FrancophonIA/ELRC3.0 huggingface dataset:
English: GlaxoSmithKline EOOD Ivan Vasov Complex Dimitar Manov street,
Maltese: Bulgarija GlaxoSmithKline EOOD Ivan Vasov Complex Dimitar Manov street,
English: Valeas S.p.A. via Vallisneri 10 20133 Milano
Maltese: 400/57mg via Vallisneri 10 20133 Milano
English: Stonemasons Way, Rathfarnham
Maltese: Way, Rathfarnham
English: pro infantibus 275mg
Maltese: Augmentan i.v. pro infantibus 275mg
English: Bial - Portela & Cª, S.A À Av. da Siderurgia Nacional - 4745-457 S. Mamede do Coronado Portugal
Maltese: Bial - Portela & Cª, S.A À Av. da Siderurgia Nacional - 4745-457 S. Mamede do Coronado Portugall
English: Allen Farmacéutica, S.A.P.T.M.- C/Severo Ochoa, 2
Maltese: Allen Farmacéutica, S.A.P.T.M.- C/Severo Clavumox
English: Augmentin (80 /11.97 mg/ml) 400/57mg/ 5ml Powder for oral suspension
Maltese: Augmentin (80 /11.97 mg/ml) 400/57mg/ 5ml Trab għal suspensjoni orali
English: GSK d.o.o., Ljubljana Knezov štradon 90 SI-1000 Ljubljana Slovenija
Maltese: Slovenja GSK d.o.o., Ljubljana Knezov štradon 90
English: Glaxo Smith Kline B.V. Huis ter Heideweg 62 3705 LZ ZEIST THE NETHERLANDS
Maltese: Huis ter Heideweg 62 3705 LZ ZEIST OLANDA
English: Laboratórios BIAL À Av. da Siderurgia Nacional - 4745-457 S. Mamede do Coronado Portugal
Maltese: Laboratórios BIAL À Av. da Siderurgia Nacional - 4745-457 S. Mamede do Coronado Portugall
English: Dispersible tablets Oral use
Maltese: Dispersible Tablets
English: United Kingdom Beecham Group PLC SB House
Maltese: Renju Unit Beecham Group PLC SB House
English: Luxembourg GlaxoSmithKline s.a. / n.v. Rue du Tilleul 13
Maltese: Lussemburgu GlaxoSmithKline s.a. / n.v. Rue du Tilleul 13
English: Augmentin 500/125mg FilmCoated Tablets
Maltese: Augmentin 500/125mg Film Coated Tablets
English: Augmentin 125/31 SF Sachet 125/31.25mg Powder for oral suspension
Maltese: Augmentin 125/31 SF Sachet 125/31.25mg Trab għal suspensjoni orali
English: Clavamox Duo - Trockensaft 400/57mg/ 5 ml Powder for oral suspension
Maltese: Clavamox Duo - Trockensaft 400/57mg/ 5 ml Trab għal suspensjoni orali
English: Czech Republic
Maltese: Repubblika Slovakka
English: Belgium GlaxoSmithKline s.a. / n.v. Rue du Tilleul 13
Maltese: GlaxoSmithKline s.a. / n.v. Rue du Tilleul 13
English: Beecham Group plc.
Maltese: Litwanja Beecham Group plc.
English: Clavamel 125mg/31.25mg Paediatric Powder for Oral Suspension
Maltese: Clavamel 125mg/31.25mg Paediatric Trab għal suspensjoni orali
English: amoxicilline/clavulaanzuur 250/62.5 mg Powder for oral suspension
Maltese: amoxicilline/clavulaanzuur 250/62.5 mg Trab għal suspensjoni orali
English: GlaxoSmithKline GmbH & Co. KG
Maltese: Ġermanja GlaxoSmithKline GmbH & Co.
English: Clavamel 125mg/62.5mg Junior Powder for Oral Suspension
Maltese: Clavamel 125mg/62.5mg Junior Trab għal suspensjoni orali
English: Clavamox intravenös 550 mgTrockenstechampullen
Maltese: Clavamox intravenös 550 mg - Trockenstechampullen
English: 400/57mg/ 5ml
Maltese: 400/57mg
English: 980 Great West Road Brentford, Middlesex, TW8
Maltese: 980 Great West Road Brentford, Middlesex, TW8 9GS
English: SmithKline Beecham plc trading as
Maltese: SmithKline Beecham plc fil-kummerċ
English: À Av. da Siderurgia Nacional - 4745-457 S. Mamede do Coronado Portugal
Maltese: À Av. da Siderurgia Nacional - 4745-457 S.
English: Clavamox 1 g - Filmtabletten 875/125 mg
Maltese: Clavamox 1 g - Filmtabletten875/125 mg Pillola miksija b'rita Użu orali
English: Augmentin 875/125mg tablets 875/125 mg
Maltese: Augmentin 875/125mg tablets875/125 mg Pillola miksija b'rita Użu orali
English: 2000mg : 200mg/ vial
Maltese: 2000mg : 200mg/ kunjett
English: GlaxoSmithKline Kft. 1124 Bp, Csörsz u. 43 Hungary
Maltese: Ungerija GlaxoSmithKline Kft. 1124
English: Middlesex TW8 9GS UK
Maltese: Brentford, Middlesex TW8 9GS
English: 2000/200 mg Powder for infusionIntravenous use
Maltese: 2000/200 mg Trab għall-infużjoni
English: Middlesex TW8 9GS United Kingdom
Maltese: Middlesex TW8 9GS Renju Unit
English: 125/31.25 mg/ 5ml
Maltese: 125/31.25mg/ 5ml (Amoxicillin 25 mg/ml)
English: 1000mg : 200mg/ 20.9ml or 120ml
Maltese: 9ml or 120ml
English: 1000mg : 100mg/ vial
Maltese: 1000mg : 100mg/ kunjett
English: 500mg : 50mg/ vial
Maltese: 500mg : 50mg/ kunjett
English: Augmentin Intravenous 600mg 500/100 mg
Maltese: Augmentin Intravenous 600mg
English: 1000/62.5mg modified-release tablet
Maltese: 1000/62.5 mg Pillola li terħi lmediċina b'mod modifikat
English: 500mg / 50mg/ 10.5ml or 25ml
Maltese: 500mg / 50mg/ 10.
English: 1000/100 mg Powder for infusionIntravenous use
Maltese: 1000/100 mg Trab għall-infużjoni
English: Augmentan Filmtabletten 875/125mg
Maltese: 875/125mg
English: Augmentin 375 mg Tablets 250/125mg
Maltese: Augmentin 375 mg Tablets 250/125mg Pillola miksija b'rita Użu orali Augmentin 375 mg
English: GlaxoSmithKline S.p.A.Via A. Fleming, 237135 Verona
Maltese: Fleming, 237135
English: 1000/200 mg Powder for injection/infusion
Maltese: 1000/200 mg Trab għall-injezzjoni /infużjoni
English: Augmentin Intravenous 1.2g 1000/200 mg Powder for solution for injection or infusion
Maltese: Augmentin Intravenous 1.2g 1000/200 mg Trab għal soluzzjoni għall-injezzjoni jew infużjoni
English: 1000/62.5mg Prolonged-release tablet
Maltese: 1000/62.5mg Pillola li terħi lmediċina bil-mod
English: EMA/499888/2010 EMEA/V/C/151
Maltese: EMEA/V/C/151
English: Meloxoral contains the active substance meloxicam in a strength of 0.5 mg/ml (cats) or 1.5 mg/ml (dogs) for the oral suspension.
Maltese: Meloxoral fih is-sustanza attiva meloxicam f'żewġ qawwiet 0.5ml/mg (qtates) u 1.5mg/ml (klieb) għal sospensjoni orali.
English: Meloxoral is a ‘generic' which means that Meloxoral is similar to a ‘reference veterinary medicine' already authorised in the EU (Metacam).
Maltese: Meloxoral huwa ‘ġeneriku' li jfisser li Meloxoral huwa simili għal ‘mediċina veterinarja ta' referenza' li hija diġà awtorizzata fl-UE (Metacam).
English: What are the side-effects of Meloxoral?
Maltese: X'inhuma l-effetti sekondarji ta' Meloxoral?
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Meloxoral to LeVet B.V. on 19/11/2010.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Meloxoral lil LeVet B.V fl-19/11/2010.
English: Occasional side effects of Meloxoral are those seen with NSAIDs, such as loss of appetite, vomiting, diarrhoea, blood appearing in the stools, renal failure and apathy (lack of vitality).
Maltese: Effetti sekondarji okkażjonali ta' Meloxoral huma dawk li jidhru bl-NSAIDs, bħat-telf ta' aptit, rimetter, dijarrea, demm fil-feċi, kollass renali u apatija (nuqqas ta' vitalità).
English: In very rare cases they may be serious or fatal.
Maltese: F'każijiet verament rari, jistgħu jkunu serji jew fatali.
English: These side effects occur generally within the first week of treatment and are usually temporary and disappear once treatment has stopped.
Maltese: Ġeneralment, dawn l-effetti sekondarji jseħħu mal-ewwel ġimgħa tat-trattament u huma temporanji u jisparixxu ladarba ttrattament jitwaqqaf.
English: Meloxoral contains meloxicam, which belongs to a class of medicines called non-steroidal antiinflammatory drugs (NSAIDs).
Maltese: Meloxoral fih meloxicam li jappartjeni għall-klassi ta' mediċini msejħa mediċini anti-infjammatorji mhux sterojdi (NSAIDs). Meloxicam jaġixxi billi jinibixxi s-sinteżi tal-prostaglandini.
English: What is Meloxoral?
Maltese: X'inhu Meloxoral?
English: Studies have been carried out to prove that Meloxoral is ‘bioequivalent' to the reference veterinary medicine which means that Meloxoral is equivalent to Metacam in the way it is absorbed and used by the body.
Maltese: Saru studji sabiex jagħtu prova li Meloxoral huwa ‘bijoekwivalenti' għal mediċina veterinarja ta' referenza li tfisser li Meloxoral huwa ekwivalenti għal Metacam bil-mod li huwa assorbit u użat mill-ġisem.
English: In cats Meloxoral is used to alleviate inflammation and pain in chronic musculo-skeletal disorders.
Maltese: Fil-qtates Meloxoral jintuża biex itaffi infjammazzjoni u wġigħ f'disturbi muskoskeletali kroniċi.
English: Why has Meloxoral been approved?
Maltese: Għaliex ġie approvat Meloxoral?
English: People who are hypersensitive (allergic) to NSAIDs should avoid contact with Meloxoral.
Maltese: Il-persuni ipersensittivi (allerġiċi) għall-NSAIDs għandhom jevitaw il-kuntatt ma' Meloxoral.
English: This summary was last updated: 19/11/2010
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fl-19/11/2010.
English: Meloxoral is used in dogs to relieve inflammation and pain in musculo-skeletal disorders.
Maltese: Meloxoral jintuża fil-klieb sabiex jitnaqqsu l-infjammazzjoni u l-uġigħ fil-problemi muskuloskeletali.
English: Therefore the CVMP's view was that, as for Metacam, Meloxoral's benefits are greater than its risks to alleviate inflammation and pain in musculo-skeletal disorders and they recommended that Meloxoral should be given a marketing authorisation.
Maltese: Għalhekk l-opinjoni tasCVMP kienet li, l-istess bħal Metacam, il-benefiċċji ta' Meloxoral huma akbar mir-riskji tiegħu meta jintuża sabiex tittaffa infjammazzjoni jew f'uġigħ muskoskeletali u rrakomandaw li Meloxoral għandu jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) considered that, in accordance with European Union requirements, Meloxoral has been shown to be bioequivalent to Metacam.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu Veterinarju (CVMP) ikkunsidra li, skont ir-rekwiżiti talUnjoni Ewropea, Meloxoral kien jidher bħala bijoekwivalenti għal Metacam.
English: In the case of accidental ingestion medical advice should be sought immediately, showing the package leaflet or label to the physician.
Maltese: Jekk teħtieġ aktar informazzjoni dwar il-kundizzjoni medika jew il-kura tal-kundizzjoni medika tal-annimal tiegħek, ikkuntattja lill-veterinarju tiegħek.
English: Other information about Meloxoral:
Maltese: Aktar tagħrif dwar Meloxoral:
English: It can be used for both acute disorders, such as those seen after an injury, and chronic (long term) disorders.
Maltese: Jista' jintuża kemm għad-disturbi akuti, osservati pereżempju wara korriment, kif ukoll għad-disturbi kroniċi (fit-tul).
English: prostaglandins are substances that trigger inflammation, pain, exudation and fever, meloxicam reduces those responses.
Maltese: Minħabba li lprostaglandini huma sustanzi li jikkawżaw l-infjammazzjoni, l-uġigħ, il-ħruġ ta' għaraq u d-deni, meloxicam inaqqas dawn ir-reazzjonijiet.
English: Other information about Ytracis:
Maltese: Informazzjoni oħra dwar Ytracis:
English: 90Y, yttrium-90, is a radioactive form of the chemical element yttrium.
Maltese: 90Y, yttrium-90, huwa forma radjuattiva ta' l-element kimiku ittriju.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) YTRACIS EPAR summary for the public
Maltese: RAPPORT TA' VALUTAZZJONI PUBBLIKA EWROPEW (EPAR) YTRACIS Sommarju EPAR għall-pubbliku
English: The marketing authorisation was renewed on 24 March 2008.
Maltese: L-awtorizzazzjoni għat-tqegħid fissuq ġiet imġedda fl-24 ta' Marzu 2008.
English: It must be mixed outside the body, usually in a laboratory, with the medicine that needs radiolabelling.
Maltese: Għandu jitħallat barra mill-ġisem, normalment f'laboratorju, bilmediċina li teħtieġ radjutikkettar.
English: The active substance in Ytracis, yttrium (90Y) chloride, is a radioactive compound.
Maltese: Is-sustanza attiva f'Ytracis, klorur ta' l-ittriju (90Y), hija kompost radjuattiv.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Ytracis to CIS bio international on 24 March 2003.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida madwar l-Unjoni Ewropea kollha għal Ytracis lil CIS bio international fl-24 ta' Marzu 2003.
English: Why has Ytracis been approved?
Maltese: Għalfejn Ytracis ġie approvat?
English: What is Ytracis?
Maltese: Kif jintuża Ytracis?
English: Ytracis is a solution containing the active substance yttrium (90Y) chloride.
Maltese: Ytracis hija soluzzjoni li fiha s-sustanza attiva klorur ta' l-ittriju (yttrium)(90Y).
English: The company presented information from scientific articles already published on 90Y.
Maltese: Il-kumpanija ppreżentat informazzjoni minn artikoli speċifiċi diġà ppubblikati fuq 90Y.
English: It emits beta radiation.
Maltese: Temetti radjazzjonijiet beta.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Ytracis's benefits are greater than its risks for the radiolabelling of carrier molecules which have been specifically developed and authorised for radiolabelling with this radionuclide.
Maltese: Il-Kumitat għal Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) iddeċieda li l-benefiċċji ta' Ytracis huma ikbar mir-riskji tiegħu għar-radjutikkettar ta' molekuli ġarriera li ġew speċifikament żviluppati u awtorizzati għar-radjutikkettar b'dan ir-radjunuklide.
English: More information on the restrictions for the medicines radiolabelled with Ytracis will be given in the Package Leaflet of the particular medicine that is radiolabelled with Ytracis.
Maltese: Aktar informazzjoni dwar ir-restrizzjonijiet għall-mediċini radjuttikkettati b'Ytracis sejra tingħata fil-Fuljett ta' Tagħrif tal-mediċina partikolari li hija radjuttikkettata b'Ytracis.
English: The company also presented published information supporting the use of 90Y in radiolabelling other medicines.
Maltese: Ilkumpanija ppreżentat ukoll l-informazzjoni ppubblikata li tappoġġa l-użu ta' 90Y għar-radjutikkettar ta' mediċini oħra.
English: In the case of Ytracis, the product is used to label medicines that have been specially developed for use with the active ingredient yttrium (90Y) chloride.
Maltese: Fil-każ ta' Ytracis, il-prodott jintuża sabiex jittikketta mediċini li ġew speċifikament żviluppati sabiex jintużaw bis-sustanza attiva klorur ra' l-ittriju (90Y).
English: Ytracis is radioactive and its use may carry a risk of cancer and hereditary defects.
Maltese: Ytracis huwa radjuattiv u l-użu tiegħu jista' jġorr riskju ta' kanċer u ta' difetti ereditarji.
English: How has Ytracis been studied?
Maltese: Kif ġie studjat Ytracis?
English: The 90Y contained in Ytracis then attaches itself to the carrier medicine and the resulting mixture is given according to the instructions in the Package Leaflet of the carrier medicine.
Maltese: Il-kwantità ta' Ytracis meħtieġa għar-radjutikkettar u l-kwantità tal-mediċina radjutikkettata li mbagħad tingħata jiddependu fuq il-mediċina li hija radjutikkettata u fuq il-marda li tkun qiegħda tiġi kkurata.
English: What is the risk associated with Ytracis?
Maltese: Għal x'hiex jintuża Ytracis?
English: Radiolabelling is a technique where a substance is tagged (labelled) with a radioactive compound.
Maltese: Ir-radjutikkettar hija teknika li fiha sustanza tiġi ittikkettata b'kompost radjuattiv.
English: As Ytracis is a precursor and will not be given on its own, it has no side effects.
Maltese: Minħabba li Ytracis huwa ‘prekursur' u mhuwiex se jingħata waħdu, m'għandu ebda effetti sekondarji.
English: Medicines radiolabelled with Ytracis should not be used in people who may be hypersensitive (allergic) to yttrium chloride or any of the other ingredients.
Maltese: Mediċini radjuttikkettati b'Ytracis ma għandhomx jintużaw fuq nies li jkunu ipersensittivi (allerġiċi) għall-klorur ta' l-ittriju jew għal xi sustanzi oħra.
English: The effects of the medicine that is radiolabelled with Ytracis will be fully explained in its Package Leaflet.
Maltese: Dawn l-effetti sekondarji jiddependu fuq il-mediċina li tkun qiegħda tintuża, u jiġu deskritti fil-Fuljett ta' Tagħrif tal-mediċina ttikkettata b'Ytracis.
English: Version 10.1, 06/201902/2016
Maltese: Verżjoni 10, 046//20196 Language rev.1, 04/2016
English: UNIQUE IDENTIFIER - 2D BARCODE <2D barcode carrying the unique identifier included.> <Not applicable.>
Maltese: IDENTIFIKATUR UNIKU - BARCODE 2D <barcode 2D li jkollu l-identifikatur uniku inkluż.> <Mhux applikabbli.>
English: <Absorption> <Distribution> <Biotransformation> <Elimination> <Linearity/non-linearity> <Pharmacokinetic/pharmacodynamic relationship(s)>
Maltese: <Assorbiment> <Distribuzzjoni> <Bijotrasformazzjoni> <Eliminazzjoni> <Linearità/nuqqas ta' linearità> <Relazzjoni(-jiet) farmakokinetika(ċi)/farmakodinamika(ċi)>
English: <Mechanism of action> <Pharmacodynamic effects> <Clinical efficacy and safety> <Paediatric population>
Maltese: <Mekkaniżmu ta' azzjoni> <Effetti farmakodinamiċi> <Effikaċja klinika u sigurtà> <Popolazzjoni pedjatrika>
English: MARKETING AUTHORISATION NUMBER(S) EU/0/00/000/000
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/0/00/000/000
English: <{(Invented) Nname} is a biosimilar medicinal product.
Maltese: <{Isem (Ivvintat)} huwa prodott mediċinali bijoloġiku simili.
English: 6.1 List of excipients <None.>
Maltese: 6.1 Lista ta' eċċipjenti <Xejn.>
English: 4.8 Undesirable effects <Paediatric population>
Maltese: .8 Effetti mhux mixtieqa <Popolazzjoni pedjatrika>
English: • Risk Mmanagement Pplan (RMP)
Maltese: • Pjan tal-ġĠestjoni tar-rRiskju (RMP)
English: Ísland {Nafn} <{Heimilisfang} IS-000 {Borg/Bær}> Sími: + {Símanúmer}
Maltese: Ísland {Nafn} <{Heimilisfang} IS-000 {Borg/Bær}> Sími: + {Símanúmer} <{Netfang}>
English: • <Additional risk minimisation measures>
Maltese: • < Miżuri addizzjonali għall-minimizzazzjoni tar-riskji >
English: • Periodic Ssafety Uupdate Rreports (PSURs)
Maltese: • Rapporti pPerjodiċi aAġġornati dwar is-sSigurtà (PSURs)
English: <Additional side effects in children <and adolescents>> Reporting of side effects
Maltese: <Effetti sekondarji oħra fit-tfal <u l-adolexxenti>> Rappurtar tal-effetti sekondarji
English: 6.3 Shelf life <...> <6 months> <...> <1 year> <18 months> <2 years> <30 months> <3 years> <...> 6.4 Special precautions for storage <For storage conditions after <reconstitution> <dilution> <first opening> of the medicinal product, see section 6.3.>
Maltese: 6.3 Żmien kemm idum tajjeb il-prodott mediċinali <...> <6 xhur> <…> <sena> <18-il xahar> <sentejn> <30 xahar> <3 snin> <…> 6.4 Prekawzjonijiet speċjali għall-ħażna <Għall-kondizzjonijiet ta' ħażna wara <r-rikostituzzjoni> <d-dilwizzjoni> <l-ewwel ftuħ> tal-prodott mediċinali, ara sezzjoni 6.3.>
English: Danmark {Navn} <{Adresse} DK-0000 {by}>
Maltese: Danmark {Navn} <{Adresse}
English: <{tel}> <{fax}> <{e-mail}>
Maltese: {Isem u indirizz} <{telefon}> <{fax}> <{e-mail}>
English: <The <safety> <and> <efficacy> of {X} in children aged {x to y} <months> <years> [or any other relevant subsets, e.g. weight, pubertal age, gender] <has> <have> not <yet> been established.> <No data are available.> <Currently available data are described in section <4.8> <5.1> <5.2> but no recommendation on a posology can be made.>
Maltese: <Is- <sigurtà> <u> l- <effikaċja> ta'{X} fit-tfal minn età { x sa y} <xhur> <snin> [jew xi kategoriji rilevanti oħra eż. piż, età tal- pubertà, sess] <għadu> <għadhom> <ma ġiex/ma ġewx> determinati s'issa.> <M'hemm l-ebda data disponibbli.> <Data disponibbli hija deskritta fis-sezzjoni <4.8> <5.1> <5.2> iżda ma tista' ssir l-ebda rakkomandazzjoni dwar pożoloġija.>
English: SK-000 00 {Mesto}> Tel: + {Telefónne číslo}
Maltese: SK-000 00 {Mesto}> Tel: + {Telefónne číslo} <{e-mail}>
English: <Paediatric population>
Maltese: Popolazzjoni pedjatrika
English: <The requirements for submission of PSURs periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.>
Maltese: <Ir-rekwiżiti biex jiġu ppreżentati rapporti perjodiċi aġġornati dwar is-sigurtàPSURs għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il-portal elettroniku Ewropew tal-mediċini.>
English: 4.3 Contraindications <Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1 <or {name of the residue(s)}>.>
Maltese: 4.3 Kontraindikazzjonijiet <Sensittività eċċessiva għas-sustanza(i) attiva(i) jew għal kwalunkwe sustanza mhux attiva elenkata fis-sezzjoni 6.1 <jew {isem tar-residwu(i)}>.>
English: What X contains - The active substance(s) is (are)… - The other <ingredient(s)> <(excipient(s))> is (are)...
Maltese: X'fih X - Is-sustanza(i) attiva(i) hi (huma)… - ˂Is-sustanza(i) mhux attiva(i)˃ <(eċċipjent(i)) > l-oħra hija / huwa (huma)…
English: The reference medicine for X has been authorised under ‘exceptional circumstances'.
Maltese: Il-prodott mediċinali ta' referenza għal X gie awtorizzat taħt ‘ċirkustanzi eċċezzjonali'.
English: <This being a conditional marketing authorisation and pursuant to Article 14a(47) of Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following measures:>
Maltese: <Peress li din hi Awtorizzazzjoni għat-Tqegħid fis-Suq kondizzjonali u skont l-Artikolu 14a(74) tarRegolament (KE) 726/2004, l-MAH għandu jtemm, fiż-żmien stipulat, il-miżuri li gejjin:>
English: <Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development.> <Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.> <Adverse reactions not observed in clinical studies, but seen in animals at exposure levels similar to clinical exposure levels and with possible relevance to clinical use were as follows:> <Environmental Rrisk Aassessment (ERA)>
Maltese: <Tagħrif mhux kliniku ibbażat fuq studji konvenzjonali ta' sigurtà farmakoloġika, effett tossiku minn dożi ripetuti, effett tossiku fuq il-ġeni, riskju ta' kanċer, effett tossiku fuq is-sistema riproduttiva u liżvilupp, ma juri l-ebda periklu speċjali għall-bnedmin.>
English: The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Mmarketing Aauthorisation and any agreed subsequent updates of the RMP.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq L-(MAH) għandu jwettaq l-attivitajiet u linterventi meħtieġa ta' farmakoviġilanza dettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 tal-aAwtorizzazzjoni għat-tTqegħid fis-sSuq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: INFORMATION IN BRAILLE <Justification for not including Braille accepted.>
Maltese: INFORMAZZJONI BIL-BRAILLE <Il-ġustifikazzjoni biex ma jkunx inkluż il-Braille hija aċċettata.>
English: Detailed information is available on the website of the European Medicines Agency http://www.ema.europa.eu.>
Maltese: Informazzjoni dettaljata dwar din ilmediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu.>
English: <The European Medicines Agency has deferred the obligation to submit the results of studies with <{(Invented) Nname}> [or for generics: <the reference medicinal product containing {name of the active substance(s)}>] in one or more subsets of the paediatric population in {condition, as per Ppaediatric Iinvestigation Pplan (PIP) decision, for the granted indication} (see section 4.2 for information on paediatric use).>
Maltese: <il-prodott mediċinali ta' referenza li fih {isem tas-sustanza(i) attiva(i)}>] f'kull sett tal-popolazzjoni pedjatrika fil-{kondizzjoni kif imniżżel fiddeċiżjoni tal-Pjan ta' Investigazzjoni Pedjatrika (PIP), fl-indikazzjoni mogħtija} (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).>
English: It may harm them,
Maltese: Dan ifisser li għad trid tingħata aktar evidenza dwar dan il-prodott mediċinali.