Synjardy now partially reimbursed from 10 years old

Type 2 diabetes. However, long considered as an adult pathology, is now increasingly affecting children, in a context marked by the worrying increase in infantile obesity. However, In this context, Synjardy, combining empagliflozine and metformin, represents an option now accessible, under conditions. Furthermore, It is available orally in two dosages: 5 mg/1,000 mg and 12.5 mg/1,000 mg.

AMM extension in children – Synjardy now partially reimbursed 10

Already authorized in adults. For example, Synjardy obtained in 2024 an extension of its marketing authorization (AMM) for children from 10 years old. In April 2025. the High Authority for Health (HAS) issued an opinion favorable to the care of drugs in children from 10 years old, but in a more limited framework of use.

Indeed. the indication of the AMM allows the association with several other antidiabetics, while that of the has limited this association with insulin only, excluding other antidiabetic drugs.

The medical service synjardy now partially reimbursed 10 rendered (SMR) is considered important. with an improvement in the level V -rendered medical service (ASMR), it does not provide additional improvement compared to existing treatments. The target population of the drug is estimated between 934 and 2,076 patients.

This decision was formalized by the publication in the Official Journal of July 25.

Well -defined situations

Synjardy can thus be taken care of in children 10 years. more affected by type 2 diabetes, in addition to a diet and physical activity:

• In patients who are insufficiently controlled by metformin alone at the maximum tolerated dose,
• In combination with insulin, in patients insufficiently controlled by metformin and insulin,
• In patients already treated by the combination of empagliflozine and metformin administered in the form of separate tablets.

Apart from these situations, especially in first intention or in already stabilized patients, the HAS opinion is unfavorable to reimbursement.

Pediatric dosage

Synjardy’s dosage must be adapted to the synjardy now partially reimbursed 10 patient according to his current treatment. his effectiveness and his tolerance:

• In patients already treated with metformin, the addition of empagliflozine does not require a modification of the dose of metformin. The recommended initial dose of empagliflozine is 5 mg twice a day (i.e. 10 mg per day in total). In patients who tolerate this dose well and require better glycemic control, the dosage can be increased to 12.5 mg twice a day (or 25 mg per day in total).
• When Synjardy is prescribed in relay of taking empagliflozine. metformin in the form of separate tablets, the patient must receive the same daily dose of empagliflozine and metformin, or the nearest therapeutic dose adapted to Metformin.

The maximum recommended daily dose of Synjardy is 25 mg of empagliflozine and 2,000 mg of metformin.