FrancophonIA/ELRC3.0 huggingface dataset:
English: The Board thanked the topic coordinators -Jean Marimbert and Lisette Tiddens - for their contribution to this work.
Maltese: Il-Bord irringrazzja lill-koordinaturi tas-suġġettiJean Marimbert u Lisette Tiddens - għall-kontribut tagħhom f'dan ix-xogħol.
English: Analysis and assessment of the Executive Director's annual activity report 2009
Maltese: Analiżi u valutazzjoni tar-rapport ta' attività annwali 2009 tad-Direttur Eżekuttiv
English: • Presentation on key principles of a revised policy and procedures on the handling of conflicts of interests of scientific committees' members and experts: Impact analysis and proposed way forward.
Maltese: • Preżentazzjoni tal-prinċipji ewlenin ta' politika riveduta u l-proċeduri dwar it-trattament ta' konflitti ta' interessi tal-membri u l-esperti ta' kumitati xjentifiċi:
English: Ref. EMEA/652773/2009 EMEA/H/C/1040
Maltese: EMEA/769843/2009 EMEA/H/C/1040
English: London, 22 October 2009 Doc.
Maltese: Londra, 22 ta' Ottubru 2009 Dok. ta' Ref.
English: It was expected to be available as tablets (50 and 150 mg).
Maltese: Kien mistenni li jkun disponibbli f'pilloli (50 u 150 mg).
English: The active substance in Zunrisa, casopitant, is a ‘neurokinin 1 (NK1) receptor antagonist'.
Maltese: Is-sustanza attiva f'Zunrisa, casopitant, hija ‘antagonista tar-riċettur neurokinin 1 (NK1)'.
English: What is Zunrisa?
Maltese: X'inhu Zunrisa?
English: Zunrisa is a medicine that contains the active substance casopitant.
Maltese: Zunrisa huwa mediċina li fiha s-sustanza attiva casopitant.
English: The CHMP normally takes up to 210 days to evaluate a new application.
Maltese: Is-CHMP normalment jieħu sa 210 ijiem sabiex jevalwa applikazzjoni ġdida.
English: How is Zunrisa expected to work?
Maltese: Għalxiex kien mistenni li jintuża Zunrisa?
English: On 25 September 2009, Glaxo Group Ltd officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Zunrisa, for the prevention of nausea and vomiting in patients undergoing surgery or receiving chemotherapy.
Maltese: Fil-25 ta' Settembru 2009, Glaxo Group Ltd innotifikat uffiċjalment lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) li tixtieq tirtira l-applikazzjoni tagħha għal awtorizzazzjoni għat-tqegħid fis-suq għal Zunrisa, għall-prevenzjoni tad-dardir u r-rimettar f'pazjenti li jkunu għaddejjin minn intervent kirurġiku jew li jkunu qegħdin jirċievu l-kimoterapija.
English: Zunrisa was expected to be used in combination with other medicines to prevent nausea and vomiting in patients receiving chemotherapy treatments (medicines to treat cancer) that are moderate or strong triggers of nausea and vomiting.
Maltese: Zunrisa kien mistenni li jintuża flimkien ma' mediċini oħrajn sabiex jipprevjeni d-dardir u r-rimettar f'pazjenti li jkunu qegħdin jirċievu trattamenti bil-kimoterapija (mediċini għat-trattament tal-kanċer) li jikkawżaw dardir u rimettar b'mod moderatjew qawwi.
English: The effects of Zunrisa were first tested in experimental models before being studied in humans.
Maltese: L-effetti ta' Zunrisa għall-ewwel ġew ittestjati f'mudelli sperimentali qabel ma ġew studjati fuq ilbniedem.
English: Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Zunrisa could not have been approved for use with other medicines in the prevention of nausea and vomiting in patients receiving chemotherapy or in those undergoing surgery.
Maltese: Abbażi tal-analiżi tad-dejta u t-tweġiba mogħtija mill-kumpanija għal-lista ta' mistoqsijiet tas-CHMP, fiż-żmien tal-irtirar, is-CHMP kellu xi tħassib u kien tal-opinjoni provviżorja li Zunrisa ma setax jiġi approvat għall-użu ma' mediċini oħrajn fil-prevenzjoni tad-dardir u tar-rimettar f'pazjenti li jkunu qegħdin jirċievu kimoterapija jew f'dawk li jkunu għaddejjin minn intervent kirurġiku.
English: The company also presented data from studies in patients at a high risk of having nausea and vomiting after surgery.
Maltese: Il-kumpanija ppreżentat ukoll dejta minn studji f'pazjenti f'riskju għoli li jaqbadhom id-dardir u rrimettar wara intervent kirurġiku.
English: After the CHMP had assessed the responses from the company to a list of questions, there were still some unresolved issues.
Maltese: Wara li s-CHMP evalwa t-tweġibiet mill-kumpanija għal lista ta' mistoqsijiet, xorta kien għad hemm xi kwistjonijiet pendenti mhux solvuti.
English: By blocking the receptors, casopitant was expected to prevent nausea and vomiting which often happens during chemotherapy or as a complication of surgery.
Maltese: Minħabba li jimblokka r-riċetturi, casopitant kien mistenni li jipprevjeni d-dardir u r-rimettar li spiss iseħħ waqt il-kimoterapija jew bħala kumplikazzjoni tal-kirurġija.
English: The patients received Zunrisa with ondansetron or ondansetron alone.
Maltese: Il-pazjenti rċevew Zunrisa ma' ondansetron jew ondansetron waħdu.
English: However that trial was being stopped.
Maltese: Madankollu l-prova kienet qiegħda titwaqqaf.
English: The company presented data from large studies in cancer patients receiving chemotherapy.
Maltese: Il-kumpanija ppreżentat dejta minn studji kbar f'pazjenti bil-kanċer li kienu qegħdin jirċievu l-kimoterapija.
English: After looking at the results of the main studies, the CHMP noted that, while the studies showed that Zunrisa was effective in some cancer patients receiving chemotherapy, its use in patients receiving chemotherapy treatments that are moderate triggers of nausea and vomiting was not fully supported by the results.
Maltese: Jekk inti pazjent f'din il-prova u trid iżjed tagħrif dwar it-trattament tiegħek, ikkuntattja lit-tabib li jkun qed jagħtik dan it-trattament.
English: Nucala (mepolizumab)
Maltese: Nucala (mepoliżumab)
English: Further information on Nucala can be found on the Agency's website: ema.europa.eu/en/medicines/human/EPAR/nucala.
Maltese: Aktar informazzjoni dwar Nucala tinstab fis-sit web tal-Aġenzija: ema.europa.eu/en/medicines/human/EPAR/nucala.
English: Nucala received a marketing authorisation valid throughout the EU on 2 December 2015.
Maltese: Nucala rċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fit-2 ta' Diċembru 2015.
English: Over half (37 of 69) of the patients given Nucala were able to reduce their daily corticosteroid dose by more than 50% to a dose of 5 mg or less, and 10 of them were able to stop corticosteroids altogether, compared with about a third of those given placebo (22 of 66, of whom 5 were able to stop corticosteroids).
Maltese: Aktar min-nofs (37 minn 69) talpazjenti li ngħataw Nucala rnexxielhom inaqqsu d-doża ta' kuljum tagħhom tal-kortikosterojdi b'aktar minn 50 % għal doża ta' 5 mg jew anqas, u 10 minnhom irnexxielhom iwaqqfu l-kortikosterojdi għalkollox, meta mqabbel ma' madwar terz ta' dawk li ngħataw plaċebo (22 minn 66, li minnhom 5 rnexxielhom iwaqqfu l-kortikosterojdi).
English: Other information about Nucala
Maltese: Informazzjoni oħra dwar Nucala
English: The second study involved 576 adults and adolescents given Nucala every 4 weeks for 28 weeks.
Maltese: It-tieni studju involva 576 adult u adolexxent li ngħataw Nucala kull 4 ġimgħat għal 28 ġimgħa.
English: In children, eosinophilic asthma is rare and the data available are therefore limited.
Maltese: Fit-tfal, l-ażma eosinofilika hija rari u għalhekk, id-data disponibbli hija limitata.
English: The recommended dose is 100 mg in patients aged 12 years and above, and 40 mg in patients aged 6 to 11 years.
Maltese: Id-doża rakkomandata hija 100 mg f'pazjenti minn 12-il sena 'l fuq u 40 mg f'pazjenti li għandhom bejn 6 snin u 11-il sena.
English: Nucala contains the active substance mepolizumab.
Maltese: Nucala fih is-sustanza attiva mepoliżumab.
English: The active substance in Nucala, mepolizumab, is a type of protein called a monoclonal antibody, which attaches to a specific substance in the body.
Maltese: Is-sustanza attiva f'Nucala, il-mepoliżumab, hija tip ta' proteina li tissejjaħ antikorp monoklonali, li teħel ma' sustanza speċifika fil-ġisem.
English: The third study involved 135 mostly adult patients with eosinophilic asthma severe enough to need regular treatment by mouth with corticosteroids (potent anti-inflammatory medicines such as prednisone and prednisolone), and the main measure of effectiveness was how much the corticosteroid dose could be reduced using Nucala for 24 weeks compared with placebo.
Maltese: It-tielet studju involva 135 pazjent, l-aktar adulti, b'ażma eosinofilika severa biżżejjed li teħtieġ kura regolari mill-ħalq bil-kortikosterojdi (mediċini antiinfjammatorji qawwijin bħal prednisone u prednisolone), u l-kejl ewlieni tal-effikaċja kien kemm setgħet titnaqqas id-doża tal-kortikosterojdi permezz ta' Nucala għal 24 ġimgħa meta mqabbel ma' plaċebo.
English: An additional study was carried out in children aged 6 years to 11 years which showed that a dose of 40 mg Nucala given under the skin produced comparable levels of active substance in the body to those seen with standard doses in adults.
Maltese: Sar studju addizzjonali fi tfal li kellhom bejn 6 snin u 11-il sena li wera li doża ta' 40 mg Nucala mogħtija taħt il-ġilda pproduċiet livelli komparabbli tas-sustanza attiva fil-ġisem għal dawk li dehru b'dożi standard fl-adulti.
English: In addition, a reduction in corticosteroid dose was considered clinically relevant, given the potential complications of long-term corticosteroid treatment.
Maltese: Barra minn hekk, tnaqqis fid-doża tal-kortikosterojdi tqies klinikament relevanti, minħabba lkumplikazzjonijiet potenzjali ta' kura fit-tul ta' kortikosterojdi.
English: In eosinophilic asthma, symptoms are associated with having too many eosinophils (a type of white blood cell) in the blood and in phlegm in the lungs.
Maltese: Fl-ażma esinofilika, is-sintomi huma assoċjati ma' eosinofili żejda (tip ta' ċellola bajda tad-demm) fiddemm u fil-bili fil-pulmun.
English: The first study involved 616 adults and adolescents given Nucala every 4 weeks for a year, in addition to their regular asthma medicines.
Maltese: L-ewwel studju involva 616-il adult u adolexxent li ngħataw Nucala kull 4 ġimgħat għal sena, bħala żieda mal-mediċini kontra l-ażma regolari tagħhom.
English: By attaching to interleukin-5, mepolizumab blocks its action and thereby reduces the numbers of eosinophils.
Maltese: Billi teħel ma' interleukin-5, il-mepoliżumab timblokka l-azzjoni tiegħu u għaldaqstant tnaqqas in-numru ta' eosinofili.
English: Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands
Maltese: Ħarsa ġenerali lejn Nucala u għalfejn huwa awtorizzat fl-UE
English: What are the risks associated with Nucala?
Maltese: X'inhuma r-riskji assoċjati ma' Nucala?
English: For the full list of side effects and restrictions with Nucala, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet irrappurtati b'Nucala, ara l-fuljett ta' tagħrif.
English: Mepolizumab attaches to a substance called interleukin-5 which encourages the production and survival of eosinophils.
Maltese: Il-mepoliżumab teħel ma' sustanza li tissejjaħ interleukin-5 li tinkoraġixxi l-produzzjoni u s-sopravivenza tal-eosinofili.
English: The Agency concluded that the data available indicate that Nucala acts in a similar way in adults and children and the results in adults therefore also apply to children with eosinophilic asthma.
Maltese: L-Aġenzija kkonkludiet li d-data disponibbli tindika li Nucala jaħdem jaġixxi b'mod simili fl-adulti u fit-tfal u għalhekk, ir-riżultati fl-adulti japplikaw ukoll għal tfal b'ażma eosinofilika.
English: How does Nucala work?
Maltese: Kif jintuża Nucala?
English: As for all medicines, data on the use of Nucala are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Nucala hija ssorveljata kontinwament.
English: The medicine is given by injection under the skin of the upper arm, thigh or abdomen (belly) once every 4 weeks.
Maltese: Il-mediċina tingħata permezz ta' injezzjoni taħt ilġilda tal-parti ta' fuq tad-driegħ, fil-koxxa jew fl-addome (iż-żaqq) darba kull 4 ġimgħat.
English: In adults the reduction seen in severe asthma attacks and consequent need for hospital treatment was considered important and outweighed the low risk of side effects.
Maltese: Fl-adulti, it-tnaqqis li deher fl-attakki severi tal-ażma u l-bżonn konsegwenti għal kura fi sptar tqiesu importanti u kienu akbar mir-riskju baxx tal-effetti sekondarji.
English: The benefits of Nucala in severe eosinophilic asthma that is not well controlled by previous treatment have been shown in three main studies, in which it was compared with a placebo (dummy) injection.
Maltese: Il-benefiċċji ta' Nucala f'ażma eosinofilika severa li mhijiex ikkontrollata tajjeb minn kura preċedenti ntwerew fi tliet studji ewlenin, fejn tqabbel ma' injezzjoni tal-plaċebo (finta).
English: Nucala is an asthma medicine used to treat patients aged 6 years and above with a particular type of asthma called eosinophilic asthma.
Maltese: Nucala huwa mediċina kontra l-ażma użat sabiex jikkura pazjenti minn 6 snin ‘il fuq b'tip partikolari ta' ażma li tissejjaħ ażma eosinofilika.
English: 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea.europa.eu http://www.emea.europa.eu©EMEA 2007 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged
Maltese: (44-20) 74 18 84 00 Fax (44-20) 74 18 84 47 E-mail: mail@emea.europa.eu http://www.emea.europa.eu©EMEA 2007 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) EQUILIS StrepE EPAR summary for the public
Maltese: RAPPORT TAL-VALUTAZZJONI PUBBLIKA EWROPEW (EPAR) EQUILIS StrepE Sommarju ta' l-EPAR għall-pubbliku
English: Equilis StrepE is a vaccine which contains the active substance live deletion mutant Streptococcus equi bacteria.
Maltese: StrepE huwa vaċċin li fih is-sustanza attiva live deletion mutant Streptococcus equi bacteria.
English: The benefit-risk balance may be found in module 6 of this EPAR.
Maltese: Il-bilanċ bejn il-benefiċċju-riskju jista' jinstab fil-modulu 6 ta' dan l-EPAR.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Equilis StrepE to Intervet International B.V. on 7 May 2004.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida madwar l-Unjoni Ewropea kollha għal Equilis StrepE lil Intervet International B.V. fis-7 ta' Mejju 2004.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Equilis StrepE exceed the risks for immunisation of horses against S. equi to reduce clinical signs and occurrence of lymph node abscesses, and recommended that Equilis StrepE be given a marketing authorisation.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għal Użu Veterinarju (CVMP) ikkonkluda li l-benefiċċji ta' Equilis StrepE jisbqu r-riskji għall-immunizzazzjoni taż-żwiemel kontra S. equi biex jitnaqqsu s-sinjali kliniċi u l-okkorrenza ta' axxesi tal-glandoli limfatiċi, u rrakkomanda li Equilis StrepE jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: In very rare cases depression may develop.
Maltese: F'każijiet rari tista' tiżviluppa dipressjoni.
English: The vaccine is provided together with the solvent, applicator and a syringe with needle.
Maltese: Il-vaċċin huwa pprovdut flimkien mas-solvent, applikatur u siringa b'labra.
English: What is Equilis StrepE?
Maltese: X'inhu Equilis StrepE?
English: If you want more information on the basis of the CVMP recommendations, read the Scientific Discussion (also part of the EPAR).
Maltese: Jekk trid iktar informazzjoni fuq il-bażi tar-rakkomandazzjonijiet tal-CVMP, aqra d-Diskussjoni Xjentifika (parti wkoll ta' l-EPAR).
English: Equilis StrepE reduces the clinical signs of disease and the occurrence of lymph node abscesses (collections of pus).
Maltese: Equilis StrepE inaqqas is-sinjali kliniċi tal-marda u l-okkorrenza ta' axxesi tal-glandoli limfatiċi (ġbir ta' materja).
English: How has Equilis StrepE been studied?
Maltese: Kif ġie studjat Equilis StrepE?
English: Equilis StrepE is a vaccine.
Maltese: StrepE huwa vaċċin.
English: The horses had not had any disease including strangles in the past and had never been vaccinated.
Maltese: Iżżwiemel ma ħadu ebda marda inkluż strangles fil-passat u qatt ma kienu ġew imlaqqma.
English: No adjuvant or preservative is included.
Maltese: Ebda addittiv jew preservattiv m'huwa inkluż.
English: Equilis StrepE is available as a lyophilisate (freeze-dried pellet) which is made up into a suspension for injection.
Maltese: Equilis StrepE huwa disponibbli bħala lyophilisate (pelit imnixxfa bil-friża) li hija magħmula f'sospensjoni għal injezzjoni.
English: Fewer of the horses receiving Equilis StrepE had symptoms of strangles.
Maltese: Inqas żwiemel li kienu qed jieħdu Equilis StrepE kellhom simtomi ta' strangles.
English: Other information about Equilis StrepE:
Maltese: Tagħrif ieħor dwar Equilis StrepE:
English: Equilis StrepE is used to vaccinate horses against the respiratory disease caused by the bacteria Streptococcus equi.
Maltese: StrepE jintuża biex ilaqqam liż-żwiemel kontra mard respiratorju ikkawżat mill-batterji Streptococcus equi.
English: The effectiveness of Equilis StrepE has been studied in safety studies and one main field study.
Maltese: L-effettività ta' Equilis StrepE ġiet studjata fi studji ta' sigurtà u fi studju tal-qasam prinċipali wieħed.
English: An increase in body temperature of up to 2°C may occur on the day of vaccination.
Maltese: Fil-jum tat-tilqima tista' sseħħ żieda fit-temperatura talġisem ta' mhux aktar minn 2°C.
English: The studies demonstrated that Equilis StrepE is effective in the active immunisation of horses from 4 months of age against Streptococcus equi to reduce clinical signs and occurrence of lymph node abscesses.
Maltese: L-istudji wrew li Equilis StrepE huwa effettiv fl-immunizzazzjoni attiva taż-żwiemel li għandhom 4 xhur jew aktar kontra Streptococcus equi sabiex jitnaqqsu s-sinjali kliniċi u lokkorrenza ta' axxesi tal-glandoli limfatiċi.
English: Why has Equilis StrepE been approved?
Maltese: Għaliex ġie approvat Equilis StrepE?
English: What is the risk associated with Equilis StrepE?
Maltese: X'inhu r-riskju assoċjat ma' Equilis StrepE?
English: ©EMEA 2007
Maltese: Equilis
English: Route of administratio n
Maltese: Mod ta' Amministrazzjoni
English: Leptospira interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae strain MSLB 1089
Maltese: --1 Sospensjoni (inattivata) Leptospira interrogans serogrupp Icterohaemorrhagiae serovar Icterohaemorrhagiae strejn MSLB 1089
English: Conten t
Maltese: Perjodu ta' Tiżmim
English: 15 September 2017 EMA/564631/2017 EMEA/H/C/004346
Maltese: 15 ta' Settembru 2017 EMA/564631/2017 EMEA/H/C/004346
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom structure (called an antigen) that is found on certain cells in the body.
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
English: The active substance in Ogivri and Herceptin, trastuzumab, is a monoclonal antibody.
Maltese: Is-sustanza attiva f'Ogivri u f'Herceptin, it-trastuzumab, hija antikorp monoklonali.
English: Withdrawal of the marketing authorisation application for Ogivri (trastuzumab) EMA/564631/2017
Maltese: (trastuzumab) EMA/564631/2017
English: What is Ogivri?
Maltese: Kif jaħdem Ogivri?
English: Ogivri was developed as a ‘biosimilar' medicine.
Maltese: Ogivri ġie żviluppat bħala mediċina “bijosimili”.
English: Ogivri is a medicine that contains the active substance trastuzumab.
Maltese: Ogivri huwa mediċina li fiha s-sustanza attiva trastuzumab.
English: What was Ogivri expected to be used for?
Maltese: Għal xiex kien mistenni li jintuża Ogivri?
English: Trastuzumab has been designed to attach to HER2.
Maltese: It-trastuzumab tfasslet biex jeħel ma' HER2.
English: In a third study, Ogivri in combination with a taxane was compared with Herceptin used in combination with a taxane in 500 patients with metastatic breast cancer whose tumour cells overexpressed HER2.
Maltese: Fit-tielet studju, Ogivri, flimkien ma' taxane, tqabblu mal-Herceptin użata flimkien ma' taxane f'500 pazjent b'kanċer tas-sider metastatika li ċ-ċelloli tat-tumur tagħhom esprimew iżżejjed HER2.
English: For more information on biosimilar medicines, see here.
Maltese: Għal aktar informazzjoni dwar il-mediċini bijosimili, ara hawnhekk.
English: Ogivri was expected to be used to treat early and metastatic breast cancer and metastatic gastric (stomach) cancer.
Maltese: Ogivri kien mistenni li jintuża biex jikkura l-kanċer tas-sider fi stadju bikri u metastatiku u l-kanċer (tal-istonku) gastriku metastatiku.
English: HER2 is overexpressed in about a quarter of breast cancers and a fifth of gastric cancers.
Maltese: HER2 hija espressa żżejjed f'madwar kwart tal-kanċers tas-sider u wieħed minn kull ħames kanċers gastriċi.
English: Two studies were carried out in healthy volunteers to investigate whether Ogivri produces the same levels of the active substance in the body as the reference medicine Herceptin and therefore has the same effect.
Maltese: Saru żewġ studji f'voluntieri f'saħħithom biex jiġi investigat jekk Ogivri tipproduċix l-istess livelli tassustanza attiva fil-ġisem bħall-mediċina ta' referenza Herceptin u għalhekk għandhiex l-istess effett.
English: Based on the review of the data at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Ogivri could not have been approved for the treatment of breast cancer and gastric cancer.
Maltese: Fuq il-bażi tar-reviżjoni tad-data, fiż-żmien tal-irtirar, is-CHMP kellu xi tħassib u kien tal-idea provviżorja li Ogivri ma setax jiġi approvat għall-kura tal-kanċer tas-sider u tal-kanċer gastriku.
English: The CHMP's main concern was the lack of a valid certificate confirming that the manufacturing facility of the product complies with good manufacturing practice (GMP) requirements.
Maltese: It-tħassib ewlieni tas-CHMP kien in-nuqqas ta' ċertifikat validu li jikkonferma li l-faċilità tal-manifattura tal-prodott tikkonforma mar-rekwiżiti ta' prattika tajba ta' manifattura (PTM).
English: Withdrawal of the marketing authorisation application for Ogivri (trastuzumab)
Maltese: L-irtirar tal-applikazzjoni għall-awtorizzazzjoni għattqegħid fis-suq għal Ogivri (trastuzumab)
English: By attaching to HER2, trastuzumab activates cells of the immune system, which then kill the tumour cells.
Maltese: Billi teħel mal-HER2, it-trastuzumab tattiva ċ-ċelloli tas-sistema immunitarja, li mbagħad joqtlu liċ-ċelloli tat-tumur.
English: It was to be available as a powder to be made up into a solution for infusion (drip) into a vein.
Maltese: Dan kellu jiġi bħala trab biex isir soluzzjoni għall-infużjoni (dripp) ġo vina.
English: A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific
Maltese: Antikorp monoklonali huwa antikorp (tip ta' proteina) li jkun imfassal biex jagħraf u jeħel ma' struttura speċifika
English: MA (EU) number (Invented) name Strength Pharmaceutical Form
Maltese: Numru tal-proċedura tal-EMEA
English: Tablet, Klebsiella Ozaenae 6 Milli I.U.
Maltese: Pillola, Klebsiella Ozaenae 6 Milli I.U.
English: Granules
Maltese: Granuli
English: Lek Pharmaceuticals D.D.
Maltese: Lek Pharmaceuticals D.D. Ljubljana
English: Tablet, Haemophilus Influenzae 6000 Milli I.U.
Maltese: Pillola, Haemophilus Influenzae 6000 Milli I.U.
English: Luxembourg Om Pharma S.A.
Maltese: Il-Lussemburgu Om Pharma S.A.
English: Tablet, Klebsiella Pneumoniae 6000 Milli I.U.
Maltese: Pillola, Klebsiella Pneumoniae 6000 Milli I.U.
English: Streptococcus Agalactiae 1000 Mega Units Tablet, Haemophilus Influenzae 1500 Mega Units Tablet, Staphylococcus Aureus 1000 Mega Units Tablet, Streptococcus Pneumoniae 1000 Mega Units Tablet
Maltese: Streptococcus Agalactiae 1000 Unità Mega Pillola, Haemophilus Influenzae 1500 Unità Mega Pillola, Staphylococcus Aureus 1000