natgillin/translations-raw huggingface dataset:
NO - Норвегия ratiopharm GmbH, GrafArco-Strasse 3, D-89070 
NO - Norway ratiopharm GmbH, GrafArco-Strasse 3, D-89070 Ulm Germany
Hospira UK Limited Queensway Royal Leamington Spa Warwickshire, CV31 3RW United Kingdom 
Hospira UK Limited, Queensway Royale Leamington Spa, Warwickshire CV31 3RW United Kingdom
Qualigen 35 mg 
Risedronat Qualigen 35 mg
Gideon Richter Plc, Gyomrui Utca 19-21, Budapest H 
Gideon Richter Plc, Gyomrui Utca 19-21, Budapest H1103, Hungary alendronic acid
- Португалия Apotex Europe, B.V. Darwinweg 20 
Apotex Europe, B.V. Darwinweg 20
WARNER CHILCOTT 
WARNER CHILCOTT ITALY Srl
JUVERITAL 35 mg film coated tablets 
JUVERITAL 35 mg film coated tablets film coated tablets
BG - България Merck Sharp & Dohme 
Merck Sharp & Dohme Bulgaria
Инжекционен разтвор 
Intramuscular
HERTS EN6 1TL ENGLAND 
STATION CLOSE POTTERS BAR HERTS EN6 1TL ENGLAND
Лекарствени продукти, съдържащи Ибандронова киселина _(Ibandronic acid) с разрешение за употреба в Европейския съюз Държава членка 
Ibandronic acid containing medicinal products with Marketing Authorisation in the European Union
IE - Ирландия Bayer Limited The Atrium 
Bayer Limited The Atrium Blackthorn Road Dublin 18
25 de Abril, 15, 2º F 
Edifício Cyprium, Av. 25 de Abril, 15, 2º F, 2795-195 Linda-a-Velha Portugal
6/2 LT-09310 Vilnius, 
UAB “SANOFI-AVENTIS LIETUVA”, A.Juozapavičiaus g. 6/2 LT-09310 Vilnius, Lithuania
TEVANATE 70 MG 70 mg 
TEVANATE 70 MG
BG - България Actavis Group PTC ehf, 
SE - Sweden Actavis Group PTC ehf.
LEFOSAN SEMANAL 70 mg comprimidos tablets 
LEFOSAN SEMANAL 70 mg comprimidos
- Финландия BMM Pharma AB, Blasieholmsgatan 2, 11148 
DK - Denmark BMM Pharma AB, Blasieholmsgatan 2, SE11148 Stockholm, Sweden
AB Box 1070 251 10 Helsingborg 
251 10 Helsingborg Sweden
Zone F - Bloc B 
A e 8 B - Fervenca
1A,Clădirea C1, Etaj 
Bucureşti-Ploieşti, Nr. 1A,Clădirea C1, Etaj 3,Sector 1, Bucureşti, România
Bonefos 800 mg filmsko obložene tablete 
Bonefos 800 mg filmsko obložene tablete film-coated tablet
Actavis Group PTC EHF, Reykjavikurvegi 76-78, Hafnarfirdi IS-220 
Actavis Group PTC EHF, Reykjavikurvegi 76-78, Hafnarfirdi IS-220 Iceland
30MG/TAB ФИЛМИРАНИ 
30MG/TAB FILM COATED TABLET
RISEDRONATO SEMANAL QUALIGEN 35 mg comprimidos recubiertos con película 
RISEDRONATO SEMANAL QUALIGEN 35 mg comprimidos recubiertos con película film coated tablets
Gendron 70 Tablety 70 mg 
Gendron 70 Tablety
Torrex Chiesi Pharma GmbH Gonzagagasse 16/16, 1010 Vienna 
Torrex Chiesi Pharma GmbH Gonzagagasse 16/16, 1010 Vienna AUSTRIA
ALENDRONATO AHCL 10 mg 
ALENDRONATO AHCL
9 mg/ml Pamidronic acid ( equal 
9 mg/ml Pamidronic acid ( equal to pamidronate disodium )
J.E. Mommaertslaan 14 1831 Diegem-Machelen 
Mommaertslaan B-1831 Diegem
Bonefos pro infusione 
Soluction for infusion
ACTONEL 30 mg comprimidos recubiertos 
ACTONEL 30 mg comprimidos recubiertos film coated tablets
Merck Sharp & Dohme Magyarország Kft. 
Merck Sharp & Dohme Magyarország Kft. Alkotás u. 48-50.
IS - Исландия Arrow Generics Ltd., Unit 2 Eastman Way Stevenage, Hertz SG1 4SZ U.K 
Arrow Generics Ltd., Unit 2 Eastman Way Stevenage, Hertz SG1 4SZ U.K
MIOSEN SEMANAL 35 mg comprimidos recubiertos con película 
MIOSEN SEMANAL 35 mg comprimidos recubiertos con película film coated tablets
RISEDRONAT GALEX 35 mg filmtabletta mgRisedronate sodium (equivalent 
RISEDRONAT GALEX 35 mg filmtabletta mgRisedronate sodium (equivalent to 40,17 mg Risedronate sodium hemipentahydr ate film-coated tablet Oral use
tablety 
tablets
Stada Arzneimittel AG, Stadastrasse 2-8, DE61118 Bad Vilbel, Германия 
DK - Denmark Stada Arzneimittel AG, Stadastrasse 2-8, DE61118 Bad Vilbel, Germany
Joan Despi, (Barcelona) 
Barcelona 69 08970 , Sant Joan Despi, (Barcelona) Spain
Alendor 70 mg tablete 70 mg 
Alendor 70 mg tablete
Hexal A/S Kanalholmen 8-12 DK-2650 Hvidovre 
SE - Sweden Hexal A/S Kanalholmen 8-12
Risontel Once a week 35mg Filmcoated tablets 
Risontel Once a week 35mg film-coated tablets film-coated tablets
PAMIRED 60 Прах за инфузионен разтвор 
PAMIRED 60 powder for solution for infusion powder for solution for infusion
Hospira UK Limited, Queensway, Royal Leamington Spa, GB-CV31 3RW Warwickshire, England 
Hospira UK Limited, Queensway, Royal Leamington Spa, CV31 3RW Warwickshire, Great Britain
5 MG/TAB 
5 MG/TAB TABLET
Pharmaceutical Works Polpharma S.A. 
SE - Sweden Pharmaceutical Works Polpharma S.A. 19
Riserdonat Galex 35 mg filmsko obložene tablete 
Riserdonat Galex 35 mg filmsko obložene tablete film-coated tablet Oral use
PLIVA Pharma Ltd, Vision House, Bedford Road, Petersfield Hampshire, GU32 3QB, United Kingdom and Northern Ireland 
Vision House, Bedford Road, Petersfield, Hants, GU32 3QB, United Kingdom
ACREL SEMANAL 35 mg comprimidos recubiertos con película 
ACREL SEMANAL 35 mg comprimidos recubiertos con película film coated tablets
Teva Pharma B.V., Computerweg 10 3542 DR Utrecht, The 
Teva Pharma B.V., Computerweg 10 3542 DR Utrecht, The Netherlands
Таблетки и Филмирани таблетки 
Tablet and film-coated tablet
JUVERITAL 5 mg filmtabletta mgRisedronate sodium (equivalent 
JUVERITAL 5 mg filmtabletta mgRisedronate sodium (equivalent to 5,74 mg Risedronate sodium hemipentahydr ate film-coated tablet Oral use
ACREL 75 mg comprimidos recubiertos con película 
ACREL 75 mg comprimidos recubiertos con película film coated tablets
Mylan AB, Postbox 230 33, Ynglingagatan 14, Se-104 35 Stockholm, Швеция 
DK - Denmark Mylan AB, Postbox 230 33, Ynglingagatan 14, Se-104
RISEDRONATE ACTAVIS 35 mg filmtabletta mgRisedronate sodium (equivalent 
RISEDRONATE ACTAVIS 35 mg filmtabletta mgRisedronate sodium (equivalent to 40,17 mg Risedronate sodium hemipentahydr ate film-coated tablet Oral use
Reykjavikurvegur 76-78, IS-220, Hafnarfjordur 
Reykjavíkurvegi, 76-78, IS-220 Hafnarfjörour Islândia
ACTONEL 75 mg comprimidos recubiertos con película 
ACTONEL 75 mg comprimidos recubiertos con película film coated tablets
Avestra 
Avda.
Лекарствени продукти, съдържащи Клодронова киселина (clodronic acid), с разрешение за употреба в Европейския съюз Държава членка 
Clodronic acid containing medicinal products with Marketing Authorisation in the European Union
Ranbaxy (UK) Ltd 20 Baldertoon Street London W1K 6TL United Kingdom 
SE - Sweden Ranbaxy (UK) Ltd 20 Baldertoon Street London W1K 6TL
- Словакия Torrex Chiesi -Pharma GmbH, Gonzagagasse 16/16, 1010 Viena, Австрия 
SK - Slovakia Torrex Chiesi -Pharma GmbH, Gonzagagasse 16/16, 1010 Viena, Austria
Gedeon Richter Plc. Gyömrõi ut 19-21 1103 Budapest 
GEDEON RICHTER Gyömroi ut 19-21 1103 Budapest X HONGRIE
6 mg/ml Pamidronic acid ( equal 
6 mg/ml Pamidronic acid ( equal to pamidronate disodium )
SK - Словакия Sanofi-aventis 
Sanofi-aventis Slovakia s.r.o.
RISEDRONATO SEMANAL STADA 35 mg comprimidos recubiertos con película 
RISEDRONATO SEMANAL STADA 35 mg comprimidos recubiertos con película film coated tablets
Actavis Group PTC ehf Reykjavikurvegi 76-78 220 Hafnarfjördur 
Actavis Group PTC ehf Reykjavikurvegi 76-78 220 Hafnarfjördur ICELAND
RISEDRONATE WINTHROP 75 mg, comprimé pelliculé 
RISEDRONATE WINTHROP 75 mg, comprimé pelliculé film-coated tablet Oral use
Лекарствени продукти, съдържащи Алендронова киселина (Alendronic acid), с разрешение за употреба в Европейския съюз Държава членка 
Alendronic acid containing medicinal products with Marketing Authorisation in the European Union
ALENDRONIQUE QUALIMED 70 mg, comprimé tablet 
ALENDRONIQUE QUALIMED 70 mg, comprimé
A-6250 Kundl, Австрия 
Biochemie strasse, A-6250 Kundl, Austria
PT - Португалия Pharmakern Португалия 
DE - Germany HIKMA Farmaceutica (Portugal) S.A.
Zentiva k.s., U kabelovny 130, Dolní Měcholupy, 102 37 Praha 10, Чешка 
Zentiva k.s., U kabelovny 130, Dolní Měcholupy, 102
35MG/TAB ФИЛМИРАНИ 
35MG/TAB FILM COATED TABLET
PAMIDRONAT TORREX 15 mg/ml 
Pamidronat "Hexal" 15 mg/ml
10 MG/TAB 
10 MG/TAB TABLET
Actonel® 30 mg, filmomhulde tabletten 
Actonel® 30 mg, filmomhulde tabletten filmcoated tablets Oral use
Disodium Clodronate 60mg/ml 
Disodium Clodronate 60mg/ml solution for Injection
QUIMICA FARMACEUTICA BAYER, S.L.Av. Baix Llobregat, 3-5 08970 Sant 
COMBINO PHARM, S.L.Fructuos Gelabert, 6-8 08970 Sant Joan Despi
Филмирани таблетки/ефервес центни гранули 
film-coated tablet/effervesce nt granules
3 mg/ml Pamidronic acid ( equal 
3 mg/ml Pamidronic acid ( equal to pamidronate disodium )
RISEMYL SEMANAL 35 mg comprimidos recubiertos con película 
RISEMYL SEMANAL 35 mg comprimidos recubiertos con película film coated tablets
Merck Sharp & Dohme BV Waarderweg 39, 2031 BN 
Merck Sharp & Dohme BV Waarderweg 39, 2031 BN Haarlem, Netherlands
RISEDRONAT TEVA 35 mg film coated tablets 
RISEDRONAT TEVA 35 mg film coated tablets film coated tablets
- Ирландия Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, The Нидерландия 
Teva Pharma B.V., Computerweg 10, 3542 DR Utrecht, Netherlands
Apsala Limited, bayview 
Apsala Limited, bayview House, 49 Northstrand Road,Dublin 3, Ireland
Fosamax week tablet 70 mg 
Fosamax tablet 70mg
Mylan AB, P.O.box 23033, Ynglingagatan 14, SE-104 35 Stockholm; Sweden 
DK - Denmark Mylan AB, P.O.box 23033, Ynglingagatan 14, SE-104
75.00 mg Risedronate sodium (equal 
75.00 mg Risedronate sodium (equal to Risendronic acid)
ACTONEL 5 mg film-coated tablets 
Actonel 5 mg film coated tablets film-coated tablets
MSD Polska Sp. z o.o. Chlodna st., 51 
Chlodna st., 51
Лекарствени продукти, съдържащи Тилудронова киселина (Tiludronic acid) с разрешение за употреба в Европейския съюз Държава членка 
Tiludronic acid containing medicinal products with Marketing Authorisation in the European Union
ACTONEL SEMANAL 35 mg comprimidos recubiertos con película 
ACTONEL SEMANAL 35 mg comprimidos recubiertos con película film coated tablets
- Финландия Arrow Generics Limited, Unit 2, Eastman Way Stevenage, HERTS SG14SZ, United 
Arrow Generics Limited, Unit 2, Eastman Way Stevenage, HERTS SG14SZ, United Kingdom
ИРЛАНДИЯ LTD 
Ireland Ltd, 25/28 North
LOSENTRA SEMANAL 35 mg comprimidos recubiertos con película 
LOSENTRA SEMANAL 35 mg comprimidos recubiertos con película film coated tablets
SK - Словакия Arrow Generics Limited Unit 2, Eastman Way, Stevenage, Hertfordshire, SG14SZ 
Arrow Generics Limited Unit 2, Eastman Way, Stevenage, Hertfordshire, SG14SZ
Actavis Group PTC ehf, Reykjavikurvegur 76-78, 220 Hafnarfjördur, Исландия 
Actavis Group PTC ehf, Reykjavikurvegur 76-78, 220 Hafnarfjördur, Iceland
2333 CN Leiden, 
2333 CN Leiden, Netherlands
Actonel® 5 mg, filmomhulde tabletten 
Actonel® 5 mg, filmomhulde tabletten filmcoated tablets Oral use
ACTONEL 5 mg comprimidos recubiertos 
ACTONEL 5 mg comprimidos recubiertos film coated tablets
Alkotás u. 
Crta.
Torrex Chiesi -Pharma GmbH, Gonzagagasse 16/16, 1010 Viena, Австрия 
Torrex Chiesi Pharma GmbH, Gonzagagasse 16/16, 1010 Vienna, Austria
- Финландия Hospira UK Limited, Queensway, Royal 
DK - Denmark Hospira UK Limited, Queensway, Royal
Ácido Alendrónico Alter 70 mg 
Ácido Alendrónico Ecosis 70 mg
Turku, Финландия 
FI - Finland
Clasteon капсула 
Clodrobon capsule, hard
McDermott Laboratories Ltd. 
LABORATORIOS RANBAXY, S.L.
36/A 1145 Budapest 
Ratiopharm Hungária Kft. Uzsoki u. 36/A 1145 Budapest Hungary
Risedronat Genericon 5 mg 
Risedronat Galex 5mg 5mg
Таблетки и Капсули, меки 
tablet and soft capsules Oral Use
Лекарствени продукти, съдържащи Ризедронова киселина (risedronic acid), с разрешение за употреба в Европейския съюз 
Risedronic acid containing medicinal products with Marketing Authorisation in the European Union
2795-195 Linda-a-Velha 
Edifício Cyprium, Av. 25 de Abril, 15, 2º F 2795-195 Linda-a-Velha Portugal
90MG/VIAL ПРАХ 
90MG/VIAL POWDER AND SOLUTION FOR INFUSION
- Финландия Orifarm Generics A/S, Energivej 15, 5260 ODENSE 
DK - Denmark Orifarm Generics A/S, Energivej 15, DK-5260
Таблетки + гранулат Комбинирана опаковка 
Tablet + granulate combination package
Bonefos capsules 400 mg 
Bonefos capsules 400 mg hard capsules
Обвита таблекта 
Coated tablet
Cosméticos, S.A. Rua António Quadros, 9GEscritório 3, 
ISUS - Produtos Farmacêuticos e Cosméticos, S.A. Rua António Quadros, 9GEscritório 3, 1600-875 Lisboa Portugal
LABORATORIOS RANBAXY, S.L. Passeig de Gracia, 9 08007 Barcelona 
Passeig de Gracia, 9 08007 Barcelona
Филмирани таблетки перорално приложение 
filmcoated tablets Oral use
HA1 4HF, Middlesex 
GB-UB4 9EB HAYES, MIDDLESEX
Actavis Group PTC ehf; Reykjavikurvegi 76-78, 220 Hafnarfjordur 
Actavis Group PTC ehf; Reykjavikurvegi 76-78, 220 Hafnarfjordur Iceland
S.A. 
P.O.
NORIFAZ 35 mg filmtabletta mgRisedronate sodium (equivalent 
NORIFAZ 35 mg filmtabletta mgRisedronate sodium (equivalent to 40,17 mg Risedronate sodium hemipentahydr ate film-coated tablet Oral use
Филмирани таблетки и ефервесцентни гранули 
film coated tablets and efervescent granules
9 mg Концентрат за инфузионен разтвор 
9 mg Concentrate for solution for infusion
- Финландия ratiopharm GmbH, GrafArco-Strasse 3, 89079 Ulm, 
Ratiopharm GmbH, GrafArco-Strasse 3, 89079 Ulm, Germany
ACTONEL 30 mg, comprimé pelliculé 
ACTONEL 30 mg, comprimé pelliculé film-coated tablet Oral use
FOSAMAX 70 MG 70 mg 
FOSAMAX 70 MG
RO - Румъния Teva Pharmaceuticals S.R.L, Str Domnita Ruxandra nr. 
PHARMACEUTICALS S.R.L.,Str.
60MG/VIAL ПРАХ 
60MG/VIAL POWDER AND SOLUTION FOR INFUSION
Natriumrisedronaat 35 mg Ranbaxy 
Natriumrisedronaat 35 mg Ranbaxy filmcoated tablets Oral use
92,75 mg Прах за инфузионен разтвор 
Bonefos pro infusione 75 mg
Actonel Combi 35mg + 500mg 
Actonel Combi 35mg + 500mg film-coated tablets
Прах и разтворител за инфузионен 
powder and solvent for solution for infusion
Risedronaatnatrium Mylan Wekelijks 35 mg 
Risedronaatnatrium Mylan Wekelijks 35 mg filmcoated tablets Oral use
NO - Норвегия Arrow Generics Ltd, 2 Eastman Way, Stevenage, Hertfordshire, SG1 4SZ, united Kingdom 
BE - Belgium Arrow Generics Limited 2 Eastman Way, Stevenage, Hertfordshire, SG1 4SZ, United Kingdom
Actavis Group PTC ehf., Reykjavikurvegi 76-78, 220 Hafnarfjordur, Исландия 
Actavis Group PTC ehf., Reykjavíkurvegi 76-78, 220 Hafnarfjordur, Iceland
Обвита таблетки 
Skelid tablet
Quinta da Fonte, Rua Vitor Câmara, 2 - Edifício D. 
Quinta da Fonte, Rua Vitor Câmara, 2 - Edifício D. Amélia, Piso 1, Ala B, 2770-229 Paço de Arcos Portugal
RISEDRONATE WINTHROP 35 mg, comprimé pelliculé 
RISEDRONATE WINTHROP 35 mg, comprimé pelliculé film-coated tablet Oral use
Orion Corporation, Orion Pharma PO Box 65 
SE - Sweden Orion Corporation, Orion Pharma
- Португалия Premium PharmaSociedade Técnico 
Premium PharmaSociedade Técnico Medicinal, Lda.
JUVERITAL 35 mg filmtabletta mgRisedronate sodium (equivalent 
JUVERITAL 35 mg filmtabletta mgRisedronate sodium (equivalent to 40,17 mg Risedronate sodium hemipentahydr ate film-coated tablet Oral use
DE - Германия Gedeon Richter Plc. Gyömröi ut 19 - 21 
DE - Germany Gedeon Richter Plc.
319, Pinner Road North Harrow Middlesex 
319, Pinner Road North Harrow Middlesex HA1 4 HF United Kingdom
Sindronat 
Prenteral
Alendronat "Ranbaxy" 70 mg 
Alendronat "Ranbaxy"
Actavis Group PTC ehf, Reykjavikurvegi 76-78, 220 Hafnarfjordur, Исландия 
Actavis Group PTC ehf, Reykjavikurvegi 76-78, 220 HAFNARFJORDUR, Iceland
Accord Healthcare Ltd, Sage House, 319 Pinner Road, North Harrow, Middlesex 
Accord Healthcare Ltd, Sage House, 319 Pinner Road, North Harrow, Middlesex HA1 4HF, UK
- Португалия PharmathenPharmaceutical Industry, S.A. 6, Dervenakion Street, GR-15351 Pallini Attiki Grécia 
DK - Denmark Pharmathen S.A., 6, Dervenakion str., GR-15351
Actonel® 75 mg, filmomhulde tabletten 
Actonel® 75 mg, filmomhulde tabletten filmcoated tablets Oral use
Ácido Alendrónico ToLife 70 mg 
Ácido Alendrónico ToLife 70 mg Comprimidos
Actonel enkrat tedensko 35 mg filmsko obložene tablete 
Actonel enkrat tedensko 35 mg filmsko obložene tablete film-coated tablet Oral use
Heizel Esplanade b22 1020 Brussels 
BE - Belgium Eurogenerics N.V. Heizel Esplanade b22
84-B, 1549-005 Lisboa 
Baldacci - Portugal, S.A. Rua Cândido de Figueiredo, 84-B, 1549-005 Lisboa Portugal
A - Piso 2, 
Tó u. 1-5.
Natriumrisedronaat Sandoz® wekelijks 35 mg 
Natriumrisedronaat Sandoz® wekelijks 35 mg filmcoated tablets Oral use
Unit 2 - Eastman Way, SG1 
Unit 2 - Eastman Way, SG1 4SZ StevenageHertfordshire
35,0 mg Risedronate sodium (equivalent 
35.00 mg Risedronate sodium (equivalent to 32,5 mg Risendronic acid)
Risedronate Teva 35 mg filmomhulde tabletten 
Risedronate Teva 35 mg filmomhulde tabletten film-coated tablets
RO - Румъния ACCORD HEALTHCARE LIMITED, Sage house, 319 
SE - Sweden Accord Healthcare Limited Sage House
IS - Исландия Actavis Group PTC ehf., Reykjavíkurvegi 76-78, 220 
DK - Denmark Actavis Group PTC ehf., Reykjavikurvegi 76-78, P.O.
ACTONEL 5 mg, comprimé pelliculé 
ACTONEL 5 mg, comprimé pelliculé film-coated tablet Oral use
ACTONEL 35 mg, comprimé pelliculé 
ACTONEL 35 mg, comprimé pelliculé film-coated tablet Oral use
10 mgTabletten tablet 
10 mg Tablets
На 8 септември 2014 г. Aastrom Biosciences уведомява Европейската агенция по лекарствата за оттеглянето от датските органи на разрешението за производство за производствения обект за активното вещество, готовия продукт и освобождаването на партиди MACI (типизирани култивирани автоложни хондроцити, в матрица): Genzyme Biosurgery ApS, Oliefabriksvej 45, DK 
On 8 September 2014, Aastrom Biosciences notified the European Medicines Agency of the withdrawal by the Danish authorities of the manufacturing licence for the manufacturing site for the active substance, finished product and batch release of MACI (matrix-applied characterised autologous cultured chondrocytes): Genzyme Biosurgery ApS, Oliefabriksvej 45, DK - 2770 Kastrup, Denmark.
Основания за временно спиране на разрешението за 
Grounds for the suspension of the marketing authorisation
Европейската комисия започва процедура по член 20 от Регламент (EО) № 726/2004, искайки от Агенцията да даде своето становище дали разрешението за употреба за MACI трябва да бъде временно спряно или отменено съгласно член 
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
Лондон, 25 септември 2008 г. 
London, 25 September 2008 Doc.
Документ за справка EMEA/548370/2008 
Ref. EMEA/477488/2008
Международно непатентовано име (INN): далбавацин 
International non-proprietary name (INN): dalbavacin
Съществуват опасения и по отношение на това дали EXULETT може да бъде произвеждано с постоянно добро качество. 
There were also concerns over whether EXULETT could be manufactured with consistent good quality.
По този начин се унищожават бактериите, причиняващи инфекцията. 
This kills the bacteria causing the infection.
Съдържа активното вещество далбаванцин. 
It contains the active substance dalbavancin.
Очаквало се е да действа, като възпрепятства бактериите да изграждат клетъчните си стени. 
It is expected to work by stopping the bacteria making their cell walls.
Компанията е представила резултатите от едно основно проучване, в което ефектите на EXULETT са сравнени с линезолид (друг антибиотик) при 873 възрастни. 
The company presented the results of one main study that compared the effects of EXULETT with those of linezolid (another antibiotic) in 873 adults.
Основната мярка за ефективност е броят на пациентите, чиято инфекция е успешно излекувана и при които не се налага допълнително лечение с други антибиотици. 
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.
Тези бактерии включват Staphylococcus aureus (включително метицилин-резистентните му щамове, известни като ‘MRSA') и Streptococcus pyogenes. 
These bacteria include Staphylococcus aureus (including ‘methicillin-resistant' forms known as ‘MRSA') and Streptococcus pyogenes.
„Усложнена“ означава, че инфекцията трудно се поддава на лечение, тъй като се е разпространила дълбоко в тъканите под кожата, възможно е да се наложи оперативно лечение или пациентът страда от други заболявания, които могат да влияят върху отговора на лечението. 
‘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.
Компанията уведомява CHMP, че няма последствия за пациентите, включени понастоящем в клинични изпитвания с EXULETT. 
The company informed the CHMP that there are no consequences for patients currently included in clinical trials of EXULETT.
Поради това, към момента на оттеглянето позицията на CHMP е, че ползата от EXULETT не е достатъчно добре доказана, и като цяло ползите не превишават установените рискове. 
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.
Какви са последствията от оттеглянето за пациентите, участващи в клинични изпитвания с EXULETT? 
What are the consequences of the withdrawal for patients undergoing clinical trials with EXULETT?
Активното вещество в EXULETT, далбавацин, е антибиотик, който принадлежи към групата на гликопептидите. 
The active substance in EXULETT, dalbavancin, is an antibiotic that belongs to the group ‘glycopeptides'.
CHMP има опасения, че поради начина на провеждане на единственото основно проучване резултатите от него са твърде ограничени, за да подкрепят одобряването на лекарството, и счита, че е необходимо друго проучване, за да бъдат потвърдени резултатите. 
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.
В допълнение, CHMP изразява опасения относно значимостта на резултатите от основното проучване, тъй като изглежда не всички пациенти, включени в проучването, са имали достатъчно тежка инфекция, за да се нуждаят от лечение с антибиотици, прилагано чрез вливане във вена. 
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.
На 9 септември 2008 г. Pfizer Limited уведомява официално Комитета по лекарствените продукти за хуманна употреба (CHMP), че желае да оттегли заявлението си за издаване на разрешение за употреба за EXULETT, показан за лечение на усложнени инфекции на кожата и меките тъкани при възрастни, когато е известно или се подозира, че са причинени от чувствителни грам-положителни бактерии. 
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.
Въпроси и отговори относно оттегляне на заявлението за разрешение за употреба за 
Questions and answers on the withdrawal of the marketing application for EXULETT
EXULETT се е очаквало да се използва единствено при инфекция, за която е известно или се счита, че е причинена от видове бактерии, класифицирани като „грам-положителни“, които ще бъдат унищожени от лекарството. 
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.
Пациентите, включени в това проучване, са имали усложнени инфекции на кожата и меките тъкани (например абсцеси или инфектирани рани), причинени от грам-положителни батерии. 
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.
За какво се е очаквало да се използва EXULETT? 
What was EXULETT expected to be used for?
Как се очаква да действа EXULETT? 
How is EXULETT expected to work?