FrancophonIA/ELRC3.0 huggingface dataset:
English: Verkazia is used to treat children and adolescents aged 4 to 18 years with severe vernal keratoconjunctivitis (an allergic condition of the eye that occurs more frequently in spring and affects the transparent layer in the front part of the eye and the thin membrane covering the front part of the eye).
Maltese: Verkazia jintuża biex jikkura tfal u adolexxenti ta' età minn 4 snin sa 18-il sena b'keratokonġuntivite vernali severa (kondizzjoni allerġika tal-għajn li sseħħ l-aktar frekwenti fir-rebbiegħa u taffettwa lkisja trasparenti fil-parti ta' quddiem tal-għajn u l-membrana rqiqa li tgħatti l-parti ta' quddiem talgħajn).
English: Eye drops, emulsion
Maltese: TWISSIJA(IET) SPEĊJALI
English: Clinical relevance of the primary efficacy endpoint was however difficult to address.
Maltese: Madankollu r-rilevanza klinika tal-punt finali primarju tal-effikaċja kienet diffiċli biex tiġi indirizzata.
English: Cough.
Maltese: Treddigħ
English: However, in clinical studies, 18 patients received Verkazia (4 times daily) in co-administration with eye drops containing corticosteroids and no increase in the risk of adverse reactions related to the immune system was identified.
Maltese: Madankollu, fi studji kliniċi, 18-il pazjent irċevew Verkazia (4 darbiet kuljum) flimkien ma' qtar għall-għajnejn li fihom kortikosterojdi u ma kienet identifikata lebda żieda fir-riskju ta' reazzjonijiet avversi relatati mas-sistema immuni.
English: 5 patients had measurable values (maximum 0.300 ng/mL), all considered to be negligible values.
Maltese: 5 pazjenti kellhom valuri li setgħu jitkejlu (massimu 0.300 ng/mL), kollha meqjusa bħala valuri negliġibbli. Ciclosporinemia ma ġietx imkejla għal 3 pazjenti.
English: How to use Verkazia
Maltese: Twissijiet u prekawzjonijiet
English: There was a significantly higher number of CFS responders in both active groups as compared to vehicle (p=0.005 for the high dose group, and p=0.010 for the low dose group) with 55.4%, 50.0% and 27.6% of responders in the high dose, low dose and vehicle groups respectively.
Maltese: Kien hemm numru ogħla b'mod sinifikanti ta' persuni b'rispons tas-CFS fiż-żewġ gruppi bis-sustanza attiva meta mqabbel mas-sustanza mingħajr ilmediċina attiva (p = 0.005 għall-grupp ta' doża għolja, u p=0.010 għall-grupp ta' doża baxxa) b'55.
English: Formal pharmacokinetic studies have not been conducted in humans with Verkazia.
Maltese: Ma sarux studji farmakokinetiċi formali fil-bnedmin b'Verkazia.
English: Gently shake the single-dose container
Maltese: Ż-ŻGĦAR EWLENIN TIKKETTA TAL-KONTENITUR B'DOŻA WAĦDA
English: Studies in animals have shown reproductive toxicity following systemic administration of ciclosporin at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to the clinical use of Verkazia.
Maltese: Studji f'annimali urew effett tossiku fuq is-sistema riproduttiva wara għoti sistemiku ta' ciclosporin f'esponimenti meqjusa ferm ogħla mill-esponiment massimu fil-bniedem li jindika rilevanza żgħira għall-użu kliniku ta' Verkazia.
English: Open the aluminium pouch, which contains 5 single-dose containers 3.
Maltese: Ħawwad bil-mod il-kontenitur b'doża waħda 5.
English: One pouch contains 5 single-dose containers.
Maltese: Borża żgħira waħda fiha 5 kontenituri ta' doża waħda.
English: Verkazia has not been studied in patients with an active orofacial herpes simplex infection, a history of ocular herpes, varicella-zoster, or vaccinia virus infection and should therefore be used with caution in such patients.
Maltese: Verkazia ma ġiex studjat f'pazjenti b'infezzjoni attiva tal-herpes simplex fil-ħalq u l-wiċċ, storja ta' herpes fl-għajnejn, varicella-zoster, jew infezzjoni kkawżata mill-virus vaccinia għalhekk għandu jintuża b'attenzjoni f'dawn il-pazjenti.
English: Ciclosporin reduces the activity of the body's immune (defence) system and in this way it reduces inflammation (body response to harmful stimuli).
Maltese: Verkazia fih is-sustanza attiva, ciclosporin. Ciclosporin inaqqas l-attività tas-sistema immuni (difiża) tal-ġisem u b'hekk inaqqas l-infjammazzjoni (rispons tal-ġisem għal stimuli ta' ħsara).
English: Common side effects which are not related to the eye: Upper respiratory tract infection, cough, headache.
Maltese: Infezzjoni fl-apparat respiratorju ta' fuq, sogħla, uġigħ ta' ras.
English: Common side effects (may affect up to 1 in 10 people)
Maltese: Effetti sekondarji komuni (jistgħu jaffettwaw sa persuna waħda minn kull 10)
English: Adults The effect of Verkazia has not been studied in patients above 18 years of age.
Maltese: L-effett ta' Verkazia ma ġiex studjat f'pazjenti b'età 'l fuq minn 18-il sena.
English: 12 patients had measurable values (maximum 0.291 ng/mL), all considered to be negligible values.
Maltese: 12-il pazjent kellhom valuri li setgħu jitkejlu (massimu 0.291 ng/mL), kollha meqjusa bħala valuri negliġibbli. Ciclosporinemia ma ġietx imkejla għal 8 pazjenti.
English: Inactivated bluetongue virus, serotype 4 (BTV-4), strain BTV-4/SPA-1/2004 RP* ≥ 1
Maltese: --1 Virus tal-ilsien blu inattivat, serotip 1 (BTV-1), razza ALG2006/01 E1 RP* ≥ 1 Virus tal-ilsien blu inattivat, serotip 4 (BTV-4), razza BTV-4/SPA-1/2004
English: --1 Inactivated bluetongue virus, serotype 1 (BTV-1), strain ALG2006/01 E1 RP* ≥ 1
Maltese: RP* ≥ 1 Virus tal-ilsien blu inattivat, serotip 8 (BTV-8), razza BEL2006/01/2004
English: Inactivated bluetongue virus, serotype 8 (BTV-8), strain BEL2006/01 RP* ≥ 1 *Relative potency measured by ELISA in relation to a reference vaccine whose efficacy has been demonstrated by challenge in the target species.
Maltese: RP* ≥ 1 *Qawwa relattiva mkejla mill-ELISA fir-rigward ta' vaċċin ta' referenza li l-effikaċja tiegħu ntweriet bi sfida fl-ispeċi fil-mira.
English: London, 17 June 2008 EMEA/CHMP/332403/2008
Maltese: Londra, 17 ta' Ġunju 2008 EMEA/332393/2008
English: The Reference Member State was Netherlands and the Concerned Member States were Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Slovakia, Slovenia, Spain and Sweden.
Maltese: L-Istat Membru ta' referenza kienet l-Olanda u l-Istati Membri kkonċernati kienu l-Awstrija, il-Belġju, Ċipru, ir-Repubblika Ċeka, id-Danimarka, l-Estonja, ilFinlandja, Franza, il-Ġermanja, il-Greċja, l-Irlanda, l-Italja, il-Latvja, il-Litwanja, il-Lussemburgu, Malta, inNorveġja, il-Polonja, il-Portugall, is-Slovakkja, is-Slovenja, Spanja, l-Ungerija u l-Iżvezja.
English: Belanette and associated names, is a combined oral contraceptive containing 0.02 mg of ethinylestradiol and 3 mg of drospirenone.
Maltese: Belanette u l-ismijiet assoċjati, hija kontraċċettiv orali kombinat li fih 0.02 mg ethinylestradiol u 3 mg drospirenone.
English: During their December 2007 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/risk ratio is favourable for Yasminelle and associated names, that the objections raised by Hungary should not prevent the approval of the variation applied for and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be the final versions achieved during the Coordination group procedure.
Maltese: Waqt il-laqgħa tiegħu f'Diċembru 2007, is-CHMP, fid-dawl tat-tagħrif kollu mressaq u fid-dawl taddiskussjoni xjentifika fi ħdan il-Kumitat, kien tal-fehma li l-bilanċ bejn il-benefiċċji u r-riskji huwa favorevoli għal Belanette u l-ismijiet assoċjati, li l-oġġezzjonijiet imqajma mill-Ungerija ma għandhomx jimpedixxu l-approvazzjoni tal-varjazzjoni li għalihom tressqet applikazzjoni u li s-Sommarju talKaratteristiċi tal-Prodott, it-tikketta u l-fuljett ta' tagħrif ta' l-Istat Membru ta' Referenza għandhom ikunu lverżjonijiet finali milħuqa waqt il-proċedura tal-grupp ta' koordinament.
English: These Member States were not able to reach an agreement in respect of the variation to the Marketing Authorisation within the time frame as referred to in Article 5(6) of Commission Regulation (EC) No 1084/2003.
Maltese: Dawn l-Istati Membri ma setgħux jilħqu qbil fir-rigward tal-varjazzjoni ta' l-Awtorizzazzjoni għat-Tqegħid fis-Suq sażżmien previst mill-Artikolu 5(6) tar-Regolament tal-Kummissjoni (KE) Nru 1084/2003.
English: The MAH submitted variation application subject to the Mutual Recognition Procedure to the Marketing Authorisations of the medicinal product in the framework of Article 5 of Commission Regulation (EC) No 1084/2003.
Maltese: Id-detentur ta' l-awtorizzazzjoni għat-tqegħid fuq is-suq (MAH) ippreżenta applikazzjoni għal varjazzjoni suġġetta għall-Proċedura ta' Rikonoxximent Reċiproku ta' l-Awtorizzazzjoni għat-Tqegħid fis-Suq talmediċinal fl-ambitu ta' l-Artikolu 5 tar-Regolament tal-Kummissjoni (KE) Nru 1984/2003.
English: A positive opinion was adopted by majority on 13 December 2007.
Maltese: Fit-13 ta' Diċembru 2007 ġiet adottata opinjoni pożittiva b'maġġoranza.
English: Belanette and associated names (see Annex I)
Maltese: Belanette u ismijiet oħra assoċjati (ara anness I)
English: It is available as white tablets (round: 2.5, 5, 7.5 and 10 mg; oval: 15 and 20 mg).
Maltese: Huwa disponibbli f'pilloli bojod (tondi: 2.5, 5, 7.5 u 10 mg; ovali: 15 mg u 20 mg).
English: This summary was last updated in 08-2008.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fi: 08-2008.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) OLANZAPINE MYLAN EPAR summary for the public
Maltese: RAPPORT TA' VALUTAZZJONI PUBBLIKA EWROPEW (EPAR) OLANZAPINE MYLAN Sommarju tal-EPAR għall-pubbliku
English: Olanzapine Mylan is a ‘generic medicine'.
Maltese: Olanzapine Mylan huwa ‘mediċina ġenerika'.
English: The active substance in Olanzapine Mylan, olanzapine, is an antipsychotic medicine.
Maltese: Is-sustanza attiva f'Olanzapine Mylan, olanzapine, hija mediċina antipsikotika.
English: The recommended starting dose of Olanzapine Mylan tablets depends on the disease being treated: 10 mg per day is used in schizophrenia and in the prevention of manic episodes, and 15 mg per day in the treatment of manic episodes, unless it is used with other medicines, in which case the starting dose can be 10 mg per day.
Maltese: Doża ta' 10 mg kuljum tintuża għall-iskizofrenija u fil-prevenzjoni ta' episodji manijaċi, u 15 mg kuljum fit-trattament ta' episodji manijaċi, sakemm ma tintużax ma' mediċini oħra, f'liema każ iddoża tal-bidu tista' tkun ta' 10 mg kuljum.
English: It is thought that olanzapine's beneficial effect is due to it blocking receptors for the neurotransmitters 5-hydroxytrypamine (also called serotonin) and dopamine.
Maltese: Hu maħsub li l-effett benefiku ta' olanzapine huwa dovut għall-imblokkar tar-riċetturi għan-newrotrażmettituri 5-idrossitriptamina (5-hydroxytrypamine, msejħa wkoll serotonina) u dopamina.
English: Olanzapine Mylan is also used to treat moderate to severe manic episodes (extremely high mood) in adults.
Maltese: Olanzine Mylan tintuża wkoll fit-trattament ta' episodji moderati jew severi tal-manija (burdata tajba b'mod estrem) f'adulti.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Olanzapine Mylan to Generics [UK] Ltd. on 7 October 2008.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida madwar l-Unjoni Ewropea kollha, għal Olanzapine Mylan lil Generics [UK] Ltd. fil-7 ta' Ottubru 2008.
English: This means that Olanzapine Mylan is similar to a ‘reference medicine' already authorised in the European Union (EU) called Zyprexa.
Maltese: Dan ifisser li Olanzapine Mylan huwa simili għall‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) li jisimha Zyprexa.
English: It is known as an ‘atypical' antipsychotic because it is different from the older antipsychotic medicines that have been available since the 1950s.
Maltese: Hija magħrufa bħala antipsikotiku 'atipiku' minħabba li hija differenti mill-mediċini antipsikotiċi iktar antiki li ilhom disponibbli mill-Ħamsinijiet.
English: Because Olanzapine Mylan is a generic medicine, studies have been limited to tests to demonstrate that it is bioequivalent to the reference medicine (i.e. that the two medicines produce the same levels of the active substance in the body).
Maltese: Minħabba li Olanzapine Mylan huwa mediċina ġenerika, l-istudji ġew limitati għal testijiet biex jintwera li hija bijoekwivalenti għall-mediċina ta' referenza (huma jipproduċu l-istess livelli ta' sustanza attiva fil-ġisem).
English: Olanzapine Mylan is a medicine containing the active substance olanzapine.
Maltese: Olanzapine Mylan huwa mediċina li fiha s-sustanza attiva olanzapine.
English: Because Olanzapine Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.
Maltese: Minħabba li Olanzapine Mylan huwa mediċina ġenerika u hija bijoekwivalenti għall-mediċina ta' referenza, il-benefiċċju u r-riskju tiegħu huma meqjusa li huma l-istess bħal dawk tal-mediċina ta' referenza.
English: Olanzapine Mylan is not recommended for use in patients below 18 years of age because of a lack on information on safety and effectiveness in this age group.
Maltese: Olanzapine Mylan mhuwiex rakkomandat sabiex jintuża f'pazjenti ta' inqas minn 18-il sena minħabba nuqqas ta' tagħrif dwar is-sigurtà u leffikaċja f'dan il-grupp.
English: What is Olanzapine Mylan?
Maltese: X'inhu Olanzapine Mylan?
English: Patients over 65 years of age and patients who have problems with their liver or kidneys may need a lower starting dose of 5 mg per day.
Maltese: Il-pazjenti li jkollhom iktar minn 65 sena u pazjenti li jkollhom problemi fil-fwied jew fil-kliewi tagħhom jista' jkollhom bżonn ta' doża iktar baxxa fil-bidu 5 mg kuljum.
English: Schizophrenia is a mental illness that has a number of symptoms, including disorganised thinking and speech, hallucinations (hearing or seeing things that are not there), suspiciousness and delusions (mistaken beliefs).
Maltese: Din hija marda mentali, li għandha numru ta' sintomi, inkluż disturbi fil-ħsieb u fid-diskors, alluċinazzjonijiet (jiġifieri d-dehra u s-smigħ ta' affarijiet li jkunu immaġinarji), suspetti u delirji (thewdin u ħsibijiet żbaljati).Olanzine Mylan huwa effikaċi wkoll biex iżomm it-titjib li jkun sar f'pazjenti li jkunu rrispondew għal kors inizjali ta' trattament.
English: Why has Olanzapine Mylan been approved?
Maltese: Għaliex ġie approvat Olanzapine Mylan?
English: Other information about Olanzapine Mylan:
Maltese: Tagħrif ieħor dwar Olanzapine Mylan:
English: The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Olanzapine Mylan has been shown to have comparable quality and to be bioequivalent to Zyprexa.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) ikkonkluda li, b'mod konformi mar-rekwiżiti tal-UE, intwera li Olanzine Mylan għandu kwalità komparabbli ma' Zyprexa u li hija bijoekwivlenti għal din il-mediċina tal-aħħar.
English: The full EPAR for the reference medicine can also be found on the EMEA's website.
Maltese: L-EPARs sħaħ għall-mediċina ta' referenza huma disponibbli fuq il-websajt tal-EMEA wkoll.
English: How has Olanzapine Mylan been studied?
Maltese: Kif ġie studjat Olanzapine Mylan?
English: It can also be used to prevent the recurrence (when symptoms come back) of these episodes in adults with bipolar disorder (a mental illness with alternating periods of high mood and depression) who have responded to an initial course of treatment.
Maltese: Jista' jintuża wkoll biex jipprevjeni li sintomi ta' dawn l-episodji jerġgħu jitfaċċaw f'pazjenti b'disturbi polari (marda mentali b'perjodi jalternaw bejn burdata tajba ħafna u depressjoni) li jkunu rrispondew għal kors inizjali ta' trattament.
English: What is the risk associated with Olanzapine Mylan?
Maltese: X'inhu r-riskju assoċjat ma' Olanzapine Mylan?
English: The full EPAR for Paglitaz 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: Paglitaz is a ‘generic medicine'.
Maltese: Paglitaz huwa ‘mediċina ġenerika'.
English: EPAR summary for the public pioglitazone
Maltese: Sommarju tal-EPAR għall-pubbliku pioglitazone
English: The European Commission granted a marketing authorisation valid throughout the European Union for Paglitaz on 21 March 2012.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Paglitaz fil-21 ta' Marzu 2012.
English: Paglitaz is a medicine that contains the active substance pioglitazone.
Maltese: Paglitaz huwa mediċina li fiha s-sustanza attiva pioglitazone.
English: This is a summary of the European public assessment report (EPAR) for Paglitaz.
Maltese: Dan huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Paglitaz.
English: The CHMP concluded that, in accordance with EU requirements, Paglitaz has been shown to have comparable quality and to be bioequivalent to Actos.
Maltese: Is-CHMP kkonkluda li, f'konformità mar-rekwiżiti tal-UE, Paglitaz wera li għandu kwalità komparabbli u li huwa bijoekwivalenti ma' Actos.
English: This means that Paglitaz is similar to a ‘reference medicine' already authorised in the European Union (EU) called Actos.
Maltese: Dan ifisser li Paglitaz huwa simili għall-‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Europea (UE) li jisimha Actos.
English: The active substance in Paglitaz, pioglitazone, makes cells (fat, muscle and liver) more sensitive to insulin, which means that the body makes better use of the insulin it produces.
Maltese: Is-sustanza attiva f'Paglitaz, pioglitazone, tagħmel iċ-ċelloli (tax-xaħam, tal-muskoli u tal-fwied) aktar sensittivi għall-insulina, li jfisser li l-ġisem jagħmel użu aħjar mill-insulina li jipproduċi.
English: The recommended starting dose of Paglitaz is 15 or 30 mg once a day.
Maltese: Id-doża tal-bidu rakkomandata ta' Paglitaz hi ta' 15 jew 30 mg darba kuljum.
English: Because Paglitaz is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Actos.
Maltese: Minħabba li Paglitaz huwa mediċina ġenerika, l-istudji fil-pazjenti kienu limitati għal testijiet sabiex tiġi determinata l-bijoekwivalenza tiegħu għall-mediċina ta' referenza, Actos.
English: Why has Paglitaz been approved?
Maltese: Għaliex ġie approvat Paglitaz?
English: Paglitaz can also be used together with both metformin and a sulphonylurea in patients who are not satisfactorily controlled despite dual therapy by mouth (‘triple therapy').
Maltese: Paglitaz jista' jintuża' wkoll flimkien kemm ma' metaformina kif ukoll ma' sulfonilurea f'pazjenti li mhumiex ikkontrollati b'mod sodisfaċenti minkejja terapija doppja mill-ħalq (‘terapija tripla').
English: Because Paglitaz is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Minħabba li Paglitaz huwa mediċina ġenerika u huwa bijoekwivalenti għall-mediċina ta' referenza, ilbenefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk tal-mediċina ta' referenza.
English: What is Paglitaz?
Maltese: Kif jintuża Paglitaz?
English: Other information about Paglitaz
Maltese: Informazzjoni oħra dwar Paglitaz
English: Paglitaz can also be used in combination with metformin in patients who are not satisfactorily controlled on metformin alone, or with a sulphonylurea (another type of antidiabetes medicine) when metformin is not suitable (‘dual therapy').
Maltese: Paglitaz jista' jintuża wkoll flimkien ma' metformina f'pazjenti li ma jkunux jistgħu jiġu kkontrollati b'mod sodisfaċenti meta jkunu fuq metformina biss, jew b'sulfonilurea (tip ieħor ta' mediċina antidijabetika) meta metformina ma tkunx tista' tintuża ('terapija doppja').
English: This dose may need to be increased after one or two weeks to up to 45 mg once a day if better blood glucose (sugar) control is needed.
Maltese: Din id-doża tista' teħtieġ li tiżdied wara ġimgħa jew ġimagħtejn sa 45 mg darba kuljum jekk ikun meħtieġ kontroll aħjar talglukożju fid-demm (zokkor).
English: Paglitaz should not be used in patients on dialysis (a blood clearance technique used in people with kidney disease).
Maltese: Paglitaz m'għandux jintuża f'pazjenti fuq dijaliżi (teknika ta' tisfija taddemm użata f'nies b'mard fil-kliewi).
English: Paglitaz is used on its own in patients for whom metformin (another antidiabetes medicine) is not suitable.
Maltese: Paglitaz jintuża waħdu f'pazjenti li ma jistgħux jieħdu metformina (mediċina antidijabetika oħra).
English: Paglitaz can also be used together with insulin in patients who are not satisfactorily controlled with insulin alone and cannot take metformin.
Maltese: Paglitaz jista' jintuża flimkien mal-insulina f'pazjenti li mhumiex ikkontrollati b'mod sodisfaċenti blinsulina waħidha u li ma jistgħux jieħdu metformina.
English: Paglitaz is used to treat type 2 diabetes in adults (aged 18 years or over), particularly those who are overweight.
Maltese: Paglitaz jintuża għall-kura tad-dijabete tat-tip 2 f'aduli (minn 18-il sena 'l fuq), b'mod partikolari dawk b'piż eċċessiv.
English: Therefore, the CHMP's view was that, as for Actos, the benefit outweighs the identified risk.
Maltese: Għaldaqstant, il-fehma tas-CHMP kienet li, bħal fil-każ ta' Actos, ilbenefiċċju huwa akbar mir-riskju identifikat.
English: How has Paglitaz been studied?
Maltese: Kif ġie studjat Paglitaz?
English: Placebo n=293
Maltese: Plaċebo n=293
English: Date of renewal: 14 April 2004
Maltese: Data ta' tiġdid: 14 ta' April 2004
English: D-79639 Grenzach-Wyhlen GERMANY
Maltese: D-79639 Grenzach-Wyhlen
English: Pharmacotherapeutic group: selective immunosuppressive agents ATC code: L04A A08
Maltese: Kategorija farmakoterapewtika: aġenti immunosoppressivi selettivi Kodiċi ATC: L04A A08
English: - The active substance is daclizumab.
Maltese: - Is-sustanza attiva hija daclizumab.
English: Manufacturer Roche Pharma AG Emil-Barell-Strasse 1, D-79639 Grenzach-Wyhlen Germany
Maltese: Roche Pharma AG Emil-Barell-Strasse 1, D-79639 Grenzach-Wyhlen