FrancophonIA/ELRC3.0 huggingface dataset:
English: CONDITIONS OF THE MARKETING AUTHORISATIONS National Competent Authorities, coordinated by the Reference Member State where applicable, shall ensure that the following conditions are fulfilled by the Marketing Authorisation Holders:
Maltese: FIS-SUQ L-Awtoritajiet Kompetenti Nazzjonali, ikkoordinati mill-Istat Membru ta' Referenza fejn applikabbli, għandhom jiżguraw li l-kundizzjonijiet li ġejjin jiġu sodisfatti mid-Detenturi tal-Awtorizzazzjoni għat-Tqegħid fis-Suq:
English: Condition of the marketing authorisations
Maltese: Kundizzjoni tal-awtorizzazzjonijiet għat-tqegħid fis-suq
English: Communication Plan
Maltese: Pjan ta' Komunikazzjoni
English: MA (EU) number (Invented) name Strength Pharmaceutical Form
Maltese: Numru tal-MA (UE)
English: EMEA/457286/2008-EN
Maltese: EMEA/457286/2008-MT
English: London, August 2008 EMEA/457286/2008
Maltese: Londra, Awwissu 2008 EMEA/457286/2008
English: BACKGROUND INFORMATION
Maltese: TAL-ISFOND
English: The CVMP Opinion was adopted on 12 December 2007 and the subsequent Commission Decision on 11 March 2008.
Maltese: L-Opinjoni tas-CVMP ġiet adottata fit-12 ta' Diċembru 2007 u d-Deċiżjoni tal-Kummissjoni sussegwenti fil-11 ta' Marzu 2008.
English: The Marketing Authorisation Holders were requested in a list of questions to provide:
Maltese: IdDetenturi tal-Awtorizzazzjoni għat-Tqegħid fis-Suq intalbu permezz ta' lista ta' mistoqsijiet jipprovdu:
English: On 11 July 2007, France presented to the EMEA a referral under Article 35 of Directive 2001/82/EC, as amended, concerning Tribrissen Oral Paste for Horses (including associated names) and authorised products for which this product served as a reference product, containing trimethoprim and sulfadiazine as active ingredient.
Maltese: Fil-11 ta' Lulju tal-2007, Franza ppreżentat lill-EMEA riferiment skont l-Artikolu 35 tad-Direttiva 2001/82/KE, kif emendata, dwar Pejst Orali għaż-Żwiemel Tribrissen (inkluż ismijiet assoċjati) u prodotti awtorizzati li għalihom dan il-prodott serva bħala prodott ta' referenza, li fihom trimethoprim u sulfadiazine bħala sustanzi attivi.
English: o Part I Summary of the dossier, including the Summary of Product Characteristics, the expert reports and the quantitative and qualitative composition of the product; o If applicable, Part IV Efficacy information, including information on pharmacokinetics, pharmacodynamics and anti-microbial resistance data.
Maltese: o Parti I Sommarju tad-dokumentazzjoni, inkluż is-Sommarju tal-Karatteristiċi tal-Prodott, irrapporti esperti u l-kompożizzjoni kwantitattiva u kwalitattiva tal-prodott; o Jekk applikabbli, Parti IV Tagħrif dwar l-Effikaċja, inkluż tagħrif dwar il-farmakokinetika, ilfarmakodinamika u d-dejta dwar ir-reżistenza antimikrobika. o Ir-Rapporti ta' Aġġornament Perjodiku dwar is-Sigurtà għal tal-anqas l-aħħar 3 snin.
English: OPINION FOLLOWING AN ARTICLE 35 REFERRAL FOR VETERINARY MEDICINAL PRODUCTS WHICH CONTAIN THE ACTIVE SUBSTANCES TRIMETHOPRIM AND SULFADIAZINE
Maltese: IS-SUSTANZI ATTIVI TRIMETHOPRIM
English: The efficacy of a dose of 1x30 mg/kg body weight per day to be administered over a maximum period of 5 days has been substantiated for all indications, except for salmonellosis.
Maltese: L-effikaċja ta' doża ta' 1x30 mg/kg piż korporali kuljum li trid tiġi amministrata fuq perjodu massimu ta' 5 ijiem ġiet issostanzjata għall-indikazzjonijet kollha ħlief għas-salmonellożi.
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR VETERINARY USE (CVMP)
Maltese: IL-KUMITAT GĦALL-PRODOTTI MEDIĊINALI GĦALL-UŻU VETERINARJU (CVMP)
English: Having assessed the responses, the CVMP concluded that:
Maltese: Wara li vvaluta r-risposti, is-CVMP ikkonkluda li: 1.
English: Neither the Periodic Safety Update Reports of the products nor the literature presented included reports of lack of efficacy in the field.
Maltese: La r-Rapporti ta' Aġġornament Perjodiku dwar is-Sigurtà tal-prodotti u lanqas il-letteratura ppreżentata ma inkludew rapporti ta' nuqqas ta' effikaċja fil-qasam.
English: Marketing Authorisation Holders submitted written responses, defending the authorised dose of 1x30 mg/kg body weight per day for all indications but suggesting a higher dose may be required in the case of salmonellosis.
Maltese: Id-Detenturi tal-Awtorizzazzjoni għat-Tqegħid fis-Suq issottomettew tweġibiet bil-miktub, li jiddefendu d-doża awtorizzata ta' 1x30 mg/kg piż korporali kuljum għall-indikazzjonijiet kollha iżda ssuġġerew li tista' tkun meħtieġa doża ogħla fil-każ ta' salmonellożi.
English: The CVMP started the referral procedure during its meeting of 10-12 July 2007.
Maltese: Is-CVMP beda proċedura ta' riferiment waqt il-laqgħa tiegħu ta' bejn l-10 u t-12 ta' Lulju 2007.
English: The CVMP recommended varying the Marketing Authorisations of the concerned veterinary medicinal products in accordance with the conclusions where applicable.
Maltese: Is-CVMP irrakkomanda l-varjazzjoni tal-Awtorizzazzjonijiet għat-Tqegħid fis-Suq tal-prodotti mediċinali veterinarji kkonċernati bi qbil mal-konklużjonijiet fejn applikabbli.
English: It considered that this may lead to lack of efficacy and furthering resistance development in target pathogens, which could possibly lead to risks to human health where zoonotic bacteria are concerned.
Maltese: Qieset li dan jista' jwassal għal nuqqas ta' effikaċja u jsaħħaħ l-iżvilupp tar-reżistenza fil-patoġeni fil-mira, li possibbilment jista' jwassal għal riskji għas-saħħa tal-bniedem fejn għandhom x'jaqsmu batterji żoonotiċi.
English: No dose could be established for the treatment of salmonellosis.
Maltese: Ma setgħet tiġi stabbilita l-ebda doża għat-trattament tas-salmonellożi.
English: • Justification of the recommended dose for each of the indications claimed in relation to efficacy and potential selection of antimicrobial resistant bacteria.
Maltese: • Ġustifikazzjoni tad-doża rakkomandata għal kull waħda mill-indikazzjonijiet imsemmija b'rabta mal-effikaċja u l-għażla potenzjali ta' batterji b'reżistenza antimikrobika.
English: France considered that the dosing regime of the product is not correct.
Maltese: Franza qieset li r-reġim tad-dożaġġ tal-prodott mhuwiex korrett.
English: There is no documented evidence of problems relating to lack of efficacy or any change in the resistance situation of the relevant target pathogens that would constitute a concern relating to animal or human health.
Maltese: Ma hemm l-ebda evidenza dokumentata ta' problemi relatati man-nuqqas ta' effikaċja jew ma' xi tibdil fis-sitwazzjoni ta' reżistenza tal-patoġeni fil-mira relevanti li kienu se jwasslu għal tħassib relatat mas-saħħa tal-annimali jew tal-bnedmin.
English: • patients with relapsing multiple sclerosis (MS).
Maltese: • pazjenti bi sklerożi multipla rikaduta (MS).
English: Further information on Avonex can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/avonex.
Maltese: ema.europa.eu/medicines/human/EPAR/avonex.
English: Avonex received a marketing authorisation valid throughout the EU on 13 March 1997.
Maltese: Avonex irċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fit-13 ta' Marzu 1997.
English: Other information about Avonex
Maltese: Informazzjoni oħra dwar Avonex
English: Each syringe and pen contains 30 micrograms of interferon beta-1a.
Maltese: Kull siringa u pinna fiha 30 mikrogramma ta' interferon beta-1a.
English: Avonex contains the active substance interferon beta-1a.
Maltese: Avonex fih is-sustanza attiva interferon beta-1a.
English: The estimated risk of having a second attack of demyelination was lower in the patients taking Avonex than in the patients taking placebo: with Avonex, the risk was 21% in two years and 35% in three years, whereas the risk with placebo was 39% in two years and 50% in three years.
Maltese: Ir-riskju stmat li jkollhom it-tieni attakk ta' demijelinazzjoni kien aktar baxx fil-pazjenti li kienu qed jieħdu Avonex milli fil-pazjenti li kienu qed jieħdu plaċebo: b'Avonex, ir-riskju kien 21 % f'sentejn u 35 % fi tliet snin, filwaqt li r-riskju bil-plaċebo kien 39 % f'sentejn u 50 % fi tliet snin.
English: The side effects are similar in adults and in children.
Maltese: L-effetti sekondarji huma simili fl-adulti u fit-tfal.
English: In adults (aged 18 years or over), the recommended dose of Avonex is 30 micrograms, given by injection into a muscle once a week.
Maltese: Fl-adulti (minn 18-il sena 'l fuq), id-doża rakkomandata ta' Avonex hija 30 mikrogramma, mogħtija b'injezzjoni f'muskolu darba fil-ġimgħa.
English: In MS, the immune system (the body's natural defences) malfunctions and attacks parts of the central nervous system (the brain, spinal cord and optic nerve [nerve that sends signals from the eye to the brain]), causing inflammation that damages the nerves and the insulation around them.
Maltese: Fl-MS, issistema immunitarja (id-difiżi naturali tal-ġisem) ma taħdimx tajjeb u tattakka partijiet tas-sistema nervuża ċentrali (il-moħħ, is-sinsla tad-dahar u n-nerv ottiku [nerv li jibgħat sinjali mill-għajn għallmoħħ]), li tikkawża infjammazzjoni li tagħmel ħsara lin-nervituri u l-insulazzjoni madwarhom.
English: After two years, 22% of the patients who were treated with Avonex and 35% of the patients treated with placebo had a worsening of disability.
Maltese: Wara sentejn, 22 % tal-pazjenti kkurati b'Avonex u 35 % tal-pazjenti kkurati bi plaċebo kellhom aggravar tad-diżabilità.
English: The company has not carried out any formal studies of patients under 16 years of age.
Maltese: Il-kumpanija ma wettqet l-ebda studju formali ta' pazjenti ta' inqas minn 16-il sena.
English: The active substance in Avonex is the protein interferon beta-1a, one of a group of interferons that can be naturally produced by the body to help it fight against viruses and other attacks.
Maltese: Is-sustanza attiva f'Avonex hija l-proteina interferon beta-1a, waħda minn grupp ta' interferons li tista' tiġi prodotta b'mod naturali mill-ġisem biex tgħinu fil-ġlieda kontra l-viruses u attakki oħra.
English: The second study involved 383 adults who had experienced a single attack of demyelination and compared the ability of Avonex and placebo to reduce the risk of a second attack.
Maltese: It-tieni studju involva 383 adult li esperjenzaw attakk wieħed ta' demijelinazzjoni u qabbel l-abbiltà ta' Avonex u plaċebo biex inaqqsu r-riskju ta' attakk ieħor.
English: What are the risks associated with Avonex?
Maltese: X'inhuma r-riskji assoċjati ma' Avonex?
English: Avonex slows the progression of disability and reduces the number of relapses;
Maltese: Avonex inaqqas irritmu tal-progressjoni tad-diżabbiltà u jnaqqas in-numru ta' rikaduti;
English: However, it presented information from published studies on the use of Avonex in patients aged between 12 and 18 years, which showed that they had a decrease in the rate of relapse, possibly due to Avonex treatment.
Maltese: Madankollu, din ippreżentat informazzjoni minn studji ppubblikati dwar l-użu ta' Avonex f'pazjenti li għandhom bejn 12 u 18-il sena, li wrew li kellhom tnaqqis fir-rata ta' rikaduti, possibbilment minħabba kura b'Avonex.
English: The most common side effects with Avonex (which may affect more than 1 in 10 people) are headache, flu-like symptoms, pyrexia (fever), chills and sweating.
Maltese: L-effetti sekondarji l-aktar komuni b'Avonex (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 10) huma wġigħ ta' ras, sintomi li jixbhu l-influwenza, piressija (deni), sirdat u għaraq.
English: • patients who have had a single attack of demyelination, when this is severe enough to need treatment with injectable corticosteroids (anti-inflammatory medicines).
Maltese: • pazjenti li kellhom attakk wieħed ta' demijelinazzjoni, meta dan huwa sever biżżejjed biex ikun hemm bżonn ta' kura b'kortikosterojdi injettabbli (mediċini antiinfjammatorji).
English: A painkiller that prevents fever can be given before each injection and for 24 hours after injection to reduce the flu-like symptoms that may occur during the first few months of treatment.
Maltese: Pillola kontra l-uġigħ li tipprevjeni d-deni tista' tingħata qabel kull injezzjoni u għal 24 siegħa wara l-injezzjoni biex tnaqqas is-sintomi simili għal dawk tal-influwenza li jistgħu jseħħu matul l-ewwel ftit xhur ta' kura.
English: As for all medicines, data on the use of Avonex are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Avonex hija ssorveljata kontinwament.
English: The exact way that Avonex works in MS is not yet known but the active substance, interferon beta-1a, seems to calm down the immune system, and prevents relapses of MS.
Maltese: Il-mod eżatt ta' kif jaħdem Avonex fl-MS għadu mhux magħruf iżda s-sustanza attiva, interferon beta-1a, tidher li tikkalma s-sistema immunitarja, u tipprevjeni r-rikaduti tal-MS.
English: Avonex has been compared with placebo (a dummy treatment) in two main studies.
Maltese: Avonex tqabbel ma' plaċebo (kura finta) f'żewġ studji ewlenin.
English: Side effects reported with Avonex are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati b'Avonex huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: The first study involved 301 patients aged 16 years and older with relapsing MS who had experienced at least two relapses in the previous three years or at least one relapse per year if they had had the disease for less than three years.
Maltese: L-ewwel studju involva 301 pazjent minn 16-il sena 'l fuq b'MS rikaduta li esperjenzaw minn tal-inqas żewġ rikaduti fit-tliet snin preċedenti jew mill-inqas rikaduta waħda kull sena jekk kellhom il-marda għal inqas minn tliet snin.
English: For the full list of side effects and restrictions with Avonex, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet b'Avonex, ara l-fuljett ta' tagħrif.
English: Avonex is a medicine used to treat:
Maltese: Avonex huwa mediċina li tintuża għall-kura ta':
English: This can only be done with the pre-filled syringe, when it is fitted with a special device that attaches onto the syringe and only allows the lower dose of Avonex to be injected.
Maltese: Dan jista' jsir biss permezz ta' siringa mimlija lesta, meta tkun mgħammra b'apparat speċjali li jeħel mas-siringa u jippermetti biss li tiġi injettata d-doża aktar baxxa ta' Avonex.
English: Avonex (interferon beta-1a)
Maltese: Għaliex Avonex ġie awtorizzat fl-UE?
English: What measures are being taken to ensure the safe and effective use of Avonex?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Avonex?
English: The European Medicines Agency decided that Avonex's benefits are greater than its risks and it can be authorised for use in the EU.
Maltese: L-Aġenzija Ewropea għall-Mediċini ddeċidiet li l-benefiċċji ta' Avonex huma akbar mir-riskji tiegħu u li jista' jiġi awtorizzat għall-użu fl-UE.
English: In relapsing MS, the patient has attacks (relapses) between periods with no symptoms.
Maltese: Fl-MS rikaduta, il-pazjent ikollu attakki (rikaduti) bejn perjodi mingħajr sintomi.
English: MS is a disease in which inflammation damages the protective insulation around nerves (demyelination) as well as the nerves themselves.
Maltese: L-MS hija marda li fiha l-infjammazzjoni tagħmel ħsara lill-iżolament ta' protezzjoni madwar in-nervituri (demijelinazzjoni) kif ukoll in-nervituri nfushom.
English: Based on the submitted data during the procedure, the medicinal products Tadalafil Mylan 2.5 mg, 5 mg, 10 mg and 20 mg; Paracetamol DAWA 1000 mg film-coated tablets; Memantine Pharmascope 10 mg and 20 mg; Memantine DAWA 10 mg and 20 mg; Morysa 10 mg and 20 mg - SVUS Pharma a.s.; Bendroflumetiazid Alternova 2.5 mg and 5 mg tablets; the CHMP concluded that bioequivalence has been demonstrated vis-à-vis the EU reference medicinal product and recommended the maintenance of these marketing authorisations.
Maltese: Abbażi tad-data sottomessa waqt il-proċedura, il-prodotti mediċinali Tadalafil Mylan 2.5 mg, 5 mg, 10 mg u 20 mg; Paracetamol DAWA 1000 mg pilloli miksijin b'rita; Memantine Pharmascope 10 mg u 20 mg; Memantine DAWA 10 mg u 20 mg; Morysa 10 mg u 20 mg - SVUS Pharma a.s.;
English: Scientific conclusions
Maltese: c.
English: Grounds for CHMP opinion Whereas,
Maltese: Raġunijiet għal opinjoni tas-CHMP Billi,
English: • The Committee reviewed all available data and information provided by the MAHs/applicants, as well as information provided by Micro Therapeutic Research Labs Limited;
Maltese: • Il-Kumitat irreveda d-data u l-informazzjoni kollha disponibbli pprovduti mill-MAHs/applikanti, kif ukoll l-informazzjoni pprovduta minn Micro Therapeutic Research Labs Limited;
English: Critical findings were identified following inspections to check compliance with Good clinical practice (GCP) by the Austrian Federal Office for Safety in Healthcare (BASG) and the Health Care Inspectorate of the Netherlands (IGZ) in February 2016 at Micro Therapeutic Research Labs Pvt. Ltd, Chennai, India.
Maltese: Wara spezzjonijiet biex tiġi verifikata l-konformità mal-Prassi klinika tajba (PKT) mill-Uffiċċju Federali Awstrijak għas-Sigurtà fil-Kura tas-Saħħa (BASG) u l-Ispettorat tal-Kura tas-Saħħa tan-Netherlands (IGZ) fi Frar 2016 f'Micro Therapeutic Research Labs Pvt.
English: • The Committee considered the procedure under Article 31 of Directive 2001/83/EC for marketing authorisations and marketing authorisation applications for medicinal products for which the clinical and/or bioanalytical parts of the bioequivalence studies were performed at Micro Therapeutic Research Labs Limited during the period between June 2012 and June 2016;
Maltese: • Il-Kumitat ikkunsidra l-proċedura skont l-Artikolu 31 tad-Direttiva 2001/83/KE għallawtorizzazzjonijiet għat-tqegħid fis-suq u għall-applikazzjoni għall-awtorizzazzjoni għat-tqegħid fissuq għall-prodotti mediċinali li għalihom il-partijiet kliniċi u/jew bijoanalitiċi tal-istudji ta' bijoekwivalenza twettqu f'Micro Therapeutic Research Labs Limited waqt il-perjodu bejn Ġunju 2012 u Ġunju 2016;
English: For the Hydrokortison Alternova (Orifarm) and Hydrokortison BBS marketing authorisation applications, the CHMP concluded that the Member State(s) will have to consider whether the bridging between the proposed product and the medicinal products described in the literature as par Annex I of Directive 2001/83/EC is sufficiently established as the applications relate to Article 10a of Directive 2001/83/EC (‘Well-established use').
Maltese: Għall-applikazzjonijiet għall-awtorizzazzonijiet għat-tqegħid fis-suq ta' Hydrokortison Alternova (Orifarm) u Hydrokortison BBS, is-CHMP ikkonkluda li l-Istat(i) Membru(i) irid jikkunsidra jekk il-konnessjoni bejn il-prodott propost u l-prodotti mediċinali deskritti filletteratura skont l-Anness I għad-Direttiva 2001/83/KE hijiex stabbilita biżżejjed peress li lapplikazzjonijiet jirrelataw mal-Artikolu 10a tad-Direttiva 2001/83/KE (“Użu stabbilit sew”).
English: Micro Therapeutic Research Labs Ltd is a contract research organisation (CRO) which conducts the analytical and clinical parts of bioequivalence studies, some of which have been used to support marketing authorisation applications of medicines in the EU.
Maltese: Micro Therapeutic Research Labs Ltd hija organizzazzjoni ta' riċerka b'kuntratt (CRO, contract research organisation) li twettaq il-partijiet analitiċi u kliniċi tal-istudji ta' bijoekwivalenza, li xi ftit minnhom intużaw biex jappoġġjaw l-applikazzjonijiet għall-awtorizzazzjoni għat-tqegħid fis-suq tal-mediċini flUE.
English: − Marketing authorisation applications for which no alternative data or a justification was submitted.
Maltese: − L-applikazzjonijiet għall-awtorizzazzjoni għat-tqegħid fis-suq li għalihom ma ġietx sottomessa data alternattiva jew ġustifikazzjoni.
English: Both the Chennai site and the Coimbatore site follow the same provisions.
Maltese: Ltd f'Coimbatore.
English: − Authorised medicinal products for which alternative data or a justification was submitted but considered insufficient by the CHMP to establish bioequivalence vis-à-vis the EU reference medicinal product;
Maltese: − Prodotti mediċinali awtorizzati li għalihom ġiet sottomessa data alternattiva jew ġustifikazzjoni iżda s-CHMP ikkunsidraha bħala mhux biżżejjed sabiex tiġi stabbilita l-bijoekwivalenza firrigward tal-prodott mediċinali ta' referenza tal-UE;
English: In view of the critical inspection findings and the necessity to protect public health in the EU, several Member States considered that it is in the interest of the Union to refer the matter to the CHMP and request that it assesses the impact of the findings mentioned above on the benefit-risk balance of the medicinal products which have been authorised by the Member States on the basis of relevant trials performed at these sites between June 2012 and June 2016 and also that of pending marketing authorisation applications (MAA) that include such studies.
Maltese: Fid-dawl tas-sejbiet kritiċi mill-ispezzjoni u l-ħtieġa li tiġi protetta s-saħħa pubblika fl-UE, diversi Stati Membri kkunsidraw li huwa fl-interess tal-Unjoni li tirreferi l-kwistjoni lis-CHMP u li titlob li jiġi vvalutat l-impatt tas-sejbiet imsemmijin hawn fuq dwar il-bilanċ bejn il-benefiċċju u r-riskju tal-prodotti mediċinali li ġew awtorizzati mill-Istati Membri abbażi ta' provi kliniċi rilevanti mwettqin f'dawn is-siti bejn Ġunju 2012 u Ġunju 2016 kif ukoll dak tal-applikazzjonijiet pendenti għall-awtorizzazzjoni għattqegħid fis-suq (MAA) li jinkludi studji bħal dawn.
English: Data from bioequivalence studies submitted to the Competent Authorities to demonstrate bioequivalence of medicinal products with their originator is considered unreliable.
Maltese: Id-data mill-istudji kollha ta' bijoekwivalenza sottomessa lill-Awtoritajiet Kompetenti biex turi l-bijoekwivalenza ta' prodotti mediċinali mal-oriġinatur tagħhom hija kkunsidrata bħala mhux affidabbli.
English: For the suspension of the marketing authorisations to be lifted the MAH shall demonstrate bioequivalence data vis-à-vis a valid EU reference medicinal product based on relevant data, in accordance with the requirements of Article 10 of Directive 2001/83/EC (e.g. a bioequivalence study conducted vis-à-vis the EU reference medicinal product).
Maltese: Sabiex titneħħa s-sospensjoni tal-awtorizzazzjonijiet għat-tqegħid fis-suq, l-MAH għandu juri data ta' bijoekwivalenza fir-rigward ta' prodott mediċinali ta' referenza tal-UE validu abbażi ta' data rilevanti, skont ir-rekwiżiti tal-Artikolu 10 tad-Direttiva 2001/83/KE (eż. studju ta' bijoekwivalenza mtwettaq fir-rigward ta' prodott mediċinali ta' referenza tal-UE).
English: The findings of the Austrian and Dutch inspections raise serious concerns relating to the suitability of the quality management system in place at Micro Therapeutics Research LTd, India.
Maltese: Is-sejbiet tal-ispezzjonijiet Awstrijaċi u Olandiżi jqajmu tħassib serju dwar l-adegwatezza tas-sistema ta' ġestjoni tal-kwalità stabbilita f'Micro Therapeutics Research LTd, l-Indja.
English: Some of these authorised medicinal products may be considered critical by the individual EU Member States on the evaluation of the potential unmet medical need, considering the availability of suitable alternative medicinal products in the respective EU Member State(s) and, as appropriate, the nature of the disease to be treated.
Maltese: Prodott mediċinali awtorizzat jista' jitqies kritiku mill-Istati Membri tal-UE abbażi tal-evalwazzjoni talħtieġa medika potenzjali mhux issodisfata, meta tiġi kkunsidrata d-disponibilità ta' prodotti mediċinali alternattivi xierqa fl-Istati Membri tal-UE rispettivi u, kif ikun xieraq, in-natura tal-marda li trid tiġi kkurata.