FrancophonIA/ELRC3.0 huggingface dataset:
Spanish: Alendronat Actavis Veckocomprimidot
Bulgarian: Alendronat Actavis Veckotablett
Spanish: DK - Dinamarca Orifarm Generics A/S, Postbox 69, Energivej 15, DK-5260 Odense S,
Bulgarian: Orifarm Generics A/S, Postbox 69, Energivej 15, DK-5260 Odense S,
Spanish: Warner Chilcott Nederland BV
Bulgarian: NL - Нидерландия Warner Chilcott Nederland BV
Spanish: TEVA PHARMACEUTICALS S.R.L.
Bulgarian: RO - Румъния TEVA PHARMACEUTICALS S.R.L.
Spanish: ÁCIDO ALENDRÓNICO SEMANAL KERN PHARMA 70 mg Comprimidos comprimidos
Bulgarian: ÁCIDO ALENDRÓNICO SEMANAL KERN PHARMA 70 mg Comprimidos
Spanish: Pamitor 15 mg/mlKonzentrat zur Herstellung einer Perfusiónslösung
Bulgarian: Pamitor 15 mg/mlKonzentrat zur Herstellung einer Infusionslösung
Spanish: Alendronat Polpharma Veckocomprimidot
Bulgarian: Alendronat Polpharma Veckotablett
Spanish: Alendronate Richter 70 mg Filmcomprimidoten
Bulgarian: Alendronate Richter 70 mg Filmtabletten
Spanish: SK - Eslovaquia Bentley Pharmaceuticals Irlanda Limited
Bulgarian: SK - Словакия Bentley Pharmaceuticals
Spanish: 2790-221 Carnaxide, Portugal
Bulgarian: 2790-221 Carnaxide,
Spanish: Medico Uno Pharma Kft. Viadukt u. 12.
Bulgarian: Medico Uno Pharma Kft.
Spanish: 29g, 9000 Murska Sobota, Eslovenia
Bulgarian: Tišinska ul. 29g, 9000 Murska Sobota,
Spanish: Merck Sharp & Dohme B.V., Waaderveg 39, PC Haarlem, The Holanda
Bulgarian: IS - Исландия Merck Sharp & Dohme B.V., Waaderveg 39, PC Haarlem,
Spanish: Alendronat Hexal Veckocomprimidot
Bulgarian: Alendronat Hexal Veckotablett
Spanish: Alter, S.A.
Bulgarian: - Португалия Alter, S.A.
Spanish: FI - Finlandia medac Gesellschaft für klinische Spezialpräparate mbH, Fehlandtstrasse 3, 20354 Hamburg, Alemania
Bulgarian: - Финландия medac Gesellschaft für klinische Spezialpräparate mbH, Fehlandtstrasse 3, 20354 Hamburg, Германия
Spanish: Soluction para perfusión
Bulgarian: Пътища на въвеждане perfusión
Spanish: Bonefos 800 mg filmsko obložene comprimidoe
Bulgarian: Bonefos 800 mg filmsko obložene tablete
Spanish: Alendronate Arrow veckocomprimidot
Bulgarian: Alendronate Arrow veckotablett
Spanish: Sandoz A/S, Edvard Thomsens Vej 14, DK-2300 København S, Danmark
Bulgarian: NO - Норвегия Sandoz A/S, Edvard Thomsens Vej 14, DK-2300
Spanish: Merck Sharp & Dohme BV, PO Box 581, NL-2003 PC Harlem, Holanda (NLD)
Bulgarian: Merck Sharp & Dohme BV, PO Box 581, NL-2003 PC
Spanish: 13,053 mg Comprimido
Bulgarian: 13,053 mg Таблетки
Spanish: Aredia 15 mgTrockensubstanz zur Perfusiónsbereitung mit Lösungsmittel
Bulgarian: Aredia 15 mgTrockensubstanz zur Infusionsbereitung mit Lösungsmittel
Spanish: Teva Pharma - Produtos Farmacêuticos, Lda.
Bulgarian: - Португалия Teva Pharma - Produtos Farmacêuticos, Lda.
Spanish: UK - Reino Unido Generics (UK) Limited, Station Close, Potters Bar, Hertfordshire EN6 1TL
Bulgarian: Generics (UK) Limited, Station Close, Potters Bar, Hertfordshire EN6 1TL
Spanish: 2710-089 Sintra Portugal
Bulgarian: 2710-089 Sintra Португалия
Spanish: 1180 Brussels Bélgica
Bulgarian: 1180 Brussels
Spanish: BONEACT 35 mg filmcomprimidota
Bulgarian: BONEACT 35 mg filmtabletta
Spanish: Arrow Generics, Ltd.
Bulgarian: PT - Португалия Arrow Generics, Ltd.
Spanish: Aredia 90 mgTrockensubstanz zur Perfusiónsbereitung mit Lösungmittel
Bulgarian: Aredia 90 mgTrockensubstanz zur Infusionsbereitung mit Lösungmittel
Spanish: NOVAPAM 60 mg Pulver zur Herstellung einer Perfusiónslösung
Bulgarian: NOVAPAM 60 mg Pulver zur Herstellung einer Infusionslösung
Spanish: Rua da Tapada Grande, n2 P-2710-089 ABRUNHEIRA, SINTRA
Bulgarian: P-2710-089 ABRUNHEIRA, SINTRA
Spanish: APceuticals - Farmacêutica, Lda.
Bulgarian: PT - Португалия APceuticals - Farmacêutica, Lda.
Spanish: Romax Once Weekly 70 mg Comprimidos
Bulgarian: Romax Once Weekly 70 mg Tablets
Spanish: Arrow Generics Ltd, Unit 2 Eastman Way, Stevenage, Hertfordshire SGI 4SZ, Reino Unido and Northern Irlanda (GBR)
Bulgarian: Arrow Generics Ltd, Unit 2 Eastman Way, Stevenage, Hertfordshire SGI 4SZ, United Kingdom and Northern Ireland (GBR)
Spanish: Orifarm Generics A/S, Energivej 15, 5260 ODENSE S, Dinamarca
Bulgarian: Orifarm Generics A/S, Energivej 15, DK-5260 Odense S., Дания
Spanish: Zaklad Farmaceutyczny Adamed Pharma S.A., Szkolna Street 33, 95-054 Ksawerow, Polonia
Bulgarian: Zaklad Farmaceutyczny Adamed Pharma S.A., Szkolna Street 33, 95-054 Ksawerow, Полша
Spanish: NOVAPAM 15 mg Pulver zur Herstellung einer Perfusiónslösung
Bulgarian: NOVAPAM 15 mg Pulver zur Herstellung einer Infusionslösung
Spanish: República Checa
Bulgarian: ЧЕШКА РЕПУБЛИКА
Spanish: ACTONEL OAW 35MG/TAB COMPRIMIDO RECUBIERTO
Bulgarian: ACTONEL OAW 35MG/TAB ФИЛМИРАНИ
Spanish: ActoCalD comprimidoten 35 mg + 500 mg / 400 IE filmomhulde comprimidoten, combinatieverpakking
Bulgarian: ActoCalD tabletten 35 mg + 500 mg / 400 IE filmomhulde tabletten, combinatieverpakking
Spanish: RISEDRONATE / TEVA 35MG/TAB COMPRIMIDO RECUBIERTO
Bulgarian: RISEDRONATE / TEVA 35MG/TAB ФИЛМИРАНИ
Spanish: BG - Bulgaria Actavis Group PTC ehf, Islandia Reykjavikurvegur 76-78, IS-220,
Bulgarian: BG - България Actavis Group PTC ehf, Iceland Reykjavikurvegur 76-78, IS-220,
Spanish: House 97-107 Uxbridge Road, Ealing Londo W5 5TL U.K
Bulgarian: Road, Ealing Londo W5 5TL U.K
Spanish: LU - Luxembourg Bayer s.a. 14, J.E.
Bulgarian: LU - Люксембург Bayer s.a. 14, J.E. Mommaertslaan B-1831 Diegem
Spanish: Alendronat Orion Veckocomprimidot
Bulgarian: Alendronat Orion Veckotablett
Spanish: SK - Eslovaquia Sanofi-aventis Eslovaquia s.r.o.
Bulgarian: SK - Словакия Sanofi-aventis
Spanish: 169,32 mg Comprimido recubierto
Bulgarian: 169,32 mg Филмирани
Spanish: Actonel® Wekelijks 35 mg, filmomhulde comprimidoten
Bulgarian: Actonel® Wekelijks 35 mg, filmomhulde tabletten
Spanish: Alendronsäure Sandoz 70 mg - einmal wöchentlich Filmcomprimidoten comprimido recubierto oral
Bulgarian: Alendronsäure Sandoz 70 mg - einmal wöchentlich Filmtabletten
Spanish: Antibiotice S.A.
Bulgarian: RO - Румъния Antibiotice S.A.
Spanish: Krka, tovarna zdravil, d.d., Šmarješka cesta 6, SI-8501 Novo mesto, Eslovenia
Bulgarian: SI - Словения Krka, tovarna zdravil, d.d., Šmarješka cesta 6, SI-8501
Spanish: ACIDO ALENDRONICO TEVA 70 mg comprimidos comprimidos
Bulgarian: ACIDO ALENDRONICO TEVA 70 mg comprimidos
Spanish: Alendronat Mylan Veckocomprimidot
Bulgarian: Alendronat Mylan Veckotablett
Spanish: Alendronsäure Tecnimede 70 mg Filmcomprimidoten
Bulgarian: Alendronsäure Tecnimede 70 mg Filmtabletten
Spanish: RISEPALLIN COMPRIMIDOS 30MG
Bulgarian: RISEPALLIN TABLETS 30MG
Spanish: Nordic Pharma B.V.
Bulgarian: Nordic Pharma B.V. Tolweg 15
Spanish: España alendronic acid
Bulgarian: Испания alendronic acid
Spanish: Disodium Clodronate 60mg/ml solución inyectable
Bulgarian: Disodium Clodronate 60mg/ml
Spanish: SI - Eslovenia Novartis Pharma GmbH, Roonstrasse 25, Nuernberg D-90429 , Alemania
Bulgarian: - Словения Novartis Pharma GmbH, Roonstrasse 25, Nuernberg D-90429 , Германия
Spanish: Alendronic Acid Once Weekly 70mg Comprimidos
Bulgarian: Alendronic Acid Once Weekly 70mg Tablets
Spanish: Risedronat STADA 35 mg Filmcomprimidoten
Bulgarian: Risedronat STADA 35 mg Filmtabletten
Spanish: Alendronsäure Bluefish 70 mg einmal wöchentlich Comprimidoten
Bulgarian: Alendronsäure Bluefish 70 mg einmal wöchentlich Tabletten
Spanish: Alendron Winthrop einmal wöchentlich 70 mg Comprimidoten
Bulgarian: Alendron Winthrop einmal wöchentlich 70 mg Tabletten
Spanish: Clodron 800 mg HEXAL
Bulgarian: Clodron 800 mg HEXAL Filmtabletten
Spanish: 75 mg Concentrado para solución para perfusión intravenoso
Bulgarian: 75 mg Концентрат за инфузионен разтвор интравенозно
Spanish: Tetrafarma - Produtos Farmacêuticos, Lda.
Bulgarian: - Португалия Tetrafarma - Produtos Farmacêuticos, Lda.
Spanish: Tecnimede - Sociedade Técnico-Medicinal, S.A. Rua da Tapada Grande, 2Abrunheira
Bulgarian: DE - Германия TECNIMEDE - Sociedade Técnico-Medicinal, S.A. (BS Rua da Tapada Grande, n2
Spanish: Barcelona, 69 08970 Sant Joan Despi
Bulgarian: Barcelona, 69 08970 Sant
Spanish: Generics UK Ltd., Station Close, Potters Bar, Hertford Shire EN6 1AG, UK
Bulgarian: SI - Словения Generics UK Ltd., Station Close, Potters Bar, Hertford Shire EN6 1AG, UK
Spanish: DE - Alemania cell Pharm GmbH Theodor-Heuss-Str. 52
Bulgarian: DE - Германия cell Pharm GmbH Theodor-Heuss-Str.
Spanish: RATIOPHARM 3 mg/ml, solución à diluer pour perfusion
Bulgarian: RATIOPHARM 3 mg/ml, solution à diluer pour perfusion
Spanish: CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN
Bulgarian: concentrate for solution for infusion
Spanish: Merck Sharp & Dohme BV Waarderweg 39
Bulgarian: NL - Нидерландия Merck Sharp & Dohme BV Waarderweg 39
Spanish: Rowex Ltd Bantry Co. Cork
Bulgarian: - Ирландия Rowex Ltd Bantry
Spanish: UTERITRIN 70 mg filmcomprimidota
Bulgarian: UTERITRIN 70 mg filmtabletta
Spanish: Aredia 30 mgTrockensubstanz zur Perfusiónsbereitung mit Lösungsmittel
Bulgarian: Aredia 30 mgTrockensubstanz zur Infusionsbereitung mit Lösungsmittel
Spanish: Eastbourne, East Sussex, BN22 9AG
Bulgarian: Teva UK Limited, Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG
Spanish: AREDIA 15 mg/5 ml, poudre et solvant pour solución pour perfusion
Bulgarian: AREDIA 15 mg/5 ml, poudre et solvant pour solution pour perfusion
Spanish: Gedeon Richter Plc., 1103 Budapest, Gyomroi ut 1921, Hungría
Bulgarian: Gedeon Richter Plc., 1103 Budapest, Gyomroi ut 19
Spanish: DK - Dinamarca Stada Arzneimittel AG, Stadastrasse 2-8, DE-61118
Bulgarian: BG - България Stada Arzneimittel AG, Stadastrasse 2-18, 61118
Spanish: STADA Arzneimittel AG, Stadastrasse 2-18, DE61118 Bad Vilbel, Alemania (DEU)
Bulgarian: STADA Arzneimittel AG, Stadastrasse 2-18, DE61118 Bad Vilbel, Германия (DEU)
Spanish: Estrada Marco do GriloZemouto,
Bulgarian: - Португалия Alter, S.A. Estrada Marco do GriloZemouto,
Spanish: Alendron-Hexal 10 mg Comprimidoten
Bulgarian: Alendron-Hexal 10 mg Tabletten
Spanish: III/5.
Bulgarian: Mester u. 28. III/5.
Spanish: RANBAXYGEN 70 mg Comprimidos comprimidos
Bulgarian: RANBAXYGEN 70 mg Comprimidos
Spanish: Norifaz 35mg comprimido
Bulgarian: Norifaz 35mg tablet
Spanish: ALENDRONSÄURE BASICS einmal wöchentlich 70 mg Comprimidoten
Bulgarian: ALENDRONSÄURE BASICS einmal wöchentlich 70 mg Tabletten
Spanish: PHARMAGENUS 70 mg comprimidos comprimidos
Bulgarian: PHARMAGENUS 70 mg comprimidos
Spanish: Actonel Plus Ca & D Comprimido 35mg and 500mg/400 IU Comprimidos recubiertos.
Bulgarian: Actonel Plus Ca & D Tablet 35mg and 500mg/400 IU FilmCoated Tablets.
Spanish: Alendroarrow veckocomprimidot
Bulgarian: Alendroarrow veckotablett
Spanish: 1180 Brussel Bélgica
Bulgarian: 1180 Brussel
Spanish: ACTONEL OAW/"ONCE A WEEK"
Bulgarian: ACTONEL OAW/"ONCE A WEEK" TABLETS 35MG
Spanish: Alendron esparma 70 mg einmal wöchentlich Comprimidoten
Bulgarian: Alendron esparma 70 mg einmal wöchentlich Tabletten
Spanish: ALENDRONSAV APOTEX 70 mg comprimidota
Bulgarian: ALENDRONSAV APOTEX 70 mg tabletta
Spanish: UK - Reino Unido Warner Chilcott UK Limted, Old Belfast Road, Millbrook, Larne, Co. Antrim BT40
Bulgarian: Warner Chilcott UK Limted, Old Belfast Road, Millbrook, Larne, Co. Antrim BT40 2SH, UK
Spanish: Merck Sharp & Dohme Limited
Bulgarian: - Ирландия Merck Sharp & Dohme Limited
Spanish: UK - Reino Unido Sandoz Limited, 37 Woolmer Way, Bordon, Hampshire GU35 9QE
Bulgarian: Woolmer Way, Bordon, Hampshire GU35 9QE
Spanish: Alenat 70 mg - einmal wöchentlich Comprimidoten
Bulgarian: Alenat 70 mg - einmal wöchentlich Tabletten
Spanish: PHARMABILL Jægersborg Alle 213 2 th DK-2820 Gentofte Dinamarca
Bulgarian: th DK-2820 Gentofte Дания
Spanish: Novartis Hungária Kft. Pharma részlege Bartók Béla út 43-47.
Bulgarian: Bartók Béla út 43-47.
Spanish: Alendronsäure STADA 10 mg Comprimidoten
Bulgarian: Alendronsäure STADA 10 mg Tabletten
Spanish: DE - Alemania Actavis Group PTC ehf Reykjavikurvegur 76 - 78
Bulgarian: DE - Германия Actavis Group PTC ehf Reykjavikurvegur 76 - 78
Spanish: 91,371 mg Comprimido
Bulgarian: 91,371 mg Таблетки
Spanish: DK - Dinamarca Pharmachemie B.V., PO Box 552, Swensweg 5, NL-2031
Bulgarian: Pharmachemie B.V., PO Box 552, Swensweg 5, NL-2031 GA Haarlem, Nederlands
Spanish: RISEPALLIN COMPRIMIDOS 5MG
Bulgarian: RISEPALLIN TABLETS 5MG
Spanish: Sodium clodronate
Bulgarian: Sodium clodronate капсула
Spanish: Alendronsäure Accord 10 mg Comprimidoten
Bulgarian: Alendronsäure Accord 10 mg Tabletten
Spanish: NOVAPAM 30 mg Pulver zur Herstellung einer Perfusiónslösung
Bulgarian: NOVAPAM 30 mg Pulver zur Herstellung einer Infusionslösung
Spanish: Alendronsäure 1A Pharma 70 mgeinmal wöchentlich Filmcomprimidoten comprimido recubierto oral
Bulgarian: Alendronsäure 1A Pharma 70 mgeinmal wöchentlich Filmtabletten
Spanish: PAMINJECT 3 mg/ml, solución à diluer pour perfusion
Bulgarian: PAMINJECT 3 mg/ml, solution à diluer pour perfusion
Spanish: BIFODRON COMPRIMIDOS 30MG
Bulgarian: BIFODRON TABLETS 30MG
Spanish: Tišinska ul.
Bulgarian: Uzsoki u.
Spanish: Alendro-Q 10 mg Comprimidoten
Bulgarian: Alendro-Q 10 mg Tabletten
Spanish: Alendronate Sodium Accord 10 mg Comprimidos
Bulgarian: Alendronate Sodium Accord 10 mg Tablets
Spanish: 91,363 mg Comprimido
Bulgarian: 91,363 mg Таблетки
Spanish: CLASTOBAN 400 mg, gélule cápsula
Bulgarian: CLASTOBAN 400 mg, gélule
Spanish: comprimido y cápsulas blandas
Bulgarian: Таблетки и Капсули, меки
Spanish: Risedronat STADA einmal wöchentlich 35 mg Filmcomprimidoten
Bulgarian: Risedronat STADA einmal wöchentlich 35 mg Filmtabletten
Spanish: Actonel enkrat tedensko 35 mg filmsko obložene comprimidoe
Bulgarian: Actonel enkrat tedensko 35 mg filmsko obložene tablete
Spanish: 1A Pharma GmbH, StellaKlein-Löw-Weg 17, A-1020 Wien, Austria
Bulgarian: 1A Pharma GmbH, StellaKlein-Löw-Weg 17, A-1020
Spanish: BIOMEDICA FOSCAMA INDUSTRIA CHIMICA FARMACEUTICA SpA Via Morolense, 87 - 03013 Ferentino (FR)
Bulgarian: Via Morolense, 87 - 03013 Ferentino (FR)
Spanish: BIFODRON COMPRIMIDOS 5MG
Bulgarian: BIFODRON TABLETS 5MG
Spanish: Ranbaxy (UK) Ltd 20 Baldertoon Street London W1K 6TL Reino Unido
Bulgarian: Ranbaxy (UK) Ltd 20 Baldertoon Street London W1K 6TL United Kingdom
Spanish: Alendronsäure Ovamex 70 mg Comprimidoten
Bulgarian: Alendronsäure Ovamex 70 mg Tabletten
Spanish: ITF Farma - Produtos Farmacêuticos, Lda.
Bulgarian: PT - Португалия ITF Farma - Produtos Farmacêuticos, Lda.
Spanish: Pamifos 3 mg/ml Konzentrat zur Herstellung eriner Perfusiónslösung
Bulgarian: Pamifos 3 mg/ml Konzentrat zur Herstellung eriner Infusionslösung
Spanish: Alendronsäure Heumann 10 mg Comprimidoten
Bulgarian: Alendronsäure Heumann 10 mg Tabletten
Spanish: Alendronorm 70 mgeinmal wöchentlich Comprimidoten
Bulgarian: Alendronorm 70 mgeinmal wöchentlich Tabletten
Spanish: Alendronat 1A Farma Veckocomprimidot comprimido recubierto oral
Bulgarian: Alendronat 1A Farma Veckotablett
Spanish: HANTRUX 70 mg filmcomprimidota
Bulgarian: HANTRUX 70 mg filmtabletta
Spanish: Alendron beta einmal wöchentlich 70 mg Comprimidoten
Bulgarian: Alendron beta einmal wöchentlich 70 mg Tabletten
Spanish: HOSPIRA UK LIMITED Queensway.
Bulgarian: ES - Испания HOSPIRA UK LIMITED Queensway.
Spanish: Gedeon Richter Plc., 1103 Budapest Gyömrői út 19-21, Hungría
Bulgarian: Gedeon Richter Plc., 1103 Budapest Gyömrői út 19-21,
Spanish: Tevanate 10 mg Comprimidoten
Bulgarian: Tevanate 10 mg Tabletten
Spanish: SK - Eslovaquia Arrow Generics Limited Unit 2, Eastman Way, Stevenage, Hertfordshire, SG14SZ
Bulgarian: SK - Словакия Arrow Generics Limited Unit 2, Eastman Way, Stevenage, Hertfordshire, SG14SZ
Spanish: IV
Bulgarian: PL
Spanish: 91,36 mg Comprimido
Bulgarian: 91,36 mg Таблетки
Spanish: Pamidronat Onkovis 3mg/ml Konzentrat zur Herstellung einer Perfusiónslösung
Bulgarian: Pamidronat Onkovis 3mg/ml Konzentrat zur Herstellung einer Infusionslösung
Spanish: Norsed einmal wöchentlich 35 mg Filmcomprimidoten
Bulgarian: Norsed einmal wöchentlich 35 mg Filmtabletten
Spanish: Alendronsäure AWD 10 mg Comprimidoten
Bulgarian: Alendronsäure AWD 10 mg Tabletten
Spanish: ÁCIDO ALENDRÓNICO SEMANAL RANBAXY 70 mg comprimidos comprimidos
Bulgarian: ÁCIDO ALENDRÓNICO SEMANAL RANBAXY 70 mg comprimidos
Spanish: Alendronic Acid Bluefish Once weekly 70 mg Comprimidos comprimidos
Bulgarian: Alendronic Acid Bluefish Once weekly 70 mg Tablets
Spanish: Cápsulas
Bulgarian: Капсули
Spanish: Mogilska 80 st.
Bulgarian: Farmacom Sp. z o.o. Mogilska 80 st.
Spanish: Hexal Pharma GmbH, StellaKlein-Löw-Weg 17, A-1020 Wien, Austria
Bulgarian: Hexal Pharma GmbH, StellaKlein-Löw-Weg 17, A-1020
Spanish: El CHMP evaluó los datos disponibles para determinar si podían apoyarse las dos indicaciones.
Bulgarian: СНМР разглежда наличните данни с цел да установи дали двете показания могат да бъдат подкрепени.
Spanish: En resumen, el CHMP consideró que la eficacia del medicamento supera su toxicidad y que la relación entre beneficio y riesgo es positiva.
Bulgarian: В заключение СНМР счита, че тази ефикасност превишава токсичността на продукта и че съотношението полза/риск е положително.
Spanish: En consecuencia, el CHMP consideró aceptable esta indicación.
Bulgarian: По тези причини СНМР счита показанието за приемливо.
Spanish: Lo mismo puede decirse para la indicación en el cáncer de pene, que está avalada por informes que señalan una modesta eficacia en esta enfermedad.
Bulgarian: Същото може да се каже за показанието „рак на пениса"; то се подкрепя от доклади, показващи умерена ефикасност при това заболяване.
Spanish: La solicitud de comercialización de Bleomicina Pharmachemie fue una solicitud para un genérico basada en la autorización de comercialización concedida al producto de referencia en los Países Bajos el 18 de noviembre de 1997.
Bulgarian: За Bleomycin Pharmachemie е подадено генерично заявление въз основа на разрешението за употреба, издадено за референтния продукт в Нидерландия на 18 ноември 1997 г.
Spanish: El CHMP señaló que la bleomicina se utiliza en clínica desde la década de 1960, lo que explica que no exista un programa de desarrollo clínico.
Bulgarian: СНМР отбелязва, че блеомицин се използва в клиничната практика от 60-те години, с което се обяснява липсата на клинична програма за развитие.
Spanish: Aunque el solicitante estaba dispuesto a suprimir las indicaciones a las que se oponía el Estado miembro afectado (EMA) contrario, el Estado miembro de referencia (EMR) y los demás EMA conformes se mostraron partidarios de mantenerlas.
Bulgarian: Въпреки че заявителят е склонен да премахне показанията, срещу които възразява възразяващата заинтересована държава-членка, референтната държава-членка и други позитивно настроени заинтересовани държави-членки подкрепят запазването им.
Spanish: Alemania, un Estado miembro contrario a la autorización, planteó diversas cuestiones relacionadas con las indicaciones propuestas.
Bulgarian: Възразяващата държавачленка, Германия, изразява опасения относно предложените показания.
Spanish: Dado que la evaluación de la relación entre beneficio y riesgo en estas indicaciones fue negativa para el producto original y dado que estas indicaciones se suprimieron en consecuencia de la lista autorizada para todos los productos que contenían bleomicina en Alemania, las indicaciones se consideraron nuevas y el Estado miembro contrario a la autorización consideró que los datos presentados eran insuficientes para conceder una autorización de comercialización para las nuevas indicaciones propuestas.
Bulgarian: Тъй като оценката на съотношението полза/риск за тези показания е отрицателно за оригиналния продукт и тъй като покъсно те са премахнати от одобрените за всички съдържащи блеомицин продукти в Германия, тези показания се смятат за нови и възразяващата държава-членка счита, че представената информация не е достатъчна за издаване на разрешение за употреба за предложените нови показания.
Spanish: En los Países Bajos, la bleomicina está aprobada en las indicaciones siguientes:
Bulgarian: В Нидерландия понастоящем блеомицин е одобрен за приложение при следните показания:
Spanish: Por consiguiente, a pesar de la toxicidad manifiesta y la modesta eficacia, el CHMP consideró que la bleomicina representa una opción valiosa para el tratamiento sistémico cuando se considera necesario en estas indicaciones.
Bulgarian: Следователно, въпреки явната токсичност и умерена ефикасност СНМР счита, че блеомицин е ценна възможност за системно лечение, ако се прецени като необходим при тези показания.
Spanish: - Linfoma de Hodgkin.
Bulgarian: - Ходжкинов лимфом.
Spanish: Titular de la autorización de comercializació nr
Bulgarian: Притежател на разрешението за употреба
Spanish: El Resumen de las Características del Producto, etiquetado y prospecto válidos son las versiones finales alcanzadas durante el procedimiento de coordinación del grupo.
Bulgarian: Валидните Кратка характеристика на продукта, означенията върху опаковката и листовката за пациента са последни версии, постигнати при процедура на Координационната група.
Spanish: Pese a que las tasas de respuesta suelen ser más altas con los tratamientos que contienen bleomicina, se admite sin dudas la toxicidad adicional.
Bulgarian: Въпреки че отговорът на лечението е като цяло по-висок при схемите, съдържащи блеомицин, допълнителната токсичност е ясно изразена.
Spanish: - Linfoma no hodgkiniano de grado intermedio y alto de malignidad en los adultos.
Bulgarian: - Не-Ходжкинов лимфом със средна и висока степен на злокачественост при възрастни.
Spanish: Al no poderse alcanzar un consenso, el CMD(h) remitió el procedimiento al CHMP.
Bulgarian: Тъй като не може да се постигне консенсус, Координационната група за процедурата за взаимно признаване и за децентрализираната процедура (CMD(h)) сезира Комитета по лекарствените продукти за хуманна употреба (CHMP).
Spanish: Estado Miembro EU
Bulgarian: В СТРАНА-ЧЛЕНКА
Spanish: Por consiguiente, el CHMP opina que la bleomicina sigue siendo un quimioterápico valioso y aprobó la totalidad de las indicaciones propuestas para Bleomicina Pharmachemie:
Bulgarian: СНМР изразява становището, че блеомицин все още е ценно лекарство за химиотерапия, и приема целостта на предложените показания за Bleomycin Pharmachemie:
Spanish: La bleomicina pertenece al grupo de los antibióticos citostáticos: es una mezcla de antibióticos glucopeptidicos, hidrosolubles, alcalinos con estructuras relacionadas que tienen un efecto citostático.
Bulgarian: Блеомицин принадлежи към цитостатичните антибиотици: представлява смес от структурно свързани, алкални, водоразтворими, гликопептидни антибиотици с цитостатичен ефект.
Spanish: El efecto de la bleomicina se basa en su intercalación entre las cadenas sencillas y dobles de ADN, lo que provoca rupturas de las cadenas tanto sencillas como dobles que inhiben la división y el crecimiento celulares y la síntesis de ADN.
Bulgarian: Ефектът на блеомицин се дължи на взаимодействието му с едно- и двойноверижна ДНК, водещо до разкъсвания в единичната и двойната верига, в резултат на което се потискат клетъчното делене, растежът и синтезът на ДНК.
Spanish: La bleomicina se administra casi siempre en combinación con otros fármacos citostáticos, con radioterapia o con ambos.
Bulgarian: Блеомицин почти винаги се прилага в комбинация с други цитостатични лекарства и/или лъчетерапия.
Spanish: En menor medida, la bleomicina afecta también a la síntesis de proteínas y de ARN.
Bulgarian: В по-малка степен блеомицин повлиява и синтеза на РНК и белтъците.