FrancophonIA/ELRC3.0 huggingface dataset:
English: Both carbidopa and entacapone block some of the enzymes that are involved in the breakdown of levodopa in the body: carbidopa blocks the enzyme dopa decarboxylase, and entacapone blocks the enzyme catechol-O-methyl transferase (COMT).
Maltese: Kemm il-karbidopa u kemm l-entakapone jimblukkaw l-enzimi li huma involuti fid-dekompożizzjoni tal-levodopa fil-ġisem: il-karbidopa timblokka l-enzima dopa dekarbossilażi filwaqt li l-entakapone timblokka l-enzima katekol-O-metil transferażi (COMT).
English: The company used some of the data from Comtess/Comtan to support the use of Stalevo and presented data from the published literature for levodopa and carbidopa.
Maltese: Il-kumpanija użat diversi siltiet mit-tagħrif dwar Comtess/Comtan biex tappoġġja l-użu ta' Stalevo, u ppreżentat dejta mid-dokumentazzjoni li kienet ġiet ippubblikata dwar il-levodopa u l-karbidopa.
English: The CHMP decided that Stalevo's benefits are greater than its risks for the treatment of patients with Parkinson's disease and end-of-dose motor fluctuations not stabilised on levodopa/dopa decarboxylase inhibitor treatment.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Stalevo huma ikbar mir-riskji tiegħu għat-trattament ta' pazjenti li jbatu mill-marda ta' Parkinson u li jkollhom fluttwazzjonijiet motorji fid-doża finali li ma jkunux ġew stabbilizzati bit-trattament bil-levotopa/inibituri tad-dopa dekarbossilażi.
English: The company carried out ‘bioequivalence' studies to show that taking Stalevo produces the same levels of levodopa, carbidopa and entecapone in the blood as taking separate tablets containing entacapone and the combination of levodopa and carbidopa.
Maltese: Il-kumpanija għamlet studji ta' ‘bijoekwivalenza‘ biex turi li t-teħid ta' Stalevo jipproduċi l-istess livelli tas-sustanzi attivi levodopa, karbidopa u entakapone fid-demm daqs it-teħid b'mod separat ta' pilloli li jkun fihom l-entakapone u t-tal-levodopa mal-karbidopa.
English: The most common side effects with Stalevo (seen in more than 1 patient in 10) are dyskinesia (uncontrollable movements), aggravated Parkinsonism (worsening of Parkinson's disease), nausea (feeling sick) and harmless urine discoloration.
Maltese: L-effetti sekondarji l-aktar komuni ta' Stalevo (li feġġu f'iżjed minn pazjent wieħed minn kull 10) huma diskineżija (movimenti bla kontroll), taħżin fis-sintomi tal-marda ta' Parkinson, nawżja (jħossuhom ma jifilħux) u tidnis mhux malinn fil-lewn tal-urina.
English: Stalevo must not be used together with other medicines that belong to the group ‘monoamine oxidase inhibitors' (a type of antidepressant).
Maltese: Stalevo ma għandux jintuża flimkien ma' mediċini oħrajn li jappartienu lill-grupp tal-‘inibituri talmonoaminoossidażi' (tip ta' antidepressiv).
English: How does Stalevo work?
Maltese: Kif jintuża Stalevo?
English: Levodopa is converted into dopamine in the brain.
Maltese: Il-levodopa tiġi konvertita f'dopamina fil-moħħ.
English: Stalevo is used in patients who are being treated with a combination of levodopa and an inhibitor of dopa decarboxylase (two standard treatments for Parkinson's disease) but are having ‘fluctuations' towards the end of the period between two doses of their medication.
Maltese: Stalevo jintuża f'pazjenti li jkunu qed jiġu ttrattati b'taħlita tal-levodopa u tal-inibitur tad-dopa dekarbossilażi (żewġ trattamenti standard għall-kura tal-marda ta' Parkinson) u li jkollhom ‘varjazzjonijiet' lejn tmiem il-perjodu ta' bejn żewġ dożi tal-kura tagħhom.
English: What benefit has Stalevo shown during the studies?
Maltese: Kif ġie studjat Stalevo?
English: Parkinson's disease is a progressive brain disorder that causes shaking, slow movement and muscle stiffness.
Maltese: Il-marda ta' Parkinson hija disturb progressiv fil-moħħ li jikkawża rogħda, dewmien fil-movimenti u ebusija fil-muskoli.
English: The studies showed that Stalevo is bioequivalent to the separate tablets.
Maltese: L-istudji wrew li Stalevo huwa bijoekwivalenti għall-pilloli separati.
English: EMA/HMPC/446032/2013
Maltese: Marrubja EMA/HMPC/446032/2013
English: White horehound
Maltese: Marrubja
English: White horehound should only be used in adults and adolescents aged over 12 years.
Maltese: Il-marrubja għandha tintuża biss minn adulti u adolexxenti ta' aktar minn 12-il sena.
English: This means that, although there is insufficient evidence from clinical trials, the effectiveness of these herbal medicines is plausible and there is evidence that they have been used safely in this way for at least 30 years (including at least 15 years within the EU).
Maltese: Dan ifisser li, għalkemm hemm nuqqas ta' evidenza minn provi kliniċi, l-effikaċja ta' dawn il-mediċini erbali hija plawżibli u hemm evidenza li ntużaw b'mod sigur b'dan il-mod għal ta' lanqas 30 sena (inklużi ta' lanqas 15-il sena fl-UE).
English: For detailed information on the data assessed by the HMPC, see the HMPC assessment report.
Maltese: Għal informazzjoni dettaljata dwar l-istudji vvalutati mill-HMPC, ara rrapport ta' valutazzjoni tal-HMPC.
English: • in patients with a temporary loss of appetite.
Maltese: • f'pazjenti b'nuqqas ta' aptit temporanju.
English: What are the risks associated with white horehound medicines?
Maltese: X'inhuma r-riskji assoċjati mal-mediċini bil-marrubja?
English: The HMPC conclusions on the use of white horehound medicines in patients with cough, dyspepsia symptoms and loss of appetite are based on their ‘traditional use'.
Maltese: Il-konklużjonijiet tal-HMPC dwar l-użu ta' mediċini bil-marrubja f'pazjenti b'sogħla, b'sintomi ta' dispepsija u b'nuqqas ta' aptit huma bbażati fuq l-‘użu tradizzjonali' tagħhom.
English: Other information about white horehound medicines
Maltese: Aktar informazzjoni dwar il-mediċini bil-marrubja
English: Further information on the risks associated with white horehound medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Maltese: Aktar informazzjoni dwar ir-riskji assoċjati mal-mediċini bil-marrubija, inklużi l-prekawzjonijiet xierqa għall-użu sigur tagħhom, tinsab fil-monografu taħt it-tab ‘Id-dokumenti kollha' fis-sit elettroniku talAġenzija:
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of white horehound.
Maltese: Dan id-dokument huwa sommarju tal-konklużjonijiet xjentifiċi li wasal għalihom il-Kumitat għallProdotti Mediċinali Erbali (HMPC) dwar l-użu mediċinali tal-marrubja.
English: Further information on the HMPC assessment of white horehound medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Maltese: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: Herbal medicines containing white horehound are usually available in a comminuted form for herbal tea, or in solid or liquid forms to be taken by mouth.
Maltese: Mediċini erbali li fihom il-marrubja huma normalment diponibbli f'biċċiet żgħar għal tè erbali, jew f'forma solida jew likwida biex jittieħdu mill-ħalq.
English: • as an expectorant (a medicine to help bring up phlegm) in patients with cough associated with a cold;
Maltese: • bħala espettorant (mediċina li tgħin biex ittella' l-katarru) f'pazjenti b'sogħla assoċjata ma' riħ;
English: White horehound can also be found in combination with other herbal substances in some herbal medicines.
Maltese: Il-marrubja tinstab ukoll f'kombinazzjoni ma' sustanzi erbali oħrajn f'xi mediċini erbali.
English: What evidence supports the use of white horehound medicines?
Maltese: X'evidenza tappoġġa l-użu tal-mediċini bil-marrubja?
English: Any applications for the licensing of medicines containing white horehound have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.
Maltese: Kwalunkwe applikazzjoni għal-liċenzjar ta' mediċini li fihom il-marrubja għandha tiġi ppreżentata lillawtoritajiet nazzjonali responsabbli mill-prodotti mediċinali li jivvalutaw l-applikazzjoni għall-mediċina erbali u jqisu l-konklużjonijiet xjentifiċi tal-HMPC.
English: Moreover, the intended use does not require medical supervision.
Maltese: Barra minn hekk, l-użu intenzjonat m'għandux bżonn superviżjoni medika.
English: • Rheumatoid arthritis (RA)
Maltese: • Artrite rewmatika (RA)
English: • Psoriasis
Maltese: • Psorjasi
English: Posology:
Maltese: Pożoloġija:
English: • Clinical aspects
Maltese: • Aspetti kliniċi
English: Sections 4.3 - Contraindications
Maltese: Sezzjonijiet 4.3 - Kontraindikazzjonijiet
English: Whereas
Maltese: MAH.
English: Sections 4.3 to 4.9 - from “Contraindications” to “Overdose”
Maltese: Sezzjonijiet 4.3 sa 4.9 - minn “Kontraindikazzjonijiet” sa “Doża Eċċessiva”
English: • Aplastic Anemia
Maltese: • Anemija aplastika
English: Switching between oral ciclosporin formulations
Maltese: Qalba bejn formulazzjonijiet orali ta' ciclosporin
English: • Solid organ transplantation:
Maltese: • Trapjant ta' organu solidu:
English: The dossier of
Maltese: Id-dossier ta'
English: The CHMP endorses this proposal
Maltese: Is-CHMP japprova din il-proposta
English: Section 5.2 - Pharmacokinetic Properties
Maltese: Sezzjoni 5.2 - Proprjetajiet farmakokinetiċi
English: In the following, the entire section 4.2 is reviewed, sub-section by sub-section.
Maltese: F'dan li ġej, is-sezzjoni 4.2 kollha ġiet riveduta, sottosezzjoni b'sottosezzjoni.
English: In November 2011, a full review of the company label (CDSs for both products Sandimmun and Sandimmun Neoral) was initiated.
Maltese: F'Novembru 2011, inbdiet reviżjoni sħiħa tat-tikketta tal-kumpanija (is-CDSs għaż-żewġ prodotti Sandimmun u Sandimmun Neoral).
English: • Solid organ transplantation
Maltese: • Trapjant ta' organu solidu
English: Section 4.5 - Interaction with Other Medicinal Products and Other Forms of Interaction
Maltese: Sezzjoni 4.5 - Interazzjoni ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni
English: Ciclosporin is contraindicated for some HMG-CoA reductase inhibitors (statins) due to the CYP3A4 and/or Pgp inhibitory potential of ciclosporin.
Maltese: Ciclosporin huwa kontraindikat għal xi inibituri ta' HMG-CoA reductase (statins) minħabba l potenzjal inibitorju ta' CYP3A4 u/jew Pgp ta' ciclosporin.
English: This type of information is in line with SmPCs of several Member States.
Maltese: Din it-tip ta' informazzjoni hija f'konformità mal-SmPCs ta' bosta Stati Membri.
English: Section 5.1 - Pharmacodynamic Properties
Maltese: Sezzjoni 5.1 - Proprjetajiet farmakodinamiċi
English: General monitoring of posology.
Maltese: Monitoraġġ ġenerali tal-pożoloġija.
English: • Bone marrow transplantation (BMT)
Maltese: • Trapjant tal-mudullun (BMT)
English: • Endogenous uveitis
Maltese: • Uveite endoġena
English: The agreed Core Safety profile (CSP) from the last PSUR 13 work sharing procedure (EE/H/PSUR/0007/001) and the public AR from the paediatric article 45 procedure (CZ/W/04/pdWS/01, 2010) were also used.
Maltese: Intużaw ukoll il-profil tas-Sigurtà Ewlenija (CSP) maqbul mill-aħħar proċedura ta' kondiviżjoni tax-xogħol 13 talPSUR (EE/H/PSUR/0007/001) u l-AR pubbliku mill-proċedura pedjatrika skont l-artikolu 45 (CZ/W/04/pdWS/01, 2010).
English: At the time of the submission of the oil-based formulation of ciclosporin, Sandimmun, in 1987, a comprehensive clinical data summary on endogenous uveitis was available (Nussenblatt 1987).
Maltese: Fiż-żmien tas-sottomissjoni tal-formulazzjoni b'bażi ta' żejt ta' ciclosporin, Sandimmun, fl-1987, kien hemm disponibbli sommarju komprensiv tad-dejta klinika dwar l-uveite endoġena (Nussenblatt 1987).
English: The indication aplastic anemia is only approved in France.
Maltese: L-indikazzjoni tal-anemija aplastika hija approvata biss fi Franza.
English: The MAH confirmed that the storage conditions in the SmPCs of Sandimmun Neoral soft gelatin capsules and oral solutions are already aligned with the requirements set in the Guideline on Declaration of Storage Conditions (CPMP/QWP/609/96/Rev 2 dated 19 Nov 2007).
Maltese: Il-MAH ikkonferma li l-kundizzjonijiet għall-ħażna fl-SmPCs ta' Sandimmun Neoral, kapsuli tal ġelatina ratba u soluzzjonijiet orali huma diġà allinjati mar-rekwiżiti stabbiliti fil-Linja Gwida dwar id-Dikjarazzjoni ta' Kondizzjonijiet għall-Ħażna (CPMP/QWP/609/96/Rev 2 datata 19 ta' Nov 2007).
English: Sandimmun is available as Sandimmun soft gelatin capsules (25 mg, 50 mg and 100 mg), Sandimmun oral solution, 100 mg/ml and Sandimmum concentrate for solution for infusion, 50mg/ml.
Maltese: Sandimmun huwa disponibbli bħala Sandimmun kapsuli tal-ġelatina ratba (25 mg, 50 mg u 100 mg), Sandimmun soluzzjoni orali, 100 mg/ml u Sandimmum konċentrat għal soluzzjoni għall-infużjoni, 50mg/ml.
English: The CHMP therefore requested the MAH to justify the positive benefit risk for all nephrotic conditions except the primary minimal change glomerulonephritis, primary focal segmental glomerulosclerosis, or primary membranous glomerulonephritis.
Maltese: jiġġustifika l-benefiċċju-riskju pożittiv għall-kondizzjonijiet nefrotiċi kollha ħlief għal glomerulonefrite primarja b'tibdil minimu, glomerulosklerożi segmentali fokali primarja, jew glomerulonefrite membrana primarja.
English: In the European Union (EU), Sandimmum and Sandimmun Neoral are registered via national procedures.
Maltese: Fl-Unjoni Ewropea (UE), Sandimmum u Sandimmun Neoral huma rreġistrati permezz ta' proċeduri nazzjonali.
English: The MAH proposed two different wordings for each of the paragraphs on transplantation:
Maltese: Il-MAH ippropona żewġ kitbiet differenti għall kull paragrafu dwar it-trapjanti:
English: The administration started within 2-20 hours prior to surgery.
Maltese: L-għoti beda fi żmien 2-20 siegħa qabel l-operazzjoni.
English: The MAH proposed wordings for the sub-sections “Food interactions, Drug interactions, Drugs that decrease ciclosporin levels, Drugs that increase ciclosporin levels, Other relevant drug interactions, Recommendations, Paediatric population and Other relevant drug interactions.”
Maltese: Il-MAH ippropona kliem għas-sottosezzjonijiet “Interazzjonijiet mal-ikel, Interazzjonijiet tal mediċina, Mediċini li jnaqqsu l-livelli ta' ciclosporin, Mediċini li jżidu l-livelli ta' ciclosporin, Interazzjonijiet rilevanti oħra tal-mediċina, Rakkomandazzjonijiet, Popolazzjoni pedjatrika u Interazzjonijiet rilevanti oħra tal-mediċina.
English: The CHMP considered that the use of Hypericum perforatum (St. John's wort, SJW) products in the treatment of a mild depression was not considered to balance the potential risk of an acute organ rejection caused by SJW induction; the CHMP requested the introduction of a contraindication accordingly.
Maltese: Is-CHMP ħass li l-użu ta' prodotti ta' Hypericum perforatum (St. John's wort, SJW) fil-kura ta' dipressjoni ħafifa ma kienx meqjus li jibbilanċja r-riskju potenzjali ta' rifjut akut ta' organu kkawżat mill-induzzjoni ta' SJW; is-CHMP talab l-introduzzjoni ta' kontraindikazzjoni kif xieraq.
English: The control groups were either using placebo, or azathioprine, or D-penicillamine.
Maltese: jew azathioprine, jew D-penicillamine.
English: The approach taken by the MAH to achieve a proposed harmonized SmPC with regard to the safety sections of the SmPC (sections 4.3 to 4.9) was to use as a basis the most recently updated MAH's Core Data Sheet (CDS) of Sandimmun Neoral, dated 13 February 2012 (as justified by a review of submitted legacy studies, and identified literature references) and the finalized Core Safety profile (CSP) from the last PSUR 13 work sharing (WS) procedure (EE/H/PSUR/0007/001).
Maltese: (CDS) tal-MAH aġġornata l-aħħar ta' Sandimmun Neoral, datata 13 ta' Frar 2012 (kif ġustifikata mir reviżjoni tal-istudji storiċi sottomessi, u r-referenzi identifikati fil-letteratura) u l-profil tas-Sigurtà Ewlenija (CSP) iffinalizzat mill-aħħar proċedura ta' qsim tax-xogħol (WS) 13 tal-PSUR (EE/H/PSUR/0007/001).
English: At the time of submission, patients of 17 years of age maximum qualified as “children”.
Maltese: Fiż-żmien tassottomissjoni, il-pazjenti ta' età massima ta' 17-il sena kienu jikkwalifikaw bħala “tfal”.
English: Sandimmun was used as a basis of the review as the dossier supporting the approval of the new ciclosporin formulation (Sandimmun Neoral) was based on pharmacokinetics evaluation that demonstrated equivalence between the 2 forms of ciclosporin (oil-based formulation versus microemulsified formulation).
Maltese: Sandimmun intuża bħala bażi tar-reviżjoni peress li d-dossier li kien jappoġġja l-approvazzjoni talformulazzjoni l-ġdida ta' ciclosporin (Sandimmun Neoral) kien ibbażat fuq evalwazzjoni farmakokinetika li wriet ekwivalenza bejn iż-żewġ forom ta' ciclosporin (formulazzjoni b'bażi ta' żejt kontra formulazzjoni mikroemulsifikata).
English: Finally the inclusion of the term “cellular” rejection was also discussed since the diagnosis of humoral rejection episodes is controversial.
Maltese: Fl-aħħar nett ġiet diskussa wkoll l-inklużjoni tat-terminu rifjut "ċellulari" peress li d-dijanjosi ta' episodji ta' rifjut umorali hija kontroversjali.
English: In comparison to Sandimmun (oil-based formulation of ciclosporin), Sandimmun Neoral (microemulsified formulation) provides improved dose linearity of ciclosporin exposure, a more consistent absorption profile and shows less influence from concomitant food intake and from diurnal rhythm.
Maltese: (formulazzjoni mikroemulsifikata) jipprovdi titjib fil-linearità tad-doża fl-espożizzjoni għal ciclosporin, profil ta' assorbiment aktar konsistenti u juri anqas influwenza mit-teħid konkomitanti tal-ikel u mir-ritmu tal-ġurnata.
English: In addition, the CHMP considered that substrates for CYP3A4 and/or P-gp and for which elevated plasma levels are associated with serious safety concerns should not be combined with ciclosporin (e.g. dabigatran etexilate, bosentan, aliskiren).
Maltese: Barra minn hekk, is-CHMP ħass li s-substrati għal CYP3A4 u/jew P-gp u li għalihom livelli għolja filplażma huma assoċjati ma' tħassib serju dwar is-sigurtà, ma għandhomx jiġu kkombinati ma‘ ciclosporin (eż. dabigatran etexilate, bosentan, aliskiren).
English: European controlled double-blind trials used 5 mg/kg/d that allowed a downward titration to find the maximum tolerated dose.
Maltese: 5 mg/kg/jum li ppermetta titrazzjoni ‘l isfel biex tinstab id-doża massima tollerata.
English: In line with this agreement, the MAH did not include the indication of aplastic anemia in the harmonized label of Sandimmun and Sandimmun Neoral since this indication is approved in only one of 27 member states and is not listed in Sandimmun and Sandimmun Neoral CDSs.
Maltese: F'konformità ma' dan il-ftehim, il-MAH ma inkludiex l-indikazzjoni għall-anemija aplastika fittikketta armonizzata ta' Sandimmun u Sandimmun Neoral peress li din l-indikazzjoni hija approvata biss f'wieħed minn 27 Stat Membru u mhix imniżżla fis-CDSs ta' Sandimmun u Sandimmun Neoral.
English: Renal dysfunction above the critical threshold, defined as creatinine increased by 3050% over baseline, was less of a problem when starting with a dose of 2.5 mg/kg/day.
Maltese: 'l fuq mil-limitu kritiku, definita bħala żieda fil-krejatinina ta' 30-50% fuq il-linja bażi, kienet anqas ta' problema meta d-doża nbdiet b'2.5 mg/kg/jum.
English: However the CHMP considered that this paragraph should be complemented with recommendations for further controls to be made, e.g. of liver function, bilirubin, serum electrolytes and blood pressure and that it is preferred to use glomerular filtration rate determined by a reliable and reproducible method rather than serum creatinine.
Maltese: eż. tal-funzjoni tal-fwied, tal-bilirubina, l-elettroliti fis-serum u l-pressjoni tad-demm u li preferibbilment tintuża rata ta' filtrazzjoni glomerulari determinata minn metodu affidabbli u riproduċibbli aktar milli bil-krejatinina fis-serum.
English: The CHMP questioned though the benefit-risk of ciclosporin in “prevention of graft rejection following bone marrow transplantation”: the CHMP requested the MAH to submit data confirming a positive benefit-risk of ciclosporin in terms of frequency of stem cell engrafting/graft failure beyond the benefits/risk (B/R) of conditioning treatment.
Maltese: Is-CHMP kellu madankollu dubji dwar il-benefiċċju u r-riskju ta' ciclosporin fil-“prevenzjoni ta' rifjut tat-trapjant wara trapjant tal-mudullun”: is-CHMP talab lill-MAH jissottometti dejta li tikkonferma benefiċċju-riskju pożittiv ta' ciclosporin f'termini ta' frekwenza ta' engrafting/falliment tal-graft ta' ċelloli staminali lil hinn mill-benefiċċji/riskji (B/R) ta' kura kundizzjonali.
English: Section 6.3 - Shelf life
Maltese: Sezzjoni 4.6 - Tqala u Treddigħ
English: The MAH proposed a wording that was approved in between 18 an 24 MS, depending on subsections.
Maltese: Il-MAH ippropona kliem li kien approvat f'bejn 18 u 24
English: The MAH considered that the information included in the proposed harmonized label provided relevant information to the prescribing physician to optimize patient management.
Maltese: Il-MAH qies li l-informazzjoni inkluża fit-tikketta armonizzata proposta kienet tipprovdi informazzjoni rilevanti lit-tabib li jippreskrivi biex tiġi ottimizzata l-ġestjoni tal pazjent.
English: In view of the above dataset, the CHMP considered that the efficacy of Sandimmun (oil based formulation of ciclosporin) has been demonstrated in 4 randomized controlled and 5 uncontrolled studies as well as studies conducted in pediatric patients.
Maltese: L-effikaċja ta Sandimmun (formulazzjoni b'bażi ta' żejt ta' ciclosporin) intweriet f'4 studji aleatorji kkontrollati u 5 studji mhux ikkontrollati.
English: The CHMP was in agreement with the MAH's proposal.
Maltese: Is-CHMP qabel maż-żieda proposta mill-MAH.
English: From the data provided and other published data the CHMP concluded that benefit-risk ratio for ciclosporin in treatment of endogenous refractory uveitis, including Behçet uveitis, is positive.
Maltese: Mid-dejta pprovduta u dejta oħra ppubblikata s-CHMP ikkonkluda li l-proporzjon tal-benefiċċjuriskju għal ciclosporin fil-kura ta' uveite refrattorja endoġena, inkluża l-uveite ta' Behçet, huwa pożittiv.
English: The MAH proposed the wording related to the method of oral administration which is approved in 12 EU countries.
Maltese: Il-MAH ippropona l-kliem relatat mal-metodu ta' għoti orali li huwa approvat fi 12-il pajjiż tal-UE.
English: • Atopic dermatitis
Maltese: • Dermatite atopika
English: The MAH proposed to harmonise the SmPC text along with the agreed CSP.
Maltese: Il-MAH ippropona li t-test tal-SmPC jiġi armonizzat skont s-CSP miftiehem.
English: Extensive information was provided by the MAH, including the dosages used in clinical studies that supported the approval of Sandimmun and Sandimmun Neoral in the bone marrow transplant indications.
Maltese: Il-MAH ipprovda informazzjoni estensiva, inkluż id-dożi użati fl-istudji kliniċi li appoġġaw l approvazzjoni ta' Sandimmun u Sandimmun Neoral fl-indikazzjonijiet għal trapjant tal-mudullun.
English: Rheumatoid arthritis is an approved therapeutic indication in all EU countries.
Maltese: L-artrite rewmatika hija indikazzjoni terapewtika approvata fil-pajjiżi kollha tal-UE.
English: Due to the divergent national decisions taken by Member States (MS) concerning the authorization of Sandimmun Neoral (and associated names), the European Commission (EC) notified the EMA/CHMP secretariat of an official referral under Article 30(2) of Directive 2001/83/EC as amended, to resolve divergences amongst the nationally authorised Sandimmun Neoral SmPCs across the EU/EEA region.
Maltese: Kummissjoni Ewropea (KE) innotifikat is-segretarjat tal-EMA/CHMP dwar riferiment uffiċjali skont l-Artikolu 30(2) tad-Direttiva 2001/83/KE kif emendata, biex jiġu riżolti d-diverġenzi fost l-SmPCs ta' Sandimmun Neoral awtorizzati b'mod nazzjonali madwar ir-reġjun tal-UE/ŻEE.