FrancophonIA/ELRC3.0 huggingface dataset:
English: In particular, in the main study comparing the use of Kantos Master for MART versus maintenance treatment with Kantos Master plus a short-acting bronchodilator given for relief, there were concerns that the comparison group might not have been receiving adequate maintenance treatment, which could have made the results in the MART group look better than they really were.
Maltese: B'mod partikolari, fl-istudju ewlieni li qabbel l-użu ta' Kantos Master bħala MART kontra kura ta' manteniment b'Kantos Master flimkien ma' bronkodilatur li jaġixxi tul perjodu qasir li jingħata għas-solliev, kien hemm tħassib li lgrupp ta' tqabbil seta' ma kienx qed jirċievi kura adegwata ta' manteniment, li seta' ġab ir-riżultati filgrupp ta' MART jidhru aqwa milli filfatt kienu.
English: However, the Member States were unable to reach agreement on whether to accept this indication for Kantos Master.
Maltese: Madankollu l-Istati Membri ma setgħux jilħqu ftehim dwar jekk jaċċettawx din l-indikazzjoni għal Kantos Master.
English: If patients develop symptoms of asthma (wheezing and difficulty breathing) inhalation of a separate bronchodilator medicine with a rapid onset and short duration of action is advised for relief (rescue therapy).
Maltese: Jekk il-pazjenti jiżviluppaw sintomi tal-ażżma (tħarħir u diffikultà fit-teħid tan-nifs) l-inalazzjoni ta' mediċina separata permezz ta' bronkodilatur li tibda taħdem malajr u li taġixxi tul perjodu qasir hija rakkomandata għas-solliev (terapija ta' salvataġġ).
English: Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP agreed that Kantos Master has been shown to reduce the risk of severe exacerbation of asthma and prolong the time between exacerbations when part of the dose is given on an as-needed basis as MART.
Maltese: Abbażi tal-valutazzjoni tad-dejta disponibbli bħalissa u d-diskussjoni xjentifika li saret fil-Kumitat, isCHMP qabel li ntwera li Kantos Master inaqqas ir-riskju ta' aggravar sever tal-ażżma u jtawwal iż-żmien bejn l-aggravar meta parti mid-doża tingħata abbażi ta' ħtieġa bħala
English: Vidaza azacitidine
Maltese: Vidaza azaċitidina
English: Other information about Vidaza
Maltese: Informazzjoni oħra dwar Vidaza
English: The most common side effects of Vidaza in more than 60% of patients with myelodysplastic syndromes, CMML or AML (20 to 30% abnormal cells) are blood reactions including thrombocytopenia (low platelet counts), neutropenia (low levels of neutrophils, a type of white blood cell) and leucopenia (low white blood cell counts), side effects affecting the stomach and gut including nausea and vomiting, and injection site reactions.
Maltese: L-effetti sekondarji l-aktar komuni b'Vidaza li dehru f'iktar minn 60% tal-pazjenti b'sindromi mjelodisplastiċi, CMML jew AML (20 sa 30% ta' ċelloli anormali) huma r-reazzjonijiet tad-demm inkluża tromboċitopenija (għadd baxx ta' pjastrini), newtropenija (livelli baxxi ta' newtrofili, tip ta' ċellolli bojod tad-demm) u lewkopenija (għadd baxx ta' ċelloli bojod tad-demm), effetti sekondarji li jolqtu l-istonku u l-imsaren inklużi nawżja u remettar, u reazzjonjiet fis-sit tal-injezzjoni.
English: This is a summary of the European public assessment report (EPAR) for Vidaza.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Vidaza.
English: Vidaza is a medicine that contains the active substance azacitidine.
Maltese: Vidaza huwa mediċina li fiha s-sustanza attiva azaċitidina.
English: • AML that has developed from a myelodysplastic syndrome and the bone marrow consists of 20 to 30% abnormal cells;
Maltese: • AML li żviluppa minn sindromi mjelodisplastiċi u l-mudullun jikkonsisti f'bejn 20 u 30% ta' ċelloli anormali;
English: Why has Vidaza been approved?
Maltese: Għaliex ġie approvat Vidaza?
English: Azacitidine is an analogue of cytidine, which means that it is incorporated into the genetic material of cells (RNA and DNA).
Maltese: Lazaċitidina hija analogu taċ-ċitidina, li jfisser li hija inkorporata fil-materjal ġenetiku taċ-ċelloli (RNA u DNA).
English: • chronic myelomonocytic leukaemia (CMML, a cancer affecting white blood cells called monocytes).
Maltese: • lewkimja mjelomonoċitika kronika (CMML, kanċer li jaffettwa ċ-ċelloli bojod tad-demm imsejħa monoċiti).
English: The recommended dose of Vidaza is 75 mg per square metre body surface area (calculated using the patient's height and weight).
Maltese: Id-doża inizjali rakkomandata ta' Vidaza hija ta' 75 mg għal kull metru kwadru ta' superfiċje (ikkalkolata mit-tul u mill-piż tal-pazjent).
English: In the second study in AML patients with more than 30% abnormal cells, patients receiving Vidaza survived for an average of 10.4 months, compared with 6.5 months in patients receiving conventional care.
Maltese: Fit-tieni studju fuq pazjenti bl-ALM b'aktar minn 30% taċ-ċelloli anormali, il-pazjenti li ngħataw Vidaza damu jgħixu medja ta' 10.4 xhur, meta mqabbla ma' 6.5 xhur f'pazjenti li ngħataw kura konvenzjonali.
English: What is Vidaza?
Maltese: X'inhu Vidaza?
English: Because the number of patients with these diseases is low, the diseases are considered ‘rare', and Vidaza was designated an ‘orphan medicine' (a medicine used in rare diseases) on 6 February 2002 for myelodysplastic syndromes and on 29 November 2007 for AML.
Maltese: Minħabba li l-għadd ta' pazjenti b'dan il-mard huwa wieħed baxx, il-mard huwa meqjus ‘rari', u fis-6 ta' Frar 2002, Vidaza ġie denominat bħala ‘mediċina orfni' (mediċina li tintuża għal mard rari) għassindromi mjelodisplastiċi u fid-29 ta' Novembru 2007 għall-AML.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Vidaza on 17 December 2008.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Vidaza valida fl-Unjoni Ewropea kollha fis-17 ta' Diċembru 2008.
English: In the first study, patients receiving Vidaza survived for an average of 24.5 months, compared with 15.0 months in patients receiving conventional care.
Maltese: Fl-ewwel studju, ilpazjenti li kienu qed jingħataw Vidaza damu jgħixu medja ta' 24.5 xhur, meta mqabbla ma' 15-il xahar f'pazjenti li ngħataw kura konvenzjonali.
English: The active substance in Vidaza, azacitidine, belongs to the group ‘anti-metabolites'.
Maltese: Is-sustanza attiva f'Vidaza, l-azaċitidina, hija mediċina li tagħmel parti mill-grupp ta' ‘antimetaboliti'.
English: What is the risk associated with Vidaza?
Maltese: X'inhu r-riskju assoċjat ma' Vidaza?
English: At the time of orphan medicine designation, CMML was classified as a type of myelodysplastic syndrome.
Maltese: Fi żmien tad-denominazzjoni bħala orfni, CMML ġie kklassifikat bħala tip ta' sindromu mjelodisplastiku.
English: The first study involved 358 adults with intermediate to high-risk myelodysplastic syndromes, CMML or AML, who were unlikely to go on to have a stem cell transplant.
Maltese: Fl-ewwel studju pparteċipaw 358 adult b'riskju bejn intermedjarju u għoli għas-sindromi mjelodisplastiċi, CMML jew AML, li ma kinux mistennija li jkollhom trapjant taċ-ċelloli staminali.
English: The summaries of the opinion of the Committee for Orphan Medicinal Products for Vidaza can be found on the Agency's website: here (myelodysplastic syndromes) and here (AML).
Maltese: Is-sommarji tal-opinjoni tal-Kumitat għall-Prodotti Mediċinali Orfni għal Vidaza jinstab fis-sit elettroniku tal-Aġenzija: hawnhekk (sindromi mjelodisplastiċi) u hawnhekk (AML).
English: The second study involved 488 patients with AML who were 65 years or older and could not have haematopoietic stem cell transplantation.
Maltese: Fit-tieni studju pparteċipaw 488 pazjent b'AML li kellhom 65 sena jew iktar u li ma setax isirilhom trapjant ta ċelloli staminali ematopojetiċi.
English: The full EPAR for Vidaza 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 Għal aktar informazzjoni rigward il-kura b'Vidaza, aqra l-fuljett ta' tagħrif (parti wkoll mill-EPAR) jew ikkuntattja lit-tabib jew lill-ispiżjar tiegħek.
English: Side effects were similar in AML patients with more than 30% abnormal cells.
Maltese: L-effetti sekondarji kienu simili f'pazjenti bl-AML b'iktar minn 30% taċ-ċelloli anormali.
English: • AML, when the bone marrow has more than 30% abnormal cells.
Maltese: • AML, meta l-mudullun ikun fih iktar minn 30% ta' ċelloli anormali.
English: Their bone marrow contained more than 30% abnormal cells.
Maltese: Il-mudullun tal-pazjenti kien fih sa 30% ta' ċelloli anormali.
English: • myelodysplastic syndromes, a group of conditions where too few blood cells are produced by the bone marrow.
Maltese: • sindromi mjelodisplastiċi, grupp ta' kundizzjonijiet fejn ikun hemm ftit wisq ċelloli tad-demm prodotti mill-mudullun.
English: What benefit has Vidaza shown during the studies?
Maltese: Kif ġie studjat Vidaza?
English: Vidaza is used when the bone marrow consists of 10 to 29% abnormal cells and the bone marrow is not producing large numbers of white blood cells;
Maltese: Vidaza jintuża meta l-mudullun ikun fih bejn 10 u 29% ta' ċelloli anormali u l-mudullun ma jkunx qed jipproduċi ammonti kbar ta' ċelloli bojod tad-demm;
English: The full EPAR for Spherox 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: The chondrocyte spheroids attach to the cartilage within 20 minutes.
Maltese: -qarquċa fi żmien 20 minuta.
English: Other information about Spherox
Maltese: Informazzjoni oħra dwar Spherox
English: This is a summary of the European public assessment report (EPAR) for Spherox.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta ᾽ valutazzjoni (EPAR) għal Spherox.
English: It must also not be used in patients infected with hepatitis B, C and/or HIV virus.
Maltese: B, C u/jew bil-virus tal-HIV.
English: Preliminary data from this study after one year show that Spherox improved by 22 points the outcome score and was as effective as microfracture.
Maltese: Data preliminari minn dan l-istudju wara sena turi li Spherox tejjeb il-punteġġ tar-riżultat bi 22 punt u kien effettiv daqs il-mikrofrattura.
English: Using chondrocyte spheroids that attach to the knee cartilage allows for a less invasive surgery (i.e. arthroscopy).
Maltese: -qarquċa tal-irkoppa jippermetti kirurġija inqas invażiva (jiġifieri artroskopija).
English: Spherox spheroids of human autologous matrix-associated chondrocytes
Maltese: L-EPAR sħiħ għal Spherox jinstab fis-sit elettroniku tal-Aġenzija:
English: Why is Spherox approved?
Maltese: Għaliex ġie approvat Spherox?
English: The KOOS was self-measured by patients rating the severity of their symptoms such as pain, impact on daily living, sport and recreational activities, and quality of life.
Maltese: Il-KOOS tkejjel mill-pazjenti stess li kklassifikaw is-severità tas-sintomi tagħhom bħall-uġigħ, l-impatt fuq il-ħajja ta ' kuljum, attivitajiet sportivi u rikreattivi, u l-kwalità tal-ħajja.
English: Spherox contains spheroids (spherical aggregates) of chondrocytes, cells found in healthy cartilage.
Maltese: Spherox fih sferojdi (aggregati sferi ċi) ta' kondroċiti, ċelluli li jinstab
English: What are the risks associated with Spherox?
Maltese: -riskji asso ċjati ma' Spherox?
English: Patients treated with Spherox should follow a specific rehabilitation programme, including physiotherapy.
Maltese: Il-pazjenti li jing ħataw kura bi Sphe inkluża l-fiżjoterapija.
English: How is Spherox used?
Maltese: ' Spherox.
English: Spherox contains spheroids made from the patient's own healthy cartilage cells.
Maltese: Spherox jiġi bħala sospensjoni għall-impjantazzjoni fil-ġog tal-irkoppa.
English: Spherox is a medicine used to repair defects to the cartilage in the knee in adults who are experiencing symptoms (such as pain and problems moving the knee).
Maltese: 'adulti li qed j sintomi (bħal uġigħ u problemi biex iċaqilqu l-irkoppa).
English: For the full list of all side effects reported with Spherox, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati bi Spherox, ara l-fuljett ta ' tagħrif.
English: During arthroscopy, the medicine is placed into the damaged area of the patient's cartilage.
Maltese: Madankollu, għadu mistenni aktar għarfien dwar l-effetti fit-tul tal-mediċina.
English: The cartilage cells are then grown in the laboratory to prepare a suspension of chondrocyte spheroids.
Maltese: Iċ-ċelluli tal-qarquċa mbagħad jitkabbru fil-laboratorju sabiex tit ħejja sospensjoni ta
English: The most common side effects with Spherox (seen in more than 1 patient in 10) are arthralgia (joint pain) and joint effusion (accumulation of liquid in the knee), which can cause swelling of the joint.
Maltese: ' bejn 4 u 10 cm il-pazjenti kollha ngħataw kura bi Spherox, peress li l-mikrofrattura mhijiex rakkomandata għat-tiswija ta
English: The second study looked at 73 patients with large cartilage defects of the knee from 4 to 10 cm².
Maltese: Dan jintuża fejn iż-żona affettwata ma tkunx ikbar minn 10 cm2.
English: How does Spherox work?
Maltese: 'inhu Spherox u għal xiex jintuża?
English: Spherox must not be used in patients with primary generalised osteoarthritis or with advanced osteoarthritis of the knee (conditions causing swelling and pain in the joints) and in patients whose bones in the knee joint are still growing.
Maltese: Il-materjal għal professjonisti oħrajn fil-qasam tal-kura tas-saħħa ser jinkludi informazzjoni dwar l-iskrinjar u l-ġestjoni tal-kampjun li jittieħed u kif jippreparaw Spherox għall-impjantazzjoni, u dwar kif isir is-segwitu talpazjenti u tiġi ppjanata l-fiżjoterapija rakkomandata.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom23 June 2017
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom20 ta' Ġunju 2015
English: It was to be available as tablets (5, 10, 25 and 50 mg).
Maltese: Dan kellu jiġi f'pilloli (5, 10, 25 u 50 mg).
English: What is Elmisol?
Maltese: 'inhu Elmisol?
English: Elmisol is a medicine containing the active substance levamisole hydrochloride.
Maltese: Elmisol huwa mediċina li fiha s-sustanza attiva evamisole hydrochloride.
English: Withdrawal of the marketing authorisation application for Elmisol (levamisole) EMA/CHMP/380586/2017
Maltese: (levamisole) EMA/CHMP/380586/2017
English: Elmisol was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 28 October 2005 for nephrotic syndrome.
Maltese: Elmisol kien ikklassifikat bħala ‘mediċina orfni' (mediċina li tintuża f'mard rari) fit-28 ta'Ottubru 2005 għal sindrome nefrotiku.
English: The company provided the results of studies on the quality, safety and effectiveness of the medicine, including information from the literature.
Maltese: Il-kumpanija ppreżentat ir-riżultati tal-istudji li saru dwar il-kwalità, is-sigurtà u l-effettività talmediċina, inkluż informazzjoni mil-letteratura.
English: Nephrotic syndrome is a kidney disease that is marked by presence of large amounts of protein in the urine and results in fluid build-up in the body, with swelling (oedema), high blood pressure and weight gain.
Maltese: Is-sindrome nefrotiku hija marda tal-kliewi li hija kkaratterizzata minn preżenza ta' ammonti kbar ta' proteina fl-awrina u tirriżulta fl-akkumulazzjoni tal-fluwidi fil-ġisem, b'nefħa (edema), pressjoni tad-demm għolja u żieda fil-piż.
English: It is not completely understood how levamisole works in nephrotic syndrome, but it is known to affect the immune system (the body's natural defences).
Maltese: Mhuwiex kompletement mifhum kif levamisole jaħdem fis-sindrome nefrotiku, iżda huwa magħruf li jaffettwa s-sistema immuni (id-difiżi naturali tal-ġisem).
English: What was Elmisol expected to be used for?
Maltese: Għalxiex kien mistenni li jintuża ELmisol?
English: Levamisole has been used for many years to treat a variety of conditions, including worm infections and cancers.
Maltese: Levamisole ntuża għal diversi snin biex jikkura varjetà ta' kondizzjonijiet, inkluż infezzjonijiet ikkawżati mid-dud u kanċers.
English: Other concerns included the possibility of dosing errors because the different strengths of tablet might get confused, the way the stability of the active substance in the tablets had been tested, and inadequate information on the medicine's actions, distribution in the body and risks of interactions with other medicines.
Maltese: Tħassib ieħor inkluda l-possibbiltà ta' żbalji fid-dożaġġ peress li wieħed jista' jitħawwad fil-qawwiet differenti tal-pillola, il-mod ta' kif ġiet ittestjata l-istabbiltà tas-sustanza attiva fil-pilloli, u informazzjoni mhux adegwata dwar l-azzjonijiet, id-distribuzzjoni fil-ġisem u r-riskji ta' interazzjonijiet tal-mediċina ma' mediċini oħra.
English: Elmisol was to be used in patients in whom symptoms kept coming back after responding to initial treatment with corticosteroid medicines (steroid sensitive nephrotic syndrome).
Maltese: Elmisol kellu jintuża f'pazjenti li s-sintomi tagħhom baqgħu jirritornaw wara li rrispondew għal kura inizjali b'mediċini kortikosterojdi (sindrome nefrotiku sensittiv għall-isterojdi).
English: Elmisol was to be used in children from 2 years of age to treat nephrotic syndrome.
Maltese: Elmisol kellu jintuża fi tfal minn età ta' sentejn biex jikkura sindrome nefrotiku.
English: Withdrawal of the marketing authorisation application for Elmisol (levamisole)
Maltese: L-irtirar tal-applikazzjoni għall-awtorizzazzjoni għattqegħid fis-suq għal Elmisol (levamisole)
English: On 29 May 2017, ACE Pharmaceuticals BV officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Elmisol, for the treatment of nephrotic syndrome.
Maltese: BV għarrfet uffiċjalment lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) bl-intenzjoni li tirtira l-applikazzjoni tagħha għallawtorizzazzjoni għat-tqegħid fis-suq għal Elmisol, għall-kura ta' sidnrome nefrotiku.
English: Based on the review of the data, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Elmisol could not have been approved for the treatment of nephrotic syndrome.
Maltese: Fuq il-bażi tar-reviżjoni tad-data, fiż-żmien tal-irtirar, is-CHMP kellu xi tħassib u kien tal-opinjoni provviżorja li Elmisol ma setax jiġi approvat għall-kura ta' sindrome nefrotiku.
English: The main study compared levamisole with placebo (a dummy treatment) in children with nephrotic syndrome that had been brought under control with corticosteroids.
Maltese: L-istudju ewlieni qabbel levamisole mal-plaċebo (kura finta) fi tfal b'sindrome nefrotiku li kien inżamm taħt kontroll bil-kortikosterojdi.
English: What were the reasons given by the company for withdrawing the application?
Maltese: -raġunijiet mogħtija mill-kumpanija għall-irtirar tal applikazzjoni?
English: Suppressing the immune system with corticosteroid medicines can bring the disease under control, but these medicines can have marked side effects and affect growth in young patients.
Maltese: Is-soppressjoni tas-sistema immuni bil-mediċini kortikosterojdi tista' żżomm il-marda taħt kontroll, iżda dawn il-mediċini jistgħu jkollhom effetti sekondarji kbar u jaffettwaw l-iżvilupp f'pazjenti żgħar.
English: In patients with nephrotic syndrome, the immune system is believed to attack the kidney in error, resulting in leakage of proteins out of the kidney into urine.
Maltese: F'pazjenti b'sindrome nefrotiku, huwa mifhum li s-sistema immuni tattakka lill-kliewi bi żball, b'hekk\ tirriżulta fi tnixxija talproteini barra mill-kliewi għal ġol-awrina.
English: Target species Route of administration
Maltese: Mod ta' Amministraz zjoni
English: Invented name Strength Pharmaceutical
Maltese: Prodott mediċinali li m'għadux awtorizzat għandu jintuża l-prodott
English: Page 1/1
Maltese: Paġna 1/1
English: EU Number
Maltese: Daqs talpakkett
English: ¹ Human Papillomavirus = HPV
Maltese: ¹ Papillomavirus Uman = HPV
English: 10 syringes
Maltese: 10 siringi
English: ³ adsorbed on amorphous aluminium hydroxyphosphate sulphate adjuvant (0.5 milligrams Al)
Maltese: ³ adsorbit fuq aluminium hydroxyphosphate sulphate amorfu awżiljari (0.5 milligrammi Al)
English: ² L1 protein in the form of virus-like particles produced in yeast cells (Saccharomyces cerevisiae CANADE 3C-5 (Strain 1895)) by recombinant DNA technology
Maltese: ² proteina L1 f'għamla ta' partiċelli qishom virus magħmula f'ċelluli tal-ħmira (Saccharomyces cerevisiae CANADE 3C-5 (Razza 1895)) permezz ta' teknoloġija rikombinanti tad-DNA
English: 10 syringes + 20 needles
Maltese: 10 siringi + 20 labra
English: --1 1 dose (0.5 ml) contains approximately:
Maltese: --1 Doża waħda (0.5 ml) fiha madwar:
English: Pack size vial (glass)
Maltese: Daqs tal-pakkett kunjett (ħġieġ)
English: 1 syringe + 2 needles
Maltese: kunjett wieħed siringa waħda + 2 labriet
English: Two
Maltese: Żewġ
English: 18 December 2018
Maltese: 18 ta' Diċembru 2018
English: The Agency concluded that the benefits of Perlinring outweigh its risks, and the marketing authorisation can be granted in the United Kingdom and in the following Member States of the EU: Austria, Belgium, Croatia, Czech Republic, Denmark, Estonia, Spain, Finland, France, Germany, Hungary, Ireland, Italy, Lithuania, Latvia, the Netherlands, Poland, Portugal, Romania, Slovenia, Slovakia and Sweden, plus Iceland and Norway.
Maltese: L-Awstrija, il-Belġju, il-Kroazja, ir-Repubblika Ċeka, idDanimarka, l-Estonja, Spanja, il-Finlandja, Franza, il-Ġermanja, l-Ungerija, l-Irlanda, l-Italja, ilLitwanja, il-Latvja, in-Netherlands, il-Polonja, il-Portugall, ir-Rumanija, is-Slovenja, is-Slovakkja u lIżvezja, flimkien mal-Iżlanda u n-Norveġja.
English: What is Perlinring?
Maltese: X'inhu Perlinring?
English: Perlinring was developed as a generic medicine.
Maltese: Perlinring ġie żviluppat bħala mediċina ġenerika.
English: On 18 October 2018, the European Medicines Agency completed a review of Perlinring following a disagreement among EU Member States regarding its authorisation.
Maltese: Fit-18 ta' Ottubru 2018, l-Aġenzija Ewropea għall-Mediċini lestiet rieżami ta' Perlinring wara nuqqas ta' qbil fost l-Istati Membri tal-UE dwar l-awtorizzazzjoni tiegħu.
English: Actavis Group PTC EHF submitted Perlinring to the UK medicines agency for a decentralised procedure.
Maltese: Actavis Group PTC EHF ippreżenta Perlinring lill-aġenzija għall-mediċini tar-Renju Unit għal proċedura deċentralizzata.
English: The European Commission issued an EU-wide legally binding decision on 18 December 2018.
Maltese: Il-Kummissjoni Ewropea ħarġet deċiżjoni legalment vinkolanti mal-UE kollha fit-18 ta' Diċembru 2018.
English: The review of Perlinring was initiated at the request of the United Kingdom, under Article 29 of Directive 2001/83/EC.
Maltese: Ir-rieżami ta' Perlinring inbeda fuq talba tar-Renju Unit, skont l-Artikolu 29 tad-Direttiva 2001/83/KE.
English: Bioequivalence data for week 4 were considered necessary by Germany, France and the Netherlands as Perlinring is expected to be used in the same way as Nuvaring.
Maltese: Id-data dwar il-bijoekwivalenza għal ġimgħa 4 tqieset bħala meħtieġa mill-Ġermanja, Franza u nNetherlands peress li Perlinring huwa mistenni li jintuża bl-istess mod bħal Nuvaring.
English: In its application, the company for Perlinring provided data demonstrating that Perlinring is ‘bioequivalent' to Nuvaring over a period of 3 weeks, which is the authorised length of treatment.
Maltese: Fl-applikazzjoni tagħha, il-kumpanija għal Perlinring ipprovdiet data li turi li Perlinring huwa "bijoekwivalenti" għal Nuvaring fuq perjodu ta' 3 ġimgħat, li huwa t-tul ta' kura awtorizzat.