Drug Ther Bull. 2005 Apr;43(4):25-8. doi: 10.1136/dtb.2005.43425.
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.
2004年7月,辛伐他汀10毫克在英国从仅处方药品(PoM)重新归类为非处方药品(P),并以可定心护(Zocor Heart-Pro,强生公司。默克雪兰诺消费者制药公司)的名称上市。它是世界上第一种无需处方即可销售的他汀类药物。可定心护被许可用于降低可能处于此类问题“中度风险”的人群首次发生重大冠心病(CHD)事件的风险。在此,我们回顾将辛伐他汀10毫克重新归类为非处方产品的基本原理和过程。