(2003; 15 pages)
NIMESULIDE - Product under ‘special pharmacovigilance’
Argentina. The food, drug and medical devices agency in Argentina, ANMAT, has directed that nimesulide should be brought under the category of products under ‘special pharmacovigilance’. This category includes those drugs that are put under high alert and scrutiny for adverse reactions. Manufacturers are obliged to report all adverse effects associated with nimesulide use. (For other related information on nimesulide, see WHO Pharmaceuticals Newsletter No. 2, 3 & 4, 2002; 3 & 4, 2003).
Disposicion de ANMAT no 4087/03, 6 Aug 2003.