • heart beating faster (tachycardia)
Maltese: • qalb tħabbat aktar malajr (takikardja)
English: Pharyngitis
Maltese: Bronkite
English: Chronic Obstructive Pulmonary Disease
Maltese: Infezzjoni fil-pulmun
English: Your Relvar Ellipta inhaler carton contains
Maltese: X'inhu Relvar Ellipta u għalxiex jintuża
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Relvar Ellipta 184 micrograms/22 micrograms inhalation powder fluticasone furoate/vilanterol
Maltese: Relvar Ellipta 184 mikrogramma/22 mikrogramma trab li jittieħed man-nifs, lest minn qabel fluticasone furoate/vilanterol
English: 3-4 seconds).
Maltese: 41 sa 84 sena.
English: Relvar Ellipta has been shown to reduce flare-ups of COPD symptoms.
Maltese: Id-doża għandha tiġi titrata għall-aktar doża baxxa li biha jinżamm kontroll effettiv tas-sintomi.
English: Package leaflet: Information for the user Relvar Ellipta 92 micrograms/22 micrograms inhalation powder, pre-dispensed Relvar Ellipta 184 micrograms/22 micrograms inhalation powder, pre-dispensed
Maltese: Relvar Ellipta 92 mikrogramma/22 mikrogramma trab li jittieħed man-nifs, lest minn qabel Relvar Ellipta 184 mikrogramma/22 mikrogramma trab li jittieħed man-nifs, lest minn qabel
English: Reproductive toxicity
Maltese: Effett tossiku fuq is-sistema riproduttiva
English: • fever or chills
Maltese: • spażmi fil-muskoli
English: No comparative studies versus salmeterol/FP or versus other ICS/LABA combinations have been conducted to appropriately compare the effects of asthma exacerbations.
Maltese: Ma sarux studji komparattivi kontra salmeterol/FP bit-taħrix bħala endpoint primarju.
English: Fluticasone furoate/vilanterol 92 /22 micrograms consistently demonstrated 83 mL to 95 mL improvements in trough FEV1 at weeks 12, 36 and 52 and Endpoint compared with FF 92 micrograms (p<0.001 95% CI 52, 126 mL at Endpoint).
Maltese: Relvar Ellipta 92 /22 mikrogramma wera b'mod konsistenti 83 mL sa 95 mL titjib fil-FEV1 minimu f'ġimgħat 12, 36 u 52 u l-Endpoint meta mqabbel ma' FF 92 mikrogrammi (p<0.
English: Given this low oral bioavailability, systemic exposure for fluticasone furoate and vilanterol following inhaled administration is primarily due to absorption of the inhaled portion of the dose delivered to the lung.
Maltese: Minħabba din il-bijodisponibilità orali baxxa, l-esponiment sistemiku għal fluticasone furoate u vilanterol wara t-teħid man-nifs huwa primarjament dovut għall-assorbiment tal-porzjon tad-doża meħud man-nifs li jasal filpulmun.
English: The inhaler contains two aluminium foil laminate strips of 14 or 30 doses.
Maltese: L-inalatur fih żewġ strixxi ta' laminat tal-fojl tal-aluminju ta' 14 jew 30 doża.
English: Blister (alu/Aclar)
Maltese: Folja (aluminju/Aclar) 84 kapsula
English: 100 mg
Maltese: 100 mg Kapsula, iebsa
English: Ref. EMEA/CHMP/194784/2009 EMEA/H/A-29/990
Maltese: EMEA/CHMP/194622/2009 EMEA/H/A-29/990
English: Dr Gonzalo Calvo Rojas (Spain)
Maltese: Dr Gonzalo Calvo Rojas (Spanja)
English: 19 March 2008
Maltese: 19 ta' Marzu 2008
English: Prof Michal Pirożynski (Poland)
Maltese: Prof Michal Pirożynski (Il-Polonja)
English: London, 17 March 2009 Doc.
Maltese: Londra, 17 ta' Marzu 2009 Dok. Ref.
English: Sabumalin is a ‘generic medicine'.
Maltese: Sabumalin huwa ‘mediċina ġenerika'.
English: Questions and answers on the referral for Sabumalin salbutamol, metered dose aerosol inhaler, 100 μg/dose
Maltese: Mistoqsija u tweġiba dwar ir-referenza għal Sabumalin salbutamol, inalatur ajrosol b'doża mkejla, 100 μg/doża
English: This is a procedure when one Member State (the ‘reference Member State', in this instance Sweden) assesses a medicine with a view of granting a marketing authorisation that will be valid in this country as well as in other member states (the ‘concerned Member States', in this instance Belgium, Denmark, Estonia, Finland, Germany, Greece, Hungary, Italy, Latvia, Lithuania, the Netherlands, Norway, Poland, Portugal, Slovenia, Spain and the United Kingdom).
Maltese: Din hija proċedura meta Stat Membru (l-‘Istat Membru ta' referenza, f'dan il-każ l-Iżvezja) jevalwa mediċina bil-għan li jagħti awtorizzazzjoni għat-tqegħid fissuq li tkun valida f'dan il-pajjiż kif ukoll fi Stati Membri oħrajn (l-‘Istati Membri konċernati', f'dan ilkaż, il-Belġju, id-Danimarka, l-Estonja, il-Finlandja, il-Ġermanja, il-Greċja, l-Ungerija, l-Italja, ilLatvja, il-Litwanja, l-Olanda, in-Norveġja, il-Polonja, il-Portugall, is-Slovenja, Spanja u r-Renju Unit).
English: Salbutamol is a beta2-adrenergic receptor agonist.
Maltese: Salbutamol huwa agonista tar-riċettur ta' beta2-adrenerġiku.
English: Hexal AG submitted Sabumalin to the Swedish medicines regulatory agency for a decentralised procedure on 5 December 2006.
Maltese: Hexal AG issottomettiet Sabumalin lill-aġenzija regolatorja tal-mediċini Żvediża għal proċedura deċentralizzata fil-5 ta' Diċembru 2006.
English: Company responses provided on: 30 May 2008, 20 October 2008 Opinion date:
Maltese: It-tweġibiet tal-kumpanija ngħataw 30 ta' Mejju 2008, 20 ta' Ottubru 2008
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Sabumalin outweigh its risks, and that the marketing authorisation can be granted in Sweden as well as in the following Member States of the European Union: Belgium, Denmark, Estonia, Finland, Germany, Greece, Hungary, Italy, Latvia, Lithuania, the Netherlands, Norway, Poland, Portugal, Slovenia, Spain and the United Kingdom.
Maltese: IlKumitat għall-Prodotti Mediċinali għal Użu mill-Bniedem (CHMP) tal-Aġenzija ikkonkluda li lbenefiċċji ta' Sabumalin huma akbar mir-riskji tiegħu, u li l-awtorizzazzjoni għat-tqegħid fis-suq tista' tingħata fl-Iżvezja kif ukoll fl-Istati Membri tal-Unjoni Ewropea li ġejjin: il-Belġju, id-Danimarka, lEstonja, il-Finlandja, il-Ġermanja, il-Greċja, l-Ungerija, l-Italja, il-Latvja, il-Litwanja, l-Olanda, inNorveġja, il-Polonja, il-Portugall, is-Slovenja, Spanja u r-Renju Unit.
English: What is Sabumalin?
Maltese: X'inhu Sabumalin?
English: This means that Sabumalin is similar to a ‘reference medicine' already authorised in the European Union (EU) called Sultanol inhaler.
Maltese: Dan ifisser li Sabumalin huwa simili għal ‘mediċina ta' referenza' li hija diġà awtorizzata fl-Unjoni Ewropea (UE) imsejħa Sultanol inalatur.
English: It can also be used to prevent asthma symptoms caused by exercise or other triggering factors, such as house dust, pollen, cats, dogs and cigarette smoke.
Maltese: Jista' jintuża wkoll biex jipprevjeni sintomi ta' ażżma ikkawżati bl-eżerċizzju jew fatturi oħrajn li jikkawżaw dan, bħal trab domestiku, polline, qtates, klieb u dħaħen tas-sigaretti.
English: When given by inhalation as in Sabumalin, salbutamol directly activates the beta2-receptors in the respiratory system.
Maltese: Meta mogħti b'inalazzjoni bħal f'Sabumalin, salbutamol jattiva direttament ir-riċetturi-beta2 fis-sistema respiratorja.
English: Sabumalin is a medicine in a pressurised inhaler that contains salbutamol as active substance.
Maltese: Sabumalin huwa mediċina f'inalatur taħt pressjoni li fih salbutamol bħala sustanza attiva.
English: Sabumalin is used to treat the breathing difficulties caused by asthma and chronic obstructive pulmonary disease (COPD).
Maltese: Sabumalin jintuża biex jittratta d-diffikultajiet fit-teħid tan-nifs ikkawżati mill-ażżma u minn mard pulmonari ostruttiv kroniku (COPD).
English: The European Medicines Agency (EMEA) has completed a referral procedure following a disagreement among Member States of the European Union regarding the authorisation of the medicine Sabumalin.
Maltese: L-Aġenzija Ewropea dwar il-Mediċini (EMEA) temmet proċedura ta' referenza wara nuqqas ta' qbil fost l-Istati Membri tal-Unjoni Ewropea fir-rigward tal-awtorizzazzjoni tal-mediċina Sabumalin.
English: The grounds for the referral were concerns regarding that there was not enough data showing that Sabumalin is equivalent to the reference medicine.
Maltese: Ir-raġunijiet għar-referenza kienu tħassib dwar il-fatt li ma kienx hemm biżżejjed dejta li turi li Sabumalin huwa ekwivalenti għall-mediċina ta' referenza.
English: Why was Sabumalin reviewed?
Maltese: Għaliex ġie rivedut Sabumalin?
English: On 4 March 2008, the Swedish medicines regulatory agency referred the matter to the CHMP.
Maltese: Dawn l-Istati Membri ma setgħux jaslu għal ftehim. Fl-4 ta' Marzu 2008, l-aġenzija regolatorja talmediċini tal-Iżvezja rriferiet il-kwistjoni lis-CHMP.
English: 4 pre-filled syringes
Maltese: 4 siringi mimlijin għal-lest
English: Content (concentration)
Maltese: Isem (ivvintat)
English: 1 pre-filled syringe
Maltese: 1 siringa mimlija għal-lest
English: Pack size
Maltese: Kontenut
English: (Invented) name
Maltese: (konċentrazzjon i)
English: Content (concent ration)
Maltese: Kontenut (konċent razzjoni)
English: MA (EU) number (Invented) Name
Maltese: Numru tal-MA (UE)
English: Package size
Maltese: 1 flixkun
English: MIKA Pharma GmbH requested that the marketing authorisation for Diclofenac Sodium Spray Gel 4% granted by the UK (the ‘reference Member State') in 2001, and subsequently granted by Austria, Estonia, Hungary, Ireland, Latvia, Lithuania and Slovenia, be also recognised in Germany, Italy and Spain (the ‘concerned Member States').
Maltese: MIKA Pharma GmbH talbet li l-awtorizzazzjoni għat-tqegħid fis-suq ta' Diclofenac Sodium Spray Gel 4% mogħtija mir-Renju Unit (l-"Istat Membru ta' referenza") fl-2001, u sussegwentement millAwstrija, l-Estonja, l-Ungerija, l-Irlanda, il-Latvja, il-Litwanja u s-Slovenja, tiġi rikonoxxuta wkoll filĠermanja, fl-Italja u fi Spanja (l-"Istati Membri kkonċernati").
English: What is Diclofenac Sodium Spray Gel 4%?
Maltese: X'inhu Diclofenac Sodium Spray Gel 4%?
English: Diclofenac Sodium Spray Gel 4% contains the active substance diclofenac, which belongs to the group of non-steroidal anti-inflammatory drugs (NSAIDs).
Maltese: Diclofenac Sodium Spray Gel 4% fih is-sustanza attiva diclofenac, li tappartjeni għall-grupp ta' mediċini antinfjammatorji nonsterojdali (NSAIDs).
English: The European Commission issued an EU-wide legally binding decision on the marketing authorisation of Diclofenac Sodium Spray Gel 4% on 18/01/2019.
Maltese: Il-Kummissjoni Ewropea ħarġet deċiżjoni legalment vinkolanti fl-UE kollha dwar l-awtorizzazzjoni għattqegħid fis-suq ta' Diclofenac Sodium Spray Gel 4% fit-18/01/2019.
English: On 15 November 2018, the European Medicines Agency completed a review of Diclofenac Sodium Spray Gel 4% following a disagreement among EU Member States regarding its authorisation.
Maltese: Fil-15 ta' Novembru 2018, l-Aġenzija Ewropea għall-Mediċini lestiet rieżami ta' Diclofenac Sodium Spray Gel 4% wara nuqqas ta' qbil fost l-Istati Membri tal-UE dwar l-awtorizzazzjoni tiegħu.
English: EMA completes review following disagreement among EU Member States
Maltese: L-EMA tlesti rieżami wara nuqqas ta' qbil fost l-Istati Membri tal-UE
English: The review of Diclofenac Sodium Spray Gel 4% was initiated at the request of the United Kingdom under Article 29(4) of Directive 2001/83/EC.
Maltese: Ir-rieżami ta' Diclofenac Sodium Spray Gel 4% inbeda fuq it-talba tar-Renju Unit skont l-Artikolu 29(4) tad-Direttiva 2001/83/KE
English: Since Diclofenac Sodium Spray Gel 4% is absorbed in a similar way to other diclofenac medicines applied to the skin and the supporting study demonstrated an effect similar to that of other diclofenac medicines in the published literature, the Agency considered that it was acceptable to use published data on the effectiveness and safety of other diclofenac medicines to support the use of Diclofenac Sodium Spray Gel 4%.
Maltese: Peress li Diclofenac Sodium Spray Gel 4% jiġi assorbit b'mod simili għal mediċini oħrajn ta' diclofenac applikati fuq il-ġilda u l-istudju ta' sostenn wera effett simili bħal dak ta' mediċini oħra ta' diclofenac filletteratura ppubblikata, l-Aġenzija kkunsidrat li kien aċċettabbli li tintuża d-data ppubblikata dwar leffikaċja u s-sigurtà ta' mediċini oħra ta' diclofenac biex tappoġġa l-użu ta' Diclofenac Sodium Spray Gel 4%.
English: However, the Member States were not able to reach an agreement and the UK medicines regulatory agency referred the matter to EMA for arbitration on 4 April 2018.
Maltese: Madankollu, l-Istati Membri ma setgħux jaslu għal qbil u l-aġenzija regolatorja tal-mediċini tar-Renju Unit irreferiet il-kwistjoni lill-EMA għal arbitraġġ fl-4 ta' April 2018.
English: The review was carried out by EMA's Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use.
Maltese: Ir-rieżami twettaq mill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-EMA, responsabbli mill-mistoqsijiet dwar il-mediċini għall-użu mill-bniedem.
English: Overall, the totality of the data provided by the company was considered sufficient to demonstrate that Diclofenac Sodium Spray Gel 4% is effective at treating joint swelling and pain due to trauma.
Maltese: B'mod globali, it-totalità tad-data pprovduta mill-kumpanija tqieset bħala biżżejjed biex turi li Diclofenac Sodium Spray Gel 4% huwa effettiv biex jikkura nefħa u uġigħ fil-ġogi minħabba trawma.
English: The Agency considered that the data provided by the company show that, when applied to the skin, Diclofenac Sodium Spray Gel 4% produces similar levels of diclofenac in the body to another diclofenac
Maltese: L-Aġenzija kkunsidrat li d-data pprovduta mill-kumpanija turi li, meta jiġi applikat fuq il-ġilda, Diclofenac Sodium Spray Gel 4% jipproduċi livelli simili ta' diclofenac fil-ġisem bħal ġell ieħor ta'
English: The company also provided the results of a study indicating that Diclofenac Sodium Spray Gel 4% is effective at reducing joint swelling and relieving pain.
Maltese: Il-kumpanija pprovdiet ukoll ir-riżultati ta' studju li jindikaw li Diclofenac Sodium Spray Gel 4% huwa effettiv biex inaqqas in-nefħa tal-ġogi u jtaffi l-uġigħ.
English: Plaça de la Pau s/n 08940 Cornellà de Llobregat (Barcelona) Spain
Maltese: Plaça de la Pau s/n 08940 Cornellà de Llobregat (Barcelona) Spanja
English: Data submitted by the Applicant
Maltese: Dejta ppreżentata mill-Applikant
English: Old Belfast Road, Millbrook, Larne, County Antrim, BT40 2SH United Kingdom
Maltese: Old Belfast Road, Millbrook, Larne, County Antrim, BT40 2SH
English: (Invented) Name Strength
Maltese: Isem inventat
English: Module 4 contained three preclinical risedronate studies.
Maltese: Il-Modulu 4 kien fih tliet studji prekliniċi ta' risedronate.
English: The Applicant submitted an application for mutual recognition of the marketing authorisation granted by Sweden in 2006 for Fortipan Combi D, a combination product consisting of risedronate sodium 35 mg film-coated tablets together with 1000 mg calcium carbonate and 880 IU colecalciferol effervescent granules.
Maltese: L-Applikant issottometta applikazzjoni għal rikonoxximent reċiproku talawtorizzazzjoni għat-tqegħid fis-suq mogħtija mill-Isvezja fl-2006 għal Fortipan Combi D, prodott ta' kombinazzjoni magħmul minn pilloli ta' 35 mg risedronate sodium miksijin b'rita flimkien ma' 1000 mg karbonat tal-kalċju u 880 IU granuli effervexxenti ta' colecalciferol.
English: Therefore, the proposed dosage is one risedronate tablet on day 1 followed by one sachet of calcium/colecalciferol daily for day 2 through to day 7, repeating this 7-day sequence each week.
Maltese: Għaldaqstant, id-dożaġġ propost huwa ta' pillola ta' risedronate waħda f'jum 1 segwita minn qartas wieħed ta' calcium/colecalciferol kuljum għal jum 2 sa jum 7, u din is-sekwenza ta' 7 ijiem tiġi ripetuta kull ġimgħa.
English: Grounds for positive opinion
Maltese: U RAĠUNIJIET GĦAL OPINJONI POŻITTIVA
English: The procedure was therefore referred to the CMD(h) and subsequently, to the CHMP under Article 29(4), in April 2010.
Maltese: Għaldaqstant, il-proċedura ġiet riferuta lis-CMD(h) u sussegwentament, lisCHMP skont l-Artikolu 29(4), f'April 2010.
English: A concerned member state (CMS) raised Potential Serious Risks to Public Health pertaining to the lack of evidence of efficacy; in particular regarding the claims of improved benefit compared to the individual products and improved compliance compared to standard treatment.
Maltese: Stat Membru mħasseb (CMS) qajjem Riskji Serji Potenzjali għas-Saħħa Pubblika li jappartjenu għan-nuqqas ta' evidenza tal-effikaċja; b'mod partikolari fir-rigward tal-pretensjonijiet ta' benefiċċju mtejjeb meta mqabbel mal-prodotti individwali u ma' konformità mtejba meta mqabbel ma' kura standard.
English: Module 5 contained pivotal clinical studies and study reports for the 35 mg risedronate tablet and the calcium plus colecalciferol product as well as the pivotal study for approval of the weekly 35 mg risedronate tablet, in which patients were co-administered calcium and vitamin D, along with 46 relevant clinical literature references.
Maltese: Il-Modulu 5 kien fih studji kliniċi ewlenin u r-rapporti tal-istudju għall-pillola risedronate ta' 35 mg u għall-prodott kalċju u colecalciferol kif ukoll l-istudju ewlenin għallapprovazzjoni tal-pillola risedronate ta' 35 mg ta' kull ġimgħa, li fiha, il-pazjenti ngħataw kalċju u vitamin D flimkien, kif ukoll 46 referenza ta' litteratura klinika rilevanti.
English: The CHMP noted the data submitted in the initial application.
Maltese: Is-CHMP innota d-dejta ppreżentata fl-applikazzjoni inizjali.
English: The CHMP was of the opinion that the application is approvable.
Maltese: Is-CHMP kien tal-opinjoni li l-applikazzjoni hija approvabbli.
English: Scientific conclusions and grounds for positive opinion
Maltese: Raġunijiet għal opinjoni pożittiva
English: The CHMP considered the combination pack of risedronate and calcium plus colecalciferol to be an “exceptional case”, based on the problematic dosing and the risk for interaction prohibiting concomitant intake as per the Guideline for combination products (CHMP/EWP/240/95).
Maltese: Is-CHMP qies li l-pakkett ta' kombinazzjoni ta' risedronate u kalċju kif ukoll colecalciferol huwa “każ eċċezzjonali”, minħabba d-dożaġġ problematiku u r-riskju għal interazzjoni li tipprojbixxi teħid flistess ħin skont il-Linja gwida għal prodotti ta' kombinazzjoni (CHMP/EWP/240/95).
English: Annex II
Maltese: ANNESS II
English: Module 3 contained relevant documentation for the risedronate film-coated tablet as well as for the effervescent calcium-colecalciferol effervescent granules, for the drug substance as well as for the drug product.
Maltese: Il-Modulu 3 kien fih id-dokumentazzjoni rilevanti għal risedronate pillola miksija b'rita kif ukoll għall-granuli effervexxenti ta' calcium-colecalciferol, għas-sustanza mediċinali kif ukoll għallprodott mediċinali.
English: Applicant
Maltese: LISTA