Infarmed authorizes a foreign language label Use of two drugs for diabetes

Infarmed authorized the use of two diabetes drugs with foreign language labeling. The authority warns that use must respect the approved therapeutic indication, in reference to the search for these weight loss drugs.

In a note released on its website, the National Authority of Medicines and Health Products explains that one of the medicines involved is Ozempic, Semagluctado, 0.5 mg/0.37 ml, injectable solution in pre-lame pen, which can be used with German labeling, accompanied by a Portuguese leaflet.

To facilitate access to the drug, the registration, price and reimbursement number by the National Health Service of this presentation will be the same as the authorized drug in Portugal. Thus, the prescription and dismissal may occur as usual.

Given the high demand of this medicine, Infarmed recalls that the use of semaglutado and other drugs that help control type 2 diabetes « must strictly observe the indications and conditions in which it is authorized and reimbursed for patients with diabetes. »

This medicine is one of 91 on the list whose export is prohibited because it is in stock break, but in the presentation pen with dosage 1 mg/0.74 ml. The use of Ozepic in this dosage had already been at the end of March authorized with checker language labeling.

The other medicine whose use has been exceptionally authorized in a foreign (French) language is the Wegovy FlexTouch, a pre-fucked injectable solution, also suitable for diabetes but much sought after by those who want to lose weight.

Infarmed warns of the need for the drug to be prescribed, dismissed and used “in strict observance of the approved therapeutic indication”.