FrancophonIA/ELRC3.0 huggingface dataset:
English: Table 14: Treatment outcome in HCV genotype 1 infected patients without cirrhosis receiving 12 weeks simeprevir + sofosbuvir, with or without ribavirin (study HPC2002) Treatment outcome simeprevir + sofosbuvir N = 21 % (n/N)
Maltese: Riżultat tat-trattament f'pazjenti infettati b'HCV tal-ġenotip 1 b'ċirrożi li kienu qed jirċievu 12 jew 24 ġimgħa ta' simeprevir + sofosbuvir, b'ribavirin jew mingħajru (studju HPC2002)
English: Gender had no clinically relevant effect on the pharmacokinetics of simeprevir based on a population pharmacokinetic analysis of HCV infected patients treated with simeprevir in combination with peginterferon alfa and ribavirin.
Maltese: Il-ġeneru sesswali ma kellux effett klinikament rilevanti fuq il-farmakokinetiċi ta' simeprevir abbażi tal-analiżi farmakokinetika tal-popolazzjoni dwar pazjenti infettati b'HCV trattati b'simeprevir flimkien ma' peginterferon alfa u ribavirin.
English: In patients aged > 45 years, dyspnoea was reported in 16.4% of simeprevir-treated patients compared to 9.1% in placebo-treated patients (all grades; pooled phase 3).
Maltese: F'pazjenti ta' > 45 sena, il-qtugħ ta' nifs kien rapportat f'16.4% ta' pazjenti trattati b'simeprevir meta mqabbla ma' 9.1% ta' pazjenti trattati bi plaċebo (kull grad; riżultati miġbura ta' fażi 3).
English: Chemistry
Maltese: Kimika
English: Simeprevir in combination with sofosbuvir: Rash and pruritus were reported in 8.0% and 8.4%, respectively, of patients receiving 12 weeks of treatment compared to 12.9% and 3.2%, respectively, of patients receiving 24 weeks of treatment (all grades).
Maltese: Raxx u ħakk kienu rrappurtati fi 8.0% u 8.4%, rispettivament, tal pazjenti li kienu qed jirċievu 12-il ġimgħa ta' trattament imqabbla ma' 12.9% u 3.2%, rispettivament,
English: Table 7: Treatment-emergent laboratory abnormalities observed at a higher incidence in patients receiving simeprevir in combination with peginterferon alfa and ribavirin (pooled phase 3 studies C208, C216 and HPC3007; first 12 weeks of treatments)
Maltese: peginterferon alfa u ribavirin (ġabra tal-istudji C208, C216 u HPC3007 ta' fażi 3;
English: (inhibition of CYP3A4 enzymes and P-gp transporter by both erythromycin and simeprevir)
Maltese: (impediment ta' enzimi ta' CYP3A4 u ttrasportatur ta' P-gp kemm minn erythromycin u simeprevir).
English: (strong CYP3A4 induction)
Maltese: CYP3A4)
English: Outcome for patients without SVR12 On-treatment failure Viral relapse2
Maltese: Falliment waqt it-trattament Rikaduta virali2
English: Patients with cirrhosis1
Maltese: Pazjenti b'ċirrożi1
English: OLYSIO is not recommended for patients with moderate or severe hepatic impairment (Child-Pugh class B or C) (see sections 4.4 and 5.2).
Maltese: OLYSIO mhuwiex irrakkomandat għal pazjenti b'indeboliment tal-fwied moderat jew sever (Klassi ta' Child-Pugh B jew Ċ) (ara sezzjonijiet 4.4 u 5.2).
English: 600 mg once daily efavirenz AUC 0.90 (0.85-0.95) ↔ efavirenz Cmax 0.97 (0.89-1.06) ↔ efavirenz Cmin 0.87 (0.81-0.93) ↔ simeprevir AUC 0.29 (0.26-0.33) ↓ simeprevir Cmax 0.49 (0.44-0.54) ↓ simeprevir Cmin 0.09 (0.08-0.12) ↓
Maltese: 600 mg darba kuljum efavirenz AUC 0.90 (0.85-0.95) ↔ efavirenz Cmax 0.97 (0.89-1.06) ↔ efavirenz Cmin 0.
English: Ledipasvir 30 mg once daily ledipasvir AUC 1.92 (1.77-2.07) ↑ ledipasvir Cmax 1.81 (1.69-2.94) ↑ ledipasvir Cmin not studied simeprevir AUC 2.69 (2.44-2.96) ↑ simeprevir Cmax 2.61 (2.34-2.86) ↑ simeprevir Cmin not studied
Maltese: ledipasvir Cmin ma ġiex studjat simeprevir AUC 2.69 (2.44-2.96) ↑ simeprevir Cmax 2.61 (2.34-2.86) ↑
English: HCV RNA at EOT.
Maltese: Aqra l-fuljett ta' tagħrif.
English: During the first 12 weeks of treatment, the most frequently reported adverse reactions (incidence ≥ 5%) were nausea, rash, pruritus, dyspnoea, blood bilirubin increase and photosensitivity reaction (see section 4.4).
Maltese: L-aktar reazzjonijiet avversi rrappurtati b'mod frekwenti (inċidenza ta' ≥ 5% wara 12 jew 24 ġimgħa ta' trattament) kienu raxx, ħakk, stitikezza, u reazzjoni ta' sensittività għad-dawl (ara sezzjoni 4.4).
English: Pooled phase 3 studies simeprevir + peginterferon alfa + ribavirin N = 152 n (%)
Maltese: simeprevir + peginterferon alfa + ribavirin N = 152 n (%)
English: 12 or 24 weeks SMV + sofosbuvir, with or without ribavirin4
Maltese: 12 jew 24 ġimgħa SMV + sofosbuvir, b'ribavirin jew mingħajru4
English: The safety profile of simeprevir in combination with peginterferon alfa and ribavirin is comparable between HCV genotype 1 infected patients with and without HIV-1 co-infection.
Maltese: Pazjenti koinfettati b'HIV-1 Il-profil ta' sigurtà ta' simeprevir flimkien ma' peginterferon alfa u ribavirin huwa komparabbli bejn pazjenti infettati b' HCV ta' ġenotip 1 u bi u mingħajr koinfezzjoni ta' HIV-1.
English: Table 20 shows the response rates in treatment-experienced patients with HCV genotype 1 infection.
Maltese: Tabella 19 turi r-rati ta' rispons f'pazjenti infettati b'HCV tal-ġenotip 1 li ma kinux ħadu trattament qabel.
English: 2 Following prior treatment with interferon (pegylated or non-pegylated), with or without ribavirin (see section 5.1).
Maltese: 2 Wara trattament preċedenti b'interferon (pegilat jew mhux pegilat) b'ribavirin jew mingħaju (ara sezzjoni 5.1).
English: The emerging NS3 amino acid substitutions were similar to those observed in patients who did not achieve SVR following treatment with simeprevir in combination with peginterferon alfa and ribavirin.
Maltese: Is sostituzzjonijiet fl-aċidi amminiċi ta' NS3 li kienu qed ifiġgu kienu simili għal dawk osservati f'pazjenti li ma kisbux SVR wara trattament b'simeprevir flimkien ma' peginterferon alfa u ribavirin.
English: When ribavirin is added to the combination of OLYSIO and sofosbuvir, and ribavirin needs to be discontinued, treatment of OLYSIO with sofosbuvir without ribavirin can be continued (see section 5.1).
Maltese: Meta ribavirin jiżdied mal-kombinazzjoni ta' OLYSIO u sofosbuvir, u ribavirin ikun meħtieġ li jiġi mwaqqaf, it trattament b'OLYSIO flimkien ma' sofosbuvir mingħajr ribavirin jista' jissokta (ara sezzjoni 5.1).
English: HCV geno/subtype and presence of baseline Q80K polymorphism in HCV genotype 1a HCV genotype 1a with Q80K
Maltese: Ġeno/sottotip ta' HCV u l-preżenza ta' polimorfiżmu ta' Q80K fil-linja bażi f'HCV tal-ġenotip 1a
English: 1 May include few patients with HCV non-genotype 1a/1b.
Maltese: 1 Jista' jinkludi ftit pazjenti li mhumiex ġenotip 1a/1b ta' HCV.
English: Use of a sensitive quantitative HCV RNA assay for monitoring HCV RNA levels during treatment is recommended.
Maltese: Karatteristiċi tal-Prodott rispettiv għal dawn il-prodotti mediċinali.
English: Outcome for patients without SVR12 On-treatment failure Viral relapse1
Maltese: Falliment waqt it-trattament Rikaduta virali1
English: Blood bilirubin increased
Maltese: Żieda fil bilirubin fiddemm'
English: Genotype 1a1 N = 116 % (n)
Maltese: N = 116 % (n)
English: The pharmacokinetic properties of simeprevir have been evaluated in healthy adult subjects and in adult HCV infected patients.
Maltese: .2 Tagħrif farmakokinetiku Il-karatteristiċi farmakokinetiċi ta' simeprevir ġew evalwati f'individwi adulti b'saħħithom f'pazjenti adulti infettati b'HCV.
English: OTHER SPECIAL WARNING(S), IF NECESSARY
Maltese: (n = 2), rispettivament.
English: OLYSIO in combination with peginterferon alfa and ribavirin: HCV/HIV-1 co-infected patients should be treated for the same duration as HCV mono-infected patients, except for co-infected patients with cirrhosis who should receive 36 weeks of treatment with peginterferon alfa and ribavirin after completing 12 weeks of treatment with OLYSIO, peginterferon alfa and ribavirin (total treatment duration of 48 weeks).
Maltese: Pazjenti koinfettati b'HCV/HIV-1, għandhom jiġu ttrattati għall-istess tul ta' żmien bħal pazjenti infettati b'HCV biss, ħlief għal pazjenti koinfettati b'ċirrosi li għandhom jirċievu 36 ġimgħa ta' trattament b'peginterferon alfa u ribavirin wara li jkunu lestew 12-il ġimgħa ta' trattament b'OLYSIO, peginterferon alfa u ribavirin (48 ġimgħa ta' kemm idum b'kollox it-trattament).
English: Plasma concentrations of midazolam were not affected when administered intravenously as simeprevir does not inhibit hepatic CYP3A4.
Maltese: Żidiet sinifikanti filkonċentrazzjonijiet ta' simeprevir fil-plażma hu mistenni (impediment qawwi tal-enzima ta' CYP3A4)
English: Simeprevir is metabolised in the liver.
Maltese: Bijotrasformazzjoni Simeprevir huwa metabolizzat fil-fwied.
English: (moderate CYP3A4 enzyme induction)
Maltese: (sensibilizzazzjoni tal-enzima CYP3A4)
English: 24 weeks simeprevir + sofosbuvir N = 31 n (%)
Maltese: 12-il ġimgħa simeprevir + sofosbuvir N = 286 n (%)
English: In vitro experiments with human Caco-2 cells indicated that simeprevir is a substrate of P-gp.
Maltese: Esperimenti in vitro b'ċelluli umani ta' Caco-2 kienu jindikaw li simeprevir huwa sottostrat ta' P-gp. Effett tal-ikel fuq l-assorbiment.
English: R155X+ D168X4
Maltese: Is-sostituzzjonijiet D168V u R155K
English: Median baseline HCV RNA levels (log10 IU/ml) Presence of cirrhosis no cirrhosis with cirrhosis Prior treatment history treatment-naïve treatment-experienced1 IL28B genotype CC non-CC HCV geno/subtype and presence of baseline Q80K polymorphism in HCV genotype 1a HCV genotype 1a with Q80K HCV genotype 1b
Maltese: Meta wieħed jikkonsidra t-trattament ta' kombinazzjoni ta' OLYSIO b'peginterferon alfa u ribavirin f'pazjenti li għandhom HCV b'ġenotip 1a, il-pazjenti għandhom jiġu ttestjati għall-preżenza ta' virus bil-polimorfiżmu NS3 Q80K qabel ma jibda jingħata t-trattament (ara sezzjoni 4.4).
English: Plasma exposure of simeprevir (AUC) in HCV infected patients was about 2- to 3-fold higher compared to that observed in healthy subjects.
Maltese: L-esponiment ta' simeprevir fil-plażma (AUC) f'pazjenti infettati b'HCV kien ta' darbtejn jew 3 darbiet ogħla meta mqabbel ma' dak osservat f'individwi b'saħħithom.
English: Supernumerary ribs and delayed ossification were reported in mice at 4-fold higher exposures than those observed in humans at the recommended dose of 150 mg once daily.
Maltese: Kustilji sopranumerarji u ossifikazzjoni mdewwma ġew rapportati fil-ġrieden, f'esponimenti li kienu 4 darbiet aktar minn dawk osservati fil-bniedem fid-doża rakkomandata ta' 150 mg darba kuljum.
English: Hyperbilirubinemia Grade 1
Maltese: Il-gradi kollha Grad 3
English: treatment was 24 weeks if the following on-treatment protocol-defined response-guided therapy criteria were met: HCV RNA < 25 IU/ml detectable or undetectable at week 4 AND undetectable HCV RNA at week 12.
Maltese: trattament ippjanat għal HCV kien ta' 24 ġimgħa jekk kienu ssodisfati l-kriterji ta' terapija waqt it-trattament iddefiniti bi protokoll u gwidati mir-rispons li ġejjin: RNA ta' HCV < 25 IU/ml li seta' jew ma setax jitkejjel f'ġimgħa 4 U HCV ta' RNA li ma setax jitkejjel f'ġimgħa 12.
English: Close monitoring is recommended if this medicinal product is administered with OLYSIO in combination with sofosbuvir (see section 4.4).
Maltese: qabel il-bidu tat-terapija b'OLYSIO flimkien ma' sofosbuvir (ara sezzjoni 4.4).
English: (when taken by mouth) to decrease blood pressure - dexamethasone (when given by injection or taken by mouth) to treat asthma or inflammation and auto-immune diseases - cisapride to treat stomach problems - milk thistle (a herbal medicine) for liver problems - St John's wort (Hypericum perforatum, a herbal medicine) for anxiety or depression - ledipasvir to treat hepatitis C infection - cobicistat to increase levels of some medicines used to treat HIV infection - atazanavir, darunavir, delavirdine, efavirenz, etravirine, fosamprenavir, indinavir, lopinavir,
Maltese: - tfief (mediċina magħmula mill-ħxejjex) għal problemi tal-fwied - St John's wort (Hypericum perforatum, mediċina magħmula mill-ħxejjex) għal ansjetà jew depressjoni - ledipasvir biex jittratta infezzjoni tal-epatite C
English: Ketoconazole*
Maltese: plaċebo
English: Following a single oral administration of 200 mg 14C-simeprevir to healthy subjects, the majority of the radioactivity in plasma (up to 98%) was accounted for by unchanged drug and a small part of the radioactivity in plasma was related to metabolites (none being major metabolites).
Maltese: Wara għoti orali waħda ta' 200 mg 14C-simeprevir lil individwi b'saħħithom, il-maġġoranza tar-radjoattività fil-plażma (sa 98%) ingħata kont dwarhom bħala l-mediċina mhux mibdula u parti żgħira tar-radjoattività fil-plażma kienet relatata ma' metaboliti (ebda wieħed ma kienu metaboliti prinċipali).
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanzi attivi jew għal kwalunkwe sustanza mhux attiva elenkata fis sezzjoni 6.1.
English: Genotype 1, treatment-experienced4
Maltese: Firxa tat-tossiċita tal-WHO1
English: Antifungals (systemic administration) Itraconazole
Maltese: Antifungali (għoti sistemiku)
English: ANTIARRHYTHMICS Digoxin
Maltese: Tfal u adolexxenti
English: Laboratory abnormalities
Maltese: Reżistenza inkroċjata
English: Hepatobiliary disorders: common blood bilirubin increased* blood bilirubin increased* blood bilirubin increased* Skin and subcutaneous tissue disorders: very common rash*
Maltese: - raxx fil-ġilda* - stitikezza - tkun sensittiv għad-dawl tax-xemx (fotosensittività) - żieda fil-livelli tal-‘bilirubin' fid-demm tiegħek (bilirubin huwa pigment magħmul mill-fwied).
English: Viral relapse3
Maltese: Rikaduta virali4
English: SVR12 rates for selected subgroups METAVIR fibrosis score F0-2 F3-4 F4 IL28B genotype CC CT TT HCV geno/subtype and presence of Q80K polymorphism in HCV genotype 1a Genotype 1a with Q80K without Q80K Genotype 1b
Maltese: Ħamsa u erbgħin fil-mija (13/29) tal pazjenti ttrattati b'simeprevir infettati b'HCV tal-ġenotip 1a b'polimorfiżmu Q80K kellhom RNA ta' HCV li ma setax jitkejjel f'ġimgħa 4; f'dawn il-pazjenti ir-rata ta' SVR12 kienet 77%.
English: d.o.o.
Maltese: Ħad
English: OATP1B1/3 and MRP2 are involved in the transport of bilirubin into and out of hepatocytes.
Maltese: OATP1B1/3 u MRP2
English: The efficacy of simeprevir (150 mg once daily) as part of an interferon-free regimen (sofosbuvir, 400 mg once daily) was evaluated in patients with HCV genotype 1 or 4 infection, who were treatment-naïve or treatment-experienced patients (following prior interferon-based therapy) (table 11).
Maltese: (sofosbuvir, 400 mg darba kuljum) ġiet ivvalutata f'pazjenti b'infezzjoni ta' HCV tal-ġenotip 1 jew 4, li qatt ma ħadu trattament qabel jew li kienu ħadu trattament qabel (wara terapija preċedenti abbażi ta'
English: Efficacy in patients with HCV genotype 4 infection In study HPC3011 (RESTORE), patients who were treatment-naïve or failed prior peg-IFN/RBV therapy received simeprevir (150 mg once daily) + peginterferon alfa-2a + ribavirin for 12 weeks, followed by 12 or 36 additional weeks of peginterferon alfa-2a + ribavirin (see tables 17 and 18).
Maltese: Fl-istudju HPC3011 (RESTORE), pazjenti li qatt ma kienu ħadu trattament qabel jew li kienu fallew terapija preċedenti b'peg-IFN/RBV irċivew simeprevir (150 mg darba kuljum) + peginterferon alfa-2a
English: Efficacy in treatment-experienced patients with HCV genotype 1 infection In study HPC3007 (PROMISE), patients who relapsed after prior IFN-based therapy received simeprevir (150 mg once daily) + peginterferon alfa-2a + ribavirin for 12 weeks, followed by 12 or 36 additional weeks of peginterferon alfa-2a + ribavirin (see tables 17 and 18).
Maltese: FL-istudju HPC3007 (PROMISE), pazjenti li rkadew wara li kienu rċivew terapija preċedenti abbażi ta' IFN irċivew simeprevir (150 mg darba kuljum) + peginterferon alfa-2a + ribavirin għal
English: Substitutions D168V and R155K alone or in combinations with other mutations at these positions emerged most frequently (table 10).
Maltese: Sostituzzjonijiet bħal D168V jew A, u R155K kienu ġeneralment assoċjati ma' tnaqqis kbir fis-suxxetibilità ta' simeprevir in vitro, (FC
English: The overall SVR12 rate for patients without cirrhosis receiving 8 weeks of simeprevir + sofosbuvir was 75% (15/20); all patients not achieving SVR12 had viral relapse (25%; 5/20).
Maltese: sofosbuvir kienet 75% (15/20); il-pazjenti kollha li ma kisbux SVR12 kellhom rikaduta virali (25%;
English: The HCV RNA thresholds that trigger discontinuation of treatment (i.e., treatment stopping rules) are presented in table 3.
Maltese: (i.e., regoli ta' waqfien ta' trattament) hume preżentati f'tabella 3.
English: Posology The recommended dosage of OLYSIO is one capsule of 150 mg once daily, taken with food.
Maltese: Id-dożaġġ rakkomandat ta' OLYSIO hu ta' kapsula waħda ta' 150 mg darba kuljum, mal-ikel.
English: Co-administration of OLYSIO with substances that moderately or strongly induce or inhibit cytochrome P450 3A (CYP3A4) is not recommended as this may lead to significantly lower or higher exposure of simeprevir, respectively.
Maltese: L-għoti konġunt ta' OLYSIO ma' sustanzi li b'mod moderat jew qawwi jissensibilizzaw jew jimpedixxu cytochrome P450 3A (CYP3A4) mhux rakkomandat peress li dan jista' jwassal għal tnaqqis sinifikanti jew esponiment ogħla għal simeprevir rispettivament.
English: Table 16: Treatment outcome in HCV genotype 4 infected patients receiving 12 weeks simeprevir + sofosbuvir (studies HPC2014 and HPC3021) Treatment outcome
Maltese: Riżultat tat-trattament f'pazjenti infettati b'HCV tal-ġenotip 4 li kienu qed jirċievu 12-il ġimgħa ta' simeprevir + sofosbuvir (studji HPC2014
English: Dosage adjustment or interruption of medicinal products used in combination with OLYSIO for the treatment of CHC
Maltese: Aġġustament tad-doża jew interruzzjoni ta' prodotti mediċinali użati flimkien ma' OLYSIO għat trattament ta' CHC
English: Data from an ongoing, long-term follow-up study (study HPC3002) in patients who did not achieve SVR with a simeprevir-based regimen in a previous phase 2 study showed that in 70% (16/23) of these patients emerging mutations were no longer detected after a median follow-up of 88 weeks (range 47-147 weeks).
Maltese: Tagħrif minn studju għaddej, b'sussegwirsi fuq perijodu ta' żmien twil (studju HPC3002) f'pazjenti li ma kisbux SVR bi programm ta' kura bażat fuq simeprevir fi studju ta' qabel ta' fażi 2 wera li 70% (16/23) ta' dawn il-mutazzjonijiet li tfaċċaw fil-pazjenti ma baqgħux jiġu osservati aktar wara sussegwirsi medjan ta' 88 ġimgħa (medda ta' 47-147 ġimgħa).
English: Prof. Pieter de Graeff
Maltese: Pieter de Graeff
English: 18 December 2008
Maltese: 18 Diċembru 2008
English: Ref. EMEA/CHMP/71684/2009 EMEA/H/A-29/1105
Maltese: EMEA/H/A-29/1105
English: What is Ciclosporin IDL?
Maltese: X'inhu Ciclosporin IDL?
English: An autoimmune disease is a disease which is caused by the body's own defence system attacking normal tissue, such as psoriasis (a disease causing red, scaly patches on the skin), atopic dermatitis (eczema, an itchy red rash), nephrotic syndrome (a kidney disease) and rheumatoid arthritis (inflammation of the joints).
Maltese: Marda awtoimmuni hija marda li hija kkawżata mis-sistema tal-ġisem fejn id-difiża proprja tattakka tessut normali, bħal psorjażi (marda li tikkawża ħmura, qxur rqajja fuq il-ġilda), dermatite atopika (ekżema, raxx aħmar bil-ħakk), sindromu nefrotiku (mard tal-kliewi) u artrite rewmatika (infjammazzjoni tal-ġogi).
English: Questions and answers on the referral for Ciclosporin IDL and associated names capsules containing ciclosporin 25 mg, 50 mg and 100 mg
Maltese: Mistoqsijiet u tweġibiet dwar ir-referenza għal Ciclosporin IDL u ismijiet assoċjati kapsuli li fihom ciclosporin 25 mg, 50 mg u 100 mg
English: Ciclosporin IDL is a generic medicine that is based on a reference medicine authorised in Germany (Sandimmun Optoral 25 mg capsules).
Maltese: Ciclosporin IDL hija mediċina ġenerika li hija bbażata fuq mediċina ta' referenza awtorizzata filĠermanja (kapsuli ta' Sandimmun Optoral 25 mg).
English: Company responses provided on: 16 January 2009 Opinion date:
Maltese: Risposti tal-kumpanija provduti fis- 16 Jannar 2009
English: The company International Drug Licensing (IDL) submitted Ciclosporin IDL for mutual recognition on the basis of the initial authorisation granted by the Netherlands on 10 August 2007.
Maltese: Il-kumpanija International Drug Licensing (IDL) sottomettiet Ciclosporin IDL għar-rikonoxximent reċiproku abbażi tal-awtorizzazzjoni inizjali mogħtija mill-Olanda fl-10 ta' Awwissu 2007.
English: The company wanted the authorisation to be recognised in Belgium, Germany, Italy, Spain, Sweden and the United Kingdom (the ‘concerned Member States').
Maltese: Ilkumpanija riedet li l-awtorizzazzjoni li għandha tiġi rikonoxxuta fil-Belġju, fil-Ġermanja, fl-Italja, fiSpanja, fl-Iżvezja u fir-Renju Unit (l-Istati Membri interessati).
English: The grounds for the referral were that five of the concerned Member States did not agree that enough evidence had been presented to show that Ciclosporin IDL was ‘bioequivalent' to the reference medicine.
Maltese: Ir-raġunijiet għar-referenza kienu li wieħed mill-Istati Membri kkonċernati, il-Polonja, ma qabilx li ġew ippreżentati provi suffiċjenti biex juru li Ciclosporin IDL kien ‘bijoekwivalenti' għall-mediċina ta' referenza.
English: London, 23 April 2009 Doc.
Maltese: Londra, 22 ta' Lulju 2010
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Ciclosporin IDL do not outweigh its risks, and that the marketing authorisation granted in the Netherlands cannot be recognised in other Member States of the EU.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) talAġenzija kkonkluda li l-benefiċċji ta' Ciclosporin IDL mhumiex akbar mir-riskji tiegħu, u li lawtorizzazzjoni għat-tqegħid fis-suq mogħtija fl-Olanda ma tistax tiġi rikonoxxuta fl-Istati Membri loħra tal-UE u li l-awtorizzazzjoni għat-tqegħid fis-suq ġiet sospiża fl-Olanda.
English: Ciclosporin IDL is an immunosuppressive medicine.
Maltese: Ciclosporin IDL huwa mediċina immunosoppressiva (mediċina li tnaqqas l-attività tas-sistema immunitarja, difiżi naturali tal-ġisem).
English: The European Medicines Agency has completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Ciclosporin IDL.
Maltese: Fit-23 ta' April 2009,l-Aġenzija Ewropea għall-Mediċini (EMEA) temmet proċedura ta' arbitraġġ wara nuqqas ta' qbil fost l-Istati Membri tal-Unjoni Ewropea (UE) fir-rigward tal-awtorizzazzjoni talmediċina Ciclosporin IDL.
English: It acts on some special cells in the immune system called T-cells that are responsible for attacking transplanted organs or, in auto-immune diseases, normal tissue.
Maltese: Is-sustanza attiva f'Ciclosporin IDL, ciclosporin, taġixxi fuq xi ċelloli speċjalment fis-sistema immunitarja imsejħin ċelloli T li huma responsabbli sabiex jattakkaw organi trapjantati jew fil-mard awtoimmunitarju, tessut normali.
English: The active substance in Ciclosporin IDL, ciclosporin, is an immunosuppressive agent.
Maltese: Il-kumpanija li tbiegħ Ciclosporin IDL, International Drug Licensing, talbet eżaminazzjoni mill-ġdid tal-opinjoni.
English: However, because the concerned Member States were not able to reach an agreement, the Dutch medicines regulatory agency referred the matter to the CHMP for arbitration on 2 December 2008.
Maltese: Madankollu, minħabba li l-Istati Membri kkonċernati ma setgħux jilħqu ftehim, l-aġenzija regolatorja Olandiża tal-mediċini għaddiet il-kwistjoni lill-CHMP għall-arbitraġġ fit-2 ta' Diċembru 2008.
English: In addition the Committee has also recommended that the marketing authorisation for Ciclosporin IDL in the Netherlands and other member states in the EU where the product has been authorised should be suspended until satisfactory bioequivalence data are obtained.
Maltese: Barra minn hekk il-Kumitat irrakkomanda wkoll li l-awtorizzazzjoni tattqegħid fis-suq għall-Ciclosporin IDL fl-Olanda u fl-Stati Membri oħra fl-UE fejn il-prodott ikun ġie awtorizzat għandu jkun sospiż sakemm id-dejta ta' bijoekwivalenza sodisfaċenti jiġu miksuba.