FrancophonIA/ELRC3.0 huggingface dataset:
English: Common side effects (may affect up to 1 in 10 people): - eye pain - inflammation of the front of the eye - red eyes - swelling of the cornea (the clear layer over the front of the eye) - sensitivity to light
Maltese: Effetti sekondarji komuni (jistgħu jaffettwaw sa persuna 1 minn kull 10): - uġigħ fl-għajnejn - infjammazzjoni tal-parti ta' quddiem tal-għajn - għajnejn ħomor - nefħa tal-kornea (is-saff ċar fuq il-parti ta' quddiem tal-għajn) - sensittività għad-dawl
English: Component of a multipack, cannot be sold separately.
Maltese: Komponent ta' pakkett b'ħafna, ma jistax jinbiegħ separatament
English: Intraocular metabolic interactions are unlikely because phenylephrine and ketorolac are removed from the anterior chamber by irrigation during the surgical procedure and by normal aqueous humour circulation postoperatively.
Maltese: Interazzjonijiet metaboliċi intraokulari mhumiex probabbli minħabba li matul il-proċedura kirurġika, fenilefrina u ketorolac jitneħħew mill-kompartiment anterjuri bl-irrigazzjoni u permezz ta' ċirkolazzjoni normali tal-umuri milwiem wara l-operazzjoni.
English: EMA/56994/2015 EMEA/H/C/002066
Maltese: EMEA/H/C/002066
English: Ikervis ciclosporin
Maltese: Ikervis ċiklosporina
English: About 29% (44 of 154) of those given Ikervis responded, compared with 23% (21 of 91) given the vehicle.
Maltese: Madwar 29% (44 minn 154) ta' dawk li ngħataw Ikervis irrispondew, meta mqabbel ma' 23% (21 minn 91) li ngħataw il-vehicle.
English: The full EPAR and risk management plan summary for Ikervis 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: Ikervis contains the active substance ciclosporin.
Maltese: Ikervis fih is-sustanza attiva ċiklosporina.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Ikervis on 19 March 2015.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Ikervis fid-19 ta' Marzu 2015.
English: Other information about Ikervis
Maltese: Informazzjoni oħra dwar Ikervis
English: If other eye drops are used, the different medicines must be given at least 15 minutes apart.
Maltese: Jekk jintużaw qtar tal-għajnejn oħrajn, il-mediċini differenti għandhom jingħataw tal-anqas 15-il minuta minn xulxin.
English: This is a summary of the European public assessment report (EPAR) for Ikervis.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Ikervis.
English: Why is Ikervis approved?
Maltese: Għaliex ġie approvat Ikervis?
English: The active substance in Ikervis, ciclosporin, acts on cells of the immune system (the body's natural defences) that are involved in the processes that cause inflammation.
Maltese: Is-sustanza attiva f'Ikervis, iċ-ċiklosporina, taġixxi fuq iċ-ċelloli tas-sistema immunitarja (id-difiżi naturali tal-ġisem) li huma involuti fil-proċessi li jikkawżaw infjammazzjoni.
English: The most common side effects with Ikervis (which may affect more than 1 in 10 people) are pain and irritation in the eye; other common side effects are lacrimation (excessive tears), ocular hyperaemia (red eye), and erythema (redness) of the eyelid.
Maltese: L-effetti sekondarji l-aktar komuni b'Ikervis (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 10) huma uġigħ u irritazzjoni fl-għajn; effetti sekondarji komuni oħra huma dmugħ (dmugħ eċċessiv), iperimija okulari (għajnejn ħomor), u eritema (ħmura) tal-kappell tal-għajn.
English: What are the risks associated with Ikervis?
Maltese: X'inhuma r-riskji assoċjati ma' Ikervis?
English: The benefits of Ikervis have been shown in one main study involving 246 patients with severe dry eye disease, where Ikervis was compared with the vehicle (the same eye drop formula but without any active substance).
Maltese: Il-benefiċċji ta' Ikervis intwerew fi studju wieħed li involva 246 pazjent b'mard sever tal-għajnejn xotti, fejn Ikervis tqabbel mal-vehicle (l-istess formula ta' qtar tal-għajnejn iżda mingħajr ebda sustanza attiva).
English: Without sufficient protection from the tear fluid, the cornea can get damaged and become inflamed (keratitis), which can eventually lead to ulceration, infection and reduced vision.
Maltese: Mingħajr biżżejjed protezzjoni mill-fluwidu tad-dmugħ, il-kornea jista' jsirilha ħsara u tinfjamma (keratite), li eventalwemt jista' jwassal għal ulċera, infezzjoni jew indeboliment fil-vista.
English: Ikervis is a medicine used to treat severe keratitis, an inflammation of the cornea (the transparent layer covering the front of the eye) in adult patients with dry eye disease.
Maltese: Ikervis huwa mediċina li tintuża biex tikkura keratite severa, infjammazzjoni tal-kornea (is-saff trasparenti li jkopri l-parti ta' quddiem tal-għajn) f'pazjenti adulti b'mard tal-għajnejn xotti.
English: The CHMP considered that this was clinically meaningful, since none of the available medicines for the condition have been shown to reduce damage to the surface of the eye, which might help prevent the progression of the disease.
Maltese: Is-CHMP ikkunsidra li dan kien klinikament sinifikanti, peress li l-ebda waħda mill-mediċini disponibbli għall-kundizzjoni ma ntweriet li tnaqqas il-ħsara lill-wiċċ tal-għajn, li jaf tgħin biex twaqqaf il-progressjoni tal-marda.
English: A risk management plan has been developed to ensure that Ikervis is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Ikervis jintuża bl-aktar mod sigur possibbli.
English: For the full list of all side effects reported with Ikervis, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati b'Ikervis, ara l-fuljett ta' tagħrif.
English: Although Ikervis had not been shown to be any better than the vehicle in improving symptoms such as discomfort and pain, there was evidence that it could reduce the inflammation and damage to the cornea associated with keratitis.
Maltese: Għalkemm Ikervis ma ntweriex li huwa aħjar mill-vehicle biex itejjeb sintomi bħal skonfort u uġigħ, kien hemm evidenza li seta' jnaqqas l-infjammazzjoni u l-ħsara lill-kornea assoċjata ma' keratite.
English: How does Ikervis work?
Maltese: Kif jaħdem Ikervis?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Ikervis's benefits are greater than its risks and recommended that it be approved for use in the EU.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) iddeċieda li l-benefiċċji ta' Ikervis huma akbar mir-riskji tiegħu u rrakkomanda li jkun approvat għall-użu fl-UE.
English: The proportion of patients who responded to treatment was therefore similar in the two groups, but when only the damage to the cornea was considered, Ikervis was significantly better than the vehicle at reducing it. Levels of HLADR (a measure of inflammation in eye cells) were also reduced in patients using Ikervis compared with the dummy treatment.
Maltese: Il-proporzjon ta' pazjenti li rrispondew għall-kura kien għalhekk simili fiż-żewġ gruppi, iżda meta ġiet ikkunsidrata l-ħsara lillkornea biss, Ikervis kien ferm aħjar mill-vehicle fit-tnaqqis tagħha.
English: Ikervis should be given last.
Maltese: Ikervis għandu jingħata l-aħħar.
English: In patients with dry eye disease, either not enough tear fluid is produced to create the protective film of moisture that normally coats the surface of the eye, or abnormalities in the tear fluid cause it to dry out too quickly.
Maltese: F'pazjenti b'mard tal-għajnejn xotti, jew ma jiġix prodott biżżejjed fluwidu tad-dmugħ biex jinħoloq kisi protettiv ta' umdu li normalment jiksi l-wiċċ tal-għajn, jew anomalitajiet fil-fluwidu tad-dmugħ iwasslu biex dan jixxotta wisq malajr.
English: After vaccination, animals may have a slightly raised temperature (usually not more than 0.5°C, but in individual cases up to about 2°C) for up to three days after vaccination.
Maltese: Wara tilqima, l-annimali jista' jkollhom temperatura kemxejn ogħla (normalment mhux aktar minn 0.5°C, iżda f'każijiet individwali sa madwar 2°C) għal mhux aktar minn tlitt ijiem wara t-tilqima.
English: Inactivated adjuvanted vaccine against bluetongue virus serotype 8
Maltese: Vaċċin adjuvant inattivat kontra s-serotip 8 tal-vajrus tal-bluetongue
English: Bovilis BTV8 is a vaccine that contains an inactivated (killed) bluetongue serotype 8 virus as the active substance.
Maltese: Bovilis BTV8 huwa vaċċin li fih vajrus tal-bluetongue tas-serotip 8 inattivat (maqtul) bħala s-sustanza attiva.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Bovilis BTV8 on 06/09/2010.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha, għal Bovilis BTV8 fis-06/09/2010.
English: The virus exists in several forms (serotypes) throughout the world; the type used in Bovilis BTV8 is serotype 8.
Maltese: Il-vajrus jeżisti f'diversi forom (serotipi) madwar id-dinja; it-tip użat f'Bovilis BTV8 huwa serotip 8.
English: The risk of bluetongue transmission to cattle following vaccination with Bovilis BTV8 was further investigated in two epidemiological models.
Maltese: Ir-riskju tat-trażmissjoni tal-bluetongue lill-frat wara l-vaċċin b'Bovilis BTV8 ġiet investigata aktar f'2 mudelli epidemjoloġiċi.
English: Other information about Bovilis BTV8:
Maltese: Informazzjoni oħra dwar Bovilis BTV8:
English: The benefit-risk balance may be found in the scientific discussion module of this EPAR.
Maltese: Il-bilanċ bejn il-benefiċċju u r-riskju jista' jinstab fil-modulu tad-diskussjoni xjentifika f'dan l-EPAR.
English: Bovilis BTV8 is a vaccine.
Maltese: Bovilis BTV8 huwa vaċċin.
English: Bovilis BTV8 is used in cattle and sheep to protect them against bluetongue disease, an infection caused by the bluetongue virus which is transmitted by midges.
Maltese: Bovilis BTV8 jintuża fi frat u n-nagħaġ biex jipproteġihom kontra l-marda tal-bluetongue, li hija infezzjoni kkawżata mill-vajrus tal-bluetongue trażmess mill-insetti dipteri.
English: The studies showed that the vaccine is safe for both sheep and cattle and that it prevents viraemia in sheep from one month of age when infected with bluetongue virus serotype 8, whereas Bovilis BTV8 reduces viraemia in cattle from six weeks of age.
Maltese: L-istudji wrew li l-vaċċin huwa sikur kemm għan-nagħaġ kif ukoll għall-ifrat u li jimpedixxi viremja finnagħaġ minn età ta' xahar meta infettati bil-vajrus bluetongue serotip 8 filwaqt li Bovilis BTV8 inaqqas il-viremja fil-frat minn età ta' sitt ġimgħat.
English: The safety of the vaccine was studied in laboratory safety studies carried out with an overdose of Bovilis BTV8 in young lambs and calves and in pregnant ewes and cows.
Maltese: Is-sigurtà tal-vaċċin ġiet studjata fl-istudji tas-sigurtà fil-laboratorju mwettqa b'doża eċċessiva ta' Bovilis BTV8 fi ħrief u għoġġiela żgħar u f'nagħaġ nisa u baqar tqal.
English: What is Bovilis BTV8?
Maltese: X'inhu Bovilis BTV8?
English: This document is a summary of the European Public Assessment Report.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR).
English: Why has Bovilis BTV8 been approved?
Maltese: Għaliex ġie approvat Bovilis BTV8?
English: What is the risk associated with Bovilis BTV8?
Maltese: X'inhu r-riskju assoċjat ma' Bovilis BTV8?
English: How has Bovilis BTV8 been studied?
Maltese: Kif ġie studjat Bovilis BTV8?
English: The efficacy of the vaccine in cattle and sheep was studied in a number of laboratory trials; in cattle from six weeks of age and in sheep from one month of age..
Maltese: L-effikaċja tal-vaċċin fil-frat u fin-nagħaġ ġiet studjata f'għadd ta' provi tal-laboratorju; fi frat ta' età minn sitt ġimgħat u nagħaġ minn età ta' xahar.
English: The CVMP concluded that the benefits of Bovilis BTV8 exceed the risks and recommended that Bovilis BTV8 be given a marketing authorisation.
Maltese: Għall-ewwel Bovilis BTV8 ġie awtorizzat taħt ‘ċirkostanzi ta' eċċezzjoni'.
English: This summary was last updated in 02-2018.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fi: 02-2018.
English: The full EPAR for Omnitrope can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: L-EPAR sħiħ għal Omnitrope jinstab fis-website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports tal-Aġenzija.
English: • have a genetic condition called Prader-Willi syndrome.
Maltese: • ikollhom kondizzjoni ġenetika msejħa sindrome ta' Prader-Willi.
English: In adults, side effects related to fluid retention, such as peripheral oedema (swelling, especially of the ankles and feet), paraesthesia (numbness or tingling), joint and muscle pain, and stiffness of the limbs are common (may affect between 1 and 10 patients in 100).
Maltese: Fl-adulti, effetti sekondarji relatati maż-żamma tal-fluwidi, bħal edema periferali (nefħa, speċjalment tal-għekiesi u tas-saqajn), paresteżija (tnemnim jew tagħrix), uġigħ fil-ġogi u fil-muskoli, u ebusija tad-dirgħajn u r-riġlejn huma komuni (jistgħu jaffettwaw bejn 1 u 10 pazjenti minn kull 100).
English: Other information about Omnitrope
Maltese: Informazzjoni oħra dwar Omnitrope
English: Somatropin is produced by a method known as ‘recombinant DNA technology': the hormone is made by bacteria into which a gene (DNA) has been introduced that makes them able to produce somatropin.
Maltese: Somatropin jiġi prodott permezz ta' metodu magħruf bħala ‘teknoloġija tad-DNA rikombinanti': l-ormon isir minn batterja li fihom jiġi introdott ġene (DNA) li jagħmilhom kapaċi jipproduċu somatropin.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Omnitrope on 12 April 2006.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Omnitrope fit-12 ta' April 2006.
English: Omnitrope contains the active substance somatropin and is a ‘biosimilar' medicine.
Maltese: Omnitrope fih is-sustanza attiva somatropin u huwa ‘mediċina bijosimili'.
English: The reference medicine for Omnitrope is Genotropin.
Maltese: Il-mediċina ta' referenza għal Omnitrope hija Genotropin.
English: This is a summary of the European public assessment report (EPAR) for Omnitrope.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Omnitrope.
English: Omnitrope somatropin
Maltese: Sommarju tal-EPAR għall-pubbliku somatropin
English: Why is Omnitrope approved?
Maltese: Għaliex ġie approvat Omnitrope?
English: Omnitrope is also used as replacement therapy in adult patients with pronounced growth hormone deficiency.
Maltese: Omnitrope jintuża wkoll bħala terapija ta' sostituzzjoni f'pazjenti adulti b'defiċjenza evidenti tal-ormon tat-tkabbir.
English: What are the risks associated with Omnitrope?
Maltese: X'inhuma r-riskji assoċjati ma' Omnitrope?
English: This means that Omnitrope is highly similar to a biological medicine (the ‘reference medicine') that is already authorised in the EU.
Maltese: Dan ifisser li Omnitrope huwa simili għal mediċina bijoloġika (magħrufa wkoll bħala l-'mediċina ta' referenza') li diġà hija awtorizzata fl-Unjoni Ewropea (UE).
English: Omnitrope was studied to show that it is comparable to the reference medicine, Genotropin.
Maltese: Omnitrope ġie studjat biex jintwera li huwa komparabbli għall-mediċina ta' referenza, Genotropin.
English: As with all protein medicines, some patients may develop antibodies (proteins that are produced in response to Omnitrope).
Maltese: Bħal b'kull mediċina li fiha l-proteini, xi pazjenti jistgħu jiżviluppaw antikorpi (proteini li jiġu prodotti b'reazzjoni għal Omnitrope).
English: The European Medicines Agency considered that, in accordance with EU requirements for biosimilar medicines, Omnitrope has been shown to have a comparable quality, safety and effectiveness to Genotropin.
Maltese: L-Aġenzija Ewropea għall-Mediċini ddeċidiet li, b'mod konformi mar-rekwiżiti tal-UE għal mediċini bijosimili, Omnitrope wera li għandu kwalità, sigurtà u effikaċja komparabbli għal Genotropin.
English: These side effects are uncommon in children (may affect between 1 and 10 patients in 1,000).
Maltese: Dawn leffetti sekondarji mhumiex komuni fit-tfal (jistgħu jaffettwaw bejn 1 u 10 pazjenti minn kull 1,000).
English: The active substance in Omnitrope, somatropin, is identical to the human growth hormone, which it replaces.
Maltese: Is-sustanza attiva f'Omnitrope, somatropin, hija identika għall-ormon tat-tkabbir fil-bniedem, li jissostitwixxih.
English: Growth hormone is released by the pituitary gland (a gland at the base of the brain).
Maltese: L-ormon tat-tkabbir jiġi rilaxxat mill-glandola pitwitarja (glandola fin-naħa t'isfel tal-moħħ).
English: For the full list of side effects of Omnitrope, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji ta' Omnitrope, ara l-fuljett ta' tagħrif.
English: Omnitrope is a medicine used to treat children who:
Maltese: Omnitrope huwa mediċina li tintuża biex tikkura tfal li:
English: The medicine is available as a powder and solvent, which are made up into a solution for injection, or as a ready-to-use solution in a cartridge.
Maltese: Il-mediċina tiġi bħala trab u solvent, li jsiru f'soluzzjoni għall-injezzjoni, jew bħala soluzzjoni lesta għall-użu fi stoċċ.
English: How does Omnitrope work?
Maltese: Kif jintuża Omnitrope?
English: Results showed that, after treatment for 9 months, Omnitrope was as effective as Genotropin in improving growth.
Maltese: Ir-riżultati wrew li, wara kura għal 9 xhur, Omnitrope kien effettiv daqs Genotropin fit-titjib tattkabbir.
English: Belgium N.V. Novartis Pharma S.A. Medialaan 40,
Maltese: Il-Belġju N.V. Novartis Pharma S.A. Medialaan 40,
English: FIN-02130 Espoo, Finland
Maltese: FIN-02130
English: Novartis Finland Oy Metsänneidonkuja 10
Maltese: Il-Finlandja Novartis Finland OY Metsänneidonkuja 10
English: Novartis Pharma GmbH Roonstrasse 25, 90429 Nuremberg
Maltese: Il-Bulgarija Novartis Pharma GmbH Roonstrasse 25, 90429
English: 100mg/cap Capsule, soft
Maltese: 100mg/cap Kapsula, ratba
English: 25mg/cap Capsule, soft
Maltese: 25mg/cap Kapsula, ratba
English: Luxembourg Novartis Pharma GmbH Roonstrasse 25
Maltese: Il-Polonja Novartis Pharma GmbH Roonstrasse 25
English: 50mg/cap Capsule, soft
Maltese: 50mg/cap Kapsula, ratba
English: Slovak Republic
Maltese: Ir-Repubblika
English: 21 March 2014
Maltese: 21 ta' Marzu, 2014
English: Article 33(4) of Directive 2001/82/EC, as amended
Maltese: L-Artikolu 33(4) tad-Direttiva 2001/82/KE, kif emendata
English: The Committee appointed C. Ibrahim as rapporteur and H. Jukes as co-rapporteur.
Maltese: Ibrahim bħala rapporteur u lil H. Jukes bħala ko-rapporteur.
English: Committee for medicinal products for veterinary use (CVMP)
Maltese: Mediċini veterinarji
English: International non-proprietary name (INN): eprinomectin
Maltese: Isem internazzjonali mhux proprjetarju (INN): eprinomectin
English: Norbonex 5 mg/ml Pour-On Solution for Beef and Dairy Cattle contains eprinomectin as an active substance and is intended for use in cattle as a topical application for the treatment and control of infections from gastrointestinal roundworms (adults and fourth stage larvae), lungworms (adults and fourth stage larvae), warbles (parasitic stages), mange mites, lice and horn flies.
Maltese: Norbonex 5 mg/ml Soluzzjoni Li Titferra' għall-Frat taċ-Ċanga u tal-Ħalib fih l-eprinomektin bħala sustanza attiva u huwa maħsub għall-użu fil-frat bħala applikazzjoni topika għall-kura u l-kontroll ta' infezzjonijiet minn dud gastrointestinali (adulti u larva fir-raba' stadju), lungworms (adulti u larva firraba' stadju), dud tad-dubbien abjad (stadji parassitiċi), mange mites, qamel u horn flies.
English: This is a ‘hybrid' application according to Article 13(3) of Directive 2001/82/EC, as amended, referring to the reference product Eprinex PourOn Solution for Beef and Dairy Cattle.
Maltese: Din hija applikazzjoni ‘ibrida' skont l-Artikolu 13(3) tad-Direttiva 2001/82/KE, kif emendata, li tirreferi għall-prodott ta' referenza Eprinex Soluzzjoni Li Titferra' għall-Frat taċ-Ċanga u tal-Ħalib.
English: Opinion following an Article 33(4)0F referral for Norbonex 5 mg/ml Pour-On Solution for Beef and Dairy Cattle
Maltese: Opinjoni wara riferiment tal-Artikolu 33(4)0F għal Norbonex 5 mg/ml Soluzzjoni Li Titferra' għall-Frat taċ-Ċanga u tal-Ħalib
English: The applicant, Norbrook Laboratories Ltd, submitted an application for a decentralised procedure for Norbonex 5 mg/ml Pour-On Solution for Beef and Dairy Cattle.
Maltese: L-applikant, Norbrook Laboratories Ltd, issottometta applikazzjoni għal proċedura deċentralizzata għal Norbonex 5 mg/ml Soluzzjoni Li Titferra' għall-Frat taċ-Ċanga u tal-Ħalib.
English: On 26 April 2013, the reference Member State, the United Kingdom, notified the Agency that the CMD(v) had failed to reach an agreement regarding the product and referred the matter to the CVMP pursuant to Article 33(4) of Directive 2001/82/EC.
Maltese: Fis-26 ta' April 2013, l-Istat Membru ta' referenza, ir-Renju Unit, innotifika lill-Aġenzija li s-CMD(v) naqas milli jilħaq qbil dwar il-prodott u rrefera l-kwistjoni lis-CVMP skont l-Artikolu 33(4) tadDirettiva 2001/82/KE.
English: Potential serious risks were identified during the decentralised procedure by Germany regarding the environmental safety of the product.
Maltese: Il-Ġermanja identifikat riskji potenzjali serji matul il-proċedura deċentralizzata fir-rigward tas-sigurtà ambjentali tal-prodott.
English: Therefore, the Committee adopted by consensus a positive opinion on 15 January 2014 recommending the granting of the marketing authorisations for Norbonex 5 mg/ml Pour-On Solution for Beef and Dairy Cattle with amendment to the summary of product characteristics and package leaflet of the reference Member State.
Maltese: Għalhekk, fil-15 ta' Jannar 2014, il-Kumitat adotta b'konsensus opinjoni pożittiva li tirrakkomanda lgħoti ta' awtorizzazzjonijiet għat-tqegħid fis-suq ta' Norbonex 5 mg/ml Soluzzjoni Li Titferra' għall-Frat taċ-Ċanga u tal-Ħalib b'emenda għas-sommarju tal-karatteristiċi tal-prodott u l-fuljett ta' tagħrif talIstat Membru ta' referenza.
English: Day 60 of the CMD(v) procedure was on 18 April 2013, and since the Member States concerned failed to reach an agreement regarding the product the procedure was referred to the CVMP.
Maltese: Il-jum 60 tal-proċedura CMD(v) kien it-18 ta' April 2013, u minħabba li l-Istati Membri kkonċernati naqsu li jilħqu qbil dwar ilprodott, il-proċedura ġiet riferuta lis-CVMP.
English: Written explanations were provided by the applicant on 19 November
Maltese: Spjegazzjonijiet bil-miktub ġew ipprovduti mill-applikant fid-19 ta' Novembru 2013.
English: On day 210, these issues remained unsolved and therefore a referral under Article 33(1) of Directive 2001/82/EC to the Coordination group for Mutual recognition and Decentralised procedures (veterinary) (CMD(v)) was started on 18 February 2013.
Maltese: Fil-jum 210, dawn il-kwistjonijiet baqgħu mhux solvuti u għalhekk, fit-18 ta' Frar 2013, ingħata bidu għal riferiment skont l-Artikolu 33(1) tad-Direttiva 2001/82/KE għall-grupp Koordinazzjoni għarRikonoxximent Reċiproku u Proċeduri Deċentralizzati (veterinarju) (CMD(v)).
English: Lilly Portugal - Produtos Farmacêuticos, Lda.
Maltese: Portugal (Portugal) Lilly Portugal - Produtos Farmacêuticos, Lda.
English: A-1030 Wien
Maltese: A-1030
English: Terminal half-life (hrs)
Maltese: Half-life terminali (sigħat)
English: Str. Menuetului nr. 12
Maltese: Menuetului nr.
English: Eli Lilly Benelux Stoofstraat 52
Maltese: Luxembourg/Luxemburg Eli Lilly Benelux Stoofstraat 52
English: Eli Lilly Romania SRL
Maltese: Eli Lilly Romania SRL Str.
English: ATCvet code: QN02AB03
Maltese: QN02AB03
English: Time to 1.0 ng/ml (hrs)
Maltese: Ħin sa 1.0 ng/ml (sigħat)
English: The systemic bioavailability of the veterinary medicinal product is approximately 40%.
Maltese: Il-bijodisponibilità sistemika tal-prodott mediċinali veterinarju hi ta' madwar 40%.
English: Bodyweight (kilograms)
Maltese: Piż tal-ġisem (kilogrammi)