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Priority review Notice Amended Final

Voxzogo (vosoritidum) Packaging Text Error Identified

Favicon for www.swissmedic.ch Swissmedic Health Professional Communications
Published March 11th, 2026
Detected March 12th, 2026
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Summary

Swissmedic has identified a packaging text error on Voxzogo (vosoritidum) outer packaging. The incorrect dosage information was printed on specific batches, and affected batches have been identified. The company has issued an information letter detailing the error and corrective actions.

What changed

Swissmedic has issued a communication regarding a packaging error identified on Voxzogo (vosoritidum) outer packaging. The error involves incorrect milligram (mg) indications for the active ingredient Vosoritid, with 0.4 mg printed instead of the correct 0.56 mg or 1.2 mg. Additionally, the concentration after reconstitution is incorrectly stated as 0.8 mg/ml instead of 2 mg/ml on the 1.2 mg packaging. Several specific batch numbers have been identified as affected by this labeling defect.

Healthcare providers and potentially patients who have received affected batches should be aware of this discrepancy. While the error is in the packaging text and not the product itself, it is crucial to refer to the company's information letter for precise details on the affected batches and any recommended actions. This notice serves to inform professionals about the identified issue and ensure awareness of the correct product specifications.

What to do next

  1. Review affected Voxzogo batches
  2. Consult company information letter for specific guidance

Source document (simplified)

Context sidebar

DHPC – Voxzogo (vosoritidum)

Textfehler auf der Faltschachtel

11.03.2026

| Präparat | Voxzogo, Pulver und Lösungsmittel zur Herstellung einer Injektionslösung |
| --- | --- |
| Zulassungsnummer | 69569 |
| Wirkstoff | vosoritidum |
| Zulassungsinhaberin | DRAC AG |
| Betroffene Chargen | A003448, A007709, A003644, A006931, A007313, A008181, A009332, A013137, A012838, A013690 |

Die Zusammensetzung auf der Faltschachtel der 0.56 mg oder 1.2 mg Packungen zeigt eine fehlerhafte mg-Angabe für den Wirkstoff Vosoritid an. Aufgedruckt sind 0.4 mg anstelle der korrekten 0.56 mg bzw. 1.2 mg. Auf der 1.2 mg Packung ist zudem die Konzentration nach Rekonstitution falsch angegeben (0.8 mg/ml anstelle der korrekten 2 mg/ml).

Weitere Informationen entnehmen Sie bitte dem Informationsschreiben der Firma.


- Firmenschreiben
DHPC – Voxzogo (vosoritidum) (PDF, 258 kB, 11.03.2026)

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Classification

Agency
Various
Published
March 11th, 2026
Instrument
Notice
Legal weight
Non-binding
Stage
Final
Change scope
Minor

Who this affects

Applies to
Drug manufacturers Healthcare providers
Geographic scope
Switzerland

Taxonomy

Primary area
Pharmaceuticals
Operational domain
Compliance
Topics
Product Labeling Market Surveillance

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