EMA keeps diethylamine-salicylate/escin authorisations unchanged after PSUSA review

What happened

On 5 November 2026 the European Medicines Agency published the outcome of a periodic safety update report single assessment (PSUSA) for diethylamine-salicylate/escin. The regulatory outcome is listed as maintenance, meaning the marketing authorisations stay in place.

The published record gives little else. It does not say what data the assessment reviewed, whether any wording changes were considered, or which products and member states are covered. Teams that hold affected authorisations will need to read the full outcome page on the EMA website, which the agency links from its PSUSA repository, rather than rely on the headline.

What 'maintenance' means in practice

A PSUSA is the EU mechanism for assessing periodic safety update reports for medicines that contain the same active substance or combination, so that nationally authorised products are reviewed together rather than country by country. The outcome sets out whether authorisations should be maintained, varied, suspended or revoked.

Maintenance is the least disruptive result. In general terms, it signals that the assessment did not lead to a change in the terms of the authorisations. It does not mean the review found nothing to discuss, and it does not by itself say whether product information was touched. Only the detail in the published outcome can answer that, and the record here does not include it.

For PV teams, a maintenance outcome still closes a loop. It resets the expectation for the next periodic reporting cycle, and it is a reference point for aggregate-data reviews and signal-management discussions on the substance.

A day of contrasting safety signals

The lead item was published on the same day as a near-identical PSUSA outcome for ethinylestradiol/gestodene, which also ended in maintenance and came with a list of nationally authorised products. Two maintenance outcomes in one release show that most periodic reviews end without regulatory action.

Other items from the same week show the other end of the PV workload. Greece's EOF reports that the EMA safety committee, PRAC, is examining a rise in batch-specific allergic reactions with normal human immunoglobulin medicines. EOF also reports that a separate review of Deanxit has been opened. No outcome for either review is in the records, so any conclusions would be premature.

In the UK, the MHRA has proposed interim monitoring advice for Duvyzat (givinostat), with more frequent ECG and electrolyte checks, after international reports of deaths in patients with Duchenne muscular dystrophy. The MHRA says no deaths have been reported in the UK, and implementation depends on an ongoing independent review. In Italy, AIFA published a DHPC on stopper defects in certain Respreeza batches that could prevent administration or allow microbial contamination.

Each of these items is a different type of PV event: a periodic review, a batch-linked signal, a risk-mitigation proposal and a quality-related communication. A PV system has to handle all of them at once, and the routine outcomes should not be allowed to crowd out the live ones.

Who is affected

Marketing authorisation holders for diethylamine-salicylate/escin products in the EU are the direct audience. QPPVs and local PV contacts should confirm that their products are covered, check whether any follow-up is expected at national level, and record the outcome in their PV system documentation.

Other readers have less to do. For them, the main value is calibration: a PSUSA that ends in maintenance is a normal result, and it should not be read as a signal of concern or of reassurance beyond what the outcome states.

The same day also brought an EMA Q&A for MAHs and applicants on the CHMP nitrosamine opinion under Article 5(3), reference EMEA-H-A5(3)-1490. That document is mainly a quality and CMC matter, but PV and quality teams often share ownership of the resulting product-quality communications.

What to watch

First, the detail behind the outcome. Check whether the EMA page contains any product-information implications, and whether the assessment's scope matches your portfolio.

Second, the next step in the periodic reporting cycle. Confirm the timetable for your products against the EU list of Union reference dates and frequency of submission. The records do not give this information for this substance.

Third, the open items elsewhere. PRAC's work on immunoglobulin batches and Deanxit, and the MHRA's independent review on givinostat, are not resolved in the records. Outcomes there could alter expectations for signal detection, batch-level monitoring and risk-minimisation communications.