FrancophonIA/ELRC3.0 huggingface dataset:
English: Death due to AEs on therapy or within 30 days from the last dose of study drug were 5 (1.9%) vs 3 (1.2%) (investigational arm: pulmonary embolism in 2 subjects, acute respiratory failure, aspiration and pneumonia in one patient each; control arm: cerebrovascular accident, ischemic stroke and sepsis, each in one patient).
Maltese: Mewt minħabba AEs waqt it-terapija jew fi żmien 30 jum mill-aħħar doża talmediċina tal-istudju kienu 5 (1.9%) kontra 3 (1.2%) (fergħa investigattiva: emboliżmu pulmonari f'2 individwi, insuffiċjenza respiratorja akuta, aspirazzjoni u pulmonite f'pazjent kull wieħed; fergħa talkontroll: aċċident ċerebrovaskulari, puplesija iskemika u sepsis, kull waħda f'pazjent wieħed).
English: • The Committee considered the procedure under Article 20 of Regulation (EC) No 726/2004 for Lartruvo.
Maltese: • Il-Kumitat ikkunsidra l-proċedura skont l-Artikolu 20 tar-Regolament (KE) Nru 726/2004 għal Lartruvo.
English: No difference was seen in OS in the LMS population either.
Maltese: Lanqas ma dehret differenza fl-OS fil-popolazzjoni LMS.
English: When excluding the event of oedema not associated with an AE suggestive of cardiac dysfunction or a significant decrease in left ventricular function, the true incidence of cardiac dysfunction was 9.3% in the investigational arm and 6.8% in the control arm.
Maltese: Meta jiġi eskluż l-episodju ta' edema mhux assoċjat ma' AE, li jissuġġerixxi disfunzjoni kardijaka jew indeboliment sinifikanti fil-funzjoni ventrikolari tax-xellug, l-inċidenza vera ta' disfunzjoni kardijaka kienet ta' 9.3 % fil-fergħa investigattiva u 6.8 % fil-fergħa tal-kontroll.
English: Annex Scientific conclusions
Maltese: Konklużjonijiet xjentifiċi
English: In this trial, treatment with olaratumab in combination with doxorubicin resulted in an improvement in progression-free survival (PFS) (8.2 vs. 4.4 months according to independent assessment; 6.6 vs. 4.1 months, hazard ratio (HR) 0.672 [95% CI: 0.442, 1.021], p = 0.0615 according to investigator assessment) and overall survival (OS) (26.5 months vs. 14.7 months, HR = 0.463; p = 0.0003).
Maltese: 0615 skont valutazzjoni tal-investigatur) u sopravivenza globali (OS) (26.5 xhur kontra 14.7 xhur, HR = 0.463; p = 0.0003).
English: The sample size, conduct of the study, endpoints, statistical methods or randomisation do not seem to explain the discrepancy between ANNOUNCE and the phase II JGDG.
Maltese: Id-daqs tal-kampjun, it-twettiq tal-istudju, l-end-points, il-metodi statistiċi jew ir-randomizzazzjoni ma jidhrux li jispjegaw id-diskrepanza bejn ANNOUNCE u JGDG ta' fażi
English: In order to confirm the efficacy and safety of olaratumab, the marketing authorisation holder was required to submit as specific obligation, by January 2020, the clinical study report of a phase III randomised double-blind confirmatory study comparing doxorubicin plus olaratumab versus doxorubicin in patients with advanced or metastatic soft tissue sarcoma (Study I5B-MCJGDJ [JGDJ]; ANNOUNCE), including exploratory biomarker data.
Maltese: III randomizzat double-blind li jqabbel doxorubicin u olaratumab kontra doxorubicin f'pazjenti b'sarkoma tat-tessut artab avvanzata jew metastatika (Studju I5B-MCJGDJ [JGDJ]; ANNOUNCE), inkluż data tal-bijomarkatur spjegatorja.
English: The different exposure to doxorubicin between investigational arm and the control group was noted.
Maltese: Ġie nnutat l-esponiment differenti għal doxorubicin bejn il-fergħa investigattiva u l-grupp ta' kontroll.
English: The median of the number of cycles received were higher in the control arm (6 vs 7) and the median of cumulative dose per body surface area (mg/m2) was also higher for the control group (409 vs 483).
Maltese: Il-medjan tan-numru ta' ċikli li ġew riċevuti kien ogħla fil-fergħa tal-kontroll (6 kontra 7) u l-medjan ta' doża kumulattiva skont l-erja tas-superfiċje tal-ġisem (mg/m2) kien ogħla wkoll għall-grupp tal-kontroll (409 kontra 483).
English: Few more SAE (38.9% vs 34.9%) occurred in the investigational arm than in the control arm. Febrile neutropenia was the most frequently SAE occurring with similar frequency in both arms (12.8% vs 13.3%).
Maltese: Newtropenja bid-deni kienet is-SAE li seħħet bl-aktar mod frekwenti bi frekwenza simili fiż-żewġ fergħat (12.8% kontra 13.3%).
English: The primary endpoint for this study was OS in the ITT population and in the LMS population.
Maltese: L-end-point primarju għal dan l-istudju kien OS fil-popolazzjoni ITT u fil-popolazzjoni LMS.
English: However, this remains higher in the investigational arm.
Maltese: Anki t-terapija ta' wara t-twaqqif hija bbilanċjata.
English: ‘in combination with doxorubicin, for the treatment of adult patients with advanced soft tissue sarcoma who are not amenable to curative treatment with surgery or radiotherapy and who have not been previously treated with doxorubicin'.
Maltese: “flimkien ma' doxorubicin, għall-kura ta' pazjenti adulti b'sarkoma tat-tessut artab avvanzata li mhumiex emenabbli għal kura kurattiva b'kirurġija jew radjoterapija u li ma ġewx ikkurati preċedentement b'doxorubicin”.
English: The ANNOUNCE (JGDJ) study was then requested as a specific obligation to confirm the efficacy and safety of olaratumab in same population for whom Lartruvo is currently indicated.
Maltese: L-istudju ANNOUNCE (JGDJ) imbagħad intalab bħala obbligu speċifiku, jikkonferma l-effikaċja u s-sigurtà ta' olaratumab fl-istess popolazzjoni li attwalment huwa indikat għaliha Lartruvo.
English: No data on AE adjusted by exposure are available.
Maltese: M'hemm disponibbli l-ebda data dwar AE aġġustat skont l-esponiment.
English: • The Committee, as a consequence, concluded that Lartruvo lacks therapeutic efficacy and that the benefit-risk of Lartruvo is not favourable.
Maltese: • Bħala konsegwenza, il-Kumitat, ikkonkluda li Lartruvo għandu nuqqas ta' effikaċja terapewtika u li l-benefiċċju u r-riskju ta' Lartruvo mhuwiex favorevoli.
English: In the LMS population, ORR was in favour of the control arm (no statistical significance) and DCR was statistically significant in favour of the control arm.
Maltese: Filpopolazzjoni LMS, l-ORR kienet favur il-fergħa tal-kontroll (l-ebda sinifikanza statistika) u d-DCR kienet statistikament sinifikanti f'favur il-fergħa tal-kontroll.
English: Therefore, pursuant to Article 116 of Directive 2001/83/EC, the Committee recommends the revocation of the marketing authorisation for Lartruvo.
Maltese: Għalhekk, skont l-Artikolu 116 tad-Direttiva 2001/83/KE, il-Kumitat jirrakkomanda r-revoka talawtorizzazzjoni għat-tqegħid fis-suq għal Lartruvo.
English: The raw data were made available as separate documentation.
Maltese: Id-dejta mhix ipproċessata saret disponibbli bħala dokumenti separati.
English: INN Strength Pharmaceutical form
Maltese: INN Qawwa Għamla farmaċewtika
English: There are five presentations, one for cats (52.5 mg) and four for different sizes of dogs (S, M, L, XL) corresponding to 75, 150, 300 and 412.5 mg, respectively.
Maltese: Jeżistu ħames varjazzjonijiet, waħda għallqtates (52.5 mg) u erba' għal daqsijiet differenti ta' klieb (S, M, L, XL) li jikkorrispondu għal 75, 150, 300 u 412.5 mg, rispettivament.
English: Fiprex is a spot-on formulation containing fipronil as the active substance (pharmacotherapeutic group: ectoparasiticides for topical use).
Maltese: Fiprex hija formulazzjoni topika li fiha l-fipronil bħala s-sustanza attiva tagħha (kategorija farmakoterapewtiku: ektoparassitiċidi għal użu topiku).
English: The legal basis of the application was Article 13a of Directive 2001/82/EC i.e. citing well-established use.
Maltese: Il-bażi legali talapplikazzjoni kienet l-Artikolu 13a tad-Direttiva 2001/82/KE, jiġifieri ċitazzjoni ta' użu stabbilit sew.
English: Belgium VET-AGRO TRADING Sp. z o.o.
Maltese: VET-AGRO TRADING Sp. z o.o.
English: The MAH's grounds for re-examination of the CVMP opinion of 11 December 2013 focused on the factors to be taken into account to establish a “well-established veterinary medicinal use of constituents of veterinary medicinal products”, largely following the headings contained under Title III of Annex I to Directive 2001/82/EC (Directive 2009/9/EC).
Maltese: Ir-raġunijiet li l-MAH ta għal eżami mill-ġdid tal-opinjoni tal-CVMP tal-11 ta' Diċembru 2013 iffukaw fuq il-fatturi li għandhom jitqiesu biex jiġi stabbilit “użu mediċinali veterinarju stabbilit sew ta' kostitwenti ta' prodotti mediċinali veterinarji”, b'segwitu ġenerali tal-intestaturi ta' taħt it-Titolu III tal-Anness I mad-Direttiva 2001/82/KE (id-Direttiva 2009/9/KE).
English: Direct therapeutic benefit
Maltese: Il-benefiċċju terapewtiku dirett
English: United Kingdom VET-AGRO TRADING Sp. z o.o.
Maltese: Ir-Renju Unit VET-AGRO TRADING Sp. z o.o.
English: The application was submitted for a mutual recognition procedure, using the legal basis of well-established use (Article 13a of Directive 2001/82/EC).
Maltese: L-applikazzjoni tressqet għal proċedura ta' rikonoxximent reċiproku, bl-użu tal-bażi legali ta' użu stabbilit sew (l-Artikolu 13a tadDirettiva 2001/82/KE).
English: Greece
Maltese: Il-Greċja
English: Overall summary of the scientific evaluation of Fiprex CAT 52.5 mg spot-on solution for cats, Fiprex S 75 mg spot-on solution for dogs, Fiprex M 150 mg spot-on solution for dogs, Fiprex L 300 mg spot-on solution for dogs and Fiprex XL 412.5 mg spot-on solution for dogs (see Annex I)
Maltese: Sommarju ġenerali tal-evalwazzjoni xjentifika tas-soluzzjoni topika Fiprex CAT 52.5 mg għall-qtates, is-soluzzjoni topika Fiprex S 75 mg għall-klieb, is-soluzzjoni topika Fiprex M 150 mg għall-klieb, is-soluzzjoni topika Fiprex L 300 mg għall-klieb u s-soluzzjoni topika Fiprex XL 412.5 mg għallklieb (ara l-Anness I)
English: It has therefore not been possible to establish the efficacy profile of the formulation for Fiprex spot-on.
Maltese: Għaldaqstant, ma kienx possibbli li jiġi stabbilit il-profil ta' effikaċja għall-formulazzjoni topika ta' Fiprex.
English: List of the names, pharmaceutical form, strengths of the veterinary medicinal product, animal species, route of administration, marketing authorisation holder in the Member States
Maltese: Lista ta' ismijiet, għamliet farmaċewtiċi, qawwiet tal-prodotti mediċinali veterinarji, speċi ta' annimal, mnejn jingħata, detentur tal-awtorizzazzjoni għat-tqegħid fis-suq fl-Istati Membri
English: The literature cited by the MAH relates to products that are quantitatively different in terms of the active substance and both qualitatively and quantitatively different in terms of the excipients.
Maltese: Il-materjal ikkwotat mill-MAH huwa relatat ma' prodotti li huma differenti b'mod kwantitattiv mis-sustanza attiva u li huma differenti kemm kwalitattivament kif ukoll kwantitattivament fir-rigward tal-eċċipjenti.
English: • Appropriate efficacy data, in accordance with legislative requirements and with regard to the relevant CVMP guidelines, should be provided in support of the claimed indications for Fiprex CAT 52.5 mg spot-on solution for cats, Fiprex S 75 mg spot-on solution for dogs, Fiprex M 150 mg spot-on solution for dogs, Fiprex L 300 mg spot-on solution for dogs and Fiprex XL 412.5 mg spoton solution for dogs.
Maltese: • Għandha tingħata dejta xierqa dwar l-effikaċja, skont ir-rekwiżiti leġiżlattivi u fir-rigward tal-linji gwida relevanti tal-CVMP, bħala sostenn tal-indikazzjonijiet iddikjarati għas-soluzzjoni topika Fiprex CAT 52.5 mg għall-qtates, għas-soluzzjoni topika Fiprex S 75 mg għall-klieb, għassoluzzjoni topika Fiprex M 150 mg għall-klieb, għas-soluzzjoni topika Fiprex L 300 mg għall-klieb u għas-soluzzjoni topika Fiprex XL 412.5 mg għall-klieb.
English: The CVMP is of the opinion that the MAH has inadequately bridged the difference between the formulations of the products cited in the published literature and the formulation of Fiprex.
Maltese: Il-CVMP huwa tal-opinjoni li l-MAH laqqa' d-differenzi bejn il-formulazzjonijiet tal-prodotti msemmijin fil-materjal stampat u ppubblikat u l-formulazzjoni ta' Fiprex b'mod inadegwat.
English: The MAH highlighted paragraph 3.5 of Title III of Directive 2009/9/EC which states that: “Post-marketing experience with other products containing the same constituents is of particular importance and applicants shall put a special emphasis on this issue.”
Maltese: L-MAH għamel enfasi fuq il-paragrafu 3.5 tat-Titolu III tad-Direttiva 2009/9/KE li jiddikjara li: “L-esperjenza ta' wara l-kummerċjalizzazzjoni bi prodotti oħrajn li fihom listess kostitwenti hija ta' importanza partikolari u l-applikanti għandhom ipoġġu enfasi speċjali fuq din il-kwistjoni.”
English: The MAH additionally presented a study to compare the physicochemical properties of a number of different fipronil-containing spot-on products, including Fiprex and the pioneer product.
Maltese: Barra minn dan, il-MAH ippreżenta studju biex iqabbel il-proprjetajiet psikokimiċi ta' numru ta' prodotti topiċi differenti li fihom fipronil, inklużi Fiprex u l-prodott ewlieni.
English: Therefore, the CVMP recommended the refusal of the granting of the marketing authorisation for Fiprex CAT 52.5 mg spot-on solution for cats, Fiprex S 75 mg spot-on solution for dogs, Fiprex M 150 mg spot-on solution for dogs, Fiprex L 300 mg spot-on solution for dogs, Fiprex XL 412.5 mg spot-on solution for dogs and the suspension of the existing marketing authorisations (see Annex I).
Maltese: Għalhekk, il-CVMP irrakkomanda li l-għoti ta' awtorizzazzjoni għat-tqegħid fis-suq jiġi rrifjutat għassoluzzjoni topika Fiprex CAT 52.5 għall-qtates, għas-soluzzjoni topika Fiprex S 75 mg għall-klieb, għassoluzzjoni topika Fiprex M 150 mg għall-klieb, għas-soluzzjoni topika Fiprex L 300 mg għall-klieb, għas-soluzzjoni topika Fiprex XL 412.5 mg għall-klieb u s-sospensjoni tal-awtorizzazzjonijiet għattqegħid fis-suq eżistenti (ara l-Anness I).
English: The MAH stated that all necessary criteria were fulfilled under Art. 13a of Directive 2001/82/EC (wellestablished use).
Maltese: L-MAH iddikjara li l-kriterji neċessarji kollha ġew issodisfati skont l-Artikolu 13a tad-Direttiva 2001/82/KE (użu stabbilit sew).
English: Bibliographic data has been provided in order to cover all aspects of the safety and/or efficacy assessment of the product for the proposed indication in the target species using the proposed route of administration and dosage regimen.
Maltese: Id-dejta bibljografika ngħatat sabiex ikunu koperti l-aspetti kollha talvalutazzjoni tas-sigurtà u/jew tal-effikaċja tal-prodott għall-indikazzjoni proposta fl-ispeċijiet fil-mira bl-użu tar-rotta proposta ta' amministrazzjoni u u l-iskeda tad-doża.
English: The MAH presented proprietary clinical studies investigating the efficacy of Fiprex spot-on (the product concerned) and Fiprex spray (not concerned by this procedure) against fleas and ticks in dogs and cats.
Maltese: L-MAH ippreżenta studji kliniċi proprjetarji li jinvestigaw l-effikaċja ta' Fiprex topiku (il-prodott ikkonċernat) u l-isprej tal-Fiprex (li mhuwiex milqut minn din il-proċedura) kontra l-briegħed u lqurdien fil-klieb u l-qtates.
English: Despite differences in formulation and dose between Fiprex and other fipronil-containing spot-on products cited in the published literature, it is accepted that such products are generally well tolerated and have a wide margin of safety.
Maltese: Minkejja d-differenzi fil-formulazzjoni u d-dożi bejn Fiprex u prodotti topiċi oħrajn li fihom fipronil u li jissemmew fil-materjal stampat ippubblikat, ġie aċċettat li ġeneralment prodotti bħal dawn ikunu relattivament ittollerati u għandhom marġini wiesa' ta' sigurtà.
English: Ticks are obligate parasites that are vectors for diseases to animals and humans e.g. Lyme disease.
Maltese: Il-qurdien huma parassiti obbligatorji li huma vetturi tal-mard għall-annimali u għall-bnedmin, pereżempju l-marda Lyme (Lyme borreliosis).
English: Applicant/Marketing authorisation holder
Maltese: Applikant/Detentur talAwtorizzazzjoni għatTqegħid fis-Suq
English: According to the MAH, the submitted published reports provided sufficient comfort relating to the safety and efficacy of different fipronil spot-on products, such that any quantitative differences in active ingredient content or quantitative/qualitative differences in excipient content between products would not result in different safety or efficacy outcomes.
Maltese: Skont l-MAH, ir-rapporti ppubblikati sottomessi pprovdew biżżejjed serħan il-moħħ fir-rigward tassigurtà u l-effikaċja ta' prodotti topiċi differenti li fihom fipronil, b'tali mod li kull differenza kwantitattiva fil-kontenut tal-ingredjenti attivi jew differenza kwantitattiva/kwalitattiva fil-kontenut eċċipjenti bejn il-prodotti ma twassalx għal riżultati differenti ta' sigurtà jew effikaċja.
English: Therefore the CVMP concludes that it is not possible to establish the efficacy profile of Fiprex through extrapolation of data from the published literature.
Maltese: Għaldaqstant, il-CVMP jikkonkludi li mhuwiex possibbli li jiġi stabbilit il-profil ta' effikaċja ta' Fiprex permezz tal-estrapolazzjoni tad-dejta mill-materjal stampat u ppubblikat.
English: Consequently, the CVMP cannot conclude that the findings of the MAH's in vitro investigations can be applied to the in vivo situation or to the expected efficacy of the products.
Maltese: Konsegwentement, il-CVMP ma jistax jikkonkludi li s-sejbiet tal-investigazzjonijiet in vitro tal-MAH jistgħu jiġu applikati għas-sitwazzjoni in vivo jew għall-effikaċja mistennija tal-prodotti.
English: Spot-on products containing fipronil provide a user-friendly means of targeting flea and tick infestations in the aforementioned companion animal species, as well as the consequential complications that these parasites can cause to both their hosts and pet owners.
Maltese: Il-prodotti topiċi li bħalissa huma awtorizzati u li fihom fipronil, jibqgħu effikaċi bejn erba' sa tmien ġimgħat għallbriegħed u minn ġimgħa sa erba' ġimgħat għal speċijiet differenti ta' qurdien.
English: Having reviewed the documentation submitted by the MAH, the CVMP concluded that there were not sufficient scientific grounds to revise its conclusions of 11 December 2013, and that the overall benefitrisk balance for the range of Fiprex spot-on formulations is negative.
Maltese: Wara li rreveda d-dokumentazzjoni mressqa mill-MAH, il-CVMP ikkonkluda li ma kienx hemm biżżejjed raġunijiet xjentifiċi biex jirrevedi l-konklużjonijiet tiegħu tal-11 ta' Diċembru 2013, u li l-bilanċ ġenerali tal-benefiċċji u r-riskji għall-firxa ta' formulazzjonijiet topiċi ta' Fiprex kien negattiv.
English: The pharmacovigilance data submitted by the MAH did not meet the standard of published, peerreviewed post-marketing data, i.e. controlled studies or epidemiological studies, as required by the legislation, and therefore could not be considered in the frame of this assessment.
Maltese: Id-dejta ta' farmakoviġilanza mressqa mill-MAH ma kinitx tissodisfa l-istandard tad-dejta ta' wara lkummerċjalizzazzjoni ppubbikata u rriveduta mill-pari, jiġifieri studji kkontrollati jew studji epidemjoloġiċi, kif inhu stipulat fil-leġiżlazzjoni, u għaldaqstant ma setgħetx titqies fil-qafas ta' din ilvalutazzjoni.
English: During the procedure, there was disagreement between the reference Member State and a concerned Member State, Ireland, on the adequacy of the data presented by the marketing authorisation holder (MAH) in support of efficacy and target animal safety.
Maltese: Waqt il-proċedura, kien hemm nuqqas ta' qbil bejn l-Istat Membru ta' referenza u l-Istat Membru kkonċernat, l-Irlanda, dwar l-adegwatezza tad-dejta ppreżentata mid-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq (marketing authorisation holder (MAH)) bħala sostenn tal-effikaċja u tas-sigurtà tal-annimali fil-mira.
English: The MAH disagreed with the previous CVMP conclusion that differences in the formulation between Fiprex and other fipronil-containing products would impact on the absorption, the rate and extent of distribution, and persistence of the active substance on the target species.
Maltese: L-MAH ma qabilx mal-konklużjoni preċedenti tal-CVMP, li d-differenzi fil-formulazzjoni bejn Fiprex u prodotti oħrajn li fihom il-fipronil iħallu impatt fuq l-assorbiment, ir-rata u l-estent tad-distribuzzjoni, u l-persistenza tas-sustanza attiva fuq l-ispeċijiet fil-mira.
English: ELI LILLY Finland Oy Ab Rajatorpantie 41 C 01641 Vantaa Finland
Maltese: ELI LILLY Finland Oy Ab Rajatorpantie 41 C 01641 Vantaa
English: France société TEVA CLASSICS, Le pallatin 1, 1 cour du triangle, 92936 Paris la défence cedex, France
Maltese: Franza société TEVA CLASSICS, Le pallatin 1, 1 cour du triangle, 92936 Paris la défence cedex, France
English: PFIZER holding France 23-25 rue du docteur Lannelongue 75014 Paris, France
Maltese: PFIZER holding France 23-25 rue du docteur Lannelongue 75014
English: IVAX Scandinavia AB, Mailbox 386, 111 73 Stockholm, Sweden
Maltese: AB, Mailbox 386, 111 73 Stockholm, Sweden
English: ELI LILLY Italia SpA - Via Gramsci, 731/733 - 50019 Sesto Fiorentino (FI), Italy Nopar
Maltese: Italia SpA - Via Gramsci, 731/733 - 50019 Sesto Fiorentino (FI), Italy Nopar
English: EG SpA - via Domenico Scarlatti, 3120124 Milano, Italy
Maltese: EG SpA - via Domenico Scarlatti, 3120124
English: RATIOPHARM ESPAÑA, SA Avda.
Maltese: ESPAÑA, SA Avda.
English: NEURAXPHARM ARZNEIMITTEL Arzneimittel GmbH & Co.KG Postfach 400455
Maltese: ARZNEIMITTEL Arzneimittel GmbH & Co.KG Postfach 400455
English: TEVA Pharma BV, Industrieweg 23, PO Bpx 217, 3640 AE Mijdrecht, The Netherlands
Maltese: BV, Industrieweg 23, PO Bpx 217, 3640 AE Mijdrecht, The Netherlands
English: ELI LILLY, Pobřežní 1A, building, 186 00 Praha 8, Czech Republic
Maltese: LILLY, Pobřežní 1A, building, 186 00
English: United Kingdom SANDOZ Limited, Woolmer Way, Borden, Hampshire GU35 9QE, UK
Maltese: SANDOZ Limited, Woolmer Way, Borden, Hampshire GU35 9QE, UK
English: TEVA Pharma Belgium N.V. , Laarstraat 16 B-2610 Wilrijk, Belgium
Maltese: TEVA Pharma Belgium N.V. , Laarstraat 16 B-2610
English: PHARMACIA & UPJOHN S.p.A.
Maltese: UPJOHN S.p.A.
English: SANDOZ GmbH, Biochemiestraße 10, 6250 Kundl, Austria
Maltese: SANDOZ GmbH, Biochemiestraße 10, 6250
English: ELI LILLY GmbH, Kölblgasse 8-10, 1030 Wien, Austria
Maltese: GmbH, Kölblgasse 8-10, 1030
English: PFIZER B.V, Rivium Westlaan 142; 2909 LD Capelle a/d IJSSEL/NL, Netherlands Dostinex
Maltese: Westlaan 142; 2909 LD Capelle a/d IJSSEL/NL, Netherlands Dostinex
English: IVAX Pharmaceuticals s.r.o, Ostravska 29, 74770 Opava 9, Czech Republic
Maltese: IVAX Pharmaceuticals s.r.o, Ostravska 29, 74770
English: ELI LILLY & Company Limited, Lilly House, Priestley Rd, Basingstoke, Hampshire RG24 9NL, UK
Maltese: LILLY & Company Limited, Lilly House, Priestley Rd, Basingstoke, Hampshire RG24 9NL, UK
English: EUROGENERICS N.V. Heizel Esplanade b22 1020 Brussels, Belgium
Maltese: Heizel Esplanade b22 1020
English: PFIZER S.A, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium
Maltese: PFIZER S.A, Boulevard de la Plaine 17, 1050
English: 1.3056 mg Tablet
Maltese: 1.3056 mg Pillola
English: SANDOZ A/S, C.F. Tietgens Boulevard 40, DK-5220 Odense SØ, Denmark
Maltese: SANDOZ A/S, C.F. Tietgens Boulevard 40, DK-5220
English: RATIOPHARM Nederland BV Ronde Tocht 11 1507 CC Zaandam, Netherlands
Maltese: Nederland BV Ronde Tocht 11 1507 CC
English: PFIZER ITALIA Srl - Strada Statale, Borgo San Michele SS 156 km 50 - 04010 Latina, Italy
Maltese: Srl - Strada Statale, Borgo San Michele SS 156 km 50 - 04010
English: 0.3275 mg Tablet
Maltese: 0.3275 mg Pillola
English: Box 43011 3540 AA Utrecht, The Netherlands
Maltese: TEVA Pharma B.V., P.O. Box 43011 3540 AA Utrecht, The Netherlands
English: RATIOPHARM GmbH, Graf-Arco-Strasse 3, DE-89079 Ulm, Germany
Maltese: GmbH, Graf-Arco-Strasse 3, DE-89079 Ulm, Germany
English: TEVA Pharmaceuticals ČR, s.r.o.
Maltese: ČR, s.r.o.
English: United Kingdom NORTON HEALTHCARE Limited, Albert Basin, Royal Docks, London E16 2QJ, UK
Maltese: NORTON HEALTHCARE Limited, Albert Basin, Royal Docks, London E16 2QJ, UK
English: Box 1070 251 10 Helsingborg, Sweden
Maltese: TEVA Sweden AB, Sundstorget 2, Helsingborg P.O. Box 1070 251 10 Helsingborg, Sweden
English: United Kingdom PHARMACIA Limited, Ramsgate Road, Sandwich, Kent CT13 9NJ, UK
Maltese: PHARMACIA Limited, Ramsgate Road, Sandwich, Kent CT13 9NJ, UK
English: Ostravska 28, 74770 Opava-Komarov, Czech Republic
Maltese: Ostravska 28, 74770