FrancophonIA/ELRC3.0 huggingface dataset:
Italian: RANBAXY PHARMACIE GENERIQUES 11-15 Quai Dion Bouton 92816 Puteaux Cedex Francia
Latvian: RANBAXY PHARMACIE GENERIQUES 11-15 Quai Dion Bouton 92816 Puteaux Cedex France
Italian: Regno Unito
Latvian: United Kingdom
Italian: EG LABO - LABORATOIRES EUROGENERICS Le Quintet - bâtiment A 12 rue Danjou 92517 Boulogne Billancourt Cedex Francia
Latvian: EG LABO - LABORATOIRES EUROGENERICS Le Quintet - bâtiment A 12 rue Danjou 92517 Boulogne Billancourt Cedex France
Italian: EFFIK BENELUX Lenniksebaan 451 1070 Anderlecht Belgio
Latvian: EFFIK BENELUX Lenniksebaan 451 1070 Anderlecht Belgium
Italian: Bayer Vital GmbH Kaiser-Wilhelm-Allee 51373 Leverkusen Germania
Latvian: Bayer Vital GmbH Kaiser-Wilhelm-Allee 51373 Leverkusen Germany
Italian: Lussemburgo EFFIK BENELUX Lenniksebaan 451
Latvian: Luksemburga EFFIK BENELUX Lenniksebaan 451
Italian: Repubblica Ceca
Latvian: Czech Republic
Italian: 5 Ks. J. Poniatowskiego Street 05-825 Grodzisk Mazowiecki Polonia
Latvian: 5 Ks. J. Poniatowskiego Street 05-825 Grodzisk Mazowiecki Poland
Italian: Farmitalia Industrie Chimico Farmaceutiche Via Alcide De Gasperi, 165 B 95127 Catania Italia
Latvian: Farmitalia Industrie Chimico Farmaceutiche Via Alcide De Gasperi, 165 B 95127 Catania Italy
Italian: DE-61118 Bad Vibel, Germania
Latvian: DE-61118 Bad Vibel, Germany
Italian: B 2340 Beerse Belgio
Latvian: B 2340 Beerse Belgium
Italian: Lussemburgo N.V.
Latvian: Luksemburga N.V.
Italian: Stragen Nordic A/S Hesselvej 41 Ganlose 3660 Stenlose Danimarca
Latvian: Stragen Nordic A/S Hesselvej 41 Ganlose 3660 Stenlose Denmark
Italian: Pfizer ApS, Lautrupvang 8, DK-2750 Ballerup, Danimarca
Latvian: Pfizer ApS, Lautrupvang 8, DK-2750 Ballerup, Denmark
Italian: 61118 Bad Vilbel Germania
Latvian: 61118 Bad Vilbel Germany
Italian: Nijverheidsweg 3 3771 ME Barneveld Paesi Bassi
Latvian: 3771 ME Barneveld The Netherlands
Italian: 05-825 Grodzisk Mazowiecki Polonia
Latvian: 05-825 Grodzisk Mazowiecki Poland
Italian: 06796 Brehna
Latvian: 06796 Brehna Germany
Italian: 178 13353 Berlin Germania
Latvian: 178 13353 Berlin Germany
Italian: Portogallo Mylan, Lda.
Latvian: Mylan, Lda.
Italian: 86156 Augsburg Germania
Latvian: 86156 Augsburg Germany
Italian: LABORATORIO STADA, S.L. Frederic Mompou, 5 08960 Sant Just Desvern Barcelona
Latvian: Frederic Mompou, 5 08960 Sant Just Desvern Barcelona
Italian: 28023 Aravaca (Madrid) Spagna
Latvian: 28023 Aravaca (Madrid)
Italian: Lussemburgo Madaus GmbH Colonia Allee 15
Latvian: Luksemburga Madaus GmbH Colonia Allee 15
Italian: Organon Kloosterstraat 6 5349 AB, Oss Paesi Bassi
Latvian: Organon Kloosterstraat 6 5349 AB, Oss The Netherlands
Italian: Danimarca Stada Arzneimittel AG, Stadastrasse 2-8,
Latvian: Nīderlande Stada Arzneimittel AG, Stadastrasse 2-8,
Italian: Lussemburgo Helm AG Nordkanalstrasse 28 20097 Hamburg Germania
Latvian: Luksemburga Helm AG Nordkanalstrasse 28 20097 Hamburg Germany
Italian: Šmartinska cesta 53 1000 Ljubljana Slovenia
Latvian: Šmartinska cesta 53 1000 Ljubljana Slovenija
Italian: Medimpex UK Ltd, 127 Shirland Road, London W9 2EP Regno Unito
Latvian: Medimpex UK Ltd, 127 Shirland Road, London W9 2EP United Kingdom
Italian: Via D. Scarlatti, 31 20124 Milano Italia
Latvian: Via D. Scarlatti, 31 20124 Milano Italy
Italian: Regno Unito Gedeon Richter France, 1-3 Ruse Caumartin, Paris 75009,
Latvian: Lielbritānija Gedeon Richter France, 1-3 Ruse Caumartin, Paris 75009,
Italian: LadeePharma Kft Lajos utca 48-66 H-1036 Budapest Ungheria
Latvian: LadeePharma Kft Lajos utca 48-66 H-1036 Budapest Hungary
Italian: Janssen-Cilag Limited 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG
Latvian: Janssen-Cilag Limited 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12
Italian: Portogallo Berlex Especialidades Farmacêuticas Lda.
Latvian: Berlex Especialidades Farmacêuticas Lda.
Italian: 85737 Ismaning Germania
Latvian: 85737 Ismaning Germany
Italian: Via Vittor Pisani 20 20124 Milano Italia
Latvian: Via Vittor Pisani 20 20124 Milano Italy
Italian: Surrey RH2 9RJ Regno Unito
Latvian: Surrey RH2 9RJ United Kingdom
Italian: Portogallo Berlifarma, Especialidades Farmacêuticas, Lda.
Latvian: Berlifarma, Especialidades Farmacêuticas, Lda.
Italian: 17 Boulevard de la Plaine 1050 Brussels Belgio
Latvian: 17 Boulevard de la Plaine 1050 Brussels Belgium
Italian: Merck Sharp and Dohme de España, S.A c/ Josefa Valcárcel, 38 28027 Madrid
Latvian: Merck Sharp and Dohme de España, S.A c/ Josefa Valcárcel, 38 28027 Madrid España (Spain)
Italian: WYETH FARMA, S.A. Ctra.
Latvian: WYETH FARMA, S.A.
Italian: Lagedijk 1-3;
Latvian: Nīderlande WeCare, Lagedijk 1-3;
Italian: Teva Nederland B.V.
Latvian: Nīderlande Teva Nederland B.V.
Italian: ZYDUS FRANCE ZAC Les Hautes Patures 25 Rue des peuliers 92752 Nanterre Cedex Francia
Latvian: ZYDUS FRANCE ZAC Les Hautes Patures 25 Rue des peuliers 92752 Nanterre Cedex France
Italian: Slovacchia LADEEPHARMA Slovakia s.r.o.
Latvian: LADEEPHARMA Slovakia s.r.o.
Italian: Lussemburgo Teva Pharma Belgium N.V.
Latvian: Luksemburga Teva Pharma Belgium N.V.
Italian: 9-11 rue Jeanne Braconnier Bâtiment « Le Newton » 92366 Meudon la Foret cedex Francia
Latvian: 9-11 rue Jeanne Braconnier Bâtiment « Le Newton » 92366 Meudon la Foret cedex France
Italian: Dr. Kade Pharmazeutische Fabrik GmbH
Latvian: Kade Pharmazeutische Fabrik GmbH
Italian: Portogallo Medimpex France, S.A 1-3, Rue Caumartin F-75009 Paris
Latvian: Medimpex France, S.A 1-3, Rue Caumartin F-75009 Paris France
Italian: Portogallo Laboratórios Pfizer, Lda.
Latvian: Laboratórios Pfizer, Lda.
Italian: Dienogest Estradiolo
Latvian: Dienogest Estradiol
Italian: Teva Pharmaceuticals S.R.L. Str. Domniţa Ruxandra nr. 12, parter, Sector 2
Latvian: Teva Pharmaceuticals S.R.L. Str. Domniţa Ruxandra nr.
Italian: Aristo Pharma GmbH Wallenroder Straße 8-10 13435 Berlin Germania
Latvian: Aristo Pharma GmbH Wallenroder Straße 8-10 13435 Berlin Germany
Italian: Cimizt Tablets 150 mg/30 mg
Latvian: Cimizt Tabletes 150 mg/30 mg
Italian: H-1103 Budapest Ungheria
Latvian: H-1103 Budapest Hungary
Italian: Portogallo Italfarmaco - Produtos Farmacêuticos, Lda.
Latvian: Italfarmaco - Produtos Farmacêuticos, Lda.
Italian: Portogallo Sanofi - Produtos Farmaceuticos, Lda.
Latvian: Sanofi - Produtos Farmaceuticos, Lda.
Italian: C/ La Vallina s/n, Pol. Ind., Navatejera
Latvian: C/ La Vallina s/n, Pol.
Italian: MADAUS GmbH Colonia Allee 15 51101 Colonia Germania
Latvian: MADAUS GmbH Colonia Allee 15 51101 Colonia Germany
Italian: HU-1103 Budapest Ungheria
Latvian: HU-1103 Budapest Hungary
Italian: 34 avenue Léonard de Vinci 92418 Courbevoie Cedex Francia varnoline continu 0,15 mg 0,03 mg
Latvian: 34 avenue Léonard de Vinci 92418 Courbevoie Cedex France varnoline continu 0,15 mg 0,03 mg
Italian: Irlanda
Latvian: Ireland
Italian: Lussemburgo Ratiopharm GmbH Graf-Arco-Strasse 3
Latvian: Luksemburga Ratiopharm GmbH Graf-Arco-Strasse 3
Italian: Bâtument le Newton 9-11, rue Jeanne Braconnier 92366 Meudon la Forêt Frankrijk
Latvian: Nīderlande EFFIK Bâtument le Newton 9-11, rue Jeanne Braconnier 92366 Meudon la Forêt Frankrijk
Italian: Madaus GmbH Colonia Allee 15 51067 Köln Germania
Latvian: Madaus GmbH Colonia Allee 15 51067 Köln Germany
Italian: Mithra Pharmaceuticals S.A. Rue Saint Georges 5 4000 Liège
Latvian: Rue Saint Georges 5 4000 Liège
Italian: Budapest 1123 Ungheria
Latvian: Budapest 1123 Hungary
Italian: Slovacchia Teva Pharmaceuticals Slovakia s.r.o.
Latvian: Teva Pharmaceuticals Slovakia s.r.o.
Italian: Romania
Latvian: România
Italian: Slovacchia Bayer, spol.
Latvian: Bayer, spol.
Italian: Temapharm Sp. z o.o.
Latvian: Temapharm Sp. z o.o. ul.
Italian: Famy Care Europe Ltd. 1 Wood Street EC2V7WS London Regno Unito
Latvian: Famy Care Europe Ltd. 1 Wood Street EC2V7WS London United Kingdom
Italian: Ladee Pharma Baltics UAB Žemaitijos g.13/Šiaulių g.10, LT-01134 Vilnius Lituania
Latvian: Ladee Pharma Baltics UAB Žemaitijos g.13/Šiaulių g.10, LT-01134 Vilnius Lithuania
Italian: SymPhar Sp. z o.o.
Latvian: SymPhar Sp. z o.o. ul.
Italian: Stada Arzneimittel AG, Stadastrasse 2-8, DE-61118 Bad Vibel, Germania
Latvian: Stada Arzneimittel AG, Stadastrasse 2-8, DE-61118 Bad Vibel, Germany
Italian: LABORATORIOS CINFA, S.A. Olaz-Chipi, 10
Latvian: Olaz-Chipi, 10
Italian: Stragen Nordic A/S, Helsingørgade 8C, DK-3400 Hillerød, Danimarca
Latvian: Stragen Nordic A/S, Helsingørgade 8C, DK-3400 Hillerød, Denmark
Italian: Stada Arzneimittel Aktiengesellschaft Stadastrasse 2/18 61118 Bad Vilbel Germania
Latvian: Stada Arzneimittel Aktiengesellschaft Stadastrasse 2/18 61118 Bad Vilbel Germany
Italian: UAB Orivas J.Jasinskio 16B, LT-01112 Vilnius Lituania
Latvian: UAB Orivas J.Jasinskio 16B, LT-01112 Vilnius Lithuania
Italian: 48940 Lamiaco-Lejona (Vizcaya)
Latvian: Maximo Aguirre, 14. 48940 Lamiaco-Lejona (Vizcaya)
Italian: Ratiopharm GmbH Graf-Arco-Strasse 3 DE-89079 Ulm Germania
Latvian: Ratiopharm GmbH Graf-Arco-Strasse 3 DE-89079 Ulm Germany
Italian: Actavis Group PTC ehf Reykjavikurvegi 76-78 220 Hafnarfjordur Islanda
Latvian: Actavis Group PTC ehf Reykjavikurvegi 76-78 220 Hafnarfjordur Iceland
Italian: Edifício Cyprium, Av. 25 de Abril, 15, 2º F
Latvian: Teva Pharma - Produtos Farmaceuticos, Lda Edifício Cyprium, Av. 25 de Abril, 15, 2º F 2795-195 Linda-a-Velha Portugal
Italian: Orivas UAB J.Jasinskio 16B LT-01112 Vilinius Lituania
Latvian: Orivas UAB J.Jasinskio 16B LT-01112 Vilinius Lithuania
Italian: Estradiolo valerato Dienogest
Latvian: Estradiol valerate Dienogest
Italian: 851 01 Bratislava Slovacchia
Latvian: 851 01 Bratislava Slovak republic
Italian: Islanda ratiopharm GmbH Graf-Arco Strasse 3 89079 ULM Germania
Latvian: Islande ratiopharm GmbH Graf-Arco Strasse 3 89079 ULM Germany
Italian: Famy Care Europe Ltd One Wood Street EC2V 7WS London Regno Unito
Latvian: Famy Care Europe Ltd One Wood Street EC2V 7WS London United Kingdom
Italian: Paesi Bassi betapharm Arzneimittel GmbH Kobelweg 95
Latvian: Nīderlande betapharm Arzneimittel GmbH Kobelweg 95
Italian: LadeePharma Kft Lajos u 48-66 1036 Budapest
Latvian: Nīderlande LadeePharma Kft Lajos u 48-66 1036
Italian: Pharmacia Grupo Pfizer S.L. Avda.
Latvian: Pharmacia Grupo Pfizer S.L.
Italian: Dienogest Etinilestradiolo maxim
Latvian: Dienogest Ethinylestradiol maxim
Italian: Portogallo Sandoz Farmaceutica, Lda.
Latvian: Sandoz Farmaceutica, Lda.
Italian: Kloosterstraat 6 5340 BH, Oss Paesi Bassi
Latvian: Kloosterstraat 6 5340 BH, Oss The Netherlands
Italian: STADA Arzneimittel AG Stadastrasse 2-18 D-61118 Bad Vilbel Germania
Latvian: STADA Arzneimittel AG Stadastrasse 2-18 D-61118 Bad Vilbel Germany
Italian: 49 avenue Georges Pompidou 92593 Levallois-Perret Cedex Francia
Latvian: 49 avenue Georges Pompidou 92593 Levallois-Perret Cedex France
Italian: Italia
Latvian: Italy
Italian: 5340 BH Oss Paesi Bassi
Latvian: 5340 BH Oss The Netherlands
Italian: 49 avenue Georges Pompidou 92593 Levellois-Perret Cedex Francia
Latvian: 49 avenue Georges Pompidou 92593 Levellois-Perret Cedex France
Italian: ACTAVIS SPAIN, S.A. Avda.
Latvian: ACTAVIS SPAIN, S.A.
Italian: Pfizer Hungary LTD. Alkotás street 53 Budapest 1123
Latvian: Alkotás street 53 Budapest 1123
Italian: 5340 BH, Oss Paesi Bassi
Latvian: 5340 BH, Oss The Netherlands
Italian: S.C. SANDOZ S.R.L. Str. Livezeni nr. 7A, 540472 Târgu Mureş, Romania.
Latvian: 7A, 540472 Târgu Mureş, România.
Italian: Danimarca Actavis Group PTC ehf Reykjavikurvegi 76-78
Latvian: Nīderlande Actavis Group PTC ehf Reykjavikurvegi 76-78
Italian: Aramis Pharma Kft. Mester u. 28B III/5 1095 Budapest Ungheria
Latvian: 28B III/5 1095 Budapest Hungary
Italian: Lussemburgo PFIZER S.A. 17 Boulevard de la Plaine 1050 Brussels
Latvian: 17 Boulevard de la Plaine 1050 Brussels
Italian: Slovacchia Sandoz Pharmaceuticals d.d.
Latvian: Sandoz Pharmaceuticals d.d.
Italian: Polígono Industrial Emiliano Revilla Sanz Av. De Ágreda 31 42110 Ólvega (Soria) Spagna
Latvian: De Ágreda 31 42110 Ólvega (Soria)
Italian: 34 avenue Léonard de Vinci 92418 Courbevoie Cedex Francia
Latvian: 34 avenue Léonard de Vinci 92418 Courbevoie Cedex France
Italian: 2740-271 Porto Salvo Portogallo
Latvian: Lagoas Park, Edificio 10 2740-271 Porto Salvo Portugal
Italian: Slovacchia Heaton a.s.
Latvian: Heaton a.s.
Italian: Computerweg 10 3542 DR Utrecht Paesi Bassi
Latvian: 3542 DR Utrecht The Netherlands
Italian: Einsteinova 25
Latvian: Digital Park II Einsteinova 25
Italian: Dispositivo vaginale Uso vaginale
Latvian: Vaginālai lietošanai
Italian: Lussemburgo Mithra Pharmaceuticals S.A. Rue Saint Georges 5
Latvian: Luksemburga Mithra Pharmaceuticals S.A.
Italian: Laboratorios Leon Farma SA C/Roa de la Vega 15
Latvian: Laboratorios Leon Farma SA C/Roa de la Vega 15 1-24008 Leon
Italian: Mylan B.V.
Latvian: Nīderlande Mylan B.V.
Italian: Lussemburgo JANSSEN-CILAG N.V.
Latvian: Luksemburga JANSSEN-CILAG N.V.
Italian: 34 avenue Léonard de Vinci 92418 Courbevoie Cedex Francia varnoline
Latvian: 34 avenue Léonard de Vinci 92418 Courbevoie Cedex France varnoline
Italian: UCB Pharma GmbH Alfred-Nobel-Str. 10 40789 Monheim Germania previva sanol 30 Tabletten
Latvian: 10 40789 Monheim Germany previva sanol 30 Tabletten
Italian: UAB „Johnson & Johnson" Geležinio Vilko g. 18A LT-08104 Vilnius Lituania
Latvian: UAB „Johnson & Johnson" Geležinio Vilko g.
Italian: Berlipharm B.V.
Latvian: Nīderlande Berlipharm B.V.
Italian: UCB Pharma GmbH Alfred-Nobel-Str. 10 40789 Monheim Germania previva sanol 20 Tabletten
Latvian: 10 40789 Monheim Germany previva sanol 20 Tabletten
Italian: Dienogest Etinilestradiolo ladonna sanol 2 mg /0,03 mg
Latvian: Dienogest Ethinylestradiol ladonna sanol 2 mg /0,03 mg
Italian: 82109 Bratislava
Latvian: 82109 Bratislava Slovak Republic
Italian: Centrafarm B.V.
Latvian: Nīderlande Centrafarm B.V.
Italian: Veluwezoom 22 1327 AH Almere Paesi Bassi
Latvian: 1327 AH Almere The Netherlands
Italian: Sandoz B.V.
Latvian: Nīderlande Sandoz B.V.
Italian: Lituania
Latvian: Lithuania
Italian: Grecia
Latvian: Greece
Italian: Rowex Ltd Bantry Co. Cork Irlanda
Latvian: Rowex Ltd Bantry Co.
Italian: GAIA 0,15 MG/0,02 MG
Latvian: GAIA 0,15 MG/0,02
Italian: Rua Consiglieri Pedroso, 123Queluz de Baixo
Latvian: Rua Consiglieri Pedroso, 123Queluz de Baixo 2730-056 Barcarena Portugal
Italian: Bayer Pharma AG D-13342 Berlin Germania
Latvian: Bayer Pharma AG D-13342 Berlin Germany
Italian: Apothecon B.V.
Latvian: Nīderlande Apothecon B.V.
Italian: 0,12 mg/0,015 mg Dispositivo vaginale Uso vaginale
Latvian: 0.12 mg/0.015 mg Vaginālās ievadīšanas sistēma
Italian: Alkotás u. 53 Budapest 1123 Ungheria
Latvian: 53 Budapest 1123 Hungary
Italian: Pfizer B.V.
Latvian: Nīderlande Pfizer B.V.
Italian: PFIZER HOLDING France 23-25 avenue du Docteur Lannelongue
Latvian: PFIZER HOLDING France 23-25 avenue du Docteur Lannelongue 75668 PARIS Cedex 14 France
Italian: GYNEA LABORATORIOS, S.L. Colón, 5
Latvian: GYNEA LABORATORIOS, S.L.
Italian: 821 08 Bratislava
Latvian: 821 08 Bratislava Slovak republic
Italian: 821 02 Bratislava
Latvian: 821 02 Bratislava Slovak republic
Italian: 2700-487 Amadora
Latvian: Rua João de Deus, 19 2700-487 Amadora Portugal
Italian: NYSSIELA 3 MG/0,02 MG
Latvian: NYSSIELA 3 MG/0,02
Italian: Mikrogramm + 30
Latvian: Mikrogramm + 30 Mikrogramm Dragees
Italian: Alameda da Beloura
Latvian: Alameda da Beloura Edificio 1, 2º
Italian: LABORATORIOS EFFIK, S.A. San Rafael, 3
Latvian: LABORATORIOS EFFIK, S.A.
Italian: VELMARI 3 MG/0,02 MG
Latvian: VELMARI 3 MG/0,02
Italian: (carne e latte)
Latvian: (gaļai un pienam)
Italian: • l'efficacia di Combisyn non è stata confermata;
Latvian: • Combisyn efektivitāte nav apstiprināta;
Italian: La domanda di autorizzazione è stata presentata agli Stati membri interessati nel quadro della procedura di mutuo riconoscimento.
Latvian: Pieteikums tika iesniegts iesaistītajās dalībvalstīs savstarpējās atzīšanas procedūras ietvaros.
Italian: Combisyn è stato autorizzato nel Regno Unito il 30 gennaio 2003 ai sensi dell'articolo 13, paragrafo 1, della direttiva 2001/82/CE.
Latvian: 2003. gada 30. janvārī saskaņā ar Direktīvas 2001/82/EK 13. panta 1. punktu Combisyn tika reģistrētas Apvienotajā Karalistē.
Italian: Il CVMP è stato invitato a fornire un parere in merito alle preoccupazioni sollevate dagli Stati membri interessati e a trarre conclusioni sul rapporto rischi/benefici per Combisyn.
Latvian: CVMP tika lūgta sniegt savu atzinumu par iesaistīto dalībvalstu izteiktajām bažām un izdarīt secinājumus par Combisyn ieguvumu un riska attiecību.
Italian: • il periodo di sospensione proposto per Combisyn non è stato sufficientemente motivato;
Latvian: • Combisyn ieteiktais izdalīšanās periods netika pietiekami pamatots;
Italian: Il CVMP ha pertanto concluso che i particolari forniti a sostegno della domanda di autorizzazione non sono conformi all'articolo 13 della direttiva 2001/82/CE e ha raccomandato il rifiuto del rilascio dell'autorizzazione all'immissione in commercio negli Stati membri interessati e la sospensione dell'autorizzazione già rilasciata nello Stato membro di riferimento.
Latvian: Tādēļ CVMP secināja, ka dati, kas iesniegti pieteikuma pamatošanai, neatbilst Direktīvas 2001/82/EK 13. panta nosacījumiem, un ieteica atteikt reģistrācijas apliecības izsniegšanu iesaistītajās dalībvalstīs un apturēt esošo reģistrācijas apliecību atsauces dalībvalstī.
Italian: Gli Stati membri interessati ritenevano che l'autorizzazione di Combisyn potesse presentare un grave rischio potenziale per la salute umana e animale poiché la sicurezza e l'efficacia del prodotto non erano state sufficientemente dimostrate.
Latvian: Iesaistītās dalībvalstis uzskatīja, ka Combisyn reģistrācija var radīt potenciāli nopietnu risku cilvēku un dzīvnieku veselībai, tā kā zāļu drošība un efektivitāte nav pietiekami uzrādīta.
Italian: Richiedente/ Titolare dell'autorizzazione all'immissione in commercio
Latvian: Pieteikuma iesniedzējs/ reģistrācijas apliecības īpašnieks
Italian: Sintesi generale della valutazione scientifica di Combisyn Lactating Cow Intramammary Suspension
Latvian: Combisyn Lactating Cow Intramammary Suspension zinātniskā novērtējuma vispārējs kopsavilkums
Italian: Nel corso della procedura è emerso un disaccordo tra lo Stato membro di riferimento e gli Stati membri interessati in merito all'applicabilità della dimostrazione della bioequivalenza sistemica per un prodotto che viene applicato ed è attivo localmente; inoltre sono stati manifestati timori circa l'adeguatezza del periodo di sospensione proposto.
Latvian: Procedūras laikā bija nesaskaņas starp atsauces valsti un iesaistītajām dalībvalstīm attiecībā uz sistemātiskas bioloģiskās ekvivalences uzrādīšanu lokāli ievadāmām, lokālās darbības zālēm, kā arī bija papildu bažas par ieteiktā izdalīšanās perioda piemērotību.
Italian: È stato concluso che, sebbene Combisyn si sia dimostrato simile al prodotto di riferimento per quanto riguarda la formulazione, le dimensioni delle particelle e la viscosità, tale dimostrazione può essere considerata comprovante solo in questo caso e non può sostituire studi clinici per dimostrare l'efficacia.
Latvian: Tika secināts, ka, lai gan tika pierādīts, ka Combisyn ir līdzīgas atsauces zālēm attiecībā uz to sastāvu, daļiņu lielumu un viskozitāti, šajā gadījumā to var uzskatīt tikai kā papildinājumu, nevis kā klīnisko pētījumu aizstājēju, lai pierādītu efektivitāti.
Italian: Un'ulteriore questione esaminata dal CVMP riguardava un cambiamento apportato alla formulazione di Combisyn nel corso del suo sviluppo, per aumentare la stabilità del prodotto, che è stato considerato tale da influire potenzialmente sul rilascio delle sostanze attive dal prodotto al tessuto.
Latvian: Vēl viens jautājums, kuru CVMP pārskatīja, bija Combisyn sastāva izmaiņas izstrādes procesa laikā, lai palielinātu zāļu stabilitāti; šīs izmaiņas varētu ietekmēt zāļu aktīvās vielas atbrīvošanos audos.
Italian: Nell'elaborare l'approccio usato per esaminare la similarità in termini di efficacia per Combisyn, il richiedente non aveva condotto studi clinici comparativi poiché si riteneva che le sperimentazioni cliniche non avrebbero avuto sufficiente sensibilità per rilevare le differenze tra Combisyn e il prodotto di riferimento.
Latvian: Sagatavojot metodi, kas izmantojama līdzības izpētīšanai Combisyn efektivitātes ietvaros, pieteikuma iesniedzējs neveica salīdzinošos klīniskos pētījumus, tā kā tika paredzēts, ka klīniskie pētījumi nebūs pietiekami sensitīvi, lai noteiktu atšķirības starp Combisyn un atsauces zālēm.
Italian: I risultati degli studi sul latte hanno dimostrato che le concentrazioni delle sostanze attive erano simili a quelle del prodotto di riferimento in seguito all'infusione intramammaria di Combisyn, benché sia stata osservata una notevole variabilità tra quarti e tra individui in ciascuno dei parametri farmacocinetici misurati.
Latvian: Piena pētījumu rezultātos bija redzams, ka aktīvo vielu koncentrācijas bija līdzīgas atsauces zāļu koncentrācijām pēc Combisyn intramammāras infūzijas, lai gan tika atzīmēts, ka pastāvēja vērā ņemams mainīgums starp ceturkšņiem un dzīvniekiem katram noteiktajam farmakokinētiskajam parametram.
Italian: Combisyn è destinato al trattamento di mastiti nelle bovine in lattazione causate dai principali patogeni che colpiscono comunemente la mammella bovina (Staphylococci, Streptococci ed Escherichia coli).
Latvian: Combisyn ir paredzētas lietot laktējošu govju mastīta ārstēšanai, ko izraisa galvenie patogēni, kas parasti rodas liellopa tesmenī (Staphylococci, Streptococci un Escherichia coli).
Italian: Devono essere forniti dati clinici atti a confermare l'efficacia di Combisyn sospensione intramammaria per bovine in lattazione.
Latvian: Jāiesniedz atbilstoši klīniskie dati, kas apstiprina Combisyn Lactating Cow Intramammary Suspension efektivitāti.
Italian: Stato membro UE/SEE
Latvian: ES/EEZ dalībvals ts
Italian: Quando gli è stato chiesto di comprovare ulteriormente questa affermazione, il richiedente ha fornito dati comparativi sulle caratteristiche fisico-chimiche del prodotto, comprendenti viscosità, dimensioni delle particelle ed escrezione nel latte, tra Combisyn e il prodotto di riferimento.
Latvian: Kad pieteikuma iesniedzējam tika lūgts sniegt papildu pamatojumu šim apgalvojumam, tas iesniedza salīdzinošos datus par zāļu fizikoķīmiskajām īpašībām, tostarp viskozitāti, daļiņu lielumu un izšķīšanu pienā, attiecībā uz Combisyn un atsauces zālēm.
Italian: Sono stati effettuati tre studi comparativi farmacocinetici su Combisyn e il prodotto di riferimento, ciascuno con una configurazione incrociata di due periodi.
Latvian: Zālēm Combisyn un atsauces zālēm tika veikti trīs salīdzinošie farmakokinētiskie pētījumi, kuriem visiem bija divu posmu krusteniska plānošana.
Italian: Combisyn Lactating Cow Intramammary Suspension (in prosieguo Combisyn) è una sospensione intramammaria contenente amoxicillina (come amoxicillina triidrato), acido clavulanico (come potassio clavulanato) e prednisolone.
Latvian: Combisyn Lactating Cow Intramammary Suspension (turpmāk tekstā - Combisyn) ir suspensija intramammārai lietošanai, kas satur amoksicilīnu (kā amoksicilīna trihidrātu), klavulānskābi (kā kālija klavulanātu) un prednizolonu.
Italian: Il richiedente ha presentato dati comparativi sulla viscosità tra la "vecchia" e la "nuova" formulazione di Combisyn.
Latvian: Pieteikuma iesniedzējs uzrādīja salīdzinošos viskozitātes datus vecajam un jaunajam Combisyn sastāvam.
Italian: Il richiedente affermava inoltre che la formulazione di Combisyn era sufficientemente simile al prodotto di riferimento per consentire un esonero dall'obbligo di presentare dati in vivo.
Latvian: Tāpat pieteikuma iesniedzējs apgalvoja, ka Combisyn sastāvs bija pietiekami līdzīgs atsauces zāļu sastāvam, lai varētu nesniegt in vivo datus.
Italian: A sostegno di Combisyn, sono stati presentati studi mirati al confronto della farmacocinetica di latte e plasma tra il prodotto generico e il prodotto di riferimento.
Latvian: Lai pamatotu Combisyn lietošanu, pētījumi tika iesniegti, lai salīdzinātu piena un plazmas farmakokinētiku starp ģenēriskajām un atsauces zālēm.
Italian: Motivi per il rifiuto del rilascio delle autorizzazioni all'immissione in commercio e la sospensione dell'autorizzazione già rilasciata
Latvian: Pamatojums reģistrācijas apliecību izsniegšanas atteikumam un esošās reģistrācijas apliecības apturēšanai