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Spanish to English: Certificado de Renovación General field: Medical Detailed field: Medical: Pharmaceuticals
Source text - Spanish Como resultado de su solicitud de Renovación de Registro Sanitario Nº SRR-EF-80-5000, actuando en representación de XXXXXX S.A., el Instituto Nacional de Higiene “Rafael Rangel” de conformidad con lo previsto en el Artículo 60 del Reglamento de la Ley de Ejercicio de la Farmacia, publicado en Gaceta Oficial Nº 4.582 Extraordinaria de fecha 21 de mayo de 1993 y en concordancia con la Resolución del Ministerio de Salud y Desarrollo Social (actual Ministerio del Poder Popular para la Salud y Protección Social) Nº 0033 del 25 de octubre de 1999, publicado en Gaceta Oficial de la República Bolivariana de Venezuela Nº 36.817 de 28 de Octubre de 1999; acuerda renovar el Registro Sanitario, según Normas de la Junta Revisora de Productos Farmacéuticos, 5ª Revisión de julio de 1998, para el Producto Farmacéutico: XXXXX 1% CREMA EN BASE GEL
Principio(s) Activo(s): DICLOFENACO SÓDICO
En su(s) presentación(es): TUBO COLAPSIBLE DE ALUMINIO CON RECUBRIMIENTO INTERIOR EPOXIFENÓLICO Y TAPA DE POLIPROPILENO A ROSCA CONTENTIVO DE 5, 10, 15, 20, 30, 40, 50, 60, 75, 80 Y/O 100 g, EN ESTUCHE DE CARTÓN
Muestra médica: CONTENTIVA DE 5 g, EN ESTUCHE DE CARTÓN
Régimen de venta: SIN Prescripción Facultativa
Propietario: XXXXXXXX
Elaborado por: XXXXXXX
La presente autorización ha quedado registrada bajo el Nº E.F. 80.000/09, sometida a todo lo previsto en la Ley de Medicamentos y demás disposiciones legales que regulen este Producto Farmacéutico.
Translation - English As a result of your application, on behalf of XXXXXX S.A., concerning to the Renovation of the Health Registration No. SRR-EF-80-5000, the National Institute of Hygiene “Rafael Rangel” approves the Renovation of the Health Registration for the pharmaceutical product: XXXXXXX 1% GEL-BASED CREAM, according to:
- the Article 60 of the Pharmacy Practice Law Regulations (Reglamento de la Ley de Ejercicio de la Farmacia), published on the Extraordinary Official Gazette No. 4,582 the 21st of May , 1993;
- the Resolution of The Health and Social Development Department (current Department of the People’s Power for Health and Social Protection), No. 0033 of the 25th October, 1999, published on the Official Gazette of the Bolivarian Republic of Venezuela No. 36,817 the 28th October, 1999;
- the Regulations of the Revision Board of Pharmaceutical Products, 5th revision of July, 1998.
Active principle: DICLOFENAC SODIUM
In its presentation it is: COLLAPSIBLE ALUMINIUM TUBE WITH AN INNER EPOXY-PHENOLIC COVERAGE AND A THREAD POLYPROPYLENE TOP, WHICH CONTAINS 5, 10, 15, 20, 30, 40, 50, 60, 70, 80 AND/OR 100 gr., IN A CARDBOARD BOX
Medical sample: CONTAINS 5 gr., IN A CARDBOARD BOX
Selling schedule: WITHOUT physician’s order
Owner: XXXXXXXX
Manufactured by: XXXXXXXX
The current authorization has been registered under the No. E.F.80.000/09, according to all the Regulations of the Drugs Law (Ley de Medicamentos), and other legal dispositions which may regulate this pharmaceutical product.
English to Spanish (Trágora Formación - Cursos online para traductores y estudiantes de traducción) English to Spanish (University of Granada) French to Spanish (University of Granada)
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Shaped by a 4-year University Degree in Translation and Interpreting by the University of Granada (Spain) and a 4-year University Degree in Nursing by the University of Jaén (Spain), I have been working as a Registered Nurse in the British National Health Service since 2015, but also as a freelance translator (sworn translations included).
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