FrancophonIA/ELRC3.0 huggingface dataset:
English: Elderly: The clinical experience in patients > 65 years of age is very limited.
Maltese: L-esperjenza klinika f'pazjenti ta' > 65 sena hi limitata ħafna.
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Maltese: Prodott mediċinali li jingħata b'riċetta ristretta tat-tabib (ara Anness I: Sommarju tal-Karatteristiċi talProdott, sezzjoni 4.2).
English: • Digestive problems including wind or discomfort after eating meals
Maltese: • Problemi diġestivi li jinkludu gass jew skonfort wara li tiekol xi ikla
English: In the HBeAg negative study patients on adefovir dipivoxil (0-48 weeks) were re-randomised in a blinded-manner to continue on adefovir dipivoxil or receive placebo for an additional 48 weeks.
Maltese: Fl-istudju ta' pazjenti b'HBeAg negattiv li kienu fuq adefovir dipivoxil (0-48 ġimgħat) kienu randomised mill-ġdid b'mod blinded biex ikomplu fuq adefovir dipivoxil jew jirċievu plaċebo għal 48 ġimgħa addizzjonali.
English: Consequently, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicinal product.
Maltese: Konsegwentement, pazjenti li għandhom problemi ereditarji rari ta' intolleranza għall-galactose, nuqqas ta' Lapp lactase jew għandhom problemi biex jassorbu l-glucosegalactose m'għandhomx jieħdu dan il-prodott mediċinali.
English: Treatment with adefovir dipivoxil may result in renal impairment.
Maltese: Trattament b'adefovir dipivoxil jista' jwassal għal indeboliment renali.
English: • Stomach pain
Maltese: • Dgħufija
English: Clinical resistance in studies where adefovir dipivoxil was added to ongoing lamivudine in patients with lamivudine-resistance: In an open-label study of pre- and post-liver transplantation patients with clinical evidence of lamivudine-resistant HBV, no adefovir-associated resistance mutations were observed at week 48.
Maltese: Fi studju open-label ta' pazjenti qabel u wara li kellhom it-trapjant tal-fwied, b'evidenza klinika ta' HBV reżistenti għal lamivudine, l-ebda mutazzjonijiet assoċjati mar-reżistenza għal adefovir ma kienu osservati fil-Ġimgħa 48.
English: Long-term treatment with adefovir dipivoxil may increase the risk of renal impairment.
Maltese: Kura fit-tul b'adefovir dipivoxil tista' żżid ir-riskju ta' indeboliment renali.
English: Gilead Sciences Poland Sp. z o.o.
Maltese: Gilead Sciences Netherlands B.V.
English: Due to the high pharmacokinetic variability of pegylated interferon, no definitive conclusion can be drawn regarding the effect of adefovir and pegylated interferon co-administration on the pharmacokinetic profile of either medicinal product.
Maltese: Minħabba l-varjabilità farmakokinetika għolja ta' pegylated interferon, ma tistax tasal għal konklużjoni definittiva dwar l-effett tal-għoti flimkien ta' adefovir u pegylated interferon fuq il-profil farmakokinetiku ta' xi wieħed minn dawn il-prodotti mediċinali.
English: Adefovir diphosphate selectively inhibits HBV DNA polymerases at concentrations 12-,
Maltese: • epatite B kronika HBeAg pożittiva u HBeAg negattiva b'mard tal-fwied kumpensat.
English: Nephrotoxicity was observed in animals at systemic exposures at least 3-10 times higher than those achieved in humans at the recommended therapeutic dose of 10 mg/day.
Maltese: In-nefrotossiċità ġiet innutata f'annimali waqt esponimenti sistemiċi li kienu mill-anqas 3-10 darbiet ogħla minn dawk li ntlaħqu fil-bniedem fid-doża terapewtika rakkomandata ta' 10 mg/kuljum.
English: Adefovir diphosphate has an intracellular half-life of 12 to 36 hours in activated and resting lymphocytes.
Maltese: Adefovir diphosphate għandu half-life ta' bejn 12 u 36 siegħa f'limfoċiti attivati u dawk li jkunu jistrieħu.
English: As a result, the frequency category of proximal renal tubulopathy and Fanconi syndrome is revised from unknown to uncommon in section 4.8 of Hepsera SmPC and in the corresponding section of the package leaflet.
Maltese: Bħala riżultat, il-kategorija tal-frekwenza ta' tubulopatija prossimali renali u sindrome ta' Fanconi hija riveduta minn mhux magħruf għal mhux komuni fissezzjoni 4.8 tal-SmPC għal Hepsera u fis-sezzjoni korrispondenti tal-fuljett ta' tagħrif.
English: Immediate Packaging Pack size
Maltese: Daqs tal-pakkett
English: MA (EU) number
Maltese: Numru tal-MA
English: Armisarte is a ‘hybrid medicine'.
Maltese: Armisarte hija ‘mediċina ibrida'.
English: It is given once every three weeks as an infusion lasting 10 minutes.
Maltese: Tingħata darba kull tliet ġimgħat bħala infużjoni li ddum 10 minuti.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Pemetrexed Actavis on 18 January 2016.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha għal Pemetrexed Actavis fit-18 ta' Jannar 2016.
English: This summary was last updated in 02-2016.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'02-2016.
English: Other information about Armisarte
Maltese: Aktar informazzjoni dwar Armisarte
English: Armisarte contains the active substance pemetrexed.
Maltese: Armisarte fih is-sustanza attiva pemetrexed.
English: In the body, pemetrexed is converted into an active form that blocks the activity of the enzymes that are involved in producing ‘nucleotides' (the building blocks of DNA and RNA, the genetic material of cells).
Maltese: Filġisem, pemetrexed jinbidel f'forma attiva li timblokka l-attività tal-enzimi li huma involuti filproduzzjoni ta' ‘nukleotidi' (nucleotides - li fuqhom jinbnew DNA u RNA, il-materjal ġenetiku taċċelloli).
English: The company provided data from the published literature on pemetrexed.
Maltese: Il-kumpanija pprovdiet data minn dokumentazzjoni ppubblikata dwar pemetrexed.
English: What are the benefits and risks of Armisarte?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Armisarte?
English: This is a summary of the European public assessment report (EPAR) for Armisarte.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Armisarte.
English: • malignant pleural mesothelioma (a cancer of the lining of the lungs that is usually caused by exposure to asbestos), where it is used together with cisplatin in patients who have not received chemotherapy before and whose cancer cannot be removed by surgery;
Maltese: • mesoteljoma plewrika malinna (kanċer tar-rita tal-pulmun, normalment ikkawżat minn esponiment għall-asbestos), meta jintuża flimkien ma' ċisplatina f'pazjenti li ma ngħatawx il-kimoterapija qabel u li l-kanċer li għandhom ma jistax jitneħħa b'intervent kirurġiku;
English: Armisarte is a cancer medicine used to treat two types of lung cancer:
Maltese: Armisarte hija mediċina kontra l-kanċer li tintuża biex tikkura żewġ tipi ta' kanċers tal-pulmun:
English: This means that Armisarte is similar to a ‘reference medicine' already authorised in the European Union (EU) called Alimta, but it is available in a different form.
Maltese: Dan ifisser li Armisarte huwa simili għall-‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) bl-isem ta' Alimta, iżda huwa disponibbli f'forma differenti.
English: Why is Armisarte approved?
Maltese: Għaliex ġie approvat Armisarte?
English: Previously known as Pemetrexed Actavis.
Maltese: Preċedentement magħruf bħala Pemetrexed Actavis
English: A risk management plan has been developed to ensure that Armisarte is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Armisarte jintuża bl-aktar mod sigur possibbli.
English: The name of the medicine was changed to Armisarte on 10 February 2016.
Maltese: L-isem tal-mediċina nbidel f'Armisarte fl-10 ta' Frar 2016.
English: The active substance in Armisarte, pemetrexed, is a cytotoxic medicine (a medicine that kills cells that are dividing, such as cancer cells), which belongs to the group ‘antimetabolites'.
Maltese: Is-sustanza attiva f'Armisarte, pemetrexed, hija mediċina ċitotossika (mediċina li toqtol iċ-ċelloli li jkunu qed jiddividu ruħhom, bħaċ-ċelloli tal-kanċer) li jagħmlu parti mill-grupp tal-‘antimetaboliti'.
English: The full EPAR and risk management plan summary for Armisarte can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports Għal aktar informazzjoni rigward il-kura b'Armisarte, aqra l-fuljett ta' tagħrif (parti wkoll mill-EPAR) jew ikkuntattja lit-tabib jew lill-ispiżjar tiegħek.
English: Armisarte is available as a concentrate for solution for infusion into a vein.
Maltese: Armisarte huwa disponibbli bħala konċentrat għal soluzzjoni għall-infużjoni ġo vina.
English: The conversion of pemetrexed into its active form occurs more readily in cancer cells than in normal cells, leading to higher levels of the active form of the medicine and a longer duration of action in cancer cells.
Maltese: Il-konverżjoni ta' pemetrexed għall-forma attiva tiegħu ssir iktar malajr fiċ-ċelloli tal-kanċer milli f'ċelloli normali, u dan iwassal għal livelli ogħla tal-forma attiva tal-mediċina u l-azzjoni ddum iktar fiċ-ċelloli tal-kanċer.
English: No additional studies were needed as Armisarte is a hybrid medicine that is given by infusion and contains the same active substance as the reference medicine, Alimta.
Maltese: L-ebda studju addizzjonali ma kien meħtieġ minħabba li Armisarte huwa mediċina ibrida li tingħata permezz ta' infużjoni u li fiha l-istess sustanza attiva bħal tal-mediċina ta' referenza, Alimta.
English: For more information, see the summary of product characteristics (also part of the EPAR).
Maltese: Għal aktar informazzjoni, ara s-sommarju tal-karatteristiċi tal-prodott (parti wkoll mill-EPAR).
English: The Committee recommended that Armisarte be approved for use in the EU.
Maltese: Il-Kumitat irrakkomanda li Armisarte ikun approvat għall-użu fl-UE.
English: The recommended dose is 500 mg per square metre of body surface area (calculated using the patient's height and weight).
Maltese: Id-doża rakkomandata hija 500 mg għal kull metru kwadru tal-erja tas-superfiċje tal-ġisem (ikkalkulata permezz tat-tul u l-piż tal-pazjent).
English: How has Armisarte been studied?
Maltese: Kif ġie studjat Armisarte?
English: While Alimta is available as a powder to be made up into a solution for infusion (drip) into a vein, Armisarte is available as a concentrated liquid to be made up into a solution for infusion.
Maltese: Meta Alimta huwa disponibbli bħala trab biex isir soluzzjoni għall-infużjoni (dripp) fil-vina, Armisarte huwa disponibbli bħala likwidu kkonċentrat li jsir soluzzjoni għall-infużjoni.
English: To reduce side effects, patients should take a corticosteroid (a type of medicine that reduces inflammation) and folic acid (a type of vitamin), and receive injections of vitamin B12 during treatment with Armisarte.
Maltese: Biex jitnaqqsu l-effetti sekondarji, il-pazjenti għandhom jieħdu kortikosterojde (tip ta' mediċina li tnaqqas l-infjammazzjoni) u aċidu foliku (tip ta' vitamina), u għandhom jirċievu injezzjonijiet ta' vitamina
English: The full EPAR for the reference medicine can also be found on the Agency's website.
Maltese: L-EPAR sħiħ għall-mediċina ta' referenza jista' jinstab ukoll fis-sit web tal-Aġenzija.
English: It is not intended to provide practical advice on how to use Armisarte.
Maltese: Dan mhux maħsub biex jipprovdi konsultazzjoni prattika dwar l-użu ta' Armisarte.
English: Because Armisarte is a hybrid medicine that is given by infusion and contains the same active substance as the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Peress li Armisarte jingħata b'infużjoni u fih l-istess sustanza attiva bħall-mediċina ta' referenza, ilbenefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk tal-mediċina ta' referenza.
English: • advanced non-small-cell lung cancer of the kind known as ‘non-squamous', where it is used either in combination with cisplatin in previously untreated patients or on its own in patients who have previously received cancer treatment.
Maltese: • kanċer tal-pulmun avvanzat mhux b'ċelloli żgħar tat-tip magħruf bħala 'mhux skwamuż', meta jintuża jew flimkien ma' ċisplatina f'pazjenti li qatt ma kienu ngħataw kura qabel jew waħdu f'pazjenti li diġà ngħataw kura għal kontra l-kanċer.
English: What measures are being taken to ensure the safe and effective use of Armisarte?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Armisarte?
English: The full EPAR for Vipidia can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Vipidia alogliptin
Maltese: Vipidia alogliptina
English: The active substance in Vipidia, alogliptin, is a dipeptidyl-peptidase-4 (DPP 4) inhibitor.
Maltese: Is-sustanza attiva f'Vipidia, l-alogliptina, hija inibitur tad-dipeptidil peptidażi (dipeptidyl peptidase ) -4 (DPP-4).
English: Vipidia is available as tablets (6.25, 12.5 and 25 mg) and can only be obtained with a prescription.
Maltese: Vipidia jiġi f'pilloli ta' (6.25, 12.5 and 25 mg) u jista jinkiseb biss b'riċetta ta' tabib.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Vipidia on 19 September 2013.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Vipidia fil-19 ta' Settembru 2013.
English: This is a summary of the European public assessment report (EPAR) for Vipidia.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Vipidia.
English: Vipidia has been studied in seven main studies involving 5,675 adults with type 2 diabetes.
Maltese: Vipidia ġie studjat f'seba' studji ewlenin li jinvolvu 5,675 adult bid-dijabete tat-tip 2.
English: What are the risks associated with Vipidia?
Maltese: X'inhuma r-riskji assoċjati ma' Vipidia?
English: The CHMP considered that the effects of Vipidia on HbA1c levels were similar to those of other DPP-4 inhibitors and were modest but clinically relevant.
Maltese: Is-CHMP ikkunsidra li leffetti ta' Vipidia fuq il-livelli HbA1c kienu simili għal dawk ta' inibituri oħra tad-DPP-4 u kienu modesti iżda klinikament rilevanti.
English: Why is Vipidia approved?
Maltese: Għalxiex ġie approvat Vipidia?
English: Vipidia is a diabetes medicine that contains the active substance alogliptin.
Maltese: Vipidia huwa mediċina li fiha s-sustanza attiva l-alogliptina.
English: When used alone or in combination with other anti-diabetes medicines, Vipidia reduced HbA1c levels by 0.48-0.61% more than placebo.
Maltese: HbA1c b'0.480.61% aktar mill-plaċebo.
English: A risk management plan has been developed to ensure that Vipidia is used as safely as possible.
Maltese: Pjan ta' ġestjoni tar-riskju ġie żviluppat biex jassigura li Vipidia jintuża bl-aktar mod sigur possibbli.
English: What measures are being taken to ensure the safe and effective use of Vipidia?
Maltese: X'miżuri qegħdin jittieħdu biex jassiguraw użu sigur u effettiv ta' Vipidia?
English: It works by blocking the breakdown of ‘incretin' hormones in the body.
Maltese: Taħdem billi timblokka t-tkissir tal-ormoni 'inkretini' fil-ġisem.
English: HbA1c levels were measured after 26 weeks when Vipidia was used alone or added to other diabetes medicines, and after 52 weeks when Vipidia was compared with glipizide or pioglitazone.
Maltese: HbA1c tkejlu wara 26 ġimgħa meta Vipidia intuża waħdu jew flimkien ma' mediċini oħra tad-dijabete, u wara 52 ġimgħa meta Vipidia tqabbel ma' glipizide jew pioglitazone.
English: When Vipidia is added to a sulphonylurea (a type of diabetes medicine) or insulin, the doctor may need to lower the dose of these medicines to reduce the risk of hypoglycaemia (low blood sugar level).
Maltese: Meta Vipidia jitħallat ma' sulphonylurea (tip ta' mediċina għad-dijabete) jew linsulina, it-tabib jista' jnaqqas id-doża ta' dawn il-mediċini biex inaqqas ir-riskju ipogliċemija (livelli baxxi ta' zokkor fid-demm).
English: How is Vipidia used?
Maltese: Kif jintuża Vipidia?
English: Alogliptin also reduces the amount of glucose made by the liver, by increasing insulin levels and decreasing the levels of the hormone glucagon.
Maltese: L-Alogliptin tnaqqas ukoll l-ammont ta' glukożju magħmul mill-fwied billi tgħolli llivelli tal-insulina u tnaqqas il-livelli tal-ormon glukagonu.
English: By blocking the breakdown of incretin hormones in the blood, alogliptin prolongs their action in stimulating the pancreas to produce more insulin when blood glucose levels are high.
Maltese: Billi timblokka t-tkissir tal-ormoni talinkretin fid-demm, l-alogliptin ittawwal l-azzjoni tagħhom billi tistimula l-frixa biex tipproduċi aktar insulina meta l-livelli tal-glukożju fid-demm ikunu għoljin.
English: Vipidia was as least as affective as pioglitazone in lowering HbA1c when added to metformin, but the study comparing Vipidia with glipizide was not conclusive.
Maltese: Vipidia għallinqas kien effettiv daqs pioglitazone fit-tnaqqis ta' HbA1c meta jintuża flimkien mal-metformin, iżda l-istudju li jqabbel Vipidia ma' glipizide ma kienx konklużiv.
English: Regarding its safety, Vipidia's safety profile was consistent with that seen with other DPP-4 inhibitors.
Maltese: Rigward is-sigurtà tiegħu, il-profil ta' sigurtà ta' Vipidia kien konsistenti ma inibituri oħra tad-DPP-4.
English: These hormones are released after a meal and stimulate the pancreas to produce insulin.
Maltese: Dawn l-ormoni jiġu rilaxxati wara ikla u jistimulaw lill-frixa sabiex tipproduċi l-insulina.
English: Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively.
Maltese: Id-dijabete tat-tip 2 hija marda li fiha l-frixa ma tipproduċix biżżejjed insulina biex tikkontrolla l-livell ta' glukożju fid-demm jew meta l-ġisem ma jkunx kapaċi juża l-insulina b'mod effettiv.
English: In all of the studies, the main measure of effectiveness was the change in the level of glycosylated haemoglobin (HbA1c), which is the percentage of haemoglobin in the blood that has glucose attached.
Maltese: Il-kejl ewlieni tal-effikaċja fl-istudji kollha kienu l-bidliet fil-livelli tal-emoglobina glikosilata (HbA1c), li hija perċentwal tal-emoglobina fid-demm li magħha jeħel il-glukożju.
English: 8 January 2010
Maltese: 8 ta' Jannar 2010
English: Tylosin is a macrolide antibiotic.
Maltese: Tylosin huwa antibijotiku makrolide.
English: 1 Article 33(4) of Directive 2001/82/EC, as amended.
Maltese: 1 L-Artikolu 33(4) tad-Direttiva 2001/82/KE, kif emendata.
English: The Decentralised Procedure NL/V/0127/001/DC started on 23 March 2007.
Maltese: Il-Proċedura Deċentralizzata NL/V/0127/001/DC bdiet fit-23 ta' Marzu 2007.
English: The rapporteur and co-rapporteur appointed were: Dr Cristina Muñoz Madero (Spain) and Dr Boris Kolar (Slovenia), respectively.
Maltese: Ir-rapporteur u l-korapporteur maħturin kienu: Dr Cristina Muñoz Madero (Spanja) u Dr Boris Kolar (Slovenja), rispettivament.
English: Opinion following an Article 33(4)
Maltese: Opinjoni wara referenza skont l-Artikolu 33 (4)
English: The application was submitted in the framework of Article 32 of Directive 2001/82/EC, as amended, where the reference member state was the Netherlands and the concerned member states (CMSs) were Austria, Belgium, Bulgaria, Czech Republic, Germany, Denmark, Spain, Hungary, Ireland, Italy, Poland, Portugal, Romania and United Kingdom.
Maltese: L-applikazzjoni ġiet ippreżentata fil-qafas talArtikolu 32 tad-Direttiva 2001/82/KE, kif emendata, fejn l-Istat Membru tar-referenza kien l-Olanda u l-Istati Membri kkonċernati (CMSs) kienu l-Awstrija, il-Belġju, il-Bulgarija, ir-Repubblika Ċeka, ilĠermanja, id-Danimarka, Spanja, l-Ungerija, l-Irlanda, l-Italja, il-Polonja, il-Portugall, ir-Rumanija u rRenju Unit.
English: Committee for medicinal products for veterinary use (CVMP)
Maltese: Kumitat għall-prodotti mediċinali għall-użu veterinarju (CVMP)
English: Opinion following an Article 33(4)F F referral for Pharmasin 100% W/W Water Soluble Granules and associated names
Maltese: Opinjoni wara referenza skont l-Artikolu 33 (4)F F għal Pharmasin 100% W/W Granuli li Jinħallu fl-Ilma u l-ismijiet assoċjati
English: The referral procedure started on 14 May 2008.
Maltese: Il-proċedura ta' referenza bdiet fl-14 ta' Mejju 2008.
English: The rapporteur and co-rapporteur appointed for the re-examination were: Dr Ruth Kearsley as the rapporteur and Dr Michael Holzhauser-Alberti as the co-rapporteur respectively.
Maltese: Ir-rapporteur u l-korapporteur maħturin għall-eżami mill-ġdid kienu: Dr Ruth Kearsley bħala r-rapporteur u Dr Michael Holzhauser-Alberti bħala l-korapporteur rispettivament.
English: The re-examination procedure started on 6 February 2009 and oral explanations were given by Huvepharma NV on 10 March 2009.
Maltese: Il-proċedura ta' eżaminazzjoni mill-ġdid bdiet fis-6 ta' Frar 2009 u fl-10 ta' Marzu 2009 ingħataw spjegazzjonijiet orali minn Huvepharma NV.
English: The applicant, Huvepharma NV, submitted an application for a decentralised procedure for Pharmasin 100% W/W Water Soluble Granules and associated names indicated for oral use in pigs, chickens (broilers, pullets), turkeys and calves.
Maltese: L-applikant, Huvepharma NV, issottometta applikazzjoni għal proċedura deċentralizzata għal Pharmasin 100% W/W Granuli li Jinħallu fl-Ilma u l-ismijiet assoċjati indikati għall-użu orali fil-majjali, tiġieġ (brojlers, għewietaq), dundjani u għoġġiela.
English: During its 10-12 March 2009 meeting, the Committee, having considered the grounds for appeal and the oral explanations provided by Huvepharma NV, concluded by consensus that its opinion of 10 December 2008 should not be revised and that the marketing authorisations for Pharmasin 100% W/W Water Soluble Granules and associated names should be refused by the member states.
Maltese: Waqt il-laqgħa tiegħu tal-10-12 ta' Marzu 2009, il-Kumitat, wara li kkunsidra r-raġunijiet għall-appell u l-ispjegazzjonijiet orali pprovduti minn Huvepharma NV, ikkonkluda b'konsensus li l-opinjoni tiegħu tal10 ta' Diċembru 2008 ma għandhiex tkun riveduta u li l-awtorizzazzjonijiet għat-tqegħid fis-suq ta' Pharmasin 100% W/W Granuli li Jinħallu fl-Ilma u l-ismijiet assoċjati għandha tiġi rrifjutata mill-Istati Membri.
English: On 29 April 2008 the Netherlands referred the matter to the European Medicines Agency (the Agency) under Article 33 (4) of Directive 2001/82/EC, due to concerns, raised by Germany, that tylosin may present a potential serious risk to the environment (risk to algae and to terrestrial plants).
Maltese: Fid-29 ta' April 2008, l-Olanda rreferiet il-kwistjoni lill-Aġenzija Ewropea tal-Mediċini (l-Aġenzija) skont l-Artikolu 33 (4) tad-Direttiva 2001/82/KE, minħabba tħassib, imqajjem mill-Ġermanja, li tylosin jista' jippreżenta riskju serju potenzjali għall-ambjent (riskju għall-alga u pjanti tal-art).
English: On 16 September 2008 the CVMP agreed a list of outstanding issues and the written explanations were provided by the applicant on 12 November 2008.
Maltese: Fis-16 ta' Settembru 2008, is-CVMP qabel fuq lista ta' kwistjonijiet pendenti u l-ispjegazzjonijiet bilmiktub ġew ipprovduti mill-applikant fit-12 ta' Novembru 2008.
English: 100% W/W Water Soluble Granules and associated names
Maltese: Pharmasin 100% W/W Granuli li Jinħallu fl-Ilma u lismijiet assoċjati
English: In line with the restrictions in legislation with respect to data on environmental risk, the Committee limited its considerations to the data presented by Huvepharma NV in the dossier for Pharmasin 100% W/W Water Soluble Granules and associated names.
Maltese: B'mod konformi mar-restrizzjonijiet fil-leġiżlazzjoni fir-rigward tad-dejta dwar ir-riskju ambjentali, ilKumitat illimita l-kunsiderazzjonijiet tad-dejta ppreżentata minn Huvepharma NV fid-dossier għal Pharmasin 100% W/W Granuli li Jinħallu fl-Ilma u l-ismijiet assoċjati.