PharmacovigilanceOfficial

BASG lists levofloxacin template text pointing to September 2026 CMDh minutes

🇦🇹 BASG · Thu 22 Oct 2026

Austria's medicines authority has added a levofloxacin entry, covering intravenous and oral forms, to its PV template-text page, directing readers to CMDh meeting minutes.

The Austrian Federal Office for Safety in Health Care (BASG) has posted a new entry for levofloxacin (intravenous and oral) on its page of template texts. The page collects safety information that must be implemented in product information following a pharmacovigilance procedure. The entry is dated 22 October 2026 and filed under 'other template text'.

The listing does not describe the content of the change. It asks readers to consult the minutes of the Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) from its meeting of 15-17 September 2026. A template-text attachment of 488 KB accompanies the entry, but its contents are not reproduced in the source, so the specific wording or safety issue cannot be confirmed here.

The same page shows other recent updates. Alendronic acid has a new PSUR-outcome entry dated 22 October 2026, and diacerein has one dated 27 October 2026. An earlier entry, dated 29 September 2026, covers a PRAC signal recommendation for oxacillin on the risk of drug reaction with eosinophilia and systemic symptoms (DRESS).

BASG notes that the EMA relaunched its website in December 2023, and that current links for entries before 1 December 2023 can be found by searching the EMA site. Queries about implementation can be sent to the authority's pharmacovigilance implementation mailbox, pv-implementation@basg.gv.at.

What it means for your team

  • Marketing authorisation holders for levofloxacin (intravenous and oral) in Austria should read the BASG template text and the September 2026 CMDh minutes to see what product-information wording is required.
  • Because the source does not describe the change, teams should not assume its scope, such as a new warning or a restriction, until they have checked the attachment.
  • PV and regulatory teams can use the BASG page as a tracker for national implementation of PSUR outcomes and PRAC signal recommendations, including the oxacillin DRESS item.

Official source: BASG ↗

Article written by VigiEye from the official source (BASG). AI-assisted; check the source before acting.

More Pharmacovigilance All →