Infarmed authorizes drug for diabetes with foreign label

The National Medicines Authority (Infarmed) authorized the use of the drug Bydureon, indicated for people with diabetes, with labeling in a foreign language to avoid stock outages in Portugal.

“In order to avoid the occurrence of a stock outage, Infarmed authorized, on an exceptional basis, the use” of Bydureon (with the Common International Denomination of Exenatide), maintaining the 90% co-payment of the National Health Service, it adds. an information circular released today.

This medication is indicated for adults, adolescents and children from 10 years of age with type 2 diabetes to improve glycemic control, in combination with other hypoglycemic drugs.

According to the national regulator, to facilitate accessibility for users, the “registration number and price of this presentation will be the same as the medicine authorized in Portugal, so prescription and dispensing may occur as usual”.

This drug from the pharmaceutical company AstraZeneca AB is administered by injection and has a retail price of 96.73 euros.

Bydureon packages with Italian language labeling will be accompanied by an information leaflet in Portuguese.

It is up to Infarmed to monitor information on shortages, disruptions and cessation of sales on a daily basis, in order to identify and avoid critical situations that could affect the availability of medicines.

According to the latest report on drug availability management, in 2021 Infarmed granted 77 marketing authorizations in a foreign language, a reduction compared to the 83 in 2020.

In addition, in 2021, 3152 orders for the export of medicines that had problems with availability in Portugal were prohibited.