FrancophonIA/ELRC3.0 huggingface dataset:
English: List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the member states
Polish: Aneks I Wykaz nazw, postaci farmaceutycznych, mocy produktów leczniczych, droga podania, podmioty odpowiedzialne posiadające pozwolenie na dopuszczenie do obrotu w państwach członkowskich
English: Ranbaxy Portugal - Comércio e Desenvol.
Polish: PT - Portugalia Ranbaxy Portugal - Comércio e Desenvol.
English: EL - Greece PHARMACEUTICAL INDUSTRY PROEL EPAM.
Polish: EL - Grecja PHARMACEUTICAL INDUSTRY PROEL EPAM.
English: HU - Hungary sanofi-aventis zrt.
Polish: HU - Węgry sanofi-aventis zrt.
English: Rega Farma - Promoção de Produtos Farmacêuticos,
Polish: PT - Portugalia Rega Farma - Promoção de Produtos Farmacêuticos,
English: HU - Hungary PannonPharma Kft. Pannonpharma út 1.
Polish: HU - Węgry PannonPharma Kft. Pannonpharma út 1.
English: HU - Hungary Eurodrug Lab. BV Laan Copes van Cattenbruch 74.
Polish: HU - Węgry Eurodrug Lab. BV Laan Copes van Cattenbruch 74.
English: 2114 Aglantzia
Polish: 2114 Aglantzia Lefkosia
English: Damastown - Dublin Ireland
Polish: Damastown - Dublin
English: PL - Poland Pabianickie Zakłady Farmaceutyczne Polfa S.A. Marszałka J. Piłsudskiego 5,
Polish: PL - Polska Pabianickie Zakłady Farmaceutyczne Polfa S.A. Marszałka J. Piłsudskiego 5,
English: FR - France CLL PHARMA Nice Premier - Arenas 455, promenade des Anglais 06299 NICE Cedex 03
Polish: FR - Francja CLL PHARMA Nice Premier - Arenas 455, promenade des Anglais 06299 NICE Cedex 03 France
English: EL - Greece ANTONIOS POLYCHRONIS OF MARINOU Ethnikis Antistaseos 6A
Polish: EL - Grecja ANTONIOS POLYCHRONIS OF MARINOU Ethnikis Antistaseos 6A
English: Rua João deDeus,19 Venda Nova
Polish: Rua João deDeus,19
English: EL - Greece LEOVAN, M. LEWN & SIA EE Argonafton 22
Polish: EL - Grecja LEOVAN, M. LEWN & SIA EE Argonafton 22
English: BG - Bulgaria Chaikapharma - Highquality medicines AD, 1 G.M.Dimitrov Blvd
Polish: BG - Bułgaria Chaikapharma - Highquality medicines AD, 1 G.M.Dimitrov Blvd
English: 25125 Brescia Italy
Polish: 25125 Brescia
English: BG - Bulgaria Inbiotech Ltd 5A Triaditza str.
Polish: BG - Bułgaria Inbiotech Ltd 5A Triaditza str.
English: FR - France THERABEL LUCIEN PHARMA 19 rue Alphonse de Neuville 75017 PARIS
Polish: FR - Francja THERABEL LUCIEN PHARMA 19 rue Alphonse de Neuville 75017 PARIS
English: SK - Slovakia Zentiva k.s., Evropská 846/176a, 160 00, Praha
Polish: SK - Słowacja Zentiva k.s., Evropská 846/176a, 160 00, Praha
English: BG - Bulgaria CSC Pharmaceuticals Ltd-Bulgaria EOOD, 10 Assen Jordanov str.,
Polish: BG - Bułgaria CSC Pharmaceuticals Ltd-Bulgaria EOOD, 10 Assen Jordanov str.,
English: BG - Bulgaria Actavis EAD 29 Atanas Dukov str. Sofia 1407
Polish: BG - Bułgaria Actavis EAD 29 Atanas Dukov str. Sofia 1407
English: New Research Srl Via della Tenuta di Torrenova, 142 00133 Roma
Polish: IT - Włochy New Research Srl Via della Tenuta di Torrenova, 142 00133 Roma
English: SI - Slovenia CSC Pharma d.o.o.
Polish: SI - Słowenia CSC Pharma d.o.o.
English: EL - Greece ALET PHARMACEUTICALS M. Alexander 121
Polish: EL - Grecja ALET PHARMACEUTICALS M. Alexander 121
English: EL - Greece INTERMED ABEE Kalyftaki 27
Polish: EL - Grecja INTERMED ABEE Kalyftaki 27
English: BG - Bulgaria Sopharma AD 16 Iliensko shosse str. 1220 Sofia
Polish: BG - Bułgaria Sopharma AD 16 Iliensko shosse str. 1220 Sofia
English: Almus Srl Via Cesarea, 11/10 16121 Genova Italy
Polish: IT - Włochy Almus Srl Via Cesarea, 11/10 16121 Genova Italy
English: RO - Romania S.C. FARMEX COMPANY SRL Str.Drumul Potcoavei nr. 30, Pipera Voluntari, Jud.
Polish: RO - Rumunia S.C. FARMEX COMPANY SRL Str.Drumul Potcoavei nr. 30, Pipera Voluntari, Jud.
English: Benedetti & Co spa Via Bolognese,
Polish: IT - Włochy Benedetti & Co spa Via Bolognese,
English: RO - Romania S.C.
Polish: RO - Rumunia S.C.
English: EL - Greece B.I.
Polish: EL - Grecja B.I.
English: Baldacci - Portugal, S.A. Rua Cândido de Figueiredo, 84-B 1549-005 Lisboa Portugal
Polish: PT - Portugalia Baldacci - Portugal, S.A. Rua Cândido de Figueiredo, 84-B 1549-005 Lisboa
English: Largo Boccioni 1 21040 Origgio Varese Italy
Polish: 21040 Origgio Varese Italy
English: EL - Greece EVAGGELOS KALOFOLIAS & SIA O.E.
Polish: EL - Grecja EVAGGELOS KALOFOLIAS & SIA O.E.
English: Wynn Industrial Pharma, S.A. Rua Tierno Galvan, Torre 3, 16º Piso, Amoreiras
Polish: PT - Portugalia Wynn Industrial Pharma, S.A. Rua Tierno Galvan, Torre 3, 16º Piso,
English: EL - Greece MED-ONE S.A., HELLAS Parnithos Avenue 211
Polish: EL - Grecja MED-ONE S.A., HELLAS Parnithos Avenue 211
English: CY - Cyprus CODAL SYNTO LTD 33 Thekla Lysioti str.
Polish: CODAL SYNTO LTD 33 Thekla Lysioti str.
English: Via Domenico Scarlatti, 31 20124 Milano Italy
Polish: Via Domenico Scarlatti, 31 20124 Milano
English: EL - Greece ANTOR EPE P. Mavromihali 1
Polish: EL - Grecja ANTOR EPE P. Mavromihali 1
English: Dolni Mecholupy Praha 10, CZ-10237 Czech Republic
Polish: Dolni Mecholupy Praha 10, CZ-10237
English: Magis Farmaceutici Spa Via Cacciamali, 34-36-38/B 25125 Brescia Italy
Polish: IT - Włochy Magis Farmaceutici Spa Via Cacciamali, 34-36-38/B 25125 Brescia
English: Farmac.Caber Spa Viale Città D'Europa, 681 00144 Roma Italy
Polish: IT - Włochy Farmac.Caber Spa Viale Città D'Europa, 681 00144 Roma
English: EL - Greece DEMO ABEE 21ST Km National Highway Athens-Lamia 14565 Greece
Polish: EL - Grecja DEMO ABEE 21ST Km National Highway Athens-Lamia 14565 Greece
English: EL - Greece S.J.A.
Polish: EL - Grecja S.J.A.
English: Labesfal - Laboratórios Almiro, S.A. Zona Industrial do Lagedo 3465-157 Santiago de Besteiros
Polish: PT - Portugalia Labesfal - Laboratórios Almiro, S.A. Zona Industrial do Lagedo 3465-157 Santiago de Besteiros
English: So.Se.Pharm Srl Via dei Castelli Romani, 22 00040 Pomezia (Roma) Italy
Polish: IT - Włochy So.Se.Pharm Srl Via dei Castelli Romani, 22 00040 Pomezia (Roma) Italy
English: Francia Farmac.Ind.Far.Bio.Srl Via dei Pestagalli, 7
Polish: IT - Włochy Francia Farmac.Ind.Far.Bio.Srl Via dei Pestagalli, 7
English: Bluepharma Genéricos - Comércio de Medicamentos, S.A.
Polish: PT - Portugalia Bluepharma Genéricos - Comércio de Medicamentos, S.A.
English: RO - Romania Zentiva k.s., U kabelovny 130, Dolní Měcholupy 102 37, Praha 10, Czech Republic
Polish: RO - Rumunia Zentiva k.s., U kabelovny 130, Dolní Měcholupy 102 37, Praha 10, Czech Republic
English: C.T.Laboratorio Farmaceutico Srl Villa Sayonara - Strada Solaro, 75/77 18038 Sanremo (IM) Italy
Polish: IT - Włochy C.T.Laboratorio Farmaceutico Srl Villa Sayonara - Strada Solaro, 75/77 18038 Sanremo (IM)
English: Laboratori Alter Srl Via Egadi, 7
Polish: IT - Włochy Laboratori Alter Srl Via Egadi, 7
English: RO - Romania CSC PHARMACEUTICALS HANDELS GmbH Gewerbestrasse 18-20 Gewerbegebiet Klein-Engersdorf A-2102 Bisamberg Austria
Polish: RO - Rumunia CSC PHARMACEUTICALS HANDELS GmbH Gewerbestrasse 18-20 Gewerbegebiet Klein-Engersdorf A-2102 Bisamberg Austria
English: Selvi Laboratorio Bioterapico Spa Via Procoio, 28
Polish: IT - Włochy Selvi Laboratorio Bioterapico Spa Via Procoio, 28
English: EL - Greece RAFARM AEBE Korintou 12
Polish: EL - Grecja RAFARM AEBE Korintou 12
English: APceuticals-Farmacêutica, Lda Av Aida, Edif.
Polish: PT - Portugalia APceuticals-Farmacêutica, Lda Av Aida, Edif.
English: EL - Greece FARMILIA E.E.
Polish: EL - Grecja FARMILIA E.E.
English: CY - Cyprus CHR. K. UNIMED LTD 21 Davlou
Polish: CHR. K. UNIMED LTD 21 Davlou
English: EL - Greece BROS EPE Avgis & Gallinis 15
Polish: EL - Grecja BROS EPE Avgis & Gallinis 15
English: EL - Greece HELP ABEE Valaoritou 10
Polish: EL - Grecja HELP ABEE Valaoritou 10
English: Arrowblue Produtos Farmacêuticos S.A. Av. D. João II,
Polish: PT - Portugalia Arrowblue Produtos Farmacêuticos S.A. Av. D. João II,
English: RO - Romania LABORATORI GUIDOTTI SpA Via Livornese, 897
Polish: RO - Rumunia LABORATORI GUIDOTTI SpA Via Livornese, 897
English: EL - Greece COUP ABEE Agias Varvaras 53-55 Dafni, Athens 17235
Polish: EL - Grecja COUP ABEE Agias Varvaras 53-55 Dafni, Athens 17235
English: EL - Greece KLEVA EPE Parnithos Avenue 189 Aharnai Attikis 13671 Greece
Polish: EL - Grecja KLEVA EPE Parnithos Avenue 189 Aharnai Attikis 13671 Greece
English: S.A. Rua João Chagas, 53 - 3º 1495-764 Cruz Quebrada Portugal
Polish: S.A. Rua João Chagas, 53 - 3º 1495-764 Cruz Quebrada
English: Germed Pharma Spa Via Cesare Cantù, 11
Polish: IT - Włochy Germed Pharma Spa Via Cesare Cantù, 11
English: RO - Romania Dr. REDDY'S LABORATORIES ROMÂNIA S.R.L, Str. Nicolae Caramfil nr. 71-73, et. 5 spaţiul 10, sector 1, Bucureşti
Polish: RO - Rumunia Dr. REDDY'S LABORATORIES ROMÂNIA S.R.L, Str. Nicolae Caramfil nr. 71-73, et. 5 spaţiul 10, sector 1, Bucureşti
English: RO - Romania S.C. LABORMED PHARMA S.A. B-dul Theodor Pallady nr. 44B sector 3, Bucuresti
Polish: RO - Rumunia S.C. LABORMED PHARMA S.A. B-dul Theodor Pallady nr. 44B sector 3, Bucuresti
English: Laboratórios Basi - Indústria Farmacêutica, S.A. Rua do Padrão, 98
Polish: PT - Portugalia Laboratórios Basi - Indústria Farmacêutica, S.A. Rua do Padrão, 98
English: ARENA GROUP S.A. Str. Ştefan Mihăileanu, Nr. 31, Sector 2, Bucureşti,
Polish: Str. Ştefan Mihăileanu, Nr. 31, Sector 2, Bucureşti,
English: 2700-487 Amadora Portugal
Polish: 2700-487 Amadora
English: EL - Greece BIOMEDICA-CHEMICA A.E. G. Lyra 25
Polish: EL - Grecja BIOMEDICA-CHEMICA A.E. G. Lyra 25
English: Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda.
Polish: PT - Portugalia Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda.
English: Zona Industrial da AbrunheiraEdifício 1 - 2º I - Sintra Business Park 2710-089 Sintra
Polish: PT - Portugalia Laboratórios Inibsa, S.A. Zona Industrial da AbrunheiraEdifício 1 - 2º I - Sintra Business Park 2710-089 Sintra
English: Laboratori Guidotti S.p.A (Menarini Group).
Polish: CZ - Czechy Laboratori Guidotti S.p.A (Menarini Group).
English: 2700-451 Amadora Portugal
Polish: 2700-451 Amadora
English: EL - Greece VELKA HELLAS AEBE Kapodistriou & Korinthou 12 Neo Psychiko 15451
Polish: EL - Grecja VELKA HELLAS AEBE Kapodistriou & Korinthou 12 Neo Psychiko 15451
English: EL - Greece FARMANIC CHEMIPHARMA S.A. Fylis 137
Polish: EL - Grecja FARMANIC CHEMIPHARMA S.A. Fylis 137
English: Aurobindo Pharma Italia Srl Vicolo San Giovanni sul Muro, 9 20121 Milano
Polish: IT - Włochy Aurobindo Pharma Italia Srl Vicolo San Giovanni sul Muro, 9 20121 Milano
English: NIMESIL, granule pentru suspensie orală, 100 mg mg/sachet
Polish: NIMESIL, granule pentru suspensie orală, 100 mg mg/saszetkę
English: EL - Greece NORMA HELLAS A.E. Menandrou 54
Polish: EL - Grecja NORMA HELLAS A.E. Menandrou 54
English: Estrada Marco do Grilo - Zemouto 2830-000 Coina
Polish: PT - Portugalia Alter, S.A. Estrada Marco do Grilo - Zemouto 2830-000 Coina
English: Industriestrasse, 25 D-83607 HolzkirchenGermany
Polish: IT - Włochy Hexal AG Industriestrasse, 25 D-83607 HolzkirchenGermany
English: BG - Bulgaria Zentiva k.s.
Polish: BG - Bułgaria Zentiva k.s.
English: AULIN, granule pentru suspensie orală, 100 mg/plic mg/sachet
Polish: AULIN, granule pentru suspensie orală, 100 mg/plic mg/saszetkę
English: Rua Quinta do PinheiroEdifício Tejo - 6º Piso
Polish: Edifício Tejo - 6º Piso
English: EL - Greece BALU EPE 30 Km Athens-Lavrion Markopoulo 19003
Polish: EL - Grecja BALU EPE 30 Km Athens-Lavrion Markopoulo 19003
English: MG/SACHET
Polish: MG/SASZETKĘ
English: EL - Greece REMEK PHARMACEUTICALS ABEE Pentelis 34
Polish: EL - Grecja REMEK PHARMACEUTICALS ABEE Pentelis 34
English: EL - Greece BOEHRINGER INGELHEIM HELLAS S.A. Ellinikou 2
Polish: EL - Grecja BOEHRINGER INGELHEIM HELLAS S.A. Ellinikou 2
English: EL - Greece VIOFAR EPE Ethnikis Antistaseos & Trifyllias Aharnai 13671
Polish: EL - Grecja VIOFAR EPE Ethnikis Antistaseos & Trifyllias Aharnai 13671
English: EL - Greece ELPEN A.E. PHARMACEUTICAL INDUSTRY, Marathonos Avenue 95
Polish: EL - Grecja ELPEN A.E. PHARMACEUTICAL INDUSTRY, Marathonos Avenue 95
English: Pharmakern Portugal - Produtos Farmacêuticos, Sociedade Unipessoal, Lda.
Polish: PT - Portugalia Pharmakern Portugal - Produtos Farmacêuticos, Sociedade Unipessoal, Lda.
English: EL - Greece MINERVA PHARMAKEFTIKI A.E. Kifissou Avenue 132
Polish: EL - Grecja MINERVA PHARMAKEFTIKI A.E. Kifissou Avenue 132
English: GP - genéricos portugueses, Lda.
Polish: PT - Portugalia GP - genéricos portugueses, Lda.
English: Aesculapius Farmaceutici Srl Via Cozzaglio, 24
Polish: IT - Włochy Aesculapius Farmaceutici Srl Via Cozzaglio, 24
English: EL - Greece VOCATE PHARMAKEFTIKI A.E. Gounari 150
Polish: EL - Grecja VOCATE PHARMAKEFTIKI A.E. Gounari 150
English: EL - Greece MEDARTE PHARMACEUTICLS ABEE Spyrou Vretou 10
Polish: EL - Grecja MEDARTE PHARMACEUTICLS ABEE Spyrou Vretou 10
English: EL - Greece PHARMATHEN INTERNATIONAL S.A. GREECE, Dervenakion 4
Polish: EL - Grecja PHARMATHEN INTERNATIONAL S.A. GREECE, Dervenakion 4
English: EL - Greece PHARMACYPRIA HELLAS A.E. Paster 6
Polish: EL - Grecja PHARMACYPRIA HELLAS A.E. Paster 6
English: CY - Cyprus MEDOCHEMIE LTD 1-10 Constantinoupoleos str. P.O.Box 51409
Polish: MEDOCHEMIE LTD 1-10 Constantinoupoleos str. P.O.Box 51409
English: EL - Greece MEDICHROM A.E. 6 Km Markopoulou-Koropi Avenue Markopoulo Mesogeion 19003 Greece
Polish: EL - Grecja MEDICHROM A.E. 6 Km Markopoulou-Koropi Avenue Markopoulo Mesogeion 19003 Greece
English: Edifício Monsanto 2790-012 Portela de Carnaxide Portugal
Polish: 2790-012 Portela de Carnaxide Portugal
English: Levofarma Srl Via Conforti, 42
Polish: IT - Włochy Levofarma Srl Via Conforti, 42
English: SIAR Pharma Srl Via Verdi, 33
Polish: IT - Włochy SIAR Pharma Srl Via Verdi, 33
English: RO - Romania S.C. SLAVIA PHARM SRL Str. Ştirbei Vodă nr. 53-55 sector 1, Bucureşti
Polish: RO - Rumunia S.C. SLAVIA PHARM SRL Str. Ştirbei Vodă nr. 53-55 sector 1, Bucureşti
English: CY - Cyprus CDL PHARMACEUTICAL LTD 5 Diomedous str.
Polish: CDL PHARMACEUTICAL LTD 5 Diomedous str.
English: Mer Medicamentos, Lda.
Polish: PT - Portugalia Mer Medicamentos, Lda.
English: Ciclum Farma Unipessoal, Lda.
Polish: PT - Portugalia Ciclum Farma Unipessoal, Lda.
English: Granules for oral solution in sachet
Polish: Granulat do sporządzania roztworu doustnego w saszetce
English: PL - Poland Medicom International s.r.o.
Polish: PL - Polska Medicom International s.r.o.
English: EL - Greece LAVIPHARM HELLAS A.E. Agias Marinas
Polish: EL - Grecja LAVIPHARM HELLAS A.E. Agias Marinas
English: EL - Greece ARMEDICA A.E. Agias Markellis 17
Polish: EL - Grecja ARMEDICA A.E. Agias Markellis 17
English: 3508 Lemessos
Polish: 3508 Lemessos Cyprus
English: 3505 Lemessos
Polish: 3505 Lemessos Cyprus
English: EL - Greece FINIXFARM EPE Dervenakion 38 & Sahini Gerakas 15344
Polish: EL - Grecja FINIXFARM EPE Dervenakion 38 & Sahini Gerakas 15344
English: HU - Hungary Lab. Guidotti S.p.A.
Polish: HU - Węgry Lab. Guidotti S.p.A.
English: EL - Greece REMEDINA ABEE Gounari 25 & Areos Kamatero Attikis 13451
Polish: EL - Grecja REMEDINA ABEE Gounari 25 & Areos Kamatero Attikis 13451
English: Dr Reddy's Srl Via Fernanda Wittengs, 3 20123 Milano Italy
Polish: IT - Włochy Dr Reddy's Srl Via Fernanda Wittengs, 3 20123 Milano
English: Actavis Group PTC EHF Reykjavikurvegi 76-78 Hafnarf Joerdur Iceland
Polish: IT - Włochy Actavis Group PTC EHF Reykjavikurvegi 76-78
English: São Martinho do Bispo 3045-016 Coimbra Portugal
Polish: 3045-016 Coimbra
English: EL - Greece BIOSPRAY ABEE 18TH Km Marathonos Avenue Pallini 15344
Polish: EL - Grecja BIOSPRAY ABEE 18TH Km Marathonos Avenue Pallini 15344
English: 20144 Milano Italy
Polish: 20144 Milano
English: EL - Greece FARMEDIA A.E. Athinas 22 & Apollonos Gerakas Attikis 15344
Polish: EL - Grecja FARMEDIA A.E. Athinas 22 & Apollonos Gerakas Attikis 15344
English: SK - Slovakia Medicom International s.r.o.
Polish: SK - Słowacja Medicom International s.r.o.
English: Constantinoupoleos Str. 1-10 Limassol, CY-3011
Polish: LV - Łotwa Medochemie Ltd. Constantinoupoleos Str. 1-10 Limassol, CY-3011
English: RO - Romania ANFARM HELLAS S.A. Perikleous 53-57
Polish: RO - Rumunia ANFARM HELLAS S.A. Perikleous 53-57
English: EL - Greece GENEPHARM A.E. 18th Km Marathonos Avenue Pallini Attikis 15351
Polish: EL - Grecja GENEPHARM A.E. 18th Km Marathonos Avenue Pallini Attikis 15351
English: Mylan Spa Via Vittor Pisani, 20 20124 Milano Italy
Polish: IT - Włochy Mylan Spa Via Vittor Pisani, 20 20124 Milano
English: Pensa Pharma Spa Via Rosellini Ippolito, 12 20124 Milano Italy
Polish: IT - Włochy Pensa Pharma Spa Via Rosellini Ippolito, 12 20124 Milano
English: Farmoz - Sociedade Técnico Medicinal, S.A. Rua da Tapada Grande, 2, Abrunheira
Polish: PT - Portugalia Farmoz - Sociedade Técnico Medicinal, S.A. Rua da Tapada Grande, 2,
English: LV - Latvia
Polish: LT - Litwa
English: Cinfa Portugal, Lda.
Polish: PT - Portugalia Cinfa Portugal, Lda.
English: Limassol, CY-3505
Polish: P.O. Box 51409 Limassol, CY-3505 Cyprus
English: RO - Romania S.C. MAGISTRA C&C S.R.L.
Polish: MAGISTRA C&C S.R.L.
English: Lagoas Park, Edificio 5, Torre C, Piso 3
Polish: PT - Portugalia Jaba Recordati, S. A. Lagoas Park, Edificio 5, Torre C, Piso 3
English: Viale Papiniano, 22/B 20100 Milano Italy
Polish: IT - Włochy MDM Spa Viale Papiniano, 22/B 20100 Milano
English: RO - Romania MEDOCHEMIE LTD. - CYPRUS, P.O.
Polish: RO - Rumunia MEDOCHEMIE LTD. - CYPRUS, P.O. Box 51409
English: Angelini Farmacêutica, Lda.
Polish: PT - Portugalia Angelini Farmacêutica, Lda.
English: Sandoz Farmacêutica, Lda.
Polish: PT - Portugalia Sandoz Farmacêutica, Lda.
English: SK - Slovakia Laboratori Guidotti S.p.A.
Polish: SK - Słowacja Laboratori Guidotti S.p.A.
English: Tecnimede - Sociedade Técnico-Medicinal, S.A. Rua da Tapada Grande, 2 - Abrunheira
Polish: PT - Portugalia Tecnimede - Sociedade Técnico-Medicinal, S.A. Rua da Tapada Grande,
English: BG - Bulgaria Laboratori Guidotti S.p.A.
Polish: BG - Bułgaria Laboratori Guidotti S.p.A.
English: Sarda Pharmaceutica Srl Via Castiglione, 92/B 09100 Cagliari Italy
Polish: IT - Włochy Sarda Pharmaceutica Srl Via Castiglione, 92/B
English: Sandoz Spa Largo U. Boccioni, 1 21040 Origgio (VA) Italy
Polish: IT - Włochy Sandoz Spa Largo U. Boccioni, 1
English: LT - Lithuania Zentiva k.s.
Polish: LV - Łotwa Zentiva k.s.
English: Mylan, Lda.
Polish: PT - Portugalia Mylan, Lda.
English: Sofar Spa Via Isonzo, 8 20100 Milano Italy
Polish: IT - Włochy Sofar Spa Via Isonzo, 8
English: Union Health Srl Via Roccamandolfi, 1 00156 Roma Italy
Polish: IT - Włochy Union Health Srl Via Roccamandolfi, 1
English: Almus,Lda.
Polish: PT - Portugalia Almus,Lda.
English: Germed Farmacêutica, Lda.
Polish: PT - Portugalia Germed Farmacêutica, Lda.
English: I.B.N.
Polish: IT - Włochy I.B.N.
English: Helsinn Birex Pharmaceutical Ltd. Damastown, Mulhuddart Dublin-15
Polish: Helsinn Birex Pharmaceuticals Ltd. Damastown Mulhuddart Dublin 15
English: Coated tablet
Polish: Tablet
English: Savio Srl Via E. Bazzano, 14 16019 Ronco Scrivia (GE) Italy
Polish: 16019 Ronco Scrivia (GE) Italy
English: Edifício D. Amélia, Piso 1, Ala B 2770-229 Paço de Arcos Portugal
Polish: Edifício D. Amélia, Piso 1, Ala B
English: Ranbaxy Italia Spa Piazza Filippo Meda, 3 20121 Milano Italy
Polish: IT - Włochy Ranbaxy Italia Spa Piazza Filippo Meda, 3
English: Italfarmaco S.p.A. Viale Fulvio Testi, 330 20126 Milano Italy
Polish: Viale Fulvio Testi, 330
English: Farmac.Damor Spa Via Emilio Scaglione, 27 80145 Napoli Italy
Polish: IT - Włochy Farmac.Damor Spa Via Emilio Scaglione, 27
English: ES - Spain HELSINN BIREX PHARMACEUTICALS LTD. Damastown Mulhuddart
Polish: ES - Hiszpania HELSINN BIREX PHARMACEUTICALS LTD. Damastown Mulhuddart
English: Orodispersible tablet Oral use
Polish: Tabletka musująca Podanie doustne
English: Eg S.p.A.
Polish: IT - Włochy Eg S.p.A.
English: FR - France HELSINN BIREX PHARMACEUTICALS Ltd Damastown Mulhuddart
Polish: FR - Francja HELSINN BIREX PHARMACEUTICALS Ltd Damastown Mulhuddart
English: Medicom International, s.r.o.
Polish: CZ - Czechy Medicom International, s.r.o.
English: Helsinn Birex Pharmac.Ltd Mulhuddart, 15
Polish: IT - Włochy Helsinn Birex Pharmac.Ltd Mulhuddart, 15
English: Angenerico Spa Via Nocera Umbra, 75 00181 Roma Italy
Polish: IT - Włochy Angenerico Spa Via Nocera Umbra, 75
English: Teva Italia Srl Via Messina, 38 20154 Milano Italy
Polish: IT - Włochy Teva Italia Srl Via Messina, 38
English: Ratiopharm GmbH Graf-Arcostrasse, 2 ULM D-89070
Polish: IT - Włochy Ratiopharm GmbH Graf-Arcostrasse, 2
English: 100 MG/TAB Effervescent tablet Oral use
Polish: 100 MG/TABL Tabletka musująca Podanie doustne
English: Piam Farmaceutici Spa Via Padre G. Semeria, 5 16131 Genova Italy
Polish: IT - Włochy Piam Farmaceutici Spa Via Padre G. Semeria, 5
English: Italy
Polish: Iceland
English: Dorom Srl Via Messina, 38 20154 Milano Italy
Polish: IT - Włochy Dorom Srl Via Messina, 38
English: Laboratori Guidotti, S.p.A.
Polish: PT - Portugalia Laboratori Guidotti, S.p.A.
English: Ecobi Farmaceutici sas Via E. Bazzano, 26 16019 Ronco Scrivia (GE) Italy
Polish: IT - Włochy Ecobi Farmaceutici sas Via E. Bazzano, 26
English: Pantafarm Srl Via Palestro, 14 00185 Roma Italy
Polish: IT - Włochy Pantafarm Srl Via Palestro, 14
English: 100mg/sachet Granules for oral suspension
Polish: 100mg/saszetkę Granulat do sporządzania zawiesiny doustnej
English: Agips Farmaceutici Srl Via Amendola, 4 16035 Rapallo (GE) Italy
Polish: IT - Włochy Agips Farmaceutici Srl Via Amendola, 4
English: Doc Generici Srl Via Manuzio, 7 20124 Milano Italy
Polish: IT - Włochy Doc Generici Srl Via Manuzio, 7
English: Pisa-La Vettola
Polish: Hafnarf Joerdur
English: Crinos spa Via Pavia, 6 20136 Milano Italy
Polish: IT - Włochy Crinos spa Via Pavia, 6
English: LT - Lithuania Laboratori Guidotti S.p.A.
Polish: LV - Łotwa Laboratori Guidotti S.p.A.
English: PL - Poland Laboratori Guidotti S.p.A. (Menarini Group) Via Livornese 897
Polish: IT - Włochy Lab.Guidotti Spa Via Livornese, 897
English: LT - Lithuania Helsinn Birex Pharmaceuticals Ltd. Damastown Mulhuddart
Polish: LV - Łotwa Helsinn Birex Pharmaceutical Ltd. Damastown, Mulhuddart
English: Via Livornese, 897 I-56010 La VettolaPisa
Polish: Via Livornese, 897 Pisa-La Vettola Italy
English: 50 MG/5ML Oral suspension Oral use
Polish: 50 MG/5ML
English: Film-coated tablet Oral use
Polish: Tabletka ulegająca rozpadowi w jamie ustnej
English: The warnings are appropriate.
Polish: Ostrzeżenia te są adekwatne.
English: Member State EU/EEA
Polish: Kraj członkowski EU/EEA
English: The reference member state (RMS) is the United Kingdom for both products.
Polish: Referencyjnym państwem członkowskim (RMS) w przypadku obydwu produktów jest Wielka Brytania.
English: The active substance is well known and is included in veterinary medicinal products currently authorised in the EU.
Polish: Substancja czynna jest dobrze poznana i wchodzi w skład leków weterynaryjnych aktualnie dopuszczonych do stosowania w Unii Europejskiej.
English: The ERA was complete in terms of data requirements and quality of data.
Polish: ERA była kompletna pod względem wymaganych danych i ich jakości.
English: Add the following text in the relevant sections of the product information:
Polish: Dodać poniższy tekst w odpowiednich punktach informacji o produkcie:
English: For the pour-on product 24 concerned member states (CMS) are involved: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, the Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia and Spain.
Polish: W zakresie produktu do polewania zainteresowanymi państwami członkowskimi (CMS) są następujące 24 państwa: Austria, Belgia, Bułgaria, Cypr, Czechy, Dania, Estonia, Francja, Niemcy, Grecja, Węgry, Islandia, Irlandia, Włochy, Łotwa, Litwa, Luksemburg, Holandia, Polska, Portugalia, Rumunia, Słowacja, Słowenia i Hiszpania.
English: The benefit-risk for the products can be considered to be positive.
Polish: Stosunek korzyści do ryzyka stosowania tych produktów uważa się za korzystny.
English: No additional studies were carried out in order to further refine the risk as guidance in this area is not currently available.
Polish: Nie przeprowadzono dodatkowych badań w celu bliższego określenia ryzyka, gdyż aktualnie brak jest dostępnych wskazówek w tym zakresie.
English: Direct therapeutic benefit
Polish: Bezpośrednie korzyści z leczenia