Abstract

In July 2004, simvastatin 10mg was reclassified in the UK from a Prescription-only medicine (PoM) to a Pharmacy (P) medicine and launched as Zocor Heart-Pro (Johnson & Johnson.MSD Consumer Pharmaceuticals). It is the first statin in the world to be sold without prescription. Zocor Heart-Pro is licensed to reduce the risk of a first major coronary heart disease (CHD) event in people likely to be at "moderate risk" of such problems. Here we review the rationale and process for reclassifying simvastatin 10mg as an over-the-counter product.