FrancophonIA/ELRC3.0 huggingface dataset:
English: The European Commission granted a marketing authorisation valid throughout the European Union for Lixiana on 19 June 2015.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Lixiana fid-19 ta' Ġunju 2015.
English: The most common side effects with Lixiana (which may affect up to 1 in 10 people) are bleeding from skin and soft tissues, nose bleeds (epistaxis) and the vagina.
Maltese: L-effetti sekondarji l-aktar komuni b'Lixiana (li jistgħu jaffettwaw sa persuna 1 minn kull 10) huma fsada mill-ġilda u mit-tessuti rotob, fsada mill-imnieħer (epistassi) u l-vaġina.
English: How does Lixiana work?
Maltese: Kif jintuża Lixiana?
English: What measures are being taken to ensure the safe and effective use of Lixiana?
Maltese: X'miżuri qegħdin jitteħdu biex jiġi żgurat l-użu sigur u effettiv ta' Lixiana?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Lixiana's benefits are greater than its risks and recommended that it be approved for use in the EU.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) iddeċieda li l-benefiċċji ta' Lixiana huma akbar mir-riskji tiegħu u rrakkomanda li jkun approvat għall-użu fl-UE.
English: Ref.: EMEA/487740/2009 EMEA/H/C/1059
Maltese: EMEA/487731/2009 EMEA/H/C/1059
English: Grepid is a ‘generic medicine'.
Maltese: Grepid huwa ‘mediċina ġenerika'.
English: Grepid clopidogrel EPAR summary for the public
Maltese: Grepid clopidogrel Sommarju tal-EPAR għall-pubbliku
English: The European Commission granted a marketing authorisation valid throughout the EU for Grepid to Pharmathen S.A. on 28 July 2009.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Grepid, valida fl-Unjoni Ewropea kollha, lil Pharmathen S.A. fil-28 ta' Lulju 2009.
English: What are the benefit and risk of Grepid?
Maltese: X'inhu l-benefiċċju u r-riskju ta' Grepid?
English: The active substance in Grepid, clopidogrel, is an inhibitor of platelet aggregation.
Maltese: Is-sustanza attiva f'Grepid, clopidogrel, hu inibitur ta' l-aggregazzjoni tal-pjastrini (platelets).
English: • patients with peripheral arterial disease (problems with blood flow in the arteries).
Maltese: • pazjenti b'mard fl-arterji periferiku (problemi bil-fluss tad-demm fl-arterji).
English: Grepid is a medicine that contains the active substance clopidogrel.
Maltese: Grepid huwa mediċina li fih s-sustanza attiva clopidogrel.
English: What is Grepid?
Maltese: X'inhu Grepid?
English: This means that Grepid is similar to a ‘reference medicine' already authorised in the European Union (EU) called Plavix.
Maltese: Dan ifisser li Grepid huwa simili għall-‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) bl-isem Plavix.
English: Grepid is used in adults to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries).
Maltese: Grepid jintuża f'adulti biex jipprevjeni każijiet aterotrombotiċi (problemi li jirriżultaw minn demm magħqud u t-twebbis tal-arterji).
English: Because Grepid is a generic medicine, studies have been limited to tests to determine that it is bioequivalent to the reference medicine, Plavix.
Maltese: Billi Grepid huwa mediċina ġenerika, l-istudji ġew limitati għal testitjiet biex jiddeterminaw ilbijoekwivalenza tiegħu mal-mediċina ta' referenza, Plavix.
English: Grepid can be given to the following groups of patients:
Maltese: Grepid jista' jingħata lill-gruppi ta' pazjenti li ġejjin:
English: Because Grepid is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.
Maltese: Billi Grepid huwa mediċina ġenerika u huwa bijoekwivalenti għall-mediċina ta' referenza, ilbenefiċċji u r-riskji jitqiesu li kienu l-istess bħal dawk tal-mediċina ta' referenza.
English: The standard dose of Grepid is one 75 mg tablet once a day, taken with or without food.
Maltese: Id-doża standard ta' Grepid hija ta' pillola waħda ta' 75 mg darba kuljum, ma' l-ikel jew fuq stonku vojt.
English: Other information about Grepid:
Maltese: Aktar tagħrif dwar Grepid:
English: The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Grepid has been shown to have comparable quality and to be bioequivalent to Plavix.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) ikkonkluda li, b'mod konformi mar-rekwiżiti tal-UE, Grepid wera li għandu kwalità komparabbli ma' u huwa bijoekwivlenti għal Plavix.
English: How has Grepid been studied?
Maltese: Kif ġie studjat Grepid?
English: Why has Grepid been approved?
Maltese: Għaliex ġie approvat Grepid?
English: Therefore, the CHMP's view was that, as for Plavix, the benefit outweighs the identified risk.
Maltese: Għaldaqstant, il-fehma tas-CHMP kienet li, bħal fil-każ ta' Plavix, il-benefiċċji huwa akbar mir-riskji identifikati.
English: • patients who have had a recent ischaemic stroke (stroke caused by failure of the blood supply to part of the brain).
Maltese: • pazjenti li reċentement tathom puplessija iskemika (puplesija kkawżata minn inkapaċità tal provvista tad-demm li tissupplixxi parti mill-moħħ).
English: The full EPAR for Zalmoxis 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 summary of the opinion of the Committee for Orphan Medicinal Products for Zalmoxis can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Maltese: Is-sommarju tal-opinjoni tal-Kumitat għall-Prodotti Mediċinali Orfni għal Zalmoxis jinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: Other information about Zalmoxis
Maltese: Informazzjoni oħra dwar Zalmoxis
English: This is a summary of the European public assessment report (EPAR) for Zalmoxis.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Zalmoxis.
English: The number of patients who survived after one year was 51% for patients who received Zalmoxis compared with 34 to 40% for patients who did not receive Zalmoxis.
Maltese: In-numru ta' pazjenti li għexu wara sena kien ta' 51 % għallpazjenti li rċevew Zalmoxis meta mqabbla ma' 34 sa 40 % għal pazjenti li ma rċevewx Zalmoxis.
English: 77% of the patients receiving Zalmoxis (23 out of 30) had their immune systems restored.
Maltese: Is-sistema immuni ta' 77 % tal-pazjenti li rċevew Zalmoxis (23 minn 30) treġġgħet lura.
English: Why is Zalmoxis approved?
Maltese: Għaliex ġie approvat Zalmoxis?
English: Zalmoxis has been investigated in a main study involving 30 patients who had haploidentical HSCT for serious blood cancers.
Maltese: Zalmoxis ġie investigat fi studju ewlieni li involva 30 pazjent li kellhom HSCT aploidentiku għal kanċers serji tad-demm.
English: Zalmoxis has been given ‘conditional approval'.
Maltese: Zalmoxis ingħata ‘approvazzjoni b'kundizzjoni'.
English: Data from the main study were also combined with data from a second ongoing study, and survival rates for 37 patients treated with Zalmoxis (23 from the main study and 14 from the ongoing study) were compared with rates from a patient database of 140 patients who have undergone haploidentical HSCT in the past.
Maltese: Id-data mill-istudju ewlieni kienet ikkombinata wkoll mad-data mit-tieni studju li għadu għaddej, u rrati ta' sopravivenza minn 37 pazjent ikkurati b'Zalmoxis (23 mill-istudju ewlieni u 14 mill-istudju li għadu għaddej) kienu mqabbla mar-rati minn bażi tad-data tal-pazjenti ta' 140 pazjent li għaddew minn HSCT aploidentiku fil-passat.
English: Because the number of patients undergoing haploidentical HSCT is low, Zalmoxis was designated an ‘orphan medicine' (a medicine used in rare diseases) on 20 October 2003.
Maltese: Peress li n-numru ta' pazjenti li għaddejjin minn HSCT aploidentiku huwa wieħed baxx, Zalmoxis ġie kklassifikat bħala "mediċina orfni" (mediċina li tintuża f'mard rari) fl-20 ta' Ottubru 2003.
English: Zalmoxis is given as an infusion (drip) into a vein lasting 20 to 60 minutes, every month for up to four months until the circulating T cells reach a certain level.
Maltese: Zalmoxis jingħata bħala infużjoni (dripp) ġol-vina li ddum minn 20 sa 60 minuta, kull xahar sa erba' xhur sakemm iċ-ċelloli T li jiċċirkolaw jilħqu ċertu livell.
English: What are the risks associated with Zalmoxis?
Maltese: X'inhuma r-riskji assoċjati ma' Zalmoxis?
English: What information is still awaited for Zalmoxis?
Maltese: Liema informazzjoni għadha mistennija għal Zalmoxis?
English: When using Zalmoxis, this can be treated with ganciclovir or valganciclovir.
Maltese: Meta tuża Zalmoxis, dan jista' jiġi kkurat b'ganciclovir jew valganciclovir.
English: Zalmoxis is a medicine used as an add-on treatment in adults who have received a haematopoietic stem cell transplant (HSCT, a transplant of cells that can develop into different types of blood cells) from a partially matched donor (a so-called haploidentical transplant).
Maltese: Zalmoxis huwa mediċina użata bħala kura addizzjonali fl-adulti li rċevew trapjant taċ-ċelloli staminali ematopojetiċi (HSCT, trapjant ta' ċelloli li jistgħu jiżviluppaw f'tipi differenti ta' ċelloli tad-demm) minn donatur imqabbel parzjalment ('l hekk imsejjaħ trapjant aploidentiku).
English: The study will compare haploidentical HSCT followed by treatment with Zalmoxis with haploidentical HSCT containing T cells followed by treatment with cyclophosphamide (a medicine to prevent graft-versus-host disease) and with haploidentical HSCT without T cells.
Maltese: L-istudju se jqabbel l-HSCT aploidentiku segwit minn kura b'Zalmoxis bl-HSCT aploidentiku li fih iċ-ċelloli T segwit minn kura b'cyclophosphamide (mediċina li tipprevjeni l-marda tat-trapjant kontra lospitu) u bl-HSCT aploidentiku mingħajr ċelloli T.
English: Zalmoxis contains T cells (a type of white blood cell) that have been genetically modified1.
Maltese: Zalmoxis fih iċ-ċelloli T (tip ta' ċellola bajda tad-demm) li ġew ġenetikament modifikati1.
English: It is given 21 to 49 days after transplantation, but only if the transplant has not already restored the patient's immune system and if the patient has not developed graft-versus-host disease (when transplanted cells attack the body).
Maltese: Dan jingħata minn 21 sa 49 jum wara t-trapjant, imma jingħata biss jekk it-trapjant ma jkunx diġà reġġa' lura s-sistema immuni tal-pazjent u jekk ilpazjent ma żviluppax il-marda tat-trapjant kontra l-ospitu (meta ċ-ċelloli trapjantanti jattakkaw ilġisem).
English: The safety profile of Zalmoxis is considered acceptable.
Maltese: Ilprofil tas-sigurtà ta' Zalmoxis huwa kkunsidrat aċċettabbli.
English: Zalmoxis is a type of advanced therapy medicine called a ‘somatic cell therapy product'.
Maltese: Zalmoxis huwa tip ta' mediċina terapewtika avvanzata msejħa “prodott terapewtiku ta' ċellola somatika”.
English: The company that markets Zalmoxis will provide educational material for healthcare professionals with detailed information on the risks, including graft-versus-host disease, and how to use the medicine correctly.
Maltese: Il-kumpanija li tqiegħed Zalmoxis fis-suq se tipprovdi materjal edukattiv għal professjonisti tal-kura tas-saħħa b'informazzjoni dettaljata dwar ir-riskji, inkluż il-marda tat-trapjant kontra l-ospitu, u kif għandek tuża l-mediċina sew.
English: The most common side effect with Zalmoxis (which may affect more than 1 in 10 people) is acute graft-versus-host disease (where the condition develops within approximately 100 days of the transplant).
Maltese: L-aktar effett sekondarju komuni b'Zalmoxis (li jista' jaffettwa aktar minn persuna 1 minn kull 10) huwa l-marda akuta tat-trapjant kontra l-ospitu (fejn il-kundizzjoni tiżviluppa f'bejn wieħed u ieħor 100 jum mit-trapjant).
English: Zalmoxis
Maltese: Kif jintuża Zalmoxis?
English: For the full list of restrictions and side effects reported with Zalmoxis, see the package leaflet.
Maltese: Għal-lista sħiħa tar-restrizzjonijiet u tal-effetti sekondarji kollha rrappurtati b'Zalmoxis, ara l-fuljett ta' tagħrif.
English: Zalmoxis is used in patients who have received a haploidentical HSCT because they have serious blood cancers, such as certain leukaemias and lymphomas.
Maltese: Zalmoxis huwa użat f'pazjenti li rċevew HSCT aploidentiku minħabba li għandhom kanċers serji tad-demm, bħal-lewkimja u limfoma.
English: Since Zalmoxis has been granted a conditional approval, the company that markets Zalmoxis will provide the results of an ongoing study in high-risk acute leukaemia patients.
Maltese: Id-doża ta' Zalmoxis tiddependi fuq il-piż talġisem tal-pazjent.
English: To make Zalmoxis, T cells from the HSCT donor are separated from the rest of the cells in the transplant.
Maltese: Sabiex isir Zalmoxis, iċ-ċelloli T mid donatur tal-HSCT huma separati mill-bqija taċ-ċelloli fit-trapjant.
English: Pandemic influenza vaccine H5N1 AstraZeneca contains live, attenuated (weakened) influenza A virus A/Vietnam/1203/2004 (H5N1) strain.
Maltese: It-tilqima kontra l-influwenza Pandemika H5N1 AstraZeneca fiha razza ħajja, attenwata (imdgħajfa) tal-virus A tal-influwenza A/Vietnam/1203/2004 (H5N1).
English: The full EPAR for Pandemic influenza vaccine H5N1 AstraZeneca 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: In those who received the second vaccine 3 weeks to 5 years after vaccination with Pandemic influenza vaccine H5N1 AstraZeneca, antibodies increased 4-fold in 73% (8 out of 11) of the individuals compared with 10% of the individuals who had not been previously vaccinated with Pandemic influenza vaccine H5N1 AstraZeneca.
Maltese: F'dawk li rċevew it-tieni tilqima 3 ġimgħat sa 5 snin wara t-tilqim bit-tilqima kontra l-influwenza Pandemika H5N1 AstraZeneca, l-antikorpi żdiedu b'4 darbiet f'73% (8 minn kull 11) tal-individwi meta mqabbla ma' 10% tal-individwi li ma kinux irċevew tilqim preċedenti bit-tilqima kontra l-influwenza Pandemika H5N1 AstraZeneca.
English: The results were similar to those from three other studies involving 170 adults given pandemic preparedness vaccines containing similar types of bird flu virus, such as H7N9 and H7N7, instead of H5N1.
Maltese: Ir-riżultati kienu simili għal dawk minn tliet studji oħra li fihom ħadu sehem 170 adult li ingħataw tilqim bi tħejjija għal pandemija li kien fihom tipi simili ta' virus tal-influwenza avarja, bħal H7N9 u H7N7, minflok H5N1.
English: The name of the medicine was changed to Pandemic influenza vaccine H5N1 AstraZeneca on 24 May 2017.
Maltese: L-isem tal-mediċina inbidel u sar tilqima kontra l-influwenza Pandemika H5N1 AstraZeneca fl-24 ta' Mejju 2017.
English: In addition, there is evidence indicating that the vaccine can protect against different strains of H5N1 virus.
Maltese: Barra minn hekk, hemm evidenza li tindika li l-vaċċin jista' jipproteġi kontra razez differenti tal-virus H5N1.
English: However, a second vaccine that acts in a different way is able to make antibodies that can be measured easily.
Maltese: Madankollu, it-tieni tilqima li taġixxi b'mod differenti hija kapaċi tagħmel antikorpi li jistgħu jitkejlu faċilment.
English: Previously known as Pandemic influenza vaccine H5N1 MedImmune
Maltese: Preċedentement magħrufa bħala Tilqima kontra l-influwenza Pandemika H5N1 MedImmune
English: Three main studies involving 107 adults found that Pandemic influenza vaccine H5N1 AstraZeneca was able to prepare the immune system to defend itself against the H5N1 virus strain in individuals who had never come into contact with it. Antibodies against this type of vaccine are not easy to measure.
Maltese: Tliet studji ewlenin li fihom ħadu sehem 107 adulti sabu li t-tilqima kontra l-influwenza Pandemika H5N1 AstraZeneca kienet kapaċi tipprepara s-sistema immunitarja biex tiddefendi lilha nnifisha kontra r-razza tal-virus H5N1 f'individwi li qatt ma kienu ġew f'kuntatt magħha.
English: Pandemic influenza vaccine H5N1 AstraZeneca must not generally be given to children who have had a severe allergic reaction to any of the substances in the vaccine including gelatin and gentamicin or to children who have had a severe allergic reaction to eggs or egg proteins, such as ovalbumin.
Maltese: Ġeneralment it-tilqima kontra l-influwenza Pandemika H5N1 AstraZeneca ma għandhiex tingħata lil tfal li kellhom reazzjoni allerġika severa għal kwalunkwe sustanza fil-vaċċin inkluż il-ġelatina u gentamicin jew lil tfal li kellhom reazzjoni allerġika severa għall-bajd jew għall-proteini tal-bajd, bħal ovalbumina.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Pandemic influenza vaccine H5N1 MedImmune on 20 May 2016.
Maltese: Il-Kummissjoni Ewropea tat l-awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għall-vaċċin tal-Influwenza Pandemika H5N1 MedImmune fl-20 ta' Mejju 2016.
English: Pandemic influenza vaccine H5N1 AstraZeneca is a vaccine developed to protect children aged between 12 months and 18 years against influenza (flu) during a flu pandemic.
Maltese: It-tilqima kontra l-influwenza Pandemika H5N1 AstraZeneca hija tilqima li ġiet żviluppata biex tipproteġi lit-tfal ta' bejn it-12-il xahar u t-18-il sena kontra l-influwenza waqt pandemija talinfluwenza.
English: Pandemic influenza vaccine H5N1 AstraZeneca has been given ‘conditional approval'.
Maltese: It-tilqima kontra l-influwenza Pandemika H5N1 AstraZeneca ngħatat ‘approvazzjoni b'kondizzjoni'.
English: Since Pandemic influenza vaccine H5N1 AstraZeneca has been granted a conditional approval, the company that markets Pandemic influenza vaccine H5N1 AstraZeneca will conduct studies to gather more information on its effectiveness and side effects during its use in a pandemic as well as its shelf life.
Maltese: Peress li t-tilqima kontra l-influwenza Pandemika H5N1 AstraZeneca ingħatat approvazzjoni b'kondizzjoni, il-kumpanija li tqiegħed it-tilqima kontra l-influwenza Pandemika H5N1 AstraZeneca fissuq se twettaq studji biex tinġabar aktar informazzjoni dwar l-effikaċja u l-effetti sekondarji tagħha matul l-użu tagħha f'pandemija kif ukoll il-perjodu ta' stabilità tagħha.
English: This is a summary of the European public assessment report (EPAR) for Pandemic influenza vaccine H5N1 AstraZeneca.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għat-tilqima kontra linfluwenza Pandemika H5N1 AstraZeneca.
English: Other information about Pandemic influenza vaccine H5N1 AstraZeneca
Maltese: Informazzjoni oħra dwar it-tilqima kontra l-influwenza Pandemika H5N1 AstraZeneca
English: What are the risks associated with Pandemic influenza vaccine H5N1 AstraZeneca?
Maltese: Kif taħdem it-tilqima kontra l-influwenza Pandemika H5N1 AstraZeneca?
English: In addition, the company presented extensive supportive data from large studies and from clinical practice on how well other similar pandemic and seasonal live attenuated influenza A vaccines work in children.
Maltese: Dan huwa ulterjorment appoġġjat minn data fi tfal li ngħataw vaċċini ħajjin attenwati staġjonali u pandemiċi simili kontra l-influwenza fi studji kbar u fil-prattika klinika.
English: The most common side effects with Pandemic influenza vaccine H5N1 AstraZeneca (which may affect more than 1 in 10 people) are decreased appetite, headache, runny or stuffy nose, and feeling unwell.
Maltese: L-effetti sekondarji l-aktar komuni bit-tilqima kontra l-influwenza Pandemika H5N1 AstraZeneca (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 10) huma tnaqqis fl-aptit, uġigħ ta' ras, imnieħer inixxi jew misdud, u tħossok ma tiflaħx.
English: How is Pandemic influenza vaccine H5N1 AstraZeneca used?
Maltese: Pandemika H5N1 AstraZeneca?
English: pandemic influenza vaccine (H5N1) (live attenuated, nasal)
Maltese: Sommarju tal-EPAR għall-pubbliku tilqima kontra l-influwenza pandemika (H5N1) (ħajja attenwata, għallimnieħer)
English: A vaccine against a specific disease ‘teaches' the immune system (the body's natural defences) to defend itself against the disease.
Maltese: Tilqima kontra marda speċifika ‘tgħallem' lis-sistema immunitarja (id-difiżi naturali tal-ġisem) kif tiddefendi ruħha kontra l-marda.
English: Instead, a pandemic preparedness vaccine can be made to contain a bird flu virus strain that could potentially cause a future pandemic.
Maltese: Mhuwiex possibbli li tipprepara tilqima għal pandemija futura minħabba li r-razza tal-virus talinfluwenza pandemika ma tkunx magħrufa minn qabel.
English: However, in a pandemic, it might be appropriate to give it to children with allergies if facilities for medical treatment of severe allergic reactions are immediately available.
Maltese: Madankollu, f'pandemija, jista' jkun xieraq li tingħata lil tfal b'allerġiji jekk ikun hemm faċilitajiet immedjatament disponibbli għall-kura medika ta' reazzjonijiet allerġiċi severi.
English: The dose is one spray (0.1 ml) into each nostril.
Maltese: Id-doża hija ta' sprejjatura waħda (0.1 ml) f'kull minfes.
English: Pandemic influenza vaccine H5N1 AstraZeneca is a pandemic preparedness vaccine.
Maltese: It-tilqima kontra l-influwenza Pandemika H5N1 AstraZeneca hija tilqima bi tħejjija għal pandemija.
English: For the full list of all side effects reported with Pandemic influenza vaccine H5N1 AstraZeneca, see the package leaflet.
Maltese: It-tilqima kontra l-influwenza Pandemika H5N1 AstraZeneca tiġi bħala sprej għall-imnieħer.
English: • hypertension;
Maltese: • ipertensjoni;
English: Plendil has been approved through national procedures in the following countries in the European Economic Area (EEA): Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Spain, Sweden and the United Kingdom.
Maltese: Plendil ġie approvat permezz ta' proċeduri nazzjonali fil-pajjiżi li ġejjin fiż-Żona Ekonomika Ewropea (ŻEE): L-Awstrija, il-Belġju, il-Bulgarija, il-Kroazja, Ċipru, ir-Repubblika Ċeka, idDanimarka, l-Estonja, il-Finlandja, Franza, il-Ġermanja, il-Greċja, l-Ungerija, l-Islanda, l-Irlanda, lItalja, il-Latvja, il-Litwanja, il-Lussemburgu, Malta, il-Pajjiżi l-Baxxi, in-Norveġja, il-Polonja, ilPortugall, ir-Rumanija, is-Slovakkja, Spanja, l-Isvezja u r-Renju Unit.
English: • stable angina pectoris.
Maltese: • anġina pectoris stabbli.
English: − UK/W/002/pdWS/001 Article 45 Paediatric Workshare, finalised 15 October 2009.
Maltese: − UK/W/002/pdWS/001 Article 45 Paediatric Workshare, iffinalizzata fil-15 ta' Ottubru 2009.
English: This method generates the Empirical Bayesian Geometric Mean (EBGM) with a 90% confidence interval (EB05 to EB95).
Maltese: Dan il-metodu jiġġenera l-Medja Ġeometrika Bajesjana Empirika (EBGM) b'intervall ta' fiduċja ta' 90 % (EB05 sa EB95).
English: The prolonged release tablet is available in three tablet strengths 2.5mg, 5mg and 10mg.
Maltese: Il-pillola ta' rilaxx bil-mod tiġi fi tliet qawwiet tal-pillola 2.5 mg, 5 mg u 10 mg.
English: The CHMP requested some additional wordings.
Maltese: Is-CHMP talab xi formulazzjonijiet addizzjonali.
English: Plendil was originally approved for marketing in Denmark on 16 March 1987, as an immediate release tablet.
Maltese: Plendil kien oriġinarjament approvat għat-tqegħid fis-suq fid-Danimarka fis-16 ta' Marzu 1987, bħala pillola ta' rilaxx immedjat.
English: − SK/H/PSUR/0006/001, PSUR (01 Jan 2007 to 31 Dec 2009), finalised 20 October 2011 with agreed Core Safety Profile (CSP).
Maltese: − SK/H/PSUR/0006/001, PSUR (1 ta' Jannar 2007 sal-31 ta' Diċembru 2009), iffinalizzata fl20 ta' Ottubru 2011 bi Profil tas-Sigurtà Ewlieni (CSP) maqbul.
English: The proposal for the harmonised EU SmPC is based on the CPS from 2011 and CDS from October 2012.
Maltese: Il-proposta għall-SmPC armonizzat tal-UE hija bbażata fuq is-CPS mill-2011 u s-CDS minn Ottubru 2012.