FrancophonIA/ELRC3.0 huggingface dataset:
English: Final analysis of these studies, after un-blinding, will provide further information on the benefit/risk of SGLT2 inhibitors particularly of the risk of lower limb amputations.
Maltese: L-analiżi finali ta' dawn l-istudji, wara l-un-blinding, se tipprovdi informazzjoni ulterjuri dwar il-benefiċċju u r-riskju tal-inibituri ta' SGLT2 partikolarment dwar ir-riskju tal-amputazzjonijiet tan-naħa ta' isfel tar-riġlejn.
English: • The PRAC therefore considered that the risk may constitute a possible class effect;
Maltese: • Għalhekk, il-PRAC ikkunsidra li l-riskju jista' jikkostitwixxi effett ta' klassi possibbli;
English: For canagliflozin, lower limb amputations (mainly of the toe) have been also included, as an adverse drug reaction, in the product information;
Maltese: Għal canagliflozin, ġew inklużi wkoll l-amputazzjonijiet tannaħa ta' isfel tar-riġlejn (prinċipalment tas-saba' tas-sieq), bħala reazzjoni avversa għal mediċina, fl-informazzjoni dwar il-prodott;
English: Sodium-glucose co-transporter 2 (SGLT2) inhibitors are used together with diet and exercise in patients with type 2 diabetes, either alone or in combination with other diabetes medicines.
Maltese: L-inibituri tal-kotrasportatur 2 ta' sodju-glukożju (SGLT2) jintużaw flimkien ma' dieta u eżerċizzju f'pazjenti bid-dijabete tat-tip 2, jew waħedhom jew flimkien ma' mediċini oħrajn tad-dijabete.
English: Consequently, the EC requested on 6 July 2016 to extend the current procedure to include all of the authorised products of the class of SGLT2 inhibitors.
Maltese: Konsegwentament, fis-6 ta' Lulju 2016, ilKE talbet biex testendi l-proċedura attwali biex tinkludi l-prodotti awtorizzati kollha tal-klassi talinibituri ta' SGLT2.
English: Therefore, having considered all the data submitted, in view of the above, the PRAC concluded that the benefit-risk balance of the bove listed products remains positive, but considered that changes to the product information of all authorised SGLT2 inhibitors adding information on the risk of lower limb amputations, as well as additional pharmacovigilance activities to be reflected in the RMP, are warranted.
Maltese: Konsegwentement, il-PRAC ikkonkluda li l-bilanċ bejn il-benefiċċju u r-riskju tal-prodotti li fihom inibitur ta' SGLT2 identifikati fl-Anness A jibqa' favorevoli, soġġett għall-emendi maqbula flinformazzjoni dwar il-prodott u attivitajiet ta' farmakoviġilanza addizzjonali li għandhom jiġu riflessi flRMP.
English: Further to the information received by the EMA, the Independent Data Monitoring Committee (IDMC) for the CANVAS and CANVAS-R studies, which has access to all un-blinded CV outcome and safety data, recommended that the study should continue, that action to minimize this potential risk should be taken and that participants should be informed adequately about this risk.
Maltese: Barra mill-informazzjoni li rċeviet l-EMA, il-Kumitat Indipendenti għall-Monitoraġġ tad-Data (IDMC, Independent Data Monitoring Committee) għall-istudji CANVAS u CANVAS-R, li għandu aċċess għaddata kollha ta' eżitu u sigurtà CV mhux blinded, irrakkomanda li l-istudju għandu jkompli, li għandha tittieħed azzjoni biex jiġi mminimizzat dan ir-riskju potenzjali u li l-parteċipanti għandhom jiġu infurmati b'mod adegwat dwar dan ir-riskju.
English: • The PRAC noted that data on amputation events from clinical trials and post-marketing surveillance for dapagliflozin and empagliflozin-containing medicines are either not available to the same extent as for canagliflozin-containing medicines or there were some limitations in the data collection of these events;
Maltese: • Il-PRAC innota li d-data dwar l-avvenimenti ta' amputazzjoni mill-provi kliniċi u mis-sorveljanza ta' wara t-tqegħid fis-suq għal mediċini li fihom dapagliflozin u mediċini li fihom empagliflozin jew mhijiex disponibbli sal-istess punt bħal dak għal mediċini li fihom canagliflozin jew kien hemm xi limitatzzjonijiet fil-ġbir tad-data ta' dawn l-avvenimenti;
English: • The PRAC was therefore of the view that the risk of lower limb amputation should be included in the product information for all products listed in Annex A, with a warning highlighting to healthcare professional and patients the importance of routine preventative foot care.
Maltese: • Għalhekk, il-PRAC kien tal-fehma li r-riskju ta' amputazzjoni tan-naħa ta' isfel tar-riġlejn għandu jiġi inkluż fl-informazzjoni dwar il-prodott għall-prodotti kollha elenkati fl-Anness A, bi twissija għall-professjonisti fil-qasam tal-kura tas-saħħa u għall-pazjenti li tenfasizza limportanza ta' kura tas-saqajn preventiva ta' rutina.
English: • The PRAC was of the view that it is currently not possible to identify an underlying cause for the observed imbalances in amputation risk that would be specifically attributable to canagliflozin-containing medicines and not to the other products of the class;
Maltese: • Il-PRAC kien ukoll tal-fehma li bħalissa mhuwiex possibbli li tiġi identifikata kawża sottostanti għall-iżbilanċi osservati fir-riskju ta' amputazzjoni li jkunu attribwiti speċifikament għal mediċini li fihom canagliflozin u mhux għall-prodotti l-oħrajn tal-klassi;
English: • Because no specific risk factors could be identified apart from general amputation risk factors potentially contributing to the events, the PRAC recommended that patients should be advised on routine preventative foot care and maintaining adequate hydration as a general advice to prevent amputation;
Maltese: • Minħabba l-fatt li ebda fattur ta' riskju speċifiku ma seta' jiġi identifikat ħlief għal fatturi ta' riskju ta' amputazzjoni ġenerali li potenzjalment jikkontribwixxu għall-avvenimenti, il-PRAC irrakkomanda li l-pazjenti għandhom jiġu avżati dwar kura tas-saqajn preventiva ta' rutina u li jżommu idratazzjoni adegwata bħala parir ġenerali biex jipprevjenu l-amputazzjoni;
English: • The PRAC considered that the available data on amputation in the CANVAS and CANVAS-R trials confirm that treatment with canagliflozin may contribute to an increased risk of amputation of the lower limb, mainly of the toe;
Maltese: • Il-PRAC ikkunsidra li d-data disponibbli dwar l-amputazzjoni fil-provi ta' CANVAS u CANVAS-R tikkonferma li l-kura b'canagliflozin tista' tikkontribwixxi għal riskju miżjud ta' amputazzjoni tan-naħa ta' isfel tar-riġlejn, prinċipalment tas-saba' tas-sieq;
English: Hence, it is currently not possible to establish whether the increased amputation risk is a class effect or not.
Maltese: Għaldaqstant, bħalissa mhuwiex possibbli li jiġi stabbilit jekk ir-riskju miżjud ta' amputazzjoni huwiex effett ta' klassi jew le.
English: The PRAC also considered that data on amputation events from clinical trials and postmarketing surveillance for dapagliflozin and empagliflozin-containing medicines are either not available to the same extent as for canagliflozin-containing medicines or here were some limitations in the data collection.
Maltese: Il-PRAC ikkunsidra wkoll li d-data dwar l-avvenimenti ta' amputazzjoni mill-provi kliniċi u mis-sorveljanza ta' wara t-tqegħid fis-suq għal mediċini li fihom dapagliflozin u l-mediċini li fihom empagliflozin jew mhijiex disponibbli sal-istess punt bħal dak għal mediċini li fihom canagliflozin jew hawn kien hemm xi limitazzjonijiet fil-ġbir tad-data.
English: Strength Pharmaceutical
Maltese: Għamla Farmaċewtika
English: GROUNDS FOR NEGATIVE OPINION
Maltese: RAĠUNIJIET GĦAL OPINJONI NEGATTIVA
English: Czech Republic PRO.MED.CS Praha a.s. Tel ská 1
Maltese: PRO.MED.CS Praha a.s. Telčská 1
English: Prokanaz 100 mg ciet s kapsulas
Maltese: Prokanaz 100 mg cietās kapsulas
English: Itraconazole is an antimycoticum active against infections caused by dermatophytes, yeasts, Aspergillus spp, Histoplasma spp., Paracoccidioides brasiliensis, Sporothrix schenckii, Fonsecaea spp., Cladosporium spp., Blastomyces dermatitidis, and various other yeasts and fungi.
Maltese: Itraconazole huwa antimikotiku attiv kontra infezzjonijiet ikkawżati minn dermatofiti, ħmejjer, Aspergillus spp, Histoplasma spp., Paracoccidioides brasiliensis, Sporothrix schenckii, Fonsecaea spp., Cladosporium spp., Blastomyces dermatitidis, u diversi ħmejjer u fungi oħrajn.
English: Tel ská 1
Maltese: Praga 4
English: Slovak Republic
Maltese: Ir-Repubblika Slovakka
English: The confidence intervals and the value of relative bioavailability for the 3 parameters (Cmax, AUCt and AUCinf) were provided.
Maltese: L-intervalli ta' kunfidenza u l-valur tal-bijodisponibbiltà relattiva għat3 parametri (Cmax, AUCt u AUCinf) kienu pprovduti.
English: - the benefit risk of the generic product Prokanazol is considered to be negative,
Maltese: - il-benefiċċju riskju tal-prodott ġeneriku Prokanazol huwa meqjus negattiv,
English: The Applicant provided both values (precision and accuracy) for both products (hidroxi-itraconazol and itraconazol) from the 6 chromatograms obtained.
Maltese: L-Applikant ipprovda ż-żewġ valuri (preċiżjoni u eżattezza) għaż-żewġ prodotti (idrossi-itraconazol u itraconazol) mis-6 kromatogrammi miksubin.
English: Volunteer number 24 showed a decreased absorption with 52% of the sampling points BLQ, and only one sampling point with quantifiable values from his maximum concentration.
Maltese: Ilvoluntier numru 24 wera assorbiment imnaqqas bi 52% tal-punti ta' teħid ta' kampjuni BLQ, u punt ta' teħid ta' kampjuni wieħed biss b'valuri kwantifikabbli mill-konċentrazzjoni massima tiegħu.
English: When including the data for subject 24, bioequivalence cannot be proven, as the 90% confidence intervals for AUC and Cmax then fall outside the normal acceptance criteria of 80 - 125%.
Maltese: Meta wieħed jinkludi d-dejta għas-suġġett 24, ilbijoekwivalenza ma tistax tiġi ppruvata, minħabba li l-intervalli ta' kunfidenza ta' 90% għal AUC u Cmax imbagħad jaqgħu barra mill-kriterji normali ta' aċċettazzjoni ta' 80-125%.
English: The CHMP therefore adopted a List of Outstanding Issues:
Maltese: Għaldaqstant is-CHMP adotta Lista ta' Kwistjonijiet Pendenti:
English: No valid arguments were provided to justify the lack of credible pharmacokinetic calculations, as the LOQ value used in analytical method was not determined by a validation process, but arbitrarily accepted as 5 ng/ml (the lowest calibrator).
Maltese: Ma ġewx ipprovduti argumenti validi li jiġġustifikaw in-nuqqas ta' kalkoli farmakokinetiċi kredibbli, minħabba li l-valur ta' LOQ użat fil-metodu analitiku ma kienx stabbilit permezz ta' proċess ta' konvalida, iżda aċċettat arbitrarjament bħala 5 ng/ml (l-iktar kalibratur baxx).
English: ANNEX II SCIENTIFIC CONCLUSIONS
Maltese: ANNESS II KONKLUŻJONIJIET XJENTIFIĊI
English: The Applicant stated that because the method to calculate the area under the curve is not described in the European guide (EMA), the method described in the FDA guide (page 9, paragraph III.A.8c) was used, applying the software WinNonlin which uses the module NCA (“Non compartmental Analysis”).
Maltese: L-Applikant iddikjara li minħabba li l-metodu biex tkun ikkalkolata l-erja taħt il-kurva mhuwiex deskritt filgwida Ewropea (EMA), intuża l-metodu deskritt fil-gwida tal-FDA (paġna 9, paragrafu III.A.8c), blapplikazzjoni tas-softwer WinNonlin li juża l-modulu NCA (“Non Compartmental Analysis”).
English: EU/EEA
Maltese: Stat Membru UE/ŻEE
English: One of the metabolites is hydroxy-itraconazole, which has in vitro antifungal activity comparable to itraconazole.
Maltese: Wieħed mill-metaboliti huwa idrossi-itraconazole, li għandu attività antifungali in vitro li tixbah lil itraconazole.
English: Disagreement remained between the concerned member states regarding the bioequivalence of Prokanazol to the originator, as no agreement could be reached with regards to the limits of quantification (LOQ) of itraconazole, the validation of calculation method of Cx/ z ratio (Cx being the last evaluable concentration and z being the last exponential elimination constant) or the justification of values of AUC residual above 20% of AUC total.
Maltese: Baqa' nuqqas ta' qbil bejn l-Istati Membri kkonċernati rigward il-bijoekwivalenza bejn Prokanazol u lmediċini oriġinarja, minħabba li ma seta' jintlaħaq ebda qbil dwar il-limiti ta' kwantifikazzjoni (limits of quantification - LOQ) ta' itraconazole, dwar il-konvalida tal-metodu ta' kalkolu tal-proporzjon Cx/λz (Cx tkun l-aħħar konċentrazzjoni evalwabbli u λz ikun l-aħħar kostanti ta' eliminazzjoni esponenzjali) jew ilġustifikazzjoni tal-valuri ta' AUC residwi 'l fuq minn 20% tal-AUC totali.
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM(S), STRENGTH(S) OF THE MEDICINAL PRODUCT(S), ROUTE(S) OF ADMINISTRATION, APPLICANT(S) / MARKETING AUTHORISATION HOLDER(S) IN THE MEMBER STATES
Maltese: TAL-PRODOTT(I), MNEJN JINGĦATA, APPLIKANT(I) / DETENTUR(I)
English: Therefore, pharmacokinetic and bioequivalence results were analysed with all the data available obtained from 35 of the 36 volunteers included in the study, after removing volunteer 24 who presented a clearly atypical absorption pattern that prevented evaluating the area under the curve.
Maltese: Għaldaqstant, ir-riżultati farmakokinetiċi u ta' bijoekwivalenza ġew analizzati bid-dejta kollha disponibbli miksuba minn 35 mis-36 voluntiera inklużi flistudju, wara li tneħħa l-voluntier 24 li ppreżenta mudell ta' assorbiment atipiku ċar u li ma kienx jippermetti l-evalwazzjoni tal-erja taħt il-kurva.
English: The CHMP considered that the applied methods for calculating the AUCt and AUCinf and the ‘last exponential elimination constant' are standard and general accepted methods and noted that the requested data were provided, with at least 3 data points being used for estimation of the elimination phase.
Maltese: Is-CHMP kkunsidra li l-metodi applikati għall-kalkolu tal-AUCt u AUCinf u ta' ‘l-aħħar kostanti ta' eliminazzjoni esponenzjali' huma standard u metodi ġeneralment aċċettati u nnota li d-dejta mitluba kienet ipprovduta, b'mill-inqas 3 punti ta' dejta użati għall-istima tal-fażi ta' eliminazzjoni.
English: The Applicant included data on Clast, providing the last quantified concentration for each volunteer and formulation and the individual semi-logarithm pharmacokinetic figures.
Maltese: L-Applikant inkluda dejta dwar Clast, billi pprovda l-aħħar konċentrazzjoni kwantifikata għal kull voluntier u kull formulazzjoni u ċ-ċifri farmakokinetiċi individwali f'forma semilogarittmika.
English: Furthermore, the elimination half-life of itraconazole is about 26 hours and blood samples were obtained over at least 3-times the elimination half-life.
Maltese: Barra minn hekk, ilhalf-life ta' eliminazzjoni ta' itraconazole huwa ta' madwar 26 siegħa u nkisbu kampjuni tad-demm fuq millinqas 3 darbiet il-half-life ta' eliminazzjoni.
English: Inter-patient variability in serum concentrations following oral administration of itraconazole has been described in the literature, and is most notable with the capsule formulation (up to 15-fold differences).
Maltese: Il-varjabbiltà bejn il-pazjenti f'konċentrazzjonijiet tas-serum wara t-teħid orali ta' itraconazole ġiet deskritta fil-letteratura, u tidher l-aktar bil-formulazzjoni f'kapsuli (differenzi sa 15-il darba).
English: Values for the pharmacokinetic parameters were presented, but without any documentation of their calculation, preventing verification.
Maltese: Ġew ippreżentati valuri għall-parametri farmakokinetiċi, iżda mingħajr l-ebda dokumentazzjoni tal-kalkolu tagħhom, li għalhekk ma jippermettix li ssir verifika.
English: It is thus impossible to calculate any AUC with a minimum robustness.
Maltese: Huwa għalhekk impossibbli li wieħed jikkalkola kwalunkwe AUC b'qawwa minima.
English: The correctness of the estimator point calculations could not be assessed and there is no summary of the specification calculations for the analysis of variance and intra- and inter-variability, individual ratios and differences for pharmacokinetic parameters.
Maltese: Il-korrettezza tal-kalkoli ta' punti ta' stima ma setgħetx tkun evalwata u m'hemm l-ebda sommarju tal-kalkoli ta' speċifikazzjoni għall-analiżi tad-differenzi u intra- u intervarjabbiltà, proporzjonijiet individwali u differenzi għall-parametri farmakokinetiċi.
English: Please produce calculations of the following after removal of volunteers with values below the LOQ: a. AUCinf; b. AUCt; c. Cmax
Maltese: AUCinf; b. AUCt; c.
English: The Applicant also provided the raw data for all volunteers as requested by the CHMP.
Maltese: Jekk jogħġbok ipprovdi d-dejta mhux ipproċessata tal-voluntiera kollha użati għall-kalkoli.
English: Therefore the potential serious potential risk to public health due to the lack of bioequivalence remains unresolved.
Maltese: Għaldaqstant ir-riskju potenzjali gravi potenzjali għas-saħħa pubblika minħabba nuqqas ta' bijoekwivalenza baqgħet mhux solvuta.
English: Peak plasma levels are reached within 3 to 4 hours following an oral dose.
Maltese: L-ogħla livelli tal-plażma jintlaħqu fi żmien 3 sa 4 sigħat wara doża orali.
English: ANNEX III CONDITIONS FOR THE LIFTING OF THE MARKETING AUTHORISATION SUSPENSION
Maltese: ANNESS III KUNDIZZJONIJIET GĦAT-TNEĦĦIJA TAS-SOSPENSJONI TAL-AWTORIZZAZZJONI GĦATTQEGĦID FIS-SUQ
English: However, excluding subject 24 because of low itraconazole plasma concentrations is not acceptable.
Maltese: Madankollu, mhux aċċettabbli li jkun eskluż is-suġġett 24 minħabba konċentrazzjonijiet ta' plażma itraconazole baxxi.
English: A more detailed analysis of the quantifiable determinations indicated that in the case of the reference formulation, 4 of 9 concentrations did not reach values above 4xLOQ and none reached these levels for the test formulation.
Maltese: Analiżi aktar dettaljata tad-determinazzjonijiet kwantifikabbli wriet li fil-każ tal-formulazzjoni ta' referenza, 4 minn 9 konċentrazzjonijiet ma laħqux valuri 'l fuq minn 4xLOQ u l-ebda waħda ma laħqet dawn il-livelli għall-formulazzjoni ta' prova.
English: Using this approach, the regression with the best adjustment is retained from the experimental data in order to provide a reliable estimation of the elimination constant and thereby of the pharmacokinetic parameters derived from it.
Maltese: Bl-użu ta' dan l-approċċ, ir-regressjoni bl-aħjar aġġustament tinżamm mid-dejta sperimentali sabiex tipprovdi stima affidabbli tal-kostanti ta' eliminazzjoni u għalhekk tal-parametri farmakokinetiċi meħuda minnu.
English: Itraconazole shows a rather long tmax (about 6 h) as a result of the long elimination half-life, however estimation of AUC was at least 4 times the tmax, indicating that in these subjects the drug has been absorbed from the gastrointestinal-tract, and that the drug in the body is not dependent on differences between the 2 formulations.
Maltese: Itraconazole juri tmax pjuttost twil (madwar 6 sigħat) bħala riżultat ta' half-life ta' eliminazzjoni twil, madankollu l-istima tal-AUC kienet mill-inqas 4 darbiet it-tmax, li jindika li f'dawn il-persuni l-mediċina kienet ġiet assorbita mill-apparat gastrointestinali, u li l-mediċina filġisem mhijiex dipendenti fuq id-differenzi bejn iż-żewġ formulazzjonijiet.
English: In the Applicant study, mean results of this pharmacokinetic parameter were 19.3 and 19.0 hours for the reference and the test compounds, respectively.
Maltese: Fl-istudju tal-Applikant, ir-riżultati medji ta' dan il-parametru farmakokinetiku kienu ta' 19.3 sigħat u 19.
English: The product was authorised in the reference member state under Article 10.1 of Directive 2001/83/EC and the application was submitted in the concerned member states under the Mutual recognition procedure.
Maltese: Il-prodott kien awtorizzat fl-Istat Membru ta' referenza skont l-Artikolu 10(1) tad-Direttiva 2001/83/KE u lapplikazzjoni ġiet sottomessa fl-Istati Membri kkonċernati skont il-proċedura ta' Rikonoxximent Reċiproku.
English: The algorithm used to calculate the “last exponential elimination constant” in the NCA module is based on least squares regression and adjustment by the determination coefficient (square R) as a function of the number of points employed in the calculations.
Maltese: L-algoritmu użat biex ikun ikkalkolat “l-aħħar kostanti ta' eliminazzjoni esponenzjali” fil-modulu NCA huwa bbażat fuq l-inqas regressjoni ta' kaxxi u aġġustament permezz tal-koeffiċjent ta' determinazzjoni (kaxxa R) bħala funzjoni tan-numru ta' punti użati fil-kalkoli.
English: The calculation of AUCinf and z could be affected by the fact that the elimination phase was not achieved in some volunteers, mainly due to the arbitrary acceptance of the limit of quantification (LOQ).
Maltese: Il-kalkolu tal-AUCinf u λz tista' tkun affettwata mill-fatt li l-fażi ta' eliminazzjoni ma ntlaħqitx f'ċerti voluntiera, l-aktar minħabba l-aċċettazzjoni arbitrarja tal-limitu ta' kwantifikazzjoni (LOQ).
English: The Applicant also provided all the different pharmacokinetic parameters, among others the area under the curve until the last quantified concentration (AUCt).
Maltese: L-Applikant ipprovda wkoll il-parametri farmakokinetiċi differenti kollha, fost oħrajn l-erja taħt il-kurva sal-aħħar konċentrazzjoni kwantifikata (AUCt).
English: The Marketing Authorisation Holder should submit the result of a properly conducted bioequivalence study, in compliance with the Questions & Answers document of the CHMP EWP subgroup on pharmacokinetics on the Bioavailability and Bioequivalence Guideline.
Maltese: Id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq għandu jissottometti r-riżultati ta' studju ta' bijoekwivalenza magħmul kif xieraq, b'konformità mad-dokument ta' Mistoqsijiet u Tweġibiet tassottogrupp EWP dwar il-farmakokinetika tas-CHMP dwar il-Linja Gwida dwar il-Bijodisponibbiltà u Bijoekwivalenza.
English: The CHMP recalculated the 90% confidence intervals and obtained comparable results to those provided by the Applicant.
Maltese: Is-CHMP kkalkola mill-ġdid l-intervalli ta' kunfidenza ta' 90% u kiseb riżultati li jixbhu lil dawk ipprovduti mill-Applikant.
English: The CHMP considers that the lack of assessment of the estimators of kinetic parameters analysis hampers the proper assessment of the data.
Maltese: Is-CHMP kkunsidra li n-nuqqas ta' evalwazzjoni tal-istimaturi tal-analiżi ta' parametri kinetiċi jfixkel il-valutazzjoni xierqa tad-dejta.
English: The CHMP noted that no values were used below the estimated LOQ of 5 ng/ml and that the last value above the LOQ was used for the estimation of AUCinf.
Maltese: Is-CHMP nnota li ma ntużawx valuri taħt l-LOQ stmat ta' 5 ng/ml u li l-aħħar valur ogħla mil-LOQ intuża għall-kalkolu tal-AUCinf.
English: Regarding the arbitrary acceptance of the lower limit of quantification (LLOQ), the Applicant considered that the LLOQ is complying with the requirements recommended by the FDA in relation to “response compared to blank response” and “precision and accuracy”.
Maltese: Rigward l-aċċettazzjoni arbitrarja tal-limitu ta' kwantifikazzjoni aktar baxx (LLOQ), l-Applikant ikkunsidra li l-LLOQ huwa konformi mar-rekwiżiti rakkomandati mill-FDA fir-rigward ta' “reazzjoni meta mqabbla ma reazzjoni vojta” u “preċiżjoni u eżattezza”.
English: the CHMP has recommended the refusal of the granting of the Marketing Authorisations in the Concerned Member States and the suspension of the Marketing Authorisation in the Reference Member State, where the product is currently authorised, for Prokanazol and associated names (see Annex I).
Maltese: is-CHMP rrakkomanda r-rifjut tal-għoti tal-Awtorizzazzjonijiet għat-Tqegħid fis-Suq fl-Istati Membri kkonċernati u s-sospensjoni tal-Awtorizzazzjoni għat-Tqegħid fis-Suq fl-Istat Membru ta' Referenza, fejn ilprodott huwa awtorizzat bħalissa, għal Prokanazol u ismijiet assoċjati (ara l-Anness I).
English: The pharmacokinetic analysis applied, following the recommendations from the regulatory agencies, was non-compartmental amodelistic.
Maltese: L-analiżi farmakokinetika applikata, skont ir-rakkomandazzjonijiet tal-aġenziji regolatorji, kienet amodellistika mhux kumpartimentali.
English: Due to these outstanding concerns and the lack of documentation, the CHMP was unable to consider Prokanazol as being bioequivalent to the reference product and considered that more data was needed before an opinion could be provided.
Maltese: Minħabba dan it-tħassib pendenti u n-nuqqas ta' dokumentazzjoni, is-CHMP ma setax jikkunsidra li Prokanazol huwa bijoekwivalenti għall-prodott ta' referenza u kkunsidra li kienet meħtieġa aktar dejta qabel ma tiġi pprovduta opinjoni.