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Título:
Descripción:
garantía de la calidad
Título:
Comité de Expertos de la OMS en Especificaciones para las Preparaciones Farmacéuticas: Resultados de las 44 Reuniones
[
Arabic
] [
Chinese
] [
English
] [
French
] [
Russian
]
Temas:
Calidad y seguridad de los medicamentos
>
Garantía de calidad
Año:
2011
Páginas:
16
Publicadores:
WHO Headquarters in Geneva
Regiones:
Global
Título:
Comité OMS d'experts des spécifications relatives aux préparations phramaceutiques: Bilan de 44 réunions
[
Arabic
] [
Chinese
] [
English
] [
Russian
] [
Spanish
]
Temas:
Qualité et innocuité des médicaments
>
Assurance de la qualité
Año:
2011
Páginas:
16
Publicadores:
WHO Headquarters in Geneva
Regiones:
Global
Título:
Considerations for Requesting Analysis of Drug Samples. WHO Technical Report Series, No. 902, 2002, Annex 4
Temas:
Quality and Safety: Medicines
>
Quality Assurance
Año:
2002
Páginas:
4
Publicadores:
WHO Headquarters in Geneva
Documentos relacionados:
Model Certificate of Analysis. WHO Technical Report Series, No. 902, 2002, Annex 10
Regiones:
Global
Título:
A Definição de Medicamentos Prioritários para o Monitoramento da Qualidade Laboratorial no Brasil: Articulação entre a Vigilância Sanitária e a Política Nacional de Medicamentos (The Definition of Priority Medicines for Monitoring Laboratory Quality in Brazil: The Interface between Health Surveillance and the National Drug Policy)
Autore:
MASSENA, Elisa Prestes
;
MIRANDA, Maria Do Carmo
;
Osorio-de-Castro, Claudia Garcia Serpa
;
PEPE, Vera Lucia Edais
;
PONTES JUNIOR, Durval Martins
;
PORTELA, Margareth Crisóstomo
;
SILVA, Raulino Sabino da
Año:
2008
Páginas:
10
Publicadores:
PAHO/WHO Collaborating Center for Pharmaceutical Policies - National School of Public Health - Oswaldo Cruz Foundation
Países:
Brasil
Título:
Drug Quality Control Laboratories
Temas:
Quality and Safety: Medicines
>
Quality Assurance
Año:
1999
Páginas:
42
Publicadores:
World Health Organization - Regional Office for Africa (WHO/AFRO)
Documentos relacionados:
Report of a Meeting on the Optimal Use of Regional Drug Quality Control Laboratories in Africa
Regiones:
África (AFRO)
Título:
Drug Quality Screening in Developing Countries: Establishment of an Appropriate Laboratory in Swaziland
Temas:
Quality and Safety: Medicines
>
Quality Assurance
Autore:
Kenyon, A.S.
;
Kenyon, T.A.
;
Sibiya, T.
Año:
1994
Páginas:
6
Publicadores:
WHO Headquarters in Geneva
Países:
Swazilandia
Título:
Ensuring Quality Medicines: A Decade of Prequalification
Temas:
Quality and Safety: Medicines
>
Quality Assurance
Prequalification of Medicines
>
WHO-UNICEF-UN Project
Autore:
van Zyl, A. J.
Año:
2011
Páginas:
9
Publicadores:
WHO Headquarters in Geneva
Regiones:
Global
Título:
Good Manufacturing Practices for Biological Products. In: WHO Expert Committee on Biological Standardization. Forty-second Report. Geneva, World Health Organization, 1992 (WHO Technical Report Series, No. 822), Annex 1; and WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirty-second Report. Geneva, World Health Organization, 1993 (WHO Technical Report Series, No. 834), Annex 3
Temas:
Quality and Safety: Medicines
>
Blood Products and Related Biologicals
Quality and Safety: Medicines
>
Quality Assurance
Año:
1992
Páginas:
11
Publicadores:
WHO Headquarters in Geneva
Documentos relacionados:
WHO Expert Committee on Biological Standardization - WHO Technical Report Series, No. 822 - Forty-second Report
WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 834 - Thirty-third Report
Enlaces relacionados:
http://www.who.int/medicines/areas/quality_safety/quality_assurance/production/en/index.html
Regiones:
Global
Título:
Good Manufacturing Practices: Supplementary Guidelines for the Manufacture of Pharmaceutical Excipients. WHO Technical Report Series, No. 885, 1999, Annex 5
Temas:
Quality and Safety: Medicines
>
Quality Assurance
Año:
1999
Páginas:
22
Publicadores:
WHO Headquarters in Geneva
Documentos relacionados:
WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 885 - Thirty-fifth Report
Enlaces relacionados:
http://www.who.int/medicines/areas/quality_safety/quality_assurance/production/en/index.html
Regiones:
Global
Título:
Good Practices for Selecting and Procuring Rapid Diagnostic Tests for Malaria
Temas:
Medicine Access and Rational Use
>
Supply Management
Quality and Safety: Medicines
>
Quality Assurance
Año:
2011
Páginas:
109
Publicadores:
WHO Headquarters in Geneva
Regiones:
Global
Título:
Guidance for Inspection of Drug Distribution Channels. WHO Technical Report Series, No. 885, 1999, Annex 6
Temas:
Quality and Safety: Medicines
>
Quality Assurance
Quality and Safety: Medicines
>
Regulatory Support
Año:
1999
Páginas:
21
Publicadores:
WHO Headquarters in Geneva
Enlaces relacionados:
http://www.who.int/medicines/areas/quality_safety/quality_assurance/inspections/en/index.html
Regiones:
Global
Título:
Guidance on Good Manufacturing Practices (GMP): Inspection Report. WHO Technical Report Series, No. 908, 2003, Annex 6
Temas:
Quality and Safety: Medicines
>
Quality Assurance
Año:
2003
Páginas:
5
Publicadores:
WHO Headquarters in Geneva
Enlaces relacionados:
http://www.who.int/medicines/areas/quality_safety/quality_assurance/inspections/en/index.html
Regiones:
Global
Título:
Guidelines on Evaluation of Similar Biotherapeutic Products (SBPs). WHO Expert Committee on Biological Standardization, 19-23 October 2009
[
Portuguese
] [
Spanish
]
Temas:
Quality and Safety: Medicines
>
Blood Products and Related Biologicals
Quality and Safety: Medicines
>
Quality Assurance
Año:
2009
Páginas:
34
Publicadores:
WHO Headquarters in Geneva
Regiones:
Global
Título:
Guidelines on Good Manufacturing Practices for Radiopharmaceutical Products. WHO Technical Report Series, No. 908, 2003, Annex 3
Temas:
Quality and Safety: Medicines
>
Quality Assurance
Año:
2003
Páginas:
10
Publicadores:
WHO Headquarters in Geneva
Documentos relacionados:
WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 908 - Thirty-seventh Report
Enlaces relacionados:
http://www.who.int/medicines/areas/quality_safety/quality_assurance/production/en/index.html
Regiones:
Global
Título:
Guidelines on Packaging for Pharmaceutical Products. WHO Technical Report Series, No. 902, 2002, Annex 9
Temas:
Quality and Safety: Medicines
>
Quality Assurance
Año:
2002
Páginas:
38
Publicadores:
WHO Headquarters in Geneva
Enlaces relacionados:
http://www.who.int/medicines/areas/quality_safety/quality_assurance/regulatory_standards/en/index.html
Regiones:
Global
Título:
Handbook: Good Laboratory Practice (GLP). Quality Practices for Regulated Non-clinical Research and Development - 2nd Ed.
Temas:
Quality and Safety: Medicines
>
Quality Assurance
Prequalification of Medicines
>
WHO-UNICEF-UN Project
Año:
2009
Páginas:
328
Publicadores:
WHO/TDR - World Health Organization Special Programme for Research and Training in Tropical Diseases
WHO Headquarters in Geneva
The World Bank (WB)
United Nations Children's Fund (UNICEF)
United Nations Development Programme (UNDP)
Documentos relacionados:
Handbook: Non-Clinical Safety Testing
Regiones:
Global
Título:
Inspection of API Manufacturing Sites
Temas:
Quality and Safety: Medicines
>
Quality Assurance
Prequalification of Medicines
>
WHO-UNICEF-UN Project
Año:
2011
Páginas:
4
Publicadores:
WHO Headquarters in Geneva
Regiones:
Global
Título:
Malaria Microscopy Quality Assurance Manual. Version 1
Temas:
Quality and Safety: Medicines
>
Quality Assurance
Año:
2009
Páginas:
149
Publicadores:
WHO Headquarters in Geneva
Regiones:
Global
Título:
Model Certificate of Analysis. WHO Technical Report Series, No. 902, 2002, Annex 10
Temas:
Quality and Safety: Medicines
>
Quality Assurance
Año:
2002
Páginas:
4
Publicadores:
WHO Headquarters in Geneva
Documentos relacionados:
Considerations for Requesting Analysis of Drug Samples. WHO Technical Report Series, No. 902, 2002, Annex 4
Regiones:
Global
Título:
Model Certificate of Good Manufacturing Practices. WHO Technical Report Series, No. 908, 2003, Annex 5
Temas:
Quality and Safety: Medicines
>
Quality Assurance
Año:
2003
Páginas:
4
Publicadores:
WHO Headquarters in Geneva
Enlaces relacionados:
http://www.who.int/medicines/areas/quality_safety/quality_assurance/inspections/en/index.html
Regiones:
Global
Título:
A Model Quality Assurance System for Procurement Agencies - Recommendations for Quality Assurance Systems Focusing on Prequalification of Products and Manufacturers, Purchasing, Storage and Distribution of Pharmaceutical Products
[
French
]
Temas:
Medicine Access and Rational Use
>
Supply Management
Quality and Safety: Medicines
>
Quality Assurance
Prequalification of Medicines
>
WHO-UNICEF-UN Project
Año:
2007
Páginas:
140
Publicadores:
WHO Headquarters in Geneva
Regiones:
Global
Título:
Procedure for Prequalification of Pharmaceutical Products. WHO Technical Report Series, No. 961, 2011 Annex 10
Temas:
Quality and Safety: Medicines
>
Quality Assurance
Prequalification of Medicines
>
WHO-UNICEF-UN Project
Año:
2011
Páginas:
17
Publicadores:
WHO Headquarters in Geneva
Documentos relacionados:
Guidelines on the Requalification of Prequalified Dossiers. WHO Technical Report Series, No. 957, 2010, Annex 6
Regiones:
Global
Título:
Provisional Guidelines on the Inspection of Pharmaceutical Manufacturers. WHO Technical Report Series 823, 1992, Annex 2
Temas:
Quality and Safety: Medicines
>
Quality Assurance
Quality and Safety: Medicines
>
Regulatory Support
Año:
1992
Páginas:
12
Publicadores:
WHO Headquarters in Geneva
Enlaces relacionados:
http://www.who.int/medicines/areas/quality_safety/quality_assurance/inspections/en/index.html
Regiones:
Global
Título:
Quality Assurance of Pharmaceuticals - A Compendium of Guidelines and Related Materials - Volume 1
[
French
]
Temas:
Quality and Safety: Medicines
>
Quality Assurance
Año:
1997
Páginas:
248
Publicadores:
WHO Headquarters in Geneva
Regiones:
Global
Título:
Quality Assurance of Pharmaceuticals - A Compendium of Guidelines and Related Materials - Volume 2, 2nd Updated Edition - Good Manufacturing Practices and Inspection
Temas:
Quality and Safety: Medicines
>
Quality Assurance
Año:
2007
Páginas:
416
Publicadores:
WHO Headquarters in Geneva
Regiones:
Global
Título:
A Rapid Quality Risk Assessment Mechanism for Assessing Needed Pharmaceutical Products that Have Not Completed a Stringent Assessment. WHO Prequalification of Medicines Programme - Briefing Paper: 27 April 2012. Expert Review Panel (ERP)
Temas:
Medicine Access and Rational Use
>
Supply Management
Quality and Safety: Medicines
>
Quality Assurance
Prequalification of Medicines
>
WHO-UNICEF-UN Project
Año:
2012
Páginas:
13
Publicadores:
WHO Headquarters in Geneva
Regiones:
Global
Título:
Recommendations for Quality Requirements when Artemisinin is Used as a Starting Material in the Production of Antimalarial Active Pharmaceutical Ingredients. WHO Technical Report Series, No. 970, 2012, Annex 6
Temas:
Quality and Safety: Medicines
>
Quality Assurance
Año:
2012
Páginas:
9
Publicadores:
WHO Headquarters in Geneva
Regiones:
Global
Título:
Report of a Meeting on the Optimal Use of Regional Drug Quality Control Laboratories in Africa
Temas:
Quality and Safety: Medicines
>
Quality Assurance
Año:
1994
Páginas:
59
Publicadores:
WHO Headquarters in Geneva
Documentos relacionados:
Drug Quality Control Laboratories
Regiones:
África (AFRO)
Título:
Règles OMS de bonnes pratiques applicables par les laboratoires de contrôle qualité pharmaceutique. OMS, Série de Rapports techniques, N° 957, 2010, Annexe 1
[
English
] [
Portuguese
] [
Spanish
] [
Thai
]
Temas:
Qualité et innocuité des médicaments
>
Assurance de la qualité
Préqualification des médicaments
>
Projet OMS-UNICEF-ONU
Año:
2010
Páginas:
38
Publicadores:
WHO Headquarters in Geneva
Enlaces relacionados:
http://apps.who.int/prequal/
Regiones:
Global
Título:
Stability Testing of Active Pharmaceutical Ingredients and Finished Pharmaceutical Products. WHO Technical Report Series, No. 953, 2009 - Annex 2. (With Table 2 - Updated 1 December 2010)
Temas:
Quality and Safety: Medicines
>
Quality Assurance
Prequalification of Medicines
>
WHO-UNICEF-UN Project
Año:
2009
Páginas:
50
Publicadores:
WHO Headquarters in Geneva
Regiones:
Global
Título:
Supplementary Guidelines on Good Manufacturing Practices for Heating, Ventilation and Air-conditioning Systems for Non-sterile Pharmaceutical Dosage Forms. WHO Technical Report Series, No. 961, 2011, Annex 5
Temas:
Quality and Safety: Medicines
>
Quality Assurance
Prequalification of Medicines
>
WHO-UNICEF-UN Project
Año:
2011
Páginas:
46
Publicadores:
WHO Headquarters in Geneva
Regiones:
Global
Título:
Supplementary Guidelines on Good Manufacturing Practices for the Manufacture of Herbal Medicines. WHO Technical Report Series, No. 937, 2006, Annex 3
Temas:
Traditional Medicine
>
Traditional, Complementary and Herbal Medicine
Quality and Safety: Medicines
>
Quality Assurance
Año:
2006
Páginas:
22
Publicadores:
WHO Headquarters in Geneva
Documentos relacionados:
WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 937 - Fortieth Report
Enlaces relacionados:
http://www.who.int/medicines/areas/quality_safety/quality_assurance/production/en/index.html
Regiones:
Global
Título:
Supplementary Guidelines on Good Manufacturing Practices: Validation. WHO Technical Report Series, No. 937, 2006, Annex 4
Temas:
Quality and Safety: Medicines
>
Quality Assurance
Año:
2006
Páginas:
72
Publicadores:
WHO Headquarters in Geneva
Documentos relacionados:
WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 937 - Fortieth Report
Enlaces relacionados:
http://www.who.int/medicines/areas/quality_safety/quality_assurance/production/en/index.html
Regiones:
Global
Título:
Survey of the Quality of Anti-tuberculosis Medicines Circulating in Selected Newly Independent States of the Former Soviet Union
Temas:
Quality and Safety: Medicines
>
Quality Assurance
Autore:
Nathanson, Eva
;
Polishchuk, Olexandr
;
Sabartova, Jitka
Año:
2011
Páginas:
108
Publicadores:
WHO Headquarters in Geneva
World Health Organization - Regional Office for Europe (WHO/EURO)
Documentos relacionados:
Survey of the Quality of Selected Antimalarial Medicines Circulating in Six Countries of Sub-Saharan Africa
Survey of the quality of antiretroviral medicines circulating in selected African countries
Regiones:
Europa (EURO)
Título:
Survey of the quality of antiretroviral medicines circulating in selected African countries
Temas:
Quality and Safety: Medicines
>
Quality Assurance
Año:
2007
Páginas:
58
Publicadores:
WHO Headquarters in Geneva
Documentos relacionados:
Survey of the Quality of Selected Antimalarial Medicines Circulating in Six Countries of Sub-Saharan Africa
Survey of the Quality of Anti-tuberculosis Medicines Circulating in Selected Newly Independent States of the Former Soviet Union
Regiones:
África (AFRO)
Título:
Survey of the Quality of Selected Antimalarial Medicines Circulating in Six Countries of Sub-Saharan Africa
Temas:
Quality and Safety: Medicines
>
Quality Assurance
Año:
2011
Páginas:
118
Publicadores:
WHO Headquarters in Geneva
Documentos relacionados:
Survey of the quality of antiretroviral medicines circulating in selected African countries
Survey of the Quality of Anti-tuberculosis Medicines Circulating in Selected Newly Independent States of the Former Soviet Union
Regiones:
África (AFRO)
Países:
Camerún
;
Etiopía
;
Ghana
;
Kenya
;
Nigeria
;
Tanzania
Título:
WHA 65.19 Produits médicaux de qualité inférieure/faux/ faussement étiquetés/falsifiés/contrefaits. 26 mai 2012
[
English
] [
Spanish
]
Temas:
Qualité et innocuité des médicaments
>
Médicaments contrefaits
Año:
2012
Páginas:
5
Publicadores:
WHO Headquarters in Geneva
Enlaces relacionados:
http://apps.who.int/gb/or/f/
Regiones:
Global
Título:
WHA65.19 Substandard/spurious/falsely-labelled/falsified/counterfeit medical products. 26 May 2012
[
French
] [
Spanish
]
Temas:
Quality and Safety: Medicines
>
Counterfeit Medicines
Año:
2012
Páginas:
5
Publicadores:
WHO Headquarters in Geneva
Enlaces relacionados:
http://apps.who.int/gb/or/
Regiones:
Global
Título:
WHO Drug Information Vol. 25, No. 3, 2011 - Recommended International Nonproprietary Names, List 66
Temas:
Medicine Information and Evidence for Policy
>
Information and Publications
Quality and Safety: Medicines
>
International Nonproprietary Names
Quality and Safety: Medicines
>
Quality Assurance
Quality and Safety: Medicines
>
Regulatory Support
Quality and Safety: Medicines
>
Safety and Efficacy
Quality and Safety: Medicines
>
The International Pharmacopoeia
Año:
2011
Páginas:
122
Publicadores:
WHO Headquarters in Geneva
Regiones:
Global
Título:
WHO Drug Information Vol. 26, No. 1, 2012 - Recommended International Nonproprietary Names, List 67
Temas:
Medicine Information and Evidence for Policy
>
Information and Publications
Quality and Safety: Medicines
>
International Nonproprietary Names
Quality and Safety: Medicines
>
Quality Assurance
Quality and Safety: Medicines
>
Regulatory Support
Quality and Safety: Medicines
>
Safety and Efficacy
Quality and Safety: Medicines
>
The International Pharmacopoeia
Prequalification of Medicines
>
WHO-UNICEF-UN Project
Año:
2012
Páginas:
96
Publicadores:
WHO Headquarters in Geneva
Regiones:
Global
Título:
WHO Drug Information Vol. 26, No. 3, 2012 - Recommended International Nonproprietary Names, List 68
Temas:
Medicine Information and Evidence for Policy
>
Information and Publications
Quality and Safety: Medicines
>
International Nonproprietary Names
Quality and Safety: Medicines
>
Quality Assurance
Quality and Safety: Medicines
>
Regulatory Support
Quality and Safety: Medicines
>
Safety and Efficacy
Quality and Safety: Medicines
>
The International Pharmacopoeia
Prequalification of Medicines
>
WHO-UNICEF-UN Project
Año:
2012
Páginas:
100
Publicadores:
WHO Headquarters in Geneva
Regiones:
Global
Título:
WHO Drug Information Vol. 26, No. 4, 2012 - Proposed International Nonproprietary Names, List 108
Temas:
Medicine Information and Evidence for Policy
>
Information and Publications
Quality and Safety: Medicines
>
International Nonproprietary Names
Quality and Safety: Medicines
>
Quality Assurance
Quality and Safety: Medicines
>
Regulatory Support
Quality and Safety: Medicines
>
Safety and Efficacy
Quality and Safety: Medicines
>
The International Pharmacopoeia
Prequalification of Medicines
>
WHO-UNICEF-UN Project
Año:
2013
Páginas:
135
Publicadores:
WHO Headquarters in Geneva
Regiones:
Global
Título:
WHO Expert Committee on Specifications for Pharmaceutical Preparations - Quality Assurance of Pharmaceuticals: Meeting a Major Public Health Challenge
Temas:
Quality and Safety: Medicines
>
Quality Assurance
Páginas:
36
Publicadores:
WHO Headquarters in Geneva
Regiones:
Global
Título:
WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 957 - Forty-fourth Report
Temas:
Prequalification of Medicines
>
WHO-UNICEF-UN Project
Año:
2010
Páginas:
292
Publicadores:
WHO Headquarters in Geneva
Documentos relacionados:
WHO Good Manufacturing Practices for Active Pharmaceutical Ingredients. WHO Technical Report Series, No. 957, 2010, Annex 2
Regiones:
Global
Título:
WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 961 - Forty-fifth Report (Geneva, 18–22 October 2010)
Temas:
Quality and Safety: Medicines
>
Quality Assurance
Quality and Safety: Medicines
>
Regulatory Support
Prequalification of Medicines
>
WHO-UNICEF-UN Project
Año:
2011
Páginas:
440
Publicadores:
WHO Headquarters in Geneva
Regiones:
Global
Título:
WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 970 - Forty-sixth Report (Geneva, 10–14 October 2011)
Temas:
Quality and Safety: Medicines
>
Quality Assurance
Quality and Safety: Medicines
>
Regulatory Support
Quality and Safety: Medicines
>
The International Pharmacopoeia
Prequalification of Medicines
>
WHO-UNICEF-UN Project
Año:
2012
Páginas:
250
Publicadores:
WHO Headquarters in Geneva
Documentos relacionados:
WHO Good Manufacturing Practices: Water for Pharmaceutical Use. WHO Technical Report Series, No. 970, 2012, Annex 2
Development of Paediatric Medicines: Points to Consider in Formulation. WHO Technical Report Series, No. 970, 2012, Annex 5
Regiones:
Global
Título:
WHO Expert Committee on Specifications for Pharmaceutical Preparations: Outcome of 44 Meetings
[
Arabic
] [
Chinese
] [
French
] [
Russian
] [
Spanish
]
Temas:
Quality and Safety: Medicines
>
Quality Assurance
Año:
2011
Páginas:
16
Publicadores:
WHO Headquarters in Geneva
Regiones:
Global
Título:
WHO Expert Committee on Specifications for Pharmaceutical Preparations: Outcome of 44 Meetings (Arabic Version)
[
Chinese
] [
English
] [
French
] [
Russian
] [
Spanish
]
Año:
2011
Páginas:
16
Publicadores:
WHO Headquarters in Geneva
Regiones:
Global
Título:
WHO Expert Committee on Specifications for Pharmaceutical Preparations: Outcome of 44 Meetings (Chinese Version)
[
Arabic
] [
English
] [
French
] [
Russian
] [
Spanish
]
Año:
2011
Páginas:
16
Publicadores:
WHO Headquarters in Geneva
Regiones:
Global
Título:
WHO Expert Committee on Specifications for Pharmaceutical Preparations: Outcome of 44 Meetings (Russian Version)
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Temas:
Качество и безопасность лекарственных средств
>
Обеспечение качества
Año:
2011
Páginas:
16
Publicadores:
WHO Headquarters in Geneva
Regiones:
Global
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Última actualización: le 3 mayo 2013