FrancophonIA/ELRC3.0 huggingface dataset:
English: The European Commission granted a marketing authorisation valid throughout the European Union for Pioglitazone Teva Pharma on 26 March 2012.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Pioglitazone Teva Pharma fil-26 ta' Marzu 2012.
English: The recommended starting dose of Pioglitazone Teva Pharma is 15 or 30 mg once a day.
Maltese: Id-doża inizjali rakkomandata ta' Pioglitazone Teva Pharma hi 15 jew 30 mg darba kuljum.
English: This is a summary of the European public assessment report (EPAR) for Pioglitazone Teva Pharma.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Pioglitazone Teva Pharma.
English: The active substance in Pioglitazone Teva Pharma, pioglitazone, makes cells (fat, muscle and liver) more sensitive to insulin, which means that the body makes better use of the insulin it produces.
Maltese: Is-sustanza attiva f'Pioglitazone Teva Pharma, il-pijoglitażonu, tagħmel iċ-ċelloli (tax-xaħam, tal-muskoli u talfwied) aktar sensittivi għall-insulina, li jfisser li l-ġisem jagħmel użu aħjar mill-insulina li jipproduċi.
English: This means that Pioglitazone Teva Pharma is similar to a ‘reference medicine' already authorised in the European Union (EU) called Actos.
Maltese: Dan ifisser li Pioglitazone Teva Pharma huwa simili għall-‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) li jisimha Actos.
English: The CHMP concluded that, in accordance with EU requirements, Pioglitazone Teva Pharma has been shown to have comparable quality and to be bioequivalent to Actos.
Maltese: Is-CHMP kkonkluda li, b'mod konformi mar-rekwiżiti tal-UE, intwera li Pioglitazone Teva Pharma għandu kwalità komparabbli u li huwa bijoekwivalenti għal Actos.
English: Because Pioglitazone Teva Pharma is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Actos.
Maltese: Peress li Pioglitazone Teva Pharma huwa mediċina ġenerika, l-istudji fuq il-pazjenti ġew limitati għal testitjiet li jistabbilixxu l-bijoekwivalenza tiegħu mal-mediċina ta' referenza Actos.
English: What is Pioglitazone Teva Pharma?
Maltese: Kif jintuża Pioglitazone Teva Pharma?
English: Pioglitazone Teva Pharma is a medicine that contains the active substance pioglitazone.
Maltese: Żewġ mediċini jkunu bijoekwivalenti meta jipproduċu l-istess livelli tas-sustanza attiva fil-ġisem.
English: What are the benefits and risks of Pioglitazone Teva Pharma?
Maltese: X'inhu l-benefiċċju u r-riskju ta' Pioglitazone Teva Pharma?
English: Because Pioglitazone Teva Pharma 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: Peress li Pioglitazone Teva Pharma huwa mediċina ġenerika u huwa bijoekwivalenti għall-mediċina ta' referenza, jitqies li l-benefiċċji u r-riskji tiegħu huma l-istess bħal dawk tal-mediċina ta' referenza.
English: Pioglitazone Teva Pharma is used to treat type 2 diabetes in adults (aged 18 years or over), particularly those who are overweight.
Maltese: Pioglitazone Teva Pharma jintuża għall-kura tad-dijabete tat-tip 2 fuq adulti (minn 18-il sena 'l fuq), b'mod partikulari fuq dawk li jkollhom piż eċċessiv.
English: Why has Pioglitazone Teva Pharma been approved?
Maltese: Għaliex ġie approvat Pioglitazone Teva Pharma?
English: Pioglitazone Teva Pharma is used on its own in patients for whom metformin (another antidiabetes medicine) is not suitable.
Maltese: Pioglitazone Teva Pharma jintuża waħdu fuq pazjenti li ma jistgħux jieħdu l-metformina (mediċina antidijabetika oħra).
English: Pioglitazone Teva Pharma should not be used in patients on dialysis (a blood clearance technique used in people with kidney disease).
Maltese: Pioglitazone Teva Pharma m'għandux jintuża fuq pazjenti bid-dijaliżi (teknika tat-tisfija tad-demm użata f'nies b'mard fil-kliewi).
English: This dose may need to be increased after one or two weeks to up to 45 mg once a day if better blood glucose (sugar) control is needed.
Maltese: Jista' jenħtieġ li din id-doża tiżdied wara ġimgħa jew ġimgħatejn sa 45 mg darba kuljum jekk ikun meħtieġ kontroll aħjar fuq il-glukożju fid-demm (zokkor).
English: As a consequence, the blood glucose levels are reduced and this helps to control type 2 diabetes.
Maltese: Dan jikkaġuna tnaqqis fil-livelli tal-glukożju fid-demm, u dan jgħin il-kontroll tad-dijabete tat-tip 2.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom28 November 2014
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom28 ta' Novembru 2014
English: The medicine is currently marketed in the following Member States of the EU: Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Latvia, Luxembourg, Malta, Netherlands, Poland, Portugal, Spain, Sweden and United Kingdom, as well as in Iceland and Norway.
Maltese: Attwalment, il-mediċina hija mqiegħda fis-suq fl-Istati Membri tal-UE li ġejjin: l-Awstrija, il-Belġju, Ċipru, ir-Repubblika Ċeka, id-Danimarka, il-Finlandja, Franza, il-Ġermanja, il-Greċja, l-Irlanda, l-Italja, il-Latvja, il-Lussemburgu, Malta, il-Pajjiżi Baxxi, il-Polonja, il-Portugall, Spanja, l-Isvezja u r-Renju Unit, kif ukoll fl-Islanda u fin-Norveġja.
English: What is EMLA cream?
Maltese: X'inhi EMLA krema?
English: The CHMP also harmonised other sections of the SmPC including sections 4.4 (special warning and precautions for use), 4.6 (fertility, pregnancy and lactation) and 4.8 (side effects).
Maltese: Is-CHMP armonizza wkoll sezzjonijiet oħrajn tal-SmPC inklużi sezzjonijiet 4.4 (twissija speċjali u prekawzjonijiet għall-użu), 4.6 (fertilità, tqala u treddigħ) u 4.8 (effetti sekondarji).
English: EMLA cream is a topical (skin) cream that contains the active substances lidocaine and prilocaine.
Maltese: EMLA krema hija krema topika (tal-ġilda) li fiha s-sustanzi attivi lidocaine u prilocaine.
English: On 25 September 2014, the European Medicines Agency completed a review of EMLA cream.
Maltese: Fil-25 ta' Settembru 2014, l-Aġenzija Ewropea għall-Mediċini temmet reviżjoni ta' EMLA krema.
English: • topical anaesthesia of the genital mucosa in adults and adolescents;
Maltese: • anestesija topika tal-mukoża ġenitali f'adulti u f'adolexxenti;
English: • topical anaesthesia of leg ulcers in adults only.
Maltese: • anestesija topika ta' ulċeri fis-saqajn f'adulti biss.
English: Why was EMLA cream reviewed?
Maltese: Għaliex ġiet riveduta EMLA krema?
English: Having harmonised the indications, the CHMP also harmonised recommendations on the doses and the duration of application of EMLA cream before different medical or surgical procedures in children, adolescents or adults.
Maltese: Wara li armonizza l-indikazzjonijiet, is-CHMP armonizza wkoll ir-rakkomandazzjonijiet dwar id-dożi u ttul tal-applikazzjoni ta' EMLA krema qabel proċeduri mediċi jew kirurġiċi differenti fit-tfal, adolexxenti jew adulti.
English: The CHMP agreed that hypersensitivity (allergy) to lidocaine and/or prilocaine or similar local anaesthetics or to any other ingredients in EMLA cream should be the only contraindication.
Maltese: Is-CHMP qabel li l-ipersensittività (allerġija) għal lidocaine u/jew prilocaine jew anestetiċi lokali simili jew għal kwalunkwe sustanza oħra f'EMLA krema għandha tkun l-unika kontraindikazzjoni.
English: EMLA cream is authorised in the EU via national procedures.
Maltese: EMLA krema ġiet awtorizzata fl-UE permezz ta' proċeduri nazzjonali.
English: The European Commission issued an EU-wide legally binding decision on 28 November 2014.
Maltese: Il-Kummissjoni Ewropea ħarġet deċiżjoni legalment vinkolanti mal-UE kollha fit-28 ta' Novembru 2014.
English: It is used as a local anaesthetic to prevent pain during medical or superficial surgical procedures.
Maltese: Tintuża bħala anastetiku lokali biex tipprevjeni uġigħ waqt proċeduri mediċi jew kirurġiċi superfiċjali.
English: In view of this, on 11 October 2013 the German medicines regulatory agency referred the matter to the CHMP in order to harmonise the marketing authorisations for EMLA cream in the EU.
Maltese: Fid-dawl ta' dan, fil-11 ta' Ottubru 2013 l-aġenzija regolatorja tal-mediċini Ġermaniża rriferiet ilkwistjoni lis-CHMP sabiex jarmonizza l-awtorizzazzjonijiet għat-tqegħid fis-suq għal EMLA krema fl-UE.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for EMLA cream in the European Union (EU).
Maltese: IlKumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija kkonkluda li jeħtieġ li linformazzjoni ta' preskrizzjoni għal EMLA krema tiġi armonizzata fl-Unjoni Ewropea (UE).
English: After reviewing the available data supporting the medicine's use, the CHMP agreed that EMLA cream can be used for the following:
Maltese: Wara li rreveda d-dejta disponibbli li tappoġġja l-użu tal-mediċina, is-CHMP qabel li EMLA krema tista' tintuża għal dan li ġej:
English: The CHMP, in the light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SmPCs, labelling and package leaflets should be harmonised across the EU.
Maltese: Is-CHMP, fid-dawl tad-dejta sottomessa u d-diskussjoni xjentifika fil-Kumitat, kien tal-fehma li lSmPCs, it-tikkettar u fuljetti ta' tagħrif għandhom jiġu amronizzati fl-UE kollha.
English: This has led to divergences across Member States in the way the medicine can be used, as seen in differences in the SmPCs (Summary of Product Characteristics), labelling and package leaflets in the countries where the medicine is marketed.
Maltese: Dan wassal għal diverġenzi flIstati Membri kollha fil-mod kif tista' tintuża l-mediċina, kif jidher mid-differenzi fl-SmPCs (Sommarju tal-Karatteristiċi tal-Prodott - Summary of Product Characteristics), it-tikkettar u l-fuljetti ta' tagħrif filpajjiżi fejn il-mediċina hija fis-suq.
English: In addition, information has been included to explain that studies did not show that EMLA cream is effective at providing adequate pain relief for circumcision (surgical removal of the foreskin).
Maltese: Barra minn hekk, ġiet inkluża informazzjoni biex tispjega li l-istudji ma wrewx li EMLA krema hija effettiva f'li tipprovdi serħan mill-uġigħ adegwat għal ċirkonċiżjoni (tneħħija kirurġika talprepuzju).
English: The company that markets these medicines is Astra Zeneca.
Maltese: Il-kumpanija li tqiegħed dawn il-mediċini fis-suq hija Astra Zeneca.
English: It is available as oblong chewable tablets, in three different strengths (8 mg, 30 mg and 80 mg).
Maltese: Jiġi bħala pilloli tawwalin li tomgħodhom, fi tliet qawwiet differenti (8 mg, 30 mg u 80 mg).
English: A study in dogs (average age 8.8 years old) with chronic osteoarthritis lasted for up to 90 days.
Maltese: Studju fuq klieb (età medja 8.8 snin) b'osteoartrite kronika dam sa 90 jum.
English: This summary was last updated on 18/02/2011.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fi 18/02/2011.
English: The active substance in Cimalgex, cimicoxib, belongs to a class of medicines called non-steroidal antiinflammatory drugs (NSAIDs).
Maltese: Is-sustanza attiva f'Cimalgex, cimicoxib, tappartjeni għall-klassi ta' mediċini msejħa mediċini kontra linfjammazzjoni mhux sterojdali (NSAIDs).
English: It works mainly by blocking an enzyme called cyclo-oxygenase-2 (COX2).
Maltese: Taħdem billi prinċipalment timblokka enzim imsejjaħ cyclooxygenase-2 (COX-2).
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Cimalgex to Vétoquinol SA on 18/02/2011.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida madwar l-Unjoni Ewropea kollha, għal Cimalgex lil Vétoquinol SA fi 18/02/2011.
English: Cimalgex is a veterinary medicine that contains cimicoxib.
Maltese: Cimalgex huwa mediċina veterinarja li fiha cimicoxib.
English: These field studies involved dogs of different age groups, genders and breeds.
Maltese: Dawn l-istudji fil-post involvew klieb ta' gruppi ta' età, sess u razez differenti.
English: Pain was assessed by the veterinarian (up to 24 hours after surgery and at the end of the follow-up treatment).
Maltese: L-uġigħ ġie vvalutat mill-veterinarju (sa 24 siegħa wara l-kirurġija u fi tmiem il-kura ta' follow-up).
English: For longer-term treatment, regular monitoring should be undertaken by the veterinary surgeon.
Maltese: Għal kura iktar fit-tul, il-monitoraġġ aktar regolari għandu jsir mill-kirurgu veterinarju.
English: For a full list of all side-effects reported with Cimalgex, see the Package Leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji rrapportati bi Cimalgex, ara l-Fuljett ta' Tagħrif fil-Pakkett.
English: Cimalgex was also shown to be as effective as the comparator NSAID, carprofen, in the management of peri-operative pain due to orthopaedic or soft tissue surgery during the first 24 hours after surgery.
Maltese: Cimalgex intwera wkoll li huwa effikaċi daqs l-NSAID komparatur, carprofen, fil-ġestjoni ta' uġigħ madwar il-perjodu tal-operazzjoni minħabba kirurġija ortopedika jew tat-tessut artab matul l-ewwel 24 siegħa wara l-kirurġija.
English: Given daily, Cimalgex reduced pain and inflammation (and the signs of these, such as lameness) in dogs with chronic osteoarthritis, and was as effective as the comparator NSAID, firocoxib.
Maltese: Mogħti kuljum, Cimalgex naqqas l-uġigħ u l-infjammazzjoni (u s-sinjali ta' dawn, bħal zappip) fi klieb b'osteoartrite kronika, u kien effikaċi daqs l-NSAID komparatur, firocoxib.
English: This enzyme is involved in producing substances called prostaglandins, which are involved in pain and inflammation.
Maltese: Dan l-enzim huwa involut fil-produzzjoni tas-sustanzi msejħin prostaglandins, li huma involuti fl-uġigħ u fl-infjammazzjoni.
English: Cimalgex has been studied in laboratory animals, as well as in dogs that were treated in various veterinary practices and clinics across Europe (“field studies”) in which Cimalgex was compared with other licensed veterinary NSAID medicines.
Maltese: Cimalgex ġie studjat f'annimali tal-laboratorju, kif ukoll fi klieb li ġew ikkurati f'diversi prattiki u kliniċi veterinarji madwar l-Ewropa (“studji fil-post”) fejn Cimalgex tqabbel ma' mediċini
English: Why has Cimalgex been approved?
Maltese: Għaliex ġie approvat Cimalgex?
English: If you want more information on the basis of the CVMP recommendations, read the Scientific Discussion (also part of the EPAR).
Maltese: Jekk trid iktar informazzjoni fuq il-bażi tar-rakkomandazzjonijiet tas-CVMP, aqra dDiskussjoni Xjentifika (parti wkoll mill-EPAR).
English: What is Cimalgex?
Maltese: X'inhu Cimalgex?
English: The CVMP decided that the benefits of Cimalgex are greater than its risks for the treatment of pain and inflammation associated with osteoarthritis, and the management of peri-operative pain due to orthopaedic or soft tissue surgery, and recommended that Cimalgex be given a marketing authorisation.
Maltese: Is-CVMP iddeċieda li l-benefiċċji ta' Cimalgex jisbqu r-riskji tiegħu għall-kura ta' uġigħ u infjammazzjoni assoċjati ma' osteoartrite, u l-ġestjoni ta' uġigħ ta' madwar il-perjodu tal-operazzjoni minħabba kirurġija ortopedika jew kirurġija tat-tessut artab, u rrakkomanda li Cimalgex jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: The dogs received either Cimalgex or a comparator product (carprofen).
Maltese: Il-klieb irċevew jew Cimalgex jew prodott komparatur (carprofen).
English: The benefit-risk balance may be found in the Scientific Discussion part of this EPAR.
Maltese: Il-bilanċ benefiċċju-riskju jista' jinstab fil-parti tad-Diskussjoni Xjentifika ta' dan l-EPAR.
English: People with a known hypersensitivity (allergy) to cimicoxib should avoid contact with Cimalgex tablets.
Maltese: Nies li għandhom sensittività eċċessiva (allerġija) għal cimicoxib għandhom jevitaw il-kuntatt mal-pilloli ta' Cimalgex.
English: Cimalgex must not be used in dogs aged less than 10 weeks old, and if the dog is less than 6 months of age careful monitoring by the veterinarian is recommended.
Maltese: Cimalgex ma għandux jintuża fi klieb li għandhom inqas minn 10 ġimgħat, u jekk il-kelb huwa inqas minn 6 xhur huwa rrakkomandat li jsir monitoraġġ attent mill-veterinarju.
English: How has Cimalgex been studied?
Maltese: Kif ġie studjat Cimalgex?
English: Cimalgex is used in dogs to treat the pain and inflammation associated with osteoarthritis (a long term disease causing damage and pain in the joints).
Maltese: Cimalgex jintuża fuq il-klieb biex jikkura uġigħ u infjammazzjoni assoċjati ma' osteoartrite (marda fittul li tikkawża ħsara u uġigħ fil-ġogi).
English: When used with surgery, the tablets are given to the dog around two hours before the start of the operation at a dose of 2 mg/kg body weight, using the appropriate tablet(s) according to the dog's weight, and then once a day for the following three to seven days, based on the judgment of the veterinary surgeon.
Maltese: Meta użati mal-kirurġija, il-pilloli jingħataw lill-kelb madwar sagħtejn qabel il-bidu tal-operazzjoni f'doża ta' 2 mg/kg piż tal-ġisem, permezz tal-pillola(i) x-xierqa skont il-piż tal-ġisem, u mbagħad darba kuljum għat-tlett sa sebat ijiem ta' wara, fuq il-bażi ta' dak li jkun iddeċieda l-kirurgu veterinarju.
English: What is the risk associated with Cimalgex?
Maltese: X'inhu r-riskju assoċjat ma' Cimalgex?
English: When used for osteoarthritis, the tablets are given to the dog once a day, with or without food, at a dose of 2 mg/kg body weight, using the appropriate tablet(s) according to the dog's weight.
Maltese: Meta użati għall-osteoartrite, il-pilloli jingħataw lill-kelb darba kuljum, flimkien ma' jew mingħajr ikel, f'doża ta' 2 mg/kg piż tal-ġisem, billi tintuża pillola/jintużaw pilloli xierqa skont il-piż tal-kelb.
English: Fenofibrato Pensa and Fenofibrato Ranbaxy contain fenofibrate, a drug of the fibrate class.
Maltese: Fenofibrato Pensa u Fenofibrato Ranbaxy fihom fenofibrate, mediċina tal-klassi tal-fibrati.
English: Fenofibrato Pensa and Fenofibrato Ranbaxy are both available as 160mg tablets.
Maltese: Fenofibrato Pensa u Fenofibrato Ranbaxy jiġu bħala pilloli ta' 160mg.
English: Whereas
Maltese: Anness II
English: The single pivotal bioequivalence study 10540314 using the 160 mg tablets was conducted by the Cetero Research facilities in Houston in 2005.
Maltese: L-istudju ta' bijoekwivalenza pivotali uniku 10540314 li uża l-pilloli ta' 160 mg twettaq mill-faċilitajiet ta' Cetero Research fi Houston fl-2005.
English: • The Committee considered the procedure under Article 31 of Directive 2001/83/EC for Fenofibrato Pensa and Fenofibrato Ranbaxy.
Maltese: • Il-Kumitat ikkunsidra l-proċedura skont l-Artikolu 31 tad-Direttiva 2001/83/KE għal Fenofibrato Pensa u Fenofibrato Ranbaxy.
English: The US Food and Drug Administration informed the European Medicines Agency that following an inspection, concerns have been raised about the conduct of bio-analytical studies performed by the Cetero Research facilities in Houston (Texas, USA) during the period from April 2005 to June 2010.
Maltese: Il-US Food and Drug Administration infurmat lill-Aġenzija Ewropea għall-Mediċini li wara spezzjoni, tqajjem tħassib dwar it-twettiq ta' studji bijoanalitiċi li saru mill-faċilitajiet ta' Cetero Research fi Houston (Texas, USA) matul il-perjodu minn April 2005 sa Ġunju 2010.
English: The inspection identified significant instances of misconduct and violations of federal regulations, including falsification of documents and manipulation of samples.
Maltese: L-ispezzjoni identifikat eżempji sinifikanti ta' mġiba ħażina u ksur tar-regolamenti federali, inkluż il-falsifikazzjoni ta' dokumenti u l-manipulazzjoni ta' kampjuni.
English: On 01 August 2012, the United Kingdom triggered a referral under Article 31 of Directive 2001/83/EC for the identified nationally authorised products.
Maltese: Fl1 ta' Awwissu 2012, ir-Renju Unit ta bidu għal riferiment skont l-Artikolu 31 tad-Direttiva 2001/83/KE għall-prodotti identifikati awtorizzati fuq livell nazzjonali.
English: Overall conclusion and benefit-risk balance
Maltese: Konklużjoni ġenerali u l-bilanċ tal-benefiċċju-riskju
English: The Committee, as a consequence, recommended the suspension of the marketing authorisations for Fenofibrato Pensa and Fenofibrato Ranbaxy, pursuant to Article 116 of Directive 2001/83/EC; as a. the risk-benefit balance cannot be considered favourable and b. the particulars supporting the application as provided in Article 10 of Directive 2001/83/EC cannot be considered correct
Maltese: B'konsegwenza ta' dan, il-Kumitat irrakkomanda s-sospensjoni tal-awtorizzazzjonijiet għat-tqegħid fis-suq għal Fenofibrato Pensa u Fenofibrato Ranbaxy, skont l-Artikolu 116 tad-Direttiva 2001/83/KE; minħabba li a. il-bilanċ tal-benefiċċju-riskju ma jistax jitqies bħala favorevoli u b. id-dettalji li jappoġġjaw l-applikazzjoni kif previst fl-Artikolu 10 tad-Direttiva 2001/83/KE ma jistgħux jitqiesu bħala korretti
English: Overall summary of the scientific evaluation of Fenofibrato Pensa and Fenofibrato Ranbaxy (see Annex I)
Maltese: Sommarju ġenerali tal-evalwazzjoni xjentifika ta' Fenofibrato Pensa u Fenofibrato Ranbaxy (ara Anness I)
English: The CHMP was requested to assess whether the deficiencies in conduct of bio-analytical studies performed by the Cetero Research facilities in Houston (Texas, USA) have impact on the benefit/risk of the concerned medicinal products and to give its opinion on whether the marketing authorisations for authorised medicinal products for which studies have been carried out or samples analysed by Cetero Research, during the identified time period, should be maintained, varied, suspended or withdrawn.
Maltese: Is-CHMP intalab jevalwa jekk in-nuqqasijiet fittwettiq ta' studji bijoanalitiċi li saru mill-faċilitajiet ta' Cetero Research fi Houston (Texas, USA) kellhomx impatt fuq il-benefiċċju/riskju tal-prodotti mediċinali kkonċernati u biex jagħti l-opinjoni tiegħu dwar jekk lawtorizzazzjonijiet għat-tqegħid fis-suq għal prodotti mediċinali awtorizzati li għalihom kienu saru studji jew ġew analizzati kampjuni minn Cetero Research, matul il-perjodu ta' żmien identifikat, għandhomx jinżammu, jiġu varjati, jiġu sospiżi jew irtirati.
English: It is used to reduce cholesterol levels in patients at risk of cardiovascular disease.
Maltese: Tintuża biex tnaqqas il-livelli ta' kolesterol f'pazjenti f'riskju ta' mard kardjovaskulari.
English: In conclusion, the CHMP considered that the potential deficiencies in the conduct of bio-analytical studies by the Cetero Research facilities invalidate the pivotal bioequivalence study.
Maltese: Bħala konklużjoni, is-CHMP ikkunsidra li n-nuqqasijiet potenzjali fit-twettiq tal-istudji bijoanalitiċi millfaċilitajiet ta' Cetero Research jinvalidaw l-istudju pivotali ta' bijoekwivalenza.
English: The MAH submitted grounds for the re-examination, which consisted of a new bioequivalence study (study 2016_FENOF_11), carried out to replace the pivotal bioequivalence study (study 10540314), for which serious doubts were raised regarding the reliability and the correctness of the data.
Maltese: L-MAH issottometta raġunijiet għall-eżami mill-ġdid, li kien magħmul minn studju ġdid ta' bijoekwivalenza (studju 2016_FENOF_11), li twettaq biex jissostitwixxi l-istudju pivotali ta' bijoekwivalenza (studju 10540314), li kienu tqajmu dubji serji dwaru fir-rigward tal-affidabbiltà u l-korrettezza tad-dejta.
English: According to Article 62(1) of Regulation (EC) 726/2004, such new data cannot be considered in the context of the re-examination.
Maltese: Skont l-Artikolu 62(1) tar-Regolament (KE) 726/2004, tali dejta ġdida ma tistax tiġi kkunsidrata fil-kuntest tal-eżami mill-ġdid.
English: The CHMP noted the absence of samples from the critical pivotal bioequivalence study 10540314 and that there is therefore no possibility to reanalyse the data.
Maltese: Is-CHMP innota n-nuqqas ta' kampjuni mill-istudju ta' bijoekwivalenza pivotali kritika 10540314 u li għaldaqstant ma hemm ebda possibbiltà li d-dejta tiġi analizzata mill-ġdid.