That over the last few weeks, diverse regulatory agencies from Central America and the Caribbean have issued alerts regarding the pharmaceutical active ingredient called Valsartan, which is included in some medicines marketed in the region, due to the finding of an impurity with carcinogenic potential (N-Nitrosodimethylamine, NDMA) in animals, impurity originating from a manufacturer of Chinese origin.
Novartis hereby clarifies that none of its drugs for the hypertension commercialized in Central America and the Caribbean are related to this alert, which has been duly informed to health authorities and physicians.
Diovan®, CoDiovan®, Exforge®, Exforge HCT® and Vymada® in Central America and the Caribbean are safe and comply with the highest quality standards. There is no type of impurity in them since they incorporate an active ingredient produced at a different production site.
For Novartis, patient safety is and will remain as our main priority. We are committed to ensure that all of our products comply with the highest quality standards.
For more information, please contact: Dirección Médica Novartis Farmacéutica, S.A. (AC). Anillo Periférico 30-31, Zona 11, 01011, Guatemala Ciudad, Centro América. Tel (502) 2422-8400. Fax (502) 2422-8606. E-mail: [email protected] / www.cac.novartis.com