In accordance with paragraph 8 of Section IV of the Procedure for Expert Evaluation, the applicant must amend the instructions for medical use of the medicinal product upon receipt of new data, including bringing the instructions for medical use into line with the approved instructions for medical use of the original (reference) medicinal product, and ensure that the information on the medicinal product corresponds to current scientific knowledge.
The European Medicines Agency (EMA) has published the minutes of the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 02 – 05 September 2024. Based on the results of the meeting, it was decided that safety-related amendments are needed to the registration materials/package leaflets of medicinal products containing dapagliflozin/metformin (dapagliflozin/metformin).
Dapagliflozin/metformin – EBYMECT; XIGDUO – PSUSA/00010294/202401
Based on the evaluation of the periodic safety update reports (PSURs), PRAC reviewed the benefit/risk balance of the medicinal products EBYMECT (dapagliflozin/metformin), XIGDUO (dapagliflozin/metformin) and provided the following recommendations.
Summary of recommendations and conclusions
- Based on the analysis of safety and efficacy data, the benefit/risk balance of the medicinal products EBYMECT (dapagliflozin/metformin) and XIGDUO (dapagliflozin/metformin) for the approved indications remains unchanged.
- Nevertheless, the package inserts need to be updated by adding a warning about increased hematocrit. Thus, the existing provisions of the package inserts must be amended1.
In the next PSUR, the registration certificate holder (RCH) must provide a cumulative review of abscesses at various body sites in patients treated with dapagliflozin/metformin, and discuss any changes to the package leaflet, if necessary. In addition, the RCH must analyze all cases of Fournier's gangrene reported with dapagliflozin in the context of urological surgery in order to track the results of the PSUR evaluation for dapagliflozin (EMEA/H/C/PSUSA/00010029/202310).
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1Update of the "Special warnings and precautions for use" section of the package inserts. The risk assessment report and PRAC recommendation are forwarded to the CHMP for decision.
List of medicinal products containing dapagliflozin/metformin that are authorized for medical use in Ukraine (according to the State Register of Medicinal Products as of 15.11.2024).
TO SUBMIT THE CORRESPONDING APPLICATION FOR AMENDMENTS TO THE REGISTRATION MATERIALS, THE APPLICANT MUST USE THE ORIGINAL TEXT POSTED AT THE LINKS, FOR ANALYSIS OF THE PUBLISHED INFORMATION:
