Reclassification of medicines: ZOCOR HEART-PRO

Home > Notice-board > Reclassification > Zocor Heart-Pro

Zocor Heart-Pro

Johnson & Johnson MSD Consumer Pharmaceuticals has asked the Medicines and Healthcare products Regulatory Agency to reclassify Zocor Heart-Pro (simvastatine 10mg tablets) as a pharmacy medicine. Zocor is currently a prescription-only medicine. The product will be licensed for the reduction of risk of non-fatal myocardial infarction and coronary heart disease in people likely to be at moderate risk. People at moderate risk are defined in the application as all men aged 55 years or more, plus men aged from 45 to 54 years and women aged more than 55 years who have one or more of four additional risk factors.

Consultation period: 17 November 2003 to 16 January 2004

ARM18: Request to reclassify Zocor Heart-Pro from POM to P
(Microsoft Word document)

Reclassification
POM to P

Status
Completed