FrancophonIA/ELRC3.0 huggingface dataset:
English: Mometasone Furoate Sandoz is a medicine that contains the active substance mometasone furoate.
Maltese: Mometasone Furoate Sandoz huwa mediċina li fiha s-sustanza attiva furoate mometasone.
English: Sandoz B.V. submitted an application for Mometasone Furoate Sandoz to the Dutch medicines regulatory agency for a decentralised procedure.
Maltese: Sandoz B.V. issottometta applikazzjoni għal Mometasone Furoate Sandoz lill-aġenzija regolatorja talmediċini Olandiża għal proċedura deċentralizzata.
English: What is Mometasone Furoate Sandoz?
Maltese: X'inhu Mometasone Furoate Sandoz?
English: The ‘reference medicine' for Mometasone Furoate Sandoz is called Nasonex.
Maltese: Il-‘mediċina ta' referenza' għal Mometasone Furoate Sandoz hija magħrufa bħala Nasonex.
English: On 19 July 2012, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Mometasone Furoate Sandoz.
Maltese: Fid-19 ta' Lulju 2012, l-Aġenzija Ewropea għall-Mediċini temmet proċedura ta' arbitraġġ wara nuqqas ta' qbil fost l-Istati Membri tal-Unjoni Ewropea (UE) dwar l-awtorizzazzjoni tal-mediċina Mometasone Furoate Sandoz.
English: Mometasone Furoate Sandoz is used in adults and children from six years of age to treat the symptoms of seasonal allergic or perennial rhinitis (inflammation of the nasal passages caused by an allergy such as hay fever, or which occurs throughout the year).
Maltese: Jinstab bħala sprej għall-imnieħer. Mometasone Furoate Sandoz jintuża fl-adulti u fit-tfal minn 6 snin ta' età għall-kura tas-sintomi ta' rinite allerġika jew perenni staġjonali (infjammazzjoni tal-passaġġi talimnieħer ikkawżata minn allerġija bħal riħ tal-ħuxlief (hay fever), jew li sseħħ matul is-sena).
English: However, the Member States were not able to reach an agreement, and the Spanish medicines regulatory agency referred the matter to the CHMP for arbitration on 23 February 2012.
Maltese: Madankollu, l-Istati Membri ma setgħux jilħqu qbil, u l-aġenzija regolatorja tal-mediċini Spanjola rriferiet il-kwistjoni lis-CHMP għall-arbitraġġ fit-23 ta' Frar 2012.
English: It works by attaching to receptors in various types of immune cells, leading to a reduction in the release of substances that are involved in the inflammation process, and thereby reducing the symptoms of allergy.
Maltese: Taħdem billi teħel ma' riċetturi f'diversi tipi ta' ċelloli immuni, li twassal għal tnaqqis fir-rilaxx ta' sustanzi involuti fil-proċess ta' infjammazzjoni, u b'hekk tnaqqas is-sintomi tal-allerġija.
English: This means that it is similar to a ‘reference medicine' already authorised in the EU that contains the same active substance, but which is given using a different type of nasal spray device.
Maltese: Dan ifisser li huwa simili għal ‘mediċina ta' referenza' diġà awtorizzata fl-UE li fiha l-istess sustanza attiva, imma li tingħata permezz ta' tip differenti ta' apparat tal-isprej għall-imnieħer.
English: The grounds for the referral were concerns over the type of in vitro (experimental) studies carried out to demonstrate that Mometasone Furoate Sandoz is comparable to Nasonex (that it produces the same levels of the active substance in the nose as Nasonex).
Maltese: Ir-raġunijiet għar-riferiment kien it-tħassib dwar it-tip ta' studji in vitro (sperimentali) li twettqu biex juru li Mometasone Furoate Sandoz huwa komparabbli ma' Nasonex (li jipproduċi l-istess livelli tassustanza attiva fl-imnieħer bħala Nasonex).
English: Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP recognised some of the concerns of the Spanish agency, but concluded that overall it was sufficiently demonstrated that possible differences between Mometasone Furoate Sandoz and the reference medicine would not affect the benefit-risk balance of the product, taking into account all the in vitro data.
Maltese: Barra minn hekk, id-dejta minn studju kliniku ipprovdiet evidenza addizzjonali li Mometasone Furoate Sandoz sprej għall-imnieħer jaħdem tajjeb daqs Nasonex sprej għall-imnieħer fil-pazjenti.
English: The CHMP therefore concluded that the benefits of Mometasone Furoate Sandoz outweigh its risks and recommended that the marketing authorisation be granted in the concerned Member States.
Maltese: Is-CHMP għalhekk ikkonkluda li l-benefiċċji ta' Mometasone Furoate Sandoz huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq fl-Istati Membri kkonċernati.
English: EMA/82654/2015 EMEA/H/C/000408
Maltese: EMEA/H/C/000408
English: Inductos dibotermin alfa
Maltese: Inductos dibotermina alfa
English: The full EPAR for Inductos 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: • patients with an active infection at the surgery site;
Maltese: • pazjenti b'infezzjoni attiva fis-sit tal-intervent kirurġiku;
English: After two years, 57% of the patients treated with Inductos (69 out of 122) had responded to treatment, compared with 59% of the patients treated with a bone graft (78 out of 133).
Maltese: Wara sentejn, 57% tal-pazjenti kkurati b'Inductos (69 minn 122) kienu rrispondew għall-kura, meta mqabbla ma' 59% tal-pazjenti kkurati bi trapjant tal-għadam (78 minn 133).
English: It is a copy of a protein called bone morphogenetic protein 2 (BMP-2), which is produced naturally by the body and helps with the formation of new bone tissue.
Maltese: Din hija kopja ta' proteina msejħa proteina-2 morfoġenika tal-għadam (bone morphogenetic protein 2), (BMP-2)) li tiġi prodotta mill-ġisem b'mod naturali u tgħin fil-formazzjoni ta' tessut tal-għadam ġdid.
English: This is a summary of the European public assessment report (EPAR) for Inductos.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Inductos.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Inductos on 9 September 2002.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Inductos valida fl-Unjoni Ewropea kollha fid-9 ta' Settembru 2002.
English: Dibotermin alfa is produced by a method known as ‘recombinant DNA technology': it is made by cells that have received a gene (DNA) which makes them able to produce dibotermin alfa.
Maltese: Id-dibotermina alfa tiġi prodotta b'metodu magħruf bħala ‘teknoloġija tad-DNA rikombinanti': hija magħmula minn ċelluli li jkunu rċevew ġene (DNA) li jagħmilha kapaċi tipproduċi d-dibotermina alfa.
English: Inductos is a kit for implant.
Maltese: Inductos huwa kitt għal impjant.
English: Inductos was compared with standard care.
Maltese: Inductos tqabbel mal-kura standard.
English: The kit consists of a powder containing the active substance, dibotermin alfa, a solvent and a matrix (collagen sponge).
Maltese: Il-kitt jikkonsisti fi trab li fih is-sustanza attiva, dibotermina alfa, f'solvent u f'matriċi (sponża tal-kollaġene).
English: Inductos should be used by a qualified surgeon.
Maltese: Inductos għandu jintuża minn kirurgu kkwalifikat.
English: The most common side effects with Inductos (seen in more than 1 patient in 10) are radiculopathic events (problems occurring at or near the root of the nerve, along the spine, resulting in pain, weakness, numbness, or difficulty controlling specific muscles) when used in spine surgery, and localised infection when used in tibia fracture surgery.
Maltese: L-effetti sekondarji l-aktar komuni b'Inductos (li dehru f'aktar minn pazjent 1 minn kull 10) huma avvenimenti radikulopatiċi (problemi li jseħħu fl-għerq tan-nerv jew ħdejh, tul l-ispina tad-dahar, li jirriżultaw f'uġigħ, dgħjufija, tnemnim, jew diffikultà fil-kontroll ta' muskoli speċifiċi) meta jintuża f'intervent kirurġiku tal-ispina tad-dahar, u infezzjoni lokalizzata meta jintuża f'intervent kirurġiku talksur tat-tibja.
English: Inductos has been studied in 450 patients with a fractured tibia.
Maltese: Inductos ġie studjat f'450 pazjent b'tibja miksura.
English: Other information about Inductos
Maltese: Aktar informazzjoni dwar Inductos
English: The active substance in Inductos, dibotermin alfa, acts on the bone structure.
Maltese: Is-sustanza attiva f'Inductos, id-dibotermina alfa, taġixxi fuq l-istruttura tal-għadam.
English: The CHMP considered that Inductos is effective in single-level lumbar spine fusion as a substitute for autogenous bone graft and for the treatment of acute tibia fractures in adults, as an adjunct to standard care.
Maltese: Is-CHMP ikkunsidra li Inductos huwa effettiv f'fużjoni tal-ispina lombari b'livell singolu bħala sostitut għal trapjant awtoġenu tal-għadam u għall-kura ta' ksur tat-tibja akut f'adulti, bħala żieda mal-kura standard.
English: What is Inductos?
Maltese: X'inhu Inductos?
English: Inductos is made up into a solution before use, applied to the matrix and left for at least 15 minutes (but no more than two hours).
Maltese: Qabel l-użu Inductos isir f'soluzzjoni, jiġi applikat fuq il-matriċi u jitħalla għal mill-inqas 15-il minuta (iżda mhux għal aktar minn sagħtejn).
English: The replacement dibotermin alfa acts in same way as BMP-2 produced naturally by the body.
Maltese: Id-dibotermina alfa sostituttiva taġixxi bl-istess mod bħall-proteina BMP-2 li tiġi prodotta mill-ġisem b'mod naturali.
English: • surgery to heal fractures (breaks) of the tibia (shin bone).
Maltese: • f'interventi kirurġiċi li jfejqu l-ksur tat-tibja (l-għadma tal-qasba tas-sieq).
English: This material will include information on the risk of heterotopic ossification and the potential risk of medication errors and incorrect use of Inductos.
Maltese: Dan il-materjal se jinkludi informazzjoni dwar ir-riskju ta' ossifikazzjoni eterotopika u r-riskju potenzjali ta' żbalji ta' medikazzjoni u użu mhux korrett ta' Inductos.
English: Additional studies and analysis of data from the published literature showed that Inductos was more effective than bone graft at inducing fusion of the lower back vertebrae, irrespective of the surgical technique or the type of approved medical device used to hold the bone in position.
Maltese: Studji addizzjonali u analiżi ta' data mid-dokumentazzjoni ppubblikata wrew li Inductos kien aktar effettiv minn trapjant tal-għadam fl-induzzjoni ta' fużjoni tal-vertebri tal-parti t'isfel tad-dahar, irrispettivament mit-teknika tal-intervent kirurġiku jew it-tip ta' apparat mediku approvat biex iżomm l-għadma fil-pożizzjoni.
English: Patients undergoing treatment with Inductos may be at risk of heterotopic ossification (the growth of bone in abnormal places like soft tissue); this risk is considered to be manageable with the proposed risk minimisation measures.
Maltese: Pazjenti li jkunu qed jiġu kkurati b'Inductos jistgħu jkunu f'riskju ta' ossifikazzjoni eterotopika (l-iżvilupp ta' għadam f'partijiet anomali bħat-tessut artab); ir-riskju huwa kkunsidrat maniġġabbli bil-miżuri proposti tal-minimizzazzjoni tar-riskju.
English: The most severe side effect is localised oedema (swelling at the surgery site) when used in upper spine (neck) surgery.
Maltese: L-effett sekondarju l-aktar gravi huwa edema lokalizzata (nefħa fis-sit tal-intervent kirurġiku) meta jintuża f'intervent kirurġiku fin-naħa ta' fuq tas-sinsla tad-dahar (l-għonq).
English: When implanted, dibotermin alfa stimulates the bone tissue around the matrix to make new bone.
Maltese: Meta tiġi impjantata, id-dibotermina alfa tistimula t-tessut tal-għadma madwar il-matriċi biex jiżviluppa għadam ġdid.
English: Of the patients in the standard care group, 46% needed a further intervention within a year to repair their fracture, while the proportion was 26% for those also receiving Inductos.
Maltese: 46% tal-pazjenti li ngħataw kura standard kellhom bżonn intervent ieħor fi żmien sena biex jitfejqilhom il-ksur, filwaqt li l-proporzjon ta' dawk li ngħataw Inductos ukoll kien 26%.
English: A risk management plan has been developed to ensure that Inductos is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Inductos jintuża bl-aktar mod sigur possibbli.
English: Inductos has been studied in 279 patients having lower back spine fusion.
Maltese: Inductos ġie studjat f'279 pazjent li kien sarilhom intervent ta' fużjoni spinali tal-parti t'isfel tas-sinsla tad-dahar.
English: Why has Inductos been approved?
Maltese: Għaliex ġie approvat Inductos?
English: In patients with a fractured tibia, using Inductos in addition to standard care was more effective than standard care alone in reducing the risk of treatment failure.
Maltese: Fil-pazjenti b'tibja miksura, l-użu ta' Inductos flimkien ma' kura standard kien aktar effettiv mill-kura standard waħedha għat-tnaqqis tar-riskju tal-falliment tal-kura.
English: What is the risk associated with Inductos?
Maltese: Għal xiex jintuża Inductos?
English: In spinal fusion, Inductos was as effective as bone grafts.
Maltese: Ġeneralment kitt wieħed ikun biżżejjed.
English: How has Inductos been studied?
Maltese: Kif ġie studjat Inductos?
English: For the full list of restrictions with Inductos, see the package leaflet.
Maltese: Għal-lista sħiħa ta' restrizzjonijiet b'Inductos, ara l-fuljett ta' tagħrif.
English: EMA/668463/2014 EMEA/H/C/002548
Maltese: EMEA/H/C/002548
English: Scenesse contains the active substance afamelanotide.
Maltese: Scenesse fih is-sustanza attiva afamelanotide.
English: Other information about Scenesse
Maltese: Informazzjoni oħra dwar Scenesse
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Scenesse 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 Scenesse jinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: The full EPAR and risk management plan summary for Scenesse 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: What information is still awaited for Scenesse?
Maltese: Liema informazzjoni għadha mistennija għal Scenesse?
English: This is a summary of the European public assessment report (EPAR) for Scenesse.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Scenesse.
English: Daily records of exposure to sunlight between 10 am and 6 pm showed that patients treated with Scenesse spent on average 116 hours in direct sunlight without experiencing pain during the six-month period compared with 61 hours for patients treated with placebo.
Maltese: Rekords ta' kuljum tal-esponiment għad-dawl tax-xemx bejn l-10 am u 6 pm urew li l-pazjenti kkurati b'Scenesse qattgħu medja ta' 116-il siegħa f'dawl tax-xemx dirett mingħajr ma eperjenzaw uġigħ waqt il-perjodu ta' sitt xhur meta mqabbel ma' 61 siegħa għal pazjenti kkurati bi plaċebo.
English: Because the number of patients with EPP is low, the disease is considered ‘rare', and Scenesse was designated an ‘orphan medicine' (a medicine used in rare diseases) on 8 May 2008.
Maltese: Peress li n-numru ta' pazjenti li jbatu minn EPP huwa baxx, il-marda hija kkunsidrata ‘rari', u Scenesse ġie kklassifikat bħala ‘mediċina orfni' (mediċina li tintuża f'mard rari) fit-8 ta' Mejju 2008.
English: Patients with EPP have high levels of a substance called protoporphyrin IX in the body.
Maltese: Pazjenti b'EPP għandhom livelli għoljin ta' sustanza msejħa protoporphyrin IX fil-ġisem.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Scenesse on 22 December 2014.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Scenesse fit-22 ta' Diċembru 2014.
English: The active substance in Scenesse, afamelanotide, is similar to a hormone in the body known as alphamelanocyte stimulating hormone, which stimulates the production of a brown-black pigment in the skin.
Maltese: Is-sustanza attiva f'Scenesse, afamelanotide, hija simili għal ormon fil-ġisem magħruf bħala ormon li jistimula alfamelanoċiti, li jistimulaw il-produzzjoni ta' pigment kannella-iswed fil-ġilda.
English: EPAR summary for the public
Maltese: Sommarju tal-EPAR għall-pubbliku afamelanotide
English: Why is Scenesse approved?
Maltese: Għaliex ġie approvat Scenesse?
English: Patients should be observed for allergic reactions for 30 minutes after the injection of each implant.
Maltese: Il-pazjenti għandhom jiġu osservati għal reazzjonijiet allerġiċi għal 30 minuta wara l-injezzjoni ta' kull impjant.
English: Scenesse is an implant used to treat patients with erythropoietic protoporphyria (EPP), a rare disease that causes intolerance to light.
Maltese: Scenesse huwa impjant li jintuża għall-kura ta' pazjenti bi protoporfirja eritropoetika (EPPerythropoietic protoporphyria), marda rari li tikkawża intolleranza għad-dawl.
English: In the study, involving 93 patients with EPP, patients were treated with either Scenesse or a placebo (a dummy treatment) over a six-month period.
Maltese: Fl-istudju, li involva 93 pazjenti b'EPP, il-pazjenti ġew ikkurati jew b'Scenesse jew bi plaċebo (kura finta) fuq perjodu ta' 6 xhur.
English: Scenesse has been authorised under ‘exceptional circumstances'.
Maltese: Scenesse ġie awtorizzat taħt ‘ċirkustanzi ta' eċċezzjoni'.
English: What are the risks associated with Scenesse?
Maltese: X'inhuma r-riskji assoċjati ma' Scenesse?
English: the maximum number is 4.
Maltese: In-numru ta'
English: A risk management plan has been developed to ensure that Scenesse is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Scenesse jintuża bl-aktar mod sigur possibbli.
English: How does Scenesse work?
Maltese: Kif jintuża Scenesse?
English: These affected around 1 in 5 patients and were generally mild in severity.
Maltese: Dawn affettwaw madwar pazjent wieħed minn kull 5 u ġeneralment kienu ħfief fis-severità.
English: The Committee also consulted individual patients and experts on their experience with Scenesse.
Maltese: Dan mhux intiż biex jipprovdi konsultazzjoni prattika dwar l-użu ta' Scenesse.
English: Since Scenesse has been approved under exceptional circumstances, the company that markets Scenesse will provide longer-tem data on the benefits and safety of the medicine from an EU registry of patients taking the medicine.
Maltese: Minħabba li Scenesse ġie approvat taħt ċirkostanzi ta' eċċezzjoni, il-kumpanija li tqiegħed Scenesse fissuq se tipprovdi dejta aktar fit-tul fuq il-benefiċċji u s-sigurtà tal-mediċina minn reġistru tal-UE ta' pazjenti li qegħdin jieħdu l-mediċina.
English: For the full list of all side effects and restrictions with Scenesse, see the package leaflet.
Maltese: Għal-lista sħiħa taleffetti sekondarji u r-restrizzjonijiet kollha b'Scenesse, ara l-fuljett ta' tagħrif.
English: Protoporphyrin IX is phototoxic and, when exposed to light, causes the painful reactions seen with this condition.
Maltese: Protoporphyrin IX huwa fototossiku u, meta jiġi espost għad-dawl, jikkawża reazzjonijiet b'uġigħ li jidhru f'din il-kundizzjoni.
English: The most common side effects seen in studies with Scenesse were nausea (feeling sick), headache and reactions at the implant site (such as discoloration, pain and redness).
Maltese: L-effetti sekondarji l-aktar komuni li ntwerew fl-istudji b'Scenesse kienu dardir (tħossok ma tiflaħx), uġigħ ta' ras u reazzjonijiet fis-sit tal-impjant (bħal telf fil-kulur, uġigħ u ħmura).
English: Further information can be found in the summary of the risk management plan.
Maltese: Aktar informazzjoni tista' tinstab fis-sommarju tal-pjan tal-ġestjoni tar-riskju.
English: Although the additional time spent in sunlight was small, the Committee considered the possible improvements in quality of life, the unmet medical need in patients with EPP, and the mild side effects seen during short-term treatment with the medicine in deciding to recommend approval for Scenesse in the EU.
Maltese: Għalkemm il-ħin addizzjonali li qattgħu fid-dawl taxxemx kien qasir, il-Kumitat ikkunsidra t-titjib possibbli fil-kwalità tal-ħajja, il-ħtieġa medika mhux sodisfatta f'pazjenti b'EPP, u l-effetti sekondarji ħfief li dehru waqt il-kura għal żmien qasir bil-mediċina fid-deċiżjoni ta' rakkomandazzjoni tal-approvazzjoni għal Scenesse fl-UE.
English: By stimulating the production of eumelanin in the skin, Scenesse reduces the penetration of light through the skin, thus helping to prevent the painful reactions.
Maltese: Billi jistimula l-produzzjoni ta' eumelanina fil-ġilda, Scenesse jnaqqas ilpenetrazzjoni tad-dawl mill-ġilda, b'hekk jgħin biex jipprevjeni reazzjonijiet bl-uġigħ.
English: In patients with EPP, exposure to light can lead to symptoms such as pain and swelling of the skin, which prevent patients from being able to spend time outdoors or in places with bright light.
Maltese: F'pazjenti b'EPP, espożizzjoni għad-dawl tista' twassal għal sintomi bħal uġigħ u nefħa tal-ġilda, li jistgħu jipprevjenu lill-pazjenti milli jkunu jistgħu jqattgħu ħin barra jew f'postijiet b'dawl qawwi.
English: Pharmaceutic al Form
Maltese: Għamla farmaċewtika
English: Ref. EMEA/90664/2009
Maltese: EMEA/246579/2009.
English: London, 19 February 2009 Doc.
Maltese: Londra, 19 ta' Frar 2009 Dok. ta' Ref.
English: International non-proprietary name (INN): vorinostat
Maltese: Denominazzjoni Komuni Internazzjonali (DKI): vorinostat
English: What is Vorinostat MSD?
Maltese: X'inhu Vorinostat MSD?
English: Vorinostat MSD is a medicine that contains the active substance vorinostat.
Maltese: Vorinostat MSD huwa mediċina li fiha s-sustanza attiva vorinostat.
English: Vorinostat MSD was not compared with any other treatment.
Maltese: Vorinostat MSD ma tqabbel mal-ebda trattament ieħor.
English: Vorinostat MSD was expected to be used to treat adults with advanced cutaneous T-cell lymphoma (CTCL).
Maltese: Vorinostat MSD kien mistenni li jiġi użat fit-trattament ta' adulti b'linfoma avvanzata tat-T-cell talġilda (CTCL).
English: The active substance in Vorinostat MSD, vorinostat, blocks the activity of proteins called histone deacetylases, which are involved in turning genes ‘on' and ‘off' within cells.
Maltese: Is-sustanza attiva f'Vorinostat MSD, vorinostat, timblokka l-attività tal-proteini msejħa histone deaceylases, li huma involuti fit-tibdil tal-ġene fiċ-ċelloli minn ‘on' għal ‘off' (minn attivi għal mhux attivi).
English: Vorinostat MSD was designated as an orphan medicinal product on 21 June 2004.
Maltese: Vorinostat MSD ġie kklassifikat bħala prodott mediċinali orfni fil-21 ta' Ġunju 2004.
English: On 13 February 2009 Merck Sharp & Dohme Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Vorinostat MSD, for the treatment of adults with advanced cutaneous T-cell lymphoma.
Maltese: Fit-13 ta' Frar 2009 Merck Sharp & Dohme Limited uffiċjalment għarrfet lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) li tixtieq tirtira l-applikazzjoni tagħha għallawtorizzazzjoni għat-tqegħid fis-suq għal Vorinostat MSD, għat-trattament ta' adulti b'linfoma avvanzata taċ-ċellola T tal-ġilda.
English: 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 75 23 71 29 E-mail: mail@emea.europa.eu http://www.emea.europa.eu
Maltese: Skont l-analiżi tad-dejta u t-tweġiba tal-kumpanija għal-lista ta' mistoqsijiet tas-CHMP, fi żmien lirtirar, il-Kumitat kellu xi tħassib u kellu opinjoni proviżorja li Vorinostat MSD ma setax jiġi approvat għat-trattament ta' CTCL fi stadju avvanzat.
English: In particular, the CHMP was concerned about the risk of thromboembolic events (problems caused by the formation of clots in the blood vessels) in patients taking Vorinostat MSD.
Maltese: B'mod partikolari, is-CHMP kien imħasseb dwar ir-riskju ta' każijiet tromboemboliċi (problemi kkawżati mill-formazzjoni ta' ċapep fil-vini u fl-arterji) f'pazjenti li jieħdu l-Vorinostat MSD.