FrancophonIA/ELRC3.0 huggingface dataset:
English: The CHMP therefore decided that Somac Control's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Somac Control huma akbar mirriskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: It is available as gastroresistant tablets (20 mg).
Maltese: Jiġi bħala pilloli gastroreżistenti (20 mg). ‘Gastroreżistenti' tfisser li l-kontenut tal-pilloli jgħaddi mill-istonku u jibqa' intatt sa meta jilħaq il-musrana.
English: How does Somac Control work?
Maltese: Liema benefiċċji wera Somac Control waqt l-istudji mwettqa?
English: Somac Control must not be used in people who are hypersensitive (allergic) to pantoprazole, soya or any of the other ingredients.
Maltese: Somac Control m'għandux jintuża f'nies li huma ipersensittivi (allerġiċi) għal pantoprazole, soja jew għal xi sustanza oħra tiegħu.
English: Why has Somac Control been approved?
Maltese: Għaliex ġie approvat Somac Control?
English: By blocking the pumps, pantoprazole reduces acid production, relieving the symptoms of acid reflux.
Maltese: Minħabba li jimblokka l-pompi, pantoprazole inaqqas il-produzzjoni tal-aċidu, biex b'hekk itaffi s-sintomi tar-rifluss tal-aċidu.
English: What is Diotop?
Maltese: X'inhu Diotop?
English: The two active substances in Diotop have different effects.
Maltese: Iż-żewġ sustanzi attivi f'Diotop għandhom effetti differenti.
English: EMA recommends authorisation of Diotop (diclofenac / omeprazole capsules) in the EU
Maltese: EMA tirrakkomanda l-awtorizzazzjoni ta' Diotop (kapsuli ta' diklofenak/omeprażol) fl-UE
English: The European Commission issued an EU-wide legally binding decision on the marketing authorisation of Diotop on 31/01/2019.
Maltese: Il-Kummissjoni Ewropea ħarġet deċiżjoni legalment vinkolanti fl-UE kollha dwar l-awtorizzazzjoni għattqegħid fis-suq ta' Diotop fi 31/01/2019.
English: The company submitted data from the published literature on the use of several NSAIDs (including diclofenac at the dose of 50 to 150 mg a day) and omeprazole in combination.
Maltese: Il-kumpanija ssottomettiet data mil-letteratura ppubblikata dwar l-użu ta' diversi NSAIDs (inkluż iddiklofenak bid-doża ta' 50 sa 150 mg kuljum) u l-omeprażol flimkien.
English: On 15 November 2018, the European Medicines Agency completed a review of Diotop following a disagreement among EU Member States regarding its authorisation.
Maltese: Fil-15 ta' Novembru 2018, l-Aġenzija Ewropea għall-Mediċini lestiet rieżami ta' Diotop wara nuqqas ta' qbil fost l-Istati Membri tal-UE dwar l-awtorizzazzjoni tiegħu.
English: Temmler Pharma GmbH requested that the marketing authorisation for Diotop granted by the UK and Austria in 2016 be recognised in Germany (the ‘concerned Member State').
Maltese: GmbH talbet li l-awtorizzazzjoni għat-tqegħid fis-suq għal Diotop mogħtija mir-Renju Unit u l-Awstrija fl-2016 tiġi rikonoxxuta fil-Ġermanja (“l-Istat Membru kkonċernat”).
English: The Agency considered that, although the particular combination in Diotop (diclofenac 75 mg / omeprazole 20 mg) has never been tested in any published study, the data from studies of higher doses of diclofenac or other NSAIDs taken with omeprazole are enough to support the use of the specific combination in Diotop.
Maltese: L-Aġenzija kkunsidrat li, għalkemm il-kombinazzjoni partikolari f'Diotop (diklofenak 75 mg/omeprażol 20 mg) qatt ma ġiet ittestjata fi kwalunkwe studju ppubblikat, id-data minn studji ta' dożi ogħla ta' diklofenak jew NSAIDs oħra meħuda mal-omeprażol, hija biżżejjed biex tappoġġa l-użu tal-kombinazzjoni speċifika f'Diotop.
English: Diotop is used in adult patients who are at risk of developing stomach ulcers and whose disease is already controlled by diclofenac and omeprazole, the two active substances in Diotop, taken separately.
Maltese: Diotop jintuża f'pazjenti adulti li huma f'riskju li jiżviluppaw ulċeri fl-istonku u li l-marda tagħhom hija diġà kkontrollata minn diklofenak u omeprażol, iż-żewġ sustanzi attivi f'Diotop, meħuda separatament.
English: EMA completes review following disagreement among EU Member States
Maltese: EMA tlesti rieżami wara nuqqas ta' qbil fost l-Istati Membri tal-UE
English: Diclofenac is a nonsteroidal antiinflammatory drug (NSAID) used for the relief of pain and inflammation in a wide range of conditions.
Maltese: Id-diklofenak huwa mediċina antiinfjammatorja mhux sterojdali (NSAID) li tintuża biex ittaffi l-uġigħ u l-infjammazzjoni f'firxa wiesgħa ta' kondizzjonijiet.
English: The review of Diotop was initiated at the request of the United Kingdom, under Article 29(4) of Directive 2001/83/EC.
Maltese: Ir-rieżami ta' Diotop nbeda fuq talba tar-Renju Unit, skont l- Artikolu 29 (4) tad-Direttiva 2001/83/KE.
English: Diotop is a medicine used to relieve symptoms such as swelling and pain caused by the joint disorders rheumatoid arthritis, osteoarthritis or ankylosing spondylitis.
Maltese: Diotop huwa mediċina li tintuża biex ittaffi s-sintomi bħal nefħa u wġigħ ikkawżat mid-disturbi fil-ġogi, l-artite rewmatojde, l-osteoartrite jew l-ispondilite ankilosanti.
English: The grounds for the referral were concerns raised by Germany that the data provided by the company were not enough to demonstrate the safety and effectiveness of Diotop.
Maltese: Ir-raġunijiet għar-riferiment kienu tħassib imqajjem mill-Ġermanja li d-data pprovduta mill-kumpanija ma kinitx biżżejjed biex turi s-sikurezza u l-effikaċja ta' Diotop.
English: The review was carried out by EMA's Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use.
Maltese: Ir-rieżami twettaq mill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-EMA, responsabbli għall-mistoqsijiet dwar il-mediċini għall-użu mill-bniedem.
English: The Agency concluded that the benefits of Diotop outweigh its risks, and the marketing authorisation granted in the United Kingdom can be recognised in other Member States of the EU where the company has applied for a marketing authorisation.
Maltese: L-Aġenzija kkonkludiet li l-benefiċċji ta' Diotop huma akbar mir-riskji tiegħu, u l-awtorizzazzjoni għat-tqegħid fis-suq mogħtija fir-Renju Unit tista' tiġi rikonoxxuta fi Stati Membri oħra tal-UE fejn il-kumpanija tkun applikat għal awtorizzazzjoni għat-tqegħid fis-suq.
English: However, the Member States were not able to reach an agreement and the UK medicines regulatory agency referred the matter to EMA for arbitration on 28 September 2018.
Maltese: Madankollu, l-Istati Membri ma setgħux jaslu għal qbil u l-aġenzija regolatorja tal-mediċini tar-Renju Unit irreferiet il-kwistjoni lill-EMA għal arbitraġġ fit-28 ta' Settembru 2018.
English: If you want more information on the basis of the CVMP recommendations, read the scientific discussion (also part of the EPAR).
Maltese: Jekk tixtieq iktar informazzjoni relatata mar-rakkomandazzjonijiet tas-CVMP, aqra d-diskussjoni xjentifika (ukoll parti mill-EPAR).
English: The European Commission granted a marketing authorisation valid throughout the EU for ZULVAC 8 Ovis on 15 January 2010.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE għal ZULVAC 8 Ovis fil-15 ta' Jannar 2010.
English: Protection starts 25 days after the last injection and lasts for at least a year.
Maltese: Il-protezzjoni tibda taħdem 25 jum wara l-għoti tal-aħħar injezzjoni u ddum mill-inqas sena.
English: In 2013 the CVMP considered that the submitted data were adequate for the authorisation of ZULVAC 8 Ovis to convert to a normal status.
Maltese: Fl-2013 is-CVMP qies li d-dejta mressqa kienet adegwata sabiex l-awtorizzazzjoni ta' ZULVAC 8 Ovis tinbidel għal status normali.
English: The vaccine also contains ‘adjuvants' (aluminium hydroxide and saponin) to enhance the immune response.
Maltese: Il-vaċċin fih ukoll ‘aġġuvanti' (l-idrossidu tal-aluminju u s-saponina) ħalli jtejjeb ir-rispons immunitarju.
English: The virus exists in several forms (serotypes) throughout the world; the type used in ZULVAC 8 Ovis is serotype 8.
Maltese: Il-vajrus jeżisti f'diversi forom (serotipi) madwar id-dinja; it-tip użat f'ZULVAC 8 Ovis huwa serotip 8.
English: ZULVAC 8 Ovis is a vaccine that contains inactivated (killed) bluetongue serotype 8 virus as the active substance.
Maltese: ZULVAC 8 Ovis huwa vaċċin li fih vajrus tal-Lingwablu tas-serotip 8 inattivat (maqtul) bħala s-sustanza attiva.
English: Sheep may show a temporary increase in body temperature, no more than 1.2°C, in the 24 hours after vaccination.
Maltese: Fl-24 siegħa ta' wara t-tilqima, in-nagħaġ jista' jkollhom żieda temporanja fit-temperatura tal-ġisem, normalment ta' mhux aktar minn 1.2ºC.
English: Inactivated vaccine against Bluetongue disease virus, serotype 8
Maltese: Vaċċin inattivat kontra l-marda tal-vajrus tal-Lingwablu, serotip 8
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of ZULVAC 8 Ovis exceed the risks in the prevention of viraemia caused by the bluetongue virus serotype 8 in sheep from one and a half months of age.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu Veterinarju (CVMP) kkonkluda li l-benefiċċji tal-użu ta' ZULVAC 8 Ovis jisbqu lir-riskji fil-prevenzjoni tal-viremija kkawżata mis-serotip 8 tal-vajrus tallingwablu f'nagħaġ li għandhom minn xahar u xahar u nofs 'il fuq.
English: It is available as a suspension for injection.
Maltese: Huwa disponibbli bħala sospensjoni għall-injezzjoni.
English: There may also be a local reaction at the injection site, such as swelling (generally lasting less than a week) or ‘nodules' (hardening under the skin) that may last for more than 6 or 7 weeks.
Maltese: Jista' jkollhom ukoll reazzjoni lokali fis-sit tal-injezzjoni, bħal nefħa, (ġeneralment li ddum anqas minn ġimgħa) jew ‘boċċi' (twebbis taħt il-ġilda) li jistgħu jdumu għal aktar minn 6 jew 7 ġimgħat.
English: The safety of the vaccine was studied in laboratory safety studies carried out with ZULVAC 8 Ovis in sheep.
Maltese: Is-sigurtà tal-vaċċin ġiet studjata permezz ta' studji ta' sigurtà fil-laboratorju mwettqa b'ZULVAC 8 Ovis fin-nagħaġ.
English: Results from a series of laboratory safety trials performed with vaccines of similar composition but containing different serotypes of the virus were also presented.
Maltese: Ir-riżultati minn serje ta' provi ta' sigurta' laboratorja mwettqa b'vaċċini b'kompożizzjoni simili iżda b'serotipi differenti tal-vajrus kienu ppreżentati wkoll.
English: The benefit-risk balance may be found in the scientific discussion module of this EPAR.
Maltese: Il-bilanċ bejn il-benefiċċji u r-riskji jista' jiġi kkonsultat fil-modulu ta' diskussjoni xjentifika ta' dan l-EPAR.
English: The company also presented results from a series of studies with other vaccines that contain other serotypes of the bluetongue virus, as well as preliminary results from a study in sheep investigating how long the immunity produced by the vaccine lasted after vaccination.
Maltese: Il-kumpanija ppreżentat ukoll riżultati minn serje ta' studji b'vaċċini oħrajn li fihom serotipi oħrajn tal-vajrus tal-lingwablu, kif ukoll riżultati preliminari minn studju dwar in-nagħaġ li jinvestiga kemm damet l-immunita' magħmula mill-vaċċin wara l-vaċċinazzjoni.
English: What is ZULVAC 8 Ovis?
Maltese: X'inhu ZULVAC 8 Ovis?
English: ZULVAC 8 Ovis is used in sheep to protect them against bluetongue disease, an infection caused by the bluetongue virus which is transmitted by midges.
Maltese: ZULVAC 8 Ovis jintuża fin-nagħaġ biex jipproteġihom kontra l-marda tal-lingwablu, li hija infezzjoni kkawżata mill-vajrus tal-lingwablu li jiġi trażmess mill-insetti dipteri.
English: ZULVAC 8 Ovis is a vaccine.
Maltese: ZULVAC 8 Ovis huwa vaċċin.
English: When it is given to sheep, the immune system recognises the viruses as ‘foreign' and makes antibodies against them.
Maltese: Meta tingħata lin-nagħaġ, is-sistema immunitarja tagħraf lill-vajrus bħala ‘barrani' u tipproduċi antikorpi kontrih.
English: What is the risk associated with ZULVAC 8 Ovis?
Maltese: X'riskji huma assoċjati ma' ZULVAC 8 Ovis?
English: Why has ZULVAC 8 Ovis been approved?
Maltese: Għaliex ġie approvat ZULVAC 8 Ovis?
English: Other information about ZULVAC 8 Ovis:
Maltese: Tagħrif ieħor dwar ZULVAC 8 Ovis:
English: Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against a disease.
Maltese: Il-vaċċini jaħdmu billi ‘jgħallmu' lis-sistema immunitarja (id-difiżi naturali tal-ġisem) kif tiddefendi ruħha kontra l-mard.
English: How has ZULVAC 8 Ovis been studied?
Maltese: Kif ġie studjat ZULVAC 8 Ovis?
English: The review of Alkem was initiated on 1 April 2016 at the request of the German medicines authority (BfArM), under Article 31 of Directive 2001/83/EC.
Maltese: Ir-reviżjoni ta' Alkem inbdiet fl-1 ta' April 2016 fuq talba tal-aġenzija tal-mediċini tal-Ġermanja (BfArM), skont l-Artikolu 31 tad-Direttiva 2001/83/KE.
English: Contact our press officer Monika Benstetter
Maltese: Ikkuntattja lill-uffiċjal għall-istampa tagħna Monika Benstetter
English: The recommendations followed a joint routine inspection by German and Dutch authorities in March 2015, which revealed misrepresentation of data during the conduct of two different trials performed in 2013 and 2014 at the Taloja site.
Maltese: Ir-rakkomandazzjonijiet segwew spezzjoni ta' rutina konġunta minn awtoritajiet Ġermaniżi u Olandiżi f'Marzu 2015, li żvelaw rappreżentazzjoni ħażina tad-dejta waqt it-twettiq ta' żewġ provi differenti mwettqa fl-2013 u fl-2014 fis-sit ta' Taloja.
English: The review covered medicines authorised via national procedures in individual EU Member States, whose marketing authorisation applications included data from studies conducted by Alkem Laboratories Ltd, Department of Bioequivalence, C-17/7, MIDC Industrial Estate, Taloja, Dist. Raigad410208 India.
Maltese: Ir-reviżjoni kopriet mediċini awtorizzati permezz ta' proċeduri nazzjonali fi Stati Membri tal-UE individwali, li l-applikazzjonijiet għall-awtorizzazjoni għat-tqegħid fis-suq tagħhom inkludew dejta minn studji mwettqa minn Alkem Laboratories Ltd, Department of Bioequivalence, C-17/7, MIDC
English: • Ibuprofen Orion, a painkiller currently under evaluation by national authorities, cannot be authorised on the basis of studies carried out at Alkem Laboratories Ltd.
Maltese: • Ibuprofen Orion, mediċina għal kontra l-uġigħ li bħalissa qiegħda tiġi evalwata mill-awtoritajiet nazzjonali, ma tistax tiġi awtorizzata abbażi tal-istudji mwettqa minn Alkem Laboratories Ltd.
English: EMA recommends suspension of one medicine
Maltese: L-EMA tirrakkomanda s-sospensjoni ta' mediċina waħda
English: • Cefuroxime Alkem and Cefuroxime Krka (antibiotics) can remain on the market in the EU, as alternative studies have been provided that support a positive benefit-risk balance.
Maltese: • Cefuroxime Alkem u Cefuroxime Krka (antibijotiċi) jistgħu jibqgħu fis-suq fl-UE, minħabba li ġew ipprovduti studji alternattivi li jappoġġjaw bilanċ pożittiv ta' benefiċċju-riskju.
English: The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision applicable in all EU Member States on 8 September 2016.
Maltese: L-opinjoni tas-CHMP intbagħtet lill-Kummissjoni Ewropea, li ħarġet deċiżjoni finali legalment vinkolanti applikabbli fl-Istati Membri kollha fit-8 ta' Settembru 2016.
English: On 23 June 2016, the European Medicines Agency (EMA) recommended the suspension of a medicine (Riluzole Alkem), for which studies were conducted at the Alkem Laboratories Ltd site in Taloja, India, and has required companies to provide new data for another medicine before it can be authorised in the EU.
Maltese: Fit-23 ta' Ġunju 2016, l-Aġenzija Ewropea għall-Mediċini (EMA) irrakkomandat is-sospensjoni ta' mediċina (Riluzole Alkem), li għaliha twettqu studji fis-sit ta' Alkem Laboratories Ltd, f'Taloja, l-Indja, u talbet lil kumpaniji sabiex jipprovdu dejta ġdida għal mediċina oħra qabel ma tkun tista' tiġi awtorizzata fl-UE.
English: The specific recommendations of the CHMP are as follows:
Maltese: Ir-rakkomandazzjonijiet speċifiċi tas-CHMP huwa kif ġejjin:
English: • Some studies carried out at the Alkem Laboratories Ltd site have been found to be flawed.
Maltese: • Xi studji mwettqa fis-sit ta' Alkem Laboratories Ltd instabu li kellhom xi żbalji.
English: • Cefuroxime Ingen Pharma, currently under evaluation by national authorities, can still be considered for authorisation, as studies from other sources have been provided.
Maltese: • Cefuroxime Ingen Pharma, li bħalissa qiegħda tiġi evalwata mill-awtoritajiet nazzjonali, xorta tista' titqies għall-awtorizzazzjoni, minħabba li ġew ipprovduti studji minn sorsi oħrajn.
English: Other riluzole-containing medicines remain available.
Maltese: Mediċini oħrajn li fihom riluzole għadhom disponibbli.
English: • There is no evidence of harm or lack of effectiveness with any of the medicines linked to studies conducted by Alkem Laboratories Ltd.
Maltese: • M'hemm ebda evidenza ta' ħsara jew nuqqas ta' effettività bi kwalunkwe waħda mill-mediċini marbuta mal-istudji li twettqu minn Alkem Laboratories Ltd.
English: EMA will continue to work closely with national authorities and international partners to ensure that studies underpinning marketing authorisations in the EU are carried out to the highest standards and that companies continue to comply fully with all aspects of Good Clinical Practice (GCP).
Maltese: L-EMA sejra tibqa' taħdem mill-qrib mal-awtoritajiet nazzjonali u ma' msieħba internazzjonali sabiex tiżgura li l-istudji li jsostnu l-awtorizzazzjonijiet għat-tqegħid fis-suq fl-UE jitwettqu bl-ogħla standards u li l-kumpaniji jibqgħu jkunu kompletament konformi mal-aspetti kollha ta' Prassi Klinika Tajba (GCP, Good Clinical Practice).
English: • Riluzole Alkem, a medicine for amyotrophic lateral sclerosis (ALS) which has yet to be marketed in the EU, should now be suspended.
Maltese: • Il-mediċina li qed tiġi sospiża, Riluzole Alkem, fiha riluzole u għadha mhijiex fis-suq fl-UE.
English: 8 September 2016 EMA/633777/2016 Rev. 1
Maltese: 8 ta' Settembru 2016
English: The review was carried out by the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which has adopted the Agency's opinion.
Maltese: Ir-reviżjoni twettqet mill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP), responsabbli għal kwistjonijiet li jikkonċernaw mediċini għall-użu mill-bniedem, li adotta l-opinjoni talAġenzija.
English: The findings cast doubts on the quality management system in place at the site, and thus on the reliability of the data of bioequivalence studies conducted between March 2013 and March 2015.
Maltese: Is-sejbiet jitfgħu dubji fuq is-sistema tal-ġestjoni ta' kwalità fis-seħħ fuq is-sit, u għaldaqstant fuq l-affidabbiltà tad-dejta ta' studji dwar il-bijoekwivalenza li twettqu bejn Marzu 2013 u Marzu 2015.
English: EMA's Committee for Medicinal Products for Human Use (CHMP) noted that, although there is no evidence of harm or lack of effectiveness linked to the conduct of studies by Alkem Laboratories Ltd, the studies cannot be accepted in marketing authorisation applications in the EU.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-EMA innota li, għalkemm m'hemmx evidenza ta' ħsara jew nuqqas ta' effettività relatati mat-twettiq ta' studji minn Alkem Laboratories Ltd, l-istudji ma jistgħux jiġu aċċettati fl-applikazzjonijiet għall-awtorizzazjoni għattqegħid fis-suq fl-UE.
English: It also included ongoing marketing authorisation applications for medicines which use study data from the site.
Maltese: Din inkludiet ukoll applikazzjonijiet għall-awtorizzazjoni għat-tqegħid fis-suq li ma jaqtgħu xejn għal mediċini li jużaw dejta tal-istudju mis-sit.
English: Outcome of a referral procedure under Article 35 of Directive 2001/82/EC (EMEA/V/A/124)
Maltese: Riżultat ta' proċedura ta' referenza skont l-Artikolu 35 tadDirettiva 2001/82/KE (EMEA/V/A/124)
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom28 September 2017
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom28 ta' Settembru 2017 EMA/586006/2017
English: Which data has the CVMP reviewed?
Maltese: Liema data rrieżamina s-CVMP?
English: France noted that across the European Union for Zanil and associated names, and generic products thereof, there are different approved withdrawal periods for cattle, sheep and goats, e.g. cattle meat and offal from 10 days to 28 days; cattle milk from zero hours to 108 hours; sheep meat and offal from 14 days to 28 days; sheep milk from ‘do not use in sheep producing milk for human consumption' to 7 days; goat meat and offal 14 days; goat milk zero days.
Maltese: Franza nnutat li fl-Unjoni Ewropea kollha għal Zanil u l-ismijiet assoċjati, u l-prodotti ġeneriċi tiegħu, hemm perjodi tal-irtirar approvati differenti għall-frat, għan-nagħaġ u għall-mogħoż, eż. laħam u ġewwieni tal-frat minn 10 ijiem sa 28 jum; ħalib tal-frat minn żero sigħat sa 108 sigħat; laħam u ġewwieni tan-nagħaġ minn 14-il jum sa 28 jum; ħalib tan-nagħaġ minn “tużahx f'nagħaġ li jipproduċu l-ħalib għall-konsum mill-bniedem” sa 7 ijiem; laħam u ġewwieni tal-mogħoż 14-il jum; ħalib talmogħoż żero jiem.
English: The veterinary medicinal products Zanil and associated names, and generic products thereof, are oral suspensions containing 34 mg oxyclozanide per ml.
Maltese: Il-prodotti mediċinali veterinarji Zanil u l-ismijiet assoċjati, u l-prodotti ġeneriċi tiegħu, huma sospensjonijiet orali li fihom 34 mg oxyclozanide għal kull ml.
English: Consequently, on 1 September 2016, France initiated a procedure under Article 35 of Directive 2001/82/EC for the aforementioned veterinary medicinal products.
Maltese: Konsegwentement, fl-1 ta' Settembru 2016, Franza bdiet proċedura skont l-Artikolu 35 tadDirettiva 2001/82/KE għall-prodotti mediċinali veterinarji msemmija hawn fuq.
English: Oxyclozanide is a salicylanilide anthelmintic, used for the treatment of fasciolosis in cattle, sheep and goats and also for elimination of gravid tapeworm segments (Moniezia spp).
Maltese: Oxyclozanide huwa antelmintiku tassalicylanilide, li jintuża għall-kura tal-fasciolosis fil-frat, fin-nagħaġ u fil-mogħoż u wkoll għalleliminazzjoni ta' segmenti ta' duda tqila (Moniezia spp).
English: Proprietary data and scientific references on residue depletion were provided by the marketing authorisation holders.
Maltese: Id-detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq ipprovdew data riżervata u referenzi xjentifiċi dwar it-tnaqqis tar-residwi.
English: Based on the evaluation of the currently-available data, the CVMP concluded that the overall benefitrisk balance for Zanil and associated names, and generic products thereof, is positive and agreed that the withdrawal periods (meat, milk and offal) for cattle, sheep and goats should be amended to provide assurance for consumer safety.
Maltese: Abbażi tal-evalwazzjoni tad-data disponibbli bħalissa, is-CVMP ikkonkluda li l-bilanċ globali bejn ilbenefiċċju u r-riskju għal Zanil u l-ismijiet assoċjati, u l-prodotti ġeneriċi tiegħu, huwa pożittiv u qabel li l-perjodi tal-irtirar (laħam, ħalib u ġewwieni tal-annimal) għall-frat, għan-nagħaġ u għall-mogħoż għandhom jiġu emendati biex tiġi pprovduta assigurazzjoni għas-sikurezza tal-konsumatur.
English: On 13 July 2017, the European Medicines Agency (the Agency) completed a review of the consumer safety of the withdrawal periods (meat, milk and offal) for cattle, sheep and goats for Zanil and associated names, and generic products thereof.
Maltese: Fit-13 ta' Lulju 2017, l-Aġenzija Ewropea għall-Mediċini (l-Aġenzija) temmet rieżami dwar is-sikurezza tal-konsumatur tal-perjodi tal-irtirar (laħam, ħalib u ġewwieni tal-annimali) għall-frat, għan-nagħaġ u għall-mogħoż għal Zanil u l-ismijiet assoċjati, u l-prodotti ġeneriċi tiegħu.