Austrian Federal Office for Safety in Health Care

Recent updates

Here you can find new page content of the last 4 weeks.

Safety information on communicable diseases (e.g. WNV, dengue) can be found here.

News

European Sperm Bank - Donor: 8860 RUMLE New

Safety warnings | Blood & Tissue | 06/06/2025

The Federal Office for Safety in Health Care has been informed by the Danish authority that it has been informed by the Danish tissue bank European Sperm Bank (DK257572) that 2 offspring of the sperm donor 8860 RUMLE have been diagnosed with DiGeorge syndrome (22q11 deletion syndrome). The donor/gametes were permanently blocked.

CHMP Meeting Highlights May 2025 New

CHMP Monthly News | 04/06/2025

Up-to-date information from the 19.05.-22.05.2025 meeting on new approvals, extensions of indication, newly published EPAR's and recently started procedures.

Information on the ESMP for Marketing Authorisation Holders New

messages in brief | 02/06/2025

To better monitor and, if necessary, counteract supply shortages of medicinal products at EU level, the European Shortages Monitoring Platform (ESMP) was established by the EMA in accordance with the Regulation (EU) 2022/123. The full version of the platform was launched in January 2025.

Olisir 6 mg/ml Augentropfen, Lösung New

Recall | Medicines | 02/06/2025

Recall due to visible particles in solution

Buronil 25 mg - Filmtabletten, Buronil 50 mg - Filmtabletten

Recall | Medicines | 15/05/2025

Recall due to possible metal particles in tablets

CHMP Meeting Highlights April 2025

CHMP Monthly News | 14/05/2025

Up-to-date information from the 22.04.-25.04.2025 meeting on new approvals, extensions of indication, newly published EPAR's and recently started procedures.

Cryos International - Aarhus ApS, donor: KRISS

Safety warnings | Blood & Tissue | 08/05/2025

The Federal Office for Safety in Health Care has been informed by the Danish authority that it has been informed by the Danish tissue bank Cryos International - Aarhus ApS that the donor KRISS is a carrier of haemochromatosis type 1. The donor/gametes have been permanently blocked.

Safety warning for medical devices of the manufacturer SEBBIN

Safety warnings | Medical devices | 14/04/2025

The Federal Office for Safety in Health Care (BASG) has been informed that the manufacturer SEBBIN, which went bankrupt in March 2025, has no legal successor who continues to fulfil the manufacturer obligations arising from the Regulation (EU) 2017/745 on medical devices („MDR“), as amended.

CHMP Meeting Highlights March 2025

CHMP Monthly News | 10/04/2025

Up-to-date information from the 24.03.-27.03.2025 meeting on new approvals, extensions of indication, newly published EPAR's and recently started procedures.

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Information

Shortages

Based on reports from pharmaceutical companies, BASG informs about current shortages.

Reporting to BASG

The Federal Office relies on reports from consumers, health care professionals and companies for the continuous re-evaluation of the safety profile of medicinal products and medical devices.

Online form for adverse reactions

The reporting of suspected adverse reactions to vaccines and medicinal
products is possible using a patient-friendly online form.

Austrian Medicinal Product Index

The medicinal products database contains all products authorised in Austria, including up-to-date product information leaflets and the summary of products characteristics.

For Consumers

This is the subpage with information from the BASG directed to consumers (patients, their relatives and owners of animals).

For Health Care Professionals

This is the subpage with information from the BASG directed to health care professionals (physicians, dentists, veterinarians, midwives and pharmacists).

For Companies

This is the subpage with information by the BASG directed to companies producing, controlling or distributing medicinal products or medical devices.

Market Surveillance

This is the subpage with the official announcements and public databases provided by the BASG as well as procedures for reporting to BASG.

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