FrancophonIA/ELRC3.0 huggingface dataset:
English: The legislation allows the committees to establish scientific advisory groups in connection with the evaluation of specific types of pharmaceutical products or treatments.
Spanish: La legislación permite a los comités establecer grupos de asesoramiento científico en relación con la evaluación de determinados tipos de productos o tratamientos farmacéuticos; y el plazo para la comunicación del dictamen del CVMP sobre medicamentos de uso veterinario se ha reducido a 15 días.
English: Core SPC released for further consultation in 2004 and to be finalised in 2005
Spanish: Se publicará el RCP básico para consulta en 2004 y se terminará en
English: Key initiative to meet the objective:
Spanish: Principal iniciativa para alcanzar el objetivo:
English: Revision to start in 2005
Spanish: Comenzará la revisión en 2005.
English: In 1986 he joined the University of Bordeaux and was involved in various research areas in public health, including epidemiology, clinical research, pharmacovigilance, tropical and infectious diseases, health economy and health education.
Spanish: investigación clínica, farmacovigilancia, enfermedades infecciosas y tropicales, economía sanitaria y educación sanitaria.
English: She joined the EMEA in October 1994.
Spanish: Se incorporó a la EMEA en octubre de 1994.
English: EU Comments in preparation of revised VICH Guidelines
Spanish: Comentarios de la Unión Europea durante la elaboración de las directrices revisadas del VICH.
English: CHMP meetings in 2005
Spanish: Reuniones del CHMP en 2005
English: Education: Master's degree in pharmacy and doctor of natural sciences degree in pharmacology from the University of Vienna.
Spanish: Estudios: Máster en farmacia y Doctora en ciencias naturales con especialidad en farmacología por la
English: Revision to be finalised in 3/4Q 2005
Spanish: Se terminará la revisión en el 3/4T de
English: Career to date: From 1984 Professor Vamvakas held positions in the department of pharmacology and toxicology at the University of Würzburg and in the department of pharmacology at the Medical Centre of the University of Rochester NY, USA.
Spanish: Trayectoria profesional hasta la fecha: Desde 1984 el Profesor Vamvakas ocupó varios cargos en el Departamento de Farmacología y Toxicología de la Universidad de Wuerzburg y en el Departamento de Farmacología del Centro Médico de la Universidad de Rochester, Nueva York, EE.UU. Se incorporó a la EMEA en mayo de 1999 y una de sus principales actividades en los últimos años ha sido la creación de la designación de medicamento huérfano y la asistencia en protocolos en la EMEA.
English: Status of medicinal products for the treatment of hepatitis B
Spanish: Guideline on the clinical investigation of medicinal products for the treatment of hepatitis B
English: CHMP Guideline for the preparation of assessment reports on periodic safety update reports
Spanish: Assessment Reports on Periodic Safety
English: Preparatory work for the establishment of the list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products
Spanish: Trabajo de preparación para elaborar la lista de sustancias vegetales, preparados vegetales y combinaciones de ambos para su utilización en medicamentos tradicionales de origen vegetal.
English: Tony Humphreys, Head of Sector for regulatory affairs and organisational support, b. 12 December 1961, n. Irish
Spanish: Tony Humphreys, Jefe del Sector de asuntos reglamentarios y servicios de apoyo,
English: He joined the EMEA in May 2000.
Spanish: Entró en la EMEA en mayo de 2000.
English: The target is to have 90 % of applications evaluated within these timelines
Spanish: El objetivo es evaluar el 90 % de las solicitudes dentro de ese plazo.
English: Concept paper to be prepared
Spanish: Se elaborará un documento de concepto.
English: Key initiatives to meet the objective:
Spanish: Principales iniciativas para alcanzar el objetivo:
English: She joined the EMEA in September 1997.
Spanish: Se incorporó a la EMEA en septiembre de 1997.
English: To be finalised in 4Q 2005
Spanish: Se terminará en el 4T de 2005.
English: To be released for consultation in 3Q
Spanish: Se publicará para consulta en el 3T de
English: Inspection requests received/forecast (Input)
Spanish: Solicitudes de inspección recibidas/esperadas (Entrada)
English: Ms Nuttall then served with the Food and Agriculture Organisation of the United Nations from 1990 to 1995.
Spanish: La Sra. Nuttall trabajó posteriormente en la Organización de las Naciones Unidas para la Agricultura y la Alimentación durante cinco años, hasta su incorporación a la EMEA en mayo de
English: Integrated quality management IQM adviser
Spanish: Gestión integrada de la calidad
English: Revision to be finalised in 2/3Q 2005
Spanish: Se terminará la revisión en el 2/3T de
English: HMPC meetings in 2005
Spanish: Reuniones del HMPC en 2005
English: The Agency will improve handling of referral procedures to provide faster opinions on questions related to safety of medicines 9 The Agency will remain committed to managing effectively and efficiently its increased tasks and responsibilities, ensuring that patients and users of medicines have access to safe and effective medicinal products within the timelines laid down in the legislation 9 The Agency will work for greater transparency of its operations and activities 9 EMEA will further extend its capacity to provide scientific advice and the quality of that advice 9 It will strive to increase availability of veterinary medicines intended for minor uses and minor species
Spanish: La Agencia seguirá estando comprometida con la gestión eficaz y eficiente de sus crecientes tareas y responsabilidades, garantizando que los pacientes y usuarios de los medicamentos dispongan de acceso a medicamentos seguros y eficaces dentro de los plazos fijados en la legislación.
English: To be prepared during 2005
Spanish: Se elaborará en 2005.
English: Noël Wathion, Head of Unit, b. 11 September 1956, n. Belgian
Spanish: Noël Wathion, Jefe de Unidad, nacido el 11 de septiembre de 1956, nacionalidad belga Estudios: Licenciado en farmacia por la Universidad Pública de Bruselas.
English: To be released for consultation in 1/2Q
Spanish: Se publicará para consulta en el 1/2T
English: The European Union Telematics strategy for pharmaceuticals is agreed between Member States, the EMEA and the European Commission.
Spanish: Estados miembros, la EMEA y la Comisión Europea.
English: 2.2 Scientific advice and protocol assistance 2.3 Initial evaluation
Spanish: 2.1 Medicamentos huérfanos 2.2 Asesoramiento científico y asistencia de protocolo
English: EU Comments in preparation of revised VICH Guideline
Spanish: Comentarios de la Unión Europea durante la elaboración de la directriz revisada del VICH.
English: Ms Fayl joined the EMEA in April 1995.
Spanish: La Sra. Fayl se incorporó a la
English: Revision expected to be released by mid 2005
Spanish: Se publicará la revisión a mediados de
English: Draft revision 1 to be released for consultation in 2/3Q 2005
Spanish: Se publicará el borrador de la primera revisión para consulta en el 2/3T de
English: He has been executive director of the EMEA since January 2001.
Spanish: EMEA desde enero de 2001.
English: The target is to have 100 % of applications evaluated within this timeline
Spanish: El objetivo es evaluar el 100 % de las solicitudes dentro de ese plazo.
English: Direct telephone: (44-20) 74 18 85 52 Fax: (44-20) 74 18 85 45
Spanish: Teléfono directo: (44-20) 74 18 85 81
English: Revision 3 expected in 1Q 2005
Spanish: Se publicará la revisión 3 en el 1T de
English: Introduction of the following new procedures foreseen in the new legislation: conditional marketing authorisation, accelerated assessment and compassionate use
Spanish: Introducción de los siguientes procedimientos nuevos, previstos en la nueva legislación: autorización condicional de comercialización, evaluación acelerada y uso compasivo Realización de los preparativos necesarios para la presentación progresiva de solicitudes para nuevas terapias y tecnologías, así como solicitudes de productos de venta sin receta y genéricos.
English: Medicines for human use
Spanish: medicamentos de uso humano
English: 1/2Q 2005
Spanish: D*2
English: Guideline to be developed
Spanish: Se elaborará una directriz.
English: Direct telephone: (44-20) 75 23 71 47 Fax: (44-20) 74 18 85 45
Spanish: Teléfono directo: (44-20) 75 23 71 08
English: To implement the new legislative requirements in the area of scientific advice To provide quality scientific advice to applicants and adhere to regulatory timelines The performance indicator for this activity is the percentage of applications resulting in adoption of the advice letter within the 30, 60 or 90-day deadline (depending on the procedure).
Spanish: El indicador del rendimiento para esta actividad es el porcentaje de solicitudes que culminan con la aprobación de la carta de asesoramiento en un plazo de 30, 60 ó 90 días (dependiendo del procedimiento).
English: Education: Qualified pharmacist with a master's degree in pharmaceutical chemistry and a master's degree in business administration (MBA) from Trinity College Dublin.
Spanish: Estudios: Licenciada en farmacia y Master en química farmacéutica y dirección de empresas (MBA)
English: To be released for consultation in 2/3Q 2005
Spanish: Se publicará para consulta en el 2/3T
English: Evaluations
Spanish: Recommendations and Assessment
English: From 1993 to 1994 he acted as the vice-chairman of the EFTA Expert Group on Pharmaceuticals and from 1994 to 1995 as the chairman of the Nordic Council on Medicines.
Spanish: Farmacéuticos de la EFTA (EFTA Expert Group on Pharmaceuticals), y de 1994 a 1995 fue
English: Education: Master of science in economics and bachelor of science in public administration from Trinity College Dublin.
Spanish: Estudios: Licenciada en administración pública y máster en economía por el Trinity College de
English: MRLs new applications MRL ext./mod.
Spanish: Solicitudes nuevas de MRL Solicitudes de ampliación/modificación de MRL
English: Conduct of recruitment procedures
Spanish: Gestión de los procesos de selección de personal.
English: To be released for consultation in 1Q
Spanish: Se publicará para consulta en el 1T de
English: This will allow the general public to access information in the database in all languages and it will include more information 9 The Agency will continue to develop the EudraVigilance database and will add a new component on suspected unexpected serious adverse reactions 9 EMEA will also prepare and design a database of manufacturing authorisations and good manufacturing practice certificates required under the new Directive on human medicines
Spanish: La Agencia seguirá desarrollando la base de datos EudraVigilance y añadirá un componente nuevo sobre presuntas reacciones adversas graves inesperadas.
English: Guideline on product information for
Spanish: Guideline on Handling Public
English: He joined the EMEA in September 1995.
Spanish: Se incoportó a la EMEA en septiembre de 1995.
English: Draft revision 2 to be released for consultation in 1/2Q 2005
Spanish: Se publicará el borrador de la segunda revisión para consulta en el 1/2T de
English: Unit for Veterinary medicines and inspections
Spanish: Grupo de trabajo “Medicamentos inmunológicos veterinarios”
English: For enquiries concerning certificates for centrally E-mail: certificate@emea.eu.int authorised medicines for human or veterinary use Fax: (44-20) 74 18 85 95
Spanish: E-mail: certificate@emea.eu.int Fax: (44-20) 74 18 85 95
English: If revision is required, expected to be released for consultation in 2005 and finalised in 2006
Spanish: Se publicará la revisión para consulta en 2005 y se terminará en 2006.
English: medicinal products for human use
Spanish: Communication for Medicinal Products for Human Use
English: Applications for designation (Input)
Spanish: Solicitudes de designación de medicamentos huérfanos (Entrada)
English: Applications received/forecast (Input)
Spanish: Solicitudes recibidas/esperadas (Entrada)
English: To be finalised in 3Q 2005
Spanish: Se terminará en el 3T de 2005.
English: Martin HARVEY ALLCHURCH Direct telephone (44-20) 74 18 84 27 E-mail: press@emea.eu.int
Spanish: Martin HARVEY ALLCHURCH Teléfono directo (44-20) 74 18 84 27
English: Draft revision 1 to be released for consultation in 1/2Q 2005
Spanish: Se publicará el borrador de la primera revisión para consulta en el 1/2T de
English: She joined the EMEA as head of sector for inspections in July 2002.
Spanish: Jefa del Sector de Inspecciones en julio de 2002.
English: Studies and consultants Publications
Spanish: Gastos operativos Reuniones Evaluaciones Traducción Estudios y consultas
English: Total Title 3 TOTAL EXPENDITURE 84,179,000
Spanish: Total Título 3 TOTAL GASTOS
English: He was re-elected chairman of the CHMP in 2004.
Spanish: Fue reelegido presidente en 2004.
English: Annex 1 EMEA establishment plan 2003-2005 Annex 2 Revenue and expenditure overview 2003-2005 Annex 3 Guidelines and working documents in 2005 Annex 4 EMEA contact points Annex 5 Profiles of EMEA personalities
Spanish: Anexo 2 Examen de ingresos y gastos en el período 2003-2005 Anexo 3 Directrices y documentos de trabajo en 2005
English: He was re-elected as vice-chairman of the CHMP in 2004.
Spanish: Fue reelegido vicepresidente en 2004.
English: To be finalised in 1Q 2005
Spanish: Se terminará en el 1T de 2005.
English: Pharmacovigilance Working Party Biotechnology Working Party Joint CHMP/CVMP Quality Working Party Blood Products Working Party Efficacy Working Party (plenary) Safety Working Party (plenary)
Spanish: Grupo de trabajo “Eficacia” Grupo de trabajo “Farmacovigilancia” Grupo de trabajo “Seguridad”
English: Some reasons for this:
Spanish: Como parte de este plan:
English: CHMP Guideline on handling direct healthcare professional communication for medicinal products for human use
Spanish: CHMP Guideline on Risk Assessment of Medicinal Products on Human
English: Joint CHMP/CVMP Quality Working Party Working party on Environmental Risk Assessment Scientific advisory group on Antimicrobials Scientific Advice Working Party
Spanish: Grupo de asesoramiento científico sobre antimicrobianos Grupo de trabajo sobre asesoramiento científico
English: Pharmacovigilance Working Party
Spanish: Pharmacovigilance Information
English: To be finalised in 2Q 2005
Spanish: Se terminará en el 2T de 2005.
English: To be released in 1Q 2005
Spanish: Se publicará en el 1T de 2005.
English: Guideline on the clinical investigation To be released for consultation in
Spanish: Note for guidance on the clinical investigation of recombinant Factor
English: The target is to have 90 % of applications evaluated within this timeline To encourage the use of scientific advice by the veterinary medicinal products industry Key initiatives to meet the objectives:
Spanish: Promoción del uso del asesoramiento científico por la industria de medicamentos de uso veterinario.
English: Date of first authorisation: 23 April 2014 Date of latest renewal: 15 January 2019
Spanish: Fecha de la primera autorización: 23/abril/2014 Fecha de la última renovación: 15/enero/2019
English: The safety and efficacy of Ulunar Breezhaler in children have not been established.
Spanish: No se ha establecido la seguridad y eficacia de Ulunar Breezhaler en niños.
English: In particular, please tell your doctor or pharmacist if you are using: - any medicines that may be similar to Ulunar Breezhaler (contain similar active substances).
Spanish: Especialmente, informe a su médico o farmacéutico si está usando: - cualquier medicamento que pueda ser similar a Ulunar Breezhaler (que contengan sustancias activas similares).
English: Ulunar Breezhaler should not be used for the treatment of asthma due to the absence of data in this indication.
Spanish: Ulunar Breezhaler no se debe utilizar para el tratamiento del asma debido a la ausencia de datos en esta indicación.
English: The presentation of the safety profile is based on the experience with Ulunar Breezhaler and the individual active substances.
Spanish: La presentación del perfil de seguridad está basada en la experiencia con Ulunar Breezhaler y las sustancias activas individuales.
English: COPD is a long-term disease and you should use Ulunar Breezhaler every day and not only when you have breathing problems or other symptoms of COPD.
Spanish: La EPOC es una enfermedad de larga duración y usted debe utilizar Ulunar Breezhaler cada día y no solo cuando tenga problemas respiratorios u otros síntomas de EPOC.
English: Therefore, Ulunar Breezhaler should only be used during pregnancy if the expected benefit to the patient justifies the potential risk to the foetus.
Spanish: Por lo tanto, Ulunar Breezhaler debe utilizarse únicamente durante el embarazo si el beneficio esperado para el paciente justifica el riesgo potencial para el feto.
English: Talk to your doctor, pharmacist or nurse before using Ulunar Breezhaler if any of the following applies to you: - you have asthma - this medicine should not be used as a treatment for asthma.
Spanish: Consulte a su médico, farmacéutico o enfermero antes de empezar a usar Ulunar Breezhaler si cualquiera de las situaciones siguientes le afecta a usted: - tiene asma - este medicamento no se debe utilizar como tratamiento para el asma.
English: Do not use Ulunar Breezhaler - if you are allergic to indacaterol or glycopyrronium or any of the other ingredients of this medicine (listed in section 6).
Spanish: No use Ulunar Breezhaler - si es alérgico a indacaterol o glicopirronio o a alguno de los demás componentes de este medicamento (incluidos en la sección 6).
English: Ulunar Breezhaler is recommended to be administered at the same time of the day each day.
Spanish: Se recomienda que Ulunar Breezhaler se administre a la misma hora cada día.
English: The safety experience with Ulunar Breezhaler was comprised of exposure of up to 15 months at the recommended therapeutic dose.
Spanish: La experiencia de seguridad con Ulunar Breezhaler comprende hasta 15 meses de exposición a la dosis terapéutica recomendada.
English: Patients should be informed about the signs and symptoms of acute narrow-angle glaucoma and should be informed to stop using Ulunar Breezhaler should any of these signs or symptoms develop.
Spanish: Se debe informar a los pacientes a cerca de los signos y síntomas del glaucoma de ángulo estrecho agudo y de que deben interrumpir el uso de Ulunar Breezhaler si se desarrolla alguno de estos signos o síntomas.
English: - The other ingredients of the inhalation powder are lactose monohydrate and magnesium stearate (see section 2 under “Ulunar Breezhaler contains lactose”).
Spanish: - Los demás componentes del polvo para inhalación son lactosa monohidrato y estearato de magnesio (ver sección 2 en el epígrafe “Ulunar Breezhaler contiene lactosa”).
English: There are no data from the use of Ulunar Breezhaler in pregnant women available.
Spanish: No existen datos sobre la utilización de Ulunar Breezhaler en mujeres embarazadas.
English: This will also help you to remember to use it. You can inhale Ulunar Breezhaler any time before or after food or drink.
Spanish: Puede inhalar Ulunar Breezhaler en cualquier momento antes o después de alimentos o bebidas.
English: Following inhalation of Ulunar Breezhaler, the median time to reach peak plasma concentrations of indacaterol and glycopyrronium was approximately 15 minutes and 5 minutes, respectively.
Spanish: Tras la inhalación de Ulunar Breezhaler, la mediana del tiempo para alcanzar la concentración plasmática máxima de indacaterol y glicopirronio fue aproximadamente de 15 minutos y 5 minutos, respectivamente.
English: The capsules must be administered only using the Ulunar Breezhaler inhaler (see section 6.6).
Spanish: Las cápsulas deben administrarse únicamente con la ayuda del inhalador de Ulunar Breezhaler (ver sección 6.6).
English: - When you start a new pack, use the new Ulunar Breezhaler inhaler that is supplied in the pack.
Spanish: - Cuando inicie un nuevo envase, use el nuevo inhalador de Ulunar Breezhaler que se proporciona en el envase.
English: Ulunar Breezhaler showed similar adverse reactions to the individual components.
Spanish: Ulunar Breezhaler mostró un perfil de reacciones adversas similar a los componentes individuales.
English: Following inhalation of Ulunar Breezhaler, the absolute bioavailability of indacaterol has been estimated to range from 61 to 85% of the delivered dose, and that of glycopyrronium was about 47% of the delivered dose.
Spanish: Tras la inhalación de Ulunar Breezhaler, la biodisponibilidad absoluta de indacaterol se ha estimado que variaba entre el 61 y el 85% de la dosis liberada, y la de glicopirronio fue aproximadamente del 47% de la dosis liberada.
English: If signs suggesting allergic reactions occur, in particular, angioedema (difficulties in breathing or swallowing, swelling of the tongue, lips and face), urticaria or skin rash, treatment should be discontinued immediately and alternative therapy instituted.
Spanish: Si se producen signos que sugieran una reacción alérgica, en particular, angioedema (dificultad para respirar o tragar, hinchazón de la lengua, labios y cara) urticaria o erupción cutánea, se debe interrumpir inmediatamente el tratamiento e instaurar una terapia alternativa.
English: If you use more Ulunar Breezhaler than you should If you have inhaled too much of this medicine or if someone else accidentally uses your capsules, you must immediately either tell your doctor or go to the nearest emergency unit.
Spanish: Si ha inhalado demasiado de este medicamento o si alguien usa sus cápsulas accidentalmente, informe a su médico inmediatamente o vaya al centro de urgencias más cercano.
English: Other most common adverse reactions related to the medicinal product (at least 3% of patients for Ulunar Breezhaler and also greater than placebo) were cough, nasopharyngitis and headache.
Spanish: Otras reacciones adversas más frecuentes relacionadas con el medicamento (al menos el 3% de los pacientes para Ulunar Breezhaler y también superior a placebo) fueron tos, rinofaringitis y cefalea.
English: During treatment with Ulunar Breezhaler - Stop using this medicine and seek medical help immediately if you experience any of the following: eye pain or discomfort, temporary blurring of vision, visual halos or coloured images in association with red eyes - these may be signs of an acute attack of narrow-angle glaucoma.
Spanish: Durante el tratamiento con Ulunar Breezhaler - Interrumpa el uso de este medicamento y solicite ayuda médica inmediatamente si experimenta cualquiera de las siguientes situaciones: dolor o molestia en los ojos, visión borrosa pasajera, halos visuales o imágenes coloreadas en asociación con un enrojecimiento de los ojos - estos pueden ser signos de un ataque agudo de glaucoma de ángulo estrecho.
English: Ulunar Breezhaler should be used with caution in these patient groups.
Spanish: Ulunar Breezhaler debe utilizarse con precaución en este grupo de pacientes.
English: The recommended dose is the inhalation of the content of one capsule once daily using the Ulunar Breezhaler inhaler.
Spanish: La dosis recomendada consiste en la inhalación del contenido de una cápsula una vez al día, utilizando el inhalador de Ulunar Breezhaler.
English: Uncommon Adverse reaction observed with Ulunar Breezhaler, but not with the individual components.
Spanish: Poco frecuente Reacción adversa observada con Ulunar Breezhaler, pero no con los componentes individuales.
English: No effects on the embryo or foetus were seen at any dose level of Ulunar Breezhaler during an embryo-foetal development study in rats.
Spanish: No se observaron efectos sobre el embrión o el feto a ningún nivel de dosis de Ulunar Breezhaler durante un estudio de desarrollo embriofetal en ratas.
English: The use of Ulunar Breezhaler by breast-feeding women should only be considered if the expected benefit to the woman is greater than any possible risk to the infant (see section 5.3).
Spanish: Únicamente se debe considerar el uso de Ulunar Breezhaler por mujeres en periodo de lactancia, si el beneficio esperado para la mujer es mayor que cualquier posible riesgo para el lactante (ver sección 5.3).