FrancophonIA/ELRC3.0 huggingface dataset:
English: The European Commission granted a marketing authorisation valid throughout the European Union for Xalkori on 23 October 2012.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea għal Xalkori fit-23 ta' Ottubru 2012.
English: • It is used if the NSCLC is ‘ALK-positive', which means that the cancer cells contain certain changes affecting the gene responsible for a protein called ALK (anaplastic lymphoma kinase).
Maltese: • Jintuża jekk l-NSCLC ikun 'pożittiv għall-ALK', li jfisser li ċ-ċelloli tal-kanċer ikun fihom ċerti bidliet li jaffettwaw lill-ġene responsabbli minn proteina magħrufa bħala ALK (kinażi tal-linfoma anaplastika).
English: A study in 347 previously treated ALK-positive patients showed that those taking Xalkori lived on average for nearly 8 months without their disease getting worse compared with 3 months in patients who were treated with either pemetrexed or docetaxel.
Maltese: Studju fuq 347 pazjent pożittivi għall-ALK li kienu kkurati qabel wera li dawk li ħadu Xalkori għexu medja ta' kważi 8 xhur mingħajr ma l-marda tagħhom marret għall-agħar meta mqabbla ma' 3 xhur f'pazjenti li kienu kkurati jew b'pemetrexed jew b'docetaxel.
English: ALK-positive NSCLC
Maltese: NSCLC pożittiv għall-ALK
English: The presence of the genetic changes affecting ALK (‘ALK-positive' status) or ROS1 (‘ROS1-positive' status) has to be confirmed before starting treatment with Xalkori.
Maltese: Il-preżenza tal-bidliet ġenetiċi li jaffettwaw l-ALK (status 'pożittiv għall-ALK') jew ir-ROS1 (status 'pożittiv għar-ROS1') għandha tiġi kkonfermata qabel ma tinbeda l-kura b'Xalkori.
English: What is the risk associated with Xalkori?
Maltese: X'inhu r-riskju assoċjat ma' Xalkori?
English: It works mainly by blocking the activity of ALK or ROS1, including when the genetic change is present, thereby reducing the growth and spread of the cancer in ALK-positive or in ROS1-positive NSCLC.
Maltese: Taħdem prinċipalment billi timblokka lattività ta' ALK jew ta' ROS1, inkluż meta l-bidla ġenetika tkun preżenti, b'hekk jitnaqqsu t-tkabbir u lfirxa tal-kanċer fl-NSCLC pożittiv għall-ALK jew pożittiv għar-ROS1.
English: How does Xalkori work?
Maltese: Kif jintuża Xalkori?
English: In patients either ‘ALK-positive' or ‘ROS1-positive', the ALK or ROS1 protein is abnormally active and can promote the growth of cancer cells and the development of new blood vessels that supply them.
Maltese: F'pazjenti 'pożittivi għall-ALK' jew 'pożittivi għar-ROS1', ilproteina ALK jew ROS1 hija attiva b'mod anormali u tista' tippromwovi t-tkabbir taċ-ċelloli tal-kanċer u l-iżvilupp ta' vażijiet tad-demm ġodda li jissupplixxuhom.
English: Treatment with Xalkori should be started and supervised by a doctor who is experienced in using cancer medicines.
Maltese: Il-kura b'Xalkori għandha tinbeda u tkun taħt is-superviżjoni ta' tabib li għandu l-esperjenza fl-użu ta' mediċini kontra l-kanċer.
English: Vepacel is a ‘prepandemic' vaccine.
Maltese: Vepacel huwa vaċċin ‘prepandemiku'.
English: The full EPAR for Vepacel 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: Vepacel contains a flu strain called A/Vietnam/1203/2004 (H5N1).
Maltese: Vepacel fih razza ta' influwenza msejħa A/Vietnam/1203/2004 (H5N1).
English: This is a summary of the European public assessment report (EPAR) for Vepacel.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Vepacel.
English: Influenza vaccine (whole virion, inactivated)
Maltese: Vaċċin tal-influwenza (virjon sħiħ, inattivat)
English: What is Vepacel?
Maltese: X'inhu Vepacel?
English: Why has Vepacel been approved?
Maltese: Għaliex ġie approvat Vepacel?
English: This vaccine contains a strain of the H5N1 virus.
Maltese: Dan il-vaċċin fih razza tal-virus H5N1.
English: The study in children showed that vaccination with Vepacel brought about similar levels of antibodies to those seen in adults: at 21 days after the second injection, 85.4% of children aged 9 to 17 years, 72.9% of children aged 3 to 8 years and 68.8% of children aged 6 to 35 months had levels of antibodies that would protect them against H5N1.
Maltese: 4% tat-tfal bejn 9 u 17-il sena, 72.9% tat-tfal bejn 3 u 8 snin u 68.8% tat-tfal bejn 6 u 35 xahar kellhom livelli ta' antikorpi li jipproteġuhom kontra l-H5N1.
English: In the first main study, at 21 days after the second injection, 72.5% of adults under 60 and 74.1% of adults aged 60 and over had levels of antibodies that would protect them against H5N1.
Maltese: Fl-ewwel studju prinċipali, 21 jum wara t-tieni injezzjoni, 72.5% ta' adulti taħt is-60 sena u 74.1% ta' adulti ta' 60 sena jew aktar kellhom livelli ta' antikorpi li jipproteġuhom kontra H5N1.
English: The first main study involved 561 healthy adults, while the second study involved around 3,600 adults including those at higher risk of flu (such as people with a long-term illness or a weakened immune system).
Maltese: L-ewwel studju prinċipali kien involva 561 adult b'saħħtu, filwaqt li t-tieni studju kien jinvolvi 3,600 adult inklużi dawk f'riskju ogħla ta' influwenza (bħal persuni b'marda fit-tul jew b'sistema immunitarja dgħajfa).
English: All of the studies looked at the ability of the vaccine to trigger the production of antibodies (‘immunogenicity') against H5N1.
Maltese: L-istudji kollha stħarrġu l-abbiltà tal-vaċċin li jniedi l-produzzjoni ta' antikorpi (‘immunoġeniċità') kontra l-H5N1.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Vepacel on 17 February 2012.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Vepacel fis-17 ta' Frar 2012.
English: Two main studies provided data on vaccination with Vepacel in adults.
Maltese: Żewġ studji prinċipali pprovdew data dwar it-tilqim b'Vepacel fl-adulti.
English: Vepacel is a vaccine for use in adults and children from 6 months of age to protect against flu caused by the H5N1 (“bird flu”) subtype of the influenza A virus.
Maltese: Vepacel huwa vaċċin li jintuża fl-adulti u t-tfal minn 6 xhur 'il fuq bħala protezzjoni kontra l-influwenza kkawżata mis-sottotip H5N1 (“influwenza tal-għasafar”) tal-virus tal-influwenza A.
English: What is the risk associated with Vepacel?
Maltese: X'inhu r-riskju assoċjat ma' Vepacel?
English: Vaccination with Vepacel in adults produced an antibody response that met these criteria.
Maltese: Vaċċin b'Vepacel fl-adulti pproduċa rispons antikorp li ssodisfa dawn il-kriterji.
English: The Committee also noted that Vepacel produced a reasonable antibody response against other H5N1 strains that could potentially cause a flu pandemic.
Maltese: Il-Kumitat innota wkoll li Vepacel ipproduċa rispons antikorp raġonevoli kontra razez H5N1 oħrajn li jistgħu potenzjalment jikkawżaw pandemija talinfluwenza.
English: The viruses used in Vepacel are grown in mammal cells (‘vero cells'), as opposed to hen's eggs.
Maltese: Il-viruses użati f'Vepacel jitkabbru f'ċelloli tal-mammiferi (‘ċelloli vero'), bil-kontra tal-bajd tat-tiġieġ.
English: It contains influenza (flu) viruses that have been inactivated (killed).
Maltese: Fih viruses tal-influwenza li ġew diżattivati (maqtula).
English: Moreover, protective levels of antibodies were seen in 71.6% of patients with a weakened immune system and 77.5% of patients with a long-term illness.
Maltese: 6% ta' pazjenti b'sistema immunitarja dgħajfa u 77.5% ta' pazjenti b'marda fit-tul.
English: The booster vaccination (one year after the 2-dose vaccination with Vepacel) also produced a strong antibody response against the strains used in the booster and in Vepacel.
Maltese: Il-vaċċin buster (sena wara l-vaċċin ta' 2 dożi b'Vepacel) ipproduċa wkoll rispons antikorp b'saħħtu kontra r-razez li ntużaw fil-buster u f'Vepacel.
English: Other information about Vepacel
Maltese: Vepacel huwa vaċċin.
English: Vepacel must not be given to people who have had an anaphylactic reaction (severe allergic reaction) to any of the components of the vaccine or to any of the substances found at trace (very low) levels in the vaccine such as formaldehyde, benzonase, sucrose, trypsin or vero cell protein.
Maltese: Vepacel ma għandux jingħata lil nies li fil-passat kellhom reazzjoni anafilattika (reazzjoni allerġika qawwija) għal xi wieħed mill-komponenti tal-vaċċin jew għal kwalunkwe sustanza li tinsab f'livelli (baxxi ħafna) ta' traċċi fil-vaċċin, bħall-formaldeħajd (gass bla kulur b'riħa qawwija użat bħala preżervattiv u diżinfettant meta jinħall fl-ilma), il-benzonase, iz-zokkor tal-kannamieli, it-tripsin jew ilproteina taċ-ċellola vero.
English: In the second main study, 85.8% of healthy adults under 60 and 80.2% of healthy adults aged 60 and over had protective levels of antibodies.
Maltese: 8% ta' adulti b'saħħithom taħt is-60 sena u 80.
English: According to criteria laid down by the CHMP, a prepandemic vaccine needs to bring about protective levels of antibodies in at least 70% of adults for it to be considered suitable.
Maltese: Skont il-kriterji stabbiliti mis-CHMP, vaċċin prepandemiku jeħtieġ li joħloq livelli ta' protezzjoni ta' antikorpi f'mhux inqas minn 70 % tal-adulti biex jitqies adatt.
English: A risk management plan has been developed to ensure that Vepacel is used as safely as possible.
Maltese: Pjan ta' ġestjoni tar-riskju ġie żviluppat biex jassigura li Vepacel jintuża bl-aktar mod sigur possibbli.
English: Vepacel has also been studied in a main study involving 657 healthy children aged 6 months to 17 years, who were given two doses of Vepacel, three weeks apart.
Maltese: Vepacel ġie studjat ukoll fi studju ewlieni li involva 657 tifel u tifla b'saħħithom minn sitta sa sbatax-il sena, li ngħataw żewġ dożi ta' Vepacel, bi tliet ġimgħat bejniethom.
English: The most common side effects with Vepacel (seen in more than 1 person in 10) in adults are headache, fatigue (tiredness) and pain at the site of injection.
Maltese: L-effetti sekondarji l-aktar komuni b'Vepacel (li dehru f'aktar minn persuna 1 minn 10) fl-adulti huma wġigħ ta' ras, għeja u wġigħ fis-sit tal-injezzjoni.
English: The use of Vepacel was later extended to children from 6 months of age since the vaccine was shown to produce a good antibody response also in this population, with a safety profile similar to that seen in adults.
Maltese: L-użu ta' Vepacel aktar tard ġie estiż għal tfal minn 6 xhur ‘il fuq minn meta l-vaċċin deher li jipproduċi rispons antikorp tajjeb anki f'din il-popolazzjoni, bi profil simili sigur għal dak li deher fl-adulti.
English: This may help to provide protection in the event of a pandemic caused by a new strain of the H5N1 virus.
Maltese: Dan jista' jgħin jipprovdi protezzjoni f'każ ta' pandemija kkawżata minn razza tal-virus H5N1 ġdida.
English: In both studies, participants were given two doses of Vepacel followed by a booster dose (given after six months, one year or two years) of a vaccine containing different strengths of the same H5N1 flu strain as in Vepacel or a different H5N1 flu strain.
Maltese: Fiż-żewġ studji, il-parteċipanti ngħataw żewġ dożi Vepacel u wara ngħataw doża buster (mogħtija wara sitt xhur, sena jew sentejn) ta' vaċċin li fih konċentrazzjonijiet differenti tal-istess razza tal-influwenza H5N1 bħal Vepacel jew razza tal-influwenza H5N1 differenti.
English: In both studies, patients who received Vepacel and a booster with a different H5N1 flu strain produced antibodies that could react with several strains of H5N1 virus.
Maltese: Fiż-żewġ studji, il-pazjenti li kienu rċevew Vepacel u buster b'razza ta' influwenza H5N1 differenti pproduċew antikorpi li setgħu jirreaġixxu ma' diversi razez tal-virus H5N1.
English: When a person is given the vaccine, the immune system recognises the virus parts as ‘foreign' and makes antibodies against them.
Maltese: Meta persuna tingħata l-vaċċin, is-sistema immunitarja tagħraf il-partijiet talvajrus bħala 'barranin' u tipproduċi antikorpi kontrihom.
English: What measures are being taken to ensure the safe and effective use of Vepacel?
Maltese: X'miżuri qegħdin jittieħdu biex jassiguraw użu sigur u effettiv ta' Vepacel?
English: The Committee noted that Vepacel produced a good antibody response in healthy adults and an acceptable response in healthy adults aged 60 and over and in patients with a weakened immune system or long-term illness.
Maltese: Il-Kumitat innota li Vepacel ipproduċa rispons antikorp tajjeb f'adulti b'saħħithom u rispons aċċettabbli f'adulti b'saħħithom ta' 60 sena jew aktar u f'pazjenti b'sistema immunitarja dgħajfa jew marda fit-tul.
English: The CHMP decided that the benefits of Vepacel are greater than its risks and recommended that it be granted a marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Vepacel huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: A flu pandemic happens when a new strain of flu virus appears that can spread easily from person to person because people have no immunity (protection) against it. A pandemic can affect most countries and regions around the world.
Maltese: Pandemija talinfluwenza sseħħ meta titfaċċa razza ġdida tal-vajrus tal-influwenza li tista' tinfirex faċilment minn persuna għal oħra minħabba li n-nies ma jkollhomx immunità (protezzjoni) kontriha.
English: How is Vepacel used?
Maltese: Kif jaħdem Vepacel?
English: CHMP opinion Whereas
Maltese: Opinjoni tas-CHMP Billi
English: A shortage of supply was expected from November 2015.
Maltese: Nuqqas fil-provvista kien mistenni minn Novembru 2015.
English: The final statement of non-compliance was issued and entered in the Community database by the Netherlands (IGZ) in accordance with Article 111 (7) of Directive 2001/83/EC on 23 July 2015.
Maltese: Id-dikjarazzjoni finali ta' nuqqas ta' konformità nħarġet u ddaħħlet fil-bażi ta' data Komunitarja minNetherlands (IGZ) skont l-Artikolu 111(7) tad-Direttiva 2001/83/KE fit-23 ta' Lulju 2015.
English: The kit consists of a powder containing the active substance, dibotermin alfa, a solvent and a matrix (absorbable collagen sponge, ACS).
Maltese: Il-kitt jikkonsisti fi trab li fih is-sustanza attiva, dibotermin alfa, solvent u matriċi (sponża tal-kollaġen assorbibbli, ACS).
English: • Integra LifeSciences Corporation site is not in compliance with EU GMP for the manufacture of the absorbable collagen sponge (ACS), part of the medicinal product, InductOs;
Maltese: • Is-sit ta' Integra LifeSciences Corporation mhuwiex f'konformità mal-PTM tal-UE għallmanifattura tal-isponża tal-kollaġen assorbibbli (ACS), parti mill-prodott mediċinali, InductOs;
English: On 23 July 2015, the CHMP also adopted a list of questions to be addressed by the MAH.
Maltese: Fit-23 ta' Lulju 2015, is-CHMP adotta wkoll lista ta' mistoqsijiet li għandhom jiġu indirizzati mill-MAH.
English: • The Committee reviewed all available data submitted by the MAH during the procedure under Article 20 of Regulation (EC) No 726/2004
Maltese: • Il-Kumitat irreveda d-data kollha disponibbli mill-MAH matul il-proċedura skont l-Artikolu 20 tar-Regolament (UE) Nru 726/2004
English: It was noted that alternative treatments are available, including the use of autogenous bone grafts, which are usually harvested from the iliac crest.
Maltese: Ġie nnotat li hemm disponibbli kuri alternattivi, inkluż l-użu ta' grafts tal-għadam awtoġeni, li normalment jinġabru mill-iliac crest.
English: precludes the confirmation of the benefit-risk of InductOs;
Maltese: jipprekludi l-konferma tal-benefiċċju/riskju ta' InductOs;
English: - the particulars and documents provided for in Article 8(3) of Directive 2001/83/EC, are incorrect;
Maltese: - id-dettalji u d-dokumenti previsti fl-Artikolu 8(3) tad-Direttiva 2001/83/KE, huma żbaljati;
English: InductOs, is a kit for implant, authorised centrally since 2002 for single level lumbar interbody spine fusion as a substitute for autogenous bone graft in adults with degenerative disc disease who have had at least 6 months of non-operative treatment for this condition.
Maltese: InductOs, huwa kitt għall-impjant, awtorizzat ċentralment sa mill-2002 għall-fużjoni tal-ispina interbody lumbari b'livell waħdieni bħala sostitut għal graft tal-għadam awtoġena f'adulti b'mard deġenerattiv tad-disk li tal-inqas kellhom 6 xhur ta' kura mingħajr operazzjoni għal din il-kundizzjoni.
English: ACS has been classified as an excipient of InductOs.
Maltese: L-ACS ġiet ikklassifikata bħala eċċipjent ta' InductOs.
English: Annex I Scientific conclusions
Maltese: Anness I
English: The CHMP, having considered all the data provided by the MAH, considers that there is no apparent identified safety concern nor seems to have risk to patients associated with the contamination of the ACS with particulate matter.
Maltese: Is-CHMP, wara li kkunsidra d-data pprovduta mill-MAH, jikkunsidra li m'hemm ebda tħassib evidenti identifikat għas-sigurtà u lanqas jidher li huwa ta' riskju għall-pazjenti b'rabta mal-kontaminazzjoni bi frak tal-ACS.
English: The CHMP noted that, following the inspection in April 2015, no batches of InductOs had been released in the EU as recommended by the inspectors.
Maltese: Is-CHMP innota li, wara l-ispezzjoni f'April 2015, ma nħareġ l-ebda lott ta' InductOs fl-UE kif irrakkomandat mill-ispetturi.
English: An Article 20 of Regulation (EC) No 726/2004 was initiated by the EC on 23 July 2015 for the above concerns and their impact on the benefit-risk balance of InductOs to be determined and to decide if the relevant marketing authorisation should be maintained, varied, suspended or revoked.
Maltese: Fit-23 ta' Lulju 2015, il-KE bdiet proċedura skont l-Artikolu 20 tar-Regolament (KE) Nru 726/2004 għat-tħassib ta' hawn fuq u l-impatt tiegħu fuq il-bilanċ bejn il-benefiċċju u r-riskju ta' InductOs li għandu jiġi stabbilit u biex jiġi deċiż jekk l-awtorizzazzjoni għat-tqegħid fis-suq rilevanti għandhiex tinżamm, tiġi varjata, sospiża jew revokata.
English: • There is no alternative manufacturing site authorised within the marketing authorisation dossier;
Maltese: • Ma hemm ebda sit ta' manifattura alternattiv awtorizzat fid-dossier tal-awtorizzazzjoni għattqegħid fis-suq;
English: During the previous inspection (January 2014) a number of major deficiencies were already identified.
Maltese: Matul l-ispezzjoni preċedenti (Jannar 2014) numru ta' nuqqasijiet kbar kienu diġà ġew identifikati.
English: For the suspension to be lifted, the marketing authorisation(s) holder(s) should have a valid GMP compliance statement for the manufacturer of the ACS, fulfilling the requirements set out in Article 46 of Directive 2001/83/EC.
Maltese: Sabiex titneħħa s-sospensjoni, id-detentur(i) tal-awtorizzazzjoni(jiet) għat-tqegħid fis-suq għandu jkollu/jkollhom dikjarazzjoni ta' konformità mal-PTM valida għall-manifattur tal-ACS, li tissodisfa rrekwiżiti stabbiliti fl-Artikolu 46 tad-Direttiva 2001/83/KE.
English: Given the findings, the CHMP considered that the quality of InductOs cannot be assured at present due to the lack of GMP compliance of the ACS issued on 23 July 2015.
Maltese: Fid-dawl tas-sejbiet, is-CHMP ikkunsidra li l-kwalità ta' InductOs ma tistax tiġi assigurata fil-preżent minħabba n-nuqqas ta' konformità mal-PTM tal-ACS maħruġa fit-23 ta' Lulju 2015.
English: No other ‘morphogenetic proteins' (such as InductOs) are available in the EU but substances known as ‘graft extenders' reduce the required amount of bone graft (but not completely replace the grafts).
Maltese: M'hemm disponibbli ebda 'proteina morfoġenetika' (bħal InductOs) fl-UE iżda sustanzi magħrufin bħal 'estensuri tal-graft' inaqqsu l-ammont meħtieġ ta' graft tal-għadam (iżda ma jissostitwixxux għal kollox il-grafts).
English: InductOs is also indicated for the treatment of acute tibia fractures in adults, as an adjunct to standard care using open fracture reduction and intramedullary unreamed nail fixation.
Maltese: InductOs huwa indikat ukoll għall-kura ta' ksur akut tal-qasba tas-sieq fl-adulti, bħala żieda mal-kura standard permezz ta' tnaqqis fil-ksur miftuħ u twaħħil permezz ta' msiemer unreamed intramedullari.
English: Healthcare professionals using InductOs were advised to follow the instructions in the product information as usual and a Direct Health Care Professional Communication (DHPC) was adopted and agreed to be distributed on 12 August by the MAH.
Maltese: Il-professjonisti tal-kura tas-saħħa li jużaw InductOs ġew avżati li għandhom isegwu l-istruzzjonijiet flinformazzjoni tal-prodott bħas-soltu u ġiet adottata u ntlaħaq qbil dwar Komunikazzjoni Diretta lillProfessjonisti tal-Kura tas-Saħħa (DHPC) li għandha tintbagħat fit-12 ta' Awwissu mill-MAH.
English: The latest batch was released in January 2015 into the EU market, thus prior to the above inspection.
Maltese: L-aħħar lott inħareġ f'Jannar 2015 fis-suq tal-UE, għalhekk qabel lispezzjoni ta' hawn fuq.
English: Several such products are available, both derived from human donor tissue and from ceramics.
Maltese: Hemm disponibbli diversi prodotti bħal dawn, it-tnejn idderivati mit-tessut tad-donatur tal-bniedem u miċ-ċeramika.
English: Standard of care in the EU consists of surgical intervention using reamed or unreamed intramedullary nailing with locking screws.
Maltese: Din trid tiġi applikata mal-isponża li wara tiġi impjanta fil-pazjenti.
English: At that time, following a corrective action plan, restricted GMP certificate valid until January 2015 was issued.
Maltese: Dak iż-żmien, wara pjan ta' azzjoni korrettiva, inħareġ ċertifikat ta' PTM ristrett validu sa Jannar 2015.
English: As mentioned above, the April 2015 inspection found that the corrective action plan failed and the contamination of ACS with particulate matter was not under control and quality system not aiming for continuous improvement.
Maltese: Kif intqal hawn fuq, l-ispezzjoni ta' April 2015 sabet li l-pjan ta' azzjoni korrettiva ma rnexxiex u l-kontaminazzjoni tal-ACS bil-frak ma kinitx taħt kontroll u s-sistema tal-kwalità ma kellhiex l-għan ta' titjib kontinwu.
English: Therefore, and taking into account the assessment of the latest PSUR for InductOs dated April 2015 showing no signals in this regard, the CHMP was of the view that there was no need to adopt provisional measures for InductOs.
Maltese: Għalhekk, u filwaqt li qies il-valutazzjoni tal-aħħar PSUR għal InductOs datata April 2015 li ma turi ebda sinjal f'dan ir-rigward, is-CHMP kien tal-fehma li ma kien hemm ebda bżonn li jiġu adottati miżuri provviżorji għal InductOs.
English: On the basis of the above and taking into account that InductOs has no alternative ACS manufacturing site authorised:
Maltese: Fuq il-bażi ta' dak li ntqal hawn fuq u filwaqt li jitqies li InductOS ma għandu ebda sit ta' manifattura tal-ACS alternattiv li huwa awtorizzat:
English: - The CHMP considers that the absence of GMP compliance of the manufacturing site of the absorbable collagen sponge, part of the medicinal product precludes at present the confirmation of the benefit-risk of InductOs;
Maltese: Għalhekk, filpreżent il-bilanċ pożittiv bejn il-benefiċċju u r-riskju ma jistax jiġi kkonfermat.
English: Consequently, the Netherlands issued a draft statement of GMP non -compliance for this manufacturer which is the only existent one.
Maltese: Konsegwentement, in-Netherlands ħarġu abbozz ta' dikjarazzjoni ta' nuqqas ta' konformità mal-PTM għal dan il-manifattur, li hija l-unika waħda eżistenti.
English: - the absence of GMP compliance of the manufacturing site of the absorbable collagen sponge,
Maltese: - in-nuqqas ta' konformità mal-PTM tas-sit ta' manifattura tal-isponża tal-kollaġen assorbibbli,
English: Nivolumab BMS 10 mg/ml
Maltese: Numru tal-MA (EU) Isem ivvintat Qawwa Għamla
English: Strength Pharmaceutical Form
Maltese: Prodott mediċinali li m'għadux awtorizzat
English: Tablet coating Polyvinyl alcohol Titanium dioxide (E 171) Macrogol 3350
Maltese: Polyvinyl alcohol Titanium dioxide (E 171) Macrogol 3350
English: Probability of Progression-Free Survival
Maltese: Progression Free Survival Probability
English: Duration of Response (DoR)
Maltese: Durata tar-Rispons (DoR)
English: 3 weeks
Maltese: 8 months
English: Rare (0.02%)
Maltese: Rari (0.02%)