FrancophonIA/ELRC3.0 huggingface dataset:
English: DIDRONEL 400 mg, comprimé tablet
French: DIDRONEL 400 mg, comprimé
English: Risedronato Winthrop 30 mg compresse rivestite con film film-coated tablets
French: Risedronato Winthrop 30 mg compresse rivestite con film
English: Powder and solvent for concentrate for solution for infusion
French: Poudre et solvant pour solution concentrée pour perfusion
English: Alendroninezuur 70A
French: Alendroninezuur 70A 70 mg
English: DIDRONEL 200 mg, comprimé tablet
French: DIDRONEL 200 mg, comprimé
English: film-coated tablet and chewing tablet
French: Comprimé pelliculé et comprimé à croquer
English: Risedronato Winthrop 5 mg compresse rivestite con film film-coated tablets
French: Risedronato Winthrop 5 mg compresse rivestite con film
English: SE - Sweden Ranbaxy (UK) Ltd 20 Baldertoon Street London W1K 6TL
French: Ranbaxy (UK) Ltd 20 Baldertoon Street London W1K 6TL United Kingdom
English: PAMIDRONATO DISODICO COMBINO PHARM 30 mg polvo para solución para solution for infusion
French: PAMIDRONATO DISODICO COMBINO PHARM 30 mg polvo para solución para
English: concentrate for solution for infusion
French: Solution concentrée pour solution pour perfusion
English: 70 MG/TAB TABLET
French: 70 MG/TAB
English: 15 mg polvo solution for infusion
French: 15 mg polvo Solution pour perfusion Voie intraveineuse
English: 30 mg Dry substanced and solvent Intravenous
French: 30 mg Substance sèche et solvant Voie intraveineuse
English: 200MG/CAP HARD CAPSULE
French: 200MG/CAP Gélule
English: Actonel 30 mg film coated tablets film-coated tablets
French: Actonel 30 mg film coated tablets
English: 60 mg Dry substanced and solvent Intravenous
French: 60 mg Substance sèche et solvant Voie intraveineuse
English: Soluction for infusion
French: Solution pour perfusion
English: Alenax 70 mg tablete
French: Alenax 70 mg tablete 70 mg
English: 6 mg Concentrate for solution for infusion
French: 6 mg Solution concentrée pour perfusion
English: Actonel® Wekelijks 35 mg, filmomhulde tabletten filmcoated tablets Oral use
French: Actonel® Wekelijks 35 mg, filmomhulde tabletten
English: DK - Denmark ratiopharm GmbH, GrafArco-Strasse 3, DE-89079
French: DK - Danemark Ratiopharm GmbH, GrafArco-Strasse 3, DE-89079
English: ACREL 5 mg comprimidos recubiertos con película film coated tablets
French: ACREL 5 mg comprimidos recubiertos con película
English: Bonefos 800 mg filmsko obložene tablete film-coated tablet
French: Bonefos 800 mg filmsko obložene tablete
English: DE - Germany AbZ-Pharma GmbH Dr.Georg-Spohn-Str. 7
French: AbZ-Pharma GmbH Dr.Georg-Spohn-Str. 7 D-89143 Blaubeuren
English: RISEDRONATO SEMANAL HEXAL 35 mg comprimidos recubiertos con película film coated tablets
French: RISEDRONATO SEMANAL HEXAL 35 mg comprimidos recubiertos con película
English: Risedronato Winthrop 35 mg compresse rivestite con film film-coated tablets
French: Risedronato Winthrop 35 mg compresse rivestite con film
English: NL - Netherlands Pharmachemie B.V. Swensweg 5
French: NL - Pays-Bas Pharmachemie B.V.
English: 75MG/TAB FILM COATED TABLET
French: 75MG/TAB Comprimé pelliculé Voie orale
English: NL - Netherlands Bluefish Pharmaceuticals AB, Torsgatan 11
French: Bluefish Pharmaceuticals AB, Torsgatan 11
English: RISENDROS 35 mg film coated tablets film coated tablets
French: RISENDROS 35 mg film coated tablets
English: JUVERITAL 5 mg film coated tablets film coated tablets
French: JUVERITAL 5 mg film coated tablets
English: HU - Hungary Hospira UK Limited Queensway, Royal
French: NO - Norvège Hospira UK Limited, Queensway, Royal
English: Aredia 30 mg prašek in vehikel za koncentrat za raztopino za powder and solvent for solution for injection
French: Aredia 30 mg prašek in vehikel za koncentrat za raztopino za
English: Film-coated tablets + effervescent
French: Comprimé + comprimé Effervescent
English: TEVANATE 70 MG
French: TEVANATE 70 MG 70 mg
English: JUVERITAL 35 mg film coated tablets film coated tablets
French: JUVERITAL 35 mg film coated tablets
English: ACTONEL 75 mg film coated tablets film coated tablets
French: ACTONEL 75 mg film coated tablets
English: BE - Belgium TEVA Pharma Belgium N.V, Laarstraat 16,
French: TEVA Pharma Belgium N.V, Laarstraat 16, B-2610 Wilrijk, Belgium
English: BG - Bulgaria ratiopharm GmbH, GrafArco-Strasse 3, 89079 Ulm, Germany
French: BG - Bulgarie ratiopharm GmbH, GrafArco-Strasse 3, 89079 Ulm, Germany
English: Film-Coated Tablets
French: Comprimés Pelliculés
English: Ostemax 70 comfort
French: Ostemax 70 comfort 70 mg
English: 3 mg Concentrate for solution for infusion
French: 3 mg Solution concentrée pour perfusion
English: 6 mg/ml concentrate for solution for infusion - 10 ml
French: Solution concentrée pour perfusion - 10 ml
English: FI - Finland ratiopharm GmbH, GrafArco-Strasse 3, 89079 Ulm, Germany
French: FI - Finlande ratiopharm GmbH, GrafArco-Strasse 3, 89079 Ulm, Germany
English: RISEDRONATO SEMANAL QUALIGEN 35 mg comprimidos recubiertos con película film coated tablets
French: RISEDRONATO SEMANAL QUALIGEN 35 mg comprimidos recubiertos con película
English: 10 MG/TAB TABLET
French: 10 MG/TAB
English: Gendron 70 Tablety
French: Gendron 70 Tablety 70 mg
English: Alendronic acid containing medicinal products with Marketing Authorisation in the European Union
French: Les spécialités pharmaceutiques, des exploitants de l'Union Européenne, contenant de l'acide Alendronique
English: Clodronic acid containing medicinal products with Marketing Authorisation in the European Union
French: Les spécialités pharmaceutiques, des exploitants de l'Union Européenne, contenant de l'Acide Clodronique
English: ALENDRONATO AHCL
French: ALENDRONATO AHCL 10 mg
English: 5 MG/TAB TABLET
French: 5 MG/TAB
English: BE - Belgium Eurogenerics N.V. Heizel Esplanade b22
French: Heizel Esplanade b22
English: 35,0 mg Risedronate sodium (equivalent to 40,17 mg Risedronate sodium hemipentahydr ate film-coated tablet Oral use
French: 35,0 mg Risedronate sodium (equivalent to 40,17 mg Risedronate sodium hemipentahydr ate
English: MIOSEN SEMANAL 35 mg comprimidos recubiertos con película film coated tablets
French: MIOSEN SEMANAL 35 mg comprimidos recubiertos con película
English: Riserdonat Galex 35 mg filmsko obložene tablete film-coated tablet Oral use
French: Riserdonat Galex 35 mg filmsko obložene tablete
English: Alendor 70 mg tablete
French: Alendor 70 mg tablete 70 mg
English: Optinate Once a Week 35mg Film-coated Tablets film-coated tablets
French: Optinate Once a Week 35mg Film-coated Tablets
English: GB-HA1 4HF NORTH
French: GB-HA1 4HF NORTH HARROW, MIDDLESEX
English: ACREL SEMANAL 35 mg comprimidos recubiertos con película film coated tablets
French: ACREL SEMANAL 35 mg comprimidos recubiertos con película
English: ACTAVIS S.R.L.
French: RO - Roumanie ACTAVIS S.R.L.
English: ACREL 75 mg comprimidos recubiertos con película film coated tablets
French: ACREL 75 mg comprimidos recubiertos con película
English: SE - Sweden Orion Corporation, Orion Pharma
French: Orion Corporation, Orion Pharma PO Box 65
English: RISEDRONAT GALEX 35 mg filmtabletta mgRisedronate sodium (equivalent to 40,17 mg Risedronate sodium hemipentahydr ate film-coated tablet Oral use
French: 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
French: RISEDRONATO SEMANAL STADA 35 mg comprimidos recubiertos con película
English: ACTONEL 75 mg comprimidos recubiertos con película film coated tablets
French: ACTONEL 75 mg comprimidos recubiertos con película
English: RISEDRONATE WINTHROP 75 mg, comprimé pelliculé film-coated tablet Oral use
French: RISEDRONATE WINTHROP 75 mg, comprimé pelliculé
English: Ridate Once a Week 35mg film-coated tablets film-coated tablets
French: Ridate Once a Week 35mg film-coated tablets
English: Bonefos capsules 400 mg hard capsules
French: Bonefos capsules 400 mg
English: GA Haarlem, Nederlands
French: 2031 GA Haarlem Netherlands
English: Actonel 5 mg film coated tablets film-coated tablets
French: ACTONEL 5 mg film coated tablets
English: film-coated tablet/effervesce nt granules
French: Comprimé pelliculé /granulés effervescents
English: DK - Denmark Orion Corporation Orion Pharma, Orionintie 1, FI02200 Espoo, Finland
French: Orion Corporation Orion Pharma, Orionintie 1, FI02200 Espoo, Finland
English: Risontel Once a week 35mg film-coated tablets film-coated tablets
French: Risontel Once a week 35mg film-coated tablets
English: Film-Coated Tablets and effervescent granules
French: Comprimés pelliculés et granulés effervescents
English: ACTONEL 30 mg comprimidos recubiertos film coated tablets
French: ACTONEL 30 mg comprimidos recubiertos
English: RISEMYL SEMANAL 35 mg comprimidos recubiertos con película film coated tablets
French: RISEMYL SEMANAL 35 mg comprimidos recubiertos con película
English: 30MG/TAB FILM COATED TABLET
French: 30MG/TAB Comprimé pelliculé Voie orale
English: ACTONEL 35 mg, comprimé pelliculé film-coated tablet Oral use
French: 35 mg Comprimé pelliculé Voie orale
English: RISEDRONATE ACTAVIS 35 mg filmtabletta mgRisedronate sodium (equivalent to 40,17 mg Risedronate sodium hemipentahydr ate film-coated tablet Oral use
French: RISEDRONATE ACTAVIS 35 mg filmtabletta mgRisedronate sodium (equivalent to 40,17 mg Risedronate sodium hemipentahydr ate
English: SE - Sweden STADA Arzneimittel AG, Stadastrasse 2-18, DE61118 Bad Vilbel, Germany (DEU)
French: STADA Arzneimittel AG, Stadastrasse 2-18, DE61118 Bad Vilbel, Germany (DEU)
English: ACTONEL SEMANAL 35 mg comprimidos recubiertos con película film coated tablets
French: ACTONEL SEMANAL 35 mg comprimidos recubiertos con película
English: LOSENTRA SEMANAL 35 mg comprimidos recubiertos con película film coated tablets
French: LOSENTRA SEMANAL 35 mg comprimidos recubiertos con película
English: NORIFAZ Trio 35 mg film- és rágótabletta mgRisedronate sodium (equivalent to 40,17 mg Risedronate sodium hemipentahydr ate film-coated tablet and chewing tablet
French: NORIFAZ Trio 35 mg film- és rágótabletta mgRisedronate sodium (equivalent to 40,17 mg Risedronate sodium hemipentahydr ate
English: Disodium Clodronate 60mg/ml solution for Injection
French: Disodium Clodronate 60mg/ml
English: Apotex Europe B.V. Darwinweg 20.
French: Apotex Europe B.V.
English: Actonel Once A Week 35 mg film-coated tablets film-coated tablets
French: Actonel Once A Week 35 mg film-coated tablets
English: Actonel® 30 mg, filmomhulde tabletten filmcoated tablets Oral use
French: Actonel® 30 mg, filmomhulde tabletten
English: Actonel® 5 mg, filmomhulde tabletten filmcoated tablets Oral use
French: Actonel® 5 mg, filmomhulde tabletten
English: Pamidronic acid containing medicinal products with Marketing Authorisation in the European Union
French: Les spécialités pharmaceutiques, des exploitants de l'Union Européenne, contenant de l'acide Pamidronique
English: RISEDRONAT TEVA 35 mg film coated tablets film coated tablets
French: RISEDRONAT TEVA 35 mg film coated tablets
English: 35MG/TAB FILM COATED TABLET
French: 35MG/TAB Comprimé pelliculé Voie orale
English: Tablet and Capsule soft Oral Use
French: Comprimé et Capsule molle
English: Tablet and film-coated tablet
French: Comprimé et Comprimé pelliculé
English: film-coated tablet and effervescent granules
French: Comprimé pelliculé et granulés effervescents
English: NORIFAZ 35 mg filmtabletta mgRisedronate sodium (equivalent to 40,17 mg Risedronate sodium hemipentahydr ate film-coated tablet Oral use
French: NORIFAZ 35 mg filmtabletta mgRisedronate sodium (equivalent to 40,17 mg Risedronate sodium hemipentahydr ate
English: ACTONEL 5 mg comprimidos recubiertos film coated tablets
French: ACTONEL 5 mg comprimidos recubiertos
English: tablet and soft capsules Oral Use
French: Comprimé et capsules molles
English: North Harrow, Middlesex HA1 4HF
French: 319 Pinner Road North Harrow, Middlesex HA1 4HF
English: JUVERITAL 35 mg filmtabletta mgRisedronate sodium (equivalent to 40,17 mg Risedronate sodium hemipentahydr ate film-coated tablet Oral use
French: JUVERITAL 35 mg filmtabletta mgRisedronate sodium (equivalent to 40,17 mg Risedronate sodium hemipentahydr ate
English: Film-coated tablets
French: Comprimé Pelliculés
English: Natriumrisedronaat 35 mg Ranbaxy filmcoated tablets Oral use
French: Natriumrisedronaat 35 mg Ranbaxy
English: NL - Netherlands Arrow Generics Limited Unit 2, Eastman Way, Stevenage, Hertfordshire, SG1 4SZ
French: Arrow Generics Limited Unit 2, Eastman Way, Stevenage, Hertfordshire, SG1 4SZ
English: Risonate film-coated tablets
French: Fosanate comprimé pelliculé
English: Route of administration granules
French: Voie d'administration comprimidos
English: DE-61118 Bad Vilbel
French: Bad Vilbel, 61118
English: SE - Sweden Zaklad Farmaceutyczny Adamed Pharma S.A., ul.
French: Zaklad Farmaceutyczny Adamed Pharma S.A., ul.
English: RISEDRONATE WINTHROP 35 mg, comprimé pelliculé film-coated tablet Oral use
French: RISEDRONATE WINTHROP 35 mg, comprimé pelliculé
English: Alendronat Interpharm
French: Alendronat Interpharm 10 mg
English: 70 mg Film-coated tablet
French: 70 mg Comprimé pelliculé
English: NL - Netherlands Actavis Group PTC ehf Reykjavikurvegur 76-78,220
French: RO - Roumanie Actavis Group PTC ehf Reykjavikurvegi 76-78, 220
English: BE - Belgium Arrow Generics Limited 2 Eastman Way, Stevenage, Hertfordshire, SG1 4SZ, United Kingdom
French: Arrow Generics Limited 2 Eastman Way, Stevenage, Hertfordshire, SG1 4SZ, United Kingdom
English: Risedronate Teva 35 mg filmomhulde tabletten film-coated tablets
French: Risedronate Teva 35 mg filmomhulde tabletten
English: Prenteral
French: Sindronat
English: Apotex Europe, B.V. Darwinweg 20
French: Apotex Europe, B.V.
English: ACTONEL 5 mg, comprimé pelliculé film-coated tablet Oral use
French: 5 mg Comprimé pelliculé Voie orale
English: D-51377 Leverkusen
French: Basics GmbH Hemmelrather Weg 201 D-51377 Leverkusen
English: Ácido Alendrónico ToLife 70 mg Comprimidos
French: Ácido Alendrónico ToLife 70 mg
English: Actonel® 75 mg, filmomhulde tabletten filmcoated tablets Oral use
French: Actonel® 75 mg, filmomhulde tabletten
English: Ácido Alendrónico Ecosis 70 mg
French: Ácido Alendrónico Glob 70 mg
English: Risedronaatnatrium Mylan Wekelijks 35 mg filmcoated tablets Oral use
French: Risedronaatnatrium Mylan Wekelijks 35 mg
English: ACTONEL 30 mg, comprimé pelliculé film-coated tablet Oral use
French: ACTONEL 30 mg, comprimé pelliculé
English: NL - Netherlands Roche Nederland B.V. Beneluxlaan 2a
French: NL - Pays Bas Roche Nederland B.V.
English: Neridronic acid containing medicinal products with Marketing Authorisation in the European Union
French: Les spécialités pharmaceutiques, des exploitants de l'Union Européenne, contenant de l'acide Néridronique
English: Risedronic acid containing medicinal products with Marketing Authorisation in the European Union
French: Les spécialités pharmaceutiques, des exploitants de l'Union Européenne, contenant de l'acide Risédronique
English: Natriumrisedronaat Ceft 5 mg filmcoated tablets Oral use
French: Natriumrisedronaat Ceft 5 mg
English: Natriumrisedronaat Sandoz® wekelijks 35 mg filmcoated tablets Oral use
French: Natriumrisedronaat Sandoz® wekelijks 35 mg
English: Ref. EMEA/477488/2008
French: EMEA/548378/2008
English: The effects of EXULETT were first tested in experimental models before being studied in humans.
French: Les effets d'EXULETT ont d'abord été testés sur des modèles expérimentaux avant d'être étudiés chez l'homme.
English: This kills the bacteria causing the infection.
French: Ce mécanisme éradique la bactérie causant l'infection.
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.
French: Le société a présenté les résultats d'une étude principale comparant les effets d'EXULETT avec ceux du linézolide (un autre antibiotique) chez 873 adultes.
English: Following the CHMP's opinion, it usually takes around two months for the European Commission to grant a licence.
French: Selon l'opinion du CHMP, un délai de deux mois est généralement nécessaire pour que la Commission européenne accorde une licence.
English: If you are in a clinical trial and need more information about your treatment, contact the doctor who is giving it to you.
French: Si vous participez actuellement à un essai clinique et si vous souhaitez des informations complémentaires concernant votre traitement, veuillez contacter le médecin qui vous le prescrit.
English: International non-proprietary name (INN): dalbavacin
French: Dénomination commune internationale (DCI): dalbavacin
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.
French: La principale mesure d'efficacité a été le nombre de patients dont l'infection a été traitée avec succès et qui n'ont pas eu besoin d'un traitement ultérieur à base d'autres antibiotiques.
English: It contains the active substance dalbavancin.
French: Elle contient le principe actif dalbavancin.
English: The active substance in EXULETT, dalbavancin, is an antibiotic that belongs to the group ‘glycopeptides'.
French: Le principe actif contenu dans EXULETT, le dalbavancin, est un antibiotique appartenant au groupe des « glycopeptides ».
English: Questions and answers on the withdrawal of the marketing application for EXULETT
French: Questions et réponses sur le retrait de la demande d'autorisation de mise sur le marché concernant
English: ‘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.
French: « Compliqué » signifie que l'infection est difficile à traiter, car elle s'est propagée aux tissus profonds situés sous la peau, qu'un traitement chirurgical peut s'avérer nécessaire, ou que le patient souffre d'une autre affection susceptible d'affecter la réponse au traitement.
English: Based on the review of the initial documentation, the CHMP prepares a list of questions at day 120, which is sent to the company.
French: Sur la base de l'examen de la documentation initiale, le CHMP prépare au jour 120 une liste de questions qu'il envoie à la société.
English: What are the consequences of the withdrawal for patients undergoing clinical trials with EXULETT?
French: Quelles sont les conséquences du retrait pour les patients participant aux essais cliniques relatifs à EXULETT ?
English: What is EXULETT?
French: Qu'est-ce qu'EXULETT?
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials of EXULETT.
French: La société a informé le CHMP qu'il n'y a pas de conséquences pour les patients actuellement associés aux essais cliniques d'EXULETT.
English: Once the company has supplied responses to the questions, the CHMP reviews them and may, before giving an opinion, ask any remaining questions at day 180.
French: Lorsque la société a fourni des réponses aux questions, le CHMP les examine et a la latitude, avant de rendre un avis, de poser toute question restante au jour 180.
English: These bacteria include Staphylococcus aureus (including ‘methicillin-resistant' forms known as ‘MRSA') and Streptococcus pyogenes.
French: Ces bactéries sont notamment Staphylococcus aureus (y compris les formes “résistantes à la méthicilline” designées par l'acronyme ‘SARM') et Streptococcus pyogenes.
English: EXULETT is a powder that is made up into a solution for infusion (drip into a vein).
French: EXULETT est une poudre destinée à être reconstituée en une solution pour perfusion (goutte-à-goutte dans une veine).
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.
French: Le CHMP avait des réserves inspirées par le fait que les résultats de la seule étude principale étaient trop limités pour justifier l'approbation du médicament en raison de la manière dont l'étude avait été réalisée, et a estimé qu'une autre étude serait nécessaire pour confirmer les résultats.
English: There were also concerns over whether EXULETT could be manufactured with consistent good quality.
French: Il avait également des réserves quant à la possibilité de fabriquer EXULETT en maintenant un niveau de qualité élevé homogène.
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.
French: Par conséquent, au moment du retrait de la demande, l'avis du CHMP était que les bénéfices d'EXULETT n'avaient pas été suffisamment démontrés et n'étaient pas supérieurs aux risques identifiés.
English: It is expected to work by stopping the bacteria making their cell walls.
French: Il est prévu qu'il agisse en bloquant la construction des parois cellulaires de la bactérie.
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.
French: Le 9 septembre 2008, Pfizer Limited a officiellement notifié au comité des médicaments à usage humain (CHMP) son souhait de retirer sa demande d'autorisation de mise sur le marché pour EXULETT, destiné au traitement des infections compliquées de la peau et des tissus mous chez les adultes lorsqu'il est avéré ou suspecté que l'affection est causée par une bactérie Gram positive susceptible.
English: After the CHMP had assessed the responses from the company to a list of questions, there were still some unresolved issues outstanding.
French: Après évaluation des réponses de la société à une liste de questions par le CHMP, un certain nombre d'interrogations restaient sans solution.
English: EXULETT was to be used to treat adults with complicated infections of the skin and the ‘soft tissues' below the skin.
French: Il était prévu d'utiliser EXULETT pour le traitement d'adultes atteints d'infections compliquées de la peau et des « tissus mous » situés sous la peau.
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.
French: Les patients sélectionnés pour cette étude devaient présenter des infections compliquées de la peau et des tissus mous (comme des abscès ou des lésions infectieuses) dues à la bactérie Gram positive.
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.
French: Sur la base de l'examen des données et de la réponse de la société à la liste de questions du CHMP au moment du retrait, le CHMP avait certaines réserves et estimait, à titre provisoire, qu'il n'était pas possible d'approuver EXULETT pour le traitement d'infections compliquées de la peau et des tissus mous chez les adultes lorsqu'il était avéré ou suspecté qu'elles sont/soient causées par une bactérie Gram positive susceptible.
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.
French: En outre, le CHMP avait des réserve concernant la pertinence des résultats de l'étude principale, étant donné que tous les patients inclus dans l'étude ne paraissaient pas présenter une affection suffisamment grave pour justifier l'administration d‘un traitement antibiotique par perfusion dans une veine.
English: How is EXULETT expected to work?
French: Comment EXULETT doit-il agir?