BRITAIN'S Medicines and Healthcare Products regulatory Agency (MHRA) has approved the sale of Calci-D 1000mg/1000IU tablets for sale without a prescription.
The reclassification, made pursuant to a proposal from the product's sponsor Consilient Health Limited, makes the product a pharmacy (P) medicine, under conditions including that the product be available as a 28-tablet pack and with the indication that it is to be used to correct calcium and vitamin D deficiency in elderly patients with a one tablet daily dose.
Calci-D was first approved as a prescription-only medicine in the UK in 2015.
The down-scheduling makes it the first non-prescription medicine to contain 1000 IU of Vitamin D in the UK, with each chewable tablet containing 2500mg of calcium carbonate and 1000 IU of cholecalciferol (vitamin D3).
The MHRA said the daily dose of vitamin D contained in the tablets was "only marginally more" than similar products which are already available as pharmacy medicines.
"The availability Calci-D chewable tablets which contains a slightly higher dose of vitamin D is not considered to increase the risk of indirect danger," the regulator's evaluation concluded.
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