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.

Update: West Nile Virus (WNV) - France New

Safety warnings | Blood & Tissue | 19/09/2024

The Federal Office for Safety in Health Care has been informed by the French authorities that, in addition to the regions already announced, confirmed human WNV infections have been recorded in France in the department of Hérault (Occitanie region).

Update: West Nile Virus (WNV) - Italy New

Safety warnings | Blood & Tissue | 18/09/2024

The Federal Office for Safety in Health Care (BASG) has been informed by the Italian authority that in Italy, in the previously announced province of Latina (Lazio region), the WNV preventive measures for donations of blood and blood components have been lifted again, as the originally WNV-positive case was assigned to USUTU.

Dengue - Spain New

Safety warnings | | 16/09/2024

The Federal Office for Safety in Health Care (BASG) has been informed by the ECDC (European Center for Disease Prevention and Control) that confirmed autochthonous human dengue cases have been recorded in the regions of Catalonia (province of Tarragona) and Murcia, as well as in the province of Cadiz and Ibiza.

Update: Dengue - Italy New

Safety warnings | Blood & Tissue | 16/09/2024

The Federal Office for Safety in Health Care (BASG) has been informed by the ECDC (European Centre for Disease prevention and Control) that a confirmed authochthonous human dengue case has been recorded in the province of Brescia (Lombardy region).

Senvelgo 15 mg/ml solution for oral administration for cats New

Safety warnings | Veterinary Medicines | 11/09/2024

Important information from the Federal Office for Safety in Health Care about the known risk of diabetic ketoacidosis (DKA) in cats with diabetes mellitus associated with the use of Senvelgo 15 mg/ml oral solution for cats (velagliflozin).

Update: West Nile Virus (WNV) - Romania New

Safety warnings | Blood & Tissue | 11/09/2024

The Federal Office for Safety in Health Care has been informed by the Romanian authorities that, in addition to the regions already announced, confirmed human WNV infections have been recorded in Bihor in Romania.

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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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