FrancophonIA/ELRC3.0 huggingface dataset:
English: A number of further questions were addressed to the Marketing Authorisation Holder (MAH) relating to the dosage, clarification of the statistical analyses, the concomitant NSAID treatment and the influence of exercise.
Maltese: Għadd ta' mistoqsijiet oħra ġew indirizzati lid-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq (Marketing Authorisation Holder - MAH) rigward id-doża, kjarifikazzjoni tal-analiżi statistiċi, ittrattament tal-NSAID konkomittanti u l-influwenza tal-eżerċizzju.
English: The first clinical study was carried out in accordance with GCP to assess the efficacy and tolerance of tiludronic acid in the treatment of 3 clinical conditions including bone spavin and to compare two dosage regimes with treatment administering a placebo (vehicle only).
Maltese: L-ewwel prova klinika twettqet skont il-GCP biex jiġu vvalutati l-effikaċja u t-tolleranza ta' tiludronic acid fit-trattament ta' 3 kundizzjonijiet kliniċi nkluża l-bone spavin u biex jitqabblu żewġ sistemi ta' doża ma' trattament blgħoti ta' plaċebo (vettur biss).
English: Lyophilisate for solution for infusion
Maltese: Lyophilisate għal soluzzjoni għal infużjoni
English: In the first study a number of criteria were chosen to evaluate efficacy, including lameness score, response to treatment, effect of pain on palpation or mobilisation of the limb, response to flexion test and level of activity.
Maltese: Fl-ewwel studju, intgħażlu għadd ta' kriterji biex tiġi evalwata l-effikaċja, inkluż il-grad ta' zappip, ir-reazzjoni għat-trattament, l-effett tal-uġigħ meta tintmess jew tiċċaqlaq is-sieq, ir-reazzjoni għal prova ta' flessjoni u l-livell ta' attività.
English: Further tiludronate inhibits the enzyme secretion by chondrocytes or synovial cells.
Maltese: Aktar tiludronate jinibixxi s-sekrezzjoni tal-enzimi miċ-ċelluli kondroċiti jew sinovjali.
English: Not permitted for use in lactating animals producing milk for human consumption
Maltese: Mhux permess għallużu f'annimali li jipproduċu l-ħalib għall-konsum millbniedem
English: The CVMP was asked to assess if the efficacy of Tildren had been demonstrated and to conclude on the benefit/risk balance.
Maltese: Is-CVMP ġie mitlub jivvaluta jekk intweritx l-effikaċja ta' Tildren u biex jikkonkludi dwar il-bilanċ bejn il-benefiċċji/riskji.
English: The marked improvement in the placebo group was unexpected and may have been influenced by concomitant treatment with NSAIDs and the specific exercise program.
Maltese: It-titjib ċar fil-grupp tal-plaċebo ma kienx mistenni u seta' ġie influwenzat b'kura konkomittanti b'NSAIDs u bil-programm ta' eżerċizzju speċifiku.
English: Horses Once (the treatment may be repeated on the advice of the veterinary surgeon) Intravenous use
Maltese: Darba (il-kura tista' tiġi ripetuta fuq parir talkirurgu veterinarju) Użu għal ġol-vina.
English: With regard to dosage the MAH responded that there is no existing model in the horse to mimic bone spavin and the dose was extrapolated from a model of bone resorption in rats using an allometric extrapolation.
Maltese: Fl-opinjoni talBelġju u tal-Iżvezja, il-prova klinika mwettqa skont id-doża rrakkomandata ma wrietx effett statistiku sinifikati tal-prodott.
English: By inhibiting bone resorption, tiludronate acts as a regulator of bone metabolism in situation where there is extensive bone resorption.
Maltese: Billi ma jippermettix ir-risorbiment talgħadam, tiludronate jaġixxi bħala regolatur tal-metaboliżmu tal-għadam f'sitwazzjoni fejn ikun hemm risorbiment estensiv tal-għadam.
English: Zero days
Maltese: Żero jiem
English: On the other hand treatment with Tildren has been associated with abdominal disorders.
Maltese: Min-naħa l-oħra, it-trattament b'Tildren ġie assoċjat ma' disturbi addominali.
English: EMA/765472/2010 EMEA/H/C/000174
Maltese: EMEA/H/C/000174
English: Plavix clopidogrel
Maltese: Plavix klopidogrel
English: The full EPAR for Plavix can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: L-EPAR sħiħ ta' Plavix jinsab fis-sit elettroniku tal-Aġenzija ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: In CAPRIE, there were 939 events in the Plavix group, and 1,020 in the aspirin group.
Maltese: Fl-istudju CAPRIE kien hemm 939 każ fil-grupp ta' Plavix u 1,020 fil-grupp tal-aspirina.
English: It is available as pink tablets (round: 75 mg; oblong: 300 mg).
Maltese: Jiġi f'pilloli roża (tondi: 75 mg; oblongi:
English: Plavix is a medicine that contains the active substance clopidogrel.
Maltese: Plavix huwa mediċina li fiha s-sustanza attiva klopidogrel.
English: This is a summary of the European public assessment report (EPAR) for Plavix.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Plavix.
English: The most common side effects with Plavix (seen in between 1 and 10 patients in 100) are haematoma (a collection of blood under the skin), epistaxis (nosebleeds), gastrointestinal haemorrhage (bleeding in the stomach or gut), diarrhoea, abdominal pain (stomach ache), dyspepsia (heartburn), bruising and bleeding where the skin is punctured.
Maltese: L-iktar effetti sekondarji komuni bl-użu ta' Plavix (li dehru f'bejn 1 u 10 pazjenti minn kull 100) huma ematoma (ġbir ta' demm taħt il-ġilda), epistassi (fġir tal-imnieħer), emorraġija gastrointestinali (ħruġ ta' demm fiż-żaqq jew fil-musrana), dijarrea, uġigħ addominali (fiż-żaqq), dispepsija (indiġestjoni), tbenġil u ħruġ ta' demm minn fejn il-ġilda tkun ittaqqbet.
English: The active substance in Plavix, clopidogrel, is an inhibitor of platelet aggregation.
Maltese: Is-sustanza attiva fi Plavix, jiġifieri l-klopidogrel, hija inibitur tal-aggregazzjoni tal-pjastrini.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Plavix to Sanofi Pharma Bristol-Myers Squibb SNC on 15 July 1998.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha lil Plavix lil Bristol-Myers Squibb Pharma EEIG fil-15 ta' Lulju 1998.
English: Plavix was more effective than aspirin at preventing new ischaemic events.
Maltese: Plavix kien iktar effikaċi mill-aspirina fil-prevenzjoni ta' avvenimenti iskemiċi.
English: In ST segment elevation myocardial infarction, fewer patients on Plavix had events than patients on placebo (262 against 377 in the CLARITY study, and 2,121 against 2,310 in the COMMIT study).
Maltese: Fir-rigward ta' każi ta' infart mijokardiku b'elevazzjoni tas-segment ST, l-għadd ta' pazjenti li ngħataw Plavix u li għaddew minn avvenimenti iskemiki kien inqas mill-għadd tal-pazjenti li ngħataw plaċebo (262 u 377 rispettivament fl-istudju CLARITY, u 2,121 u 2,310 rispettivament fl-istudju COMMIT).
English: Plavix is used to prevent problems caused by blood clots in adults who have:
Maltese: Plavix jintuża biex jipprevjeni problemi kkawżati minn emboli f'adulti li:
English: In acute coronary syndrome, treatment generally starts with a loading dose of one 300-mg tablet or four 75-mg tablets.
Maltese: Fis-sindromu koronarju akut, ġeneralment it-trattament jibda b'doża ta' tagħbija (loading dose) ta' pillola waħda ta' 300-mg jew erba' pilloli ta' 75-mg.
English: • atrial fibrillation (irregular rapid contractions of the upper chambers of the heart), when it should be given with aspirin.
Maltese: • fibrillazzjoni atrijali (kontrazzjonijiet irregolari u mgħaġġla tal-kavitajiet ta' fuq tal-qalb).
English: • recently had a myocardial infarction (heart attack).
Maltese: • riċentement kellhom infart mijokardijaku (attakk tal-qalb).
English: Why has Plavix been approved?
Maltese: Għaliex ġie approvat Plavix?
English: This summary was last updated in 12-2010.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'12-2010.
English: In atrial fibrillation, Plavix has been compared with placebo (both taken together with aspirin) in one main study involving around 7,500 patients who had at least one risk factor for vascular events and who could not take vitamin K antagonist therapy.
Maltese: Fl-istudju dwar il-fibrillazzjoni atrijali Plavix tqabbel ma' plaċebo (meħud kemm mal-aspirina u kemm mingħajrha) matul studju wieħed li involva madwar 7,500 pazjent li kellhom tal-inqas fattur wieħed ta' riskju li jgħaddu minn avvenimenti vaskulari u li ma setgħetx issirilhom terapija bl-għoti tal-antagonisti tal-vitamina K.
English: In the study in atrial fibrillation patients, Plavix taken together with aspirin reduced the risk of new events by 11% compared with placebo taken with aspirin, with the largest reduction (28%) seen for stroke.
Maltese: Fl-istudju fuq pazjenti b'fibrillazzjoni atrijali, it-teħid ta' Plavix flimkien mal-aspirina naqqas ir-riskju ta' avveniment iskemiku ġdid bi 11% apparagun mat-teħid ta' plaċebo ma' aspirina.
English: In acute coronary syndrome and atrial fibrillation, Plavix is used together with aspirin, the dose of which should not be higher than 100 mg.
Maltese: Fil-każi ta' sindromu koronarju akut u ta' fibrillazzjoni atrijali, Plavix jittieħed flimkien ma' aspirina u f'dal-każi d-doża m'għandhiex taqbeż il-100 mg.
English: Plavix has been compared with aspirin in a study called CAPRIE including around 19,000 patients who had recently had a heart attack or an ischaemic stroke, or who had established peripheral arterial disease.
Maltese: Plavix tqabbel mal-aspirina fi studju msejjaħ CAPRIE, li inkluda madwar 19,000 pazjent li riċentement kienu sofrew attakk tal-qalb jew puplesija iskemika, jew li kienet ħarġitilhom xi marda fl-arterji periferiċi.
English: What is the risk associated with Plavix?
Maltese: X'inhuma r-riskji assoċjati ma' Plavix?
English: What is Plavix?
Maltese: X'inhu Plavix?
English: In acute coronary syndrome, Plavix has been compared with placebo (a dummy treatment) in one study involving over 12,000 patients with non-ST segment elevation, 2,172 of whom had a stent inserted during the study (CURE study, lasting up to a year).
Maltese: Fl-istħarriġ tas-sindromu koronarju akut, Plavix tqabbel ma' plaċebo (trattament finta) fi studju wieħed li involva 'l fuq minn 12,000 pazjent b'sindromu mingħajr l-elevazzjoni tas-segment ST, li fosthom kien hemm 2,171 pazjent li waqt l-istudju ddaħħlilhom stent (l-istudju CURE, li dam mhux aktar minn sena).
English: This showed that Plavix reduces the risk of an event.
Maltese: Dan wera li Plavix inaqqas ir-riskju ta' avvenimenti bħal dawn.
English: Plavix has also been compared with placebo in two studies involving patients with ST segment elevation: CLARITY, which involved over 3,000 patients and lasted up to eight days; and COMMIT, which involved almost 46,000 patients and in which the patients received Plavix with or without metoprolol (another medicine used for heart problems or high blood pressure) for up to four weeks.
Maltese: Plavix tqabbel ukoll ma' plaċebo f'żewġ studji li involvew pazjenti b'elevazzjoni tas-segment ST: L-istudju CLARITY involva madwar 3,000 pazjent u dam madwar tmint ijiem, mentri l-istudju COMMIT involva madwar 46,000 pazjent li ngħataw Plavix kemm bil-metoprolol (mediċina oħra użata għallproblemi fil-qalb jew għall-pressjoni għolja) u kemm mingħajrha tul erba' ġimgħat.
English: In non-ST segment elevation acute coronary syndrome, the overall relative reduction in the risk of an event compared with placebo was 20%.
Maltese: Inkwantu s-sindromu koronarju akut mingħajr elevazzjoni tas-segment ST, apparagun mat-teħid talplaċebo, b'mod ġenerali, it-tnaqqis relattiv fir-riskju ta' avveniment iskemiku kien 20%.
English: The standard dose of Plavix is one 75-mg tablet once a day.
Maltese: Id-doża rakkomandata ta' Plavix hija pillola waħda ta' 75-mg kuljum.
English: This is then followed by the standard 75-mg dose once a day for at least four weeks (in ‘ST segment elevation' myocardial infarction) or for up to 12 months (in unstable angina or ‘non-Q-wave' myocardial infarction).
Maltese: Imbagħad it-trattament jitkompla b'doża standard ta' 75-mg darba kuljum tul tal-inqas erba' ġimgħat (fil-każi ta' infart mijokardiku b'elevazzjoni tas-segment ST) jew tul sa 12-il xahar (fil-każi ta' anġina instabbli jew infart mijokardiku ‘mingħajr il-mewġa Q').
English: Plavix is converted into its active form in the body.
Maltese: Il-konverżjoni ta' Plavis fil-forma attiva tiegħu ssir fil-ġisem.
English: How has Plavix been studied?
Maltese: Kif ġie studjat Plavix?
English: Acute coronary syndrome is a group of heart problems that include heart attacks and unstable angina (a severe type of chest pain).
Maltese: B'sindromu koronarju akut nifhmu ġabra ta' problemi filqalb li jinkludu l-attakki tal-qalb u l-anġina instabbli.
English: There was also a reduction in the patients who had a stent inserted.
Maltese: Kien hemm ukoll tnaqqis fil-pazjenti li kellu jiddaħħlilhom stent.
English: Ref. EMEA/404511/2008
Maltese: EMEA/404511/2008
English: London, 25 September 2008 Doc.
Maltese: Londra, 25 ta' Settembru 2008 Dok. Ref.
English: International non-proprietary name (INN): satraplatin
Maltese: Denominazzjoni Komuni Internazzjonali (DKI): satraplatin
English: Orplatna is a medicine that contains satraplatin as the active substance.
Maltese: Orplatna huwa mediċina li fiha satraplatin bħala sustanza attiva.
English: What is Orplatna?
Maltese: X'inhu Orplatna?
English: It was to be available as capsules to be taken by mouth containing 10 or 50 mg satraplatin.
Maltese: Hija disponibbli f'kapsuli għat-teħid orali li fihom 10 jew 50 mg satraplatin.
English: The active substance in Orplatna, satraplatin, is a cytotoxic (a medicine that kills cells that are dividing, such as cancer cells) that belongs to the group ‘platinum compounds'.
Maltese: Is-sustanza attiva f'Orplatna, satraplatin, hija mediċina ċitotossika (mediċina li toqtol iċ-ċelloli li jkunu qed jimmoltiplikaw bħaċ-ċelloli tal-kanċer) li jkunu parti mill-grupp ta' ‘komposti tal-platinu'.
English: These compounds are made from the metal platinum.
Maltese: Dawn il-komposti huma magħmula mill-metall tal-platinu.
English: Orplatna was expected to be used to treat prostate cancer.
Maltese: Orplatna kien mistenni li jintuża għat-trattament tal-kanċer tal-prostata.
English: What was Orplatna expected to be used for?
Maltese: Kif kien mistenni li jaħdem Orplatna?
English: On 1 August 2008, Pharmion Ltd. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Orplatna, for the treatment of patients with metastatic hormone-refractory prostate cancer who have failed prior chemotherapy.
Maltese: Fl-1 ta' Awwissu 2008, Pharmion Ltd. uffiċjalment għarraf lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) li tixtieq tirtira l-applikazzjoni tagħha għall-awtorizzazzjoni tattqegħid fis-suq għal Orplatna, użata għat-trattament ta' pazjenti li b'kanċer tal-prostata metastatiku refrattorju għall-ormoni li l-kemjoterapija ma ħadmitx fuqhom.
English: One main study compared the effectiveness of adding Orplatna or placebo (a dummy treatment) to prednisone in 950 patients with metastatic hormone-refractory prostate cancer in whom at least one previous treatment had failed.
Maltese: Studju prinċipali qabbel l-effikaċja taż-żieda ta' Orplatna jew plaċebo (trattament finta) ma' prednisone f'950 pazjent b'kanċer tal-prostata metastatiku refrattorju għall-ormoni li fih ta' l-anqas trattament preċedenti wieħed ma ħadimx.
English: The medicine was to be used with prednisone or prednisolone (anti-inflammatory medicines) in patients who had failed to respond to other anti-cancer medicines, when their cancer had spread from the original site to other parts of the body (metastatic) and had been shown to be ‘hormone-refractory'.
Maltese: Il-mediċina kellha tintuża ma' prednisone jew prednisolone (mediċini antinfjammatorji) f'pazjenti li ma rrispondewx għal mediċini oħrajn li huma kontra l-kanċer, meta l-kanċer tagħhom infirex mis-sit oriġinali għal partijiet oħra tal-ġisem (metastatiku) u li wera li huwa ‘refrattorju għallormoni'.
English: Compared with placebo, Orplatna did not increase overall survival time, and the small improvement seen in progression-free survival was not considered relevant in the absence of a benefit in terms of overall survival time.
Maltese: Meta mqabbel ma' plaċebo, Orplatna ma żiedx iż-żmien ta' sopravivenza u l-anqas progress muri fil-perjodu ta' sopravivenza mingħajr progressjoni ma kienx ikkonsidrat rilevanti fl-assenza ta' benefiċċju f'termini ta' żmien ta' sopravivenza globali.
English: The Committee also noted that docetaxel is the standard first-line treatment for hormone-refractory prostate cancer, and that it is likely that most patients who would benefit from Orplatna treatment would have failed docetaxel treatment.
Maltese: Il-Kumitat innota wkoll li docetaxel huwa t-trattament standard ta' l-ewwel linja għal kanċer talprostata metastatiku refrattorju għall-ormoni u li huwa probabbli li l-maġġoranza tal-pazjenti li jistgħu jibbenefikaw mit-trattament Orplatna kienu ġew trattati bi trattament docetaxel u dan ma kienx b'suċċess.
English: Based on the review of the data and the company's response to the CHMP's list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Orplatna could not have been approved for the treatment of metastatic hormone-refractory prostate cancer.
Maltese: Skond l-analiżi tad-dejta u t-tweġiba tal-kumpanija għal-lista ta' mistoqsijiet tas-CHMP, fi żmien lirtirar, is-CHMP kellu xi tħassib u kellu opinjoni proviżorja li Orplatna ma setax jiġi approvat għattrattament ta' kanċer tal-prostata metastatiku refrattorju għall-ormoni.
English: The effects of Orplatna were first tested in experimental models before being studied in humans.
Maltese: L-effetti ta' Orplatna għall-ewwel ġew ittestjati fuq mudelli sperimentali qabel ma ġew studjati filbniedem.
English: Based on the review of the initial documentation, the CHMP prepares a list of questions at day 120, which is sent to the company.
Maltese: Fuq il-bażi tar-reviżjoni tad-dokumentazzjoni inizjali, is-CHMP iħejji lista ta' mistoqsijiet fil-120 jum, li mbagħad tintbagħat lill-kumpanija.
English: What are the consequences of the withdrawal for patients undergoing clinical trials / compassionate use programmes with Orplatna?
Maltese: X'inhuma l-konsegwenzi ta' l-irtirar għall-pazjenti li kienu qed jieħdu sehem fi provi kliniċi / programmi ta' użu b'kumpassjoni b'Orplatna?
English: The application was at day 180 when the company withdrew.
Maltese: L-applikazzjoni kienet waslet f'jum 180 meta l-kumpanija rtiratha.
English: 6 vials
Maltese: 6 fjali
English: 7.32 g 1 pre-filled syringe
Maltese: 7.32 g 7 Siringi mimlija għal-lest
English: EU (MA) Number
Maltese: Numru ta' l-UE (MA) Isem kummerċjali
English: Bottle (HDPE)
Maltese: Flixkun (HDPE) N/A 60 pillola Laħam u lġewwieni: 26 ġurnata
English: Invented Name Strength Pharmaceutical Form
Maltese: Qawwa Għamla Farmaċewtika
English: (Invented) name Strength Pharmaceutical Form
Maltese: Qawwa Għamla farmaċewtika
English: and
Maltese: pejst
English: BACKGROUND INFORMATION
Maltese: Introduzzjoni u sfond
English: The CVMP started the referral procedure during its meeting of 6-8 November 2007.
Maltese: Is-CVMP beda l-proċedura fis-6 ta' Novembru 2007.
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR VETERINARY USE (CVMP)
Maltese: Għamla farmaċewtika
English: CVMP agreed that Equibactin vet. proved to be essentially similar to reference product Tribrissen Oral Paste.
Maltese: Pejst Orali Equibactin vet. wera li huwa essenzjalment simili għal prodott ta' referenza, Pejst Orali Tribrissen.
English: Being aware of a referral ongoing at the time under Article 35 of Directive 2001/82/EC, as amended, for reference product Tribrissen Oral Paste, CVMP recommended that the outcome of that referral procedure (EMEA/V/023) should apply to the marketing authorisation of Equibactin vet.
Maltese: Huwa rakkomandat li Pejst Orali Equibactin vet. ivarja f'konformità ma' l-eżiti ta' proċedura ta' referenza EMEA/V/023 skond l-Artikolu 35 ta' Direttiva 2001/82/KE kif emendat, għall-prodott mediċinali ta' referenza Pejst Orali Tribrissen awtorizzat fl-Olanda.
English: The matter was referred to the Co-ordination Group for Mutual Recognition and Decentralised Procedures CMD(v) and subsequently to the CVMP.
Maltese: II u l-proċedura ta' referenza f'CMD(v) minn hemm 'il quddiem.
English: Equibactin vet. is a paste for oral use containing trimethoprim and sulfadiazine as active ingredients and is indicated for treatment of infections in horses caused by bacteria sensitive to the combination of trimethoprim and sulfadiazine, particularly:
Maltese: Fuq il-bażi tal-kompożizzjoni fir-rigward tas-sustanzi attivi, Trimethoprim u Sulfadiazine, l-istess għamla farmaċewtika, u bijoekwivalenza bejn Pejst Orali Equibactin vet.
English: Staphylococcus aureus.
Maltese: Konklużjonijiet u Rakkomandazzjonijiet
English: Equibactin vet. is a generic product.
Maltese: Equibactin vet.
English: The Marketing Authorisation Holder was requested to provide a copy of the dossier and, in view of the concerns raised by France, to indicate and to substantiate where necessary, any differences between Equibactin vet. and the reference product Tribrissen Oral Paste that could justify different conclusions on the safety or efficacy.
Maltese: Fid-dawl tat-tħassib imqajjem minn Franza, li tkun indikata u ssostanzjata fejn ikun hemm bżonn kwalunkwe differenza bejn Pejst Orali għaż-Żwiemel Equibactin vet.
English: It considered this may lead to lack of efficacy and furthering resistance development in target pathogens, which could possibly lead to risks to human health where zoonotic bacteria are concerned.
Maltese: Dan jista' jwassal għal nuqqas ta' effikaċja u jkompli jżid l-iżvilupp ta' reżistenza fil-patoġeni fil-mira, li jista' possibbilment iwassal għal riskji għas-saħħa tal-bniedem fejn huma ikkonċernati batterji żoonotiċi.
English: London, August 2008 EMEA/455918/2008
Maltese: 3421 GW Oudewater L-Olanda
English: • Urogenital infections associated with beta-hemolytic streptococci;
Maltese: Franza tikkunsidra li r-reġim ta' l-iddożar tal-prodott mhijiex korretta.
English: In response to the questions, the applicant submitted the dossier and argued on the basis of a comparison of compositions and pharmacokinetic data, that there are no differences between Equibactin vet. and the reference product that would justify different conclusions on the safety and efficacy for the two products.
Maltese: F'reazzjoni għal mistoqsija nru 2, l-applikant wera li żgur ma hemm l-ebda differenza li tiġġustafika konklużjonijiet differenti fuq is-sigurtà u l-effikaċja għaż-żewġ prodotti.
English: OPINION FOLLOWING AN ARTICLE 33 (4) REFERRAL FOR EQUIBACTIN VET.
Maltese: B'mod konformi ma' l-Artikolu 33(4) tad-Direttiva tal-Kunsill 2001/82/KE, kif emendat, il-kwistjoni kienet riferuta lis-CVMP.
English: GASTROINTESTINAL PRODUCTS (PROPULSIVE) Cisapride
Maltese: PRODOTTI GASTROINTESTINALI (PROPULSJONI) Cisapride
English: paritaprevir ANTIBIOTICS (SYSTEMIC ADMINISTRATION)
Maltese: paritaprevir ANTIBIJOTIĊI (AMMINISTRAZZJONI SISTEMIKA)
English: ANTIDEPRESSANTS Escitalopram
Maltese: ANTIDEPRESSANTI Escitalopram
English: HERBAL PRODUCTS
Maltese: PRODOTTI ERBALI
English: SAPPHIRE I and II
Maltese: SAPPHIRE I u II
English: Decrease digoxin dose by 30-50%.
Maltese: Naqqas id-doża ta' digoxin bi 30-50%.
English: ALT >5-20 × ULN* (Grade 3) >20 × ULN (Grade 4)
Maltese: ALT >5-20 × ULN* (Grad 3) >20 × ULN (Grade 4)
English: Poly(vinyl alcohol) (E 1203) Macrogol (3350) Talc (E 553b)
Maltese: Kisja tal-pillola Poly(vinyl alcohol) (E 1203) Macrogol (3350) Talc (E 553b)
English: Haemoglobin <100-80 g/L (grade 2) <80-65 g/L (grade 3) <65 g/L (Grade 4)
Maltese: Emoglobina <100-80 g/L (grad 2) <80-65 g/L (grad 3) <65 g/L (Grade 4)
English: Buprenorphine / naloxone
Maltese: Buprenorphin e/ naloxone
English: HCV ANTIVIRALS Sofosbuvir
Maltese: ANTIVIRALI HCV Sofosbuvir
English: HIV ANTIVIRALS: NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS Rilpivirine2
Maltese: INIBITURI NON-NUCLEOSIDE REVERSE TRANSCRIPTASE Rilpivirine2
English: ALPHA 1-ADRENORECEPTOR ANTAGONIST Alfuzosin
Maltese: ANTAGONIST TAL-ALPHA 1-ADRENORECEPTER Alfuzosin