FrancophonIA/ELRC3.0 huggingface dataset:
English: On 24 December 2008, Huvepharma NV, notified the Agency of his intention to request the reexamination of the CVMP opinion.
Maltese: Fl-24 ta' Diċembru 2008, Huvepharma NV, innotifikat lill-Aġenzija bl-intenzjoni tagħha li titlob leżaminazzjoni mill-ġdid tal-opinjoni tas-CVMP.
English: It exerts its antimicrobial effect by inhibiting protein synthesis of susceptible micro-organisms.
Maltese: Huwa jħalli l-effett antimikrobjali tiegħu billi ma jippermettix issinteżi tal-protejini ta' mikrorganiżmi suxxettibbli.
English: During its 9-11 December 2008 meeting, the CVMP in light of the overall data submitted and the scientific discussion within the Committee, considered by consensus that the application did not satisfy the criteria for authorisation in respect of environmental risk.
Maltese: Waqt il-laqgħa tiegħu tad-9-11 ta' Diċembru 2008, is-CVMP, fid-dawl tad-dejta ġenerali sottomessa u d-diskussjoni xjentifika fi ħdan il-Kumitat, ikkunsidra b'konsensus li l-applikazzjoni ma kinitx tissodisfa l-kriterji għall-awtorizzazzjoni fir-rigward tar-riskju ambjentali.
English: No consideration was given nor conclusion drawn regarding the applicability of the conclusions to other licensed products containing the same active ingredients.
Maltese: Ma ngħatat ebda kunsiderazzjoni u ma ntlaħqet l-ebda konklużjoni għal prodotti oħrajn liċenzjati li fihom l-istess ingredjenti attivi.
English: This summary was last updated in 10-2016.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'10-2016.
English: The full EPAR for Thymanax 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: The active substance in Thymanax, agomelatine, is an antidepressant.
Maltese: Is-sustanza attiva f'Thymanax, l-agomelatina, hija antidipressiv.
English: However, the second study showed that symptoms returned in 21% of the patients taking Thymanax over 24 weeks (34 out of 165), compared with 41% of the patients taking placebo (72 out of 174).
Maltese: Madankollu, it-tieni studju wera li s-sintomi rritornaw f'21% tal-pazjenti li kienu qed jieħdu Thymanax tul 24 ġimgħa (34 minn 165), meta mqabbel ma' 41% tal-pazjenti li kienu qed jieħdu l-plaċebo (72 minn 174).
English: Other information about Thymanax
Maltese: Informazzjoni oħra dwar Thymanax
English: This is a summary of the European public assessment report (EPAR) for Thymanax.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Thymanax.
English: It works in two ways, by stimulating the MT1 and MT2 receptors and by blocking the 5-HT2C receptors in the brain.
Maltese: Taħdem b'żewġ modi, billi tistimula rriċetturi MT1 and MT2 u billi timblokka r-riċetturi 5-HT2C fil-moħħ.
English: Thymanax contains the active substance agomelatine.
Maltese: Thymanax fih is-sustanza attiva agomelatina.
English: Thymanax has been compared with placebo (a dummy treatment) in five main short-term studies involving a total of 1,893 adults with major depression.
Maltese: Thymanax tqabbel ma' plaċebo (kura finta) f'ħames studji ewlenin fil-qosor li kienu jinvolvu total ta' 1,893 adult b'dipressjoni gravi.
English: This is thought to lead to increases in the levels of the neurotransmitters dopamine and noradrenaline.
Maltese: Dan huwa maħsub li jwassal għal żidiet fil-livelli tan-newrotrażmettituri dopamina u noradrenalina.
English: Thymanax can only be obtained with a prescription and is available as tablets (25 mg).
Maltese: Thymanax jista' jinkiseb biss b'riċetta ta' tabib u jiġi bħala pilloli (25 mg).
English: Symptoms often include deep sadness, feelings of worthlessness, loss of interest in favourite activities, sleep disturbances, a feeling of being slowed down, feelings of anxiety and changes in weight.
Maltese: Is-sintomi ta' spiss jinkludu dwejjaq kbar, tħossok li ma tiswa għal xejn, telf ta' interess fl-attivitajiet favoriti, disturbi fl-irqad, tħossok li battejt, sentimenti ta' ansjetà u tibdil fil-piż.
English: EPAR summary for the public
Maltese: Sommarju tal-EPAR għall-pubbliku agomelatina
English: Since dopamine and noradrenaline are involved in the control of mood, their increase between nerve cells in the brain is believed to help relieve the symptoms of depression.
Maltese: Peress li dopamina u noradrenalina huma involuti fil-kontroll tal-burdata, iż-żieda tagħhom bejn iċ-ċelloli tan-nervituri fil-moħħ huwa mifhum li tgħin fis-soljev tas-sintomi tad-dipressjoni.
English: It must also not be used in patients who are taking medicines that slow down the breakdown of Thymanax in the body, such as fluvoxamine (another antidepressant) and ciprofloxacin (an antibiotic).
Maltese: li jdewmu l-assorbiment ta' Thymanax fil-ġisem, bħal fluwoksamina (antidipressiv ieħor) u ċiprofloksaċina (antibijotiku).
English: The main measure of effectiveness in these five studies was the change in symptoms after six weeks, as measured on a standard scale for depression called the Hamilton Depression Rating Scale (HAM D).
Maltese: Il-kejl ewlieni tal-effikaċja f'dawn il-ħames studji kien il-bidla fis-sintomi wara sitt ġimgħat, kif imkejla bl-iskala standard għal dipressjoni magħrufa bħala Hamilton Depression Rating Scale (HAM D - Skala Hamilton għall-Kejl tad-Dipressjoni).
English: The company that markets Thymanax will supply educational material for doctors prescribing Thymanax.
Maltese: Il-kumpanija li tqiegħed Thymanax fis-suq ser tipprovdi materjal edukattiv għat-tobba li jippreskrivu Thymanax.
English: However, since the medicine has a different mode of action, few side effects and a different safety profile to existing antidepressants, the Committee concluded that Thymanax could be a valuable treatment for some patients as long as their liver function is tested frequently.
Maltese: Madankollu, minħabba li l-mediċina għandha mod differenti ta' azzjoni, ftit effetti sekondarji u profil ta' sigurtà differenti minn antidipressivi eżistenti, il-Kumitat ikkonkluda li Thymanax jista' jkun kura siewja għal xi pazjenti diment li l-funzjoni tal-fwied tagħhom tiġi ttestjata spiss.
English: Why is Thymanax approved?
Maltese: Għaliex ġie approvat Thymanax?
English: Two other main studies compared the ability of Thymanax and placebo to prevent symptoms returning in 706 patients whose depression had already been controlled with Thymanax.
Maltese: Żewġ studji ewlenin oħra qabblu l-abbiltà ta' Thymanax u l-plaċebo fil-prevenzjoni tas-sintomi milli jirritornaw f'706 pazjenti li d-dipressjoni tagħhom kienet diġà ġiet ikkontrollata b'Thymanax.
English: Thymanax is a medicine used to treat major depression in adults.
Maltese: Thymanax huwa mediċina li tintuża fil-kura ta' dipressjoni gravi fl-adulti.
English: ‘Neurotransmitters' are chemicals that allow nerve cells to communicate with each other.
Maltese: In-'newrotrażmettituri' huma kimiċi li jippermettu liċ-ċelloli tan-nervituri jikkomunikaw ma' xulxin.
English: A patient booklet will also be distributed to all patients who are prescribed Thymanax so that they are aware of the risk to the liver, the importance of monitoring liver function and the signs of liver problems to look out for.
Maltese: Ser jitqassam ukoll ktejjeb għall-pazjent lill-pazjenti kollha li jiġu preskritti bi Thymanax sabiex ikunu konxji mir-riskju għall-fwied, l-importanza ta' sorveljanza tal-funzjoni tal-fwied u s-sinjali ta' problemi fil-fwied li għandhom joqogħdu attenti għalihom.
English: The company also presented the results of a further study comparing Thymanax with sertraline (another antidepressant), which showed that Thymanax was more effective than sertraline, with a reduction in HAM D scores after six weeks.
Maltese: Il-kumpanija ppreżentat ukoll ir-riżultati ta' studju ieħor li qabbel Thymanax ma' sertralina (antidipressiv ieħor), li wera li Thymanax kien aktar effettiv minn sertalina, bi tnaqqis fil-punteġġi ta' HAM D wara sitt ġimgħat.
English: The most common side effects with Thymanax (seen in more than 1 patient in 100) are headache, nausea (feeling sick) and dizziness.
Maltese: L-effetti sekondarji l-aktar komuni bi Thymanax (li dehru f'aktar minn pazjent 1 minn 100) huma wġigħ ta' ras, nawżja (dardir) u sturdament.
English: In the first study, there was no difference between Thymanax and placebo in preventing symptoms from returning during 26 weeks of treatment.
Maltese: Fl-ewwel studju, ma kien hemm l-ebda differenza bejn Thymanax u l-plaċebo fil-prevenzjoni tas-sintomi milli jirritornaw matul 26 ġimgħa ta' kura.
English: Thymanax must not be used in patients who have problems with their liver, such as cirrhosis (scarring of the liver) or active liver disease, nor in patients whose level of transaminases (liver enzymes) in the blood is more than three times the normal level.
Maltese: Thymanax m'għandux jintuża f'pazjenti li jkollhom problemi fil-fwied, bħal ċirrożi (tbajja fil-fwied) jew mard attiv tal-fwied, u lanqas f'pazjenti li l-livell tagħhom ta' tranżaminażi (enzimi tal-fwied) fid-demm ikun aktar minn tliet darbiet tal-livell normali.
English: Major depression is a condition in which patients have mood disturbances that interfere with their everyday life.
Maltese: Dipressjoni gravi hija kundizzjoni li fiha l-pazjenti jkollhom disturbi fil-burdati li jinterferixxu mal-ħajja tagħhom ta' kuljum.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Thymanax on 19 February 2009.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Thymanax fid-19 ta' Frar 2009.
English: In the two studies where no active comparator was used Thymanax was seen to be more effective than placebo.
Maltese: Fiż-żewġ studji fejn ma ntuża l-ebda komparatur attiv Thymanax deher li kien aktar effettiv minn plaċebo.
English: Three of these studies included some patients treated with other antidepressants, either fluoxetine or paroxetine, as an ‘active comparator'.
Maltese: Tlieta minn dawn l-istudji kienu jinkludu xi pazjenti kkurati b'antidipressivi oħra, jew fluwoksetina jew paroksetina, bħala ‘komparatur attiv'.
English: For the full list of all side effects reported with Thymanax, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati b'Thymanax ara l-fuljett ta' tagħrif.
English: It contains the active substance cidofovir (75 mg/ml).
Maltese: Fih issustanza attiva cidofovir (75 mg/ml).
English: The marketing authorisation holder is Gilead Sciences International.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq huwa Gilead Sciences International.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) VISTIDE EPAR summary for the public
Maltese: RAPPORT PUBBLIKU EWROPEW TA' VALUTAZZJONI (EPAR) VISTIDE Sommarju tal-EPAR għall-pubbliku
English: This summary was last updated in 01-2009.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fi: 01-2009.
English: The most common side effects with Vistide (seen in more than 1 patient in 10) are neutropenia (low white blood cell counts), headache, nausea (feeling sick), vomiting, alopecia (hair loss), rash, proteinuria (protein in the urine), increased blood creatinine levels (a breakdown product of muscles), asthenia (weakness) and fever.
Maltese: L-effetti sekondarji l-aktar komuni b'Vistide (li dehru f'iktar minn pazjent 1 minn 10) kienu newtropenija (għadd baxx ta' ċelluli tad-demm bojod), uġigħ ta' ras, nawżea (dardir), remettar, alopeċja (telf ta' xagħar), raxx, proteinurja (preżenza ta' proteini fl-awrina), żieda fil-livell talkreatinina fid-demm (prodott ta' skart tal-muskoli), astenija (debbulizza) u deni.
English: Vistide is used to treat cytomegalovirus (CMV) retinitis, a viral infection of the retina (the lightsensitive surface at the back of the eye).
Maltese: Vistide jintuża fit-trattament tar-retinite minn ċitomegalovirus (CMV), infezzjoni virali tar-retina (ilmembrana sensittiva għad-dawl li tiksi l-parti l-aktar ta' ġewwa tal-għajn).
English: How has Vistide been studied?
Maltese: Kif ġie studjat Vistide?
English: In the maintenance study, the 5-mg/kg dose was more effective than the 3-mg/kg dose (115 days and 49 days, respectively).
Maltese: Fl-istudju fuq il-manteniment id-dożaġġ ta' 5 mg/kg kien iktar effikaċi mid-dożaġġ ta' 3 mg/kg (rispettivament 115 u 49 jum).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Vistide on 23 April 1997.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq fl-Unjoni Ewropea kollha għal Vistide fit-23 ta' April 1997.
English: The active substance in Vistide, cidofovir, is an antiviral medicine that belongs to the class ‘nucleotide analogues'.
Maltese: Is-sustanza attiva f'Vistide, cidofovir, hija mediċina antivirali tal-klassi tal-‘analogi nukleosidiċi' li timblokka l-attività tal-enzimi li jissejħu ‘DNA polomerażi' fis-CMV, użat mill-virus għallproduzzjoni tad-DNA.
English: How does Vistide work?
Maltese: Liema benefiċċju wera Vistide waqt l-istudji mwettqa?
English: Vistide is used in patients with acquired immunodeficiency syndrome (AIDS) who do not have kidney disease.
Maltese: Vistide jintuża fil-pazjenti bis-sindromu minn immunodefiċjenza akkwiżita (AIDS) li ma jbatux minn mard fil-kliewi.
English: Other information about Vistide:
Maltese: Aktar tagħrif dwar Vistide:
English: What is the risk associated with Vistide?
Maltese: X'inhu r-riskju assoċjat ma' Vistide?
English: Probenecid is used because it prevents cidofovir building up in the kidneys, and saline is used to prevent dehydration.
Maltese: Il-probenecid jintuża għall-prevenzjoni tal-akkumulu ta' cidofovir fil-kliewi, filwaqt li s-soluzzjoni salina sservi biex tipprevjeni d-diżidratazzjoni.
English: The maintenance study compared two maintenance doses of Vistide (5 and 3 mg/kg body weight) in 100 patients who had stopped responding to, or could not receive other medicines for CMV retinitis (ganciclovir or foscarnet).
Maltese: L-istudju fuq il-manteniment qabbel żewġ dożaġġi ta' manteniment ta' Vistide (5 u 3 mg/kg tal-piż tal-ġisem) fuq 100 pazjent li ma baqgħux jirrispondu għal mediċini oħra kontra r-retinite minn CMV (ganciclovir jew foscarnet) jew li ma setgħux jiħduhom.
English: The effects of Vistide in CMV retinitis in AIDS patients were studied in one treatment study and one maintenance study.
Maltese: L-effetti ta' Vistide fil-pazjenti morda bl-AIDS bir-retinite minn CMV ġew eżaminati minn studju fuq it-trattament u minn studju fuq il-manteniment.
English: It took an average of 120 days for CMV retinitis to get worse in patients receiving Vistide, compared with 22 days in those who did not receive any treatment.
Maltese: Fil-pazjenti ttrattati b'Vistide ir-retinite minn CMV aggravat wara medja ta' 120 jum, filwaqt li lpazjenti li ma rċevew l-ebda trattament il-marda aggravat wara 22 jum.
English: To reduce the risk of kidney damage, patients must also take another medicine called probenecid (2 g three hours before the infusion, then 1 g two and eight hours after the infusion) and receive an infusion of one litre of saline solution one hour before the infusion of Vistide.
Maltese: Biex ir-riskju ta' ħsara fil-kliewi jitnaqqas, il-pazjenti għandhom jieħdu mediċina oħra wkoll li jisimha probenecid (2 g tliet sigħat qabel l-infużjoni, imbagħad 1 g sagħtejn u tmien sigħat wara l-infużjoni), u jirċievu infużjoni ta' litru soluzzjoni salina siegħa qabel l-infużjoni ta' Vistide.
English: What is Vistide?
Maltese: Għal xiex jintuża Vistide?
English: The marketing authorisation was renewed on 23 April 2002 and on 23 April 2007.
Maltese: L-awtorizzazzjoni għat-tqegħid fis-suq ġiet mġedda fit-23 ta' April 2002 u fit-23 ta' April 2007.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Vistide's benefits are greater than its risks for the treatment of CMV retinitis in patients with AIDS and without kidney disease.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) iddeċieda li l-benefiċċji ta' Vistide huma ikbar mir-riskji tiegħu fit-trattament tar-retinite minn CMC fil-pazjenti bl-AIDS u mingħajr mard renali.
English: The full EPAR for Vistide is available here.
Maltese: Għaliex ġie approvat Vistide?
English: In the treatment study, Vistide was more effective than no treatment.
Maltese: Fl-istudju fuq it-trattament, Vistide kien iktar effikaċi meta mqabbel mal-każijiet mingħajr trattament.
English: Treatment with Vistide should be prescribed by a doctor who has experience in the management of human immunodeficiency virus (HIV) infection.
Maltese: It-terapija b'Vistide għandha tiġi preskritta minn tabib b'esperjenza fit-trattament tal-infezzjoni talvirus tal-immunodefiċjenza umana (HIV).
English: When the virus cannot produce DNA, it cannot reproduce, slowing down the spread of infection.
Maltese: Meta l-virus ma jkunx jista' jipproduċi d-DNA, ma jistax jirriproduċi ruħu u dan inaqqas ir-ritmu tat-tifrix tal-infezzjoni.
English: Vistide should not be injected directly into the eye.
Maltese: Il-Kumitat irrakkomanda li Vistide jingħata awtorizzazzjoni għat-tqegħid fissuq.
English: Before receiving Vistide, the patient's kidneys must be checked, as the medicine must not be given to patients with kidney disease.
Maltese: Imbagħad, fil-fażi ta' ‘manteniment', il-mediċina tingħata darba kull ġimagħtejn.
English: For the full list of all side effects reported with Vistide, see the Package Leaflet.
Maltese: Għal-lista sħiħa taleffetti sekondarji rrappurtati b'Vistide, ara l-Fuljett ta' Tagħrif.
English: Syrup
Maltese: Mistura
English: treatment initiation pack: 14 tablets + 14 tablets + 14 tablets + 14 tablets
Maltese: Pakkett tal-bidu tat-trattament: 14-il pillola + 14-il pillola + 14-il pillola + 14-il pillola
English: 1 bottle + 1 measuring cup + 1 oral syringe
Maltese: flixkun wieħed + 1 tazza talkejl + 1 siringa orali
English: Oral use bottle (glass)
Maltese: Daqs talPakkett (doża singola)
English: MA (EU) Number (Invented) name Strength Pharmaceutical Form Route of Administration Immediate Packaging Pack size EU/1/12/750/001 Esmya
Maltese: Numru tal-MA Isem (inventat) Qawwa Għamla farmaċewtika
English: Outcome of a procedure under Article 29 of Directive 2001/83/EC as amended
Maltese: Riżultat ta' proċedura skont l-Artikolu 29 tad-Direttiva 2001/83/KE kif emendata
English: EMA/125006/2011 rev. 1 EMEA/H/A-29/1277
Maltese: 1 EMEA/H/A-29/1277
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Docetaxel Teva Generics outweigh its risks, and that the marketing authorisation can be granted in the Netherlands as well as in Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Poland, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom and Norway.
Maltese: IlKumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija kkonkluda li l-benefiċċji ta' Docetaxel Teva Generics jisbqu r-riskji tiegħu, u li l-awtorizzazzjoni għat-tqegħid fis-suq tista' tingħata fil-Pajjiżi l-Baxxi kif ukoll fl-Awstrija, fil-Belġju, fil-Bulgarija, f'Ċipru, fir-Repubblika Ċeka, fidDanimarka, fl-Estonja, fil-Finlandja, fi Franza, fil-Ġermanja, fil-Greċja, fl-Ungerija, fl-Irlanda, fl-Italja, fil-Latvja, fil-Litwanja, fil-Lussemburgu, f'Malta, fil-Polonja, fir-Rumanija, fis-Slovakkja, fis-Slovenja, fi Spanja, fl-Isvezja, fir-Renju Unit u fin-Norveġja.
English: 7 July 2011
Maltese: Fis-7 ta' Lulju 2011
English: What are the conclusions of the CHMP?
Maltese: X'inhuma l-konklużjonijiet tas-CHMP?
English: What is Docetaxel Teva Generics?
Maltese: X'inhu Docetaxel Teva Generics?
English: Docetaxel Teva Generics is a medicine that contains the active substance docetaxel.
Maltese: Docetaxel Teva Generics huwa mediċina li fiha s-sustanza attiva docetaxel.
English: Docetaxel Teva Generics is a generic medicine based on a ‘reference medicine', Taxotere, which has an EU-wide marketing authorisation since 1995.
Maltese: Docetaxel Teva Generics huwa mediċina ġenerika bbażata fuq il-‘mediċina ta' referenza', Taxotere, li għandha awtorizzazzjoni għat-tqegħid fis-suq valida madwar l-UE kollha sa mill-1995.
English: The active substance in Docetaxel Teva Generics, docetaxel, belongs to the group of anticancer medicines known as the taxanes.
Maltese: Is-sustanza attiva fi Docetaxel Teva Generics, docetaxel, tagħmel parti mill-grupp ta' mediċini kontra lkanċer magħrufin bħala it-taxanes.
English: Teva Generics BV submitted an application for Docetaxel Teva Generics to the Netherlands for a decentralised procedure.
Maltese: Teva Generics BV issottomettiet applikazzjoni għal proċedura deċentralizzata lill-Pajjiżi l-Baxxi għal Docetaxel Teva Generics.
English: Docetaxel Teva Generics is intended to treat the following types of cancer: breast cancer, non-small-cell lung cancer, prostate cancer, gastric adenocarcinoma (a type of stomach cancer), and head and neck cancer.
Maltese: Docetaxel Teva Generics huwa maħsub biex jikkura t-tipi ta' kanċer li ġejjin: il-kanċer tas-sider, il-kanċer tal-pulmun mhux ta' ċelloli żgħar, il-kanċer tal-prostata, l-adenokarċinoma gastika (tip ta' kanċer tal-istonku), u l-kanċer tar-ras u tal-għonq.
English: The European Medicines Agency has completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Docetaxel Teva Generics.
Maltese: L-Aġenzija Ewropea tal-Mediċini temmet proċedura ta' arbitraġġ wara nuqqas ta' qbil fost l-Istati Membri tal-Unjoni Ewropea (UE) dwar l-awtorizzazzjoni tal-mediċina Docetaxel Teva Generics.
English: Why was Docetaxel Teva Generics reviewed?
Maltese: Għaliex ġie rivedut Docetaxel Teva Generics?
English: Some Member States considered this needed since the form of Docetaxel Teva Generics (a powder and a solvent to be made into a solution) is different to the form of the reference medicine (a concentrated solution) and the two medicines contain different excipients (inactive ingredients).
Maltese: Xi Stati Membri kkunsidraw li dan kien meħtieġ għaliex il-forma ta' Docetaxel Teva Generics (trab u solvent li jkunu magħmula f'soluzzjoni) hija differenti mill-forma tal-mediċina ta' referenza (soluzzjoni kkonċentrata) u li ż-żewġ mediċini fihom eċċipjenti (sustanzi inattivi) differenti.
English: Based on an evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that additional data was not needed because Docetaxel Teva Generics is expected to produce comparable levels of the active substance in the body as the reference medicine.
Maltese: Fuq bażi tal-evalwazzjoni tad-dejta disponibbli bħalissa u d-diskussjoni xjentifika fi ħdan il-Kumitat, isCHMP ikkonkluda li ma kienx hemm il-bżonn ta' dejta addizzjonali għaliex Docetaxel Teva Generics huwa mistenni li jipproduċi livelli komparabbli tas-sustanza attiva fil-ġisem bħall-mediċina ta' referenza.
English: in this instance the Netherlands) 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 all other EU Member States (except Portugal) and Norway).
Maltese: Din hija proċedura fejn Stat Membru wieħed (l-‘Istat Membru ta' referenza', f'dan il-każ il-Pajjiżi l-Baxxi) jivvaluta mediċina bil-ħsieb li tingħata awtorizzazzjoni għat-tqegħid fis-suq li tkun valida f'dan il-pajjiż kif ukoll fi Stati Membri oħra (l-‘Istati Membri kkonċernati', f'dan il-każ lIstati Membri kollha l-oħra (ħlief il-Portugall) u n-Norveġja).
English: The grounds for the referral were that a ‘bioequivalence' study in humans, to show that Docetaxel Teva Generics produces comparable levels of the active substance in the body as Taxotere, had not been performed.
Maltese: Ir-raġunijiet għar-riferiment kienu minħabba li ma kienx sar studju ta' ‘bijoekwivalenza' fuq il-bnedmin, biex juri li Docetaxel Teva Generics jipproduċi livelli komparabbli tas-sustanza attiva fil-ġisem bħal Taxotere.