Latvia, Markets and Companies, Medicine

Representatives of the State Agency of Medicines said that quality issues were found in several series of Rigvir, which is why it was decided to suspend the registration of this preparation. Latima, the company that had registered Rigvir, still has not established the cause of the quality defect, the agency said.

The company has also failed to meet its obligations during the post-registration period and has not updated the medicine’s documentation. The State Agency of Medicines has therefore suspended the preparation’s registration certificate until these problems are dealt with. Latima is expected to meet a number of requirements before the registration is renewed.

Meanwhile, 38 patients, five medical institutions and 16 oncologists, family physicians, an oncologist-chemotherapist, an immunologist and a dermatologist have asked the Health Inspectorate permission to keep using Rigvir. Responding to this request, the Health Inspectorate has authorized the distribution of one Rigvir series to melanoma patients who are already being treated with this medicine.

This Rigvir series has been produced in January 2019 and meets the quality requirements, however the method used in testing the quality of said Rigvir series has not been properly assessed and approved. It has therefore been decided to allow the use of this medicine provided that the physicians and patients take full responsibility for their choice to continue therapy with this medicine.