FrancophonIA/ELRC3.0 huggingface dataset:
English: The European Medicines Agency therefore concluded that the benefits of Fampyra outweigh its risks for patients with a walking disability and recommended that it be given marketing authorisation.
Maltese: Il-mediċina tista' tinkiseb biss b'riċetta ta' tabib u għandha tiġi preskritta minn tabib esperjenzat filkura tal-SM.
English: (*) equivalent to titre prior to inactivation (log10)
Maltese: (*)ekwivalenti għal titlu qabel l-inattivazzjoni (log10)
English: Strength
Maltese: Tiżmim
English: Route of administration
Maltese: Amministrazzjo ni
English: Suspension for injection.
Maltese: Suspensjoni għal injezzjoni
English: Bluetongue Virus Serotype 1 antigen ≥ 8.1 CCID50*
Maltese: 50 dożi antiġen ≥ 8.1
English: EU/2/10/112/001 BTVPUR AlSap 1
Maltese: BTVPUR AlSap 1
English: Packaging Content Package size Withdrawal period
Maltese: Ippakkjar Kontenut Daqs talpakkett
English: Subcutaneous Type I glass bottle with butyl elastomere closure
Maltese: Tip I b'tapp tal-butyl elastomere doż1
English: Note:
Maltese: Nota:
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Maltese: L-informazzjoni dwar il-prodott tista' tiġi aġġornata sussegwentement mill-awtoritajiet kompetenti talIstat Membru, b'kollaborazzjoni mal-Istat Membru ta' Referenza, kif xieraq, skont il-proċeduri stabbiliti fil-Kapitolu 4 tat-Titolu III tad-Direttiva 2001/83/KE.
English: Annex III Product information
Maltese: Anness III Informazzjoni dwar il-Prodott
English: The valid product information is the final version achieved during the Coordination group procedure.
Maltese: L-informazzjoni dwar il-prodott valida hija l-verżjoni finali miksuba matul il-Proċedura tal-grupp ta' koordinazzjoni.
English: This product information is the outcome of the referral procedure to which this Commission decision relates.
Maltese: Din l-informazzjoni dwar il-prodott hija l-eżitu tal-proċedura ta' referenza li magħha tirrelata din iddeċiżjoni tal-Kummissjoni.
English: The full EPAR for HyQvia can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: It contains immunoglobulin G (IgG), which is a type of antibody.
Maltese: Fiha l-immunoglobulina G (IgG), li hija tip ta' antikorp.
English: Human normal immunoglobulin
Maltese: Immunoglobulina normali umana
English: HyQvia is used as ‘replacement therapy' to treat:
Maltese: HyQvia jintuża bħala ‘terapija ta' sostituzzjoni' fil-kura ta':
English: The European Commission granted a marketing authorisation valid throughout the European Union for HyQvia on 16 May 2013.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal HyQvia valida fl-Unjoni Ewropea kollha fis-16 ta' Mejju 2013.
English: This summary was last updated in 07-2016.
Maltese: Dan is-sommarju kien aġġornat l-aħħar f'07-2016.
English: • primary immunodeficiency syndromes (PID, when patients are born with an inability to produce enough antibodies);
Maltese: • sindromi ta' immunodefiċjenza primarja (PID, meta l-pazjenti jitwieldu b'nuqqas ta' kapaċità li jipproduċu biżżejjed antikorpi);
English: This is a summary of the European public assessment report (EPAR) for HyQvia.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal HyQvia.
English: HyQvia contains the active substance human normal immunoglobulin.
Maltese: HyQvia fih is-sustanza attiva immunoglobulina normali umana.
English: The active substance in HyQvia, human normal immunoglobulin, is a highly purified protein extracted from the blood.
Maltese: Is-sustanza attiva fi HyQvia, l-immunoglobulina umana normali, hija proteina ppurifikata ħafna estratta mid-demm.
English: Why is HyQvia approved?
Maltese: Għaliex ġie approva HyQvia?
English: HyQvia also contains recombinant human hyaluronidase.
Maltese: HyQvia fih ukoll il-jaluronidażi umana rikombinanti.
English: Other information about HyQvia
Maltese: Informazzjoni oħra dwar HyQvia
English: HyQvia is used in patients with immunodeficiency syndromes.
Maltese: HyQvia jintuża f'pazjenti b'sindromi ta' immunodefiċjenza.
English: HyQvia must not be used in people who are hypersensitive (allergic) to normal human immunoglobulin or hyaluronidase or any of the other ingredients, or in patients who are allergic to other types of immunoglobulins, especially where they have deficiency (very low levels) of immunoglobulin A (IgA) and they have antibodies against IgA.
Maltese: HyQvia m'għandux jintuża fuq persuni li huma ipersensittivi (allerġiċi) għall-immunoglobulina umana normali jew għall-jaluronidażi jew għal xi sustanza oħra tiegħu, jew fuq pazjenti li jkunu allerġiċi għal tipi oħrajn ta' immunoglobulini, b'mod speċjali meta jkollhom defiċjenza (livelli baxxi ħafna) talimmunoglobulina A (IgA) u jkollhom antikorpi kontra l-IgA.
English: • low levels of antibodies in the blood in patients who have chronic lymphocytic leukaemia or myeloma (two cancers affecting different types of white blood cell) and who have frequent infections.
Maltese: • livelli baxxi ta' antikorpi fid-demm f'pazjenti li jkollhom lewkimja linfoċitika kronika jew majeloma (żewġ kanċers li jaffettwaw tipi differenti ta' ċelloli bojod tad-demm) u li spiss ikollhom infezzjonijiet.
English: The most common side effects with HyQvia (which may affect more than 1 in 10 people) are local reactions such as swelling and discomfort at the site of the infusion.
Maltese: L-effetti sekondarji l-aktar komuni b'HyQvia (li jistgħu jolqtu aktar minn 1 minn kull 10) huma reazzjonijiet lokali bħal nefħa u skumdità fil-post tal-infużjoni.
English: What are the risks associated with HyQvia?
Maltese: X'inhuma r-riskji assoċjati ma' HyQvia?
English: This is a form of the natural human enzyme, hyaluronidase, which breaks down a substance called hyaluronic acid that is present in the tissues in the tiny spaces between cells and so makes the area between cells temporarily more liquid.
Maltese: Din hija forma tal-enzima umana naturali, jaluronidażi, li tkisser sustanza msejħa aċidu jaluroniku li tkun preżenti fit-tessuti fl-ispazji żgħar ta' bejn iċ-ċelloli u għaldaqstant tagħmel l-ispazju bejn iċ-ċelloli temporanjament aktar likwidu.
English: A solution containing recombinant human hyaluronidase is given first and a solution containing human normal immunoglobulin (100 mg/ml) is then given by infusion in the same place.
Maltese: normali (100 mg/ml) permezz ta' infużjoni fl-istess post.
English: In accordance with current guidelines for these medicines, HyQvia was investigated in one main study lasting over a year and involving 89 patients with PID who had already had treatment with human normal immunoglobulin for at least three months.
Maltese: Skont il-linji gwida attwali għal dawn il-mediċini, HyQvia ġie investigat fi studju ewlieni wieħed tul aktar minn sena fuq 89 pazjent bil-PID li kienu diġà ngħataw kura bl-immunoglobulina umana normali tul mill-inqas tliet xhur.
English: IgG has been used as a medicine since the 1950s and has a wide range of activity against organisms that can cause infection.
Maltese: IgG ilha tintuża bħala mediċina mis-snin 50 u għandha firxa wiesgħa ta' attività kontra l-organiżmi li jistgħu jikkawżaw infezzjoni.
English: How does HyQvia work?
Maltese: Kif jintuża HyQvia?
English: The Committee therefore decided that HyQvia's benefits are greater than its risks and recommended that it be approved for use in the EU.
Maltese: Għaldaqstant il-Kumitat iddeċieda li l-benefiċċji ta' HyQvia huma akbar mir-riskji tiegħu u rrakkomanda li jkun approvat għall-użu fl-UE.
English: The study showed that HyQvia was able to reduce this number to 0.03 per year.
Maltese: L-istudju wera li HyQvia kien kapaċi jnaqqas dan l-għadd għal 0.03 fis-sena.
English: HyQvia works by restoring abnormally low IgG levels to their normal range in the blood.
Maltese: HyQvia jaħdem billi jreġġa' livelli abnormalment baxxi ta' IgG għall-firxa normali fid-demm.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) noted that HyQvia produces a similar reduction in the number of serious bacterial infections to that seen with other immunoglobulin products, and using recombinant hyaluronidase allows subcutaneous infusions to be given at much longer intervals, although local reactions are slightly more common.
Maltese: Dan kien inqas mill-għadd meħtieġ li ġie stabbilit minn qabel biex tintwera l-effikaċja (infezzjoni waħda fis-sena), u kien simili għal dak li deher bi prodotti oħrajn liċenzjati tal-immunoglobulina umana normali.
English: How is HyQvia used?
Maltese: Kif jaħdem HyQvia?
English: Ref.: EMA/777733/2009 EMEA/H/C/253
Maltese: EMA/777733/2009 EMEA/H/C/253
English: • regular contractions lasting at least 30 seconds at a rate of at least four every 30 minutes;
Maltese: • kontrazzjonijiet regolari kull 30 minuta ta' mill-inqas 30 sekonda kull waħda;
English: The marketing authorisation holder is Ferring Pharmaceuticals A/S.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq huwa Ferring Pharmaceuticals A/S.
English: Tractocile atosiban EPAR summary for the public
Maltese: Tractocile atosiban Sommarju tal-EPAR għall-pubbliku
English: The active substance in Tractocile, atosiban, is an antagonist of the natural hormone oxytocin.
Maltese: Is-sustanza attiva fi Tractocile, atosiban, hija antagonista tal-ossitoċina (oxytocin), ormon naturali.
English: Both contain the active substance atosiban (7.5 mg per millilitre).
Maltese: It-tnejn li huma fihom is-sustanza attiva atosiban (7.5 mg għal kull millilitru).
English: Tractocile was compared with ritodine, terbutaline and salbutamol (all from a different class of medicines used in pre-term labour called beta-agonists).
Maltese: Tractocile tqabbel mar-ritodina (ritodine), terbutalina (terbutaline) u salbutamol (sustanzi li jagħmlu parti minn klassijiet differenti ta' mediċini msejħa beta-agonisti użati fil-każijiet ta' ħlas qabel iż-żmien).
English: Tractocile is given into a vein in three stages, over a maximum of 48 hours: an initial injection into a vein (6.75 mg), followed by a high-dose infusion (18 mg per hour) over three hours, then a lower dose infusion (6 mg per hour) lasting up to 45 hours.
Maltese: Tractocile jingħata fil-vina fi tliet fażijiet, fi żmien massimu ta' 48 siegħa: injezzjoni inizjali fil-vina (6.75 mg) u wara infużjoni b'dożaġġ qawwi (18 mg kull siegħa) għal tliet sigħat, imbagħad infużjoni b'dożaġġ baxx (6mg kull siegħa) sa mhux aktar minn 45 siegħa.
English: It must not be used in women whose pregnancy is less than 24 weeks or more than 33 weeks, in women who have premature rupture of the membranes (when the waters break early) after 30 weeks of pregnancy, bleeding from the womb, eclampsia (a dangerous condition at the end of pregnancy caused by toxins in the blood), pre-eclampsia (a condition that can lead to eclampsia) or problems with the baby or placenta, or when continuing the pregnancy could be dangerous for the mother or baby.
Maltese: Tractocile ma għandux jintuża f'nisa li t-tqala tagħhom hija inqas minn 24 ġimgħa jew iktar minn 33 ġimgħa, f'nisa li nfaqgħulhom il-membrani (infaqa' l-ilma qabel iż-żmien) wara 30 ġimgħa ta' tqala, bi dmija mill-ġuf, eklampsija (kundizzjoni perikoluża fit-tmiem tat-tqala kkawżata mit-tossini fid-demm), preeklampsija (kundizzjoni li tista' twassal għal eklampsija) jew problemi relatati mat-tarbija jew mal-plaċenta (tas-sekonda), jew meta t-tkomplija tat-tqala tista' tkun ta' periklu għall-omm jew għat-tarbija.
English: If you want more information on the basis for the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Maltese: Jekk trid aktar informazzjoni abbażi tar-rakkomandazzjonijiet ta' CHMP, aqra dDiskussjoni Xjentifika (ukoll parti mill-EPAR).
English: • dilation of the cervix (the neck of the womb) of 1 to 3 cm and an effacement (a measure of the thinness of the cervix) of 50% or more.
Maltese: • twessigħ ċervikali (tal-għonq tal-utru) ta' 1-3 cm u traqqiq tal-għonq tal-utru (tnaqqis tal-wisa'
English: The ability of Tractocile to delay pre-term birth was studied in 742 women who were 23 to 33 weeks pregnant in three main studies.
Maltese: L-effikaċja di Tractocile biex jittardja t-twelid prematur ġie eżaminat fi tliet studji ewlenin li involvew 742 mara li kienu qegħdin bejn it-23-33 ġimgħa tat-tqala.
English: What is Tractocile?
Maltese: X'inhu Tractocile?
English: Oxytocin is the hormone involved in starting contractions of the womb.
Maltese: L-ossitoċina hija ormon involut fil-bidu talkontrazzjonijiet tal-ġuf.
English: What is the risk associated with Tractocile?
Maltese: X'inhu r-riskju assoċjat ma' Tractocile?
English: Looking at the results of the three main studies together, 60% of the women treated with Tractocile were still pregnant one week after treatment (201 out of 337) compared with 48% of the women treated with the comparator medicines (163 out of 342).
Maltese: Mir-riżultati tat-tliet studji ewlenin meħudin flimkien jidher li 60% tan-nisa ttrattati bi Tractocile kienu għadhom ma welldux wara ġimgħa mill-bidu tat-trattament (201 minn 337) meta mqabbla ma' 48% tan-nisa ttrattati bil-mediċni tat-tqabbil (163 minn 342).
English: This means that atosiban blocks the action of oxytocin.
Maltese: Dan ifisser li atosiban jimblokka l-azzjoni tal-ossitoċina.
English: For the full list of all side effects reported with Tractocile, see the Package Leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji rrapportati bi Tractocile, ara l-Fuljett ta' Tagħrif.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Tractocile on 20 January 2000.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fuq is-suq fl-Unjoni Ewropea kollha għal Tractocile fl-20 ta' Jannar 2000.
English: How has Tractocile been studied?
Maltese: Kif ġie studjat Tractocile?
English: Why has Tractocile been approved?
Maltese: Għaliex ġie approvat Tractocile?
English: In addition, the baby must have a normal heart rate.
Maltese: Barra minn dawn il-kundizzjonijiet, il-fetu għandu jkollu frekwenza kardijaka normali.
English: This summary was last updated in 12-2009.
Maltese: Dan is-sommarju kien aġġornat l-aħħar fi: 12-2009.
English: Other information about Tractocile:
Maltese: Aktar tagħrif dwar Tractocile:
English: Doc.
Maltese: Dok. ta' ref.:
English: The most common side effect with Tractocile (seen in more than 1 patient in 10) is nausea (feeling sick).
Maltese: L-effett sekondarju l-aktar komuni bi Tractocile (li deher f'aktar minn pazjent 1 minn 10) hu nawżea (dardir).
English: There were too few women with a pregnancy at less than 28 weeks for the effectiveness of Tractocile in comparison to beta-agonists to be established in this group.
Maltese: In-numru ta' pazjenti li ma waslux fit28 ġimgħa tat-tqala kien baxx wisq biex setgħet tiġi ddeterminata l-effikaċja ta' Tractocile għal dan ilgrupp ta' pazjenti meta mqabbel mal-beta-agonisti.
English: Tractocile is used to delay birth in adult women who are 24 to 33 weeks pregnant, when they show signs that they may give birth pre-term (prematurely).
Maltese: Tractocile jintuża biex jittardja t-twelid f'nisa adulti ta' bejn l-24 u 33 ġimgħa ta' tqala, meta juru sinjali li jistgħu jwelldu qabel jagħlqilhom iż-żmien (prematur).
English: The Committee for Medicinal Products for Human Use (CHMP) concluded that Tractocile has shown an effectiveness in delaying pre-term birth that is the same as seen with beta-agonists, and that the better outcome with Tractocile was due to the medicine being better tolerated.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) ikkonkluda li l-effikaċja ta' Tractocile fl-ittardjar tat-twelid qabel iż-żmien hija ndaqs bħal dik tal-beta-agonisti u l-aħjar riżultati miksuba bi Tractocile kienu dovuti għal tolleranza aħjar tal-mediċina.
English: Further information on Prasugrel Mylan can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is then followed by 10 mg taken once a day, except in patients weighing less than 60 kg, who should take 5 mg once a day.
Maltese: Imbagħad din tiġi segwita b'doża ta' 10 mg meħuda darba kuljum, ħlief f'pazjenti li jiżnu inqas minn 60 kg, u li għandhom jieħdu 5 mg darba kuljum.
English: Prasugrel Mylan is taken together with aspirin to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries) in patients with acute coronary syndrome who are undergoing percutaneous coronary intervention.
Maltese: Prasugrel Mylan jittieħed flimkien mal-aspirina għall-prevenzjoni ta' episodji aterotrombotiċi (problemi kkawżati minn emboli u twebbis tal-arterji) f'pazjenti b'sindromu koronarju akut li jkunu qed isirilhom intervent koronarju perkutanju.
English: The active substance in Prasugrel Mylan, prasugrel, is an inhibitor of platelet aggregation.
Maltese: Is-sustanza attiva fi Prasugrel Mylan, prasugrel, hija inibitur tal-aggregazzjoni tal-pjastrini.
English: Prasugrel Mylan contains the active substance prasugrel and is a ‘generic medicine'.
Maltese: Prasugrel Mylan fih is-sustanza attiva prasugrel u huwa “mediċina ġenerika”.
English: Prasugrel Mylan is available as tablets (5 and 10 mg) and can only be obtained with a prescription.
Maltese: Prasugrel Mylan huwa disponibbli f'pilloli (5 u 10 mg) u jista' jinkiseb biss b'riċetta ta' tabib.
English: For more information on generic medicines, see the question-and-answer document here.
Maltese: Għal aktar informazzjoni dwar il-mediċini ġeneriċi, ara d-dokument bil-mistoqsijiet u t-tweġibiet hawn.
English: The company also carried out studies that showed that it is ‘bioequivalent' to the reference medicine.
Maltese: Il-kumpanija wettqet ukoll studji li wrew li hija “bijoekwivalenti” għall-mediċina ta' referenza.
English: Because Prasugrel Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Minħabba li Prasugrel Mylan huwa mediċina ġenerika u huwa bijoekwivalenti għall-mediċina ta' referenza, il-benefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk tal-mediċina ta' referenza.
English: Studies on the benefits and risks of the active substance in the authorised use have already been carried out with the reference medicine, Efient, and do not need to be repeated for Prasugrel Mylan.
Maltese: Diġà saru studji fuq il-benefiċċji u r-riskji tas-sustanza attiva fl-użu awtorizzat bil-mediċina ta' referenza, Efient, u m'hemmx għalfejn jiġu ripetuti għal Prasugrel Mylan.
English: Other information about Prasugrel Mylan
Maltese: Informazzjoni oħra dwar Prasugrel Mylan
English: As for all medicines, data on the use of Prasugrel Mylan are continuously monitored.
Maltese: Bħal għall-mediċini kollha, id-data dwar l-użu ta' Prasugrel Mylan tiġi ssorveljata kontinwament.
English: This stops the platelets becoming ‘sticky', reducing the risk of a blood clot forming and helping to prevent a heart attack or a stroke.
Maltese: Dan iwaqqaf lill-pjastrini milli jsiru “jwaħħlu”, u b'hekk inaqqsu r-riskju ta' formazzjoni ta' embolu u jgħinu sabiex jiġi evitat attakk tal-qalb jew puplesija.
English: Prasugrel Mylan treatment starts with one 60-mg dose.
Maltese: Il-kura bi Prasugrel Mylan tibda b'doża waħda ta' 60 mg.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Prasugrel Mylan has been shown to have comparable quality and to be bioequivalent to Efient.
Maltese: L-Aġenzija Ewropea għall-Mediċini kkonkludiet li, b'mod konformi mar-rekwiżiti tal-UE, Prasugrel Mylan wera li għandu kwalità komparabbli u huwa bijoekwivalenti għal Efient.
English: Prasugrel Mylan received a marketing authorisation valid throughout the EU on 16 May 2018.
Maltese: Prasugrel Mylan (prasugrel) EMA/203583/2018
English: It includes unstable angina (a severe type of chest pain) and heart attack.
Maltese: Dan jinkludi l-anġina mhux stabbli (tip ta' uġigħ gravi fis-sider) u lattakki tal-qalb.
English: How has Prasugrel Mylan been studied?
Maltese: Kif jintuża Prasugrel Mylan?
English: The use of Prasugrel Mylan is not recommended in patients over 75 years of age, unless the doctor has carefully considered its benefits and risks, and regards treatment with Prasugrel Mylan as necessary.
Maltese: L-użu ta' Prasugrel Mylan mhux irrakkomandat f'pazjenti li għandhom aktar minn 75 sena, sakemm ittabib ma jkunx ikkunsidra sew il-benefiċċji u r-riskji tiegħu, u jqis li l-kura bi Prasugrel Mylan hi meħtieġa.
English: This means that Prasugrel Mylan contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called Efient.
Maltese: Dan ifisser li Prasugrel Mylan fih l-istess sustanza attiva u jaħdem bl-istess mod bħal “mediċina ta' referenza” diġà awtorizzata fl-UE imsejħa Efient.
English: What are the benefits and risks of Prasugrel Mylan?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Prasugrel Mylan?
English: How does Prasugrel Mylan work?
Maltese: Għaliex ġie awtorizzat Prasugrel Mylan?
English: Strength Pharmaceutical Form
Maltese: 6 pre-filled syringes
English: MA (EU) number (Invented) name
Maltese: Subcutaneous use Siringa mimlija għal-lest (ħġieġ)
English: London, 14 November 2008 EMEA/CHMP/633842/2008
Maltese: Londra, 14 ta' Novembru 2008 EMEA/CHMP/633332/2008
English: Article 29(4) of Directive 2001/83/EC, as amended.
Maltese: L-Artikolu 29(4) tad-Direttiva 2001/83/KE, kif emendata.
English: The Rapporteur was Dr Ondřej Slanař (CZ) and Co-Rapporteur(s) was Prof János Borvendég (HU).
Maltese: Ir-Rapporteur kien Dott Ondřej Slanař (CZ) u l-Korapporteur(s) kien il-Profs János Borvendég (HU).
English: Lisonorm tablet contains 5mg amlodipine/ 10mg lisinopril and is an anti-hypertensive indicated in patients with blood pressure adequately controlled with lisinopril and amlodipine given concurrently at the same dose level.
Maltese: Pillola ta' Lisonorm fiha 5mg amlodipina/10mg lisinopril u hija antipertensiv indikat f'pazjenti bi pressjoni tad-demm ikkontrollata adegwatament b'lisinopril u amlodipina mogħtija fl-istess ħin flistess livell tad-doża.
English: The Reference Member State was Hungary and the Concerned Member States were Czech Republic, Estonia, Hungary, Lithuania, Latvia, Poland, Romania and Slovak Republic.
Maltese: L-Istat Membru ta' Referenza kien l-Ungerija u l-Istati Membri Kkonċernati kienu r-Repubblika Ċeka, l-Estonja, l-Ungerija, il-Litwanja, il-Latvja, il-Polonja, ir-Rumanija u r-Repubblika Slovakka.
English: Gedeon Richter Plc obtained a national marketing authorisation for Lisonorm which was authorised in Bulgaria on 29 December 2006, before Bulgaria joined the European Union.
Maltese: Gedeon Richter Plc kisbet awtorizzazzjoni nazzjonali għat-tqegħid fis-suq għal Lisonorm li kienet awtorizzata fil-Bulgarija fid-29 ta' Diċembru 2006, qabel ma l-Bulgarija ssieħbet fl-Unjoni Ewropea.
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 29(4)1 REFERRAL FOR Lisonorm and associated names International Non-Proprietary Name (INN): lisinopril + amlodipine
Maltese: GĦALL-UŻU MILL-BNIEDEM (CHMP) OPINJONI WARA RIFERIMENT SKONT L-ARTIKOLU 29(4)1 GĦAL Lisonorm u ismijiet assoċjati Denominazzjoni Komuni Internazzjonali (DKI): lisinopril + amlodipina
English: Concerns related to the formal proof of bioequivalence and the lack of a wide therapeutic experience which were considered a potential serious risk to public health.
Maltese: It-tħassib kellu x'jaqsam mal-prova formali ta' bioekwivalenza u n-nuqqas ta' esperjenza terapewtika wiesgħa tqies bħala riskju serju potenzjali għas-saħħa pubblika.
English: The final opinion was converted into a Decision by the European Commission on 12 November 2008.
Maltese: L-opinjoni finali inqelbet f'Deċiżjoni mill-Kummissjoni Ewropea fit-12 ta' Novembru 2008.