FrancophonIA/ELRC3.0 huggingface dataset:
English: ACREL SEMANAL 35 mg comprimidos recubiertos con película film coated tablets
Slovak: ACREL SEMANAL 35 mg comprimidos recubiertos con película
English: 35,0 mg Risedronate sodium (equivalent to 40,17 mg Risedronate sodium hemipentahydr ate film-coated tablet Oral use
Slovak: 35,0 mg Risedronate sodium (equivalent to 40,17 mg Risedronate sodium hemipentahydr ate
English: FOSAMAX ONCE WEEKLY
Slovak: Fosamax Once weekly 70mg
English: Risontel Once a week 35mg film-coated tablets film-coated tablets
Slovak: Risontel Once a week 35mg filmom coated tablety
English: Zaklad Farmaceutyczny Adamed Pharma S.A., Szkolna Street 33, 95-054 Ksawerow, Poland
Slovak: ZaKlad Farmaceutyczny, Adamed Phama S.a, 33 Szkolna Street, PL-95054 Ksawerów; Poland
English: 08228 Tarrasa
Slovak: Valcarcel, 38 28027
English: SK - Slovak Republic
Slovak: SK - Slovensko STADA
English: CLODRONATO ABC 100 mg/3,3 ml
Slovak: CLODRONATO ABC 100 mg/3,3 ml injekčný roztok intramuskulárne, intravenózne
English: PAMIDRONATO DISODICO COMBINO PHARM 90 mg polvo para solución para perfusión solution for infusion
Slovak: PHARM 90 mg polvo para solución para perfusión infúzny roztok
English: filmcoated tablets Oral use
Slovak: filmom obalené tablety perorálne použitie
English: Hospira Deutschland GmbH Rablstraße 24
Slovak: Rablstraße 24
English: 10 mg Tablets
Slovak: 10 mg Comprimidos tablety
English: Alendronsäure Tecnimede 70 mg Filmtabletten
Slovak: Tecnimede 70 mg Filmomtabletten
English: Apotex Europe Ltd.
Slovak: Apotex Europe
English: Actonel enkrat tedensko 35 mg filmsko obložene tablete film-coated tablet Oral use
Slovak: Actonel enkrat tedensko 35 mg filmomsko obložene tablete
English: Actonel 5 mg film coated tablets film-coated tablets
Slovak: ACTONEL 5 mg filmom coated tablety
English: Alendronsäure Orion 70 mg Tabletten
Slovak: Orion 70 mg Tabletten
English: ATRONATE "ONCE A WEEK" TABLETS 35MG
Slovak: Actonel Once a Week 35mg Tablet
English: Accord Healthcare Limited, Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom
Slovak: Accord Healthcare Limited, Sage Hopoužitie, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom
English: Actonel Combi D 35 mg + 1000 mg / 880 IU
Slovak: ACTONELCOMBI 35 mg + 1000 mg/880
English: OPTICALCIO D3
Slovak: OPTICALCIO
English: Alendor 70 mg tablete
Slovak: Alendor 70 mg tablete 70 mg
English: FI - Finland ratiopharm GmbH, GrafArco-Strasse 3, 89079 Ulm, Germany
Slovak: FI - Fínsko ratiopharm GmbH, GrafArco-Strasse 3, 89079 Ulm, Germany
English: SIGMA-TAU INDUSTRIE FARMACEUTICHE RIUNITE SpA
Slovak: RIUNITE SpA
English: Alendronat-ratiopharm
Slovak: Alendronat-ratiopharm tablety
English: 5 MG/TAB TABLET
Slovak: 5 MG/TAB
English: Zona Industrial da Abrunheira, Rua da Tapada Grande, 2
Slovak: Rua da Tapada Grande, 2Abrunheira
English: RISEDRONAT GALEX 35 mg filmtabletta mgRisedronate sodium (equivalent to 40,17 mg Risedronate sodium hemipentahydr ate film-coated tablet Oral use
Slovak: RISEDRONAT GALEX 35 mg filmomtabletta mgRisedronate sodium (equivalent to 40,17 mg Risedronate sodium hemipentahydr ate
English: TEVA PHARMA S.L.U.
Slovak: ES - Španielsko TEVA PHARMA S.L.U.
English: ALET PHARMACEUTICALS ABEE
Slovak: ABC FARMACEUTICI
English: film-coated tablet and chewing tablet
Slovak: filmom obalená tableta a žuvacia tableta
English: PAMIDRONATO DISODICO COMBINO PHARM 60 mg polvo para solución para perfusión solution for infusion
Slovak: PHARM 60 mg polvo para solución para perfusión infúzny roztok
English: Stada Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel,Germany
Slovak: Stada Arzneimittel AG, Stadastrasse 2-8, DE-61118 Bad Vilbel, Germany
English: RISEDRONATO SEMANAL STADA 35 mg comprimidos recubiertos con película film coated tablets
Slovak: RISEDRONATO SEMANAL STADA 35 mg comprimidos recubiertos con película
English: ACREL 75 mg comprimidos recubiertos con película film coated tablets
Slovak: ACREL 75 mg comprimidos recubiertos con película
English: Risedronatnatrium "Actavis"
Slovak: "Actavis"
English: Reykjavíkurvegi, 76-78 IS-220 Hafnarfjörour, Islândia
Slovak: Reykjavíkurvegi 76-78, 220 Hafnarfjordur, Iceland
English: Intramuscular
Slovak: Injekčný roztok
English: ACTONEL 75 mg comprimidos recubiertos con película film coated tablets
Slovak: ACTONEL 75 mg comprimidos recubiertos con película
English: Risedronato Winthrop 35 mg compresse rivestite con film film-coated tablets
Slovak: Risedronato Winthrop 35 mg compresse rivestite con
English: Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, united Kingdom
Slovak: Accord Healthcare Limited Sage Hopoužitie, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, united Kingdom
English: ÁCIDO ALENDRÓNICO SEMANAL CINFA 70 mg comprimidos
Slovak: ÁCIDO ALENDRÓNICO SEMANAL CINFA 70 mg comprimidos tablety
English: 10 MG/TAB TABLET
Slovak: 10 MG/TAB
English: RATIOPHARM GMBH Graf Arco-strasse, 3 Ulm D-89070
Slovak: Graf Arco-strasse, 3 Ulm D-89070
English: NL - Netherlands Accord Healthcare Limited, Sage House, 319, Pinner Road, North Harrow,
Slovak: Accord Healthcare Limited Sage Hopoužitie, 319 Pinner Road, North Harrow HA1
English: ÁCIDO ALENDRÓNICO SEMANAL RIMAFAR 70 mg comprimidos
Slovak: ÁCIDO ALENDRÓNICO SEMANAL RIMAFAR 70 mg comprimidos tablety
English: Alendronorm 70 mgeinmal wöchentlich Tabletten
Slovak: Alendronorm 70 mgeinmal wöchentlich
English: ÁCIDO ALENDRÓNICO SEMANAL CUVE 70 mg comprimidos
Slovak: ÁCIDO ALENDRÓNICO SEMANAL CUVE 70 mg comprimidos tablety
English: DK - Denmark Orion Corporation Orion Pharma, Orionintie 1, FI02200 Espoo, Finland
Slovak: Orion Corporation Orion Pharma, Orionintie 1, FI02200 Espoo, Finland
English: BONEFOS 400 mg, capsules capsules
Slovak: BONEFOS 400 mg, kapsuly kapsuly
English: Fostepor Once Weekly 70mg Tablets
Slovak: Once Weekly 70mg Tablety
English: 319 Pinner Road, North Harrow, Middlesex HA14HF, UK
Slovak: 10 & 11 Sage Hopoužitie 319 Pinner Road, North Harrow, Middlesex HA14HF, UK
English: DK - Denmark BLUEFISH PHARMACEUTICALS AB, Torsgatan 11, 111 23
Slovak: PHARMACEUTICALS AB, Torsgatan 11, 111 23
English: 220 Hafnarfjordur Iceland
Slovak: IS220 Hafnarfjördur, Iceland
English: Clodronic acid containing medicinal products with Marketing Authorisation in the European Union
Slovak: Lieky s obsahom kyseliny klodrónovej registrované v Európskej únii
English: ÁCIDO ALENDRÓNICO SEMANAL STADA 70 mg comprimidos
Slovak: ÁCIDO ALENDRÓNICO SEMANAL STADA 70 mg comprimidos tablety
English: Actonel® 5 mg, filmomhulde tabletten filmcoated tablets Oral use
Slovak: Actonel® 5 mg, filmomhulde tabletten
English: RISEMYL SEMANAL 35 mg comprimidos recubiertos con película film coated tablets
Slovak: RISEMYL SEMANAL 35 mg comprimidos recubiertos con película
English: Alendronsäure - 1 A Pharma 70 mg Filmtabletten
Slovak: Alendronat "1A Farma" 70 mg filmom obalené tablety perorálne
English: FARMALIDER 70 mg comprimidos recubiertos con película
Slovak: FARMALIDER 70 mg comprimidos recubiertos con película filmom obalené tablety perorálne
English: Fosamax tablet 70mg
Slovak: Fosamax week tablet 70 mg
English: ACIDO ALENDRONICO SEMANAL COMBIX 70 mg comprimidos recubiertos con película
Slovak: ACIDO ALENDRONICO SEMANAL COMBIX 70 mg comprimidos recubiertos con película filmom obalené tablety perorálne
English: tablets
Slovak: TABLETY
English: Alendronat Lek 70 mg filmsko obložene tablete
Slovak: ALENDRONATO ALMUS 70 mg filmom obalené tablety perorálne použitie
English: Actonel® 30 mg, filmomhulde tabletten filmcoated tablets Oral use
Slovak: Actonel® 30 mg, filmomhulde tabletten
English: Pamidronic acid containing medicinal products with Marketing Authorisation in the European Union
Slovak: Lieky s obsahom kyseliny pamidrónovej registrované v Európskej únii
English: RISEDRONATE ACTAVIS 35 mg filmtabletta mgRisedronate sodium (equivalent to 40,17 mg Risedronate sodium hemipentahydr ate film-coated tablet Oral use
Slovak: RISEDRONATE ACTAVIS 35 mg filmomtabletta mgRisedronate sodium (equivalent to 40,17 mg Risedronate sodium hemipentahydr ate
English: DE - Germany Basics GmbH Hemmelrather Weg 201
Slovak: DE - Nemecko Basics GmbH
English: 300 mg/5ml solution for infusion
Slovak: 300 mg/5ml infúzny roztok intravenózne použitie
English: ACTONEL SEMANAL 35 mg comprimidos recubiertos con película film coated tablets
Slovak: ACTONEL SEMANAL 35 mg comprimidos recubiertos con película
English: WARNER CHILCOTT ITALY Srl
Slovak: Warner Chilcott UK Ltd.;
English: Ranbaxy Ireland Ltd
Slovak: Ranbaxy Ireland
English: PHARMEG Srl
Slovak: PHARMA, S.L.c/
English: LOSENTRA SEMANAL 35 mg comprimidos recubiertos con película film coated tablets
Slovak: LOSENTRA SEMANAL 35 mg comprimidos recubiertos con película
English: DK - Denmark Ratiopharm GmbH, GrafArco-Strasse 3, DE-89079
Slovak: DK - Dánsko ratiopharm GmbH, GrafArco-Strasse 3, DE-89079 Ulm, Germany
English: SE - Sweden STADA Arzneimittel AG, Stadastrasse 2-18, DE61118 Bad Vilbel, Germany (DEU)
Slovak: Arzneimittel AG, Stadastrasse 2-18, DE61118 Bad Vilbel, Germany (DEU)
English: Pamidronate EG 3 mg/ml
Slovak: PAMIDRONATO TEVA 3 mg/ml
English: Risedronate Teva 35 mg filmomhulde tabletten film-coated tablets
Slovak: RISEDRONAT TEVA 35 mg filmom coated tablety
English: DK-2650 Hvidovre Denmark
Slovak: Hexal A/S Kanalholmen 8-12 DK-2650 Hvidovre Denmark
English: Actonel Plus calcium D 35 mg + 500 mg / 400 UI
Slovak: ACTONELCOMBI 35 mg + 500 mg/400
English: DK - Denmark Stada Arzneimittel AG, Stadastrasse 2-8, DE61118 Bad Vilbel, Germany
Slovak: Stada Arzneimittel AG, Stadastrasse 2-8, DE61118 Bad Vilbel, Germany
English: Arrow Generics Limited Unit 2, Eastman Way, Stevenage, Hertfordshire, SG14SZ
Slovak: SK - Slovensko Arrow Generics Limited Unit 2, Eastman Way, Stevenage, Hertfordshire, SG14SZ
English: ACTONEL 5 mg comprimidos recubiertos film coated tablets
Slovak: ACTONEL 5 mg comprimidos recubiertos
English: Ácido Alendrónico Ecosis 70 mg
Slovak: Ácido Alendrónico Alter 70 mg
English: SANOFI-AVENTIS AEBE SYNGROU AVENUE 348 BUILDING A KALITHEA 17675
Slovak: SYNGROU AVENUE 348 BUILDING A KALITHEA 17675
English: Alendromax 70 mg tabletki
Slovak: Alendromax 70 mg tabletki tablety
English: CLODRONATO TEVA 100 mg/3,3 ml
Slovak: CLODRONATO TEVA 100 mg/3,3 ml injekčný roztok intramuskulárne, intravenózne
English: PHARMACEUTICAL INDUSTRY PROEL EPAMEINONDAS G. KORONIS S.A.
Slovak: PHARMACEUTICAL INDUSTRY PROEL EPAMEINONDAS
English: MERCK SHARP AND DOHME DE ESPAÑA, S.A.Josefa Valcarcel, 38 28027 MADRID
Slovak: ES - Španielsko MERCK SHARP AND DOHME DE ESPAÑA, S.A.Josefa
English: Alendronsäure Mylan 70 mg Tabletten
Slovak: Mylan 70 mg Tabletten
English: PAMIDRONATO DISODICO COMBINO PHARM 15 mg polvo para solución para perfusión solution for infusion
Slovak: PHARM 15 mg polvo para solución para perfusión infúzny roztok
English: Coated tablet
Slovak: Ostac obalená tableta
English: Fosatrol Once weekly
Slovak: Fosalen Once
English: Prenteral
Slovak: Procter
English: Slow intravenous infusion
Slovak: roztok intravenózne použitie
English: PAMIDRONATO DISODICO COMBINO PHARM 30 mg polvo para solución para solution for infusion
Slovak: PHARM 30 mg polvo para solución para infúzny roztok
English: concentrate for solution for infusion, 5 ml
Slovak: infúzny koncentrát, 5 ml intravenózne použitie
English: ACTONEL 75 MG FILMCOATED TABLETS
Slovak: Actonel 75 mg filmomsko obložene tablete
English: Film-coated tablets + effervescent
Slovak: Filmomtabletten + Brapoužitiegranulat
English: SANOFI-AVENTIS AEBE SYNGROU AVENUE 348 BUILDING A KALITHEA 17676
Slovak: SYNGROU AVENUE 348 BUILDING A KALITHEA 17676
English: SANOFI-AVENTIS AEBE SYNGROU AVENUE 348 BUILDING A KALITHEA 17674
Slovak: SYNGROU AVENUE 348 BUILDING A KALITHEA 17674
English: SOLUTION FOR INFUSION Intravenous
Slovak: Intravenózne použitie
English: RISEDRONATE WINTHROP 35 mg, comprimé pelliculé film-coated tablet Oral use
Slovak: RISEDRONATE WINTHROP 35 mg, comprimé pelliculé
English: Fortipan film-coated tablet Oral use
Slovak: Densidron filmom obalené tablety perorálne použitie
English: Accord Healthcare Limited, Sage House, 319 Pinner Road, Harrow, Middlesex HA1 4HF, United Kingdom alendronic acid once weekly
Slovak: Pinner Road, Harrow, Middlesex HA1 4HF, United alendronic acid once weekly
English: DK - Denmark Merck Sharp & Dohme B.V., PO Box 581, Waarderweg 39, NL-2031 BN Haarlem, Nederlands
Slovak: & Dohme B.V., PO Box 581, Waarderweg 39, NL-2031
English: film coated tablets and efervescent granules
Slovak: Filmom obalené tablety a šumivý granulát
English: NORIFAZ 35 mg filmtabletta mgRisedronate sodium (equivalent to 40,17 mg Risedronate sodium hemipentahydr ate film-coated tablet Oral use
Slovak: NORIFAZ 35 mg filmomtabletta mgRisedronate sodium (equivalent to 40,17 mg Risedronate sodium hemipentahydr ate
English: For infusion
Slovak: FOR INFÚZNY
English: 6 mg/ml concentrate for solution for infusion - 10 ml
Slovak: 6 mg/ml infúzny koncentrát, 10 ml intravenózne použitie
English: Berghausen
Slovak: Berghapoužitien
English: 9 mg/ml concentrate for solution for infusion - 10 ml
Slovak: 9 mg/ml infúzny koncentrát, 10 ml intravenózne použitie
English: ACTONEL 5 MG FILMCOATED TABLETS
Slovak: Actonel 5 mg filmomsko obložene tablete
English: ACIDO ALENDRONICO SEMANAL ALMUS 70 mg comprimidos recubiertos con película
Slovak: ACIDO ALENDRONICO SEMANAL ALMUS 70 mg comprimidos recubiertos con película filmom obalené tablety perorálne
English: DE - Germany Accord Healthcare Limited Sage House, 319, Pinner Road
Slovak: Accord Healthcare Limited, Sage Hopoužitie, 319
English: ACTONEL OAW/"ONCE A WEEK" TABLETS 35MG
Slovak: Actonel Once a Week 35mg
English: SE - Sweden Ranbaxy (UK) Ltd 20 Baldertoon Street London W1K 6TL
Slovak: Ltd 20 Baldertoon Street London W1K 6TL United Kingdom
English: NL - Netherlands Mylan B.V. Dieselweg 25
Slovak: NL - Holandsko Mylan B.V.
English: ROCHE
Slovak: Cork
English: SANOFI-AVENTIS AEBE SYNGROU AVENUE 348 BUILDING A KALITHEA 17678
Slovak: SYNGROU AVENUE 348 BUILDING A KALITHEA 17678
English: Mepha Lda., Lagoas Park, 2740-298 Porto Salvo, Portugal
Slovak: Lagoas Park, 2740-298
English: SE - Sweden Orion Corporation, Orion Pharma
Slovak: Orion Corporation, Orion Pharma PO Box 65
English: film-coated tablet Oral use
Slovak: filmom obalená tableta perorálne použitie
English: Natriumrisedronaat 35 mg Ranbaxy filmcoated tablets Oral use
Slovak: Natriumrisedronaat 35 mg Ranbaxy
English: JUVERITAL 35 mg filmtabletta mgRisedronate sodium (equivalent to 40,17 mg Risedronate sodium hemipentahydr ate film-coated tablet Oral use
Slovak: JUVERITAL 35 mg filmomtabletta mgRisedronate sodium (equivalent to 40,17 mg Risedronate sodium hemipentahydr ate
English: Rigat film-coated tablets
Slovak: filmom obalené tablety perorálne
English: NL - Netherlands Merck Sharp & Dohme BV Waarderweg 39
Slovak: NL - Holandsko Merck Sharp
English: Osteomel Once weekly
Slovak: Osteomel Once weekly 70 mg
English: de Burgos, 16 D5ª Planta 28036 Madrid
Slovak: ES - Španielsko RATIOPHARM ESPAÑA, S.A.Avda. de Burgos, 16 D5ª Planta 28036
English: SANOFI-AVENTIS AEBE SYNGROU AVENUE 348 BUILDING A KALITHEA 17677
Slovak: SYNGROU AVENUE 348 BUILDING A KALITHEA 17677
English: 15 mg/ml powder and solvent for solution for infusion
Slovak: 15 mg/5 ml, poudre et solvant pour solution pour perfusion
English: AGUETTANT
Slovak: Hopoužitie
English: Bifodron film coated tablets
Slovak: Fosanate filmom obalené tablety perorálne
English: LU - Luxembourg arner Chilcott
Slovak: LU - Luxembursko HOSPIRA BENELUX
English: Pamidronate Medac 3mg/ml
Slovak: Medac 3mg/ml
English: Laboratórios AzevedosIndústria Farmacêutica, S.A. Estrada da Quinta, 148-148 A, Manique de Baixo
Slovak: Estrada da Quinta, 148-148
English: Clodrobon film-coated tablet
Slovak: Veckotablett filmom obalená tableta perorálne
English: FOSAMAX 70 MG
Slovak: FOSAMAX 70 MG 70 mg
English: Riseratio film-coated tablet Oral use
Slovak: Sedron filmom obalená tableta perorálne použitie
English: Film-Coated Tablets
Slovak: Filmom obalená tableta
English: Merck Sharp & Dohme BV Waarderweg 39, 2031 BN Haarlem, Netherlands
Slovak: & Dohme BV Waarderweg 39, 2031
English: D-61381 Friedrichsdorf
Slovak: Friedrichsdorf
English: Risedronat Adamed Pharma film-coated tablet Oral use
Slovak: Risedronato de sódio Pharmakern obalená tableta Perorálne použitie
English: Natriumrisedronaat Ceft 5 mg filmcoated tablets Oral use
Slovak: Natriumrisedronaat Ceft 5 mg
English: NOVARTIS PHARMA GmbH Roonstrasse 25 D-90429 Nürnberg, Germany
Slovak: Roonstrasse 25 D-90429
English: Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow HA1 4HF, Middlesex UNITED KINGDOM
Slovak: Accord Healthcare Limited Sage Hopoužitie 319, Pinner Road North Harrow Middlesex HA1 4 HF United Kingdom
English: Aramis Pharma Kft. Mester u. 28.
Slovak: Mester u. 28.
English: SE - Sweden Zaklad Farmaceutyczny Adamed Pharma S.A., ul.
Slovak: PT - Portugalsko Zaklad Farmaceutyczny Adamed Pharma S.A.,
English: Alendronat Interpharm
Slovak: Alendronat Interpharm 10 mg
English: Risedronaatnatrium Mylan Wekelijks 35 mg filmcoated tablets Oral use
Slovak: Risedronaatnatrium Mylan Wekelijks 35 mg
English: Ostenil
Slovak: MASTELLI
English: PAMIRED 60 powder for solution for infusion powder for solution for infusion
Slovak: PAMIRED 60 powder for infúzny roztok prášok na infúzny roztok parenterálne
English: BE - Belgium Arrow Generics Limited 2 Eastman Way, Stevenage, Hertfordshire, SG1 4SZ, United Kingdom
Slovak: Arrow Generics Limited 2 Eastman Way, Stevenage, Hertfordshire, SG1 4SZ, United Kingdom
English: Bucureşti-Ploieşti, Nr. 1A,Clădirea C1, Etaj 3,Sector 1, Bucureşti, România
Slovak: 1A,Clădirea C1, Etaj
English: Actonel® 75 mg, filmomhulde tabletten filmcoated tablets Oral use
Slovak: Actonel® 75 mg, filmomhulde tabletten
English: Lagoas Park, Edifício 5 A - Piso 2,
Slovak: Lagoas Park, Edifício 5
English: TABLET
Slovak: Tabletten
English: 3MG/1 ML
Slovak: 3MG/1
English: Fostolin Once Weekly 70mg Tablets
Slovak: Bluefish Once weekly 70 mg Tablety tablety
English: ACTONEL ONCE A WEEK 35 MG FILMCOATED TABLETS
Slovak: ACTONEL ONCE A WEEK 35 MG FILMOM- COATED
English: SANDOZ FARMACEUTICA, S.A.Avda.
Slovak: ES - Španielsko SANDOZ FARMACEUTICA,
English: ACTAVIS GROUP PTC EHF., ICELAND
Slovak: Actavis Group PTC ehf
English: Alendronat Pharmabill
Slovak: Risedronat Adamed Pharma
English: Ácido Alendrónico ToLife 70 mg Comprimidos
Slovak: Ácido Alendrónico ToLife 70 mg
English: SE - Sweden ratiopharm GmbH, GrafArco-Strasse 3, DE-89079
Slovak: SE - Švédsko ratiopharm GmbH, GrafArco-Strasse 3, DE-89079 Ulm, Germany
English: ACTONEL 30 mg, comprimé pelliculé film-coated tablet Oral use
Slovak: ACTONEL 30 mg, comprimé pelliculé
English: ALENDRONATO EG
Slovak: Alendroninezuur
English: NL - Netherlands All-gen Pharmaceuticals & Generics B.V.
Slovak: & Generics B.V.
English: BIOGARAN
Slovak: Zaragoza
English: RO - Romania TORREX CHIESI PHARMA GmbH Gonzagagasse
Slovak: ET - Estónsko Torrex Chiesi Pharma GmbH
English: Zaklad Farmaceutyczny Adamed Pharma S.A. 33 Szkolna Street, 95-054 Ksawerow
Slovak: Zaklad Farmaceutyczny Adamed Pharma S.A., ul. Szkolna 33 95-054
English: Ibamyl film-coated tablet Oral use
Slovak: Ostolek filmom obalené tablety perorálne použitie
English: Bonefos film-coated tablet
Slovak: BONEFOS FILMOMTABLET TEN
English: BEXAL FARMACEUTICA, S.A Centro Empresarial Osa Mayor.
Slovak: ES - Španielsko BEXAL FARMACEUTICA,
English: Reykjavikurvegi 76-78, IS220 Hafnarfjördur, Iceland
Slovak: Reykjavikurvegi 76-78, 220 Hafnarfjordur, Iceland
English: film-coated tablet/effervesce nt granules
Slovak: Filmom obalené tablety šumivý granulát
English: COMBINO PHARM, S.L.Fructuos Gelabert, 6-8 08970 Sant Joan Despi
Slovak: ES - Španielsko COMBINO PHARM, S.L.Fructuos Gelabert, 6-8
English: Bonefos pro infusione 75 mg
Slovak: 75 mg Infúzny koncentrát intravenózne
English: Adronat Once weekly
Slovak: Adronat Once weekly 70mg
English: 70 mg Tablets
Slovak: Medana 70 mg tablety
English: ACTONEL COMBI D 35 mg + 500 mg/400 UI film coated tablets
Slovak: D 35 mg + 500 mg/400 UI filmom coated tablety
English: The CHMP considered that this information does not impact the safety and efficacy profile of MACI but that in the absence of an authorised manufacturing site, the requirements laid down in Article 41 of Directive 2001/83/EC are no longer met.
Slovak: Výbor CHMP usúdil, že táto informácia neovplyvní profil bezpečnosti a účinnosti MACI, ale vzhľadom na neprítomnosť schváleného výrobného miesta už nie sú splnené požiadavky uvedené v článku 41
English: Ref. EMEA/477488/2008
Slovak: Dok. č.: EMEA/548388/2008
English: International non-proprietary name (INN): dalbavacin
Slovak: Medzinárodný nechránený názov (INN): dalbavacin
English: It contains the active substance dalbavancin.
Slovak: Obsahuje účinnú látku dalbavancin.
English: This kills the bacteria causing the infection.
Slovak: Tým dochádza k zničeniu baktérií spôsobujúcich infekciu.
English: The company presented the results of one main study that compared the effects of EXULETT with those of linezolid (another antibiotic) in 873 adults.
Slovak: Spoločnosť predložila výsledky jednej hlavnej štúdie, v ktorej sa porovnávali účinky lieku EXULETT s účinkami linezolidu (iné antibiotikum) u 873 dospelých.
English: The main measure of effectiveness was the number of patients whose infection was treated successfully and who did not need further treatment with any other antibiotics.
Slovak: Hlavnou mierou účinnosti bol počet pacientov, v prípade ktorých bola liečba infekcie úspešná a ktorí nepotrebovali ďalšiu liečbu inými antibiotikami.
English: These bacteria include Staphylococcus aureus (including ‘methicillin-resistant' forms known as ‘MRSA') and Streptococcus pyogenes.
Slovak: Medzi tieto baktérie patria Staphylococcus aureus (vrátane foriem „rezistentných voči meticilínu“ známych ako „MRSA“) a Streptococcus pyogenes.
English: Questions and answers on the withdrawal of the marketing application for EXULETT
Slovak: Otázky a odpovede týkajúce sa stiahnutia žiadosti o povolenie na uvedenie na trh pre
English: There were also concerns over whether EXULETT could be manufactured with consistent good quality.
Slovak: Ďalšie výhrady sa týkali toho, či je možné liek EXULETT vyrábať stále v dobrej kvalite.
English: The active substance in EXULETT, dalbavancin, is an antibiotic that belongs to the group ‘glycopeptides'.
Slovak: Účinná látka lieku EXULETT, dalbavancin, je antibiotikum, ktoré patrí do skupiny tzv. glykopeptidov.
English: What are the consequences of the withdrawal for patients undergoing clinical trials with EXULETT?
Slovak: Aké sú dôsledky stiahnutia žiadosti pre pacientov, ktorí sa zúčastňujú na klinických skúškach lieku EXULETT?
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials of EXULETT.
Slovak: Spoločnosť informovala výbor CHMP, že pre pacientov, ktorí sú v súčasnosti zapojení do klinických skúšok skúmajúcich liek EXULETT, nevyplývajú žiadne dôsledky.
English: The effects of EXULETT were first tested in experimental models before being studied in humans.
Slovak: Účinok lieku EXULETT sa najprv skúmal na pokusných modeloch a potom na ľuďoch.
English: It is expected to work by stopping the bacteria making their cell walls.
Slovak: Mal by účinkovať tak, že zabráni baktériám v tvorbe bunkových stien.
English: In addition, the CHMP was concerned over the relevance of the results of the main study, since not all of the patients included in the study seemed to have an infection that was severe enough to need antibiotic treatment given by infusion into a vein.
Slovak: Okrem toho výbor CHMP mal výhrady voči relevantnosti výsledkov hlavnej štúdie, keďže zrejme nie všetci pacienti zapojení do štúdie trpeli na infekciu, ktorá bola dostatočne závažná na to, aby si vyžadovala liečbu antibiotikami podávanými vo forme infúzie do žily.
English: The patients included in this study were required to have complicated skin and soft tissue infections (such as abscesses or wound infections) that were due to Gram-positive bacteria.
Slovak: Pacienti zapojení do štúdie museli mať komplikované infekcie kože a mäkkého tkaniva (ako abscesy alebo infekcie rán), ktoré boli zapríčinené grampozitívnymi baktériami.