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MHRA approves POM to P switch of Calci-D 1000mg/1000 IU tablets

The Medicines and Healthcare products Regulatory Agency (MHRA) has concluded that Calci-D 1000mg/1000 IU tablets are “sufficiently safe to be sold as a pharmacy medicine”.

In 2015, the regulator first approved Calci-D as a prescription-only-medicine (POM) in the UK.

 

However, the MHRA assessed the application and decided to approve the P medicine legal status of Calci-D following a request from licence holder Consilient Health Limited to reclassify this product from POM to pharmacy (P) medicine, the watchdog said in a statement yesterday (October 7).

 

The MHRA approved the reclassification under the following conditions:

  • the product should be available as a 28-tablet pack

  • it should be used to correct calcium and vitamin D deficiency in the elderly

  • adults and the elderly should take one tablet a day

  • each chewable tablet contains 2500mg calcium carbonate – equivalent to 1000mg calcium – and 1000 IU – equivalent to 0.025mg – cholecalciferol (vitamin D3).

 

The tablets can 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”, the MHRA said.

 

While there are other P medicines containing calcium and vitamin D3, Calci-D 1000mg/1000 IU tablets is the first P medicine to contain 1000 IU of vitamin D3, the MHRA added.

 

Assessing the application for the reclassification of the product, the MHRA said that the daily dose of vitamin D contained in the tablets “is only marginally more” than similar products currently available as P medicines.

 

“There is no evidence to suggest that this additional amount constitutes any additional risk,” the MHRA concluded.

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