FrancophonIA/ELRC3.0 huggingface dataset:
English: For the purpose of this report, GVK Biosciences Private Limited/Clinogent will be hereafter referred to as ‘GVK Bio'.
Maltese: Għall-iskopijiet ta' dan irrapport, GVK Biosciences Private Limited/Clinogent minn hawnhekk 'il quddiem se tissejjaħ ‘GVK Bio'.
English: • Concluded that the benefit risk of Nebivolol/Neo Balkanika is positive, therefore Nebivolol/Neo Balkanika is included in the list of medicinal products recommended for maintenance of the marketing authorisation;
Maltese: • Ikkonkluda li l-bilanċ bejn il-benefiċċju u r-riskju ta' Nebivolol/Neo Balkanika huwa po¿ittiv, għalhekk Nebivolol/Neo Balkanika huwa inklu¿ fil-lista ta' prodotti mediċinali rakkomandati għa¿-¿amma tal-awtorizzazzjoni għat-tqegħid fis-suq;
English: The European Commission initiated a referral under article 31 of Directive 2001/83/EC on 4 August 2014.
Maltese: ittiv skont l-Artikolu 116 tad-Direttiva 2001/83/KE.
English: During September 2014 CHMP plenary meeting, the CHMP adopted a LoQ to the CRO to clarify whether the findings should be confined to the period 2008-2014, to specific clinical trials and/or specific clinical activities at the Hyderabad site.
Maltese: Waqt il-laqgħa plenarja tas-CHMP ta' Settembru 2014, isCHMP adotta LoQ għas-CRO sabiex jikkjarifika jekk is-sejbiet għandhomx ikunu limitati għall-perjodu 2008-2014, għal provi kliniċi speċifiċi u/jew għal attivitajiet kliniċi speċifiċi fis-sit ta' Hyderabad.
English: The results and controls of data integrity by MAHs were not considered sufficient to override the findings of the ANSM inspection at GVK Bio-Hyderabad site.
Maltese: Ir-ri¿ultati u l-kontrolli tal-integrità tad-data mill-MAHs ma tqisux bħala suffiċjenti biex idawru s-sejbiet tal-ispezzjoni tal-ANSM fis-sit ta' GVK Bio-Hyderabad.
English: The following findings were reported in the French inspection report dated 02 July 2014, to which GVK Bio have responded on 18 July 2014 and in the final inspection report, which was issued on 21 July 2014: data manipulations of electrocardiograms (ECGs) were detected in each and every one of the 9 trials inspected by the ANSM.
Maltese: u fir-rapport tal-ispezzjoni finali, li nħareġ fil-21 ta' Lulju 2014: ġew identifikati manipulazzjonijiet tad-data tal-elettrokardjogrammi (ECGs) f'kull wieħed mid-9 provi spezzjonati mill-ANSM.
English: Subsequently, for AU generic dossier submission, a bioequivalence study was performed using Alembic's Irbesartan Hydrochlorothiazide Film-coated Tablets 300mg/25 mg against the AU reference product AVAPRO HCT 300mg Film-coated Tablets sourced from Australian market.
Maltese: Sussegwentement, għas-sottomissjoni tad-dossier talprodott ġeneriku tal-AU, twettaq studju ta' bijoekwivalenza li u¿a Irbesartan Hydrochlorothiazide Pilloli miksijin b'rita 300mg/25 mg ta' Alembic kontra l-prodott ta' referenza tal-AU, AVAPRO HCT 300mg Pilloli miksijin b'rita, miksub mis-suq Awstraljan.
English: During the November 2014 meeting, after GVK Biosciences' submission of responses as well as providing information relating to the matter before the CHMP on 22 October 2014, the CHMP determined that GVK Biosciences Pvt. Ltd. did not provide evidence to demonstrate that the problem was confined to a specific time period or specific clinical trials or specific individuals and clinical activities.
Maltese: Waqt il-laqgħa ta' Novembru 2014, wara s-sottomissjoni tat-tweġibiet minn GVK Biosciences kif ukoll lgħoti ta' informazzjoni relatata mal-kwistjoni quddiem is-CHMP fit-22 ta' Ottubru 2014, is-CHMP stabbilixxa li GVK Biosciences Pvt.
English: Not all phases of the study performed at GVK Bio: For the original submission, the MAH had conducted a bioequivalence study that compared its test product Alendronate Sodium 70 mg Tablets with the European innovator, Fosamax 70 mg tablets in healthy, adult, male, human subjects under fasting condition.
Maltese: Għas-sottomissjoni oriġinali, l-MAH wettaq studju ta' bijoekwivalenza li qabbel il-prodott tat-test tiegħu Alendronate Sodium 70 mg Pilloli malprodott mediċinali tal-marka Ewropea, Fosamax 70 mg pilloli, f'irġiel adulti b'saħħithom, sajma.
English: Some MAHs have provided results from bioequivalence data using non-EU Reference Medicinal Products.
Maltese: Xi MAHs ipprovdew ri¿ultati minn data ta' bijoekwivalenza li u¿at Prodotti Mediċinali ta' Referenza mhux tal-UE.
English: • Re-examination request for Nebivolol Neo-Balkanika:
Maltese: • Talba għal rie¿aminazzjoni għal Nebivolol Neo-Balkanika:
English: • The Committee considered the procedure under Article 31 of Directive 2001/83/EC for medicinal products concerned by the GVK Bio procedure;
Maltese: • Il-Kumitat ikkunsidra l-proċedura skont l-Artikolu 31 tad-Direttiva 2001/83/KE għall-prodotti mediċinali kkonċernati mill-proċedura ta' GVK Bio;
English: For the following medicinal products in category 3 (products of Annex IA containing Bendroflumetiazid Bosentan, Fexofenadine, Lansoprazole, Nebivolol and Venlafaxine), the CHMP is of the opinion that the results of the provided trials establish the bioequivalence vis-à-vis the EU reference medicinal product.
Maltese: IA li fihom Bendroflumetiazid Bosentan, Fexofenadine, Lansoprazole, Nebivolol u Venlafaxine), is-CHMP huwa tal-opinjoni li r-ri¿ultati tal-provi pprovduti jistabbilixxu l-bijoekwivalenza fir-rigward tal-prodott mediċinali ta' referenza tal-UE.
English: BE established versus non-EU RMP for Irbesartan: For the EU MA dossier for Irbesartan 75, 150 and 300 mg tablets, the following bioequivalence study has been performed: bioequivalence study for Irbesartan Film-coated Tablets using 300mg strength against EU reference product APROVEL 300 mg Film-coated Tablets.
Maltese: Għad-dossier tal-MA tal-UE għal Irbesartan 75, 150 u 300 mg pilloli, twettaq l-istudju ta' bijoekwivalenza li ġej: studju ta' bijoekwivalenza għal Irbesartan Pilloli miksijin b'rita li u¿a l-qawwa ta' 300mg kontra l-prodott ta' referenza tal-UE, APROVEL 300 mg Pilloli miksijin b'rita.
English: The CHMP acknowledges that a number of audits by GVK's clients and inspections by competent authorities were carried out at GVK Bio-Hyderabad over a large period without identifying critical findings.
Maltese: Is-CHMP jirrikonoxxi li twettqu numru ta' verifiki minn klijenti ta' GVK u spezzjonijiet mill-awtoritajiet kompetenti fis-sit ta' GVK Bio-Hyderabad fuq perjodu twil mingħajr ma kienu identifikati sejbiet kritiċi.
English: The data manipulations took place between at least July 2008 and 2013.
Maltese: Il-manipulazzjonijiet tad-data seħħew mill-anqas bejn Lulju 2008 u l-2013.
English: For generic products authorised under Article 10(1) of Directive 2001/83/EC, establishment of bioequivalence vis-à-vis a reference medicinal product is a pre-requisite.
Maltese: Għall-prodotti ġeneriċi awtorizzati skont l-Artikolu 10(1) tad-Direttiva 2001/83/KE, l-istabbiliment talbijoekwivalenza fir-rigward ta' prodott mediċinali ta' referenza huwa rekwi¿
English: • Category 1: No new biowaiver request or data to establish the bioequivalence vis-à-vis the EU reference medicinal product (apart from BE studies conducted at GVK Biosciences Hyderabad site)
Maltese: • Kategorija 1: L-ebda talba għal bijorinunzja jew data ġdida sabiex tiġi stabbilita lbijoekwivalenza fir-rigward tal-prodott mediċinali ta' referenza tal-UE (apparti mill-istudji ta' BE mwettqa fis-sit ta' GVK Biosciences Hyderabad)
English: The MAH has submitted a bioequivalence study for Nebivolol during the course of the reexamination.
Maltese: Dawn id-dikjarazzjonijiet kienu valutati bir-reqqa.
English: In addition, the MAH claims that in art 10 of Directive 2001/83/EC there is ‘room for interpretation', and it is not specifically mentioned that an EU reference product must be used.
Maltese: Barra minn hekk, l-MAH isostni li fl-artikolu 10 tad-Direttiva 2001/83/KE hemm ‘lok għall-interpretazzjoni', u ma jissemmiex speċifikament li jrid jintu¿a prodott ta' referenza tal-UE.
English: The seriousness of the deficiencies identified and the lack of GCP compliance at GVK Bio's clinic in Hyderabad raise questions as to the reliability of studies conducted between 2008 and 2014 at the site inspected, as well as the clinical part of all other bioequivalence trials performed prior to 2008.
Maltese: Il-gravità tad-defiċjenzi identifikati u n-nuqqas ta' konformità mal-PKT fil-klinika ta' GVK Bio f'Hyderabad iqajmu dubji dwar l-affidabbiltà tal-istudji mwettqa bejn l-2008 u l-2014 fis-sit spezzjonat, kif ukoll il-parti klinika tal-provi l-oħra kollha dwar il-bijoekwivalenza li twettqu qabel l-2008.
English: This category encompasses medicinal products for which MAHs have provided biowaiver request (i.e. claims to fulfil the criteria for a Biopharmaceutics Classification System (BCS)-based biowaiver as described in Appendix III of the Guideline on the investigation of bioequivalence (CPMP/EWP/QWP/1401/98) to establish bioequivalence to an EU Reference Medicinal Product.
Maltese: Din il-kategorija tiġbor fiha prodotti mediċinali li għalihom l-MAHs ipprovdew talba għal bijorinunzja (jiġifieri pretensjonijiet li jissodisfaw il-kriterji għal bijorinunzja bba¿ata fuq is-Sistema ta' Klassifikazzjoni tal-Bijofarmaċewtiċi (BCS) kif deskritt fl-Appendiċi III tal-Linja gwida dwar linvestigazzjoni tal-bijoekwivalenza (CPMP/EWP/QWP/1401/98) sabiex jistabbilixxu l-bijoekwivalenza ma' Prodott Mediċinali ta' Referenza tal-UE.
English: Following the adoption of the CHMP opinion during the January 2015 CHMP meeting, requests for re-examination were received from the following MAHs:
Maltese: Wara l-adozzjoni tal-opinjoni tas-CHMP matul il-laqgħa tas-CHMP ta' Jannar 2015, kienu riċevuti talbiet għal rie¿aminazzjoni mill-MAHs li ġejjin:
English: It is recognised that alendronate occupies an important place in the treatment of post-menopausal osteoporosis.
Maltese: Huwa rikonoxxut li alendronate għandu post importanti fil-kura tal-osteoporo¿i ta' wara l-menopawsa.
English: Subsequently, for Australian (AU) generic dossier submission, a bioequivalence study was performed using Irbesartan Film-coated Tablets 300 mg against the AU reference product AVAPRO 300mg Film-coated Tablets sourced from the Australian market.
Maltese: Sussegwentement, għas-sottomissjoni taddossier ġeneriku Awstraljan (AU), sar studju ta' bijoekwivalenza li u¿a Irbesartan Pilloli miksijin b'rita 300 mg kontra l-prodott ta' referenza tal-AU, AVAPRO 300 mg Pilloli miksijin b'rita, miksub mis-suq Awstraljan.
English: The systematic nature of the data manipulations of ECGs, the extended period of time during which they took place and the number of members of staff involved highlight critical deficiencies in the quality system in place at GVK Bio's clinic in Hyderabad.
Maltese: li matulu seħħew u n-numru ta' membri tal-persunal involuti jissottolinjaw defiċjenzi serji fis-sistema talkwalità pre¿enti fil-klinika ta' GVK Bio f'Hyderabad.
English: They also show a lack of GCP training, awareness and understanding of members of GVK Bio staff, a lack of understanding by them of the importance of data integrity and of the possible consequences of their acts, as well as a lack of overview of clinical trial activities by the investigators.
Maltese: Huma juru wkoll nuqqas ta' taħriġ, għarfien u fehim dwar il-PKT mill-membri tal-persunal ta' GVK Bio, nuqqas ta' fehim min-naħa tagħhom tal-importanza tal-integrità tad-data u tal-konsegwenzi possibbli tal-atti tagħhom, kif ukoll nuqqas ta' ħarsa ġenerali tal-attivitajiet ta' prova klinika mill-investigaturi.
English: The CHMP therefore concluded that all bioequivalence studies with clinical activities carried out at GVK Biosciences Pvt. Ltd. site in Hyderabad, India, since GVK Biosciences Pvt. Ltd. started these activities in 2004 are considered unreliable to support the benefit risk balance of the medicinal products they relate to.
Maltese: Is-CHMP għalhekk ikkonkluda li l-istudji kollha ta' bijoekwivalenza bl-attivitajiet kliniċi mwettqa fis-sit ta' GVK Bio f'Hyderabad, l-Indja, minn mindu GVK Bio bdiet dawn l-attivitajiet fl-2004 mhumiex ikkunsidrati bħala affidabbli biex jappoġġjaw il-bilanċ bejn il-benefiċċju u r-riskju tal-prodotti mediċinali li jirrigwardaw.
English: The CHMP noted that pharmacovigilance data reported to the competent authorities have not indicated any problems which could be attributed to non-bioequivalence, such as reduced efficacy or worsened safety and tolerability.
Maltese: Is-CHMP innota li d-data ta' farmakoviġilanza rrappurtata lill-awtoritajiet kompetenti ma indikat l-ebda problema li setgħet tiġi attribwita għan-nuqqas ta' bijoekwivalenza, bħat-tnaqqis fl-effikaċja jew ittaħ¿in fis-sigurtà u t-tollerabbiltà.
English: For the remaining medicinal products in category 2 (i.e. products of Annex IB containing Donepezil), the following issues precluding the establishment of bioequivalence to an EU Reference Medicinal Product were raised:
Maltese: Għall-prodotti mediċinali li jifdal fil-kategorija 2 (jiġifieri prodotti tal-Anness IB li fihom Donepezil), kienu mqajma l-kwistjonijiet li ġejjin li ma jippermettux l-istabbiliment tal-bijoekwivalenza ma' Prodott Mediċinali ta' Referenza tal-UE:
English: • Category 3: New bioequivalence vis-à-vis the EU reference medicinal product study submitted Discussions on the above took place during the December 2014 CHMP plenary meeting during which the CHMP endorsed the above mentioned classification.
Maltese: • Kategorija 3: Ippre¿entat studju ġdid tal-bijoekwivalenza fir-rigward tal-prodott mediċinali ta' referenza tal-UE It-temi ta' hawn fuq kienu diskussi waqt il-laqgħa plenarja tas-CHMP ta' Diċembru 2014 li matulha sCHMP approva l-klassifikazzjoni hawn fuq imsemmija.
English: Neo-Balkanika submitted the bioequivalence study (PK-05-035) which had already been submitted during the referral procedure in support of marketing authorisations for Nebivolol 5 mg tablets, with the same qualitative and quantitative composition and same manufacturers.
Maltese: Neo-Balkanika ppre¿enta l-istudju ta' bijoekwivalenza (PK-05-035) li diġà kien ġie ppre¿entat matul ilproċedura ta' riferiment b'appoġġ għall-awtorizzazzjonijiet għat-tqegħid fis-suq għal Nebivolol 5 mg pilloli, bl-istess għamla kwalitattiva u kwantitattiva u l-istess manifatturi.
English: A number of MAHs have also argued that pharmacovigilance data collected on their medicinal products have not indicated any problems, which could be attributed to non-bioequivalence, such as reduced efficacy or worsened safety and tolerability.
Maltese: Numru ta' MAHs argumentaw ukoll li d-data ta' farmakoviġilanza miġbura dwar il-prodotti mediċinali tagħhom ma indikat l-ebda problema, li setgħet tkun attribwita għan-nuqqas ta' bijoekwivalenza, bħattnaqqis fl-effikaċja jew it-taħ¿in tas-sigurtà u t-tollerabbiltà.
English: Positive inspection and audit history of the GVK Bio Hyderabad site: The MAHs argue that based on the fact that a GCP audit by the MHRA of a study conducted at the site failed to identify any critical or major breaches of GCP, the CHMP conclusions that studies conducted at GVK Bio facility cannot be relied upon to demonstrate bioequivalence cannot be justified.
Maltese: Fl-aħħar nett, is-CHMP stabbilixxa li GVK Bio ma pprovdietx evidenza biex turi li l-problema kienet limitata għal perjodu ta' ¿mien speċifiku jew provi kliniċi speċifiċi jew individwi u attivitajiet kliniċi speċifiċi.
English: In conclusion, bioequivalence with an EU authorised reference medicinal product is confirmed and therefore it can be concluded that the benefit/risk balance of Nebivolol / Neo Balkanika is positive.
Maltese: Bħala konklu¿joni, il-bijoekwivalenza ma' prodott mediċinali ta' referenza awtorizzat tal-UE hija kkonfermata u għalhekk jista' jiġi konklu¿ li l-bilanċ bejn il-benefiċċju u r-riskju ta' Nebivolol / Neo Balkanika huwa po¿
English: For the remaining medicinal products in category 3 (products of Annex IB containing Clindamycin, Esomeprazole, Phenoxymethylpenicillin, Trimetazidine), the issues precluding the establishment of bioequivalence to an EU Reference Medicinal Product pertain to: The identity of test product in the study with the authorized (marketed) product is not clear.
Maltese: IB li fihom Clindamycin, Esomeprazole, Phenoxymethylpenicillin, Trimetazidine), il-kwistjonijiet li ma jippermettux l-istabbiliment tal-bijoekwivalenza ma' Prodott Mediċinali ta' Referenza tal-UE jirrigwardaw:
English: Category 3 medicinal products This category encompasses products for which MAHs have provided data from other bioequivalence studies vis-à-vis the EU reference medicinal product than the one performed at GVK Biosciences Pvt. Ltd.'s site in Hyderbad, India.
Maltese: Prodotti mediċinali tal-kategorija 3 Din il-kategorija tiġbor fiha prodotti li għalihom l-MAHs ipprovdew data minn studji oħra ta' bijoekwivalenza fir-rigward tal-prodott mediċinali ta' referenza tal-UE, għajr dak imwettaq fis-sit ta' GVK Biosciences Pvt.
English: The CHMP therefore confirms that it cannot be ruled out beyond reasonable doubt that critical GCP violations at the site have not affected the integrity of the scientific data of other bioequivalence studies conducted at the site, and that the studies therefore remain unreliable.
Maltese: Is-CHMP għalhekk jikkonferma li ma jistax jiġi esklu¿ lil hinn minn kwalunkwe dubju raġonevoli li ksur kritiku tal-PKT fis-sit ma affettwax l-integrità tad-data xjentifika ta' studji ta' bijoekwivalenza oħra mwettqa fis-sit, u li l-istudji għalhekk baqgħu mhux affidabbli.
English: However, in light of the nature, the severity and the extent of the GCP findings identified in the ANSM's inspection in May 2014, these arguments do not demonstrate that the said studies can be relied upon.
Maltese: Madankollu, fid-dawl tan-natura, is-severità u l-firxa tas-sejbiet dwar PKT identifikati fl-ispezzjoni tal-ANSM f'Mejju 2014, dawn l-argumenti ma jurux li l-istudji msemmija huma affidabbli.
English: The MAH claimed that it had not received the official notification of the inclusion of the product in the Article 31 Referral procedure.
Maltese: joni tal-prodott fil-proċedura ta' Riferiment skont l-Artikolu 31.
English: The company that applied for authorisation is Novartis Europharm Ltd.
Maltese: Il-kumpanija li applikat għallawtorizzazzjoni hija Novartis Europharm Ltd.
English: What is Reasanz?
Maltese: Reasanz?
English: 23 May 2014 EMA/299385/2014 EMEA/H/C/002817
Maltese: EMEA/H/C/002817
English: The active substance in Reasanz, serelaxin, is a recombinant form of relaxin-2, a hormone naturally found in the body.
Maltese: Is-sustanza attiva f'Reasanz, serelaxin, hija forma rikombinanti ta' relaxin-2, ormon naturali li jinstab fil-ġisem.
English: Reasanz is a medicine that contains the active substance serelaxin.
Maltese: Reasanz huwa mediċina li fiha s-sustanza attiva serelaxin.
English: Refusal of the marketing authorisation for Reasanz (serelaxin) EMA/299385/2014
Maltese: EMA/299385/2014
English: The main measure of effectiveness was the extent to which dyspnoea was relieved, measured short-term (after 6, 12 and 24 hours) and over 5 days.
Maltese: Il-kejl ewlieni tal-effikaċja kien l-estent sa liema kienet ikkurata d-dispneja, imkejla fuq żmien qasir (wara 6, 12 u 24 siegħa) u fuq perjodu ta' 5 ijiem.
English: On 23 January 2014, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Reasanz, intended for the treatment of acute heart failure.
Maltese: Fit-23 ta' Jannar 2014, il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) adotta opinjoni negattiva, li fiha rrakkomanda r-rifjut tal-awtorizzazzjoni għat-tqegħid fis-suq għall-prodott mediċinali Reasanz, maħsub għall-kura ta' insuffiċjenza tal-qalb akuta.
English: The application was mainly based on the results of one main study involving 1,161 patients with an episode of acute heart failure.
Maltese: L-applikazzjoni kienet prinċipalment ibbażata fuq ir-riżultati ta' wieħed mill-istudji ewlenin li involva 1,161 pazjent b'episodju ta' insuffiċjenza tal-qalb akuta.
English: This lowers the
Maltese: (serelaxin)
English: After considering the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the refusal of the marketing authorisation on 22 May 2014.
Maltese: Wara li kkunsidra r-raġunijiet għal din it-talba, is-CHMP reġa' analizza l-opinjoni inizjali, u fit-22 ta' Mejju 2014, ikkonferma r-rifjut tal-awtorizzazzjoni għattqegħid fis-suq.
English: How is Reasanz expected to work?
Maltese: Kif huwa mistenni li jaħdem Reasanz?
English: At the time of the initial evaluation, the CHMP noted that the study results did not demonstrate a benefit for short-term relief of dyspnoea over up to 24 hours, and although some benefit was shown over 5 days it was not clear how this was of clinical relevance.
Maltese: Meta saret l-evalwazzjoni inizjali, is-CHMP innota li r-riżultati tal-istudju ma wrewx benefiċċju għal kura fuq żmien qasir ta' dispneja sa perjodu ta' 24 siegħa, u għalkemm intwera xi benefiċċju matul 5 ijiem, ma kienx ċar kemm dan kien ta' rilevanza klinika.
English: These symptoms include high blood pressure in the vessels leaving the lungs, leading to congestion (fluid build-up) and dyspnoea (shortness of breath).
Maltese: Dawn is-sintomi jinkludu pressjoni tad-demm għolja fl-arterji u l-vini li jibdew millpulmun, li jwasslu għal konġestjoni (akkumulazzjoni ta' fluwidu) u dispneja (qtugħ ta' nifs).
English: Recombinant means that it is produced by bacteria into which a gene (DNA) has been introduced that makes the bacteria able to produce the hormone.
Maltese: Rikombinanti tfisser li huwa prodott minn batterji li fihom ġie introdott ġene (DNA) li permezz tiegħu l-batterji jkunu jistgħu jipproduċu l-ormon.
English: The effects of Reasanz were first tested in experimental models before being studied in humans.
Maltese: L-effetti ta' Reasanz ġew ittestjati l-ewwel darba f'mudelli sperimentali qabel ma ġie studjat filbniedem.
English: It was to be available as a concentrate to be diluted and given by infusion (drip) into a vein.
Maltese: Kellu jkun disponibbli bħala konċentrat li jitħallat u jingħata b'infużjoni (drip) fil-vina.
English: Reasanz infusion was compared with placebo (a dummy treatment) as an addition to their other treatment.
Maltese: L-infużjoni b'Reasanza kienet imqabbla ma' plaċebo (kura finta) bħala żieda mal-kura l-oħra tagħhom.
English: The applicant requested a re-examination of the opinion.
Maltese: L-applikant talab analiżi mill-ġdid tal-opinjoni.
English: Reasanz was expected to be used to treat the symptoms of acute heart failure (an episode of severe or worsening symptoms in patients in whom the heart cannot pump sufficient blood around the body).
Maltese: Reasanz kien mistenni li jintuża biex jikkura sintomi ta' insuffiċjenza tal-qalb akuta (episodju ta' sintomi severi jew li jmorru għall-agħar f'pazjenti li qalbhom ma tistax tippompja biżżejjed demm madwar il-ġisem).
English: Therefore, although the safety of Reasanz seemed acceptable, the CHMP concluded that the benefits of Reasanz did not outweigh its risks and maintained its previous recommendation that the medicine be refused marketing authorisation.
Maltese: Għalhekk, minkejja li s-sigurtà ta' Reasanz dehret aċċettabbli, is-CHMP ikkonkluda li l-benefiċċji ta' Reasanz ma kinux akbar mir-riskji tiegħu u żamm ir-rakkomandazzjonijiet preċedenti tiegħu li ma tingħatax awtorizzazzjoni għat-tqegħid fis-suq tal-mediċina.
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials or compassionate use programmes with Reasanz.
Maltese: Jekk inti qed tieħu sehem fi prova klinika u teħtieġ aktar informazzjoni dwar il-kura tiegħek, ikkuntattja lit-tabib li jkun qed jagħtik il-kura.
English: Since only one main study was included in the application, the CHMP concluded that further studies would be needed to confirm the effectiveness of Reasanz in the treatment of acute heart failure.
Maltese: Barra minn hekk, il-Kumitat kellu tħassib dwar ilmod li bih ġiet analizzata l-effikaċja tal-mediċina fl-istudju.