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EMA reviews diabetes medicine canagliflozin

EMA reviews diabetes medicine canagliflozin

Review follows data on toe amputations in ongoing study

The European Medicines Agency (EMA) has started a review of the diabetes medicine canagliflozin after an increase in amputations, mostly affecting toes, was observed in an ongoing clinical trial called CANVAS. Cases of lower limb amputation occurred in both the canagliflozin and placebo groups in the trial and the possibility that canagliflozin increases lower limb amputations is currently not confirmed. EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has requested more information from the company to assess whether canagliflozin causes an increase in lower limb amputations and whether any changes are needed in the way this medicine is used in the EU.

More information on this is included in the hyperlink below:

EMA reviews diabetes medicine canagliflozin

Over-the-Counter Drugs (OTC)

Medicinal products without prescription in the Republic of Bulgaria to date 28.02.2011

The present list do not include medicinal products with expired authorization, although in the country they can be sold until exhaustion of the actual quantities, but not more than one year from the expiration date of the marketing authorization (in accordance with Art. 55, Para. (6) of LMPHM).

In the event of a favorable opinion on the marketing authorization renewal procedure, they are going to be added to the list.

Drugs without prescription

On ascertainment of inaccuracies and omissions please call: +359 2 890 34 11 +359 2 890 34 11