FrancophonIA/ELRC3.0 huggingface dataset:
Spanish: STRAGEN France SAS 52 rue de la République 69002 Lyon
Bulgarian: STRAGEN France SAS 52 rue de la République 69002 Lyon France
Spanish: Eslovaquia Sandoz Pharmaceuticals d.d.
Bulgarian: Словакия Sandoz Pharmaceuticals d.d.
Spanish: 83607 Holzkirchen Alemania
Bulgarian: 83607 Holzkirchen
Spanish: LABORATOIRES CRISTERS 22, quai Galliéni 92150 Suresnes Francia
Bulgarian: LABORATOIRES CRISTERS 22, quai Galliéni 92150 Suresnes France
Spanish: Rivium Westlaan 142 2909 LD Capelle a/d IJssel Países Bajos
Bulgarian: 2909 LD Capelle a/d IJssel The Netherlands
Spanish: Orifarm Oy Metsänneidonkuja 10 02130 Espoo Finlandia
Bulgarian: Финландия Orifarm Oy Metsänneidonkuja 10 02130 Espoo
Spanish: 10785 Berlin Alemania
Bulgarian: 10785 Berlin
Spanish: Str. Livezeni nr. 7A, 540472 Târgu Mureş, Rumanía.
Bulgarian: S.C. SANDOZ S.R.L. Str. Livezeni nr. 7A, 540472 Târgu Mureş, România.
Spanish: EG LABO - LABORATOIRES EUROGENERICS Le Quintet - bâtiment A 12 rue Danjou 92517 Boulogne Billancourt Cedex Francia
Bulgarian: EG LABO - LABORATOIRES EUROGENERICS Le Quintet - bâtiment A 12 rue Danjou 92517 Boulogne Billancourt Cedex France
Spanish: Farmitalia Industrie Chimico Farmaceutiche Via Alcide De Gasperi, 165 B 95127 Catania Italia
Bulgarian: Farmitalia Industrie Chimico Farmaceutiche Via Alcide De Gasperi, 165 B 95127 Catania Italy
Spanish: Eslovaquia Teva Pharmaceuticals Slovakia s.r.o.
Bulgarian: Словакия Teva Pharmaceuticals Slovakia s.r.o.
Spanish: Str. Domniţa Ruxandra nr. 12, parter, Sector 2
Bulgarian: Teva Pharmaceuticals S.R.L. Str. Domniţa Ruxandra nr. 12, parter, Sector 2
Spanish: EFFIK BENELUX Lenniksebaan 451 1070 Anderlecht Bélgica
Bulgarian: EFFIK BENELUX Lenniksebaan 451 1070 Anderlecht Belgium
Spanish: Frederic Mompou, 5 08960 Sant Just Desvern Barcelona
Bulgarian: LABORATORIO STADA, S.L. Frederic Mompou, 5 08960 Sant Just Desvern Barcelona
Spanish: Reino Unido Janssen-Cilag Limited 50-100 Holmers Farm Way High Wycombe
Bulgarian: Janssen-Cilag Limited 50-100 Holmers Farm Way High Wycombe
Spanish: Bayer Vital GmbH Kaiser-Wilhelm-Allee 51373 Leverkusen Alemania
Bulgarian: Германия Bayer Vital GmbH Kaiser-Wilhelm-Allee 51373 Leverkusen Germany
Spanish: Via D. Scarlatti, 31 20124 Milano Italia
Bulgarian: Via D. Scarlatti, 31 20124 Milano Italy
Spanish: Chemical Works of Gedeon Richter Plc.,
Bulgarian: Словения Chemical Works of Gedeon Richter Plc.,
Spanish: Tipperary Clonmel Irlanda
Bulgarian: Tipperary Clonmel Ireland
Spanish: 243 Messoghion Avenue, 154 51 N. Psychiko, Grecia
Bulgarian: 243 Messoghion Avenue, 154 51 N.
Spanish: 20210 Turku Finlandiaia
Bulgarian: 20210 Turku
Spanish: Varipharm Arzneimittel GmbH Lindenplatz 1
Bulgarian: Германия Varipharm Arzneimittel GmbH Lindenplatz 1
Spanish: Mylan, Lda.
Bulgarian: Португалия Mylan, Lda.
Spanish: JANSSEN-CILAG OY Vaisalantie 2
Bulgarian: Финландия JANSSEN-CILAG OY Vaisalantie 2
Spanish: Berlex Especialidades Farmacêuticas Lda.
Bulgarian: Португалия Berlex Especialidades Farmacêuticas Lda.
Spanish: DE-61118 Bad Vibel, Alemania
Bulgarian: DE-61118 Bad Vibel, Germany
Spanish: Via Vittor Pisani 20 20124 Milano Italia
Bulgarian: Via Vittor Pisani 20 20124 Milano Italy
Spanish: Mylan dura gmbH Wittstichstr.
Bulgarian: Германия Mylan dura gmbH Wittstichstr.
Spanish: Ivowen Limited 3 Anglesa St Tipperary Clonmel Irlanda
Bulgarian: Ivowen Limited 3 Anglesa St Tipperary Clonmel Ireland
Spanish: Postbox 23033, Ynglingagatan 14, SE-10435 Stockholm, Suecia
Bulgarian: Postbox 23033, Ynglingagatan 14, SE-10435 Stockholm, Sweden
Spanish: Países Bajos EFFIK Bâtument le Newton 9-11, rue Jeanne Braconnier 92366 Meudon la Forêt Frankrijk
Bulgarian: Нидерландия EFFIK Bâtument le Newton 9-11, rue Jeanne Braconnier 92366 Meudon la Forêt Frankrijk
Spanish: Edward Thomsens Vej 14 DK-2300 København S Dinamarca
Bulgarian: Edward Thomsens Vej 14 DK-2300 København S Denmark
Spanish: 02130 Espoo Finlandia
Bulgarian: 02130 Espoo
Spanish: Digital Park II
Bulgarian: s r.o. Digital Park II
Spanish: 17 Boulevard de la Plaine 1050 Brussels Bélgica
Bulgarian: 17 Boulevard de la Plaine 1050 Brussels Belgium
Spanish: 13342 Berlin Alemania
Bulgarian: 13342 Berlin Germany
Spanish: 06796 Brehna Alemania
Bulgarian: 06796 Brehna Germany
Spanish: Temapharm Sp. z o.o.
Bulgarian: Temapharm Sp. z o.o. ul.
Spanish: Berlifarma, Especialidades Farmacêuticas, Lda.
Bulgarian: Португалия Berlifarma, Especialidades Farmacêuticas, Lda.
Spanish: Stragen Nordic A/S Hesselvej 41 Ganlose 3660 Stenlose Dinamarca
Bulgarian: Финландия Stragen Nordic A/S Hesselvej 41 Ganlose 3660 Stenlose
Spanish: Sandoz Pharmaceuticals GmbH Raiffeisenstr.
Bulgarian: Германия Sandoz Pharmaceuticals GmbH Raiffeisenstr.
Spanish: Organon Kloosterstraat 6 5349 AB, Oss Países Bajos
Bulgarian: N.V. Organon Kloosterstraat 6 5349 AB, Oss The Netherlands
Spanish: Laboratórios Pfizer, Lda.
Bulgarian: Португалия Laboratórios Pfizer, Lda.
Spanish: 9-11 rue Jeanne Braconnier Bâtiment « Le Newton » 92366 Meudon la Foret cedex Francia
Bulgarian: 9-11 rue Jeanne Braconnier Bâtiment « Le Newton » 92366 Meudon la Foret cedex France
Spanish: ZYDUS FRANCE ZAC Les Hautes Patures 25 Rue des peuliers 92752 Nanterre Cedex Francia
Bulgarian: ZYDUS FRANCE ZAC Les Hautes Patures 25 Rue des peuliers 92752 Nanterre Cedex France
Spanish: Merck Sharp and Dohme de España, S.A c/ Josefa Valcárcel, 38 28027 Madrid
Bulgarian: Merck Sharp and Dohme de España, S.A c/ Josefa Valcárcel, 38 28027 Madrid España (Spain)
Spanish: 85737 Ismaning Alemania
Bulgarian: 85737 Ismaning Germany
Spanish: LadeePharma Kft Lajos utca 48-66 H-1036 Budapest Hungría
Bulgarian: LadeePharma Kft Lajos utca 48-66 H-1036 Budapest Hungary
Spanish: HU-1103 Budapest Hungría
Bulgarian: HU-1103 Budapest Hungary
Spanish: Dinamarca Mylan AB, Postbox 23033, Ynglingagatan 14, SE-10435 Stockholm, Suecia
Bulgarian: Норвегия Mylan AB, Postbox 23033, Ynglingagatan 14, SE-10435 Stockholm, Sweden
Spanish: Luxemburgo Mithra Pharmaceuticals S.A. Rue Saint Georges 5
Bulgarian: Люксембург Mithra Pharmaceuticals S.A. Rue Saint Georges 5
Spanish: Sanofi - Produtos Farmaceuticos, Lda.
Bulgarian: Португалия Sanofi - Produtos Farmaceuticos, Lda.
Spanish: 61118 Bad Vilbel Alemania
Bulgarian: 61118 Bad Vilbel Germany
Spanish: Stada Arzneimittel AG, Stadastrasse 2-8, DE-61118 Bad Vibel, Alemania
Bulgarian: Stada Arzneimittel AG, Stadastrasse 2-8, DE-61118 Bad Vibel, Germany
Spanish: Pfizer ApS, Lautrupvang 8, DK-2750 Ballerup, Dinamarca
Bulgarian: Pfizer ApS, Lautrupvang 8, DK-2750 Ballerup, Denmark
Spanish: Medimpex France, S.A 1-3, Rue Caumartin F-75009 Paris Francia
Bulgarian: Португалия Medimpex France, S.A 1-3, Rue Caumartin F-75009 Paris
Spanish: Países Bajos Sandoz B.V.
Bulgarian: Нидерландия Sandoz B.V.
Spanish: Luxemburgo Helm AG Nordkanalstrasse 28 20097 Hamburg Alemania
Bulgarian: Helm AG Nordkanalstrasse 28 20097 Hamburg Germany
Spanish: 178 D-13353 Berlin Alemania
Bulgarian: 178 D-13353 Berlin Germany
Spanish: Dinamarca Orifarm Generics A/S Postbox 69
Bulgarian: Норвегия Orifarm Generics A/S Postbox 69
Spanish: Aristo Pharma GmbH Wallenroder Straße 8-10 13435 Berlin Alemania
Bulgarian: Aristo Pharma GmbH Wallenroder Straße 8-10 13435 Berlin Germany
Spanish: Eslovaquia Ivowen Limited 3 Anglesa St
Bulgarian: Словакия Ivowen Limited 3 Anglesa St
Spanish: Dr. Kade Pharmazeutische Fabrik GmbH
Bulgarian: Германия Dr. Kade Pharmazeutische Fabrik GmbH
Spanish: 178 13353 Berlin Alemania
Bulgarian: 178 13353 Berlin Germany
Spanish: Italfarmaco - Produtos Farmacêuticos, Lda.
Bulgarian: Португалия Italfarmaco - Produtos Farmacêuticos, Lda.
Spanish: 851 01 Bratislava Eslovaquia
Bulgarian: 851 01 Bratislava Slovak republic
Spanish: 5 Ks. J. Poniatowskiego Street 05-825 Grodzisk Mazowiecki Polonia
Bulgarian: J. Poniatowskiego Street 05-825 Grodzisk Mazowiecki Poland
Spanish: Luxemburgo Madaus GmbH Colonia Allee 15
Bulgarian: Люксембург Madaus GmbH Colonia Allee 15
Spanish: Dienogest Etinilestradiol maxim
Bulgarian: Dienogest Ethinylestradiol maxim
Spanish: 05-825 Grodzisk Mazowiecki Polonia
Bulgarian: 05-825 Grodzisk Mazowiecki Полша
Spanish: Dinamarca Medimpex UK Ltd, 127 Shirland Road, London W9 2EP
Bulgarian: Норвегия Medimpex UK Ltd, 127 Shirland Road, London W9 2EP
Spanish: STADA Arzneimittel AG Stadastrasse 2-18 D-61118 Bad Vilbel Alemania
Bulgarian: STADA Arzneimittel AG Stadastrasse 2-18 D-61118 Bad Vilbel Germany
Spanish: Dr. Paul Janssenweg 150
Bulgarian: Janssen-Cilag B.V. Dr. Paul Janssenweg 150
Spanish: Ratiopharm GmbH Graf-Arco-Strasse 3 DE-89079 Ulm Alemania
Bulgarian: Ratiopharm GmbH Graf-Arco-Strasse 3 DE-89079 Ulm Germany
Spanish: Dinamarca Stragen Nordic A/S, Helsingørgade 8C, DK-3400 Hillerød,
Bulgarian: Португалия Stragen Nordic A/S, Helsingørgade 8C, DK-3400 Hillerød,
Spanish: Medimpex UK Ltd, 127 Shirland Road, London W9 2EP Reino Unido
Bulgarian: Medimpex UK Ltd, 127 Shirland Road, London W9 2EP United Kingdom
Spanish: Países Bajos LadeePharma Kft Lajos u 48-66 1036
Bulgarian: Нидерландия LadeePharma Kft Lajos u 48-66 1036
Spanish: Stadapharm GmbH Stadastr.
Bulgarian: Германия Stadapharm GmbH Stadastr.
Spanish: Reino Unido Gedeon Richter France, 1-3 Ruse Caumartin, Paris 75009,
Bulgarian: Gedeon Richter France, 1-3 Ruse Caumartin, Paris 75009, France
Spanish: Marszałka J. Piłsudskiego 5 95-200 Pabianice Polonia
Bulgarian: Pabianickie Zakłady Farmaceutyczne Polfa S.A. ul. Marszałka J. Piłsudskiego 5 95-200 Pabianice Poland
Spanish: Dinamarca Pfizer ApS, Lautrupvang 8, DK-2750 Ballerup, Dinamarca
Bulgarian: Исландия Pfizer ApS, Lautrupvang 8, DK-2750 Ballerup, Denmark
Spanish: 34 avenue Léonard de Vinci 92418 Courbevoie Cedex Francia varnoline continu 0,15 mg 0,03 mg
Bulgarian: 34 avenue Léonard de Vinci 92418 Courbevoie Cedex France varnoline continu 0,15 mg 0,03 mg
Spanish: Pfizer Pharma GmbH Linkstr.
Bulgarian: Германия Pfizer Pharma GmbH Linkstr.
Spanish: Karloveske rameno 6 841 01 Bratislava Eslovaquia
Bulgarian: VIVAX EuroAsia s.r.o. Karloveske rameno 6 841 01 Bratislava Slovensko
Spanish: Stragen Nordic A/S, Helsingørgade 8C, DK-3400 Hillerød, Dinamarca
Bulgarian: Stragen Nordic A/S, Helsingørgade 8C, DK-3400 Hillerød, Denmark
Spanish: Janssen-Cilag AS Drammensveien 288 0283 Oslo
Bulgarian: Janssen-Cilag AS Drammensveien 288
Spanish: Organon P.O.Box 20
Bulgarian: N.V. Organon P.O.Box 20
Spanish: Ladee Pharma Baltics UAB Žemaitijos g.13/Šiaulių g.10, LT-01134 Vilnius Lituania
Bulgarian: Ladee Pharma Baltics UAB Žemaitijos g.13/Šiaulių g.10, LT-01134 Vilnius Lithuania
Spanish: Madaus GmbH Colonia Allee 15 51067 Köln Alemania
Bulgarian: Madaus GmbH Colonia Allee 15 51067 Köln Germany
Spanish: ACTAVIS SPAIN, S.A. Avda. de Burgos, 16-D 28036 Madrid España
Bulgarian: de Burgos, 16-D 28036 Madrid Spain
Spanish: MADAUS GmbH Colonia Allee 15 51101 Colonia Alemania
Bulgarian: MADAUS GmbH Colonia Allee 15 51101 Colonia Germany
Spanish: BAYER OY Pansiontie 47 PL 415
Bulgarian: Финландия BAYER OY Pansiontie 47
Spanish: Dinamarca Sandoz A/S Edward Thomsens Vej 14 DK-2300 København S Dinamarca
Bulgarian: Финландия Sandoz A/S Edward Thomsens Vej 14 DK-2300 København S Denmark
Spanish: UAB Orivas J.Jasinskio 16B, LT-01112 Vilnius Lituania
Bulgarian: UAB Orivas J.Jasinskio 16B, LT-01112 Vilnius Lithuania
Spanish: Antwerpseweg 15-17 2340 Beerse Bélgica
Bulgarian: JANSSEN-CILAG N.V. Antwerpseweg 15-17 2340 Beerse Belgium
Spanish: "ARAC" At Regulatory Affairs Consulting GmbH Kichengasse 48/3
Bulgarian: Германия "ARAC" At Regulatory Affairs Consulting GmbH
Spanish: Orivas UAB J.Jasinskio 16B LT-01112 Vilinius Lituania
Bulgarian: Orivas UAB J.Jasinskio 16B LT-01112 Vilinius Lithuania
Spanish: Países Bajos betapharm Arzneimittel GmbH Kobelweg 95
Bulgarian: Нидерландия betapharm Arzneimittel GmbH Kobelweg 95
Spanish: Organon P.O. Box 20
Bulgarian: N.V. Organon P.O. Box 20
Spanish: Eslovaquia Stada Arzneimittel AG, Stadastrasse 2-8,
Bulgarian: Словакия Stada Arzneimittel AG, Stadastrasse 2-8,
Spanish: Kloosterstraat 6 5340 BH, Oss Países Bajos
Bulgarian: Kloosterstraat 6 5340 BH, Oss The Netherlands
Spanish: Budapest 1123 Hungría
Bulgarian: 53 Budapest 1123 Hungary
Spanish: Eslovaquia Zentiva, k.s.
Bulgarian: Словакия Zentiva, k.s.
Spanish: Alemania betapharm Arzneimittel GmbH Kobelweg 95
Bulgarian: Германия betapharm Arzneimittel GmbH Kobelweg 95
Spanish: Rowex Ltd Bantry Co. Cork Irlanda
Bulgarian: Ирландия Rowex Ltd Bantry
Spanish: Pharmacia Grupo Pfizer S.L.
Bulgarian: Pharmacia Grupo Pfizer S.L. Avda.
Spanish: 5340 BH Oss Países Bajos
Bulgarian: 5340 BH Oss The Netherlands
Spanish: Flow 15 µg / 60 µg Filmtabletten
Bulgarian: 15 µg / 60 µg Filmtabletten
Spanish: 49 avenue Georges Pompidou 92593 Levallois-Perret Cedex Francia
Bulgarian: 49 avenue Georges Pompidou 92593 Levallois-Perret Cedex France
Spanish: Famy Care Europe Ltd. 1 Wood Street EC2V7WS London Reino Unido
Bulgarian: Famy Care Europe Ltd. 1 Wood Street EC2V7WS London United Kingdom
Spanish: C/ La Vallina s/n, Pol. Ind., Navatejera
Bulgarian: Финландия LEON FARMA C/ La Vallina s/n, Pol. Ind., Navatejera
Spanish: Na Pankráci 14
Bulgarian: Heaton a.s. Na Pankráci 14
Spanish: 49 avenue Georges Pompidou 92593 Levellois-Perret Cedex Francia
Bulgarian: 49 avenue Georges Pompidou 92593 Levellois-Perret Cedex France
Spanish: Lagoas Park, Edificio 10 2740-271 Porto Salvo Portugal
Bulgarian: 2740-271 Porto Salvo Portugal
Spanish: Países Bajos Velvian Germany GmbH Carl-Zeiss-Ring 9
Bulgarian: Нидерландия Velvian Germany GmbH Carl-Zeiss-Ring 9
Spanish: Co Tipperary Irlanda
Bulgarian: Co Tipperary
Spanish: Países Bajos Stada Arzneimittel AG, Stadastrasse 2-8,
Bulgarian: Нидерландия Stada Arzneimittel AG, Stadastrasse 2-8,
Spanish: Talafusova 970
Bulgarian: WH-Pharma s.r.o. Talafusova 970
Spanish: Sandoz Spa Largo U. Boccioni, 1 21040 Origgio (VA) Italia
Bulgarian: Boccioni, 1 21040 Origgio (VA) Italy
Spanish: 5340 BH, Oss Países Bajos
Bulgarian: 5340 BH, Oss The Netherlands
Spanish: BAYER HISPANIA, S.L Avda. Baix Llobregat 3 y
Bulgarian: BAYER HISPANIA, S.L Avda.
Spanish: Eslovaquia LADEEPHARMA Slovakia s.r.o.
Bulgarian: Словакия LADEEPHARMA Slovakia s.r.o. Prievozská 4D
Spanish: Polígono Industrial Emiliano Revilla Sanz Av. De Ágreda 31 42110 Ólvega (Soria) España
Bulgarian: De Ágreda 31 42110 Ólvega (Soria) Spain
Spanish: Zentiva Pharma GmbH Industriepark FrankfurtHöchst, Gebäude K703 65926 Frankfurt am Main Alemania
Bulgarian: Германия Zentiva Pharma GmbH Industriepark FrankfurtHöchst, Gebäude K703
Spanish: Famy Care Europe Ltd One Wood Street EC2V 7WS London Reino Unido
Bulgarian: Famy Care Europe Ltd One Wood Street EC2V 7WS London United Kingdom
Spanish: Países Bajos Zentiva, k.s.
Bulgarian: Нидерландия Zentiva, k.s.
Spanish: GEDEON RICHTER, PLC Gyömroi ut 19-21 H-1103 Budapest Hungría
Bulgarian: Gedeon Richter Plc. Gyömröí út 19-21 HU-1103 Budapest Hungary
Spanish: 34 avenue Léonard de Vinci 92418 Courbevoie Cedex Francia
Bulgarian: 34 avenue Léonard de Vinci 92418 Courbevoie Cedex France
Spanish: Actavis Group PTC ehf Reykjavikurvegi 76-78 220 Hafnarfjordur Islandia
Bulgarian: Actavis Group PTC ehf Reykjavikurvegi 76-78 220 Hafnarfjordur Iceland
Spanish: Luxemburgo Teva Pharma Belgium N.V.
Bulgarian: Люксембург Teva Pharma Belgium N.V. Laarstraat 16
Spanish: PFIZER HOLDING France 23-25 avenue du Docteur Lannelongue
Bulgarian: PFIZER HOLDING France 23-25 avenue du Docteur Lannelongue 75668 Paris Cedex
Spanish: Luxemburgo PFIZER S.A. 17 Boulevard de la Plaine 1050 Brussels
Bulgarian: 17 Boulevard de la Plaine 1050 Brussels
Spanish: Zakłady Farmaceutyczne POLPHARMA S.A. ul.
Bulgarian: Zakłady Farmaceutyczne POLPHARMA S.A. ul. Pelplińska 19
Spanish: via Messina 38 20154 Milano Italia
Bulgarian: Teva Italia S.r.l. via Messina 38 20154 Milano Italy
Spanish: Polígono Industrial Colón II 08228 Tarrasa Barcelona
Bulgarian: 08228 Tarrasa Barcelona
Spanish: Sun-Farm Sp. z o.o.
Bulgarian: Sun-Farm Sp. z o.o. Człekówka 75
Spanish: UAB „Johnson & Johnson" Geležinio Vilko g. 18A LT-08104 Vilnius Lituania
Bulgarian: UAB „Johnson & Johnson" Geležinio Vilko g.
Spanish: 34 avenue Léonard de Vinci 92418 Courbevoie Cedex Francia varnoline
Bulgarian: 34 avenue Léonard de Vinci 92418 Courbevoie Cedex France varnoline
Spanish: Dienogest Etinilestradiol ladonna sanol 2 mg /0,03 mg
Bulgarian: Dienogest Ethinylestradiol ladonna sanol 2 mg /0,03 mg
Spanish: de Burgos, Km 23.
Bulgarian: WYETH FARMA, S.A. Ctra. de Burgos, Km 23.
Spanish: Computerweg 10 3542 DR Utrecht Países Bajos
Bulgarian: 3542 DR Utrecht The Netherlands
Spanish: Aramis Pharma Kft. Mester u. 28B III/5 1095 Budapest Hungría
Bulgarian: 28B III/5 1095 Budapest Hungary
Spanish: Organon Kloosterstraat 6
Bulgarian: Словакия N.V. Organon Kloosterstraat 6
Spanish: Eslovaquia Medico Uno Pharma Kft. Viadukt u. 12
Bulgarian: Словакия Medico Uno Pharma Kft.
Spanish: Teva Pharma B.V.
Bulgarian: Teva Pharma B.V. Computerweg 10
Spanish: Rua Consiglieri Pedroso, 123Queluz de Baixo 2730-056 Barcarena Portugal
Bulgarian: Rua Consiglieri Pedroso, 123Queluz de Baixo
Spanish: Etinilestradiol desogestrel
Bulgarian: Ethinylestradiol Desogestrel
Spanish: Eslovenia
Bulgarian: Slovenija
Spanish: Bayer Pharma AG Muellerstrasse 170-178 D-13353 Berlin Alemania
Bulgarian: Bayer Pharma AG Muellerstrasse 170-178 D-13353 Berlin Germany
Spanish: Mommaertslaan 14 1831 Diegem Bélgica
Bulgarian: BAYER SA-NV J.E. Mommaertslaan 14 1831 Diegem Belgium
Spanish: HP12 4EG
Bulgarian: HP12
Spanish: 08970 Sant Joan Despi Barcelona
Bulgarian: Joan Despi Barcelona
Spanish: Etonogestrel Etinilestradiol
Bulgarian: Etonogestrel Ethinylestradiol
Spanish: Laboratorios Leon Farma SA C/Roa de la Vega 15 1-24008 Leon
Bulgarian: Ирландия Laboratorios Leon Farma SA C/Roa de la Vega 15
Spanish: Mikrogramm + 30
Bulgarian: Mikrogramm + 30 Mikrogramm Dragees
Spanish: Eslovaquia VIVAX EuroAsia s.r.o.
Bulgarian: Словакия VIVAX EuroAsia s.r.o. Karloveske rameno 6
Spanish: Teva Pharma Belgium N.V.
Bulgarian: Teva Pharma Belgium N.V. Laarstraat 16
Spanish: (carne y leche)
Bulgarian: (месо и мляко)
Spanish: En consecuencia, el asunto fue remitido al CVMP.
Bulgarian: Впоследствие въпросът е отнесен до CVMP.
Spanish: La solicitud se presentó en los Estados miembros afectados con arreglo al procedimiento de reconocimiento mutuo.
Bulgarian: Заявлението е подадено до засегнатите държави-членки по процедурата за взаимно признаване.
Spanish: Estado miembro de la UE/EEE
Bulgarian: Държава -членка ЕС/ЕИП
Spanish: Carne: 7 días Leche: 60 horas.
Bulgarian: Месо: 7 дни Мляко: часа
Spanish: • no se había confirmado la eficacia de Combisyn;
Bulgarian: ефикасността на Combisyn не е потвърдена;
Spanish: Los Estados miembros afectados consideraron que la autorización de Combisyn podía representar un riesgo potencial grave para la salud humana y animal, al no haber quedado suficientemente demostrada la seguridad y la eficacia del medicamento.
Bulgarian: Засегнатите държави-членки са на мнение, че разрешаването на Combisyn може да представлява потенциален сериозен риск за човешкото здраве и здравето на животните, тъй като безопасността и ефикасността на продукта не са били доказани достатъчно.
Spanish: Deberá realizarse un estudio de reducción de residuos en la leche de conformidad con la «Note for guidance for the determination of withdrawal periods for milk» (EMEA/CVMP/473/98FINAL).
Bulgarian: Трябва да бъде извършено проучване за изчерпване на остатъчните количества в млякото, в съответствие с „Бележките за ръководство за определяне на карентните срокове за млякото" (EMEA/CVMP/473/98-FINAL)
Spanish: En consecuencia, el CVMP concluyó que los datos presentados en apoyo de la solicitud no cumplían lo establecido en el artículo de la Directiva 2001/82/CE y recomendó que se denegara la solicitud de comercialización en los Estados miembros afectados y se suspendiera la autorización de comercialización actual en el Estado miembro de referencia.
Bulgarian: Следователно CVMP заключава, че данните, подадени в подкрепа на заявлението, на са в съответствие с член 13 на Директива 2001/82/ЕО и препоръчва отказ от издаване на лиценза за употреба в засегнатите държави-членки и спирането на съществуващия лиценз за употреба в референтната държава-членка.
Spanish: El solicitante presentó datos comparativos sobre la viscosidad entre la formulación «antigua» y la «nueva» de Combisyn.
Bulgarian: Заявителят представя сравнителни данни за вискозитета между „старата" и „новата" формулировка на Combisyn.
Spanish: Se pidió al CVMP que emitiera un dictamen sobre las dudas planteadas por los Estados miembros afectados y también sobre la relación entre beneficio y riesgo de Combisyn.
Bulgarian: От CVMP е поискано да даде становище по въпросите, повдигнати от засегнатите държави-членки, както и да направи заключение за съотношението полза/риск за Combisyn.
Spanish: Deberá considerarse un diseño de no inferioridad frente al medicamento de referencia y prestar una especial atención a la sensibilidad de los análisis (por ejemplo, un estudio con tres grupos y placebo).
Bulgarian: Трябва да бъде приет не дизайн с не по-лошо качество спрямо референтния продукт, с особено внимание върху чувствителността на анализа (например, плацебо проучване с три рамена).
Spanish: Combisyn fue autorizado en el Reino Unido el 30 de enero de 2003 de conformidad con el apartado 1 del artículo 13 de la Directiva 2001/82/CE.
Bulgarian: 2003 г. по член 13, параграф 1 на Директива 2001/82/ЕО.
Spanish: Deberán presentarse datos clínicos adecuados para confirmar la eficacia de Combisyn suspensión intramamaria para ganado bovino en periodo de lactación.
Bulgarian: Трябва да бъдат предоставени подходящи клинични данни в потвърждение на ефикасността на Combisyn Lactating Cow Intramammary Suspension.
Spanish: Cuando se preparó el método utilizado para investigar la similitud en cuanto a la eficacia de Combisyn, el solicitante no había realizado estudios clínicos comparativos, puesto que pensaba que los ensayos clínicos no tendrían sensibilidad suficiente para detectar diferencias entre Combisyn y el medicamento de referencia.
Bulgarian: При разработване на подхода, използван за изследване на сходството по отношение на ефикасността за Combisyn, заявителят не е имал за цел извършването на сравнителни клинични проучвания, тъй като се е очаквало, че клиничните изпитвания няма да са достатъчно чувствителни, за да уловят разликите между Combisyn и референтния продукт.
Spanish: Durante el procedimiento, surgieron discrepancias entre el Estado miembro de referencia y los Estados miembros afectados respecto a la posibilidad de demostrar la bioequivalencia sistémica de un medicamento de aplicación tópica y de efecto tópico, y también respecto a otra duda relacionada con la idoneidad del tiempo de espera propuesto.
Bulgarian: По време на процедурата възниква несъгласие между референтната държава-членка и засегнатите държави-членки относно приложимостта на доказването на системната биоеквивалентност за локално приложен, локално действащ продукт, както и допълнителна загриженост относно адекватността на предложения карентен срок.
Spanish: Se realizaron tres estudios farmacocinéticos comparativos con Combisyn y el medicamento de referencia, todos ellos con un diseño de grupos cruzados y dos períodos.
Bulgarian: Проведени са три сравнителни фармакокинетични проучвания с Combisyn и с референтния продукт, всички с двуетапен cross-over дизайн.
Spanish: Los resultados de los estudios de leche demostraron que las concentraciones de los principios activos eran similares a las del medicamento de referencia después de la perfusión intramamaria de Combisyn, aunque se observó una variabilidad considerable entre cuartos de la ubre afectados y también entre animales en todos los parámetros farmacocinéticos evaluados.
Bulgarian: Резултатите от проучванията на млякото показват, че концентрациите на активните субстанции са сходни на тези от референтния продукт след интрамамарна инфузия на Combisyn, въпреки че се отбелязва наличие на значителна вариабилност между кърмата и между животните по всеки от измерваните фармакокинетични параметри.
Spanish: Resumen general de la evaluación científica de Combisyn suspensión intramamaria para ganado bovino en periodo de lactación
Bulgarian: Общо резюме на научната оценка на Combisyn Lactating Cow Intramammary Suspension