natgillin/translations-raw huggingface dataset:
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.
Det indeholder det aktive stof dalbavancin.
It contains the active substance dalbavancin.
Spørgsmål og svar vedrørende tilbagetrækningen af ansøgningen om markedsføringstilladelse for EXULETT
Questions and answers on the withdrawal of the marketing application for EXULETT
Det forventes at virke ved at forhindre bakterierne i at opbygge deres cellevægge.
It is expected to work by stopping the bacteria making their cell walls.
Firmaet fremlagde resultaterne af en hovedundersøgelse, hvori man sammenlignede virkningerne af EXULETT med virkningerne af linezolid (et andet antibiotikum) hos 873 voksne.
The company presented the results of one main study that compared the effects of EXULETT with those of linezolid (another antibiotic) in 873 adults.
Disse bakterier omfatter Staphylococcus aureus (herunder ‘meticillin-resistente' former kendt som ‘MRSA') og Streptococcus pyogenes.
These bacteria include Staphylococcus aureus (including ‘methicillin-resistant' forms known as ‘MRSA') and Streptococcus pyogenes.
Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med EXULETT?
What are the consequences of the withdrawal for patients undergoing clinical trials with EXULETT?
Det aktive stof i EXULETT, dalbavancin, er et antibiotikum, som tilhører gruppen af ‘glycopeptider'.
The active substance in EXULETT, dalbavancin, is an antibiotic that belongs to the group ‘glycopeptides'.
CHMP var betænkelig ved, at resultaterne af den eneste hovedundersøgelse var for begrænsede til at underbygge godkendelsen af lægemidlet på grund af den måde, hvorpå undersøgelsen var blevet gennemført, og var af den opfattelse, at der var behov for endnu en undersøgelse til at bekræfte resultaterne.
The CHMP was concerned that the results of the single main study were too limited to support the approval of the medicine because of the way the study had been carried out, and was of the opinion that another study would be needed to confirm the results.
Hvad forventedes EXULETT anvendt til?
What was EXULETT expected to be used for?
‘Kompliceret' betyder, at infektionen er vanskelig at behandle, fordi den har spredt sig til det dybereliggende væv under huden, fordi kirurgisk behandling kan blive nødvendig, eller for patienten har andre lidelser, som kan have indvirkning på behandlingsresponsen.
‘Complicated' means that the infection is difficult to treat, because it has spread to the deep tissues below the skin, treatment with surgery might be needed, or the patient has other conditions that might affect the response to treatment.
Hvordan forventes EXULETT at virke?
How is EXULETT expected to work?
Den vigtigste målestok for virkningen var antallet af patienter, for hvilke behandlingen af infektionen var vellykket, og som ikke havde behov for yderligere behandling med noget andet antibiotikum.
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.
På tilbagetrækningstidspunktet var det derfor CHMP's opfattelse, at fordelene ved EXULETT ikke var blevet tilstrækkeligt påvist, og at de eventuelle fordele ikke opvejede de påviste risici.
Therefore, at the time of the withdrawal, the CHMP's view was that a benefit of EXULETT had not been sufficiently demonstrated and any benefits did not outweigh the identified risks.
EXULETT er et pulver, der blandes til en opløsning til infusion (dråbetilførsel i en vene).
EXULETT is a powder that is made up into a solution for infusion (drip into a vein).
Hvad er EXULETT?
What is EXULETT?
Den 9. september 2008 meddelte Pfizer Limited officielt Udvalget for Humanmedicinske Lægemidler (CHMP), at det ønsker at tilbagetrække sin ansøgning om markedsføringstilladelse for EXULETT til behandling af komplicerede hud- og bløddelsinfektioner hos voksne, når de vides eller formodes at være forårsaget af modtagelige grampositive bakterier.
On 9 September 2008, Pfizer Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for EXULETT, for the treatment of complicated skin and soft tissue infections in adults when known or suspected to be caused by susceptible Gram-positive bacteria.
Endvidere havde CHMP betænkeligheder ved relevansen af resultaterne af hovedundersøgelsen, da ikke alle patienter, som indgik i undersøgelsen, syntes at have en infektion, der var tilstrækkelig alvorlig til at kræve antibiotikabehandling givet som infusion i en vene.
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.
Det krævedes, at patienterne, som indgik i denne undersøgelse, havde komplicerede hud- og bløddelsinfektioner (såsom bylder eller sårinfektioner), der skyldtes grampositive bakterier.
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.
EXULETT skulle have været anvendt til behandling af voksne med komplicerede infektioner i huden og ‘bløddelene' under huden.
EXULETT was to be used to treat adults with complicated infections of the skin and the ‘soft tissues' below the skin.