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N-NITROSODIMETHYLAMINE (NDMA) CONTAMINATION OF VALSARTAN, CLASSIFIED AS A PROBABLE HUMAN CARCINOGENN-NITROSODIMETHYLAMINE (NDMA) CONTAMINATION OF VALSARTAN, CLASSIFIED AS A PROBABLE HUMAN CARCINOGEN
La DIGEMID, a través del comunicado publicado el 6 de julio informa a los titulares de Registros Sanitarios de los productos farmacéuticos que contienen VALSARTAN, acerca de la contaminación de esta sustancia activa suministrada por la empresa farmacéutica Zhejiang Huahai Pharmaceuticals de China, por un probable carcinógeno humano (N-Nitrosodimetilamina).
Por lo que, los titulares de Registro Sanitario cuyos productos contengan VALSARTAN que proceda de la empresa farmacéutica antes mencionada. deberán comunicarlo a la Dirección de Farmacovigilancia, Acceso y Uso – DFAU de la DIGEMID.
Source: DIGEMID
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FORM FOR THE EXCEPTIONAL AUTHORIZATION OF IMPORTS OF PHARMACEUTICAL PRODUCTS FOR INDIVIDUAL PREVENTION AND TREATMENT (ANNEX 1 AND ANNEX 2) – Version 2 –

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