On October 20, 2025, Swissmedic announced a temporary resolution to the supply shortage of Seroquel XR 50 mg retard tablets by allowing distribution in Italian-language packaging. This decision aims to ensure uninterrupted access to treatment for patients and healthcare providers affected by the recent supply disruption.
What changed?
Swissmedic has approved a temporary strategy to mitigate the supply shortage of Seroquel XR 50 mg retard tablets. This approval allows the distribution of the medication in packaging designed for the Italian market. The measure is designed to balance regulatory compliance and patient needs, ensuring the medication remains accessible despite production or distribution challenges.
Regulatory background
Seroquel XR, a prescription-only extended-release tablet containing quetiapine fumarate, plays a vital therapeutic role in managing certain mental health conditions like depression and bipolar disorder. Supply issues prompted Swissmedic to assess suitable alternatives under their market surveillance authority. After evaluating options, the Italian-packaged variant was authorized for temporary use in Switzerland.
Swissmedic emphasized that this application aligns strictly with regulatory requirements, and only approved providers may distribute the Italian-packaged version until regular supply channels resume. All safety, performance, and labeling aspects of the product remain consistent with its therapeutic claims.
Clinical implications
Healthcare providers and patients must note that while the packaging is different, the chemical composition, efficacy, and dosage of Seroquel XR 50 mg remain unchanged. Providers should ensure patients understand the temporary nature of this measure and clarify potential concerns about using medication in Italian-language packaging.
Once standard packaging and supply chains recover, distribution under Swissmedic’s approval will revert to the regular format. This ensures continuity while minimizing the potential for confusion or disruptions to care.
Frequently Asked Questions
1. Why was Italian packaging approved?
The temporary approval addresses shortages and ensures the medication remains accessible for clinical use in Switzerland.
2. Are there differences between the Italian-packaged tablets and the Swiss-packaged ones?
No, the tablets are identical in formulation, dosage, and efficacy. Only the external packaging differs.
3. How long will this temporary measure last?
Swissmedic has not specified an exact duration, but the measure will remain in place until regular supply resumes.
Conclusion
Swissmedic’s decision to authorize the temporary distribution of Seroquel XR 50 mg tablets in Italian packaging is a critical step in addressing the ongoing supply challenge. Clinical teams and regulatory professionals should remain updated on future guidance regarding this matter while providing patients with reassurance about the therapeutic consistency of the product.
Disclaimer
This content is for informational purposes and does not constitute legal or medical advice. Healthcare professionals should access official Swissmedic documentation for detailed requirements.
Swissmedic announcement
For full information about the Swissmedic announcement, see the link below.
https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/out-of-stock/approved-applications/out-of-stock-seroquel-xr-50mg-retardtablette.html