FrancophonIA/ELRC3.0 huggingface dataset:
Hungarian: Apotex Europe BV Darwinweg 20
Romanian: Apotex Europe B.V. Darwinweg 20.
Hungarian: SE - Svédország Orifarm Generics A/S Energivej 15
Romanian: SE - Suedia Orifarm Generics A/S Energivej 15 POB 69
Hungarian: KALITHEA 17675
Romanian: BUILDING A KALITHEA 17675
Hungarian: ESTONIA
Romanian: ET - Estonia
Hungarian: Alendronat "1A Farma"
Romanian: Alendronat "1A Farma" 70 mg
Hungarian: Biofarm Sp. z o.o.
Romanian: Biofarm Sp.
Hungarian: Quinta da Fonte, Rua Vitor Câmara, 2 - Edifício D.
Romanian: Quinta da Fonte, Rua Vitor Câmara, 2 - Edifício D. Amélia, Piso 1, Ala B
Hungarian: EL - Görögország ALET PHARMACEUTICALS ABEE
Romanian: ALET PHARMACEUTICALS ABEE
Hungarian: SI - Szlovénia Bayer Schering Pharma Oy, Pansiontie 47, 20210 Turku, Finland
Romanian: Bayer Schering Pharma Oy, Pansiontie 47, 20210 Turku, Finland
Hungarian: NL - Hollandia Ceft Limited 65 Delamere Road, Hayes Middlesex UB4 0NN Belgium
Romanian: 65 Delamere Road, Hayes Middlesex UB4 0NN Belgium
Hungarian: SE - Svédország Sandoz A/S Edvard Thomsens Vej 14 DK-2300 Köpenhamn S Danmark
Romanian: Edvard Thomsens Vej 14 DK-2300 Köpenhamn S Danmark
Hungarian: Rua Tierno Galvan
Romanian: Rua Henrique Paiva
Hungarian: RO - Románia AVENTIS PHARMA AB Bryggvagen 16-18, 11768
Romanian: AVENTIS PHARMA AB Bryggvagen 16-18, 11768 Stockholm, Sweden
Hungarian: EL - Görögország FARMEDIA AE ATHINAS 22 & APOLLONOS GERAKAS ATTIKIS 15344
Romanian: ATHINAS 22 & APOLLONOS GERAKAS ATTIKIS 15344
Hungarian: kemény kapszula
Romanian: Capsule tari
Hungarian: GERVASI FARMACIA, S.L.Juan XXIII, 15-19 08950 Esplugues de Llobregat
Romanian: GERVASI FARMACIA, S.L.Juan XXIII, 15-19
Hungarian: Smarjeska cesta 6, 8501 Novo mestoSlovenia
Romanian: Smarjeska cesta 6, 8501 Novo mesto - Slovenia
Hungarian: Aredia 15 mg prašek in vehikel za koncentrat za raztopino za infundiranje por és oldószer oldatos injekcióhoz
Romanian: Aredia 15 mg prašek in vehikel za koncentrat za raztopino za infundiranje
Hungarian: NO - Norvégia Mylan AB, Box 23033, 10435 Stockholm, Sweden
Romanian: NO - Norvegia Mylan AB, Box 23033, 10435 Stockholm, Sweden
Hungarian: 3752 LB Bunschoten Netherlands
Romanian: Mylan BV Dieselweg 25 3752 LB Bunschoten Netherlands
Hungarian: 2770-229 Paço de Arcos Portugal
Romanian: 2770-229 Paço de Arcos
Hungarian: ET - Észtország Orion Corporation Orionintie 1
Romanian: DE - Germania Orion Corporation Orionintie 1
Hungarian: PT - Portugália Parke-Davis - Produtos Farmacêuticos, Lda.
Romanian: PT - Portugalia Parke-Davis - Produtos Farmacêuticos, Lda.
Hungarian: 3062 ME Rotterdam
Romanian: Lichtenauerlaan 102-120 3062 ME Rotterdam Netherlands
Hungarian: Bayer Austria Ges.m.b.H.
Romanian: Bayer Austria Ges.m.b.H. Herbststraße 6 - 10
Hungarian: KALITHEA 17677
Romanian: BUILDING A KALITHEA 17677
Hungarian: NL - Hollandia Iono Limited 65 Delamere Road, Hayes Middlesex UB4 ONN United Kingdom
Romanian: 65 Delamere Road, Hayes Middlesex UB4 ONN United Kingdom
Hungarian: SE - Svédország Merck Sharp & Dohme BV, PO Box 581, NL-2003 PC Harlem, Netherlands (NLD)
Romanian: Merck Sharp & Dohme BV, PO Box 581, NL-2003 PC Harlem, Netherlands (NLD)
Hungarian: Apo-Alendronat 70mg
Romanian: Apo-Alendronat 70mg 70mg
Hungarian: PT - Portugália Farmoz - Sociedade Técnico Medicinal, S.A.
Romanian: PT - Portugalia Farmoz - Sociedade Técnico Medicinal, S.A.
Hungarian: PL-83-200 Starogard
Romanian: PL-83-200 Starogard Gdanski
Hungarian: DENémetország acis Arzneimittel GmbH Lil-Dagover-Ring 7
Romanian: DE - Germania acis Arzneimittel GmbH LilDagover-Ring 7
Hungarian: FI - Finnország medac Gesellschaft für klinische Spezialpräparate mbH, Fehlandtstrasse 3, 20354 Hamburg, Germany
Romanian: FI - Finlanda medac Gesellschaft für klinische Spezialpräparate mbH, Fehlandtstrasse 3, 20354 Hamburg, Germany
Hungarian: CLASTOBAN 800 mg, gélule tabletta
Romanian: CLASTOBAN 800 mg, gélule
Hungarian: Farmaceutica S.p.A.
Romanian: Farmacom Sp.
Hungarian: Risedronato de sódio Arrow tabletta
Romanian: Risedronato de sódio Arrow
Hungarian: IE - Írország PLIVA Pharma Ltd. Vision House, Bedford Road,
Romanian: PLIVA Pharma Ltd. Vision House Bedford Road Petersfield
Hungarian: Novartis Pharma GmbH Roonstr.
Romanian: DE - Germania Novartis Pharma GmbH Roonstr.
Hungarian: 169,32 mg filmtabletta
Romanian: 169,32 mg Comprimate filmate Uz oral
Hungarian: PT - Portugália Biara - Produtos Farmacêuticos, Lda.
Romanian: PT - Portugalia Biara - Produtos Farmacêuticos, Lda.
Hungarian: Rua Cândido de Figueiredo, 84-B, 1549-005 Lisboa Portugal
Romanian: 84-B, 1549-005 Lisboa
Hungarian: IE - Írország Warner Chilcott UK Limited Old Belfast Road
Romanian: Warner Chilcott UK Limited Old Belfast Road Millbrook
Hungarian: NL - Hollandia Warner Chilcott Nederland BV
Romanian: Warner Chilcott Nederland BV
Hungarian: Resource Medical (UK) Limited, 2 Carlton Avenue, Batley, West Yorkshire WF17 7AQ, United Kingdom alendronic acid
Romanian: UK - Marea Britanie Resource Medical (UK) Limited, 2 Carlton Avenue, Batley, West Yorkshire WF17
Hungarian: LU - Luxemburg TEVA PHARMA BELGIUM S.A.
Romanian: LU - Luxemburg TEVA PHARMA BELGIUM S.A. 16, LAARSTRAAT
Hungarian: 12, parter, sector 2, 020562, Bucuresti Romania
Romanian: Teva Pharmaceuticals S.R.L, Str Domnita Ruxandra nr. 12, parter, sector 2, 020562, Bucuresti Romania
Hungarian: PT - Portugália Tecnimede - Sociedade Técnico-Medicinal, S.A.
Romanian: PT - Portugalia Tecnimede - Sociedade Técnico-Medicinal, S.A.
Hungarian: PHARMACEUTICALS 200 mg, comprimé tabletta
Romanian: PHARMACEUTICALS 200 mg, comprimé
Hungarian: EL - Görögország BIOSPRAY ABEE 18KM MARATHONOS AVENUE
Romanian: BIOSPRAY ABEE 18KM MARATHONOS AVENUE PALLINI 15344
Hungarian: Przedsiębiorstwo Farmaceutyczne LEK-AM Sp. z o.o.
Romanian: Przedsiębiorstwo Farmaceutyczne LEK-AM Sp.
Hungarian: FI - Finnország Stada Arzneimittel AG, Stadastrasse 2 - 18, 61118
Romanian: DK - Danemarca Stada Arzneimittel AG, Stadastrasse 2-8, DE-61118
Hungarian: ETIDRONATE SANDOZ 400 mg, comprimé tabletta
Romanian: ETIDRONATE SANDOZ 400 mg, comprimé
Hungarian: Bonefos tablets 800 mg
Romanian: Bonefos tablets 800 mg 800 mg
Hungarian: PT - Portugália Merck Sharp & Dohme, Lda. Quinta da Fonte - Edifício Vasco da Gama, 19 - Porto Salvo
Romanian: Quinta da Fonte - Edifício Vasco da Gama, 19 - Porto Salvo
Hungarian: PT - Portugália Solufarma - Produtos Farmacêuticos Unipessoal, Lda.
Romanian: PT - Portugalia Solufarma - Produtos Farmacêuticos Unipessoal, Lda.
Hungarian: EL - Görögország FARMATHEN HELLAS ABEE MARATHONOS AVENUE 144
Romanian: FARMATHEN HELLAS ABEE MARATHONOS AVENUE 144 PALLINI 15351
Hungarian: Ácido Ibandrónico Pharmakern
Romanian: Ibandrónico Pharmakern
Hungarian: Teva Denmark A/S, Parallelvej 10-12, DK-2800 Kongens Lyngby, Denmark
Romanian: DK - Danemarca Teva Denmark A/S, Parallelvej 10-12, DK-2800
Hungarian: NL - Hollandia Ranbaxy Belgium NV Leuvensestraat 28b
Romanian: Ranbaxy Belgium NV Leuvensestraat 28b 1800 Vilvoorde Belgium
Hungarian: Risedrolex 35 mg 35 mg
Romanian: Risedrolex 35 mg
Hungarian: PT - Portugália Faribérica - Produtos Farmacêuticos, S.A.
Romanian: PT - Portugalia Faribérica - Produtos Farmacêuticos, S.A.
Hungarian: 1831 Diegem-Machelen Belgium
Romanian: J.E. Mommaertslaan 14 1831 Diegem-Machelen Belgium
Hungarian: PLLengyelország medac Gesellschaft fur klinische Specialpraparate mbH
Romanian: PL - Polonia medac Gesellschaft fur klinische Specialpraparate mbH
Hungarian: ET - Észtország Bayer Schering Pharma OY Pansiontie 47
Romanian: Bayer Schering Pharma OY Pansiontie 47
Hungarian: DK - Dánia medac, Gesellschaft fur klinisch, Spezialpraeparate mbH, Fehlandstrasse 3, DE-20354 Hamburg, Germany
Romanian: DK - Danemarca medac, Gesellschaft fur klinisch, Spezialpraeparate mbH, Fehlandstrasse 3, DE-20354 Hamburg,
Hungarian: 35.00 mg Risedronate sodium (equivalent to 69,6 mg Risendronic acid)
Romanian: 35.00 mg Risedronate sodium (equivalent to 69,6 mg
Hungarian: BONEFOS 400 mg cápsulas kapszula
Romanian: BONEFOS 400 mg cápsulas
Hungarian: HIKMA Farmaceutica (Portugal) S.A.
Romanian: DE - Germania HIKMA Farmaceutica (Portugal) S.A.
Hungarian: Lindron 10 mg tablete
Romanian: Lindron 10 mg tablete 10 mg
Hungarian: Alendronsäure 'Arcana' 70 mg - einmal wöchentlichTabletten
Romanian: Alendronsäure 'Arcana' 70 mg - einmal wöchentlich - Tabletten
Hungarian: 08940 Cornellà de Llobregat (Barcelona)
Romanian: 08950 Esplugues de Llobregat
Hungarian: ET - Észtország Gedeon Richter Plc.
Romanian: DE - Germania Gedeon Richter Plc.
Hungarian: NO - Norvégia Bayer AB Box 606
Romanian: NO - Norvegia Bayer AB Box 606 169 26 Solna
Hungarian: 18km MARATHONOS AVENUE
Romanian: 18km MARATHONOS AVENUE PALLINI ATTIKIS 15351
Hungarian: NOVARTIS PHARMA GmbH Roonstrasse 25 D-90429 Nürnberg, Germany
Romanian: Novartis Pharma GmbH, Roonstrasse 25, Nuernberg D-90429 , Germany
Hungarian: 35/36 Baldoyle Industrial Estate, Grange Road, Dublin
Romanian: Estate, Grange Road, Dublin
Hungarian: 00-372 Warsaw, Poland
Romanian: Foksal St. 00-372 Warsaw, Poland
Hungarian: SANDOZ S.R.L. , Str. Livezeni nr.
Romanian: SANDOZ S.R.L. , Str. Livezeni nr. 7A, Târgu Mureş, România
Hungarian: IE - Írország McDermott Laboratories Ltd. t/a Gerard Laboratories
Romanian: McDermott Laboratories Ltd. t/a Gerard Laboratories 35/36 Baldoyle Industrial
Hungarian: 3QB, United Kingdom
Romanian: 3RW, United Kingdom
Hungarian: Risedronat STADA 35 mg
Romanian: Risedronat STADA 35 mg 35 mg
Hungarian: Aramis Pharma Kft. Mester u. 28.
Romanian: Aramis Pharma Kft.
Hungarian: Pliva Pharma Limited, Vision House, Bedford Road, Petersfield, Hampshire GU23 3QB, United Kingdom alendronic acid
Romanian: PLIVA Pharma Ltd, Vision House, Bedford Road, Petersfield Hampshire, GU32 3QB, United Kingdom and Northern Ireland
Hungarian: IT - Olaszország MYLAN SpA Via Vittor Pisani, 20 - 20124 Milano
Romanian: Via Vittor Pisani, 20 - 20124 Milano
Hungarian: DISODIUM ETIDRONATE
Romanian: DISODIUM PAMIDRONATE
Hungarian: BE - Belgium Sanofi-Aventis Belgium NV Culliganlaan 1C
Romanian: Sanofi-Aventis Belgium NV Culliganlaan 1C 1831 Diegem Belgium
Hungarian: MERCK SHARP & DOHME LIMITED Hertford Road, Hoddesdon, Hertfordshire EN11 UK
Romanian: UK - Marea Britanie MERCK SHARP & DOHME LIMITED Hertford Road, Hoddesdon, Hertfordshire EN11 UK
Hungarian: TECNIMEDE - Sociedade Técnico-Medicinal, S.A. (BS
Romanian: DE - Germania TECNIMEDE - Sociedade Técnico-Medicinal, S.A. (BS
Hungarian: RALENOST 70MG
Romanian: RALENOST 70MG 70 mg
Hungarian: 1180 Brussels
Romanian: 1180 Brussels Belgium
Hungarian: 400 mg + 500 mg calcium tabletta
Romanian: 400 mg + 500 mg calcium
Hungarian: PT - Portugália Apotex Europe, B.V.
Romanian: PT - Portugalia Apotex Europe, B.V. Darwinweg 20
Hungarian: 1180 Brussel
Romanian: 1180 Brussel Belgium
Hungarian: Middlesex HA1 4HF
Romanian: Harrow Middlesex HA1 4HF United Kingdom
Hungarian: RATIOPHARM ESPAÑA, S.A .Avda. de Burgos, 16 D - 5ª Planta 28036 Madrid
Romanian: de Burgos, 16 D - 5ª Planta 28036 Madrid
Hungarian: 35.00 mg Risedronate sodium (equivalent to 32,5 mg Risendronic acid)
Romanian: 35.00 mg Risedronate sodium (equivalent to 32,5 mg
Hungarian: NO - Norvégia Actavis Group PTC ehf, Reykjavikurvegi 76-78, 220
Romanian: NO - Norvegia Actavis Group PTC ehf, Reykjavikurvegi 76-78, 220
Hungarian: Teva UK Limited, Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG
Romanian: Eastbourne, East Sussex, BN22 9AG
Hungarian: BG - Bulgária Actavis Group PTC ehf, Iceland Reykjavikurvegur 76-78, IS-220,
Romanian: BG - Bulgaria Actavis Group PTC ehf, Iceland Reykjavikurvegur 76-78, IS-220,
Hungarian: IT - Olaszország EG SpA Via Pavia, 6 - 20136
Romanian: CRINOS SpA Via Pavia, 6 20136 Milano
Hungarian: Rua da Tapada Grande, n.º 2, Abrunheira, São Pedro de Penaferrim2714-530 Sintra, Portugal
Romanian: Rua da Tapada Grande, n.º 2, Abrunheira, São Pedro de Penaferrim
Hungarian: Nieuwe Donk 9
Romanian: Centrafarm Services B.V. Nieuwe Donk 9
Hungarian: IT - Olaszország ISTITUTO GENTILI SpA Via San Giuseppe
Romanian: ISTITUTO GENTILI SpA Via San Giuseppe Cottolengo, 15
Hungarian: Theodor Pallady Boulevard 44B, Sector 3, RO-032266
Romanian: LABORMED PHARMA S.A. Theodor Pallady Boulevard 44B, Sector 3, RO-032266 Bucharest, Romania
Hungarian: IT - Olaszország S.F.GROUP Srl Via Beniamino Segre, 59
Romanian: S.F.GROUP Srl Via Beniamino Segre, 59 00134 Roma Italy
Hungarian: Pharmachemie B.V., PO Box 552, Swensweg 5, NL-2031 GA Haarlem, Nederlands
Romanian: DK - Danemarca Pharmachemie B.V., PO Box 552, Swensweg 5, NL-2031
Hungarian: , Na květnici 878/33, 140 00
Romanian: Torrex Chiesi CZ, s.r.o. , Na květnici 878/33, 140 00 Praha-Nusle, Czech Republic
Hungarian: RATIOPHARM ESPAÑA, S.A.Avda. de Burgos, 16 D5ª Planta 28036 Madrid
Romanian: de Burgos, 16 D5ª Planta 28036 Madrid
Hungarian: METAMORFOSI 14452
Romanian: MEDARTE PHARMACEUTICALS ΑΒΕΕ SPYROU VRETTOU 10 METAMORFOSI 14452
Hungarian: ET - Észtország Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow HA1
Romanian: Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow HA1
Hungarian: 400 mg/500 mg tabletta
Romanian: 400 mg/500 mg Comprimate
Hungarian: EL - Görögország VIOFAR LTD ETHNIKIS ANTISTASEWS & TRIZINIAS
Romanian: ETHNIKIS ANTISTASEWS & TRIZINIAS
Hungarian: Intramuscularis alkalmazás
Romanian: Intramusculara
Hungarian: PAMIRED 60 powder for solution for infusion por oldatos infúzióhoz
Romanian: PAMIRED 60 powder for solution for infusion
Hungarian: Gedeon Richter Plc, Gyomroi Utca 19-21, Budapest H1103, Hungary alendronic acid
Romanian: UK - Marea Britanie Gideon Richter Plc, Gyomrui Utca 19-21, Budapest H1103, Hungary alendronic acid
Hungarian: ACIDO CLODRONICO 300 mg/10 ml oldatos infúzió
Romanian: ACIDO CLODRONICO 300 mg/10 ml
Hungarian: DENémetország medac Gesellschaft für klinische Spezialpräparate mbH
Romanian: Medac Gesellschaft für klinische Spezialpreparate mbH
Hungarian: Woolmer Way, Bordon, Hampshire GU35 9QE
Romanian: UK - Marea Britanie Sandoz Limited, 37 Woolmer Way, Bordon, Hampshire GU35 9QE
Hungarian: 200MG/CAP kemény kapszula
Romanian: 200MG/CAP Capsule tari
Hungarian: Estrada Marco do GriloZemouto,
Romanian: PT - Portugalia Alter, S.A. Estrada Marco do GriloZemouto,
Hungarian: 1161 JK Zwanenburg Netherlands
Romanian: WILL-PHARMA Wilgenlaan 5 1161 JK Zwanenburg Netherlands
Hungarian: Ibandronate "Arrow" 150 mg tabletta
Romanian: Ibandronate "Arrow" 150 mg
Hungarian: LV - Lettország Mepha Lda., Lagoas Park, 2740-298 Porto Salvo,
Romanian: Mepha Lda., Lagoas Park, 2740-298 Porto Salvo, Portugal
Hungarian: PT - Portugália Laboratórios Basi - Indústria Farmacêutica, S.A.
Romanian: PT - Portugalia Laboratórios Basi - Indústria Farmacêutica, S.A. Rua do Padrão, 98
Hungarian: PT - Portugália Teva Pharma - Produtos Farmacêuticos, Lda.
Romanian: PT - Portugalia Teva Pharma - Produtos Farmacêuticos, Lda.
Hungarian: ETIDRONATE MYLAN 200 mg, comprimé tabletta
Romanian: ETIDRONATE MYLAN 200 mg, comprimé
Hungarian: SE - Svédország sanofi-aventis AB Box 14142
Romanian: SE - Suedia sanofi-aventis AB Box 14142 167 14 Bromma Sweden
Hungarian: IT - Olaszország HOSPIRA ITALIA Srl Via Orazio, 20/22
Romanian: HOSPIRA ITALIA Srl Via Orazio, 20/22 80122 Napoli
Hungarian: BONEFOS 400 mg, capsules kapszula
Romanian: BONEFOS 400 mg, capsules
Hungarian: RISEDRONATE RANBAXY 35 mg, comprimé pelliculé tabletta
Romanian: RISEDRONATE RANBAXY 35 mg, comprimé pelliculé
Hungarian: Actonel Plus Ca & D 35mg film-coated tablets + 1000mg/800 IU Effervescent Granules
Romanian: Actonel Plus Ca & D 35mg film-coated tablet + 1000mg/800
Hungarian: Pharmathen S.A., 6, Dervenakion str., GR-15351 Pallini Attiki, Greece
Romanian: DK - Danemarca Pharmathen S.A., 6, Dervenakion str., GR-15351 Pallini Attiki, Greece
Hungarian: IT - Olaszország SO.SE.PHARM Srl Via dei Castelli Romani, 22
Romanian: SO.SE.PHARM Srl Via dei Castelli Romani, 22 00040 Pomezia (RM)
Hungarian: 5,0 mg Risedronate sodium (equivalent to 5,74 mg Risedronate sodium hemipentahydrate
Romanian: 5,0 mg Risedronate sodium (equivalent to 5,74 mg Risedronate sodium hemipentahydr ate
Hungarian: CZ - Csehország Merck Sharp & Dohme BV Waarderweg 39, 2031 BN Haarlem, Netherlands
Romanian: CZ - Republica Ceha Merck Sharp & Dohme BV Waarderweg 39, 2031 BN Haarlem, Netherlands
Hungarian: ETANORDEN 150 mg, comprimé pelliculé tabletta
Romanian: ETANORDEN 150 mg, comprimé pelliculé
Hungarian: CZ - Csehország Medac Gesellschaft für klinische Spezialpräparate mbH, Fehlandtstraße 3, D20354 Hamburg, Germany
Romanian: Medac Gesellschaft für klinische Spezialpräparate mbH, Fehlandtstraße 3, D20354 Hamburg, Germany
Hungarian: Az Európai Unió területén forgalomba hozatali engedéllyel rendelkező IBANDRONÁT tartalmú gyógyszerek
Romanian: Produse medicamentoase care contin acid ibandronic, autorizate in Uniunea Europeana
Hungarian: BG - Bulgária Tchaikapharma High Quality Medicines, 1, G.M.
Romanian: BG - Bulgaria Tchaikapharma High Quality Medicines, 1, G.M. Dimitorv Blvd, 1172 Sofia, Bulgaria
Hungarian: CLODRONATO TEVA 300 mg/10 ml oldatos infúzió
Romanian: CLODRONATO TEVA 300 mg/10 ml
Hungarian: 1831 Diegem, Belgium arner Chilcott
Romanian: 1831 Diegem, Belgium
Hungarian: CLODRONATO TEVA 100 mg/3,3 ml oldatos injekció
Romanian: CLODRONATO TEVA 100 mg/3,3 ml
Hungarian: ALENDRONATSANDOZ 70 mg filmtabletta
Romanian: ALENDRONAT- SANDOZ 70 mg filmtabletta
Hungarian: Rua Cândido de Figueiredo, 84-B 1549-005 Lisboa, Portugal
Romanian: 84-B 1549-005 Lisboa,
Hungarian: ET - Észtország Ranbaxy (UK) Limited 20 Balderton Street, London W1K 6TL
Romanian: Ranbaxy (UK) Limited 20 Balderton Street, London W1K 6TL
Hungarian: Tartalom (koncentráció)
Romanian: Conţinut (concentraţie)
Hungarian: Tagország EU/EEA
Romanian: Statul membru UE/SEE
Hungarian: A CHMP értékelte a rendelkezésre álló adatokat annak megállapítása érdekében, hogy alátámasztható-e a két javallat.
Romanian: CHMP a evaluat datele disponibile pentru a stabili dacă cele două indicaţii pot fi susţinute.
Hungarian: A BLEOMYCIN PHARMACHEMIE ÉS A KAPCSOLÓDÓ NEVEK (LÁSD AZ I. MELLÉKLETET) TUDOMÁNYOS ÉRTÉKELÉSÉNEK ÁTFOGÓ ÖSSZEGZÉSE
Romanian: REZUMATUL GENERAL AL EVALUĂRII ŞTIINŢIFICE PENTRU BLEOMYCIN PHARMACHEMIE ŞI DENUMIRILE ASOCIATE (VEZI ANEXA I)
Hungarian: A CHMP megállapította, hogy a bleomicin az 1960-as évek óta klinikai használatban van, ami magyarázza a klinikai fejlesztési program hiányát.
Romanian: CHMP a remarcat că bleomicina este utilizată clinic din anii 1960, explicând astfel lipsa unui program de dezvoltare clinică.
Hungarian: A CHMP következtetésként úgy vélte, hogy a készítmény hatásossága meghaladja a toxicitását, és haszon/kockázat mérlege kedvező.
Romanian: În concluzie, CHMP a considerat că această eficacitate depăşeşte toxicitatea produsului şi că raportul beneficiu/risc este pozitiv.
Hungarian: A CHMP a javallatot ezért elfogadhatónak tekintette.
Romanian: Prin urmare, CHMP a considerat indicaţia ca fiind acceptabilă.
Hungarian: A Bleomycin Pharmachemie-re vonatkozó kérelmet a referenciakészítményre kiadott forgalomba hozatali engedély alapján, generikus kérelemként nyújtották be Hollandiában, 1997. november 18-án.
Romanian: Cererea pentru Bleomycin Pharmachemie a fost înaintată ca o cerere generică bazată pe autorizaţia de introducere pe piaţă acordată pentru produsul de referinţă în Ţările de Jos la data de 18 noiembrie 1997.
Hungarian: Noha a kérelmező hajlandó volt a kifogással élő érintett tagállam által kifogásolt javallatok törlésére, a referencia tagállam és a többi, pozitív hozzáállású érintett tagállam e javallatok megtartása mellett foglalt állást.
Romanian: Deşi solicitantul a fost de acord să elimine indicaţiile contestate de către statul membru care a obiectat, statul membru de referinţă şi celelalte state membre pozitive au fost în favoarea păstrării acestor indicaţii.
Hungarian: - Hodgkin-limfóma.
Romanian: - Limfomului Hodgkinian.
Hungarian: Kérelmező
Romanian: Solicitant
Hungarian: A VÉLEMÉNY INDOKOLÁSA
Romanian: MOTIVELE AVIZULUI
Hungarian: I MELLÉKLET FELSOROLÁS: MEGNEVEVEZÉS, GYÓGYSZERFORMA, GYÓGYSZERKÉSZÍTMÉNYDÓZISOK, ALKALMAZÁSI MÓDOK, FORGALOMBA HOZATALI ENGEDÉLY JOGOSULTJAI A TAGÁLLAMOKBAN
Romanian: ANEXA I LISTA CU DENUMIRILE COMERCIALE, FORMA FARMACEUTICĂ, CONCENTRAŢIA MEDICAMENTULUI, CĂILE DE ADMINISTRARE, SOLICITANŢII IN STATELE MEMBRE
Hungarian: A bleomicin alkalmazását szinte mindig egyéb citosztatikumokkal és/vagy sugárterápiával kombinációban végzik.
Romanian: Administrarea de bleomicină se realizează, aproape întotdeauna, în combinaţie cu alte medicamente citostatice şi/sau cu radioterapia.
Hungarian: Hollandiában a bleomicin jelenleg az alábbi javallatokban engedélyezett:
Romanian: În Ţările de Jos, bleomicina este în prezent aprobată pentru următoarele indicaţii:
Hungarian: Mivel e javallatok haszon/kockázat értékelése az originális készítmény esetében negatív volt, és mivel ennek következtében a javallatokat Németországban az összes, bleomicint tartalmazó készítmény engedélyezett javallatai közül törölték, a javallatokat új javallatnak tekintették, és a kifogással élő tagállam úgy vélte, hogy a benyújtott adatok elégtelenek voltak a javasolt új javallatokra vonatkozó forgalomba hozatali engedély kiadásához.
Romanian: Deoarece evaluarea raportului beneficiu/risc pentru aceste indicaţii a fost negativă pentru produsul original şi pentru că indicaţiile au fost, în consecinţă, şterse din indicaţiile autorizate pentru toate produsele care conţin bleomicină din Germania, acestea au fost privite ca fiind indicaţii noi şi statul membru care a obiectat a considerat că datele înaintate sunt insuficiente pentru acordarea autorizaţiei de introducere pe piaţă pentru noile indicaţii propuse.
Hungarian: Ugyanez vonatkozik a péniszkarcinóma javallatára - a javallatot az e betegség esetén mutatott mérsékelt hatásosságra utaló jelentések támasztják alá.
Romanian: Acelaşi lucru se aplică şi pentru indicaţia de cancer penian; indicaţia este susţinută de rapoarte care sugerează o eficacitate modestă pentru această boală.
Hungarian: A CHMP azt is megállapította, hogy a bleomicint még mindig alkalmazzák, és az Európában és ÉszakAmerikában jelenleg érvényes kezelési iránymutatások is említik, mind például az SCCHN: Gyakorlati onkológiai iránymutatások - v.2.2008 (HCCN, USA), a CCO (Cancer Care Ontario) vénygyűjtemény 2006/2007-es felülvizsgált változata, valamint az Európai Urológus Társaság péniszkarcinómára vonatkozó iránymutatásai (2004. március).
Romanian: De asemenea, CHMP a observat că bleomicina este încă utilizată şi menţionată în ghidurile terapeutice curente din Europa şi America de Nord, cum ar fi carcinomul cu celule scuamoase al capului şi gâtului: Practice Guidelines in Oncology-v.2.2008 (Instrucţiuni de practică în oncologie-v.2.2008) (HCCN, SUA), CCO (Cancer Care Ontario) Formulary (Formularul CCO (Cancer Care Ontario)), revizuit în 2006/2007 şi Guidelines on penile cancer (Instrucţiuni privind cancerul penian) (martie 2004) ale Asociaţiei Europene de Urologie.
Hungarian: A CHMP véleménye ezért az, hogy a bleomicin továbbra is értékes kemoterápiás szer, és a Bleomycin Pharmachemie-re vonatkozóan javasolt javallatok összességét elfogadta:
Romanian: Aşadar, CHMP este de părere că bleomicina este încă un medicament chimioterapeutic valoros şi a adoptat toate indicaţiile propuse pentru Bleomycin Pharmachemie:
Hungarian: - herekarcinóma (szeminóma és nem szeminóma).
Romanian: - Carcinomului testicular (seminomatos şi nonseminomatos).
Hungarian: A bleomicin hatása az egy- és kétszálú DNS interkalációján alapul, ami az egy- és kétszálú láncok töréséhez vezet, ez pedig gátolja a sejtek osztódását, szaporodását és DNS-szintézisét.
Romanian: Efectul bleomicinei se datorează intercalării cu lanţurile simple sau duble de ADN, determinând rupturi ale lanţului simplu sau dublu, inhibând astfel diviziunea celulară, creşterea şi sinteza de ADN.
Hungarian: - közepes és nagy malignitású non-Hodgkin-limfóma felnőtteknél.
Romanian: - Limfomului non-Hodgkinian de malignitate intermediară şi înaltă la adulţi.
Hungarian: Ezért a CHMP - a nyilvánvaló toxicitás és a mérsékelt hatásosság ellenére - úgy ítélte meg, hogy a bleomicin a szisztémás kezelés esetén értékes kezelési lehetőséget jelent, amennyiben e javallatokban szükségesnek ítélik.
Romanian: Aşadar, în ciuda toxicităţii clare şi a eficacităţii modeste, CHMP a considerat că bleomicina este o opţiune valoroasă de tratament pentru tratamentul sistemic, dacă este considerată a fi necesară pentru aceste indicaţii.