Swissmedic Approves Extension of Therapeutic Indication for Hepcludex

On January 27, 2026, Swissmedic announced the extension of the therapeutic indication for Hepcludex, a medication used to treat a specific medical condition.

This change affects clinical, quality, and regulatory teams working with Hepcludex.

What changed?

The extension of the therapeutic indication for Hepcludex means that the medication can now be used to treat a broader range of patients.

New Indication

The new indication allows for the use of Hepcludex in patients with a specific medical condition, in addition to its previously approved use.

Who is affected?

Clinical, quality, and regulatory teams working with Hepcludex will need to update their procedures and protocols to reflect the new indication.

What does this mean?

The extension of the therapeutic indication for Hepcludex provides new treatment options for patients and may improve health outcomes.

Next Steps

Clinical, quality, and regulatory teams should review the updated indication and make necessary changes to their procedures and protocols.

FAQ

  1. Q: What is the new indication for Hepcludex?

    A: The new indication allows for the use of Hepcludex in patients with a specific medical condition.

  2. Q: Who is affected by this change?

    A: Clinical, quality, and regulatory teams working with Hepcludex will need to update their procedures and protocols.

Conclusion

The extension of the therapeutic indication for Hepcludex provides new treatment options for patients and may improve health outcomes.

Disclaimer

This article is for informational purposes only and should not be considered as legal advice.

For full information about the Swissmedic announcement, see the link below.

https://www.swissmedic.ch/swissmedic/en/home/about-us/publications/public-summary-swiss-par/public-summary-swiss-par-hepcludex-01.html