FrancophonIA/ELRC3.0 huggingface dataset:
English: Rua Quinta do PinheiroEdifício Tejo - 6º Piso 2790-143 Carnaxide, Portugal
Portuguese: Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda. Rua Quinta do PinheiroEdifício Tejo - 6º Piso 2790-143 Carnaxide, Portugal
English: ALENDRONIQUE QUALIMED 70 mg, comprimé
Portuguese: ACIDE ALENDRONIQUE QUALIMED 70 mg, comprimé
English: 6 mg Concentrate for solution for infusion
Portuguese: 6 mg Concentrado para solução para perfusão
English: SE - Sweden Ranbaxy (UK) Ltd 20 Baldertoon Street London W1K 6TL
Portuguese: Ranbaxy (UK) Ltd 20 Baldertoon Street London W1K 6TL United Kingdom
English: 3 mg/ml solution
Portuguese: 3 mg/ml solução
English: ALENDRONIQUE BIOGARAN 70 mg, comprimé
Portuguese: ACIDE ALENDRONIQUE BIOGARAN 70 mg, comprimé
English: Actonel 30 mg film coated tablets film-coated tablets
Portuguese: Actonel 30 mg film coated tablets
English: PAMIDRONATO DISODICO COMBINO PHARM 60 mg polvo para solución para perfusión solution for infusion
Portuguese: PAMIDRONATO DISODICO COMBINO PHARM 60 mg polvo para solución para perfusión solução para perfusão
English: Alenax 70 mg tablete
Portuguese: Alenax 70 mg tablete 70 mg
English: Actavis Group PTC EHF, Reykjavikurvegi 76-78, Hafnarfirdi IS-220 Iceland alendronic acid
Portuguese: UK - Reino Unido Actavis Group PTC EHF, Reykjavikurvegi 76-78, Hafnarfirdi IS-220 Iceland alendronic acid
English: 60 mg Dry substanced and solvent Intravenous
Portuguese: 60 mg Substância seca e solvente Intravenosa
English: Actonel® Wekelijks 35 mg, filmomhulde tabletten filmcoated tablets Oral use
Portuguese: Actonel® Wekelijks 35 mg, filmomhulde tabletten
English: 319 Pinner Road, North Harrow, Middlesex HA14HF, UK
Portuguese: 319 Pinner Road North Harrow, Middlesex HA1 4HF
English: film coated tablets and efervescent granules
Portuguese: comprimidos revestidos por película and efervescent granules
English: ACREL 5 mg comprimidos recubiertos con película film coated tablets
Portuguese: ACREL 5 mg comprimidos recubiertos con película
English: PAMIDRONATO DISODICO COMBINO PHARM 30 mg polvo para solución para solution for infusion
Portuguese: PAMIDRONATO DISODICO COMBINO PHARM 30 mg polvo para solución para solução para perfusão
English: Bonefos 800 mg filmsko obložene tablete film-coated tablet
Portuguese: Bonefos 800 mg filmsko obložene tablete
English: RISEDRONATO SEMANAL HEXAL 35 mg comprimidos recubiertos con película film coated tablets
Portuguese: RISEDRONATO SEMANAL HEXAL 35 mg comprimidos recubiertos con película
English: Clodronic acid containing medicinal products with Marketing Authorisation in the European Union
Portuguese: Medicamentos que contêm ácido clodrónico com Autorização de Introdução no Mercado na União Europeia
English: HU - Hungary Hospira UK Limited Queensway, Royal
Portuguese: NO - Noruega Hospira UK Limited, Queensway, Royal
English: Risedronato Winthrop 35 mg compresse rivestite con film film-coated tablets
Portuguese: Risedronato Winthrop 35 mg compresse rivestite con film
English: Mommaertslaan 14
Portuguese: Torsgatan 11
English: RISENDROS 35 mg film coated tablets film coated tablets
Portuguese: RISENDROS 35 mg film coated tablets
English: 6mg/ml solution for infusion
Portuguese: 6mg/ml solução para perfusão via intravenosa
English: JUVERITAL 5 mg film coated tablets film coated tablets
Portuguese: JUVERITAL 5 mg film coated tablets
English: Bonefos capsules 400 mg hard capsules
Portuguese: Bonefos capsules 400 mg cápsulas
English: Skelid tablet
Portuguese: Tevanate comprimidos
English: NL - Netherlands Sandoz B.V., Veluwezoom 22
Portuguese: Sandoz B.V., Veluwezoom 22 1327 AH Almere Netherlands
English: JUVERITAL 35 mg film coated tablets film coated tablets
Portuguese: JUVERITAL 35 mg film coated tablets
English: BG - Bulgaria ratiopharm GmbH, GrafArco-Strasse 3, 89079 Ulm, Germany
Portuguese: BG - Bulgária ratiopharm GmbH, GrafArco-Strasse 3, 89079 Ulm, Germany
English: 3 mg Concentrate for solution for infusion
Portuguese: 3 mg Concentrado para solução para perfusão
English: 75MG/TAB FILM COATED TABLET
Portuguese: 75MG/TAB Comprimido revestido por película
English: ACTONEL 75 mg film coated tablets film coated tablets
Portuguese: ACTONEL 75 mg film coated tablets
English: filmcoated tablets Oral use
Portuguese: COMPRIMIDO Via oral
English: Didronate tablet
Portuguese: Alenato comprimidos
English: Alendor 70 mg tablete
Portuguese: Alendor 70 mg tablete 70 mg
English: 300 mg/5 ml concentrate for solution for infusion
Portuguese: 300 mg/5 ml concentrado para solução para perfusão
English: ALENDRONATO AHCL
Portuguese: ALENDRONATO AHCL 10 mg
English: RISEDRONATO SEMANAL QUALIGEN 35 mg comprimidos recubiertos con película film coated tablets
Portuguese: RISEDRONATO SEMANAL QUALIGEN 35 mg comprimidos recubiertos con película
English: 10 MG/TAB TABLET
Portuguese: 10 MG/TAB
English: 5 MG/TAB TABLET
Portuguese: 5 MG/TAB
English: 3mg/ml solution for infusion
Portuguese: 3mg/ml solução para perfusão via intravenosa
English: 9 mg/ml concentrate for solution for infusion
Portuguese: 9 mg/ml concentrado para solução para perfusão
English: A-431, Km 19
Portuguese: Estrada Nacional n.º 10, Km 140, 260
English: MIOSEN SEMANAL 35 mg comprimidos recubiertos con película film coated tablets
Portuguese: MIOSEN SEMANAL 35 mg comprimidos recubiertos con película
English: Bayer Schering Pharma Oy, Pansiontie 47, 20210 Turku, Finland
Portuguese: SI - Eslovénia Bayer Schering Pharma Oy, Pansiontie 47, 20210 Turku, Finland
English: Riserdonat Galex 35 mg filmsko obložene tablete film-coated tablet Oral use
Portuguese: Riserdonat Galex 35 mg filmsko obložene tablete
English: FI - Finland ratiopharm GmbH, GrafArco-Strasse 3, 89079 Ulm, Germany
Portuguese: FI - Finlândia ratiopharm GmbH, GrafArco-Strasse 3, 89079 Ulm, Germany
English: Optinate Once a Week 35mg Film-coated Tablets film-coated tablets
Portuguese: Optinate Once a Week 35mg Film-coated Tablets
English: Tiludronic acid containing medicinal products with Marketing Authorisation in the European Union
Portuguese: Medicamentos que contêm ácido tiludrónico com Autorização de Introdução no Mercado na União Europeia
English: 35,0 mg Risedronate sodium (equivalent to 40,17 mg Risedronate sodium hemipentahydr ate film-coated tablet Oral use
Portuguese: 35,0 mg Risedronate sodium (equivalent to 40,17 mg Risedronate sodium hemipentahydr ate
English: ACREL SEMANAL 35 mg comprimidos recubiertos con película film coated tablets
Portuguese: ACREL SEMANAL 35 mg comprimidos recubiertos con película
English: Sanofi-Aventis - Produtos Farmacêuticos, S.A. Empreendimento Lagoas Park, Edifício 7 - 3º, 2740-244 Porto Salvo Portugal
Portuguese: Parke-Davis - Produtos Farmacêuticos, Lda. Lagoas Park, Edifício 10 2740-271 Porto Salvo, Portugal
English: NL - Netherlands Roche Nederland B.V. Beneluxlaan 2a
Portuguese: Roche Nederland B.V.
English: ACREL 75 mg comprimidos recubiertos con película film coated tablets
Portuguese: ACREL 75 mg comprimidos recubiertos con película
English: RISEDRONAT GALEX 35 mg filmtabletta mgRisedronate sodium (equivalent to 40,17 mg Risedronate sodium hemipentahydr ate film-coated tablet Oral use
Portuguese: RISEDRONAT GALEX 35 mg filmtabletta mgRisedronate sodium (equivalent to 40,17 mg Risedronate sodium hemipentahydr ate
English: RISEDRONATO SEMANAL STADA 35 mg comprimidos recubiertos con película film coated tablets
Portuguese: RISEDRONATO SEMANAL STADA 35 mg comprimidos recubiertos con película
English: ACTONEL 75 mg comprimidos recubiertos con película film coated tablets
Portuguese: ACTONEL 75 mg comprimidos recubiertos con película
English: RISEDRONATE WINTHROP 75 mg, comprimé pelliculé film-coated tablet Oral use
Portuguese: RISEDRONATE WINTHROP 75 mg, comprimé pelliculé
English: Pamidronic acid containing medicinal products with Marketing Authorisation in the European Union
Portuguese: Medicamentos que contêm ácido pamidrónico com Autorização de Introdução no Mercado na União Europeia
English: NL - Netherlands Centrafarm Services B.V. Nieuwe Donk 9
Portuguese: Centrafarm Services B.V.
English: Ridate Once a Week 35mg film-coated tablets film-coated tablets
Portuguese: Ridate Once a Week 35mg film-coated tablets
English: 15 mg/ml concentrate for solution for infusion
Portuguese: 15 mg/ml concentrado para solução para perfusão
English: Apotex Europe B.V. Darwinweg 20.
Portuguese: Apotex Europe B.V.
English: NL - Netherlands Bluefish Pharmaceuticals AB, Torsgatan 11
Portuguese: Bluefish Pharmaceuticals AB, Torsgatan 11
English: Actonel 5 mg film coated tablets film-coated tablets
Portuguese: ACTONEL 5 mg film coated tablets
English: 30MG/TAB FILM COATED TABLET
Portuguese: 30MG/TAB Comprimido revestido por película
English: Risontel Once a week 35mg film-coated tablets film-coated tablets
Portuguese: Risontel Once a week 35mg film-coated tablets
English: Accord Healthcare Limited, Sage House, 319 Pinner Road, Harrow, Middlesex HA1 4HF, United Kingdom alendronic acid
Portuguese: UK - Reino Unido Accord Healthcare Limited, Sage House, 319 Pinner Road, Harrow, Middlesex HA1 4HF, United Kingdom alendronic acid
English: Neridronic acid containing medicinal products with Marketing Authorisation in the European Union
Portuguese: Medicamentos que contêm ácido neridrónico com Autorização de Introdução no Mercado na União Europeia
English: DK - Denmark Actavis Group PTC ehf., Reykjavikurvegi 76-78, P.O.
Portuguese: DK - Dinamarca Actavis Group PTC ehf., Reykjavikurvegi 76-78, P.O. 425, IS-220
English: 15 mg/ml powder and solvent for solution for infusion
Portuguese: 15 mg/ml pó e solvente para solução para perfusão parentérica
English: ACTONEL 30 mg comprimidos recubiertos film coated tablets
Portuguese: ACTONEL 30 mg comprimidos recubiertos
English: RISEMYL SEMANAL 35 mg comprimidos recubiertos con película film coated tablets
Portuguese: RISEMYL SEMANAL 35 mg comprimidos recubiertos con película
English: Bluefish Pharmaceuticals AB Torsgatan 11, SE-11123
Portuguese: Bluefish Pharmaceuticals AB Torsgatan 11, SE-11123 Stockholm, Sweden
English: film-coated tablet/effervesce nt granules
Portuguese: comprimido revestido por película/ grânulos efervescentes
English: SE - Sweden STADA Arzneimittel AG, Stadastrasse 2-18, DE61118 Bad Vilbel, Germany (DEU)
Portuguese: STADA Arzneimittel AG, Stadastrasse 2-18, DE61118 Bad Vilbel, Germany (DEU)
English: DK - Denmark Arrow Generics Limited, Unit 2, Eastman Way Stevenage, SG1 4SZ Hertfordshire,
Portuguese: UK - Reino Unido Arrow Generics Limited, Unit 2 Eastman Way, Stevenage, Hertfordshire SG1 4SZ,
English: RISEDRONATE ACTAVIS 35 mg filmtabletta mgRisedronate sodium (equivalent to 40,17 mg Risedronate sodium hemipentahydr ate film-coated tablet Oral use
Portuguese: RISEDRONATE ACTAVIS 35 mg filmtabletta mgRisedronate sodium (equivalent to 40,17 mg Risedronate sodium hemipentahydr ate
English: Fosamax tablet 70mg
Portuguese: Fosamax tablet 70mg 70mg comprimidos
English: Disodium Clodronate 60mg/ml solution for Injection
Portuguese: Disodium Clodronate 60mg/ml
English: ACTONEL SEMANAL 35 mg comprimidos recubiertos con película film coated tablets
Portuguese: ACTONEL SEMANAL 35 mg comprimidos recubiertos con película
English: LOSENTRA SEMANAL 35 mg comprimidos recubiertos con película film coated tablets
Portuguese: LOSENTRA SEMANAL 35 mg comprimidos recubiertos con película
English: 15 mg/ml powder for solution for infusion
Portuguese: 15 mg/ml pó para solução para perfusão intravenosa
English: Tablet and Capsule soft Oral Use
Portuguese: Comprimido e Cápsula mole
English: Zaklad Farmaceutyczny Adamed Pharma SA, ul.
Portuguese: Zaklad Farmaceutyczny Adamed Pharma S.A., ul.
English: Actonel Once A Week 35 mg film-coated tablets film-coated tablets
Portuguese: Actonel Once A Week 35 mg film-coated tablets
English: NL - Netherlands Arrow Generics Limited Unit 2, Eastman Way, Stevenage, Hertfordshire, SG1 4SZ
Portuguese: SK - Eslováquia Arrow Generics Limited Unit 2, Eastman Way, Stevenage, Hertfordshire, SG14SZ
English: Actonel® 30 mg, filmomhulde tabletten filmcoated tablets Oral use
Portuguese: Actonel® 30 mg, filmomhulde tabletten
English: Arrow Generics Limited, Unit 2 Eastman Way, Stevenage, Hertfordshire SG1 4SZ, United Kingdom
Portuguese: Arrow Generics Limited, Unit 2 Eastman Way,Hertfordshire, SG1 4SZ,Stevenage,UK
English: Actavis Group PTC EHF, Reykjavikurvegi 76-78, Hafnarfirdi IS-220 Iceland
Portuguese: UK - Reino Unido Actavis Group PTC EHF, Reykjavikurvegi 76-78, Hafnarfirdi IS-220 Iceland
English: Actonel® 5 mg, filmomhulde tabletten filmcoated tablets Oral use
Portuguese: Actonel® 5 mg, filmomhulde tabletten
English: 60 mg/ml concentrate for solution for infusion
Portuguese: 60 mg/ml concentrado para solução para perfusão
English: RISEDRONAT TEVA 35 mg film coated tablets film coated tablets
Portuguese: RISEDRONAT TEVA 35 mg film coated tablets
English: 30 mg/ml concentration for solution for infusion
Portuguese: 30 mg/ml concentrado para solução para perfusão
English: Ranbaxy (UK) Limited, 95
Portuguese: UK - Reino Unido Ranbaxy (UK) Limited, 95 Park Lane, Mayfair.
English: 6 mg/ml concentrate for solution for infusion
Portuguese: 6 mg/ml concentrado para solução para perfusão
English: Rua do Padrão, 98
Portuguese: Rua do Padrão, Coimbra, Portugal
English: ALENDRONATRICHTER 70 mg filmtabletta
Portuguese: ALENDRONAT-RICHTER 70 mg filmtabletta
English: 35MG/TAB FILM COATED TABLET
Portuguese: 35MG/TAB Comprimido revestido por película
English: ACTONEL 5 mg comprimidos recubiertos film coated tablets
Portuguese: ACTONEL 5 mg comprimidos recubiertos
English: Alendronic acid containing medicinal products with Marketing Authorisation in the European Union
Portuguese: Medicamentos que contêm ácido alendrónico com Autorização de Introdução no Mercado na União Europeia
English: Apotex Europe, B.V. Darwinweg 20
Portuguese: Apotex Europe, B.V.
English: NL - Netherlands Merck Sharp & Dohme BV Waarderweg 39
Portuguese: SK - Eslováquia Merck Sharp & Dohme B.V.
English: ARROW GENERICS LIMITED, HERTS, UNITED KINGDOM Unit 2, Eastman Way, Stevenage,
Portuguese: Arrow Generics Limited 2 Eastman Way, Stevenage,
English: JUVERITAL 35 mg filmtabletta mgRisedronate sodium (equivalent to 40,17 mg Risedronate sodium hemipentahydr ate film-coated tablet Oral use
Portuguese: JUVERITAL 35 mg filmtabletta mgRisedronate sodium (equivalent to 40,17 mg Risedronate sodium hemipentahydr ate
English: NORIFAZ 35 mg filmtabletta mgRisedronate sodium (equivalent to 40,17 mg Risedronate sodium hemipentahydr ate film-coated tablet Oral use
Portuguese: NORIFAZ 35 mg filmtabletta mgRisedronate sodium (equivalent to 40,17 mg Risedronate sodium hemipentahydr ate
English: Natriumrisedronaat 35 mg Ranbaxy filmcoated tablets Oral use
Portuguese: Natriumrisedronaat 35 mg Ranbaxy
English: Concentrate for solution for infusion
Portuguese: concentrado para solução para perfusão
English: concentrate for solution for infusion
Portuguese: CONCENTRADO PARA SOLUÇÃO PARA PERFUSÃO
English: SE - Sweden Orion Corporation, Orion Pharma
Portuguese: Orion Corporation, Orion Pharma PO Box 65
English: BE - Belgium Merck Sharp & Dohme B.V. Clos du Lynx, 5- 1200
Portuguese: DK - Dinamarca Merck Sharp & Dohme B.V., PO Box 581,
English: DE-61118 Bad Vilbel
Portuguese: Bad Vilbel, 61118
English: RISEDRONATE WINTHROP 35 mg, comprimé pelliculé film-coated tablet Oral use
Portuguese: RISEDRONATE WINTHROP 35 mg, comprimé pelliculé
English: Risedronic acid containing medicinal products with Marketing Authorisation in the European Union
Portuguese: Medicamentos que contêm ácido residrónico com Autorização de Introdução no Mercado na União Europeia
English: Risedronate Teva 35 mg filmomhulde tabletten film-coated tablets
Portuguese: Risedronate Teva 35 mg filmomhulde tabletten
English: 3 mg/ml concentrate for solution for infusion
Portuguese: 3 mg/ml concentrado para solução para perfusão intravenosa
English: Prenteral
Portuguese: Avestra
English: ACTONEL 30 mg, comprimé pelliculé film-coated tablet Oral use
Portuguese: ACTONEL 30 mg, comprimé pelliculé
English: Actonel® 75 mg, filmomhulde tabletten filmcoated tablets Oral use
Portuguese: Actonel® 75 mg, filmomhulde tabletten
English: AlendronatRatiopharm 70mg
Portuguese: Alendronat-Ratiopharm 70mg
English: Alendronat "Ranbaxy"
Portuguese: Alendronat "Ranbaxy" 70 mg
English: Risedronaatnatrium Mylan Wekelijks 35 mg filmcoated tablets Oral use
Portuguese: Risedronaatnatrium Mylan Wekelijks 35 mg
English: Film-Coated Tablets and effervescent granules
Portuguese: Comprimidos Revestidos por Película e grânulos efervescentes
English: STADA Arzneimittel AG Stadastrasse 2-18 Bad Vilbel, 61118
Portuguese: STADA Arzneimittel AG Stadastrasse 2-18 DE-61118 Bad Vilbel Germany
English: Tevanate 70 mg tablete
Portuguese: Tevanate 70 mg tablete 70 mg
English: Natriumrisedronaat Ceft 5 mg filmcoated tablets Oral use
Portuguese: Natriumrisedronaat Ceft 5 mg
English: Alendronat Sandoz 70
Portuguese: ALENDRONAT SANDOZ 70 mg
English: Natriumrisedronaat Sandoz® wekelijks 35 mg filmcoated tablets Oral use
Portuguese: Natriumrisedronaat Sandoz® wekelijks 35 mg
English: DE - Germany Bluefish Pharmaceuticals AB Torsgatan 11
Portuguese: DE - Alemanha Bluefish Pharmaceuticals AB
English: There were also concerns over whether EXULETT could be manufactured with consistent good quality.
Portuguese: Existiam ainda preocupações quanto à possibilidade de fabricar o EXULETT com uma qualidade consistente.
English: This kills the bacteria causing the infection.
Portuguese: Isto resulta na morte da bactéria que causa a infecção.
English: It contains the active substance dalbavancin.
Portuguese: Contém a substância activa dalbavancin.
English: Questions and answers on the withdrawal of the marketing application for EXULETT
Portuguese: Perguntas e respostas relativas à retirada do pedido de autorização de introdução no mercado Para o EXULETT
English: The effects of EXULETT were first tested in experimental models before being studied in humans.
Portuguese: Os efeitos do EXULETT foram testados em modelos experimentais antes de serem estudados em seres humanos.
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.
Portuguese: A empresa apresentou os resultados de um estudo principal que comparou os efeitos do EXULETT com os do linezolida (outro antibiótico) em 873 adultos.
English: International non-proprietary name (INN): dalbavacin
Portuguese: Denominação Comum Internacional (DCI): dalbavancin
English: These bacteria include Staphylococcus aureus (including ‘methicillin-resistant' forms known as ‘MRSA') and Streptococcus pyogenes.
Portuguese: Estas bactérias incluem o Staphylococcus aureus (incluindo as formas “resistentes à meticilina” conhecidas como “MRSA”) e o Streptococcus pyogenes.
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.
Portuguese: O principal parâmetro de eficácia foi o número de doentes cuja infecção foi tratada com êxito e que não necessitaram de um tratamento ulterior à base de outros antibióticos.
English: It is expected to work by stopping the bacteria making their cell walls.
Portuguese: Prevê-se que este antibiótico actue ao impedir que as bactérias construam as suas paredes celulares.
English: What is EXULETT?
Portuguese: O que é o EXULETT?
English: 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.
Portuguese: Por conseguinte, no momento da retirada, o CHMP considerava que os benefícios do EXULETT não estavam suficientemente demonstrados e não eram superiores aos riscos identificados.
English: EXULETT is a powder that is made up into a solution for infusion (drip into a vein).
Portuguese: O EXULETT é um pó a ser reconstituído numa solução para perfusão (introdução gota a gota numa veia).
English: 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.
Portuguese: O CHMP tinha reservas inspiradas no facto de os resultados do único estudo principal terem sido muito limitados para justificar a aprovação do medicamento tendo em conta a forma como o estudo tinha sido realizado, e considerou necessário realizar outro estudo para confirmar os resultados.
English: The active substance in EXULETT, dalbavancin, is an antibiotic that belongs to the group ‘glycopeptides'.
Portuguese: A substância activa do EXULETT, o dalbavancin, é um antibiótico que pertence ao grupo dos “glicopéptidos”.
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials of EXULETT.
Portuguese: A empresa informou o CHMP de que não existem consequências para os doentes actualmente envolvidos em ensaios clínicos com o EXULETT.
English: What are the consequences of the withdrawal for patients undergoing clinical trials with EXULETT?
Portuguese: Quais as consequências da retirada do pedido para os doentes incluídos em ensaios clínicos em curso com o EXULETT?
English: 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.
Portuguese: Em 9 de Setembro de 2008, a Pfizer Limited notificou oficialmente o Comité dos Medicamentos para Uso Humano (CHMP) da sua decisão de retirar o pedido de autorização de introdução no mercado para o EXULETT, para o tratamento de infecções complicadas da pele e dos tecidos moles em adultos, quando se suspeita ou confirma que estas infecções são provocadas por bactérias gram-positivas.
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.
Portuguese: Além disso, o CHMP exprimiu preocupações sobre a relevância dos resultados do estudo principal uma vez que nem todos os doentes incluídos no estudo sofriam de uma infecção suficientemente grave para justificar a administração de um tratamento com antibiótico por perfusão numa veia.
English: How is EXULETT expected to work?
Portuguese: Como deveria funcionar o EXULETT?
English: EXULETT was to be used to treat adults with complicated infections of the skin and the ‘soft tissues' below the skin.
Portuguese: O EXULETT estava previsto no tratamento de adultos com infecções complicadas da pele e dos tecidos moles (tecidos por baixo da pele).
English: EXULETT was to be used only when the infection was known or thought to be caused by types of bacteria that are classified as ‘Gram-positive' and that would be killed by the medicine.
Portuguese: O EXULETT estava previsto para ser utilizado apenas nos casos em que se soubesse ou suspeitasse que a infecção era causada por tipos de bactérias classificadas como “gram-positivas” e que poderiam ser destruídas pelo medicamento.
English: Based on the review of the data and the company's response to the CHMP list of questions at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that EXULETT could not have been approved for the treatment of complicated skin and soft tissue infections in adults when known or suspected to be caused by susceptible Gram-positive bacteria.
Portuguese: Com base na análise dos dados e da resposta da empresa à lista de perguntas formuladas pelo CHMP, no momento da retirada, o CHMP tinha algumas preocupações, sendo de parecer que o EXULETT para o tratamento de infecções complicadas da pele e dos tecidos moles em adultos quando causadas ou suspeitas de serem causadas por bactérias gram-positivas não podia ser aprovado.