Public Assessment Report of the reclassification of Calci-D chewable tablets from a Prescription Only Medicine (POM) to a Pharmacy (P).
This PAR covers the assessment of an application to reclassify Calci-D chewable tablets from Prescription Only Medicine (POM) to Pharmacy (P) medicine.
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Calci-D chewable tablets can be used for the correction of calcium and Vitamin D deficiency in the elderly. Calci-D may also be used as an adjunct to specific therapy for osteoporosis, in patients with either established vitamin D and calcium combined deficiencies or in those patients at high risk of needing such therapeutic supplements.
Each chewable tablet contains 2500mg calcium carbonate (equivalent to 1000mg calcium) and 1000 I.U. (equivalent to 0.025mg) cholecalciferol (Vitamin D3).
The licence holder , Consilient Health Limited, applied to change the legal status of this medicine from a Prescription Only Medicine (POM) to a Pharmacy (P) medicine (see Background for definition).
The Medicines and Healthcare products Regulatory Agency (MHRA) considers this product sufficiently safe to be sold as a pharmacy medicine. This report outlines the evidence that the MHRA reviewed and which led to the decision to approve the application.