FrancophonIA/ELRC3.0 huggingface dataset:
English: DK - Denmark Merck Sharp & Dohme B.V., PO Box 581, Waarderweg 39, NL-2031 BN Haarlem, Nederlands
Polish: Merck Sharp & Dohme B.V., PO Box 581, Waarderweg 39, NL-2031 BN Haarlem, Nederlands
English: DIDRONEL 400 mg, comprimé tablet
Polish: DIDRONEL 400 mg, comprimé
English: MYLAN PHARMACEUTICALS, S.L.Plom 2-4, 5º Planta 08038 Barcelona
Polish: ES - Hiszpania MYLAN PHARMACEUTICALS, S.L.Plom 2-4, 5º Planta
English: D-51377 Leverkusen
Polish: Basics GmbH Hemmelrather Weg 201 D-51377 Leverkusen
English: Risedronate Sodium Actavis 35 mg film-coated tablets film-coated tablets
Polish: Risedronate Sodium Actavis 35 mg filmcoated tablets
English: Risedronato Winthrop 30 mg compresse rivestite con film film-coated tablets
Polish: Risedronato Winthrop 30 mg compresse rivestite con film
English: PAMIDRONATO DISODICO COMBINO PHARM 15 mg polvo para solución para perfusión solution for infusion
Polish: PAMIDRONATO DISODICO COMBINO PHARM 15 mg polvo para solución para perfusión
English: DIDRONEL 200 mg, comprimé tablet
Polish: DIDRONEL 200 mg, comprimé
English: SAPTAMANAL 35 mg film coated tablets film coated tablets
Polish: SAPTAMANAL 35 mg film-coated tablets
English: Warwickshire CV 31 3RW, United Kingdom
Polish: Spa,Warwickshire CV31 3RW, UK
English: SE - Sweden Zaklad Farmaceutyczny Adamed Pharma S.A., ul.
Polish: ES - Hiszpania ZAKLAD FARMACEUTYCZNY ADAMED PHARMA, S.A. ul.
English: NL - Netherlands Pharmachemie B.V. Swensweg 5
Polish: NL - Holandia Pharmachemie B.V.
English: Risedronate Sodium Actavis 30 mg film-coated tablets film-coated tablets
Polish: Risedronate Sodium Actavis 30 mg filmcoated tablets
English: Risedronato Winthrop 5 mg compresse rivestite con film film-coated tablets
Polish: Risedronato Winthrop 5 mg compresse rivestite con film
English: SE - Sweden Ranbaxy (UK) Ltd 20 Baldertoon Street London W1K 6TL
Polish: Ranbaxy (UK) Ltd 20 Baldertoon Street London W1K 6TL United Kingdom
English: LV - Latvia ratiopharm GmbH, GrafArco-Str.3, 89079 Ulm, Germany
Polish: LV - Łotwa ratiopharm GmbH, GrafArco-Str.3, 89079 Ulm, Germany
English: 60MG/VIAL POWDER AND SOLUTION FOR INFUSION
Polish: 60MG/VIAL Proszek i sporządzania roztworu do infuzji
English: D-89150 Laichingen
Polish: 08950 Esplugues de
English: Avestra Combi D 35 mg + 500 mg/400 IE
Polish: Norsed Combi D 35 mg + 500 mg/400 IE
English: PAMIDRONATO DISODICO COMBINO PHARM 90 mg polvo para solución para perfusión solution for infusion
Polish: PAMIDRONATO DISODICO COMBINO PHARM 90 mg polvo para solución para perfusión
English: Chlodna st., 51
Polish: MSD Polska Sp. z o.o. Chlodna st., 51
English: Actonel® Wekelijks 35 mg, filmomhulde tabletten filmcoated tablets Oral use
Polish: Actonel® Wekelijks 35 mg, filmomhulde tabletten
English: RISEDRONATO SEMANAL HEXAL 35 mg comprimidos recubiertos con película film coated tablets
Polish: RISEDRONATO SEMANAL HEXAL 35 mg comprimidos recubiertos con película
English: Tablet and Capsule soft Oral Use
Polish: Tabletka i Kapsułka, miękka
English: film coated tablets and efervescent granules
Polish: Tabletka powlekana i Granulat musujący
English: PAMIDRONATO DISODICO COMBINO PHARM 60 mg polvo para solución para perfusión solution for infusion
Polish: PAMIDRONATO DISODICO COMBINO PHARM 60 mg polvo para solución para perfusión
English: Risedronato Winthrop 35 mg compresse rivestite con film film-coated tablets
Polish: Risedronato Winthrop 35 mg compresse rivestite con film
English: PAMIDRONATO DISODICO COMBINO PHARM 30 mg polvo para solución para solution for infusion
Polish: PAMIDRONATO DISODICO COMBINO PHARM 30 mg polvo para solución para perfusión
English: Aredia 30 mg prašek in vehikel za koncentrat za raztopino za powder and solvent for solution for injection
Polish: Aredia 30 mg prašek in vehikel za koncentrat za raztopino za infundiranje
English: Optinate Combi D 35 mg and 1000 mg/880
Polish: Optinate Combi D 35 mg and 1000 mg/880 IU
English: 35,0 mg Risedronate sodium (equivalent to 40,17 mg Risedronate sodium hemipentahydr ate film-coated tablet Oral use
Polish: 35,0 mg Risedronate sodium (equivalent to 40,17 mg Risedronate sodium hemipentahydrate
English: Vida - Produtos Farmacêuticos, S.A. Rua da Estação, 42 - Vala do Carregado, 2600-726 Castanheira do Ribatejo
Polish: Rua da Estação, 42 - Vala do Carregado,
English: Soluction for injection
Polish: Roztwór do wstrzykiwań
English: For infusion
Polish: Roztwór do infuzji
English: DK - Denmark Mylan AB, P.O.box 23033, Ynglingagatan 14, SE-104
Polish: Mylan AB, P.O.box 23033, Ynglingagatan 14, SE-104 35 Stockholm; Sweden
English: Bonefos 800 mg filmsko obložene tablete film-coated tablet
Polish: Bonefos 800 mg filmsko obložene tablete
English: BG - Bulgaria ratiopharm GmbH, GrafArco-Strasse 3, 89079 Ulm, Germany
Polish: BG - Bułgaria ratiopharm GmbH, GrafArco-Strasse 3, 89079 Ulm, Germany
English: Risedronate Teva 35 mg filmomhulde tabletten film-coated tablets
Polish: RISEDRONAT TEVA 35 mg film-coated tablets
English: FI - Finland ratiopharm GmbH, GrafArco-Strasse 3, 89079 Ulm, Germany
Polish: FI - Finlandia ratiopharm GmbH, GrafArco-Strasse 3, 89079 Ulm, Germany
English: RISEDRONATO SEMANAL QUALIGEN 35 mg comprimidos recubiertos con película film coated tablets
Polish: RISEDRONATO SEMANAL QUALIGEN 35 mg comprimidos recubiertos con película
English: DK - Denmark Mylan AB, Postbox 230 33, Ynglingagatan 14, Se-104
Polish: Mylan AB, Postbox 230 33, Ynglingagatan 14, Se-104 35 Stockholm, Sweden
English: ACTONEL 75 mg comprimidos recubiertos con película film coated tablets
Polish: ACTONEL 75 mg comprimidos recubiertos con película
English: ACREL 75 mg comprimidos recubiertos con película film coated tablets
Polish: ACREL 75 mg comprimidos recubiertos con película
English: DK - Denmark BMM Pharma AB, Blasieholmsgatan 2, SE11148 Stockholm, Sweden
Polish: FI - Finlandia BMM Pharma AB, Blasieholmsgatan 2, 11148
English: 15 mg polvo solution for infusion
Polish: 15 mg polvo Roztwór do infuzji
English: HU - Hungary Hospira UK Limited Queensway, Royal
Polish: NO - Norwegia Hospira UK Limited, Queensway, Royal
English: 9 mg Concentrate for solution for infusion
Polish: 9 mg Koncentrat do sporządzania roztworu do infuzji
English: MIOSEN SEMANAL 35 mg comprimidos recubiertos con película film coated tablets
Polish: MIOSEN SEMANAL 35 mg comprimidos recubiertos con película
English: OSODENS 35 mg film coated tablets film coated tablets
Polish: OSODENS 35 mg filmcoated tablets
English: SK - Slovakia Torrex Chiesi -Pharma GmbH, Gonzagagasse 16/16, 1010 Viena, Austria
Polish: Torrex Chiesi -Pharma GmbH, Gonzagagasse 16/16, 1010 Viena, Austria
English: Optinate Once a Week 35mg Film-coated Tablets film-coated tablets
Polish: Optinate Once a Week 35mg film-coated tablets
English: Actonel 75 Milligram Film Coated Tablets film-coated tablets
Polish: Actonel 75 Milligram film-coated tablets
English: Pamidronic acid containing medicinal products with Marketing Authorisation in the European Union
Polish: Produkty lecznicze zawierające PAMIDRONIAN, posiadające dopuszczenie do obrotu ważne na terenie Unii Europejskiej
English: JUVERITAL 35 mg film coated tablets film coated tablets
Polish: JUVERITAL 35 mg film-coated tablets
English: GB-HA1 4HF NORTH
Polish: GB-HA1 4HF NORTH HARROW, MIDDLESEX
English: ACREL SEMANAL 35 mg comprimidos recubiertos con película film coated tablets
Polish: ACREL SEMANAL 35 mg comprimidos recubiertos con película
English: tablet and chewing tablet
Polish: Tabletka i Tabletka do rozgryzania i żucia
English: 6 mg/ml concentrate for solution for infusion - 10 ml
Polish: Koncentrat do sporządzania roztworu do infuzji - 10 ml
English: Hospira UK Limited, Queensway, Royal Leamington Spa, CV31 3RW Warwickshire, Great Britain
Polish: Hospira UK Limited, Queensway, Royal Leamington Spa, GB-CV31 3RW Warwickshire, England
English: Etidronic acid containing medicinal products with Marketing Authorisation in the European Union
Polish: Produkty lecznicze zawierające ETYDRONIAN, posiadające dopuszczenie do obrotu ważne na terenie Unii Europejskiej
English: ACTONEL 30 mg comprimidos recubiertos film coated tablets
Polish: ACTONEL 30 mg comprimidos recubiertos
English: NL - Netherlands Sandoz B.V., Veluwezoom 22
Polish: Sandoz B.V., Veluwezoom 22 1327 AH Almere Netherlands
English: SE - Sweden Orion Corporation, Orion Pharma
Polish: Orion Corporation, Orion Pharma PO Box 65
English: 3RW, UK
Polish: CV313RW, United Kingdom
English: Riserdonat Galex 35 mg filmsko obložene tablete film-coated tablet Oral use
Polish: Riserdonat Galex 35 mg filmsko obložene tablete
English: P-2705-906 TERRUGem SNT
Polish: 2705-906 Terrugem (SNT) Portugal
English: NO - Norway ratiopharm GmbH, GrafArco-Strasse 3, D-89070 Ulm Germany
Polish: NO - Norwegia ratiopharm GmbH, GrafArco-Strasse 3, D-89070
English: RISEDRONATO SEMANAL STADA 35 mg comprimidos recubiertos con película film coated tablets
Polish: RISEDRONATO SEMANAL STADA 35 mg comprimidos recubiertos con película
English: RISEDRONATE WINTHROP 75 mg, comprimé pelliculé film-coated tablet Oral use
Polish: RISEDRONATE WINTHROP 75 mg, comprimé pelliculé
English: Bonefos capsules 400 mg hard capsules
Polish: Bonefos capsules 400 mg
English: NL - Netherlands Bluefish Pharmaceuticals AB, Torsgatan 11
Polish: Bluefish Pharmaceuticals AB, Torsgatan 11
English: Neridronic acid containing medicinal products with Marketing Authorisation in the European Union
Polish: Produkty lecznicze zawierające NERIDRONIAN, posiadające dopuszczenie do obrotu ważne na terenie Unii Europejskiej
English: Ridate Once a Week 35mg film-coated tablets film-coated tablets
Polish: Ridate Once a Week 35mg film-coated tablets
English: DK - Denmark Orion Corporation Orion Pharma, Orionintie 1, FI02200 Espoo, Finland
Polish: Orion Corporation Orion Pharma, Orionintie 1, FI02200 Espoo, Finland
English: 15 mg Concentrate for solution for infusion
Polish: 15 mg Koncentrat do sporządzania roztworu do infuzji
English: LABORATORIO STADA, S.L.Frederic Mompou, 5 08960 Sant Just Desvern Barcelona
Polish: 08960 Sant Just Desvern Barcelona
English: SE - Sweden STADA Arzneimittel AG, Stadastrasse 2-18, DE61118 Bad Vilbel, Germany (DEU)
Polish: STADA Arzneimittel AG, Stadastrasse 2-18, DE61118 Bad Vilbel, Germany (DEU)
English: LORINE 35 mg film coated tablets film coated tablets
Polish: LORINE 35 mg filmcoated tablets
English: ACTONEL 5 mg comprimidos recubiertos film coated tablets
Polish: ACTONEL 5 mg comprimidos recubiertos
English: Fortipan Combi D 35 mg + 500 mg/400 IE
Polish: Fortipan Combi D 35 mg + 500 mg/400 IE Tabletka powlekana
English: RISEMYL SEMANAL 35 mg comprimidos recubiertos con película film coated tablets
Polish: RISEMYL SEMANAL 35 mg comprimidos recubiertos con película
English: Risontel Once a week 35mg film-coated tablets film-coated tablets
Polish: Risontel Once a week 35mg film-coated tablets
English: ACTONEL SEMANAL 35 mg comprimidos recubiertos con película film coated tablets
Polish: ACTONEL SEMANAL 35 mg comprimidos recubiertos con película
English: Tablet and film-coated tablet
Polish: Tabletka i Tabletka powlekana
English: AREDIA DRY POWDER 15 mg
Polish: AREDIA DRY POWDER
English: LOSENTRA SEMANAL 35 mg comprimidos recubiertos con película film coated tablets
Polish: LOSENTRA SEMANAL 35 mg comprimidos recubiertos con película
English: Actonel® 30 mg, filmomhulde tabletten filmcoated tablets Oral use
Polish: Actonel® 30 mg, filmomhulde tabletten
English: Disodium Clodronate 60mg/ml solution for Injection
Polish: Disodium Clodronate 60mg/ml
English: GA Haarlem, Nederlands
Polish: 2031 GA Haarlem Netherlands
English: ACTONEL OAW 35MG/TAB FILM COATED TABLET
Polish: ACTONEL OAW 35MG/TAB
English: BE - Belgium Merck Sharp & Dohme B.V. Clos du Lynx, 5- 1200
Polish: NO - Norwegia Merck Sharp and Dohme B.V., Postbus 581,
English: Actonel Once A Week 35 mg film-coated tablets film-coated tablets
Polish: Actonel Once A Week 35 mg film-coated tablets
English: 6 mg Concentrate for solution for infusion
Polish: 6 mg Koncentrat do sporządzania roztworu do infuzji
English: Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda.
Polish: PT - Portugalia Ratiopharm - Comércio e Indústria de Produtos
English: Actonel® 5 mg, filmomhulde tabletten filmcoated tablets Oral use
Polish: Actonel® 5 mg, filmomhulde tabletten
English: Apotex Europe B.V. Darwinweg 20.
Polish: Apotex Europe B.V.
English: CONCENTRATE FOR SOLUTION FOR INFUSION
Polish: Koncentrat do sporządzania roztworu do infuzji
English: Optinate Combi D 35 mg + 500 mg/400 IE
Polish: Optinate Combi D 35 mg + 500 mg/400 IE Tabletka powlekana
English: DK - Denmark Stada Arzneimittel AG, Stadastrasse 2-8, DE61118 Bad Vilbel, Germany
Polish: Stada Arzneimittel AG, Stadastrasse 2-8, DE61118 Bad Vilbel, Germany
English: NL - Netherlands Roche Nederland B.V. Beneluxlaan 2a
Polish: Roche Nederland B.V.
English: DE - Germany CT Arzneimittel GmbH Lengeder Str. 42a
Polish: CT Arzneimittel GmbH Lengeder Str. 42a D-13407 Berlin
English: DK - Denmark Ratiopharm GmbH, GrafArco-Strasse 3, DE-89079
Polish: DK - Dania ratiopharm GmbH, GrafArco-Strasse 3, DE-89079 Ulm, Germany
English: RATIOPHARM 3 mg/ml, solution à diluer pour perfusion
Polish: PAMIDRONATE DE SODIUM RATIOPHARM 3 mg/ml, solution à diluer pour perfusion
English: Odense S., Denmark
Polish: København S, Danmark
English: Bucureşti-Ploieşti, Nr. 1A,Clădirea C1, Etaj 3,Sector 1, Bucureşti, România
Polish: 1A,Clădirea C1, Etaj
English: DE - Germany Actavis Group PTC ehf Reykjavikurvegur 76 - 78
Polish: RO - Rumunia Actavis Group PTC ehf Reykjavikurvegi 76-78, 220
English: North Harrow, Middlesex HA1 4HF
Polish: 319 Pinner Road North Harrow, Middlesex HA1 4HF
English: NL - Netherlands Arrow Generics Limited Unit 2, Eastman Way, Stevenage, Hertfordshire, SG1 4SZ
Polish: Arrow Generics Limited Unit 2, Eastman Way, Stevenage, Hertfordshire, SG1 4SZ
English: DK - Denmark Gedeon Richter Plc., Gyömröí út 19-21, HU-1103
Polish: Gedeon Richter Plc., Gyömröí út 19-21, HU-1103 Budapest, Hungary
English: ACTONEL 30 mg, comprimé pelliculé film-coated tablet Oral use
Polish: ACTONEL 30 mg, comprimé pelliculé
English: NL - Netherlands Centrafarm Services B.V. Nieuwe Donk 9
Polish: Centrafarm Services B.V.
English: BE - Belgium Arrow Generics Limited 2 Eastman Way, Stevenage, Hertfordshire, SG1 4SZ, United Kingdom
Polish: NO - Norwegia Arrow Generics Ltd, 2 Eastman Way, Stevenage, Hertfordshire, SG1 4SZ, united Kingdom
English: RISEDRONATE WINTHROP 35 mg, comprimé pelliculé film-coated tablet Oral use
Polish: RISEDRONATE WINTHROP 35 mg, comprimé pelliculé
English: Prenteral
Polish: Sindronat
English: film-coated tablet and chewing tablet
Polish: Tabletka powlekana i Tabletka do rozgryzania i żucia
English: Natriumrisedronaat 35 mg Ranbaxy filmcoated tablets Oral use
Polish: Natriumrisedronaat 35 mg Ranbaxy
English: ISUS - Produtos Farmacêuticos e Cosméticos, S.A. Rua António Quadros, 9GEscritório 3, 1600-875 Lisboa Portugal
Polish: Cosméticos, S.A. Rua António Quadros, 9GEscritório 3,
English: DE - Germany Volkspharma GmbH August-Wessels-Str. 5
Polish: Volkspharma GmbH August-Wessels-Str. 5 D-86154 Augsburg
English: DK - Denmark Pharmathen S.A., 6, Dervenakion str., GR-15351
Polish: Pharmathen S.A., 6, Dervenakion str., GR-15351 Pallini Attiki, Greece
English: Pamidronaat Actavis 3 mg/ml
Polish: Pamidronat-ratiopharm 3 mg/ml
English: Actonel® 75 mg, filmomhulde tabletten filmcoated tablets Oral use
Polish: Actonel® 75 mg, filmomhulde tabletten
English: Pamidronato Hikma 3 mg/ml
Polish: PAMIDRONATO RATIOPHARM 3 mg/ml
English: MERCK SHARP AND DOHME DE ESPAÑA, S.A.Josefa Valcarcel, 38 28027 MADRID
Polish: ES - Hiszpania MERCK SHARP AND DOHME DE ESPAÑA, S.A.Josefa
English: ACTONEL 5 mg, comprimé pelliculé film-coated tablet Oral use
Polish: ACTONEL 5 mg, comprimé pelliculé
English: JUVERITAL 5 mg film coated tablets film coated tablets
Polish: JUVERITAL 5 mg filmcoated tablets
English: NL - Netherlands Actavis Group PTC ehf Reykjavikurvegur 76-78,220
Polish: NO - Norwegia Actavis Group PTC ehf, Reykjavikurvegi 76-78, 220
English: Risedronaatnatrium Mylan Wekelijks 35 mg filmcoated tablets Oral use
Polish: Risedronaatnatrium Mylan Wekelijks 35 mg
English: 35 mg + 500 mg/400 UI
Polish: 35 mg + 500 mg/400 UI Tabletka
English: Tablet and effervescent tablet
Polish: Tabletka i Tabletka musująca Podanie doustne
English: ACTONEL 35 mg, comprimé pelliculé film-coated tablet Oral use
Polish: ACTONEL 35 mg, comprimé pelliculé
English: Tecnimede - Sociedade Técnico-Medicinal, S.A. Rua da Tapada Grande, 2Abrunheira
Polish: PT - Portugalia Farmoz - Sociedade Técnico Medicinal, S.A. Rua da
English: DE - Germany ALIUD PHARMA GmbH Gottlieb-Daimler-Str. 19
Polish: ALIUD PHARMA GmbH Gottlieb-Daimler-Str. 19 D-89150 Laichingen
English: SE - Sweden Pharmaceutical Works Polpharma S.A. 19
Polish: RO - Rumunia PHARMACEUTICAL WORKS POLPHARMA SA,19
English: Scientific conclusions and grounds for the suspension of the marketing authorisation presented by the European Medicines Agency
Polish: Wnioski naukowe i podstawy zawieszenia pozwolenia na dopuszczenie do obrotu przedstawione przez Europejską Agencję Leków
English: Grounds for the suspension of the marketing authorisation
Polish: Podstawy zawieszenia pozwolenia na dopuszczenie do obrotu
English: The CHMP considered that this information does not impact the safety and efficacy profile of MACI but that in the absence of an authorised manufacturing site, the requirements laid down in Article 41 of Directive 2001/83/EC are no longer met.
Polish: CHMP uznał, że informacja ta nie ma wpływu na profil bezpieczeństwa stosowania ani skuteczności produktu MACI, jednak wobec braku zakładu uprawnionego do produkcji nie są w dalszym ciągu spełniane wymagania określone w art. 41 dyrektywy 2001/83/WE.
English: 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
Polish: W związku z powyższym w dniu 10 września 2014 r. Komisja Europejska wszczęła postępowanie zgodnie z art. 20 rozporządzenia (WE) nr 726/2004, zwracając się do Agencji z prośbą o wyrażenie opinii, czy zgodnie z art. 118 dyrektywy 2001/83/WE pozwolenie na dopuszczenie do obrotu dla produktu MACI powinno zostać zawieszone lub cofnięte.
English: • The Committee considered the notification under Article 20 of Regulation (EC) No 726/2004 for
Polish: • Komitet rozpatrzył powiadomienie zgodnie art. 20 rozporządzenia (WE) nr 726/2004 oraz wstępną opinię CHMP opracowaną przez CAT;
English: There were also concerns over whether EXULETT could be manufactured with consistent good quality.
Polish: Zaistniały także obawy, czy EXULETT można wytwarzać z zachowaniem ciągłej wysokiej jakości.
English: Ref. EMEA/477488/2008
Polish: Londyn, 25 września 2008 r. Nr ref. dokumentu: EMEA/548385/2008
English: Questions and answers on the withdrawal of the marketing application for EXULETT
Polish: Pytania i odpowiedzi dotyczące wycofania wniosku o dopuszczenie do obrotu dla preparatu EXULETT
English: International non-proprietary name (INN): dalbavacin
Polish: Nieopatentowana nazwa międzynarodowa: dalbawacyna
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.
Polish: Firma przedstawiła wyniki jednego badania głównego, w którym działanie preparatu EXULETT porównywano z linezolidem (inny antybiotyk) u 873 osób dorosłych.
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.
Polish: Główną miarą skuteczności była liczba pacjentów, u których zakażenie zostało wyleczone i którzy nie wymagali dalszego leczenia innymi antybiotykami.
English: These bacteria include Staphylococcus aureus (including ‘methicillin-resistant' forms known as ‘MRSA') and Streptococcus pyogenes.
Polish: Do bakterii tych należy Staphylococcus aureus (wraz z formami opornymi na metycylinę określanymi jako „MRSA”) i Streptococcus pyogenes.
English: What is EXULETT?
Polish: Co to jest EXULETT?
English: What are the consequences of the withdrawal for patients undergoing clinical trials with EXULETT?
Polish: Jakie są konsekwencje wycofania wniosku dla pacjentów biorących udział w badaniach klinicznych z użyciem preparatu EXULETT?
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials of EXULETT.
Polish: Firma poinformowała CHMP, że nie ma żadnych konsekwencji dla pacjentów biorących obecnie udział w badaniach klinicznych z użyciem preparatu 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.
Polish: W dniu 9 września 2008 r. firma Pfizer Limited oficjalnie powiadomiła Komitet ds. Produktów Leczniczych Stosowanych u Ludzi (CHMP) o zamiarze wycofania wniosku o dopuszczenie do obrotu preparatu EXULETT wskazanego w leczeniu osób dorosłych z powikłanymi zakażeniami skóry lub tkanek miękkich, co do których zachodzi podejrzenie, że zostały wywołane przez bakterie Gramdodatnie.
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.
Polish: W związku z powyższym, w momencie wycofania wniosku CHMP stwierdził, że nie wykazano w wystarczającym stopniu korzyści związanych ze stosowaniem preparatu EXULETT i że nie przeważały one nad rozpoznanym ryzykiem.
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.
Polish: CHMP wyraził zastrzeżenia, że ze względu na sposób przeprowadzenia badania, wyniki jednego badania głównego były zbyt ograniczone, by stanowić podstawę do przyznania pozwolenia na dopuszczenie do obrotu; CHMP był zdania, że należy przeprowadzić kolejne badanie w celu potwierdzenia wyników.
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.
Polish: W oparciu o przegląd danych oraz odpowiedzi firmy na listę pytań wystosowanych przez CHMP, w momencie wycofania wniosku CHMP wyraził zastrzeżenia i wydał wstępną opinię wskazującą, że preparat EXULETT nie zostanie zatwierdzony w leczeniu osób dorosłych z powikłanymi zakażeniami skóry lub tkanek miękkich, co do których zachodzi podejrzenie, że zostały wywołane przez bakterie Gram-dodatnie.
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.
Polish: EXULETT miał być stosowany tylko w przypadku, gdy było wiadomo lub domyślano się, że zakażenie zostało wywołane przez bakterie zaklasyfikowane jako „Gram-dodatnie” i że można je było zwalczyć za pomocą leku.
English: It contains the active substance dalbavancin.
Polish: Preparat zawiera substancję czynną dalbawacynę.
English: The effects of EXULETT were first tested in experimental models before being studied in humans.
Polish: Zanim przeprowadzono badania na ludziach, działanie preparatu EXULETT zbadano w modelach eksperymentalnych.