FrancophonIA/ELRC3.0 huggingface dataset:
English: The EC requested the CHMP to give its opinion on whether the marketing authorisation for medicinal products containing the above mentioned active substances should be maintained, varied, suspended or withdrawn.
Spanish: La Comisión Europea solicitó el dictamen del CHMP sobre si la autorización de comercialización de los productos médicos que contienen las substancias activas anteriormente mencionadas deberá ser mantenida, alterada, suspendida o retirada.
English: Patients beginning treatment for ADHD should be carefully monitored for the appearance or worsening of hostility and emotional lability.
Spanish: En los pacientes que inician el tratamiento de ADHD debe vigilarse cuidadosamente la aparición o el empeoramiento de la hostilidad y la inestabilidad emocional.
English: In addition, long-term safety data in children and adolescents concerning growth, maturation and cognitive and behavioural development are lacking.
Spanish: Además, carecemos de datos sobre la seguridad a largo plazo en niños y adolescentes por lo que se refiere al crecimiento, la madurez y el desarrollo cognitivo y conductual.
English: 4.4 Special warnings and precautions for use
Spanish: 4.4 Advertencias especiales y precauciones de uso
English: If, based on clinical need, a decision to treat is nevertheless taken, the patient should be carefully monitored for the appearance of suicidal symptoms.
Spanish: Si se adoptase no obstante la decisión, sobre la base de las pruebas médicas, de efectuar el tratamiento, deberá supervisarse cuidadosamente en el paciente la aparición de síntomas de suicidio.
English: You should inform your doctor if any of the symptoms listed above develop or worsen after treatment has begun.
Spanish: Debe ponerse en contacto con su médico si alguno de los síntomas enumerados a continuación se desarrolla o empeora una vez iniciado el tratamiento.
English: Following a request from the European Commission, the CHMP reviewed the data from clinical trials available to the national competent authorities for the following SSRI
Spanish: A instancias de la Comisión Europea, el CHMP analizó los datos de los ensayos clínicos a disposición de las autoridades competentes nacionales relativos a los siguientes productos SSRI
English: In addition there were some trials with patients suffering from Attention Deficit/Hyperactivity Disorder (ADHD).
Spanish: Además se efectuaron varios ensayos con pacientes que sufrían trastorno por déficit de atención con hiperactividad (ADHD).
English: With the preliminary review of the data available to the national competent authorities the CHMP concluded that there were grounds for concerns about increased suicide-related behaviours in paediatric populations.
Spanish: Tras el análisis preliminar de los datos en poder de las autoridades nacionales competentes, el CHMP concluyó que había motivos de inquietud por el incremento de los comportamientos suicidas en poblaciones pediátricas.
English: The data reviewed included short-term placebo controlled randomised clinical trials submitted to the competent authorities, randomised clinical trials published in the medical literature, observational studies and ecological studies.
Spanish: Los datos analizados incluían ensayos clínicos aleatorios controlados por placebo a corto plazo presentados a las autoridades competentes, ensayos clínicos aleatorios publicados en la bibliografía médica, estudios de observación y estudios ecológicos.
English: The majority of trials included patients with major depressive disorders (MDD) while a few included patients with various anxiety disorders (Obsessive Compulsive Disorder (OCD), Generalised Anxiety Disorder (GAD), and Social Anxiety Disorder (SAD)).
Spanish: La mayoría de los ensayos incluía a pacientes con trastornos depresivos importantes (MDD) mientras que una pequeña parte incluía a pacientes con diversos trastornos ligados a la ansiedad (Trastorno obsesivo-compulsivo (OCD), Trastorno de ansiedad generalizada (GAD), y Trastorno de ansiedad social (SAD)).
English: Moreover there was a signal concerning related adverse events like hostility, self-harm and emotional lability in almost all products and indications.
Spanish: Hubo además una señal de efectos adversos relacionados como hostilidad, autoagresividad e inestabilidad emocional en casi todos los productos e indicaciones.
English: Netherlands I.C.C.
Spanish: Países Bajos I.C.C.
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLETS PRESENTED BY THE EMEA
Spanish: ANEXO II CONCLUSIONES CIENTÍFICAS Y MOTIVOS DE LA MODIFICACIÓN DEL RESUMEN DE LAS CARACTERÍSTICAS DEL PRODUCTO Y PROYECTOS DE ETIQUETADO PRESENTADAS POR LA EMEA
English: Luxembourg Chemische Tempelhof GMBH, Lengedestr.
Spanish: Luxemburgo Chemische Tempelhof GMBH, Lengedestr.
English: [Invented Name] is not indicated for the treatment of major depressive episodes and/or anxiety as the results of clinical trials that were conducted in adults did not show any effect compare to placebo, and therefore were negative.
Spanish: El [Nombre de Fantasía]no está indicado para el tratamiento de episodios depresivos importantes y/o la ansiedad, dado que los resultados de las pruebas clínicas efectuadas en adultos no revelaron ningún efecto comparado al placebo, y fueron por tanto negativos.
English: N.V. Organon Molenstraat 110.
Spanish: Organon Molenstraat 110.
English: Pfizer Limited, Ramsgate Road, Sandwich
Spanish: Eslovaquia Pfizer Limited, Ramsgate Road, Sandwich
English: The CHMP considered that there wasn't any signal of increased risk of suicide related behaviour in the atomoxetine studies, however, there was a signal of an increased risk of behavioural abnormalities with more aggression and hostility effects.
Spanish: El CHMP consideró que no existía ninguna señal de incremento del riesgo de comportamiento suicida en los estudios sobre la atomoxetina, pese a existir, una obstante, señal de un mayor riesgo de comportamientos anormales con mayores efectos de agresión y hostilidad.
English: Netherlands Niche Generics Ltd. 1 The Cam Centre
Spanish: Países Bajos Niche Generics Ltd. 1 The Cam Centre
English: Note: This section of the Package Leaflet is the one that was Annexed to the Commission Decision on this Article 31 referral .
Spanish: Nota: La sección de este prospecto es la que estaba anexa a la Decisión de la Comisión de esta remisión conforme al Artículo 31.
English: Lithuania Latvian JSC Grindeks, Krustpils ul.
Spanish: Latvian JSC Grindeks, Krustpils ul.
English: Also, the long-term safety effects concerning growth, maturation and cognitive and behavioural development of [Invented Name] in this age group have not yet been demonstrated.
Spanish: A la vez, los efectos de seguridad a largo plazo 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.
English: Examination of suicide-related behaviours indicated that no completed suicide was reported in any of the reviewed studies.
Spanish: El examen de los comportamientos suicidas no reveló en ninguno de los estudios analizados casos de suicidios consumados.
English: The CHMP reviewed the data submitted by the MAHs in relation to the signal of suicidal behaviour in children and adolescents.
Spanish: El CHMP analizó los datos presentados por los Titulares de la Autorizaciones de Comercialización en relación con la señal de comportamiento suicida en niños y adolescentes.
English: You should inform your doctor if any of the symptoms listed above develop or worsen when patients under 18 are taking [Invented Name].
Spanish: Debe informar a su médico si alguno de los síntomas que se detallan a continuación progresa o experimenta complicaciones cuando pacientes menores de 18 años están tomando [Nombre de Fantasía].
English: PHARMACIA ENTERPRISES S.A.6 Circuit de la Foire Internationale L-1347 Luxembourg G.D. De Luxembourg
Spanish: PHARMACIA ENTERPRISES S.A.6 Circuit de la Foire Internationale L-1347 Luxembourg G.D.
English: GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS
Spanish: FUNDAMENTOS DE LA MODIFICACIÓN DE LOS RESÚMENES DE LAS CARACTERÍSTICAS DEL PRODUCTO
English: The Committee also concluded that a different warning was more appropriate for atomoxetine, which is only indicated in the treatment of ADHD.
Spanish: El Comité concluyó asimismo que en el caso de la atomoxetina, sólo indicada para el tratamiento de ADHD, era más adecuado un tipo de advertencia diferente.
English: ANNEX I LIST OF THE INVENTED NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Spanish: ANEXO 1 RELACIÓN DE LAS MARCAS DE FANTASÍA , FORMAS FARMACÉUTICAS, DOSIS , VÍA DE ADMINISTRACIÓN Y TITULARES DE LAS AUTORIZACIONES DE COMERCIALIZACIÓN EN LOS ESTADOS MIEMBROS
English: Vajnorská 100/A, SK-841 01 Bratislava
Spanish: Vajnorská 100/A, SK-841 01
English: SNRIs work on the norepinephrine and serotonin neurotransmitters
Spanish: Los SNRI actúan sobre los neurotransmisores norepinefrina y serotonina.
English: A/S GEA Farmaceut.
Spanish: Eslovaquia A/S GEA Farmaceut.
English: Netherlands Fidia Farmaceutici S.p.A., Via Ponte della Fabbrica, 3/a, I-35031 Albano Terme - Padova
Spanish: Países Bajos Fidia Farmaceutici S.p.A., Via Ponte della Fabbrica, 3/a, I-35031 Albano Terme - Padova
English: Belgium LAGEPHA S.A. Avenue Mercator 1 1300 Wavre, Belgium
Spanish: LAGEPHA S.A. Avenue Mercator 1 1300 Wavre, Belgium
English: Patients under 18 have an increased risk of side-effects such as hostility (predominantly aggression, oppositional behaviour and anger) and emotional lability.
Spanish: En los pacientes menores de 18 años hay un mayor riesgo de efectos adversos como la hostilidad (predominantemente agresión, comportamiento contrario e irritación) e inestabilidad emocional.
English: [Invented Name] should not be used in the treatment of children and adolescents under the age of 18 years <, except for patients with [approved indication]>.
Spanish: El [Nombre de Fantasía]no deberá utilizarse en el tratamiento de niños y adolescentes menores de 18 años < salvo en el caso de pacientes con [indicación aprobada]>.
English: Netherlands Merck Generics BV Dieselweg 25
Spanish: Países Bajos Merck Generics BV Dieselweg 25
English: Belgium 3 DDD PHARMA Diestersteenweg 349, 3510 Kermt, Belgium
Spanish: 3 DDD PHARMA Diestersteenweg 349, 3510 Kermt, Belgium
English: Pol. Emp. La Marina.
Spanish: Pol. Emp.
English: Denmark PSI NV, Kraanlei 27, B-9000 Gent, Belgium
Spanish: Dinamarca PSI NV, Kraanlei 27, B-9000 Gent, Belgium
English: Molteni Farmaceutici S.p.A. Strada Statale, 76 Loc. Granatieri 50018 Scandicci - Firenze Italy
Spanish: Strada Statale, 76 Loc. Granatieri 50018 Scandicci - Firenze Italy
English: ANNEX IV AMENDMENTS TO THE PACKAGE LEAFLET
Spanish: ANEXO IV MODIFICACIONES DEL PROSPECTO
English: Suspension
Spanish: Suspensión
English: Dr Reddy's Laboratories (UK) Limited; 208-214 York Road, London SW11 3SD; UK
Spanish: Reino Unido Dr Reddy's Laboratories (UK) Limited; 208-214 York Road, London SW11 3SD; UK
English: Box 7071
Spanish: Postbus 7071
English: III.2 AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTION OF THE SPC FOR ATOMOXETINE
Spanish: III.2 MODIFICACIONES QUE DEBERÁN INCLUIRSE EN LA SECCIÓN RELEVANTE DEL RCP POR LO QUE SE REFIERE A LA ATOMOXETINA
English: Also, you should know that patients under 18 have an increased risk of side-effects such as suicide attempt, suicidal thoughts and hostility (predominantly aggression, oppositional behaviour and anger) when they take this class of medicines.
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.
English: Pliva Pharma Ltd; Vision House; Bedford Road; Petersfield, Hampshire GU32 3QB; UK
Spanish: Reino Unido Pliva Pharma Ltd; Vision House; Bedford Road; Petersfield, Hampshire GU32 3QB; UK
English: [Invented Name] should normally not be used for children and adolescents under 18 years < except for patients with [approved indication]>.
Spanish: El [Nombre de Fantasía]no deberá utilizarse normalmente en el tratamiento de niños y adolescentes menores de 18 años < salvo en el caso de pacientes con [indicación aprobada]>.
English: IV.2 AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTION OF THE PL FOR ATOMOXETINE
Spanish: IV.2 MODIFICACIONES QUE DEBERÁN INCLUIRSE EN LA SECCIÓN RELEVANTE DEL RCP POR LO QUE SE REFIERE A LA ATOMOXETINA
English: Despite this, your doctor may prescribe [Invented Name] for patients under 18 because he/she decides that this is in their best interests.
Spanish: Pese a ello, el doctor que le corresponda puede prescribir [Nombre de Fantasía]a pacientes menores de 18 años cuando decida que es lo más conveniente para el paciente.
English: Wessex Fine Chemicals Limited, Thornhill Works, Coolham, West Sussex RH13 8QN; UK
Spanish: Reino Unido Wessex Fine Chemicals Limited, Thornhill Works, Coolham, West Sussex RH13 8QN; UK
English: Waymade PLC, Sovereign House, Miles Gray Road, Basildon, Essex SS14 3FR; UK
Spanish: Reino Unido Waymade PLC, Sovereign House, Miles Gray Road, Basildon, Essex SS14 3FR; UK
English: The CHMP agreed that there was a potential signal of an increase in suicidal behaviour, including suicide attempts and suicidal ideation and/or related behaviour like self-harm, hostility and mood lability in children and adolescents treated with SSRIs and SNRIs.
Spanish: El CHMP admitió que existía una posible señal de incremento de los comportamientos suicidas, incluidos intentos de suicidio e ideas de suicidio y/o comportamientos relacionados como la autoagresividad, la hostilidad y la inestabilidad emocional en niños y adolescentes tratados con SSRI y SNRI.
English: Lithuania Nycomed SEFA AS, Jaama 55B, 63308 Polva, Estonia
Spanish: Nycomed SEFA AS, Jaama 55B, 63308 Polva, Estonia
English: Netherlands Arrow Pharma B.V., C/o Resolution, Wedgewood Way, Stevenage, UKSG1 4 QT Herts
Spanish: Países Bajos Arrow Pharma B.V., C/o Resolution, Wedgewood Way, Stevenage, UKSG1 4 QT Herts
English: Netherlands Eurobase B.V., Mercuriusweg 8 - 10, NL-3771 NC Barneveld
Spanish: Países Bajos Eurobase B.V., Mercuriusweg 8 - 10, NL-3771 NC Barneveld
English: Denmark Nycomed Danmark ApS, Langebjerg 1, DK-4000 Roskilde, Denmark
Spanish: Dinamarca Nycomed Danmark ApS, Langebjerg 1, DK-4000 Roskilde, Denmark
English: SSRIs are described as 'selective' because they affect only the reuptake pumps responsible for serotonin.
Spanish: 1 SSRI significa “Inhibidor selectivo de la recaptación de serotonina” Los SSRI se describen como ‘selectivos' porque afectan únicamente a las bombas de recaptación responsables de la serotonina.
English: GlaxoSmithKline Slovakia s.r.o.
Spanish: Eslovaquia GlaxoSmithKline Slovakia s.r.o.
English: Netherlands Pharmacin Products B.V., Molenvliet 103, NL-3335 LH Zwijndrecht
Spanish: Países Bajos Pharmacin Products B.V., Molenvliet 103, NL-3335 LH Zwijndrecht
English: Netherlands Kromme Rijn Apotheek B.V., Postbus 141, 3980 CC Bunnik, the Netherlands
Spanish: Países Bajos Kromme Rijn Apotheek B.V., Postbus 141, 3980 CC Bunnik, the Netherlands
English: Teva Pharmaceuticals Limited, Barclays House, 1 Gatehouse Way, Aylesbury, Bucks HP19 8DB; UK
Spanish: Reino Unido Teva Pharmaceuticals Limited, Barclays House, 1 Gatehouse Way, Aylesbury, Bucks HP19 8DB; UK
English: Lange Munteplein 7b 4, 8500
Spanish: Lange Munteplein 7b 4, 8500 Kortrijk, Belgium
English: Netherlands Stichting Registratiebeheer, Bosstraat 69, NL-3766 AC Soest
Spanish: Países Bajos Stichting Registratiebeheer, Bosstraat 69, NL-3766 AC Soest
English: Belgium OLYMPO PHARMA B.V.B.A.
Spanish: OLYMPO PHARMA B.V.B.A.
English: Denmark Wyeth Laboratories, New Lane, P092NG Havant, Hants, GB
Spanish: Dinamarca Wyeth Laboratories, New Lane, P092NG Havant, Hants, GB
English: Luxembourg LUNDBECK S.A., 225 AV. Moliére B-1050 Bruxelles
Spanish: Luxemburgo LUNDBECK S.A., 225 AV. Moliére B-1050 Bruxelles
English: However, there was a clear suicide-related behaviours signal from the depression studies and a less strong signal from the anxiety studies.
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.
English: - The Committee, in view of available data from clinical trials, concluded that there is a signal of suicidal behaviour, including suicide attempts and suicidal ideation and/or related behaviour like self-harm, hostility and mood lability in children and adolescents treated with Selective Serotonin Reuptake Inhibitors and Serotonin-Norepinephrine Reuptake Inhibitors, such as the medicinal products mentioned above;
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;
English: Athlone Laboratories Limited, Ballymurray, Co. Roscommon, Republic of Ireland
Spanish: Reino Unido Athlone Laboratories Limited, Ballymurray, Co. Roscommon, Republic of Ireland
English: Netherlands AbZ Pharma GmbH, Postfach 1152, D-89135 Blaubeuren
Spanish: Países Bajos AbZ Pharma GmbH, Postfach 1152, D-89135 Blaubeuren
English: Netherlands Alfred Tiefenbacher (GmbH & Co. KG)
Spanish: Países Bajos Alfred Tiefenbacher (GmbH & Co. KG)
English: CP Pharmaceuticals Limited, Ash Road North, Wrexham Industrial Estate, Wrexham LL13 9UF, UK
Spanish: Reino Unido CP Pharmaceuticals Limited, Ash Road North, Wrexham Industrial Estate, Wrexham LL13 9UF, UK
English: Infusion
Spanish: Infusión
English: Netherlands Pfizer B.V., Postbus 37, NL-2900 AA Capelle a/d IJssel
Spanish: Países Bajos Pfizer B.V., Postbus 37, NL-2900 AA Capelle a/d IJssel
English: Belgium ORGANON BELGIE Terhulpsesteenweg 166 1070
Spanish: ORGANON BELGIE Terhulpsesteenweg 166 1070 BRUSSEL, Belgium
English: Denmark Billev Pharma Aps, Elmegårdsvej 1A, DK-3630 Jægerspris, Denmark
Spanish: Dinamarca Billev Pharma Aps, Elmegårdsvej 1A, DK-3630 Jægerspris, Denmark
English: Conde de Guadalhorce, 43 Nave 2, Avilés (Asturias) 33400, Spain
Spanish: LABORATORIOS AGEN GENERICOS FARMACEUTICOS, S.L., Avda. Conde de Guadalhorce, 43 Nave 2, Avilés (Asturias) 33400, Spain
English: Ratiopharm UK Limited, 5 Jackson Close, Grove Road, Cosham, Portsmouth, Hants PO6 1UP; UK
Spanish: Reino Unido Ratiopharm UK Limited, 5 Jackson Close, Grove Road, Cosham, Portsmouth, Hants PO6 1UP; UK
English: SmithKline Beecham Phamraceuticals Limited, Stockley Park West, Uxbridge, Middx UB11 1BT, UK
Spanish: Reino Unido SmithKline Beecham Phamraceuticals Limited, Stockley Park West, Uxbridge, Middx UB11 1BT, UK
English: Denmark Imi Pharma AS, Literbuen 9, DK-2740 Skovlunde, Denmark
Spanish: Dinamarca Imi Pharma AS, Literbuen 9, DK-2740 Skovlunde, Denmark
English: Milpharm Limited, Marlborough House, 298 Regent's Park Road, Finchley, London N3 2UA; UK
Spanish: Reino Unido Milpharm Limited, Marlborough House, 298 Regent's Park Road, Finchley, London N3 2UA; UK
English: Relonchem Limited, 27 Old Gloucester Street, London WC1 3XX; UK
Spanish: Reino Unido Relonchem Limited, 27 Old Gloucester Street, London WC1 3XX; UK
English: J.V.
Spanish: B.V.
English: Denmark Orion Corporation, Orionintie 1, SF02200 Espoo, Finland
Spanish: Dinamarca Orion Corporation, Orionintie 1, SF02200 Espoo, Finland
English: Netherlands ct Arzneimittel GmbH, Postfach 510124, D-13361 Berlijn
Spanish: Países Bajos ct Arzneimittel GmbH, Postfach 510124, D-13361 Berlijn
English: 2 SNRI stands for ‘Serotonin-Norepinephrine Reuptake Inhibitor'.
Spanish: 2 SNRI significa “inhibidor de la recapatación de serotonina - norepinefrina”.
English: Belgium ETHIMED N.V., Leuvensestraat 28 B2, 1800 Vilvoorde, Belgium
Spanish: ETHIMED N.V., Leuvensestraat 28 B2, 1800 Vilvoorde, Belgium
English: Solution for infusion Intravenous use
Spanish: Solución para perfusión Vía intravenosa
English: Denmark 1A Farma A/S, Herstedøstervej 27-29, DK-2620 Albertslund, Denmark
Spanish: Dinamarca 1A Farma A/S, Herstedøstervej 27-29, DK-2620 Albertslund, Denmark
English: Netherlands Neuraxpharm Arzneimittel GmbH & Co KG, Postfach 1439, D-40739
Spanish: Países Bajos Neuraxpharm Arzneimittel GmbH & Co KG, Postfach 1439, D-40739
English: Angenerico S.p.A. via Nocera Umbra 75 00100 Roma Italy
Spanish: via Nocera Umbra 75 00100 Roma Italy
English: Luxembourg WYETH PHARMACEUTICALS, 15 Rue Du Bosquet, B-1348 Louvain-LaNeuve, Belgium
Spanish: Luxemburgo WYETH PHARMACEUTICALS, 15 Rue Du Bosquet, B-1348 Louvain-LaNeuve, Belgium
English: Luxembourg Pharmacia S.A., 17 Boulevard De La, B-1050 Bruxelles, Belgium
Spanish: Luxemburgo Pharmacia S.A., 17 Boulevard De La, B-1050 Bruxelles, Belgium
English: Denmark Jacobsen Pharma A/S, Vemmingbund Strandvej 111, DK-6310 Broager, Denmark
Spanish: Dinamarca Jacobsen Pharma A/S, Vemmingbund Strandvej 111, DK-6310 Broager, Denmark
English: Denmark PharmaCoDane ApS, Marielundvej 46A, DK-2730 Herlev, Denmark
Spanish: Dinamarca PharmaCoDane ApS, Marielundvej 46A, DK-2730 Herlev, Denmark
English: Netherlands GenRx B.V., Postbus 75, NL-6920 AB Duiven
Spanish: Países Bajos GenRx B.V., Postbus 75, NL-6920 AB Duiven
English: Gastro-resistant capsule hard
Spanish: Cápsula dura gastrorresistente
English: Goldshield Pharmaceuticals Limited, NLA Tower, 12-16 Addiscombe Road, Croydon, Surrey CR0 0XT; UK
Spanish: Reino Unido Goldshield Pharmaceuticals Limited, NLA Tower, 12-16 Addiscombe Road, Croydon, Surrey CR0 0XT; UK
English: Netherlands Centrafarm Services B.V., Postbus 289, NL-4870 AG Etten Leur
Spanish: Países Bajos Centrafarm Services B.V., Postbus 289, NL-4870 AG Etten Leur
English: Belgium SOLVAY PHARMA & CIE Avenue Demunter 3 1090 Brussel, Belgium
Spanish: SOLVAY PHARMA & CIE Avenue Demunter 3 1090 Brussel, Belgium
English: Netherlands Eli Lilly Nederland BV, Postbus 379, NL-3990 GD Houten
Spanish: Países Bajos Eli Lilly Nederland BV, Postbus 379, NL-3990 GD Houten
English: Belgium APOGENPHARMA B.V. Europark Oost 34, 9100 St. Niklaas, Belgium
Spanish: Europark Oost 34, 9100 St. Niklaas, Belgium
English: Concentrate for oral solution Oral use
Spanish: Concentrado para solución oral Vía oral
English: 20 mg/0,5 ml Concentrate for solution for infusion
Spanish: 20 mg/0,5 ml Concentrado para solución para perfusión
English: Netherlands Betapharm Arzneimittel GmbH, Kobelweg 95, D-86156 Augsburg
Spanish: Países Bajos Betapharm Arzneimittel GmbH, Kobelweg 95, D-86156 Augsburg
English: Netherlands Genfarma B.V., Postbus 2062, NL1500 GB Zaandam
Spanish: Países Bajos Genfarma B.V., Postbus 2062, NL1500 GB Zaandam
English: Netherlands Katwijk Farma B.V., Postbus 408, NL2300 AK Leiden
Spanish: Países Bajos Katwijk Farma B.V., Postbus 408, NL2300 AK Leiden
English: Zoloft 25 mg + 50 mg 25 mg + 50 mg Film-coated tablet
Spanish: Zoloft 25 mg + 50 mg 25 mg + 50 mg Comprimido recubierto con película
English: Netherlands Wyeth Pharmaceuticals B.V., Postbus 255, NL-2130 AG Hoofddorp
Spanish: Países Bajos Wyeth Pharmaceuticals B.V., Postbus 255, NL-2130 AG Hoofddorp
English: Denmark Neuraxpharm Arzneimittel GmbH, Elisabeth-Selbert-Strasse 23, D-40764
Spanish: Dinamarca Neuraxpharm Arzneimittel GmbH, Elisabeth-Selbert-Strasse 23, D-40764
English: Denmark GlaxoSmithKline Pharma A/S, Nykær 68, DK-2605 Brøndby, Denmark
Spanish: Dinamarca GlaxoSmithKline Pharma A/S, Nykær 68, DK-2605 Brøndby, Denmark
English: N.V. ORGANON Kloosterstraat 6P.O.Box 205340 BH OssHolland
Spanish: ORGANON Kloosterstraat 6P.O.Box 205340 BH OssHolland
English: AREMIS 20 mg/ml concentrated liquid for oral use
Spanish: AREMIS 20 mg/ml concentrated liquid for Vía oral
English: Denmark Gerard Laboratories, 35 Balcloyle Industrial Estate, Dublin, Ireland
Spanish: Dinamarca Gerard Laboratories, 35 Balcloyle Industrial Estate, Dublin, Ireland
English: B.V. Postbus 75
Spanish: Postbus 75