Swissmedic has issued a temporary authorization allowing the distribution of Selectol 200 mg film-coated tablets in French-language packaging. This regulatory decision is intended to address an ongoing supply shortage and maintain patient access to this essential medicine. Clinical, quality, and regulatory teams responsible for the supply chain or patient care should note these changes.
What has changed?
On 19 November 2025, Swissmedic approved a temporary measure permitting the marketing of Selectol 200 mg tablets in packaging designed for the French market. This decision reflects the current shortage of the medicine in Swiss-specific packaging. The approval ensures that healthcare providers and patients will continue to have access to the product despite packaging adjustments.
Who is impacted by the approval?
This announcement primarily affects clinical and regulatory teams, pharmaceutical distributors, and healthcare providers. Patients reliant on Selectol for managing cardiovascular conditions will also benefit from this decision. The approval ensures therapy continuity without compromising patient safety or product quality.
What are the details of the approval?
Swissmedic’s temporary authorization allows for the use of Selectol packaging designed for the French market. While the packaging language differs from standard Swiss packaging, the content, quality, and safety of the tablet remain unchanged. Healthcare professionals are encouraged to provide patients with support and if necessary, additional information regarding the labeling.
This temporary measure signals Swissmedic’s commitment to addressing supply challenges proactively while maintaining adherence to safety and quality regulations. Such flexibility is crucial during supply chain disruptions to ensure that patients experience minimal impact.
FAQ
1. Why was this measure necessary?
Swissmedic approved this measure to mitigate the impact of a supply shortage for Selectol 200 mg tablets, which are critical for certain patient groups. French-packaged products are now authorized to maintain availability.
2. Does the French-language packaging affect the product’s quality?
No, only the packaging language has changed. The product remains identical in terms of content, dosage, and safety.
3. How long will the temporary authorization last?
The duration of the approval has not been explicitly mentioned. It will likely depend on the resolution of the supply issues.
4. Are healthcare providers required to take specific actions?
Healthcare providers should confirm that patients understand the change in packaging and provide support for interpreting the French-language details if necessary.
Conclusion
Swissmedic’s temporary authorization for Selectol 200 mg tablets in French packaging addresses a critical supply gap, ensuring uninterrupted patient access. Clinical teams, distributors, and prescribers should adapt quickly and monitor the situation for future updates. Cooperation across stakeholders will be vital during this temporary measure.
Disclaimer
This content is intended for informational purposes only and does not constitute legal or regulatory advice. Healthcare professionals should consult the original Swissmedic notice and their internal compliance teams for guidance.
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-selectol-200mg-filmtabletten.html