natgillin/translations-raw huggingface dataset:
NL - Holland Medac Gesellschaft für klinische Spezialpreparate mbH 
NL - Netherlands Medac Gesellschaft für klinische Spezialpreparate mbH
2031 BN Haarlem Netherlands 
2031 BN Haarlem
D-76327 PfinztalBerghausen 
D-76327 Pfinztal
HU - Ungarn Torrex Chiesi Pharma GmbH 
HU - Hungary Torrex Chiesi Pharma GmbH
DK-5260 Odense S Denmark 
DK-5260 Odense S
UK - Storbritannien Strandhaven Limited, 600 High Road, Seven Kings, Ilford, Essex IG3 8BS, 
Strandhaven Limited, 600 High Road, Seven Kings, Ilford, Essex IG3 8BS, United Kingdom alendronic acid
ES - Spanien MYLAN PHARMACEUTICALS, S.L. 
MYLAN PHARMACEUTICALS, S.L.
Koncentrat til infusionsvaeske 
Concentrate for infusion Intravenous
EL - Grækenland ALET PHARMACEUTICALS ABEE 
ALET PHARMACEUTICALS ABEE
Overtrukket tablet 
Skelid tablet
FR - Frankrig BAYER SANTE 220, avenue de la Recherche 
BAYER SANTE 220, avenue de la Recherche 59120 Loos FRANCE
Genericon Pharma Gesellschaft m.b.H. 
NL - Netherlands Genericon Pharma Gesellschaft m.b.H.
BG - Bulgarien Novartis Pharma GmbH, Roonstrasse 25, D-90429 
BG - Bulgaria Novartis Pharma GmbH, Roonstrasse 25, D-90429
UK - Storbritannien Prostrakan Limited, 3 Galabank Business Park, Queen Street, Galashiels, TD1 1QH, United Kingdom 
Galabank Business Park, Queen Street, Galashiels, TD1 1QH, United Kingdom
BG - Bulgarien Atavis EAD 1407 Sofia 
Atavis EAD 1407 Sofia 29 Atanas Dukov Str. Bulgaria
167 14 Bromma Sweden 
167 14 Bromma
DE - Tyskland acis Arzneimittel GmbH Lil-Dagover-Ring 7 
DE - Germany acis Arzneimittel GmbH Lil-Dagover-Ring 7
169,32 mg Filmovertrukket tablet Oral anvendelse 
169,32 mg Film-coated tablet
DK - Danmark Pharmathen S.A., Dervenakion str. 6, GR15351 Pallini Attiki, Greece 
DK - Denmark Pharmathen S.A., Dervenakion str. 6, GR15351 Pallini Attiki, Greece
MARATHONOS 106, GERAKAS 15344 
PHARMANEL PHARMACEUTICALS S.A. MARATHONOS 106, GERAKAS 15344
Pamidronaat dinatrium 90 mg 90 mg 
Pamidronaat dinatrium 90 mg
EL - Grækenland SANDOZ GMBH, KUNDL, AUSTRIA 
SANDOZ GMBH, KUNDL, AUSTRIA
ACHAIAS AND TROIZINIAS, KIFISSIA 14564 
FARAN ABEE PRODUCTION AND COMMERCE OF MEDICINAL PRODUCTS ACHAIAS AND TROIZINIAS, KIFISSIA 14564
Actonel Plus Ca & D 35mg film-coated tablets + 1000mg/800 IU Effervescent Granules 
Actonel Plus Ca & D 35mg film-coated tablet + 1000mg/800 IU Effervescent Granules
RO - Rumænien AVENTIS PHARMA AB Bryggvagen 16-18, 11768 
AVENTIS PHARMA AB Bryggvagen 16-18, 11768 Stockholm, Sweden
DK - Danmark Actavis Group PTC ehf., PO Box 425, Reykjavikurvegi 76-78, IS-220 
DK - Denmark Actavis Group PTC ehf., PO Box 425, Reykjavikurvegi 76-78, IS-220
RO - Rumænien SANDOZ S.R.L. 
SANDOZ S.R.L.
Risedronate Sodium 35mg Once A Week film-coated tablets 
Risedronate Sodium 35mg Once A Week Film-Coated Tablets film-coated tablets
Arrow ApS, Hovedgaden 41, 2, DK-2970 Hørsholm, Denmark 
DK - Denmark Arrow ApS, Hovedgaden 41, 2, DK-2970 Hørsholm,
RO - Rumænien TERAPIA SA,Str. 
TERAPIA SA,Str.
Mommaertslaan 14 1831 Diegem-Machelen Belgium 
1831 Diegem-Machelen Belgium
ProduktionsgmbH, Effingerstrasse 21, AT-1160 Wien, Austria (AUT) 
SE - Sweden Interpharm ProduktionsgmbH, Effingerstrasse 21, AT-1160 Wien, Austria (AUT)
ES - Spanien KERN PHARMA, S.L. 
KERN PHARMA, S.L.
HU - Ungarn Actavis Group PTC ehf. 
SE - Sweden Actavis Group PTC ehf.
RO - Rumænien TERAPIA SA Str. Fabricii nr. 124, ClujNapoca, Romania 
Str. Fabricii nr. 124, ClujNapoca, Romania
Accord Healthcare Limited Sage House, 319, Pinner Road 
DE - Germany Accord Healthcare Limited Sage House, 319, Pinner Road
markedsføringstilladelse DE - Tyskland axios Pharma GmbH Hauptstr. 
DE - Germany axios Pharma GmbH Hauptstr.
BE - Belgien Actavis Group PTC EHF Reykjavikuregur 76-78 
BE - Belgium Actavis Group PTC EHF Reykjavikuregur 76-78
Pamidronaat dinatrium 60 mg 60 mg 
Pamidronaat dinatrium 60 mg
PHARMACEUTICALS 
PHARMACEUTICAL INDUSTRY
ES - Spanien RATIOPHARM ESPAÑA, S.A .Avda. 
RATIOPHARM ESPAÑA, S.A .Avda.
Pamidronaat dinatrium 30 mg 30 mg 
Pamidronaat dinatrium 30 mg
EL - Grækenland IASIS PHARMAC.HELLAS 137 FYLIS AVENUE 
IASIS PHARMAC.HELLAS 137 FYLIS AVENUE KAMATERO 13451
HU - Ungarn Bayer Schering Pharma Oy Pansiontie 47. 
Bayer Schering Pharma Oy Pansiontie 47.
Tablet og Filmovertrukket tablet 
Tablet and film-coated tablet
EL - Grækenland VIOFAR LTD ETHNIKIS ANTISTASEWS & TRIZINIAS 
ETHNIKIS ANTISTASEWS & TRIZINIAS
Warner Chilcott Nederland B.V. 
NL - Netherlands Warner Chilcott Nederland B.V.
BG - Bulgarien Actavis Group PTC ehf, Iceland Reykjavikurvegur 76-78, IS-220, 
BG - Bulgaria Actavis Group PTC ehf, Iceland Reykjavikurvegur 76-78, IS-220,
C.F. Tietgens Boulevard 40 DK-5220 Odense SØ Denmark 
SE - Sweden Sandoz A/S C.F. Tietgens Boulevard 40 DK-5220 Odense SØ Denmark
TECNIMEDE - Sociedade Técnico-Medicinal, S.A. (BS 
DE - Germany TECNIMEDE - Sociedade Técnico-Medicinal, S.A. (BS
Tablet og Brusetablet 
tablet and chewing tablet
EL - Grækenland FARMATHEN HELLAS ABEE MARATHONOS AVENUE 144 
FARMATHEN HELLAS ABEE MARATHONOS AVENUE 144 PALLINI 15351
Orifarm Generixs A/S Energivej 15 
DE - Germany Orifarm Generixs A/S Energivej 15
LT - Litauen Hospira UK Limited, Queensway Royal 
LT - Lithuania Hospira UK Limited, Queensway Royal
Alendronsäure 'Arcana' 70 mgeinmal wöchentlichTabletten 
Alendronsäure 'Arcana' 70 mg - einmal wöchentlichTabletten
Merck Sharp & Dohme BV, PO Box 581, NL-2003 PC Harlem, Netherlands (NLD) 
SE - Sweden Merck Sharp & Dohme BV, PO Box 581, NL-2003 PC Harlem, Netherlands (NLD)
Koncentrat til infusionsvaeske, opløsningg, 5 ml 
concentrate for solution for infusion, 5 ml
DE - Tyskland biomo pharma GmbH Josef-Diezgen-Str 3 D-53773 Hennef 
DE - Germany biomo pharma GmbH Josef-Diezgen-Str 3
Optinate 75mg filmcoated tablets 
Optinate 75mg Filmcoated Tablets film-coated tablets
DK - Danmark Hospira UK Limited, Queensway, Royal 
DK - Denmark Hospira UK Limited, Queensway, Royal
PAMIRED 30 powder for solution for infusion 
PAMIRED 30 powder for solution for infusion powder for solution for infusion
HU - Ungarn Hospira UK Limited Queensway, Royal 
HU - Hungary Hospira UK Limited Queensway, Royal
65 Delamere Road, Hayes Middlesex UB4 ONN United Kingdom 
NL - Netherlands Iono Limited 65 Delamere Road, Hayes Middlesex UB4 ONN United Kingdom
NL - Holland Centrafarm Services B.V. 
NL - Netherlands Centrafarm Services B.V. Nieuwe Donk 9
PAMIRED 60 powder for solution for infusion 
PAMIRED 60 powder for solution for infusion powder for solution for infusion
90MG/VIAL Pulver og opløsning til infusionsvæske 
90MG/VIAL POWDER AND SOLUTION FOR INFUSION
SK - Slovakiet ratiopharm GmbH Graf-Arco-Strasse 3 Ulm, 89079 
SK - Slovakia ratiopharm GmbH Graf-Arco-Strasse 3 Ulm, 89079
RISEDRONAT SODIC HF 35 mg, film-coated tablets 
RISEDRONAT SODIC HF 35 mg, film coated tablets film coated tablets
UK - Storbritannien Dr Reddy's Laboratories (UK) Limited, 6 Riverview Road, Beverley, East 
Dr Reddy's Laboratories (UK) Limited, 6 Riverview Road, Beverley, East Yorkshire HU17 0LD, United Kingdom alendronic acid
Pulver til injektionsvæske Intravenøs anvendelse 
Powder for Injection
BG - Bulgarien Genericon Pharma Gesellschaft m.b.H, Hafnerstabe 211, 8054 
Genericon Pharma Gesellschaft m.b.H, Hafnerstabe 211, 8054 Graz, Austria
EL - Grækenland VERISFIELD (UK) LTD, U.K. 41 Chalton street, 
VERISFIELD (UK) LTD, U.K. 41 Chalton street, London, NW1 1JD, United Kingdom
Biomedica Foscama Industria ChimicoFarmaceutica S.p.A. 
NL - Netherlands Biomedica Foscama Industria Chimico
EL - Grækenland MEDICUS S.A. VALAORITOU 10 
SE - Sweden HELP S.A. Pharmaceuticals 10, Valaoritou Str.
RO - Rumænien S.C. TEVA PHARMACEUTICALS S.R.L.,Str. 
PHARMACEUTICALS S.R.L.,Str.
RO - Rumænien BLUEFISH PHARMACEUTICALS AB, Torsgatan 11, 111 23 
DK - Denmark BLUEFISH PHARMACEUTICALS AB, Torsgatan 11, 111 23
DK - Danmark Stada Arzneimittel AG, Stadastrasse 2-8, DE61118 Bad Vilbel, Germany 
DK - Denmark Stada Arzneimittel AG, Stadastrasse 2-8, DE61118 Bad Vilbel, Germany
NL - Holland Nordic Pharma B.V. 
NL - Netherlands Nordic Pharma B.V. Tolweg 15
ET - Estland ratiopharm GmbH Graf-Arco-Strasse 3 D-89079 Ulm GERMANY 
ET - Estonia ratiopharm GmbH Graf-Arco-Strasse 3 D-89079 Ulm GERMANY
SI - Slovenien Novartis Pharma GmbH, Roonstrasse 25, Nuernberg D-90429 , Germany 
Novartis Pharma GmbH, Roonstrasse 25, Nuernberg D-90429 , Germany
UK - Storbritannien Resource Medical (UK) Limited, 2 Carlton Avenue, Batley, West Yorkshire 
Resource Medical (UK) Limited, 2 Carlton Avenue, Batley, West Yorkshire WF17 7AQ, United Kingdom alendronic acid
Koncentrat til infusionsvaeske, opløsning 
Concentrat for infusion, solution
15 mg Pulver og solvens 
15 mg/5 ml powder and solvent
BONEFOS 400 mg cápsulas 
BONEFOS 400 mg cápsulas capsules
NO - Norge ratiopharm GmbH, GrafArco-Strasse 3, D-89070 Ulm Germany 
NO - Norway ratiopharm GmbH, GrafArco-Strasse 3, D-89070 Ulm Germany
SK - Slovakiet medac GmbH Theaterstraße 6 D-22880 Wedel Germany 
SK - Slovakia medac GmbH Theaterstraße 6
PLIVA Pharma Ltd, Vision House, Bedford Road, Petersfield Hampshire, GU32 3QB, United Kingdom and Northern Ireland 
Pliva Pharma Limited, Vision House, Bedford Road, Petersfield, Hampshire GU23 3QB, United Kingdom alendronic acid
Ovamex Limited 118 larch crescent GB-UB4 9EB HAYES, MIDDLESEX 
GB-UB4 9EB HAYES, MIDDLESEX
PL - Polen ratiopharm GmbH Graf-Arco-Strasse 3, Ulm, 89073, Germany 
PL - Poland ratiopharm GmbH Graf-Arco-Strasse 3, Ulm, 89073, Germany
DK - Danmark LABORMED-PHARMA S.A., Theodor Pallady Boulevard 44B, Sector 3, RO-032266 
DK - Denmark LABORMED-PHARMA S.A., Theodor Pallady Boulevard 44B, Sector 3, RO-032266
EL - Grækenland GENEPHARM S.A. 18km MARATHONOS AVENUE 
18km MARATHONOS AVENUE
Filmovertrukket tablet og Brusegranulat 
film coated tablets and efervescent granules
200MG/CAP Kapsel, hård 
200MG/CAP HARD CAPSULE
Filmovertrukket tablet Oral anvendelse 
film-coated tablet Oral use
90 mg Pulver og solvens 
90 mg/10 ml powder and solvent
RO - Rumænien TEVA PHARMACEUTICALS S.R.L. 
TEVA PHARMACEUTICALS S.R.L.
Sanofi-Aventis Belgium NV Culliganlaan 1C 1831 Diegem Belgium 
BE - Belgium Sanofi-Aventis Belgium NV Culliganlaan 1C
IBANDRONAT indeholder medicinsk product med markeføringstilladelse i den Europoeiske Union 
Ibandronic acid containing medicinal products with Marketing Authorisation in the European Union
60MG/VIAL Pulver og opløsning til infusionsvæske 
60MG/VIAL POWDER AND SOLUTION FOR INFUSION
OSTEORON 35 mg film-coated tablets 
OSTEORON 35 mg film coated tablets film coated tablets
60 mg Pulver og solvens 
60 mg/10 ml powder and solvent
ATHENS 12131 
KIFISSOU AVENUE 132 ATHENS 12131
NL - Holland Mylan B.V. 
NL - Netherlands Mylan B.V. Dieselweg 25
BE - Belgien Teva Pharma Belgium N.V. 
BE - Belgium Teva Pharma Belgium N.V. Laarstraat 16
ES - Spanien SANDOZ FARMACEUTICA, S.A. Avda. 
SANDOZ FARMACEUTICA, S.A. Avda.
Intramuskulær anvendelse 
Intramuscular
Ácido Alendrónico J. Neves 70 mg Comprimidos 
Ácido Alendrónico J. Neves 70 mg
300MG/CAP Kapsel, hård 
300MG/CAP HARD CAPSULE
Street, Guildford, Surrey GU1 4YS, United Kingdom alendronic acid 
Winthrop Pharmaceuticals UK Limited, One Onslow Street, Guildford, Surrey GU1 4YS, United Kingdom alendronic acid
Industrial Estate, Wrexham LL13 9UF, UK 
Wockhardt UK Limited, Ash Road North, Wrexham Industrial Estate, Wrexham LL13 9UF, UK
RISENDROS 35 mg film-coated tablets 
RISENDROS 35 mg 35 mg film-coated tablets
LT - Litauen Torrex Chiesi -Pharma GmbH, Gonzagagasse 16/16, 1010 Viena, Austria 
LT - Lithuania Torrex Chiesi -Pharma GmbH, Gonzagagasse 16/16, 1010 Viena, Austria
LV - Letland ratiopharm GmbH, GrafArco-Str.3, 89079 Ulm, Germany 
LV - Latvia ratiopharm GmbH, GrafArco-Str.3, 89079 Ulm, Germany
ACHAIAS AND TRIZINIAS NEA KIFISSIA 14564 
ROTTAPHARM HELLAS S.A. PRDUCTION AND COMMERCE OF PHARMACEUTICALS ACHAIAS AND TRIZINIAS NEA KIFISSIA 14564
EU/EØS 
HELP ΑΒΕΕ
NERIDRONAT indeholder medicinsk product med markeføringstilladelse i den Europoeiske Union 
Neridronic acid containing medicinal products with Marketing Authorisation in the European Union
DK - Danmark CT Arzneimittel GmbH, Lengeder Str. 42A, DE13407 Berlin, Germany 
DK - Denmark CT Arzneimittel GmbH, Lengeder Str. 42A, DE
Risedronate 5mg filmcoated tablets 
Risedronate 5mg film coated tablets
RO - Rumænien ACTAVIS S.R.L. 
ACTAVIS S.R.L.
Risedronate Sodium Actavis 5 mg filmcoated tablets 
Risedronate Sodium Actavis 5 mg film-coated tablets film-coated tablets
400MG/CAP Kapsel, hård 
400MG/CAP HARD CAPSULE
5,0 mg Risedronate sodium (equivalent to 5,74 mg Risedronate sodium hemipentahydrate 
5,0 mg Risedronate sodium (equivalent to 5,74 mg Risedronate sodium hemipentahydr ate film-coated tablet Oral use
Parenteral anvendelse 
Parenteral
LT - Litauen ratiopharm GmbH, GrafArco-Strasse 3, Ulm D89079, Germany 
LT - Lithuania ratiopharm GmbH, GrafArco-Strasse 3, Ulm D89079, Germany
Norsed Combi D 35 mg + 500 mg/400 IE 
Avestra Combi D 35 mg + 500 mg/400 IE
ES - Spanien ZAKLAD FARMACEUTYCZNY ADAMED PHARMA, S.A. ul. 
SE - Sweden Zaklad Farmaceutyczny Adamed Pharma S.A., ul.
AbZ-Pharma GmbH Dr.Georg-Spohn-Str. 7 D-89143 Blaubeuren 
DE - Germany AbZ-Pharma GmbH Dr.Georg-Spohn-Str. 7
Risedronate Sodium Actavis 35 mg filmcoated tablets 
Risedronate Sodium Actavis 35 mg film-coated tablets film-coated tablets
SAPTAMANAL 35 mg film-coated tablets 
SAPTAMANAL 35 mg film coated tablets film coated tablets
Risedronate Sodium Actavis 30 mg filmcoated tablets 
Risedronate Sodium Actavis 30 mg film-coated tablets film-coated tablets
Orifarm Generics A/S, Postbox 69, Energivej 15, DK-5260 Odense S, Denmark 
DK - Denmark Orifarm Generics A/S, Postbox 69, Energivej 15, DK-5260 Odense S,
ES - Spanien HOSPIRA UK LIMITED Queensway. 
HOSPIRA UK LIMITED Queensway.
KORONIS S.A. 
MEDICUS S.A.
ALENDRONAT indeholder medicinsk product med markeføringstilladelse i den Europoeiske Union 
Alendronic acid containing medicinal products with Marketing Authorisation in the European Union
DK - Danmark Ratiopharm GmbH, GrafArco-Strasse 3, DE-89079 
DK - Denmark Ratiopharm GmbH, GrafArco-Strasse 3, DE-89079
DK - Danmark ratiopharm GmbH, GrafArco-Strasse 3, DE-89079 
DK - Denmark ratiopharm GmbH, GrafArco-Strasse 3, DE-89079
70 mg Filmovertrukket tablet Oral anvendelse 
70 mg film - coated tablets Oral Use
KORINTHOU 12 
VALAORITOU 10
NL - Holland Pharmachemie B.V. 
NL - Netherlands Pharmachemie B.V. Swensweg 5
PAMIDRONATO DISODICO COMBINO PHARM 30 mg polvo para solución para perfusión 
PAMIDRONATO DISODICO COMBINO PHARM 30 mg polvo para solución para solution for infusion
Optinate Combi D 35 mg and 1000 mg/880 IU 
Optinate Combi D 35 mg and 1000 mg/880
ETIDRONAT indeholder medicinsk product med markeføringstilladelse i den Europoeiske Union 
Etidronic acid containing medicinal products with Marketing Authorisation in the European Union
35,0 mg Risedronate sodium (equivalent to 40,17 mg Risedronate sodium hemipentahydrate 
35,0 mg Risedronate sodium (equivalent to 40,17 mg Risedronate sodium hemipentahydr ate film-coated tablet Oral use
Torrex Chiesi -Pharma GmbH, Gonzagagasse 16/16, 1010 Viena, Austria 
Torrex Chiesi Pharma GmbH, Gonzagagasse 16/16, 1010 Vienna, Austria
NL - Holland Roche Nederland B.V. 
NL - Netherlands Roche Nederland B.V. Beneluxlaan 2a
BG - Bulgarien ratiopharm GmbH, GrafArco-Strasse 3, 89079 Ulm, Germany 
BG - Bulgaria ratiopharm GmbH, GrafArco-Strasse 3, 89079 Ulm, Germany
Empreendimento Lagoas Park, Edifício 7 - 3º, 2740-244 Porto Salvo Portugal 
Sanofi-Aventis - Produtos Farmacêuticos, S.A. Empreendimento Lagoas Park, Edifício 7 - 3º, 2740-244 Porto Salvo Portugal
RISEDRONAT TEVA 35 mg film-coated tablets 
Risedronate Teva 35 mg filmomhulde tabletten film-coated tablets
TEVA Pharma Belgium N.V, Laarstraat 16, B-2610 Wilrijk, Belgium 
BE - Belgium TEVA Pharma Belgium N.V, Laarstraat 16,
CLODRONAT indeholder medicinsk product med markeføringstilladelse i den Europoeiske Union 
Clodronic acid containing medicinal products with Marketing Authorisation in the European Union
HIGHWAY ATHENS-LAMIA KIFISSIA 14566 
UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES 14KM OF NATIONAL HIGHWAY ATHENS-LAMIA KIFISSIA 14566
OSODENS 35 mg filmcoated tablets 
OSODENS 35 mg film coated tablets film coated tablets
Optinate Once a Week 35mg film-coated tablets 
Optinate Once a Week 35mg Film-coated Tablets film-coated tablets
Heizel Esplanade b22 
BE - Belgium Eurogenerics N.V. Heizel Esplanade b22
Actonel 75 Milligram film-coated tablets 
Actonel 75 Milligram Film Coated Tablets film-coated tablets
JUVERITAL 35 mg film-coated tablets 
JUVERITAL 35 mg film coated tablets film coated tablets
GB-HA1 4HF NORTH HARROW, MIDDLESEX 
GB-HA1 4HF NORTH
HIGHWAY ATHENS-LAMIA KIFISSIA 14564 
UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES 14KM OF NATIONAL HIGHWAY ATHENS-LAMIA KIFISSIA 14564
Stada Arzneimittel AG, Stadastrasse 2-8, DE-61118 Bad Vilbel, Germany 
Stada Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel,Germany
PAMIDRONAT indeholder medicinsk product med markeføringstilladelse i den Europoeiske Union 
Pamidronic acid containing medicinal products with Marketing Authorisation in the European Union
RO - Rumænien ACCORD HEALTHCARE LIMITED, Sage house, 319 
SE - Sweden Accord Healthcare Limited Sage House
SI - Slovenien Bayer Schering Pharma Oy, Pansiontie 47, 20210 Turku, Finland 
Bayer Schering Pharma Oy, Pansiontie 47, 20210 Turku, Finland
Bluefish Pharmaceuticals AB, Torsgatan 11 
NL - Netherlands Bluefish Pharmaceuticals AB, Torsgatan 11
2031 GA Haarlem Netherlands 
GA Haarlem, Nederlands
Ridate Once a Week 35mg film-coated tablets 
Ridate Once a Week 35mg film-coated tablets film-coated tablets
HIGHWAY ATHENS-LAMIA KIFISSIA 14565 
UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES 14KM OF NATIONAL HIGHWAY ATHENS-LAMIA KIFISSIA 14565
EL - Grækenland SANOFI-AVENTIS AEBE SYNGROU AVENUE 348 
SANOFI-AVENTIS AEBE SYNGROU AVENUE 348 BUILDING A KALITHEA 17678
Orion Corporation Orion Pharma, Orionintie 1, FI02200 Espoo, Finland 
DK - Denmark Orion Corporation Orion Pharma, Orionintie 1, FI02200 Espoo, Finland
LORINE 35 mg filmcoated tablets 
LORINE 35 mg film coated tablets film coated tablets
STADA Arzneimittel AG, Stadastrasse 2-18, DE61118 Bad Vilbel, Germany (DEU) 
SE - Sweden STADA Arzneimittel AG, Stadastrasse 2-18, DE61118 Bad Vilbel, Germany (DEU)
Risontel Once a week 35mg film-coated tablets 
Risontel Once a week 35mg film-coated tablets film-coated tablets
DE - Tyskland 
EL - Greece
AREDIA DRY POWDER 
AREDIA DRY POWDER 15 mg
Apotex Europe B.V. 
Apotex Europe B.V. Darwinweg 20.
ACTONEL OAW 35MG/TAB 
ACTONEL OAW 35MG/TAB FILM COATED TABLET
Actonel Once A Week 35 mg film-coated tablets 
Actonel Once A Week 35 mg film-coated tablets film-coated tablets
RISEDRONAT indeholder medicinsk product med markeføringstilladelse i den Europoeiske Union 
Risedronic acid containing medicinal products with Marketing Authorisation in the European Union
ACHARNES ATTIKIS 13675 
KLEVA AFBEE PARNITHOS AVENUE 189 ACHARNES ATTIKIS 13675
RO - Rumænien Actavis Group PTC ehf Reykjavikurvegi 76-78, 220 
NL - Netherlands Actavis Group PTC ehf Reykjavikurvegur 76-78,220
TILUDRONAT indeholder medicinsk product med markeføringstilladelse i den Europoeiske Union 
Tiludronic acid containing medicinal products with Marketing Authorisation in the European Union
UK - Storbritannien Gedeon Richter Plc, Gyömrői Utca 19-21, 
DK - Denmark Gedeon Richter Plc., Gyömröí út 19-21, HU-1103
GU23 3QB, United Kingdom alendronic acid 
GU32 3QB, United Kingdom and Northern Ireland
PAMIDRONATE DE SODIUM RATIOPHARM 3 mg/ml, solution à diluer pour perfusion 
RATIOPHARM 3 mg/ml, solution à diluer pour perfusion
LV - Letland Torrex Chiesi Pharma GmbH, Gonzagagasse 16/16, 1010 Vienna, 
Torrex Chiesi Pharma GmbH, Gonzagagasse 16/16, 1010 Vienna,
ET - Estland Torrex Chiesi Pharma GmbH Gonzagagasse 16/16, 1010 Vienna 
Torrex Chiesi Pharma GmbH Gonzagagasse 16/16, 1010 Vienna AUSTRIA
319 Pinner Road North Harrow, Middlesex HA1 4HF 
North Harrow, Middlesex HA1 4HF
Filmovertrukket tablet og Tyggetablet 
film-coated tablet and chewing tablet
Ácido Alendrónico Ecosis 70 mg Comprimidos 
Ácido Alendrónico Ecosis 70 mg
Arrow Generics Limited Unit 2, Eastman Way, Stevenage, Hertfordshire, SG1 4SZ 
NL - Netherlands Arrow Generics Limited Unit 2, Eastman Way, Stevenage, Hertfordshire, SG1 4SZ
Mylan AB, Postbox 230 33, Ynglingagatan 14, Se-104 35 Stockholm, Sweden 
DK - Denmark Mylan AB, Postbox 230 33, Ynglingagatan 14, Se-104
30 mg Pulver og solvens 
30 mg Dry substanced and solvent Intravenous
Arrow Generics Limited 2 Eastman Way, Stevenage, Hertfordshire, SG1 4SZ, United Kingdom 
BE - Belgium Arrow Generics Limited 2 Eastman Way, Stevenage, Hertfordshire, SG1 4SZ, United Kingdom
EL - Grækenland S.J.A. 
ANFARM HELLAS S.A.
CT Arzneimittel GmbH Lengeder Str. 42a D-13407 Berlin 
DE - Germany CT Arzneimittel GmbH Lengeder Str. 42a
Actonel Plus Ca & D 35mg + 1000mg/880IU Filmovertrukket tablet og 
Actonel Plus Ca & D 35mg + 1000mg/880IU
Apotex Europe, B.V. 
Apotex Europe, B.V. Darwinweg 20
Basics GmbH Hemmelrather Weg 201 D-51377 Leverkusen 
D-51377 Leverkusen
Pamidronat-ratiopharm 3 mg/ml 
Pamidronaat Actavis 3 mg/ml
UK - Storbritannien Actavis Group PTC EHF, Reykjavikurvegi 76-78, 
DK - Denmark Actavis Group PTC ehf., Reykjavikurvegi 76-78, P.O.
PAMIDRONATO RATIOPHARM 3 mg/ml 
Pamidronato Hikma 3 mg/ml
9 mg Koncentrat til infusionsvaeske, opløsningg 
9 mg Concentrate for solution for infusion
JUVERITAL 5 mg filmcoated tablets 
JUVERITAL 5 mg film coated tablets film coated tablets
EL - Grækenland PHARMA LINE S.A. TH. PETALA 41 
TH. PETALA 41
35 mg + 500 mg/400 UI Tablet 
35 mg + 500 mg/400 UI
CHMP fandt, at denne oplysning er uden betydning for sikkerheds- og virkningsprofilen af MACI, men at kravene i artikel 41 i direktiv 2001/83/EF ikke længere er opfyldt i mangel af et godkendt 
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.
På denne baggrund indledte Europa-Kommissionen den 10. september 2014 en procedure i medfør af artikel 20 i forordning (EF) nr. 726/2004, idet agenturet blev anmodet om at fremsætte en udtalelse om, hvorvidt markedsføringstilladelsen for MACI burde suspenderes eller inddrages i medfør af artikel 
In view of the above, the European Commission initiated a procedure under Article 20 of Regulation (EC) No 726/2004 on 10 September 2014, requesting the Agency to give its opinion on whether the marketing authorisation for MACI should be suspended or revoked in accordance with Article 118 of
Begrundelse for suspenderingen af 
Grounds for the suspension of the marketing authorisation
• udvalget behandlede den procedure, som var indledt i henhold til artikel 20 i forordning (EF) nr. 726/2004 for MACI og udkastet til CHMP's beslutning, der var udarbejdet af Udvalget for 
• The Committee considered the notification under Article 20 of Regulation (EC) No 726/2004 for
For at suspenderingen af markedsføringstilladelsen kan ophæves, skal indehaveren af markedsføringstilladelsen registrere et fremstillingssted for det aktive stof, det færdige lægemiddel og 
For the suspension of the marketing authorisation to be lifted, the MAH shall register a site for manufacture of the active substance, finished product and batch release.
• udvalget konkluderede, at kravene i artikel 41 i direktiv 2001/83/EF ikke længere er opfyldt i fravær af et godkendt fremstillingssted for det aktive stof, det færdige lægemiddel og anbefaler CHMP suspendering af markedsføringstilladelsen for MACI i medfør af artikel 118 i direktiv 
• The Committee concluded that in view of the absence of an authorised manufacturing site for the active substance, finished product and batch release, the requirements laid down in Article 41 of
Dette dræber de bakterier, som forårsager infektionen. 
This kills the bacteria causing the infection.
Der var også betænkeligheder ved, om EXULETT kunne fremstilles, så det konsekvent var af god kvalitet. 
There were also concerns over whether EXULETT could be manufactured with consistent good quality.
Internationalt fællesnavn (INN): dalbavancin 
International non-proprietary name (INN): dalbavacin
Virkningerne af EXULETT blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker. 
The effects of EXULETT were first tested in experimental models before being studied in humans.