FrancophonIA/ELRC3.0 huggingface dataset:
Spanish: Winthrop Arzneimittel GmbH Industriestr.
Danish: Tyskland Winthrop Arzneimittel GmbH Industriestr.
Spanish: ALLERTEC HELLAS AE, 20 Phaethonos, 55132 N.Krini Thessaloniki, Greece
Danish: Grœkenland ALLERTEC HELLAS AE, 20 Phaethonos, 55132 N.Krini Thessaloniki, Greece
Spanish: Dinamarca N.V.
Danish: Danmark N.V.
Spanish: Holsten Pharma GmbH Im Buergerstock 7
Danish: Tyskland Holsten Pharma GmbH Im Buergerstock 7
Spanish: TEVA Generics GmbH Kandelstr.
Danish: Tyskland TEVA Generics GmbH Kandelstr.
Spanish: Reino Unido Milpharm Limited, Marlborough House, 298 Regent's Park Road, Finchley, London N3 2UA; UK
Danish: Storbritannien Milpharm Limited, Marlborough House, 298 Regent's Park Road, Finchley, London N3 2UA; UK
Spanish: LABORATORIOS AGEN GENERICOS FARMACEUTICOS, S.L., Avda. Conde de Guadalhorce, 43 Nave 2, Avilés (Asturias) 33400, Spain
Danish: Conde de Guadalhorce, 43 Nave 2, Avilés (Asturias) 33400, Spain
Spanish: REMEDINA, 25 Gounari & Areos, 13451 Kamatero Attikis, Greece
Danish: Grœkenland REMEDINA, 25 Gounari & Areos, 13451 Kamatero Attikis, Greece
Spanish: Dinamarca Imi Pharma AS, Literbuen 9, DK-2740 Skovlunde, Denmark
Danish: Danmark Imi Pharma AS, Literbuen 9, DK-2740 Skovlunde, Denmark
Spanish: Desitin Arzneimittel GmbH Postfach 630164
Danish: Tyskland Desitin Arzneimittel GmbH Postfach 630164
Spanish: LUNDBECK HELLAS, 64a Kifissias Aven, 15125 Maroussi, Greece
Danish: Grœkenland LUNDBECK HELLAS, 64a Kifissias Aven, 15125 Maroussi, Greece
Spanish: Reino Unido Relonchem Limited, 27 Old Gloucester Street, London WC1 3XX; UK
Danish: Storbritannien Relonchem Limited, 27 Old Gloucester Street, London WC1 3XX; UK
Spanish: Concentrado para solución oral Vía oral
Danish: Koncentrat til oral opløsning Oral anvendelse
Spanish: ANEXO IV MODIFICACIONES DEL PROSPECTO
Danish: BILAG IV ÆNDRINGER I INDLÆGSSEDLEN
Spanish: Países Bajos ct Arzneimittel GmbH, Postfach 510124, D-13361 Berlijn
Danish: Holland ct Arzneimittel GmbH, Postfach 510124, D-13361 Berlijn
Spanish: Países Bajos AbZ Pharma GmbH, Postfach 1152, D-89135 Blaubeuren
Danish: AbZ Pharma GmbH, Postfach 1152, D-89135 Blaubeuren
Spanish: RAFARM AEBEE, Kapodistriou & Korinthou 12, 15451 N.Psyhiko, Greece
Danish: Grœkenland RAFARM AEBEE, Kapodistriou & Korinthou 12, 15451 N.Psyhiko, Greece
Spanish: Luxemburgo MERCK N.V.
Danish: Luxembourg MERCK N.V.
Spanish: Wyeth Whitehall, Podružnica v Sloveniji, Topniška 4a, SI-1000 Ljubljana, Slovenia
Danish: Slovenien Wyeth Whitehall, Podružnica v Sloveniji, Topniška 4a, SI-1000
Spanish: A la vez, debe saber que en pacientes menores de 18 años existe un mayor riesgo de efectos adversos como intentos de suicidio, ideas de suicidio y hostilidad (predominantemente agresión, comportamiento de confrontación e irritación) cuando ingieren esta clase de medicamentos.
Danish: Desuden gøres opmærksom på, at patienter under 18 år har øget risiko for bivirkninger som f.eks. selvmordsforsøg, selvmordstanker og fjendtlighed (fortrinsvis aggression, oppositionel adfærd og vrede), når de behandles med denne klasse af lægemidler.
Spanish: Países Bajos Centrafarm Services B.V., Postbus 289, NL-4870 AG Etten Leur
Danish: Centrafarm Services B.V., Postbus 289, NL-4870 AG Etten Leur
Spanish: Luxemburgo TOPGEN E.S.V., E. Demunterlaan 1, B-1090 Bruxelles, Belgium
Danish: Luxembourg TOPGEN E.S.V., E. Demunterlaan 1, B-1090 Bruxelles, Belgium
Spanish: Dinamarca Orion Corporation, Orionintie 1, SF02200 Espoo, Finland
Danish: Danmark Orion Corporation, Orionintie 1, SF02200 Espoo, Finland
Spanish: - El Comité, en vista de los datos disponibles de los ensayos clínicos, concluyó que hay una señal de comportamiento suicida, incluidos intentos de suicidio e ideas de suicidio y/o comportamientos relacionados como autoagresión, hostilidad e inestabilidad emocional en niños y adolescentes tratados con inhibidores selectivos de la recaptación de serotonina e inhibidores de la recaptación de serotonina y norepinefrina, como los medicamentos mencionados anteriormente;
Danish: - Udvalget konkluderede på baggrund af de tilgængelige data fra kliniske undersøgelser, at der er signaler på selvmordsadfærd, herunder selvmordsforsøg og selvmordstanker og/eller relateret adfærd, f.eks. selvbeskadigelse, fjendtlighed og humørlabilitet hos børn og unge, der behandles med selektive serotonin-genoptagelseshæmmere og serotonin-noradrenalingenoptagelseshæmmere, såsom de ovennævnte lægemidler.
Spanish: GlaxoSmithKline d.o.o., družba za promet s farmacevtskimi izdelki, Knezov štradon 90, SI-1000 Ljubljana, Slovenia
Danish: Slovenien GlaxoSmithKline d.o.o., družba za promet s farmacevtskimi izdelki, Knezov štradon 90, SI-1000 Ljubljana, Slovenia
Spanish: Dinamarca 1A Farma A/S, Herstedøstervej 27-29, DK-2620 Albertslund, Denmark
Danish: Danmark 1A Farma A/S, Herstedøstervej 27-29, DK-2620 Albertslund, Denmark
Spanish: ANTOR EPE, 4 Omirou Street, Maroussi Attikis 15126, Greece
Danish: Grœkenland ANTOR EPE, 4 Omirou Street, Maroussi Attikis 15126, Greece
Spanish: BIOMEDICA-CHEMICA AE, 25 G.LYRA 14564 K.Kifissia, Greece
Danish: Grœkenland BIOMEDICA-CHEMICA AE, 25 G.LYRA 14564 K.Kifissia, Greece
Spanish: SOLVAY PHARMA, 63 Agiou Dimitriou 17456 Alimos, Greece
Danish: Grœkenland SOLVAY PHARMA, 63 Agiou Dimitriou 17456 Alimos, Greece
Spanish: Países Bajos GenRx B.V., Postbus 75, NL-6920 AB Duiven
Danish: GenRx B.V., Postbus 75, NL-6920 AB Duiven
Spanish: Dinamarca Jacobsen Pharma A/S, Vemmingbund Strandvej 111, DK-6310 Broager, Denmark
Danish: Danmark Jacobsen Pharma A/S, Vemmingbund Strandvej 111, DK-6310 Broager, Denmark
Spanish: ELPEN AE, 21Km Leoforos Marathonos, 19009 Pikermi Attikis, Greece
Danish: Grœkenland ELPEN AE, 21Km Leoforos Marathonos, 19009 Pikermi Attikis, Greece
Spanish: Países Bajos Genfarma B.V., Postbus 2062, NL1500 GB Zaandam
Danish: Genfarma B.V., Postbus 2062, NL1500 GB Zaandam
Spanish: Luxemburgo WYETH PHARMACEUTICALS, 15 Rue Du Bosquet, B-1348 Louvain-LaNeuve, Belgium
Danish: Luxembourg WYETH PHARMACEUTICALS, 15 Rue Du Bosquet, B-1348 Louvain-LaNeuve, Belgium
Spanish: Países Bajos Eli Lilly Nederland BV, Postbus 379, NL-3990 GD Houten
Danish: Eli Lilly Nederland BV, Postbus 379, NL-3990 GD Houten
Spanish: Dinamarca PharmaCoDane ApS, Marielundvej 46A, DK-2730 Herlev, Denmark
Danish: Danmark PharmaCoDane ApS, Marielundvej 46A, DK-2730 Herlev, Denmark
Spanish: Cipralex Oral Drops
Danish: Cipralex Orale dråber
Spanish: Países Bajos Katwijk Farma B.V., Postbus 408, NL2300 AK Leiden
Danish: Katwijk Farma B.V., Postbus 408, NL2300 AK Leiden
Spanish: Zoloft 25 mg + 50 mg 25 mg + 50 mg Comprimido recubierto con película
Danish: Zoloft 25 mg + 50 mg 25 mg + 50 mg Filmovertrukket tablet
Spanish: PHARMACYPRIA HELLAS, 6 Paster, 11521 Ampelokipi Athens, Greece
Danish: Grœkenland PHARMACYPRIA HELLAS, 6 Paster, 11521 Ampelokipi Athens, Greece
Spanish: VERISFIELD LTD UK, 41 Chalton Street, London, NW1 1JD, U.K.
Danish: Grœkenland VERISFIELD LTD UK, 41 Chalton Street, London, NW1 1JD, U.K.
Spanish: Neuraxpharm Arzneimittel GmbH & Co.KG
Danish: Tyskland Neuraxpharm Arzneimittel GmbH & Co.KG
Spanish: ORGANON HELLAS Vouliagmenis Avenue 122 P.O Box 73893, 16777 Elliniko, Greece
Danish: Grœkenland ORGANON HELLAS Vouliagmenis Avenue 122 P.O Box 73893, 16777
Spanish: Luxemburgo Pharmacia S.A., 17 Boulevard De La, B-1050 Bruxelles, Belgium
Danish: Luxembourg Pharmacia S.A., 17 Boulevard De La, B-1050 Bruxelles, Belgium
Spanish: Países Bajos Wyeth Pharmaceuticals B.V., Postbus 255, NL-2130 AG Hoofddorp
Danish: Wyeth Pharmaceuticals B.V., Postbus 255, NL-2130 AG Hoofddorp
Spanish: Luxemburgo EUROGENERICS N.V.
Danish: Luxembourg EUROGENERICS N.V.
Spanish: Cápsula blanda
Danish: Kapsel blød
Spanish: Reino Unido Goldshield Pharmaceuticals Limited, NLA Tower, 12-16 Addiscombe Road, Croydon, Surrey CR0 0XT; UK
Danish: Storbritannien Goldshield Pharmaceuticals Limited, NLA Tower, 12-16 Addiscombe Road, Croydon, Surrey CR0 0XT; UK
Spanish: Esparma GmbH Postfach 1461
Danish: Tyskland Esparma GmbH Postfach 1461
Spanish: Reino Unido Eli Lilly & Company Limited; Lilly House, Priestley Road; Basingstoke, Hants RG24 9NL; UK
Danish: Storbritannien Eli Lilly & Company Limited; Lilly House, Priestley Road; Basingstoke, Hants RG24 9NL; UK
Spanish: Torrex Pharma, d.o.o., Trdinova 4, SI1000 Ljubljana, Slovenia
Danish: Slovenien Torrex Pharma, d.o.o., Trdinova 4, SI1000 Ljubljana, Slovenia
Spanish: IV.2 MODIFICACIONES QUE DEBERÁN INCLUIRSE EN LA SECCIÓN RELEVANTE DEL RCP POR LO QUE SE REFIERE A LA ATOMOXETINA
Danish: IV.2 ÆNDRINGER I DE RELEVANTE DELE AF INDLÆGSSEDLEN FOR ATOMOXETIN
Spanish: Krewel Meuselbach GmbH Postfach 1263
Danish: Tyskland Krewel Meuselbach GmbH Postfach 1263
Spanish: Dinamarca Neuraxpharm Arzneimittel GmbH, Elisabeth-Selbert-Strasse 23, D-40764
Danish: Danmark Neuraxpharm Arzneimittel GmbH, Elisabeth-Selbert-Strasse 23, D-40764
Spanish: Hormosan-Kwizda GmbH Postfach 600340
Danish: Tyskland Hormosan-Kwizda GmbH Postfach 600340
Spanish: Dinamarca Gerard Laboratories, 35 Balcloyle Industrial Estate, Dublin, Ireland
Danish: Danmark Gerard Laboratories, 35 Balcloyle Industrial Estate, Dublin, Ireland
Spanish: Países Bajos Centrafarm Services B.V.
Danish: Centrafarm Services B.V.
Spanish: GLAXOSMITHKLINE AEBE, 266 Kifissias Av 15232 Halandri, Greece
Danish: Grœkenland GLAXOSMITHKLINE AEBE, 266 Kifissias Av 15232 Halandri, Greece
Spanish: WYETH HELLAS, Kyprou 126& 25 Martiou, 164 52 Argyroupoli, Greece
Danish: Grœkenland WYETH HELLAS, Kyprou 126& 25 Martiou, 164 52 Argyroupoli, Greece
Spanish: Países Bajos Apothecon B.V., Postbus 324, NL3770 AH Barneveld
Danish: Apothecon B.V., Postbus 324, NL3770 AH Barneveld
Spanish: GENERICS PHARMA HELLAS 577a Vouliagmenis Av 16451 Argyroupoli Greece
Danish: Grœkenland GENERICS PHARMA HELLAS 577a Vouliagmenis Av 16451 Argyroupoli Greece
Spanish: Merck dura GmbH Postfach 100635
Danish: Tyskland Merck dura GmbH Postfach 100635
Spanish: ALLEN FARMAKEUTIKI AE, 34 Filellinon Street, 15232 Halandri, Greece
Danish: Grœkenland ALLEN FARMAKEUTIKI AE, 34 Filellinon Street, 15232 Halandri, Greece
Spanish: No obstante, los estudios sobre la depresión sí alertaban claramente sobre comportamientos suicidas, al igual, aunque en menor medida, que los estudios sobre la ansiedad.
Danish: Der var dog tydelige signaler på selvmordsrelateret adfærd i undersøgelserne af depression og mindre stærke signaler i undersøgelserne af angst.
Spanish: Países Bajos Pharmachemie B.V., Postbus 552, 2003 RN Haarlem, The Netherlands
Danish: Pharmachemie B.V., Postbus 552, 2003 RN Haarlem, The Netherlands
Spanish: ANEXO III MODIFICACIONES DEL RESUMEN DE LAS CARACTERÍSTICAS DEL PRODUCTO
Danish: BILAG III ÆNDRINGER I PRODUKTRESUMEET
Spanish: Dinamarca GlaxoSmithKline Pharma A/S, Nykær 68, DK-2605 Brøndby, Denmark
Danish: Danmark GlaxoSmithKline Pharma A/S, Nykær 68, DK-2605 Brøndby, Denmark
Spanish: Países Bajos Alpharma B.V., Postbus 313, NL-3740 AH Baarn
Danish: Alpharma B.V., Postbus 313, NL-3740 AH Baarn
Spanish: Países Bajos Betapharm Arzneimittel GmbH, Kobelweg 95, D-86156 Augsburg
Danish: Betapharm Arzneimittel GmbH, Kobelweg 95, D-86156 Augsburg
Spanish: AREMIS 20 mg/ml concentrated liquid for Vía oral
Danish: AREMIS 20 mg/ml concentrated liquid for oral use
Spanish: Países Bajos Merck Generics BV, Dieselweg 25, NL-3752 LB Bunschoten, The Netherlands
Danish: Merck Generics BV, Dieselweg 25, NL-3752 LB Bunschoten, The Netherlands
Spanish: Solvay Arzneimittel GmbH Postfach 220
Danish: Tyskland Solvay Arzneimittel GmbH Postfach 220
Spanish: Dinamarca Wyeth Lederle Nordiska AB, Hagahuset, S-17124 Solna, Sweden
Danish: Danmark Wyeth Lederle Nordiska AB, Hagahuset, S-17124 Solna, Sweden
Spanish: Países Bajos Lundbeck B.V., Postbus 12021, NL1100 AA Amsterdam
Danish: Lundbeck B.V., Postbus 12021, NL1100 AA Amsterdam
Spanish: Sandoz Pharmaceuticals GmbH Dieselstr.
Danish: Tyskland Sandoz Pharmaceuticals GmbH Dieselstr.
Spanish: Dinamarca Medis Danmark A/S, H. C. Andersens Boulevard 2, DK-1780 København V, Denmark
Danish: Danmark Medis Danmark A/S, H. C. Andersens Boulevard 2, DK-1780 København V, Denmark
Spanish: Juta Pharma GmbH Gutenbergstr.
Danish: Tyskland Juta Pharma GmbH Gutenbergstr.
Spanish: Dinamarca BMM Pharma AB, Blasieholmgatan 2, S-11148 Stockholm, Sweden
Danish: Danmark BMM Pharma AB, Blasieholmgatan 2, S-11148 Stockholm, Sweden
Spanish: IIP-Institut fuer industrielle Pharmazie Benzstr.
Danish: Tyskland IIP-Institut fuer industrielle Pharmazie Benzstr.
Spanish: GENERICS PHARMA HELLAS 577a Vouliagmenis Av 16451 Argyroupoli, Greece
Danish: Grœkenland GENERICS PHARMA HELLAS 577a Vouliagmenis Av 16451 Argyroupoli, Greece
Spanish: Reino Unido Neolab Limited, 57 High Street, Odiham, Hants RG29 1LF, UK
Danish: Storbritannien Neolab Limited, 57 High Street, Odiham, Hants RG29 1LF, UK
Spanish: Países Bajos Merck Generics BV, Dieselweg 25, NL-3752 LB Bunschoten
Danish: Merck Generics BV, Dieselweg 25, NL-3752 LB Bunschoten
Spanish: Alfred E.Tiefenbacher GmbH & Co. Van-der-Smissen-Str. 1
Danish: Tyskland Alfred E.Tiefenbacher GmbH & Co. Van-der-Smissen-Str. 1
Spanish: Dinamarca Betapharm Arzneimittel GmbH, Steinerne Furt 78, D-86167 Augsburg, Germany
Danish: Danmark Betapharm Arzneimittel GmbH, Steinerne Furt 78, D-86167 Augsburg, Germany
Spanish: Pharmacia GmbH Pfizerstr.
Danish: Tyskland Pharmacia GmbH Pfizerstr.
Spanish: Países Bajos Hexal B.V., Postbus 251, NL-2180 AG Hillegom
Danish: Hexal B.V., Postbus 251, NL-2180 AG Hillegom
Spanish: Dinamarca Alternova A/S, Industriparken 25, DK2750 Ballerup, Denmark
Danish: Danmark Alternova A/S, Industriparken 25, DK2750 Ballerup, Denmark
Spanish: A la vez, los efectos a largo plazo por lo que a la seguridad se refiere y relativos al crecimiento, la madurez y el desarrollo cognitivo y conductual de [Nombre de Fantasía]en este grupo de edad todavía no han quedado demostrados.
Danish: Derudover foreligger der ikke langtidsdata om sikkerhed for[særnavn] med hensyn til vækst, modning og kognitiv og adfærdsmæssig udvikling i denne aldersgruppe.
Spanish: Dinamarca Merck NM AB, Ynglingagatan 14, 11347, P.Box 22033, S-10435
Danish: Danmark Merck NM AB, Ynglingagatan 14, 11347, P.Box 22033, S-10435
Spanish: Reino Unido Neolab Limited; 57 High Street; Odiham; Hants RG29 1LF, U.K.
Danish: Storbritannien Neolab Limited; 57 High Street; Odiham; Hants RG29 1LF, U.K.
Spanish: Heumann Pharma GmbH & Co. Generica KG
Danish: Tyskland Heumann Pharma GmbH & Co. Generica KG
Spanish: Dinamarca Scand Pharm Generics AB, Ynglinagatan 14, S-11347 Stockholm, Sweden
Danish: Danmark Scand Pharm Generics AB, Ynglinagatan 14, S-11347 Stockholm, Sweden
Spanish: Cápsula dura de liberación modificada
Danish: Kapsel med modificeret udløsning
Spanish: Wilbury Way
Danish: 1 The Cam Centre Wilbury Way
Spanish: BC Biochemie Pharma GmbH Dieselstr.
Danish: Tyskland BC Biochemie Pharma GmbH Dieselstr.
Spanish: Estado miembro Titular de la autorización de comercialización
Danish: Medlemsland Indehaver af markedsføringstilladelsen
Spanish: Boehringer Ingelheim Pharma GmbH & Co.KG
Danish: Tyskland Boehringer Ingelheim Pharma GmbH & Co.KG
Spanish: Zoloft 20 mg/ml, solution for Vía oral
Danish: Zoloft 20 mg/ml, solution for oral use
Spanish: III.2 MODIFICACIONES QUE DEBERÁN INCLUIRSE EN LA SECCIÓN RELEVANTE DEL RCP POR LO QUE SE REFIERE A LA ATOMOXETINA
Danish: III.2 ÆNDRINGER I DE RELEVANTE DELE AF PRODUKTRESUMEET FOR ATOMOXETIN
Spanish: Reino Unido Organon Laboratories Limited, Cambridge Science Park, Milton Road, Cambs CB4 0FL; UK
Danish: Storbritannien Organon Laboratories Limited, Cambridge Science Park, Milton Road, Cambs CB4 0FL; UK
Spanish: Wyeth Pharma GmbH Postfach 8806
Danish: Tyskland Wyeth Pharma GmbH Postfach 8806
Spanish: Países Bajos Katwijk Farma B.V.
Danish: Katwijk Farma B.V.
Spanish: Luxemburgo GLAXO SMITH KLINE S.A. Rue du Tilleul 13, B-1332 GENVAL, Belgium
Danish: Luxembourg GLAXO SMITH KLINE S.A. Rue du Tilleul 13, B-1332 GENVAL, Belgium
Spanish: Países Bajos Solvay Pharma B.V., Postbus 501, NL1380 AM Weesp
Danish: Solvay Pharma B.V., Postbus 501, NL1380 AM Weesp
Spanish: Frankfurter Str. 129a D-64293 Darmstadt
Danish: Tyskland Generics (UK) Ltd. Frankfurter Str. 129a D-64293 Darmstadt
Spanish: Reino Unido Norton Healthcare Limited; Ivax Quay; Albert Basin; Royal Docks;
Danish: Storbritannien Norton Healthcare Limited; Ivax Quay; Albert Basin; Royal Docks;
Spanish: Van-der-Smissen-Strasse 1
Danish: KG) Van-der-Smissen-Str. 1
Spanish: STADA GmbH Stadastr.
Danish: Tyskland STADA GmbH Stadastr.
Spanish: La hostilidad (predominantemente agresión, comportamiento contrario e irritación) y la inestabilidad emocional fueron constatadas con más frecuencia en ensayos clínicos con niños y adolescentes tratados con [Nombre de Fantasía]frente a aquellos tratados con placebo.
Danish: Fjendtlighed (fortrinsvis aggression, oppositionel adfærd og vrede) og emotionel labilitet blev observeret hyppigere i kliniske undersøgelser blandt børn og unge behandlet med [særnavn] sammenholdt med gruppen behandlet med placebo.
Spanish: Eslovaquia Eli Lilly Export S.A. 16, Chemin de Coquelicots CH - 1214 Geneva
Danish: 16, Chemin de Coquelicots CH - 1214 Geneva
Spanish: Países Bajos Sandoz B.V., Postbus 216, NL-1380 AE Weesp
Danish: Sandoz B.V., Postbus 216, NL-1380 AE Weesp
Spanish: Reino Unido Solvay Healthcare Limited, Mansbridge Road, West End, Southampton SO18 3JD; UK
Danish: Storbritannien Solvay Healthcare Limited, Mansbridge Road, West End, Southampton SO18 3JD; UK
Spanish: Medis, Podjetje za proizvodnjo in trženje d.o.o., Brnčičeva 1, SI-1001 Ljubljana, Slovenia
Danish: Slovenien Medis, Podjetje za proizvodnjo in trženje d.o.o., Brnčičeva 1, SI-1001
Spanish: NOVEXAL HELLAS, Agiou Dimitriou 25 17455 Kalamaki Greece
Danish: Grœkenland NOVEXAL HELLAS, Agiou Dimitriou 25 17455 Kalamaki Greece
Spanish: PHARMATEN, 6 Dervenakion, 15351 Pallini Attikis, Greece
Danish: Grœkenland PHARMATEN, 6 Dervenakion, 15351 Pallini Attikis, Greece
Spanish: Fluoxetine Solución oral 4mg/ml
Danish: Fluoxetine Oral Solution 4mg/ml
Spanish: Países Bajos Neuraxpharm Arzneimittel GmbH & Co KG, Postfach 1439, D-40739
Danish: Neuraxpharm Arzneimittel GmbH & Co KG, Postfach 1439, D-40739 Langefeld
Spanish: Países Bajos Pharmachemie B.V., Postbus 552, NL2003 RN Haarlem
Danish: Pharmachemie B.V., Postbus 552, NL2003 RN Haarlem
Spanish: Países Bajos Docpharma NV, Ambachtenlaan 13 H, B-3001 Heverlee
Danish: Docpharma NV, Ambachtenlaan 13 H, B-3001 Heverlee
Spanish: Eslovaquia Pharmacia Italia S.p.A., Via Robert Koch 1.2, 201 52, Milano, Italy
Danish: Pharmacia Italia S.p.A., Via Robert Koch 1.2, 201 52, Milano, Italy
Spanish: NOVARTIS HELLAS, 12 Km National Road Athinon-Lamias, 14410 Metamorfosi, Greece
Danish: Grœkenland NOVARTIS HELLAS, 12 Km National Road Athinon-Lamias, 14410 Metamorfosi, Greece
Spanish: Hennig Arzneimittel GmbH & Co.KG Postfach 1240
Danish: Tyskland Hennig Arzneimittel GmbH & Co.KG Postfach 1240
Spanish: Reino Unido Alpharma Limited; Whiddon Valley; Barnstaple; Devon EX32 8NS; UK
Danish: Storbritannien Alpharma Limited; Whiddon Valley; Barnstaple; Devon EX32 8NS; UK
Spanish: FARAN, Ahaias & trizinias, 14564 N.Kifissia, Greece
Danish: Grœkenland FARAN, Ahaias & trizinias, 14564 N.Kifissia, Greece
Spanish: Reino Unido Sterwin Medicines Limited, PO Box 611, Guildford,Surrey GU1 4YS, U.K.
Danish: Storbritannien Sterwin Medicines Limited, PO Box 611, Guildford,Surrey GU1 4YS, U.K.
Spanish: ELI LILLY BENELUX S.A. Rue de l'Etuve 52 1000 Bruxelles, Belgium
Danish: Luxembourg ELI LILLY BENELUX S.A. Rue de l'Etuve 52 1000 Bruxelles, Belgium
Spanish: ANFARM HELLAS AE K.Paleologou& Perikleous 27 15232 Halandri, Greece
Danish: Grœkenland ANFARM HELLAS AE K.Paleologou& Perikleous 27 15232 Halandri, Greece
Spanish: Fabrik , Holger Danskaes Vej 89, DK - 2000
Danish: Fabrik , Holger Danskaes Vej 89, DK - 2000 Frederiksberg
Spanish: Países Bajos Lichtenstein Pharmazeutika GmbH & Co. OHG, Industriestrasse 26, D56218 Mülheim-Kärlich
Danish: Lichtenstein Pharmazeutika GmbH & Co. OHG, Industriestrasse 26, D56218 Mülheim-Kärlich
Spanish: Luxemburgo PFIZER S.A. Bld de la Plaine 17 1050 Bruxelles, Belgium
Danish: Luxembourg PFIZER S.A. Bld de la Plaine 17 1050 Bruxelles, Belgium
Spanish: NOVEXAL HELLAS, Agiou Dimitriou 25, 17455 Kalamaki, Greece
Danish: Grœkenland NOVEXAL HELLAS, Agiou Dimitriou 25, 17455 Kalamaki, Greece
Spanish: ALPHARMA Whiddon ValleyBarnstaple, North Devon EX 32 8NS, England
Danish: Estland Estland ALPHARMA Whiddon ValleyBarnstaple, North Devon EX 32 8NS, England
Spanish: Reino Unido Sterwin Medicines Limited, PO Box 611, Guildford,Surrey GU1 4YS, UK
Danish: Storbritannien Sterwin Medicines Limited, PO Box 611, Guildford,Surrey GU1 4YS, UK
Spanish: Países Bajos Synthon B.V., Postbus 7071, NL-6503 GN Nijmegen
Danish: Synthon B.V., Postbus 7071, NL-6503 GN Nijmegen
Spanish: SOLVAY PHARMA, 3 Avenue du Bourgmestre, E. Demunter, B-1090 Bruxelles, Belgium
Danish: Luxembourg SOLVAY PHARMA, 3 Avenue du Bourgmestre, E. Demunter, B-1090
Spanish: Países Bajos GlaxoSmithKline B.V.
Danish: GlaxoSmithKline B.V.
Spanish: UXAFARMA S.A., Avda. J.V.
Danish: UXAFARMA S.A., Avda.
Spanish: ALVIA AE, 18Km Leoforos Marathonos, 15344 Pallini Attikis, Greece
Danish: Grœkenland ALVIA AE, 18Km Leoforos Marathonos, 15344 Pallini Attikis, Greece
Spanish: Países Bajos Genthon B.V., Postbus 7071, NL-6503 GN Nijmegen
Danish: Genthon B.V., Postbus 7071, NL-6503 GN Nijmegen
Spanish: Países Bajos Hexal AG, Postfach 1263, D-83602 Holzkirchen
Danish: Hexal AG, Postfach 1263, D-83602 Holzkirchen
Spanish: BROS, Avgis &Galinis 15, 14564 N.kifissia, Greece
Danish: Grœkenland BROS, Avgis &Galinis 15, 14564 N.kifissia, Greece
Spanish: AWD.pharma GmbH & Co. KG Lepziger Strasse 7-13 D-01097 Dresden Tyskland (DEU)
Danish: KG Lepziger Strasse 7-13 D-01097 Dresden Tyskland (DEU)
Spanish: PFIZER HELLAS, 5 Alketou, 116 33 Athens, Greece
Danish: Grœkenland PFIZER HELLAS, 5 Alketou, 116 33 Athens, Greece
Spanish: Dinamarca Teva Pharma B.V., Industrieweg 23, NL-3640 AE, Mijdrecht, Netherland
Danish: Danmark Teva Pharma B.V., Industrieweg 23, NL-3640 AE, Mijdrecht, Netherland
Spanish: Dinamarca Ivax Scandinavia AB, Birger Jarlsgatan 37, S-11145 Stockholm, Sweden
Danish: Danmark Ivax Scandinavia AB, Birger Jarlsgatan 37, S-11145 Stockholm, Sweden
Spanish: Reino Unido John Wyeth & Sons Limited, Huntercombe Lane South, Taplow, Maidenhead, Berks SL6 0PH, UK
Danish: Storbritannien John Wyeth & Sons Limited, Huntercombe Lane South, Taplow, Maidenhead, Berks SL6 0PH, UK
Spanish: (intentos de suicidio e ideas de suicidio), y la hostilidad (predominantemente agresión, comportamiento de confrontación e irritación) fueron constatadas con más frecuencia en ensayos clínicos con niños y adolescentes tratados con antidepresivos frente a aquellos tratados con placebo.
Danish: Selvmordsrelateret adfærd (selvmordsforsøg og selvmordstanker) og fjendtlighed (fortrinsvis aggression, oppositionel adfærd og vrede) blev observeret hyppigere i kliniske undersøgelser blandt børn og unge behandlet med antidepressive midler i forhold til gruppen behandlet med placebo.
Spanish: Dinamarca Pharmascope Ltd, Medici House, Unit 107, Ashbourne Industrial Estate, CoMeath, Ireland
Danish: Danmark Pharmascope Ltd, Medici House, Unit 107, Ashbourne Industrial Estate, CoMeath, Ireland
Spanish: Considerando que: - el Comité ha examinado la remisión efectuada conforme al artículo 31 de la Directiva 2001/83/CE, modificada, respecto a los medicamentos que contienen atomoxetina, citalopram, escitalopram, fluoxetina, fluvoxamina, mianserina, milnacipran, mirtazapina, paroxetina, reboxetina, sertralina y venlafaxina;
Danish: - Udvalget behandlede sagen, der var indbragt i henhold til artikel 31 i direktiv 2001/83/EF, med senere ændringer, vedrørende lægemidler indeholdende atomoxetin, citalopram, escitalopram, fluoxetin, fluvoxamin, mianserin, milnacipran, mirtazapin, paroxetin, reboxetin, sertralin og venlafaxin.
Spanish: Aliud Pharma GmbH & Co.KG Postfach 1380
Danish: Tyskland Aliud Pharma GmbH & Co.KG Postfach 1380
Spanish: Reino Unido Pharmafile Limited, Medici House, Ashbourne Industrial Estate, Ashbourne, Co. Meath, Republic of Ireland
Danish: Storbritannien Pharmafile Limited, Medici House, Ashbourne Industrial Estate, Ashbourne, Co. Meath, Republic of Ireland
Spanish: Dinamarca NM Pharma A/S, Lautrupvang 8, DK2750 Ballerup, Denmark
Danish: Danmark NM Pharma A/S, Lautrupvang 8, DK2750 Ballerup, Denmark