FrancophonIA/ELRC3.0 huggingface dataset:
English: Gardasil 9 contains the purified L1 proteins for the nine HPV types above, produced by a method known as ‘recombinant DNA technology'.
Maltese: Gardasil 9 fih il-proteini L1 ippurifikati għad-disa' tipi ta' HPV ta' hawn fuq, prodotti minn metodu magħruf bħala 'teknoloġija rikombinanti tad-DNA'.
English: The main measure of effectiveness was the development of antibodies against HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 one month after the third dose.
Maltese: Ilkejl ewlieni tal-effikaċja kien l-iżvilupp ta' antikorpi kontra t-tipi 6, 11, 16, 18, 31, 33, 45, 52 u 58 talHPV xahar wara t-tielet doża.
English: All papillomaviruses have a shell, or ‘capsid', that is made up of proteins called ‘L1 proteins'.
Maltese: Il-vajrusijiet tal-papilloma kollha għandhom qoxra jew ‘kapsida', magħmula minn proteini msejħin ‘proteini L1'.
English: After vaccination, the immune system is able to produce antibodies more quickly when it is exposed to the real viruses.
Maltese: Wara lvaċċinazzjoni, is-sistema immunitarja ssir kapaċi tipproduċi antikorpi b'ritmu aktar mgħaġġel meta tkun esposta għall-vajrusijiet reali.
English: This study found that Gardasil 9 stimulates similar levels of protection against all nine virus types in young men and women.
Maltese: Dan l-istudju sab li Gardasil 9 jistimula livelli simili ta' protezzjoni kontra d-disa' tipi kollha tal-vajrus f'irġiel u nisa żgħażagħ.
English: Why is Gardasil 9 approved?
Maltese: Għaliex ġie approvat Gardasil 9?
English: Gardasil 9 is a vaccine used in males and females from the age of nine years to protect against the following conditions caused by nine types of the human papillomavirus (HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58):
Maltese: Gardasil 9 huwa vaċċin li jintuża fl-irġiel u fin-nisa li għandhom minn disa' snin 'il fuq biex jipproteġi kontra l-kundizzjonijiet li ġejjin ikkawżati minn disa' tipi tal-vajrus tal-papilloma uman (tipi 6, 11, 16, 18, 31, 33, 45, 52 u 58 tal-HPV):
English: The fourth main study compared the levels of antibodies against all nine HPV types one month after the third dose in around 1,419 young men aged 16 to 26 with those in 1,101 women aged 16 to 26.
Maltese: Ir-raba' studju ewlieni qabbel il-livelli ta' antikopri mad-disa' tipi kollha ta' HPV xahar wara t-tielet doża f'madwar 1,419-il raġel żgħażugħ li għandhom bejn 16-il sena u 26 sena ma' dawk f'1,101 mara li għandhom bejn 16-il sena u 26 sena.
English: In studies, the most common side effects with Gardasil 9 (seen in more than 1 patient in 10) were reactions at the site of the injection (redness, pain and swelling) and headache.
Maltese: Fl-istudji, l-effetti sekondari l-aktar komuni b'Gardasil 9 (li dehru f'aktar minn pazjent 1 minn kull 10) kienu reazzjonijiet fis-sit tal-injezzjoni (ħmura, uġigħ u nefħa) u uġigħ ta' ras.
English: This study showed that 1 out of 6,016 women vaccinated with 3 doses of Gardasil 9 developed disease related to HPV types 31, 33, 45, 52 and 58, compared with 30 out of 6,017 women vaccinated with 3 doses of Gardasil.
Maltese: Dan l-istudju wera li mara waħda minn 6,016-il mara mlaqqma bi 3 dożi ta' Gardasil 9 żviluppaw marda relatata mat-tipi 31, 33, 45, 52 u 58 tal-HPV, meta mqabbla ma' 30 minn 6,017-il mara mlaqqma bi 3 dożi ta' Gardasil.
English: The third study compared the effect of Gardasil 9 with the effect of Gardasil in 600 girls aged 9 to 15 years.
Maltese: It-tielet studju qabbel l-effett ta' Gardasil 9 mal-effett ta' Gardasil f'600 tifla li għandhom bejn 9 snin u 15-il sena.
English: What are the risks associated with Gardasil 9?
Maltese: X'inhuma r-riskji assoċjati ma' Gardasil 9?
English: The CHMP considered that Gardasil 9 offers a broader protection against cancer than its precursor Gardasil, since it protects against additional 5 new types of HPV (31, 33, 45, 52 and 58), which although less common than types 16 and 18, are also considered high-risk HPV types.
Maltese: Is-CHMP ikkunsidra li Gardasil 9 joffri protezzjoni usa' kontra l-kanċer mill-prekursur tiegħu Gardasil, peress li jipproteġi kontra 5 tipi addizzjonali ġodda ta' HPV (31, 33, 45, 52 u 58), li għalkemm huma anqas komuni mit-tipi 16 u 18, huma kkunsidrati wkoll tipi ta' HPV b'riskju għoli.
English: It contains purified proteins from the nine types of HPV listed above.
Maltese: Fih proteini ppurifikati mid-disa' tipi ta' HPV elenkati hawn fuq.
English: This study also showed that antibody levels against types 6, 11, 16 and 18 were adequate to protect against these four types of HPV infection.
Maltese: Dan l-istudju wera wkoll li l-livelli ta' antikorpi kontra t-tipi 6, 11, 16 u 18 kienu adegwati biex jipproteġu kontra dawn l-erba' tipi ta' infezzjoni tal-HPV.
English: The second study in 3066 subjects compared the effect of Gardasil 9 in girls and boys aged nine to 15 years with the effect of Gardasil 9 in young women aged 16 to 26 years.
Maltese: It-tieni studju fi 3066 individwu qabbel l-effett ta' Gardasil 9, fi bniet u subien li għandhom bejn disa' snin u 15-il sena mal-effett ta' Gardasil 9 f'nisa żgħażagħ li għandhom bejn 16-il sena u 26 sena.
English: Patients who show signs of an allergy after a dose of Gardasil 9 (or of its precursor vaccines Gardasil or Silgard) should stop the vaccination course or should not receive Gardasil 9 at all.
Maltese: Il-pazjenti li juru sinjali ta' allerġija wara doża ta' Gardasil 9 (jew il-vaċċini prekursuri tiegħu Gardasil jew Silgard) għandhom iwaqqfu l-kors tal-vaċċinazzjoni jew ma għandhomx jingħataw Gardasil 9.
English: For the full list of all side effects reported with Gardasil 9, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati b'Gardasil 9, ara l-fuljett ta' tagħrif.
English: The study looked at the development of antibodies one month after the third dose, and it showed that girls vaccinated with Gardasil 9 have similar levels of protection against types 6, 11, 16 and 18 as girls vaccinated with Gardasil.
Maltese: L-istudju eżamina l-iżvilupp ta' antikorpi xahar wara t-tielet doża, u wera li l-bniet mlaqqmin b'Gardasil 9 għandhom livelli simili ta' protezzjoni kontra t-tipi 6, 11, 16 u 18 bħal bniet imlaqqmin b'Gardasil.
English: The first study looked at the effectiveness of Gardasil 9 in over 14,000 women aged between 16 and 26 years.
Maltese: L-ewwel studju ta ħarsa lejn l-effikaċja ta' Garadisil 9 f'aktar minn 14,000 mara ta' bejn is-16 u s26 sena.
English: The study looked at how many women given Gardasil 9 developed disease (growths or cancer) due to HPV infection caused by HPV types 31, 33, 45, 52 and 58 when compared with Gardasil vaccine (a previously approved vaccine which protects against types 6, 11, 16 and 18).
Maltese: L-istudju eżamina kemm kien hemm nisa li ngħataw Gardasil 9 li żviluppaw marda (tkabbir jew kanċer) minħabba infezzjoni HPV ikkawżata mit-tipi 31, 33, 45, 52 u 58 tal-HPV meta mqabbel mal-vaċċin ta' Gardasil (vaċċin approvat qabel li jipproteġi kontra t-tipi 6, 11, 16 u 18).
English: The fifth main study involving 1,518 subjects compared the effect of a two-dose schedule of Gardasil 9 with a three-dose schedule.
Maltese: Il-ħames studju li involva 1,518-il suġġett qabbel l-effett ta' skeda ta' żewġ dożi ta' Gardasil 9 ma' skeda ta' tliet dożi.
English: Thus Gardasil 9 is expected to prevent the majority of cervical, vaginal and vulvar cancers and premalignant lesions, as well as genital warts associated with HPV.
Maltese: Għalhekk Gardasil 9 huwa mistenni li jipprevjeni l-maġġoranza tal-kanċers ċervikali, tal-vaġina u vulvari u leżjonijiet premalinni, kif ukoll felul ġenitali assoċjati ma' HPV.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Gardasil 9 on 10 June 2015.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Gardasil 9 fl-10 ta' Ġunju 2015.
English: The vaccine is given as an injection into a muscle, preferably in the shoulder or the thigh.
Maltese: Il-vaċċin jingħata bħala injezzjoni f'muskolu, preferibbilment fl-ispalla jew il-koxxa.
English: Other information about Gardasil 9
Maltese: Kif jintuża Gardasil 9?
English: The proteins are assembled in ‘virus-like particles' (structures that look like HPV, so that the body can recognise them easily).
Maltese: Il-proteini jinġemgħu f''partiċelli qishom vajrus' (strutturi li jixbhu l-HPV, sabiex il-ġisem ikun jista' jagħrafhom faċilment).
English: This study looked at the development of antibodies one month after the last dose, and it showed that boys and girls given two doses of Gardasil 9 have similar levels of protection against all nine virus types to girls and women given three doses of Gardasil 9.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Gardasil 9 jintuża bl-aktar mod sigur possibbli.
English: The study showed that the vaccine stimulates the production of adequate levels of antibodies against HPV of all nine types in girls and boys aged between nine and 15 years when compared with women 16-26 years of age, for whom protection against disease was demonstrated in the first study.
Maltese: L-istudju wera li l-vaċċin jistimula l-produzzjoni ta' livelli adegwati ta' antikorpi kontra l-HPV tad-disa' tipi kollha fil-bniet u s-subien li għandhom bejn disa' snin u 15-il sena meta mqabbel ma' nisa li għandhom bejn 16-il sena u 26 sena, li għalihom intweriet protezzjoni kontra l-marda fl-ewwel studju.
English: Gardasil 9 can provide protection against all nine types of HPV infection, as seen in five main studies.
Maltese: Gardasil 9 jista' jipprovdi protezzjoni kontra d-disa' tipi kollha ta' infezzjoni tal-HPV, kif muri f'ħames studji ewlenin.
English: It is not intended to provide practical advice on how to use Gardasil 9.
Maltese: Dan mhux intiż biex jipprovdi konsultazzjoni prattika dwar l-użu ta' Gardasil 9.
English: Gardasil 9 is normally given according to a either a two-dose schedule or a three-dose schedule for males and females from 9 to 14 years old and a three-dose schedule for males and females 15 years old and over.
Maltese: Normalment Gardasil 9 jingħata skont skeda ta'żewġ dożi jew inkella skont skeda ta' tliet dożi għallirġiel u għan-nisa minn 9 snin sa 14-il sena u skeda ta' tliet dożi għall-irġiel u għan-nisa minn 15-il sena 'l fuq.
English: The protocol shall be submitted in accordance with Article 107n (1) of Directive 2001/83/EC:
Maltese: Il-protokoll għandu jiġi sottomess skont l-Artikolu 107n(1) tadDirettiva 2001/83/KE:
English: These should be submitted to the National Competent Authorities: By 12 January 2015
Maltese: Sat-12 ta' Jannar 2015
English: Further interim reports should be submitted to the PRAC 6-monthly thereafter for the first 2 years.
Maltese: Għandhom jiġu sottomessi aktar rapporti interim lill-PRAC kull 6 xhur minn hemm ‘il quddiem għall-ewwel sentejn.
English: The Marketing Authorisation Holders of valproate and related substances shall perform a drug utilisation study to assess the effectiveness of the risk minimisation measures and to further characterise the prescribing patterns for valproate.
Maltese: Id-Detenturi tal-Awtorizzazzjoni għat-Tqegħid fis-Suq ta' valproate u sustanzi relatati għandhom iwettqu studju tal-utilizzazzjoni talmediċina biex tiġi vvalutata l-effikaċja tal-miżuri ta' minimizzazzjoni tar-riskju u biex jiġi kkaratterizzat ulterjorment il-mudelli ta' għoti għal valproate.
English: National competent authorities of Member State(s) or reference Member State(s), if applicable, shall ensure that the following conditions are fulfilled by the MAH(s):
Maltese: L-Awtoritajiet Nazzjonali Kompetenti tal-Istat(i) Membru/i jew l-Istat(i) Membru/i ta' referenza, jekk ikun applikabbli, għandhom jiżguraw li l-MAH(s) jissodisfa(w) il-kundizzjonijiet li ġejjin:
English: The study should be conducted in more than one Member State.
Maltese: L-istudju għandu jitwettaq f'aktar minn Stat Membru wieħed.
English: The Marketing Authorisation Holders of valproate and related substances shall develop and submit educational materials according to agreed core elements.
Maltese: Id-Detenturi tal-Awtorizzazzjoni għat-Tqegħid fis-Suq ta' valproate u sustanzi relatati għandhom jiżviluppaw materjal edukattiv skont lelementi ewlenin maqbula.
English: Within 6 months of the Coordination group agreement.
Maltese: Fi żmien 6 xhur mill-ftehim tal-grupp ta'
English: 10 (1 x 10) vial (multipack)
Maltese: 10 (1 x 10) kunjett (pakkett multiplu)
English: Concentrate for solution for intraocular irrigation
Maltese: Konċentrat għal soluzzjoni għal irrigazzjoni intraokulari.
English: Intraocular use vial (glass)
Maltese: Użu intraokulari kunjett (ħġieġ)
English: MA (EU) number (Invented) name Strength Pharmaceutical Form
Maltese: Numru MA (UE) Isem (ivvintat) Qawwa
English: Route of Administration
Maltese: Għamla Farmaċewtika
English: 28 March 2014
Maltese: 28 ta' Marzu 2014
English: EMA/197955/2014 Veterinary Medicines
Maltese: EMA/197955/2014
English: International non-proprietary name (INN): barium selenate
Maltese: Isem internazzjonali komuni (INN): barium selenate
English: Committee for medicinal products for veterinary use (CVMP)
Maltese: Mediċinali Veterinarji
English: An oral explanation was given by the applicant/marketing authorisation holders on 6 March 2013.
Maltese: Spjegazzjoni orali ngħatat mill-applikant/detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq fis-6 ta' Marzu, 2013.
English: The Committee appointed C. Ibrahim as rapporteur and H. Jukes as co-rapporteur.
Maltese: Ibrahim bħala rapporteur u lil H. Jukes bħala korapporteur.
English: Written explanations were provided by the applicants and marketing authorisation holders on 14 November 2011 and on 30 November 2012.
Maltese: Spjegazzjonijiet bil-miktub ġew ipprovduti mill-applikanti u mid-detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq fl-14 ta' Novembru 2011 u fit-30 ta' Novembru, 2012.
English: The consolidated detailed grounds for the re-examination were submitted by Cross Vetpharm Group Limited and Tairgi Tread-Lia Baile na Sceilge Teo (Ballinskelligs Veterinary Products - BVP) on 10 June 2013.
Maltese: Tread-Lia Baile na Sceilge Teo (Prodotti Veterinarji Ballinskelligs - BVP) fl10 ta' Ġunju 2013.
English: Opinion following an Article 350F referral for long-acting formulations for injection containing barium selenate for all food producing species EMA/197955/2014
Maltese: Opinjoni wara riferiment tal-Artikolu 350F għal formulazzjonijiet li jaġixxu fit-tul għal injezzjonijiet li fihom barium selenate għall-ispeċijiet kollha li jipproduċu l-ikel
English: On 26 April 2013, Cross Vetpharm Group Limited and Tairgi Tread-Lia Baile na Sceilge Teo (Ballinskelligs Veterinary Products - BVP) notified the Agency of their intention to request a reexamination of the CVMP opinion of 10 April 2013.
Maltese: Tread-Lia Baile na Sceilge Teo (Prodotti Veterinarji Ballinskelligs - BVP) innotifikaw lill-Aġenzija bl-intenzjoni tagħhom li jitolbu eżami mill-ġdid tal-opinjoni tas-CVMP tal-10 ta' April, 2013.
English: On 6 November 2013, the CVMP adopted by majority a revised opinion confirming the recommendation included in its opinion of 17 July 2013, that the benefit-risk balance for the concerned veterinary medicinal products was negative and therefore the CVMP recommended the refusal of the granting of the marketing authorisation and suspension of the existing marketing authorisations for the products concerned.
Maltese: Fis-6 ta' Novembru 2013, is-CVMP adotta b'maġġoranza, opinjoni riveduta li tikkonferma rrakkomandazzjoni inkluża fl-opinjoni tiegħu tas-17 ta' Lulju 2013, li l-bilanċ bejn il-benefiċċjuu r-riskju għall-prodotti mediċinali veterinarji kkonċernati kien negattiv u għalhekk is-CVMP irrakkomanda r-rifjut tal-għoti tal-awtorizzazzjoni għat-tqegħid fis-suq u s-sospensjoni tal-awtorizzazzjonijiet għat-tqegħid fis-suq eżistenti għall-prodotti kkonċernati.
English: During its meeting of 14-16 May 2013 the CVMP appointed K. Törneke as rapporteur and K. Baptiste as co-rapporteur for the re-examination procedure.
Maltese: Waqt il-laqgħa tiegħu tal-14 sas-16 ta' Mejju 2013, is-CVMP ħatar lil K. Törneke bħala rapporteur u lil K. Baptiste bħala korapporteur għall-proċedura ta' eżami mill-ġdid.
English: Selenium is an essential micronutrient for both animals and man. Barium selenate has been used in slow-release injectable veterinary medicinal products for therapeutic and prophylactic use against selenium deficiencies in cattle and sheep.
Maltese: Barium selenate ntuża fil-prodotti mediċinali veterinarji injettabbli b'rilaxx bil-mod għall-użu terapewtiku u profilattiku kontra nuqqasijiet tas-selenju fl-ifrat u n-nagħaġ.
English: On 14 September 2011, Germany presented to the Agency a referral notification under Article 35 of Directive 2011/82/EC, regarding all long-acting formulations for injection containing barium selenate for all food producing species.
Maltese: Fl-14 ta' Settembru 2011, il-Ġermanja ppreżentat lill-Aġenzija notifika ta' riferiment skont l-Artikolu 35 tad-Direttiva 2011/82/KE, fir-rigward tal-formulazzjonijiet li jaġixxu fit-tul għal injezzjonijiet li fihom barium selenate għall-ispeċijiet kollha li jipproduċu l-ikel.
English: Based on the evaluation of the available data, the CVMP considered that the benefit-risk balance for the concerned veterinary medicinal products was negative as, following treatment at recommended doses, barium selenate remains at injection sites for long time periods after treatment and, consequently, consumption of injection-site residues could pose a significant risk to human health.
Maltese: Abbażi tal-evalwazzjoni tad-dejta disponibbli, is-CVMP ikkunsidra li l-bilanċ tal-benefiċċju-riskju għallprodotti mediċinali veterinarji kkonċernati kien wieħed negattiv għaliex, wara kura bid-dożi rakkomandati, barium selenate jibqa' fis-siti ta' injezzjoni għal perjodi twal ta' żmien wara l-kura u,
English: On 17 July 2013, the CVMP adopted by majority an opinion confirming the recommendation for suspension of the marketing authorisations for the concerned veterinary medicinal products.
Maltese: Fis-17 ta ' Lulju 2013, is-CVMP adotta b'maġġoranza opinjoni li tikkonferma r-rakkomandazzjoni għassospensjoni tal-awtorizzazzjonijiet għat-tqegħid fis-suq għall-prodotti mediċinali veterinarji kkonċernati.
English: 29 January 2016
Maltese: April 2016
English: EMEA/H/A-29/1428
Maltese: EMA/55653/2016 Rev.1 EMEA/H/A-29/1428
English: What is Tobramycin VVB?
Maltese: X'inhu Tobramycin VVB?
English: Tobramycin VVB is a ‘hybrid medicine' that has been developed to be comparable to a ‘reference medicine' containing tobramycin called Tobi (300 mg/5 ml nebuliser solution).
Maltese: Tobramycin VVB huwa "mediċina ibrida" li ġiet żviluppata biex tkun komparabbli ma' "mediċina ta' referenza" li jkun fiha t-tobramiċina msejjaħ Tobi (300 mg/5 ml soluzzjoni tan-nebulizzatur).
English: UAB VVB submitted Tobramycin VVB to the Lithuanian medicines regulatory agency for a decentralised procedure.
Maltese: VVB ippreżentat Tobramycin VVB lill-aġenzija regolatorja tal-mediċini Litwena għal proċedura deċentralizzata.
English: The active substance in Tobramycin VVB, tobramycin, belongs to the group of antibiotics known as ‘aminoglycosides'.
Maltese: Issustanza attiva f'Tobramycin VVB, tobramiċina, tagħmel parti mill-grupp ta' antibijotiċi magħrufin bħala 'aminoglikosidi'.
English: This is a procedure where one Member State (the ‘reference Member State', in this instance Lithuania) assesses a medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other Member States (the ‘concerned Member States', in this instance Bulgaria, Estonia, Hungary, Latvia, Poland and Romania).
Maltese: Din hija proċedura fejn Stat Membru wieħed (l-"Istat Membru ta' referenza", f'dan ilkaż il-Litwanja) jivvaluta mediċina bil-għan li jagħti awtorizzazzjoni għat-tqegħid fis-suq li sejra tkun valida f'dan il-pajjiż kif ukoll fi Stati Membri oħra (l-"Istati Membri kkonċernati", f'dan il-każ ilBulgarija, l-Estonja l-Ungerija, il-Latvja, il-Polonja u r-Rumanija).
English: However, the Member States were not able to reach an agreement and the Lithuanian medicines regulatory agency referred the matter to the CHMP for arbitration on 14 October 2015.
Maltese: Madankollu, l-Istati Membri ma kinux kapaċi jaslu għal qbil u l-aġenzija regolatorja tal-mediċini Litwena irreferiet il-kwistjoni lis-CHMP għal arbitraġġ fl-14 ta' Ottubru 2015.
English: Demonstration of clinical superiority is required because Tobi Podhaler is an orphan medicine and was granted market exclusivity in the EU at the time of its market authorisation in July 2011.
Maltese: It-turija tas-superjorità klinika hija meħtieġa għaliex Tobi Podhaler huwa mediċina orfni u ngħata l-esklussività tas-suq fl-UE fil-ħin talawtorizzazzjoni għat-tqegħid fis-suq tiegħu f'Lulju 2011.
English: Cystic fibrosis is an inherited disease in which there is an accumulation of thick mucus in the lungs that allows bacteria to grow more easily and cause infections.
Maltese: Fibrożi ċistika hija marda li tintiret fejn ikun hemm akkumulazzjoni ta' mukus oħxon fil-pulmun li jippermetti lill-batterji jikbru aktar faċilment u jikkawżaw infezzjonijiet.
English: Tobramycin VVB is to be available as a nebuliser solution (300 mg/5 ml) to be inhaled.
Maltese: Mistoqsijiet u tweġibiet dwar Tobramycin VVB u ismijiet assoċjati (tobramycin, 300 mg/5 ml soluzzjoni tan nebulizzatur)
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that Tobramycin VVB can be granted marketing authorisation in Lithuania and in the following Member States of the EU: Bulgaria, Estonia, Hungary, Latvia, Poland and Romania.
Maltese: Il-Bulgarija, l-Estonja, l-Ungerija, il-Latvja, il-Polonja u r-Rumanija.
English: Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that Tobramycin VVB is clinically superior to Tobi Podhaler because a substantial proportion of patients are intolerant to Tobi Podhaler but can be treated with Tobramycin VVB.
Maltese: Skont il-valutazzjoni tad-data disponibbli bħalissa u d-diskussjoni xjentifika fi ħdan il-Kumitat, is-CHMP ikkonkluda li Tobramycin VVB huwa klinikament superjuri għal Tobi Podhaler għaliex proporzjon sostanzjali ta' pazjenti huma intolleranti għal Tobi Podhaler iżda jistgħu jiġu kkurati b'Tobramycin VVB. Is-CHMP għalhekk irrakkomanda li Tobramycin VVB jingħata awtorizzazzjoni għat-tqegħid fis-suq filLitwanja kif ukoll fl-Istati Membri l-oħrajn ikkonċernati.
English: This means that during the period of market exclusivity similar products, such as Tobramycin VVB, cannot be placed on the market; there are, however, exceptions such as where clinically superiority over Tobi Podhaler can be shown.
Maltese: Dan ifisser li matul il-perjodu tal-esklussività tas-suq, prodotti simili bħal Tobramycin VVB, ma jistgħux jitqiegħdu fis-suq; hemm, madankollu, eċċezzjonijiet bħal meta tista' tintwera klinikament, is-superjorità fuq Tobi Podhaler.
English: Tobramycin VVB is an antibiotic for treating long-term lung infection caused by the bacteria Pseudomonas aeruginosa in patients aged 6 years and older who have cystic fibrosis.
Maltese: Tobramycin VVB huwa antibjotiku użat għall-kura ta' infezzjoni tal-pulmun għal żmien twil ikkawżata mill-batterja Pseudomonas aeruginosa f'pazjenti li għandhom 6 snin jew aktar u li għandhom fibrożi ċistika.
English: On 28 January 2015, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Tobramycin VVB.
Maltese: Fit-28 ta' Jannar 2015, l-Aġenzija Ewropea għall-Mediċini temmet proċedura ta' arbitraġġ wara nuqqas ta' qbil fost l-Istati Membri tal-Unjoni Ewropea (UE) dwar l-awtorizzazzjoni tal-mediċina Tobramycin VVB. Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bnedmin (CHMP) tal-Aġenzija kkonkluda li Tobramycin VVB jista' jingħata l-awtorizzazzjoni għat-tqegħid fis-suq fil-Litwanja u fl-Istati Membri talUE li ġejjin:
English: EMA/601025/2014 EMEA/H/C/003953
Maltese: EMEA/H/C/003953