Austrian Federal Office for Safety in Health Care

Recent updates

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

News

Transition of clinical trials of medicinal products - the countdown is on! Top-News

messages in brief | 25/03/2024

All ongoing clinical trials need to be converted to Clinical Trials Information System ("CTIS") in accordance with Regulation (EU) 536/2014 ("CTR") by January 31, 2025. This date marks the end of a three-year transition period that began when the CTR came into force in the EU. Clinical trials that are not converted by the sponsor in time lose their legal basis and will have to be terminated by the National authority.

Safety information on the quality defect/recall of "Amoxilan 250 mg/5 ml - Trockensaft" New

Safety warnings | Medicines | 12/04/2024

Precautionary batch recall as a glass splinter was discovered in a 60 ml bottle.

Amoxilan 250 mg/5 ml - Trockensaft New

Recall | Medicines | 12/04/2024

Recall due to possible contamination with glass splinters

CHMP Meeting Highlights March 2024 New

CHMP Monthly News | 09/04/2024

Up-to-date information from the February 27.03.-30.03.2024 meeting on new approvals, extensions of indication, newly published EPAR's and recently started procedures.

Tetracaine hydrochloride, active ingredient

Recall | Medicines | 09/04/2024

Recall due to appearance of the solution

OPDIVO 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung (parallel distribution Haemato Pharm GmbH)

Recall | Medicines | 05/04/2024

Recall due to a possible incorrect closure of the crimp caps

Prostapax Forte

Enforcement | 05/04/2024

Das BASG warns against the product "Prostapax Forte", because it is categorised as an illegal medicinal product (medicinal product by presentation) due to its claims in the advertising brochure.

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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.