FrancophonIA/ELRC3.0 huggingface dataset:
English: • PASI 50 to <PASI 90 were re-randomised to either continue adalimumab or switch to risankizumab
Maltese: • PASI 50 sa <PASI 90 ġew randomizzati mill-ġdid biex jew ikomplu adalimumab jew jaqilbu għal risankizumab
English: Each pre-filled syringe contains 75 mg risankizumab in 0.83 ml.
Maltese: Kull siringa mimlija għal-lest fiha 75 mg risankizumab f'0.83 ml.
English: Reductions in epidermal thickness, infiltration of inflammatory cells, and expression of psoriatic disease markers were also observed in psoriatic lesions.
Maltese: It-tnaqqis fil-ħxuna epidermali, l-infiltrazzjoni ta' ċelluli infjammatorji, u l-espressjoni tal-markaturi tal-marda psorjatika ġew osservati wkoll fil-leżjonijiet psorjatiċi.
English: Needle guard
Maltese: Pazjenti pedjatriċi
English: Nonclinical data revealed no special hazard for humans based on repeat-dose toxicity studies including safety pharmacology evaluations, and a reproductive and developmental toxicity study in cynomolgus monkeys at doses of up to 50 mg/kg/week (producing exposures of about 70 times the clinical exposure at maximum recommended human dose [MRHD]).
Maltese: Tagħrif mhux kliniku ibbażat fuq studji ta' effett tossiku minn dożi ripetuti inkluż evalwazzjonijiet tassigurtà farmakoloġika, u studju tal-effett tossiku fuq is-sistema riproduttiva u l-iżvilupp f'xadini cynomolgus b'dożi sa 50 mg/kg/ġimgħa (li jipproduċu esponiment ta' madwar 70 darba l-esponiment kliniku bid-doża massimma rakkomandata tal-bniedem [MRHD]) ma juri l-ebda periklu speċjali għallbnedmin.
English: By blocking IL-23 from binding to its receptor, risankizumab inhibits IL-23-dependent cell signalling and release of proinflammatory cytokines.
Maltese: IL-23 milli teħel marriċettur tagħha, risankizumab jinibixxi għoti ta' sinjali taċ-ċellula dipendenti minn IL-23 u r-rilaxx ta' ċitokini pro-infjammatorji.
English: Following subcutaneous dosing of risankizumab, peak plasma concentrations were achieved between 3-14 days after dosing with an estimated absolute bioavailability of 89%.
Maltese: Wara dożaġġ taħt il-ġilda ta' risankizumab, inkisbu konċentrazzjonijiet massimi fil-plażma bejn 3-14il jum wara d-dożaġġ b'bijodisponibilità assoluta stmata ta' 89 %.
English: Missed dose
Maltese: Aktar dożi
English: • if the expiry date (EXP) has passed
Maltese: • jekk tkun skadiet id-data ta' skadenza (JIS)
English: One pre-filled syringe contains 75 mg risankizumab.
Maltese: Siringa waħda mimlija għal-lest fiha 75 mg ta' risankizumab.
English: These conditions are generally not expected to have any significant impact on the pharmacokinetics of monoclonal antibodies and no dose adjustments are considered necessary (see section 5.2).
Maltese: Dawn il-kondizzjonijiet ġeneralment mhumiex mistennija li jkollhom xi impatt sinifikanti fuq il-farmakokinetika ta' antikorpi monoklonali u ma jitqies li huwa meħtieġ lebda aġġustament fid-doża (ara sezzjoni 5.2).
English: Each pre-filled syringe contains 75 mg risankizumab in 0.83 ml solution.
Maltese: Kull siringa mimlija għal-lest fiha 75 mg ta' risankizumab f'soluzzjoni ta' 0.83 ml.
English: In a study of subjects with psoriasis, expression of genes associated with the IL-23/IL-17 axis was decreased in the skin after single doses of risankizumab.
Maltese: Fi studju ta' individwi bil-psorjażi, l-espressjoni tal-ġeni assoċjata mal-assi IL-23/IL-17 tnaqqset filġilda wara dożi uniċi ta' risankizumab.
English: For the second syringe, inject at least 3 cm away from the first injection.
Maltese: Għat-tieni siringa, injetta tal-inqas 3 cm 'il bogħod mill-ewwel injezzjoni.
English: OUTER CARTON
Maltese: Tużax Skyrizi
English: This medicine works by stopping a protein in the body called ‘IL-23', which causes inflammation.
Maltese: Din il-mediċina taħdem billi twaqqaf proteina fil-ġisem imsejħa “IL-23”, li tikkawża infjammazzjoni.
English: Lifepharma (Z.A.M.)
Maltese: TWISSIJA(IET) SPEĊJALI
English: Serious side effects
Maltese: Effetti sekondarji oħra
English: Skyrizi contains the active substance risankizumab.
Maltese: Skyrizi fih is-sustanza attiva risankizumab.
English: The majority of cases were non-serious and mild to moderate in severity and did not lead to discontinuation of risankizumab.
Maltese: Il-maġġoranza tal-każijiet kienu mhux serji u ħfief sa moderati fis-severità u ma wasslux għat-twaqqif ta' risankizumab.
English: Week 52 262 (86.2) sPGA of clear (0) Week 16 112 (36.8) Week 52 175 (57.6) PASI 75
Maltese: Ġimgħa 52 sPGA ta' xejn (0) Ġimgħa 16
English: • Do not inject into skin that is sore, bruised, red, hard, scarred, or has stretch marks
Maltese: • Tinjettax f'ġilda li hija sensittiva, imbenġla, ħamra, iebsa, b'ċikatriċi jew għandha stretch marks
English: Skyrizi is used to treat adults with moderate to severe plaque psoriasis.
Maltese: Skyrizi jintuża biex jikkura adulti b'psorjażi bil-qoxra moderata sa severa.
English: • your belly (abdomen) at least 5 cm from your belly button (navel)
Maltese: • żaqqek (l-addome tiegħek) tal-inqas 5 cm miż-żokra tiegħek
English: List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, applicants / marketing authorisation holders in the Member States
Maltese: Lista ta' ismijiet, forma farmaċewtika, dożar ta' prodotti mediċinali, rottot ta' administrazjoni, applikanti/detenturi ta' l- awtorizzazzjoni għat-tqegħid fis-suq f'stati membri.
English: EMA/848040/2011 EMEA/V/C/002000
Maltese: EMA/848040/2011
English: TruScient has been developed for use in dogs based on the approved use of the InductOs product in humans (EU/1/02/226/001).
Maltese: TruScient ġie żviluppat għall-użu fil-klieb abbażi tal-użu approvat tal-prodott InductOs fuq il-bnedmin (EU/1/02/226/001).
English: After 18 weeks, the fractures of all the dogs treated with TruScient together with standard surgical care (84) were seen to have healed, compared with 95% of the dogs treated with standard surgical care alone (40 out of 42).
Maltese: Wara 18-il ġimgħa, il-fratturi tal-klieb kollha li kienu ngħataw kura bi TruScient flimkien ma' kura kirurġika standard (84) kienu dehru mfejqa, apparagun ma' 95% tal-klieb li kienu ngħataw kura permezz ta' kura kirurġika standard weħidha (40 minn 42).
English: TruScient is a medicine that contains the active substance dibotermin alfa.
Maltese: TruScient huwa mediċina li fiha s-sustanza attiva dibotermina alfa.
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: Iddibotermin alfa tiġi prodotta permezz ta' metodu magħruf bħala ‘teknoloġija rikombinanti tad-DNA': issir minn ċelloli li jkunu rċevew ġene (DNA) li jagħmilhom kapaċi jipproduċu d-dibotermina alfa.
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: Hija kopja ta' proteina msejħa ‘proteina morfoġenika ossea ' (BMP-2), li tiġi prodotta b'mod naturali mill-ġisem u tgħin fil-formazzjoni ta' tessut ġdid tal-għadam.
English: The replacement dibotermin alfa acts in the same way as BMP-2 produced naturally by the body.
Maltese: Iddibotermina alfa sostitutiva taġixxi bl-istess mod bħal BMP-2 li tiġi prodotta b'mod naturali fil-ġisem.
English: The kit allows the user to make a solution containing the active substance (0.2 mg/ml) to be applied onto collagen sponges which are implanted during surgery.
Maltese: Il-kitt jippermetti lill-utent jagħmel soluzzjoni li jkun fiha s-sustanza attiva (0.2 mg/ml) biex tiġi applikata fuq sponoż magħmula mill-kollaġen li jiġu impjantati matul il-kirurġija.
English: The study assessed TruScient used together with standard surgical care, compared with standard surgical care alone.
Maltese: L-istudju evalwa TruScient użat flimkien ma' kura kirurġika standard, apparagun ma' kura kirurġika standard weħidha.
English: What is TruScient?
Maltese: X'inhu TruScient?
English: This summary was last updated in April 2013.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fi 04-2013.
English: TruScient should only be used by a veterinarian.
Maltese: TruScient għandu jintuża biss minn veterinarju.
English: What is the risk associated with TruScient?
Maltese: X'riskji huma assoċjati ma' TruScient?
English: The European Commission granted a marketing authorisation valid throughout the European Union, for TruScient on 14 December 2011.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal TruScient fi 14-12-2011.
English: The active substance in TruScient, dibotermin alfa, acts on the bone structure.
Maltese: Is-sustanza attiva fi TruScient, id-dibotermina alfa, taġixxi fuq l-istruttura tal-għadam.
English: TruScient was investigated in one main field study in 126 dogs with fractures of the diaphysis.
Maltese: TruScient ġie studjat fi studju ewlieni wieħed fuq il-post fuq 126 kelb bil-fratturi tad-dijafiżi.
English: Other information about TruScient:
Maltese: Tagħrif ieħor dwar TruScient:
English: TruScient is used in combination with standard surgical care to treat diaphyseal bone fractures (affecting the diaphysis, the main section of long bone) in dogs.
Maltese: TruScient jintuża flimkien ma' kura kirurġika standard fil-kura ta' fratturi dijafiżarji tal-għadam (li jaffettwaw id-dijafiżi, is-sezzjoni ewlenija tal-għadma t-twila) fil-klieb.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of TruScient exceed the risks for the treatment of diaphyseal bone fractures in dogs and recommended that TruScient be given a marketing authorisation.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu Veterinarju (CVMP) ikkonkluda li l-benefiċċji ta' TruScient jegħlbu r-riskji għall-kura ta' fratturi dijafiżarji tal-għadam fil-klieb, u rrakkomanda li TruScient jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: Why has TruScient been approved?
Maltese: Għaliex ġie approvat TruScient?
English: Time to radiographic fracture healing was less when the dogs were treated with TruScient together with standard surgical care.
Maltese: Iż-żmien għal fejqan radjografiku tal-frattura kien iqsar meta l-klieb kienu ngħataw kura bi TruScient flimkien ma' kura kirurġika standard.
English: How has TruScient been studied?
Maltese: Kif ġie studjat TruScient?
English: TruScient is made up into a solution before use, applied to the collagen sponges and left for at least 15 minutes (but no more than two hours).
Maltese: TruScient jiġi magħmul f'soluzzjoni qabel l-użu, jiġi applikat fuq l-isponż magħmula mill-kollaġen u jitħalla tul mill-inqas kwarta (iżda mhux aktar minn sagħtejn).
English: It must not be used in young dogs whose bones are not fully developed, have an active infection at the site of operation, pathological fracture (caused by a disease), or any active malignancy (cancerous growth).
Maltese: Ma għandux jintuża fuq klieb żgħar li l-għadam tagħhom ma jkunx għadu żviluppa sew, li jkollhom infezzjoni attiva fis-sit tal-operazzjoni, frattura patoloġika (ikkawżata b'marda), jew xi tumur malinn attiv (tkabbir karċinoġeniku).
English: For a full list of all side effects reported with TruScient, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtata bi TruScient, ara l-fuljett ta' tagħrif.
English: TruScient is available as a kit for implant.
Maltese: TruScient jiġi f' kitt għallimpjantazzjoni.
English: The main side effects with TruScient (seen in more than 1 dog in 10) were lameness, and firm and soft swelling during the first three weeks after surgery.
Maltese: L-effetti sekondarji ewlenin bi TruScient (li dehru f'aktar minn kelb 1 minn kull 10) kienu zapzip u nefħa iebsa u ratba matul l-ewwel tliet ġimgħat wara l-kirurġija.
English: When the collagen sponge is implanted into the bone fracture, dibotermin alfa stimulates the bone tissue around the sponge to make new bone.
Maltese: Meta l-isponża tal-kollaġen tiġi impjantata fil-frattura tal-għadam, id-dibotermina alfa tistimula t-tessut tal-għadam madwar l-isponża biex tipproduċi għadam ġdid.
English: LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION, APPLICANT, MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES
Maltese: TAL-PRODOTT MEDIĊINALI, METODU TA' AMMINISTRAZZJONI, APPLIKANT, DETENTUR TALAWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ
English: (Invented) Name
Maltese: Isem (Inventat)
English: Strength Pharmaceutical form
Maltese: Qawwa Kompożizzjoni farmaċewtika
English: Ireland
Maltese: Dublin 8, Ireland
English: ANNEX I
Maltese: ANNESS I LISTA
English: United Kingdom
Maltese: FL-ISTATI
English: These dialysis solutions were thus imported from Canada, Singapore, Turkey and USA.
Maltese: Dawn is-soluzzjonijiet għaddijalisi għalhekk ġew impurtati mill-Kanada, Singapor, it-Turkija u l-Istati Uniti tal-Amerika.
English: • The CHMP considered the referral under Article 31 of Directive 2001/83/EC, as amended, for dialysis solutions from Baxter group of companies and associated companies produced at Castlebar.
Maltese: • Is-CHMP ikkunsidra r-referenza skont l-Artikolu 31 tad-Direttiva 2001/83/KE, kif emendata, għassoluzzjonijiet għad-dijalisi mill-grupp ta' kumpaniji Baxter u kumpaniji assoċjati prodotti f'Castlebar.
English: The corresponding decision from the commission was issued on 12 May 2011.
Maltese: Id-deċiżjoni korrispondenti mill-kummissjoni inħarġet fit-12 ta' Mejju 2011.
English: Terminal sterilisation has to be expressed as a minimum exposure time to a minimum temperature as per Ph. Eur.
Maltese: L-isterilizzazzjoni terminali trid tiġi espressa bħala espożizzjoni minima għal temperatura minima skont il-Ph.
English: Overall summary of the scientific evaluation on the inclusion of an additional site into the existing licenses of dialysis solutions (Dianeal PD4 and Extraneal) from Baxter group of companies and associated companies (see Annex I)
Maltese: Sommarju ġenerali tal-evalwazzjoni xjentifika dwar l-inklużjoni ta' sit addizzjonali filliċenzji eżistenti tas-soluzzjonijiet għad-dijalisi (Dianeal, PD4 u Extraneal) mill-grupp ta' kumpaniji Baxter u kumpaniji assoċjati (ara Anness I)
English: In particular, the peritoneal dialysis (PD) Dianeal, Extraneal and Nutrineal were affected by this procedure.
Maltese: B'mod partikolari, kienu affettwati minn din il-proċedura d-dijalisi tal-peritonew (PD) Dianeal, Extraneal u Nutrineal.
English: The introduction of a more sensitive kinetic turbidimetric limulus amebocyte lysate (LAL) method for endotoxin testing and the re-submission of the full description of the manufacturing processes for all sites together with its critical review should thus be undertaken.
Maltese: Għalhekk għandhom jitwettqu l-introduzzjoni ta' metodu turbidimetriku kinetiku aktar sensittiv ta' limulus amebocyte lysate (LAL) għall-ittestjar tal-endotossini u s-sottomissjoni mill-ġdid tad-deskrizzjoni sħiħa tal-proċessi talmanifattura għas-siti kollha flimkien mal-eżami kritiku tiegħu.
English: - The current minimum standards for critical process parameters and limits e.g. for terminal sterilisation should be reviewed and improved, in compliance with process capabilities and best practice.
Maltese: - L-istandards minimi attwali għall-parametri u l-limiti ta' proċessi kritiċi, eż. għall-isterilizzazzjoni terminali għandhom jiġu riveduti u mtejba, f'konformità mal-kapaċitajiet tal-proċess u l-aħjar prattika.
English: Consequently bioburden specifications of the filled containers should also be harmonised.
Maltese: Eur. u għandha tiġi armonizzata fis-siti kollha involuti.
English: In view of severe supply limitations for Dianeal, Extraneal and Nutrineal and the risk of switching patients to alternative PD solutions or therapies, the CHMP considered that the use of comparable products produced by Baxter at alternative manufacturing sites outside the EEA (European Economic Area) should be prioritised.
Maltese: Minħabba l-limitazzjonijiet severi ta' provvista għal Dianeal, Extraneal u Nutrineal u r-riskju tal-qlib tal-pazjenti għal soluzzjonijiet jew terapiji alternattivi għall-PD, is-CHMP ħass li l-użu ta' prodotti komparabbli magħmula minn Baxter f'siti alternattivi tal-manifattura barra miż-ŻEE (Żona Ekonomika Ewropea) għandu jingħata prijorità.
English: - All starting materials (including excipients) should be subject to satisfactory routine control of microbial contamination and, unless justified, endotoxin testing.
Maltese: - Il-materjali kollha tal-bidu (inklużi s-sustanzi mhux attivi) għandhom ikunu soġġetti għal kontroll regolari sodisfaċenti tal-kontaminazzjoni mikrobika u, sakemm ma jkunx ġustifikat, ittestjar talendotossini.
English: An article 31 referral procedure of Directive 2001/83/EC, as amended was initiated by the European Commission (EC) following reports of out-of-specifications results for endotoxins in dialysis solutions from Baxter group of companies and associated companies produced at Castlebar.
Maltese: Il-Kummissjoni Ewropea (KE) bdiet proċedura ta' riferiment skont l-Artikolu 31 tad-Direttiva 2001/83/KE, kif emendata, wara rapporti ta' riżultati mhux fl-ispeċifikazzjonijiet għal endotossini fissoluzzjonijiet għad-dijalisi mill-grupp ta' kumpaniji Baxter u kumpaniji assoċjati prodotti f'Castlebar.
English: - Water for injections, and other excipients, should fully comply with Ph Eur monograph requirements, where applicable.
Maltese: - L-ilma għall-injezzjonijiet, u sustanzi mhux attivi oħra, għandhom jikkonformaw b'mod sħiħ marrekwiżiti tal-monografu tal-Ph Eur, fejn applikabbli.
English: Considering the likelihood of prolonged use of large quantities of unlicensed (imported) PD solutions on the EU market, and in order to ensure continued supply of licensed medicinal products to the EU, the necessary data packages to support the inclusion of additional manufacturing sites were expedited within the ongoing article 31 referral procedure.
Maltese: Minħabba l-probabbiltà tal-użu fit-tul ta' kwantitajiet kbar ta' soluzzjonijiet (impurtati) mhux liċenzjati għall-PD fis-suq tal-UE, u sabiex ikun assigurat il-forniment kontinwu ta' prodotti mediċinali liċenzjati lill-UE, il-pakketti tad-dejta meħtieġa sabiex isostnu l-inklużjoni ta' siti addizzjonali tal-manifattura kienu mibgħuta fi ħdan il-proċedura ta' riferiment li għaddejja skont l-Artikolu 31.
English: In April 2011, the Committee considered that sufficient information was available to issue a first opinion for this Article 31 procedure recommending the addition of Canada, Poland and Turkey manufacturing sites to the existing PD solutions' marketing authorisations.
Maltese: F'April 2011, il-Kumitat ikkunsidra li kien hemm biżżejjed informazzjoni disponibbli sabiex tinħareġ l-ewwel opinjoni għal din ilproċedura skont l-Artikolu 31 li tirrakkomanda ż-żieda tas-siti ta' manifattura tal-Kanada, il-Polonja u t-Turkija mal-awtorizzazzjonijiet għat-tqegħid fis-suq ta' soluzzjonijiet eżistenti għall-PD.
English: Standard QP release should apply for all products released under the terms of EU marketing authorisations; in particular the QPs must be satisfied that the active substances are manufactured in accordance with EU GMP requirements.
Maltese: Għandu japplika rilaxx standard minn QP għall-prodotti kollha maħruġa skont it-termini talawtorizzazzjonijiet għat-tqegħid fis-suq tal-UE; b'mod partikolari l-QPs iridu jkunu sodisfatti li ssustanzi attivi jkunu mmanifatturati skont ir-rekwiżiti tal-UE dwar il-GMP.
English: Whilst all data to finalise the ongoing article 31 is not available, a stepwise approach is followed for the assessment, resulting in subsequent opinions being adopted by the CHMP.
Maltese: Filwaqt li mhix disponibbli d-dejta kollha biex tiġi finalizzata lproċedura skont l-Artikolu 31, qed jiġi segwit approċċ gradwali għall-valutazzjoni, li jwassal biex jiġu adottati opinjonijiet sussegwenti mis-CHMP.
English: • Unaffected batches of peritoneal dialysis solutions needed to be made available to patients across the EU in the shortest possible timeframe, thus alternative PD solutions produced by Baxter at alternative manufacturing sites outside the EEA (European Economic Area) were prioritised.
Maltese: • Kien meħtieġ li jkunu disponibbli fl-inqas żmien possibbli għall-pazjenti madwar l-UE lottijiet mhux affettwati ta' soluzzjonijiet għad-dijalisi tal-peritonew, u għalhekk ingħataw prijorità soluzzjonijiet alternattivi għall-PD magħmula minn Baxter f'siti alternattivi tal-manifattura barra miż-ŻEE (Żona Ekonomika Ewropea).
English: the CHMP recommends the variation to the terms of the marketing authorisations concerning the addition of the manufacturing site in the USA and for which the relevant amendments to sections of the summaries of product characteristics and package leaflets are set out in Annex III for dialysis solutions from Baxter group of companies and associated companies produced at Castlebar (see Annex I).
Maltese: III għassoluzzjonijiet għad-dijalisi mill-grupp ta' kumpaniji Baxter u kumpaniji assoċjati prodotti f'Castlebar (ara Anness I).
English: Therefore, without prejudice to the ongoing article 31 procedure, the CHMP considers that sufficient information is available to issue a second opinion for this Article 31 procedure recommending the addition of the USA manufacturing site to the relevant PD solutions' marketing authorisations, subject to conditions set out in the Annex IV.
Maltese: F'dan l-istadju tal-proċedura skont l-Artikolu 31, hemm dejta biżżejjed disponibbli biex tiġi rrakkomandata l-varjazzjoni għall-awtorizzazzjonijiet għat-tqegħid fis-suq li tikkonsisti fl-inklużjoni tassit li jinsab fl-Istati Uniti bħala sit addizzjonali ta' manifattura, minħabba li ma ġiet identifikata l-ebda kwistjoni maġġuri dwar il-kwalità.
English: To meet supply demands, the unprecedented importation of PD solutions from Canada, Turkey and USA increased.
Maltese: Sabiex jiġu ssodisfati t-talbiet għall-provvista, żdiedet l-importazzjoni bla preċedenti ta' soluzzjonijiet għall-PD mill-Kanada, it-Turkija u l-Istati Uniti tal-Amerika.
English: Taking into account the crucial nature of these medicinal products, unaffected batches of PD solutions had to be made available to patients across the EU in the shortest possible timeframe, and thus alternatives were sought.
Maltese: Minħabba n-natura kruċjali ta' dawn il-prodotti mediċinali, lottijiet mhux affettwati ta' soluzzjonijiet għall-PD kellhom jitpoġġew għad-dispożizzjoni tal-pazjenti madwar l-UE fl-inqas żmien possibbli, u għalhekk tfittxew alternattivi.
English: The CHMP reviewed all the data available for each of the sites concerned.
Maltese: Is-CHMP eżamina d-dejta kollha disponibbli għas-siti kollha kkonċernati.
English: The review of the issues identified at Castlebar, with the interruption of supply from this site, led to the need to authorise additional manufacturing sites to ensure supply of PD solutions in Europe.
Maltese: L-eżami tal-kwistjonijiet identifikati f'Castlebar, bit-twaqqif tal-provvista minn dan is-sit, wassal għallħtieġa li jiġu awtorizzati siti addizzjonali tal-manifattura sabiex tkun assigurata l-provvista tassoluzzjonijiet għall-PD fl-Ewropa.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) STARLIX EPAR summary for the public
Maltese: RAPPORT TA' VALUTAZZJONI PUBBLIKA EWROPEA (EPAR) STARLIX Sommarju ta' l-EPAR għall-pubbliku
English: The European Commission granted a marketing authorisation valid throughout the European Union for Starlix to Novartis Europharm Limited on 3 April 2001.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Starlix lil Novartis Europharm Limited fit-3 ta' April 2001.
English: Starlix is a medicine containing the active substance nateglinide.
Maltese: Starlix hu mediċina li fiha s-sustanza attiva nateglinide.
English: The marketing authorisation was renewed on 3 April 2006.
Maltese: L-awtorizzazzjoni għat-tqegħid fis-suq ġiet imġedda fit-3 ta' April 2006.
English: This summary was last updated in 08-2007.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'08-2007.
English: Other studies also looked at ‘switching' from an antidiabetes medicine to Starlix, and ‘adding' Starlix to other antidiabetes medicines.
Maltese: Studji oħra studjaw ukoll ‘il-qlib' minn mediċini antidijabetiċi għal Starlix, u ‘ż-żieda' ta' Starlix ma' mediċini antidijabetiċi oħra.