FrancophonIA/ELRC3.0 huggingface dataset:
Italian: PT - Portogallo Baldacci - Portugal, S.A. Rua Cândido de Figueiredo, 84-B, 1549-005 Lisboa Portugal
Latvian: Rua Cândido de Figueiredo, 84-B, 1549-005 Lisboa Portugal
Italian: Uso Intramuscolare, Uso Intravenoso
Latvian: Intramuskulārai, Intravenozai ievadīšanai
Italian: UK - Regno Unito Tillomed Laboratories Limited, 3 Howard Road, Eaton Socon, St. Neots, Cambridgeshire, PE19 8ET, UK
Latvian: UK - Lielbritānija Tillomed Laboratories Limited, 3 Howard Road, Eaton Socon, St.
Italian: DK - Danimarca Arrow ApS, Hovedgaden 41, 2, DK-2970 Hørsholm,
Latvian: Arrow ApS, Hovedgaden 41, 2, DK-2970 Hørsholm, Denmark
Italian: ACTONEL TRIO 75 mg film- és rágócompresseta
Latvian: ACTONEL TRIO 75 mg film- és rágótabletta
Italian: 1045 Budapest
Latvian: 1045 Budapest Hungary
Italian: PT - Portogallo Parke-Davis - Produtos Farmacêuticos, Lda.
Latvian: PT - Portugāle Parke-Davis - Produtos Farmacêuticos, Lda.
Italian: PT - Portogallo Germed Farmacêutica, Lda.
Latvian: PT - Portugāle Germed Farmacêutica, Lda.
Italian: TECNIMEDE ESPAÑA, INDUSTRIA FARMACEUTICA, S.A. Avda.
Latvian: TECNIMEDE ESPAÑA, INDUSTRIA FARMACEUTICA, S.
Italian: OSTEPAM 15 mg/ml, soluzione à diluer pour perfusion
Latvian: OSTEPAM 15 mg/ml, solution à diluer pour perfusion
Italian: PAMIRED 60 polvere per soluzione per infusione
Latvian: PAMIRED 60 powder for solution for infusion
Italian: Aredia 30 mg prašek in vehikel za koncentrat za raztopino za infundiranje
Latvian: Aredia 30 mg prašek in vehikel za koncentrat za raztopino za
Italian: LU - Luxembourg EUROGENERICS S.A ESPLANADE HEYSEL, B.22
Latvian: EUROGENERICS S.A ESPLANADE HEYSEL, B.22 B 1020 BRUXELLES
Italian: EPOLAR Trio 70 mg compresseta és rágócompresseta
Latvian: EPOLAR Trio 70 mg tabletta és rágótabletta
Italian: Concentrato per soluzione per Infusione, 5 ml
Latvian: Koncentrāts infūziju šķīduma pagatavošanai, 5 ml
Italian: RATIOPHARM 70 mg comprimidos
Latvian: RATIOPHARM 70 mg comprimidos tabletes
Italian: PT - Portogallo Vida - Produtos Farmacêuticos, S.A.
Latvian: PT - Portugāle Vida - Produtos Farmacêuticos, S.A.
Italian: PT - Portogallo Baldacci - Portugal, S.A. Rua Cândido de Figueiredo, 84-B 1549-005 Lisboa, Portugal
Latvian: Rua Cândido de Figueiredo, 84-B 1549-005 Lisboa, Portugal
Italian: Aredia 30 mgTrockensubstanz zur Infusionesbereitung mit Lösungsmittel
Latvian: Aredia 30 mgTrockensubstanz zur Infusionsbereitung mit Lösungsmittel
Italian: PT - Portogallo Zaklad Farmaceutyczny Adamed Pharma S.A., Szkolna Street 33, 95-054
Latvian: PT - Portugāle Zaklad Farmaceutyczny Adamed Pharma S.A., Szkolna Street 33, 95-054
Italian: Compresse and soft capsule
Latvian: Tablete un Mīkstā kapsula
Italian: 65 Delamere Road, Hayes Middlesex UB4 ONN United Kingdom
Latvian: NL - Nīderlande Iono Limited 65 Delamere Road, Hayes Middlesex UB4 ONN United Kingdom
Italian: NO - Norvegia Zaklad Farmaceutyczny Adamed Pharma S.A., Szkolna Street 33, 95-054
Latvian: NO - Norvēģija Zaklad Farmaceutyczny Adamed Pharma S.A., Szkolna Street 33, 95-054
Italian: Dr. REDDY'S
Latvian: REDDY'S LABORATORIES
Italian: Alendron-Hexal 10 einmal wöchentlich 70 mg Compresseten
Latvian: Alendron-Hexal 10 einmal wöchentlich 70 mg Tabletten
Italian: DK - Danimarca medac, Gesellschaft fur klinisch, Spezialpraeparate mbH, Fehlandstrasse 3, DE-20354 Hamburg,
Latvian: DK - Dānija medac, Gesellschaft fur klinisch, Spezialpraeparate mbH, Fehlandstrasse 3, DE-20354 Hamburg, Germany
Italian: Compresse e capsule molli
Latvian: tablete un mīkstās kapsulas
Italian: Atavis EAD 1407 Sofia 29 Atanas Dukov Str. Bulgaria
Latvian: "Атанас Дуков" № 29, София 1407, България
Italian: KERN PHARMA, S.L. Venus, 72.
Latvian: KERN PHARMA, S.L.
Italian: DK - Danimarca Stada Arzneimittel AG, Stadastrasse 2-8, DE-61118
Latvian: BG - Bulgārija Stada Arzneimittel AG, Stadastrasse 2-18, 61118
Italian: DE - Germania biomo pharma GmbH Josef-Diezgen-Str 3
Latvian: DE - Vācija biomo pharma GmbH Josef-Diezgen-Str 3 D-53773 Hennef
Italian: ACIDO ALENDRONICO TEVA 70 mg comprimidos
Latvian: ACIDO ALENDRONICO TEVA 70 mg comprimidos tabletes
Italian: PT - Portogallo Biara - Produtos Farmacêuticos, Lda.
Latvian: PT - Portugāle Biara - Produtos Farmacêuticos, Lda.
Italian: Alendronát Sandoz 70 mg 1 x týždenne compressey
Latvian: Alendronát Sandoz 70 mg 1 x týždenne tablety
Italian: ÁCIDO ALENDRÓNICO SEMANAL KERN PHARMA 70 mg Comprimidos
Latvian: ÁCIDO ALENDRÓNICO SEMANAL KERN PHARMA 70 mg Comprimidos tabletes
Italian: I.E. Filmcompresseten
Latvian: E. Filmtabletten
Italian: UTERITRIN 70 mg filmcompresseta
Latvian: UTERITRIN 70 mg filmtabletta
Italian: Alendronat Bluefish Veckocompresset
Latvian: Alendronat Bluefish Veckotablett
Italian: Apo-Alendronat 70mg
Latvian: Apo-Alendronat 70mg 70mg
Italian: Alendronat Interpharm veckocompresset
Latvian: Alendronat Interpharm veckotablett
Italian: Warner Chilcott Nederland BV
Latvian: NL - Nīderlande Warner Chilcott Nederland BV
Italian: FOSAMAX 10 mg Comprimidos
Latvian: FOSAMAX 10 mg Comprimidos tabletes
Italian: ALENDRONATSANDOZ 70 mg filmcompresseta
Latvian: ALENDRONATSANDOZ 70 mg filmtabletta
Italian: DE - Germania axios Pharma GmbH Hauptstr.
Latvian: DE - Vācija axios Pharma GmbH Hauptstr. 198
Italian: Alendronat Ranbaxy Veckocompresset
Latvian: Alendronat Ranbaxy Veckotablett
Italian: Clodron 800 mg HEXAL
Latvian: Clodron 800 mg HEXAL Filmtabletten
Italian: Ibandronska kislina Mylan 150 mg filmsko obložene compressee
Latvian: Ibandronska kislina Mylan 150 mg filmsko obložene tablete
Italian: AlendroLich Veckocompresset
Latvian: AlendroLich Veckotablett
Italian: Actonel Plus Ca & D Compresse 35mg and 500mg/400 IU Compresse rivestite con films.
Latvian: Actonel Plus Ca & D Tablet 35mg and 500mg/400 IU FilmCoated Tablets.
Italian: UK - Regno Unito Beacon Pharmaceuticals Limited, 85, High strret, Tunbridge Wells, TN1 1YG, UK
Latvian: UK - Lielbritānija Beacon Pharmaceuticals Limited, 85, High strret, Tunbridge Wells, TN1 1YG, UK
Italian: Alendronat Orifarm Veckocompresset
Latvian: Alendronat Orifarm Veckotablett
Italian: PT - Portogallo Tecnifar - Indústria Técnica Farmacêutica, S.A.
Latvian: PT - Portugāle Tecnifar - Indústria Técnica Farmacêutica, S.A.
Italian: Alendronate Sodium Accord 10 mg Compresse
Latvian: Alendronate Sodium Accord 10 mg Tablets
Italian: Merck Sharp & Dohme BV Waarderweg 39
Latvian: NL - Nīderlande Merck Sharp & Dohme BV Waarderweg 39
Italian: Sanofi-Aventis Malta Ltd, Triq Kan. K. Pirotta, Birkirkara, BKR 1114, Malta
Latvian: Pirotta, Birkirkara, BKR 1114, Malta
Italian: Alendronate Richter 70 mg Filmcompresseten
Latvian: Alendronate Richter 70 mg Filmtabletten
Italian: PT - Portogallo Solufarma - Produtos Farmacêuticos Unipessoal, Lda.
Latvian: PT - Portugāle Solufarma - Produtos Farmacêuticos Unipessoal, Lda.
Italian: Alendronat Mylan Veckocompresset
Latvian: Alendronat Mylan Veckotablett
Italian: LABORATOARELE PROF. Dr. MORAIT, Str. Sperantei nr.29, Bucuresti sector 2, Romania
Latvian: Sperantei nr.29, Bucuresti sector 2, Romania
Italian: DE - Germania Orifarm Generixs A/S Energivej 15
Latvian: Orifarm Generixs A/S Energivej 15
Italian: AVENTIS PHARMA AB Bryggvagen 16-18, 11768 Stockholm, Sweden
Latvian: RO - Rumānija AVENTIS PHARMA AB Bryggvagen 16-18, 11768
Italian: Alendronat Orion Veckocompresset
Latvian: Alendronat Orion Veckotablett
Italian: B-dul Ion Mihalache, nr. 11 Sector 1, Cod 011171, Bucureşti, Romania
Latvian: Sector 1, Cod 011171, Sector 1, Cod 011171,
Italian: Alendron Winthrop einmal wöchentlich 70 mg Compresseten
Latvian: Alendron Winthrop einmal wöchentlich 70 mg Tabletten
Italian: 200MG/CAP Capsule dure
Latvian: 200MG/CAP Cietā kapsula
Italian: DK - Danimarca Teva Denmark A/S, Parallelvej 10-12, DK-2800
Latvian: Teva Denmark A/S, Parallelvej 10-12, DK-2800 Kongens Lyngby, Denmark
Italian: Ranbaxy Belgium NV Leuvensestraat 28b 1800 Vilvoorde Belgium
Latvian: NL - Nīderlande Ranbaxy Belgium NV Leuvensestraat 28b
Italian: Alendronate Arrow veckocompresset
Latvian: Alendronate Arrow veckotablett
Italian: PLIVA Pharma Ltd, Vision House, Bedford Road, Petersfield Hampshire, GU32 3QB, United Kingdom and Northern Ireland
Latvian: PLIVA Pharma Ltd, Vision House, Bedford Road, Petersfield Hampshire, GU32
Italian: TERAPIA SA,Str.
Latvian: RO - Rumānija TERAPIA SA,Str.
Italian: BONEACT 35 mg filmcompresseta
Latvian: BONEACT 35 mg filmtabletta
Italian: BIOMEDICA-CHEMICA S.A. G. LYRA 25
Latvian: BIOMEDICA-CHEMICA S.A.
Italian: Alendronsäure 1A Pharma 70 mgeinmal wöchentlich Filmcompresseten
Latvian: Alendronsäure 1A Pharma 70 mgeinmal wöchentlich Filmtabletten apvalkotā tablete
Italian: D-64283 Darmstadt
Latvian: Elisabethenstr. 34 D-64283 Darmstadt
Italian: BG - Bulgaria Actavis Group PTC ehf, Iceland Reykjavikurvegur 76-78, IS-220,
Latvian: BG - Bulgārija Actavis Group PTC ehf, Iceland Reykjavikurvegur 76-78, IS-220,
Italian: DE - Germania Sandoz Pharmaceuticals GmbH
Latvian: Sandoz Pharmaceuticals GmbH
Italian: PT - Portogallo Farmoz - Sociedade Técnico Medicinal, S.A.
Latvian: PT - Portugāle Farmoz - Sociedade Técnico Medicinal, S.A.
Italian: Alendronat Hexal Veckocompresset
Latvian: Alendronat Hexal Veckotablett
Italian: DE - Germania HIKMA Farmaceutica (Portugal) S.A.
Latvian: HIKMA Farmaceutica (Portugal) S.A.
Italian: Bayer Austria Ges.m.b.H.
Latvian: Bayer Austria Ges.m.b.H. Herbststraße 6 - 10
Italian: RANBAXYGEN 70 mg Comprimidos
Latvian: RANBAXYGEN 70 mg Comprimidos tabletes
Italian: BONEFOS 400 mg, capsule
Latvian: BONEFOS 400 mg, capsules
Italian: DK - Danimarca Pharmachemie B.V., PO Box 552, Swensweg 5, NL-2031
Latvian: Pharmachemie B.V., PO Box 552, Swensweg 5, NL-2031 GA Haarlem, Nederlands
Italian: Risedronat STADA 35 mg Filmcompresseten
Latvian: Risedronat STADA 35 mg Filmtabletten
Italian: UK - Regno Unito Beacon Pharmaceuticals Ltd, 85 High Street, Tunbridge Wells, Kent TN1 1YG, UK
Latvian: UK - Lielbritānija Beacon Pharmaceuticals Ltd, 85 High Street, Tunbridge Wells, Kent TN1 1YG, UK
Italian: Alendronat STADA veckocompresset
Latvian: Alendronat STADA veckotablett
Italian: PHARMAGENUS 70 mg comprimidos
Latvian: PHARMAGENUS 70 mg comprimidos tabletes
Italian: 169,32 mg Compresse rivestite con film
Latvian: 169,32 mg Apvalkotā tablete iekšķīgai lietošanai
Italian: Alendronsäure 70 mg Volkspharma Compresseten
Latvian: Alendronsäure 70 mg Volkspharma Tabletten
Italian: RATIOPHARM 3 mg/ml, soluzione à diluer pour perfusion
Latvian: RATIOPHARM 3 mg/ml, solution à diluer pour perfusion
Italian: Alendronsäure Bluefish 70 mg einmal wöchentlich Compresseten
Latvian: Alendronsäure Bluefish 70 mg einmal wöchentlich Tabletten
Italian: Alendronat Actavis Veckocompresset
Latvian: Alendronat Actavis Veckotablett
Italian: Siranin 70 mg filmom obalené compressey
Latvian: Siranin 70 mg filmom obalené tablety
Italian: Actonel Plus Ca & D 35mg compresse rivestite con film + 1000mg/800 IU Effervescent Granules
Latvian: Actonel Plus Ca & D 35mg film-coated tablet + 1000mg/800 IU Effervescent Granules
Italian: RALENOST 70MG
Latvian: RALENOST 70MG 70 mg
Italian: Pamifos 3 mg/ml Konzentrat zur Herstellung eriner Infusioneslösung
Latvian: Pamifos 3 mg/ml Konzentrat zur Herstellung eriner Infusionslösung
Italian: PT - Portogallo Alter, S.A. Estrada Marco do GriloZemouto
Latvian: Estrada Marco do GriloZemouto
Italian: Alendrostad veckocompresset
Latvian: Alendrostad veckotablett
Italian: Alendron esparma 70 mg einmal wöchentlich Compresseten
Latvian: Alendron esparma 70 mg einmal wöchentlich Tabletten
Italian: Romax Once Weekly 70 mg Compresse
Latvian: Romax Once Weekly 70 mg Tablets
Italian: Alendronat Polpharma Veckocompresset
Latvian: Alendronat Polpharma Veckotablett
Italian: AREDIA 15 mg/5 ml, poudre et solvant pour soluzione pour perfusion
Latvian: AREDIA 15 mg/5 ml, poudre et solvant pour solution pour perfusion
Italian: Risedronat Hexal einmal wöchentlich 35 mg Filmcompresseten
Latvian: Risedronat Hexal einmal wöchentlich 35 mg Filmtabletten
Italian: Rua da Tapada Grande, n.º 2, Abrunheira, São Pedro de Penaferrim2714-530 Sintra, Portugal
Latvian: Rua da Tapada Grande, n.º 2, Abrunheira, São Pedro de Penaferrim
Italian: Vale Pharmaceuticals Ltd 1B Gurtnafleur Business Park, Gurtnafleur, clonmel, Co. Tipperary
Latvian: Vale Pharmaceuticals Ltd 1B Gurtnafleur Business Park, Gurtnafleur, clonmel, Co.
Italian: PT - Portogallo Faribérica - Produtos Farmacêuticos, S.A.
Latvian: PT - Portugāle Faribérica - Produtos Farmacêuticos, S.A.
Italian: Alendronic Acid Once Weekly 70mg Compresse
Latvian: Alendronic Acid Once Weekly 70mg Tablets
Italian: Hospira Benelux BVBA, Stallestraat 63
Latvian: NL - Nīderlande Hospira Benelux BVBA, Stallestraat 63
Italian: Alendrohexal 70 mgeinmal wöchentlich Filmcompresseten
Latvian: Alendrohexal 70 mgeinmal wöchentlich Filmtabletten apvalkotā tablete
Italian: Pamidronat Onkovis 3mg/ml Konzentrat zur Herstellung einer Infusioneslösung
Latvian: Pamidronat Onkovis 3mg/ml Konzentrat zur Herstellung einer Infusionslösung
Italian: Alendronate Sodium Accord
Latvian: Alendronate sodium Accord tabletes
Italian: Alendronate sodium Accord
Latvian: Alendronate Sodium Accord tabletes
Italian: Risedronat STADA einmal wöchentlich 35 mg Filmcompresseten
Latvian: Risedronat STADA einmal wöchentlich 35 mg Filmtabletten
Italian: Alendronate Sodium Accord 70 mg Compresse
Latvian: Alendronate Sodium Accord 70 mg Tablets
Italian: Sandoz A/S, C. F. Tietgens Boulevard 40, 5220
Latvian: F. Tietgens Boulevard 40, 5220
Italian: Alendroarrow veckocompresset
Latvian: Alendroarrow veckotablett
Italian: Alendrixen Veckocompresset
Latvian: Alendrixen Veckotablett
Italian: PAMINJECT 3 mg/ml, soluzione à diluer pour perfusion
Latvian: PAMINJECT 3 mg/ml, solution à diluer pour perfusion
Italian: UK - Regno Unito Accord Healthcare Limited, Sage House, 319 Pinner Road, Harrow, Middlesex HA1 4HF, United Kingdom alendronic acid once weekly
Latvian: UK - Lielbritānija Accord Healthcare Limited, Sage House, 319 Pinner Road, Harrow, Middlesex HA1 4HF, United Kingdom alendronic acid once weekly
Italian: PLIVA Pharma Ltd. Vision House Bedford Road Petersfield Hants, GU32 3QB United Kingdom
Latvian: Vision House Bedford Road Petersfield Hants, GU32
Italian: 1123 Budapest
Latvian: 1123 Budapest Hungary
Italian: Biomedica Foscama Industria ChimicoFarmaceutica S.p.A.
Latvian: NL - Nīderlande Biomedica Foscama Industria Chimico
Italian: LABORATORIO STADA, S.L. Frederic Mompou, 5 08960 Sant Just Desvern
Latvian: Frederic Mompou, 5 08960 Sant Just Desvern
Italian: Polvere e soluzione
Latvian: Pulveris un šķīdinātājs
Italian: KORHISPANA 70 mg comprimidos
Latvian: KORHISPANA 70 mg tabletes comprimidos
Italian: DE - Germania Bayer Vital GmbH Kaiser-Wilhelm-Allee
Latvian: Bayer Vital GmbH Kaiser-Wilhelm-Allee D-51373 Leverkusen
Italian: NO - Norvegia Actavis Group PTC ehf, Reykjavikurvegi 76-78, 220
Latvian: NO - Norvēģija Actavis Group PTC ehf, Reykjavikurvegi 76-78, 220
Italian: HU - Ungheria Novartis Hungária Kft. Pharma részlege
Latvian: HU - Ungārija Novartis Hungária Kft.
Italian: LU - Luxembourg Merck Sharp & Dohme 5, Clos du Linx
Latvian: Merck Sharp & Dohme 5, Clos du Linx B-1200 Bruxelles
Italian: 10237 Prague 10.
Latvian: 10237 Prague 10. Czech Republic
Italian: HANTRUX 70 mg filmcompresseta
Latvian: HANTRUX 70 mg filmtabletta
Italian: NOVAPAM 60 mg Pulver zur Herstellung einer
Latvian: NOVAPAM 60 mg Pulver zur Herstellung einer Infusionslösung
Italian: ADELAN SEMANAL 70 mg Comprimidos
Latvian: ADELAN SEMANAL 70 mg Comprimidos tabletes
Italian: 'Interpharm' 10 mgCompresseten
Latvian: Alendronsäure 'Interpharm' 10 mgTabletten
Italian: DK - Danimarca BMM Pharma AB, Blasieholmsgatan 2, SE11148 Stockholm, Sweden
Latvian: BMM Pharma AB, Blasieholmsgatan 2, SE11148 Stockholm, Sweden
Italian: Lichtenauerlaan 102-120 3062 ME Rotterdam Netherlands
Latvian: Lichtenauerlaan 102-120
Italian: Norsed einmal wöchentlich 35 mg Filmcompresseten
Latvian: Norsed einmal wöchentlich 35 mg Filmtabletten
Italian: HU - Ungheria Bayer Schering Pharma Oy Pansiontie 47.
Latvian: Bayer Schering Pharma Oy Pansiontie 47.
Italian: NO - Norvegia ratiopharm GmbH, GrafArco-Strasse 3, D-89070
Latvian: NO - Norvēģija ratiopharm GmbH, GrafArco-Strasse 3, D-89070
Italian: Alendronic Acid Bluefish Once weekly 70 mg Compresse
Latvian: Alendronic Acid Bluefish Once weekly 70 mg Tablets tabletes
Italian: Genericon Pharma Gesellschaft m.b.H, Hafnerstabe 211, 8054 Graz, Austria
Latvian: BG - Bulgārija Genericon Pharma Gesellschaft m.b.H, Hafnerstabe 211, 8054
Italian: House 97-107 Uxbridge Road, Ealing Londo W5 5TL U.K
Latvian: Ranbaxy (UK) Limited, C.P. House 97-107 Uxbridge Road, Ealing Londo W5 5TL U.K
Italian: 70 MG/TAB Compresse
Latvian: 70 MG/TAB
Italian: Nordic Pharma B.V.
Latvian: NL - Nīderlande Nordic Pharma B.V.
Italian: HU - Ungheria Orion Corporation Orionintie 1.
Latvian: Orion Corporation Orionintie 1.
Italian: Tevanate Once Weekly 70mg Compresse
Latvian: Tevanate Once Weekly 70mg Tablets
Italian: NOVAPAM 15 mg Pulver zur Herstellung einer
Latvian: NOVAPAM 15 mg Pulver zur Herstellung einer Infusionslösung
Italian: ÁCIDO ALENDRÓNICO EDIGEN 10 mg comprimidos
Latvian: ÁCIDO ALENDRÓNICO EDIGEN 10 mg comprimidos tabletes
Italian: DK - Danimarca Orifarm Generics A/S, Postbox 69, Energivej 15, DK-5260 Odense S,
Latvian: Orifarm Generics A/S, Postbox 69, Energivej 15, DK-5260 Odense S,
Italian: SANDOZ S.R.L. , Str. Livezeni nr. 7A, Târgu Mureş, România
Latvian: RO - Rumānija SANDOZ S.R.L. , Str. Livezeni nr.
Italian: UK - Regno Unito Actavis Group PTC EHF, Reykjavikurvegi 76-78, Hafnarfirdi IS-220 Iceland alendronic acid
Latvian: UK - Lielbritānija Actavis Group PTC EHF, Reykjavikurvegi 76-78, Hafnarfirdi IS-220 Iceland alendronic acid
Italian: Contenuto (concentrazi one)
Latvian: Saturs (koncentrācij a)
Italian: Il CHMP ha valutato i dati disponibili al fine di stabilire se le due indicazioni possano essere confermate.
Latvian: CHMP novērtēja pieejamos datus, lai varētu konstatēt, vai šīs divas indikācijas ir jāatbalsta.
Italian: Il CHMP ha quindi ritenuto accettabile l'indicazione.
Latvian: Tādējādi CHMP uzskatīja indikāciju par pieņemamu.
Italian: ALLEGATO II CONCLUSIONI SCIENTIFICHE
Latvian: PIELIKUMS II ZINĀTNISKIE SECINĀJUMI
Italian: Sebbene il richiedente fosse disposto a rimuovere le indicazioni contestate dallo Stato membro dissenziente, lo Stato membro di riferimento e gli altri Stati membri interessati e non dissenzienti erano a favore del mantenimento di tali indicazioni.
Latvian: Lai gan iesniedzējs piekrita dzēst indikācijas, pret kurām iebilda ieinteresētā dalībvalsts, atsauces dalībvalsts un citas pozitīvi ieinteresētās dalībvalstis vēlējās saglabāt šīs indikācijas.
Italian: Stato membro EU/EEA
Latvian: ES/EEZ Dalībvalsts
Italian: In conclusione il CHMP ha ritenuto che tale efficacia superi la tossicità del prodotto e che il rapporto rischi/benefici sia favorevole.
Latvian: Nobeigumā CHMP secināja, ka šis iedarbīgums atsver zāļu toksicitāti un ka ieguvuma un riska līdzsvars ir pozitīvs.
Italian: ALLEGATO I ELENCO DEI NOMI DEI MEDICINALI, DELLE FORME FARMACEUTICHE, DEI DOSAGGI, DELLE VIE DI SOMMINISTRAZIONE, DEI RICHIEDENTI NEGLI STATI MEMBRI
Latvian: PIELIKUMS I ZĀĻU NOSAUKUMU, ZĀĻU FORMU, STIPRUMA SARAKSTS, IEVADĪŠANAS VEIDI, PIETEIKUMU IESNIEDZĒJI DALĪBVALSTĪS
Italian: SINTESI GENERALE DELLA VALUTAZIONE SCIENTIFICA DI BLEOMYCIN PHARMACHEMIE E DENOMINAZIONI ASSOCIATE (CFR.
Latvian: BLEOMYCIN PHARMACHEMIE UN RADNIECĪGO NOSAUKUMU ZĀĻU ZINĀTNISKĀ NOVĒRTĒJUMA VISPĀRĒJS KOPSAVILKUMS (SKATĪT I PIELIKUMU)
Italian: Nei Paesi Bassi la bleomicina è attualmente approvata per le seguenti indicazioni:
Latvian: Pašlaik Nīderlandē zāles bleomicīns ir apstiprinātas šādām indikācijām:
Italian: La domanda per Bleomycin Pharmachemie è stata presentata come "domanda generica" in base all'autorizzazione all'immissione in commercio rilasciata per il prodotto di riferimento nei Paesi Bassi il 18 novembre 1997.
Latvian: Iesniegums zālēm Bleomycin Pharmachemie tika iesniegts kā ģenērisku zāļu iesniegums, pamatojoties uz reģistrācijas apliecību, kas izsniegta atsauces zālēm Nīderlandē 1997. gada 18. novembrī.
Italian: Il CHMP ha osservato che la bleomicina viene usata in ambito clinico fin dagli anni '60, il che spiega l'assenza di un programma di sviluppo clinico.
Latvian: CHMP atzīmēja, ka kopš 1960-tajiem gadiem bleomicīns tiek klīniski izmantots, tādējādi izskaidrojot klīniskās izstrādes programmas neesamību.
Italian: La somministrazione della bleomicina avviene quasi sempre in associazione ad altri citostatici e/o a radioterapia.
Latvian: Gandrīz vienmēr bleomicīns tiek lietots kopā ar citām citostatiskām zālēm un/vai radiācijas terapiju.
Italian: Pertanto il CHMP è del parere che la bleomicina permanga un valido farmaco chemioterapico e ha adottato tutte le indicazioni proposte per Bleomycin Pharmachemie:
Latvian: Tādēļ CHMP uzskata, ka bleomicīns joprojām ir vērtīgas ķīmijterapijas zāles, un apstiprināja visas ierosinātās indikācijas zālēm Bleomycin Pharmachemie:
Italian: MOTIVAZIONI DEL PARERE
Latvian: VIEDOKĻA PAMATOJUMS
Italian: Forma farmaceutica
Latvian: Zāļu forma Ievadīšanas veids
Italian: Il CHMP ha inoltre osservato che la bleomicina continua ad essere utilizzata ed è anche richiamata nelle linee guida terapeutiche attualmente in vigore in Europa e nel Nordamerica, come per SCCHN: Practice Guidelines in Oncology-v.2.2008 (HCCN, USA), il CCO (Cancer Care Ontario) Formulary, revisione del 2006/2007 e le Guidelines on penile cancer (marzo 2004) dell'Associazione europea di urologia.
Latvian: CHMP atzīmēja arī to, ka bleomicīnu joprojām izmanto un ka tas ir arī minēts Eiropas un Ziemeļamerikas pašreizējās ārstēšanas vadlīnijās, piemēram, SCCHN: Praktiskas vadlīnijas onkoloģijā-2008. g. 2.sējums (Practice Guidelines in Oncology-v.2.2008) (HCCN, ASV), CCO (Cancer Care Ontario) rokasgrāmatas 2006/2007. gada redakcija, un Eiropas Urologu asociācijas vadlīnijās par dzimumlocekļa vēzi (2004. gada marts) (Guidelines on penile cancer (March 2004) of the European Association of Urology).
Italian: Lo stesso vale per l'indicazione del cancro del pene; tale indicazione è sostenuta da resoconti che suggeriscono una modesta efficacia per tale patologia.
Latvian: Tas pats ir attiecināms uz indikāciju par dzimumlocekļa vēzi - indikācija tiek atbalstīta pārskatos, kuros minēts neliels iedarbīgums uz šo slimību.
Italian: Siccome la valutazione del rapporto rischi/benefici del prodotto originator per tali indicazioni era sfavorevole e siccome le indicazioni sono state successivamente cassate dalle indicazioni autorizzate in Germania per tutti i prodotti contenenti bleomicina, le indicazioni sono state considerate come nuove indicazioni e lo Stato membro dissenziente ha ritenuto che i dati presentati non fossero sufficienti per il rilascio dell'autorizzazione all'immissione in commercio per le nuove indicazioni proposte.
Latvian: Tā kā šo indikāciju priekšrocību/risku novērtējums bija negatīvs oriģinālajām zālēm un tā kā šīs indikācijas tika dzēstas no apstiprināto indikāciju saraksta visām bleomicīnu saturošam zālēm Vācijā, šīs indikācijas tika uzskatītas par jaunām indikācijām, un dalībvalsts, kas iebilda, uzskatīja, ka iesniegtie dati nebija pietiekami, lai izsniegtu reģistrācijas apliecību ieteiktajām jaunajām indikācijām.
Italian: In minor grado, la bleomicina agisce anche sull'RNA e sulla sintesi proteica.
Latvian: Mazākā apjomā bleomicīns ietekmē arī RNS un proteīnu sintēzi.
Italian: Pertanto, nonostante la manifesta tossicità e la modesta efficacia, il CHMP ha ritenuto che la bleomicina costituisca una valida opzione di trattamento sistemico, qualora sia ritenuto necessario per tali indicazioni.
Latvian: Tādēļ, neskatoties uz acīmredzamo toksicitāti un nelielo iedarbīgumu, CHMP uzskatīja, ka bleomicīns ir vērtīga ārstēšanas iespēja sistēmiskajā terapijā, ja tas tiek uzskatīts par nepieciešamu šīm indikācijām.
Italian: Il riassunto delle caratteristiche del prodotto, l'etichettatura e il foglio illustrativo validi sono le versioni finali concordate durante la procedura del gruppo di Coordinamento
Latvian: Spēkā esošais zāļu apraksts, markējuma teksts un lietošanas instrukcija ir to pēdējais variants, kas iegūts Koordinācijas grupu procedūras laikā.
Italian: La bleomicina è valida anche nelle terapie di associazione, sebbene le prove sul contributo specifico della bleomicina non siano valutabili.
Latvian: Arī kombinācijas terapijā bleomicīns ir vērtīgs, lai gan bleomicīna atsevišķa ieguldījuma pierādījumi nav novērtējami.