FrancophonIA/ELRC3.0 huggingface dataset:
English: The company presented the results of one main study in which 74 adults with advanced CTCL were given Vorinostat MSD.
Maltese: Il-kumpanija ppreżentat ir-riżulatati ta' studju prinċipali li fih 74 adult b'CTCL fi stadju avvanzat ingħataw Vorinostat MSD.
English: Questions and answers on the withdrawal of the marketing application for Vorinostat MSD
Maltese: Mistoqsija u Tweġiba dwar l-irtirar tal-applikazzjoni għat-tqegħid fis-suq għal Vorinostat MSD
English: All of the patients had progressive, persistent or recurrent disease and had received two other systemic treatments.
Maltese: Il-pazjenti kollha kellhom mard progressive, persistenti jew rikorrenti u kienu rċevew żewġ trattamenti sistemiċi oħra.
English: CTCL is a rare type of lymphoma (cancer of the lymph tissue) where some white blood cells (T-cells) grow in the skin.
Maltese: CTCL hija tip rari ta' linfoma (kanċer tat-tessut tal-limfa) fejn jikbru xi ċelloli bojod tad-demm fil-ġilda (ċelloli T).
English: Vorinostat MSD was to be used in patients whose cancer was progressive (getting worse), persistent (not responding to treatment) or recurrent (kept on coming back), and had not responded to at least two other systemic (whole-body) treatments.
Maltese: Vorinostat MSD kelli jintuża f'pazjenti li l-kanċer tagħhom kien progressiv (isir agħar), persistenti (ma jirrispondix għat-trattament) jew rikorrenti (baqa' jiġi lura), u ma rrispondiex tal-inqas żewġ trattamenti oħrajn sistemiċi (fil-ġisem kollu).
English: How is Vorinostat MSD expected to work?
Maltese: Għal xiex kien mistenni li jintuża Vorinostat MSD?
English: The full EPAR for Cervarix 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: Cervarix human papillomavirus vaccine [types 16, 18] (recombinant, adjuvanted, adsorbed)
Maltese: Cervarix vaċċin papillomavirus uman [tipi 16, 18] (rikombinanti, adjuvantat, assorbit)
English: Other information about Cervarix
Maltese: Informazzjoni oħra dwar Cervarix
English: HPV types 16 and 18 cause approximately 70% of cervical cancers and 90% of anal cancers.
Maltese: It-tipi 16 u 18 tal-HPV jikkawżaw madwar 70% tal-kanċers taċ-ċerviċi u bejn 75 u 90% tal-kanċers anali.
English: A similar study was carried out in girls aged 9 to 14 years of age.
Maltese: Studju simili sar fi bniet li għandhom minn 9 snin sa 14-il sena.
English: Cervarix contains purified L1 proteins for HPV types 16 and 18, which are produced by a method known as ‘recombinant DNA technology': they are made by cells into which a gene (DNA) has been introduced that makes the cells able to produce the L1 proteins.
Maltese: Cervarix fih proteini L1 purifikati għat-tipi 16 u 18 tal-HPV, li huma prodotti b'metodu magħruf bħala 'teknoloġija tad-DNA rikombinanti': huma magħmulin minn ċelloli li fihom tiġi introdotta ġene (DNA) li ġġiegħel liċ-ċelloli jkunu kapaċi jipproduċu l-proteini L1.
English: Cervarix is a vaccine.
Maltese: Cervarix huwa vaċċin.
English: This document is a summary of the European public assessment report (EPAR) for Cervarix.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Cervarix.
English: It is a suspension for injection that contains purified proteins for two types of the human papillomavirus (types 16 and 18).
Maltese: Dan huwa sospensjoni għal injezzjoni li fiha proteini purifikati għal żewġ tipi ta' papillomavirus uman (tipi 16 u 18).
English: • precancerous lesions (abnormal cell growth) in the genital area (cervix, vulva, vagina or anus).
Maltese: • leżjonijiet prekanċeroġeni (tkabbir anormali taċ-ċelloli) fil-parti ġenitali (ċerviċi, vulva, vaġina jew anus).
English: Cervarix is used in males and females from the age of 9 years to protect against the following conditions caused by certain types of the human papillomavirus (HPV):
Maltese: Cervarix jintuża f'irġiel u f'nisa mill-età ta' disa' snin għall-protezzjoni kontra l-kondizzjonijiet li ġejjin ikkawżati minn tipi speċifiċi ta' papillomavirus uman (HPV):
English: This compared with 56 of the more than 7,000 women who received the other vaccine.
Maltese: Dan tqabbel ma' 56 mara fost aktar minn 7,000 li ngħataw il-vaċċin l-ieħor.
English: Why has Cervarix been approved?
Maltese: Għaliex ġie approvat Cervarix?
English: For the prevention of precancerous lesions or cancer of the cervix, Cervarix has been investigated in one main study involving almost 19,000 women aged between 15 and 25 years.
Maltese: Għall-prevenzjoni ta' leżjonijiet prekanċeroġeni jew kanċer taċ-ċerviċi, Cervarix kien investigat fi studju ewlieni li kien jinvolvi kważi 19,000 mara li għandhom bejn il-15 u l-25 sena.
English: All papillomaviruses have a shell or ‘capsid', which is made up of distinctive proteins called ‘L1 proteins'.
Maltese: Il-papillomavirusis kollha jkollhom qoxra jew ‘kapside', magħmula minn proteini distintivi msejħin ‘proteini L1'.
English: The most common side effects with Cervarix (seen in more than 1 patient in 10) are headache, myalgia (muscle pain), reactions at the site of injection including pain, redness and swelling, and fatigue (tiredness).
Maltese: L-effetti sekondarji l-aktar komuni b'Cervarix (li dehru f'aktar minn pazjent 1 minn 10) huma wġigħ ta' ras, mijalġija (uġigħ fil-muskoli), reazzjonijiet fil-post tal-injezzjoni inkluż uġigħ, ħmura u nefħa, u għeja (ħedla).
English: Data on protection against precancerous vulvar and vaginal lesions indicated that Cervarix could be effective in protecting against these lesions.
Maltese: Id-data dwar il-protezzjoni mil-leżjonijiet prekanċeroġeni vulvulari u vaġinali indikat li Ceravix jista' jkun effettiv fil-protezzjoni kontra dawn il-leżjonijiet.
English: Cervarix was compared with another vaccine that is not active against HPV (in this case, a vaccine against hepatitis A virus).
Maltese: Cervarix tqabbel ma' vaċċin ieħor li mhuwiex attiv kontra l-HPV (f'dan il-każ, vaċċin kontra l-virus tal-epatite A).
English: The second main study showed that two doses of Cervarix given 5 to 13 months apart were no less effective in girls aged 9 to 14 than a standard three-dose vaccination was in older subjects: all previously unprotected subjects had developed high levels of protective antibodies against virus types 16 and 18 one month after their last dose.
Maltese: It-tieni studju ewlieni wera li żewġ dożi ta' Cervarix li jingħataw 5 xhur sa 13-il xahar bejn waħda u oħra ma kinux inqas effettivi fi bniet li għandhom minn 9 snin sa 14-il sena minn tilqima standard ta' tliet dożi f'persuni ikbar fl-età: il-persuni kollha li qabel ma kinux protetti kienu żviluppaw livelli għoljin ta' antikorpi protettivi kontra t-tipi 16 u 18 tal-virus xahar wara l-aħħar doża tagħhom.
English: What is Cervarix?
Maltese: X'inhu Cervarix?
English: After vaccination, the immune system is able to produce antibodies more quickly when it is exposed to the real viruses.
Maltese: Wara t-tilqim, is-sistema immunitarja ssir kapaċi tipproduċi antikorpi b'ritmu aktar mgħaġġel meta tkun esposta għall-virusis reali.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Cervarix on 20 September 2007.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Cervarix fl-20 ta' Settembru 2007.
English: • cancer of the cervix (neck of the womb) or anus;
Maltese: • kanċer taċ-ċerviċi (l-għonq tal-ġuf) jew l-anus;
English: The vaccine is ‘adsorbed', which means that the virus-like particles and the MPL are fixed onto an aluminium compound, to stimulate a better immune response.
Maltese: Il-vaċċin jiġi ‘assorbit', li jfisser li l-partikuli qishom virus u l-MPL jitwaħħlu fuq kompost tal-aluminju, biex jiġi stimulat titjib fir-rispons immunitarju.
English: Cervarix was more effective than the comparator vaccine in preventing abnormal cell growth in the cervix.
Maltese: Cervarix kien aktar effettiv mill-vaċċin komparatur fil-prevenzjoni ta' tkabbir anormali taċ-ċelloli fiċċerviċi.
English: Five additional studies also looked at the development of antibodies in girls and women from 9 to 25 years of age who were given three doses of Cervarix.
Maltese: Ħames studji addizzjonali ħarsu wkoll lejn l-iżvilupp ta' antikorpi fi bniet u nisa li għandhom minn 9 snin sa 25 sena li ngħataw tliet dożi ta' Cervarix.
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 fi 'frak qisu virus' (strutturi li jixbhu l-HPV, sabiex il-ġisem ikun jista' jagħrafhom faċilment).
English: For the full list of all side effects and restrictions with Cervarix, see the package leaflet
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet kollha b'Cervarix, ara l-fuljett ta' tagħrif.
English: These data indicate that Cervarix could be effective in protecting against anal lesions and cancer in males and females.
Maltese: Din id-data tindika li Cervarix jista' jkun effettiv filprotezzjoni kontra leżjonijiet u kanċer anali f'irġiel u f'nisa.
English: The company also presented data on protection against precancerous vulvar and vaginal lesions in patients given Cervarix.
Maltese: Il-kumpanija ppreżentat ukoll data dwar il-protezzjoni mil-leżjonijiet prekanċeroġeni vulvulari u vaġinali f'pazjenti li ngħataw Cervarix.
English: What is the risk associated with Cervarix?
Maltese: X'inhu r-riskju assoċjat ma' Cervarix?
English: For the prevention of anal lesions and cancer, the studies that compared either 2 doses or 3 doses of Cervarix with another HPV vaccine authorised for anal cancer showed that antibody levels in women and girls were similar or better with Cervarix than with the other vaccine.
Maltese: Għall-prevenzjoni ta' leżjonijiet u kanċer anali, l-istudji li qabblu 2 dożi jew 3 dożi ta' Cervarix ma' vaċċin ieħor tal-HPV awtorizzat għal kanċer anali wrew li l-livelli ta' antikorpi f'nisa u bniet kienu simili jew aħjar b'Cervarix milli bil-vaċċin l-ieħor.
English: The additional five studies also showed that all of those aged 9 years and older who were given three doses of Cervarix developed high levels of antibodies against HPV types 16 and 18.
Maltese: Il-ħames studji addizzjonali wrew ukoll li dawk kollha li kellhom minn 9 snin ‘il fuq li ngħataw tliet dożi ta' Cervarix żviluppaw livelli għoljin ta' antikorpi kontra t-tipi 16 u 18 tal-HPV.
English: In the first main study, after an average of 39 months, four of the more than 7,000 women who received Cervarix and who had not been infected with HPV types 16 or 18 before, developed precancerous lesions in the cervix linked to these HPV types.
Maltese: Fl-ewwel studju ewlieni, wara medja ta' 39 xahar, erbgħa minn fost aktar minn 7,000 mara li ngħataw Cervarix u li fl-imgħoddi ma ġew qatt infettati mit-tip 16 jew 18 tal-HPV, żviluppaw leżjonijiet prekanċerużi fiċ-ċerviċi marbuta ma' dawn it-tipi tal-HPV.
English: One study compared the level of protective antibodies developed in adult women after Cervarix use and compared it with those of another HPV vaccine already authorised for anal lesions and cancer.
Maltese: Studju wieħed qabbel il-livell ta' antikorpi protettivi żviluppati f'nisa adulti wara l-użu ta' Cervarix ma' dawk ta' vaċċin ieħor tal-HPV diġà awtorizzat għal leżjonijiet u kanċer anali.
English: How has Cervarix been studied?
Maltese: Kif ġie studjat Cervarix?
English: The vaccine is made using an ‘adjuvant system' that contains MPL, a purified lipid (a fat-like substance) extracted from bacteria, which enhances the response of the immune system to the vaccine.
Maltese: Il-vaċċin isir bl-użu ta' ‘sistema adjuvanti' li fiha l-MPL, lipidu purifikat (sustanza li tixbah lix-xaħam) estratt mill-batterji, li jsaħħaħ ir-rispons tas-sistema immunitarja għall-vaċċin.
English: Papillomaviruses are viruses that cause warts and abnormal tissue growth.
Maltese: Il-papillomavirusis huma virusis li jikkawżaw felul u tkabbir anormali fit-tessuti.
English: What measures are being taken to ensure the safe and effective use of Cervarix?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Cervarix?
English: Cervarix is given as two or three doses depending on age.
Maltese: Cervarix jingħata bħala żewġ dożi jew tlieta skont l-età.
English: The main measure of effectiveness was the development of protective antibodies against HPV types 16 and 18 one month after the last dose in previously unvaccinated subjects.
Maltese: Il-kejl ewlieni tal-effikaċja kien l-iżvilupp ta' antikorpi protettivi kontra t-tipi 16 u 18 tal-HPV xahar wara laħħar doża f'persuni li qatt ma' ngħataw tilqim.
English: For the prevention of anal lesions and cancer, four studies were carried out.
Maltese: Saru erba' studji dwar il-prevenzjoni ta' leżjonijiet u kanċer anali.
English: There are more than 100 types of papillomavirus, some of which are associated with genital and anal cancers.
Maltese: Hemm iktar minn 100 tip ta' papillomavirus, li xi wħud minnhom huma assoċjati ma' kanċers ġenitali u anali.
English: A second main study looked at the effect of two doses of Cervarix in girls aged 9 to 14 years compared with the effect of three doses in girls and women aged 15 to 25.
Maltese: It-tieni studju ewlieni ħares lejn l-effett ta' żewġ dożi ta' Cervarix fi bniet li għandhom minn 9 snin sa 14-il sena mqabbla mal-effett ta' tliet dożi fi bniet u nisa li għandhom minn 15 sa 25 sena.
English: Applicant
Maltese: L- applikant
English: Mommox 0,05mg/dávku 50 microgram/dose nasal spray, suspension
Maltese: Mommox 0,05mg/dávku 50 microgrammi/doża sprej għall-imnieħer, suspensjoni
English: Luxembourg Sandoz B.V. Veluwezoom 22
Maltese: Il-Lussemburgu Sandoz B.V. Veluwezoom 22
English: Belgium Sandoz B.V. Veluwezoom 22
Maltese: Il-Ġermanja Sandoz B.V. Veluwezoom 22
English: Slovak Republic Sandoz B.V. Veluwezoom 22
Maltese: Id-Danimarka Sandoz B.V. Veluwezoom 22
English: Solution for infusion
Maltese: Soluzzjoni għal infużjoni
English: EMA/826770/2016 Corr.*
Maltese: EMA/826770/2016 Korr.*
English: The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision applicable in all EU Member States on 29/11/2016 (Ammonaps) and 5/12/2016 (Dutasteride Actavis and associated names, Lutinus and associated names and SoliCol D3).
Maltese: L-opinjoni tas-CHMP intbagħtet lill-Kummissjoni Ewropea, li ħarġet deċiżjoni legalment vinkolanti applikabbli flIstati Membri kollha tal-UE fid-29/11/2016 (Ammonaps) u fil-5/12/2016 (Dutasteride Actavis u ismijiet assoċjati, Lutinus u ismijiet assoċjati u SoliCol D3).
English: The medicines that are produced at the Pharmaceutics International Inc site in the United States are: Ammonaps (sodium phenylbutyrate), Dutasteride Actavis (dutasteride), Lutigest/Lutinus (progesterone) and SoliCol D3 (colecalciferol).
Maltese: Ammonaps (fenilbutirat tas-sodju), Dutasteride Actavis (dutasteride), Lutigest/Lutinus (proġesteron) u SoliCol D3 (kolekalċiferol).
English: * This document was revised on 14 October 2016 in line with an updated CHMP opinion clarifying recommendations concerning prohibition of supply.
Maltese: * Dan id-dokument ġie rivedut fl-14 ta' Ottubru 2016 f'konformità ma' opinjoni aġġornata tas-CHMP li ċċarat irrakkomandazzjonijiet dwar il-projbizzjoni tal-provvista.
English: The review of medicines manufactured by Pharmaceutics International Inc, US, was initiated on 23 June 2016 at the request of the European Commission under Article 31 of Directive 2001/83/EC.
Maltese: Ir-rieżami tal-mediċini manifatturati minn Pharmaceutics International Inc, l-Istati Uniti, inbeda fit23 ta' Ġunju 2016 fuq talba tal-Kummissjoni Ewropea skont l-Artikolu 31 tad-Direttiva 2001/83/KE.
English: Pharmaceutics International Inc, US: supply of noncritical medicines to EU stopped due to manufacturing failings
Maltese: Pharmaceutics International Inc, L-Istati Uniti: il provvista ta' mediċini mhux kritiċi lill-UE twaqqfet minħabba nuqqasijiet fil-manifattura
English: • Failings have been found at a manufacturing site in the United States that produces medicines marketed in the EU.
Maltese: • Instabu nuqqasijiet f'sit ta' manifattura fl-Istati Uniti li jipproduċi mediċini mqiegħda fis-suq tal-UE.
English: • SoliCol D3 (cholecalciferol), a medicine for vitamin D deficiency which is also exclusively produced at Pharmaceutics International Inc but has not yet been marketed in the EU, will not be made available in the EU.
Maltese: • SoliCol D3 (kolekalċiferol), mediċina għad-defiċjenza tal-vitamina D li hija wkoll prodotta esklussivament f'Pharmaceutics International Inc iżda li għadha ma tqegħditx fis-suq tal-UE, mhijiex sejra tkun disponibbli fl-UE.
English: Ammonaps may still be supplied where no alternatives are available
Maltese: Ammonaps xorta jista' jiġi pprovdut meta ma jkunx hemm alternattivi disponibbli
English: The recommendation was the outcome of a review of good manufacturing practice (GMP) at Pharmaceutics International Inc.
Maltese: Ir-rakkomandazzjoni kienet ir-riżultat ta' rieżami tal-prassi tajba ta' manifattura (PTM) (GMP, good manufacturing practice) f'Pharmaceutics International Inc.
English: • One of the medicines affected, Ammonaps (sodium phenylbutyrate), used to treat inherited metabolic disorders, is considered a critical medicine and remains on the market where there are no alternatives.
Maltese: • Waħda mill-mediċini affettwata, Ammonaps (fenilbutirat tas-sodju), li tintuża għall-kura ta' disturbi metaboliċi li jintirtu, hija meqjusa bħala mediċina kritika u ser tibqa' fis-suq fejn ma jkunx hemm alternattivi.
English: • Ammonaps, a medicine for treating urea cycle disorders which is exclusively manufactured at Pharmaceutics International Inc, remains available where there are no treatment alternatives.
Maltese: • Ammonaps, mediċina għall-kura ta' disturbi fiċ-ċiklu tal-urea li hija manifatturata esklussivament f'Pharmaceutics International Inc, tibqa' disponibbli fejn ma jkunx hemm alternattivi ta' kura. Filpajjiżi tal-UE fejn jeżistu alternattivi ta' kura, Ammonaps ser jiġi rtirat.
English: These related to the risk of cross-contamination (the possible transfer of one medicine to another) and deficiencies in the systems for ensuring medicines' quality (quality assurance).
Maltese: Dawn kienu relatati mar-riskju ta' kontaminazzjoni inkroċjata (it-trasferiment possibbli ta' mediċina waħda għall-oħra) u nuqqasijiet fissistema biex tiġi żgurata l-kwalità tal-mediċini (assigurazzjoni tal-kwalità).
English: Ammonaps has been recalled in countries where alternatives are available.
Maltese: Ammonaps ġie irtirat fil-pajjiżi fejn hemm alternattivi disponibbli.
English: • One of the medicines manufactured at this site is Ammonaps (sodium phenylbutyrate), a medicine to treat urea cycle disorders.
Maltese: • Waħda mill-mediċini manifatturata f'dan is-sit hija Ammonaps (fenilbutirat tas-sodju), mediċina li tintuża għall-kura ta' disturbi fiċ-ċiklu tal-urea.
English: Ammonaps is a medicine authorised in the EU through the centralised procedure, whereas the other medicines have been authorised through national procedures.
Maltese: Ammonaps huwa mediċina awtorizzata fl-UE permezz tal-proċedura ċentralizzata, filwaqt li l-mediċini l-oħra ġew awtorizzati permezz ta' proċeduri nazzjonali.
English: On 15 September the European Medicines Agency (EMA) recommended that medicines manufactured by Pharmaceutics International Inc, located in the United States, should no longer be available in the EU, except Ammonaps (sodium phenylbutyrate), which is considered critical for public health.
Maltese: Fil-15 ta' Settembru l-Aġenzija Ewropea għall-Mediċini (EMA) irrakkomandat li l-mediċini manifatturati minn Pharmaceutics International Inc, li tinsab fl-Istati Uniti, ma għandhomx jibqgħu disponibbli fl-UE, ħlief Ammonaps (fenilbutirat tas-sodju), li huwa meqjus kritiku għas-saħħa pubblika.
English: • Other medicines (Dutasteride Actavis (dutasteride), Lutigest/Lutinus (progesterone), and associated names) produced at the site have alternative manufacturing sites and the availability of these medicines is unaffected.
Maltese: • Mediċini oħra (Dutasteride Actavis (dutasteride), Lutigest/Lutinus (proġesteron), u ismijiet assoċjati) prodotti fis-sit għandhom siti alternattivi ta' manifattura u d-disponibbiltà ta' dawn ilmediċini mhijiex affettwata.
English: • The medicines Dutasteride Actavis (dutasteride), Lutigest/Lutinus (progesterone), and associated names, are registered to be produced at Pharmaceutics International Inc, but are now
Maltese: • Il-mediċini Dutasteride Actavis (dutasteride), Lutigest/Lutinus (proġesteron), u ismijiet assoċjati, huma rreġistrati li jiġu prodotti f'Pharmaceutics International Inc, iżda issa qegħdin jiġu mmanifatturati f'siti alternattivi ta' manifattura reġistrati.
English: For Lutigest/Lutinus, some batches produced at the US site were still available on the EU market and were to be recalled.
Maltese: Għal Lutigest/Lutinus, xi lottijiet prodotti fis-sit tal-Istati Uniti kienu għadhom disponibbli fis-suq tal-UE u kellhom jiġu irtirati.
English: The recommendation from EMA's Committee for Medicinal Products for Human Use (CHMP) has the following impact on availability of medicines from Pharmaceutics International Inc:
Maltese: Il-mediċini li jiġu prodotti fis-sit ta' Pharmaceutics International Inc fl-Istati Uniti huma:
English: • The manufacturing site Pharmaceutics International Inc in the United States which makes a number of medicines has been found to have several shortcomings in its good manufacturing practice.
Maltese: • Is-sit ta' manifattura Pharmaceutics International Inc fl-Istati Uniti li jagħmel għadd ta' mediċini nstab li kellu diversi nuqqasijiet fil-prassi tajba ta' manifattura tiegħu.
English: • However, as a precautionary measure, medicines manufactured by Pharmaceutics International Inc that are not considered critical to public health are no longer to be used in the EU.
Maltese: • Madankollu, bħala miżura prekawzjonarja, mediċini manifatturati minn Pharmaceutics International Inc li mhumiex meqjusa kritiċi għas-saħħa pubblika mhux ser jibqgħu jintużaw fl-UE.
English: • Other Pharmaceutics International Inc medicines have alternative manufacturing sites and therefore their availability is unaffected.
Maltese: • Mediċini oħra ta' Pharmaceutics International Inc għandhom siti alternattivi ta' manifattura u għalhekk id-disponibbiltà tagħhom mhijiex affettwata.
English: The medicine is only to be marketed once evidence is provided that its manufacturing is compliant with GMP standards.
Maltese: Il-mediċina ser titqiegħed fis-suq biss ladarba tiġi pprovduta evidenza li l-manifatturar tagħha huwa konformi mal-istandards ta' PTM.
English: The review was started after a follow-up inspection of the site by the UK medicines regulatory agency (MHRA) and the US FDA.
Maltese: Ir-rieżami nbeda wara spezzjoni ta' segwitu tas-sit mill-aġenzija regolatorja tal-mediċini tar-Renju Unit (MHRA) u mill-FDA tal-Istati Uniti.
English: Ammonaps granules should only be used in patients who have a feeding tube such as a nasogastric tube or gastrostomy and require the medicine.
Maltese: Kien hemm ukoll problemi fil-mod kif tiġi ġġenerata u ċċekkjata d-data u nuqqasijiet fis-sistemi biex tiġi żgurata l-kwalità tal-mediċini (assigurazzjoni tal-kwalità).
English: London, June 2008 EMEA/532222/2007 - Rev.1
Maltese: Londra, Ġunju 2008 EMEA/532222/2007 - Rev.1
English: EMEA/532222/2007 - Rev.1
Maltese: EMEA/532222/2007 - Rev.1-MT
English: OPINION FOLLOWING AN ARTICLE 33 (4) REFERRAL FOR ENURACE 50
Maltese: OPINJONI WARA REFERENZA SKOND L-ARTIKOLU 33(4) GĦAL ENURACE 50
English: The CVMP during its meeting of December 2006 started a referral procedure under Article 33(4) of Directive 2001/82/EC as amended for Enurace 50.
Maltese: Matul il-laqgħa tiegħu ta' Diċembru 2006, is-CVMP beda proċedura ta' referenza skond l-Artikolu 33(4) tad-Direttiva 2001/82/KE kif emendata għal Enurace 50.
English: This conclusion was accepted.
Maltese: Din il-konklużjoni ġiet aċċettata.
English: The CVMP Opinion was adopted on 18 April 2007 and the subsequent Commission Decision on 10 July 2007.
Maltese: L-Opinjoni tas-CVMP ġiet adottata fit-18 ta' April 2007 u d-Deċiżjoni sussegwenti tal-Kummissjoni ġiet adottata fl-10 ta' Lulju 2007.