Swissmedic, Switzerland’s authority for therapeutic products, has announced the temporary authorization for the distribution of Abilify i.m. injection solution (7.5mg/ml) in German-language packaging. Regulatory and clinical stakeholders should take note of this change, which aims to address ongoing supply challenges.
What changed?
On January 13, 2026, Swissmedic released information regarding the temporary distribution approval of Abilify i.m. injection solution in German-language labeling. This decision responds to ongoing shortages of the therapeutic product, ensuring availability while regulatory measures support compliance standards.
Abilify i.m., containing aripiprazole, is prescribed for managing conditions such as acute agitation in patients with schizophrenia or bipolar disorder. The shortage has necessitated swift regulatory action to maintain supply, reflecting the importance of this medication in clinical contexts.
Who is affected?
The temporary distribution approval primarily impacts:
- Healthcare providers administering Abilify i.m. as an injectable treatment.
- Pharmaceutical distributors managing therapeutic product inventories.
- Regulatory teams overseeing compliance for temporary packaging and labeling adjustments.
Clinicians and quality assurance teams should monitor specific instructions regarding the German-language labeling and confirm all operational protocols align with Swissmedic directives.
Regulatory considerations
Why was this measure necessary?
The supply shortage of Abilify i.m. prompted Swissmedic to issue this temporary authorization. Ensuring continued access to critical therapeutic solutions underscores Swissmedic’s commitment to public health and patient safety while mitigating disruptions caused by limited stock availability.
Compliance with labeling changes
Abilify i.m. distributed in German-language packaging must adhere to interim regulatory standards set by Swissmedic. All professionals involved in its distribution are responsible for maintaining transparency about the product’s intended use and performance under this temporary authorization.
This temporary measure ensures adherence to MDR Annex XIV guidelines regarding labeling, packaging, and performance claims for therapeutic products within the European market.
Next steps for stakeholders
- Stay updated on Swissmedic announcements related to supply chain adjustments.
- Review operational protocols to address temporary packaging updates.
- Maintain precise recordkeeping during this authorization period.
FAQ
1. What is the active ingredient in Abilify i.m.?
Its active ingredient is aripiprazole, commonly used for managing acute episodes in schizophrenia and bipolar disorder.
2. Is the German-language packaging permanent?
No, it is a temporary measure based on regulatory approvals due to supply chain shortages.
3. Are there safety concerns with using this product?
No new safety concerns have been indicated by Swissmedic. The authorization aligns with performance and safety requirements.
4. How long will this approval last?
Swissmedic has not specified an exact duration for the temporary authorization. Stakeholders should follow updates closely.
Conclusion
Swissmedic’s temporary authorization for the distribution of Abilify i.m. with German-language labeling addresses immediate supply concerns for a vital therapeutic product. Clinical teams and regulatory professionals must adapt to these labeling changes while ensuring compliance with Swissmedic directives. This decision reflects the agency’s proactive approach to mitigating shortages without compromising safety or efficacy.
Stakeholders are encouraged to monitor updates and follow prescribed guidelines for safe distribution and administration.
Disclaimer
This content is informational and should not be interpreted as legal or regulatory advice. Always consult official regulatory documentation or guidance for final details.
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-abilify-i-m-injlsg.html