Official announcements
Search narrowed by
messages in brief
|
12/04/2018
With regard to the APA report "APA0151 5 WI 0205 WB/CI" of Thursday, April 12, 2018, the Federal Office for Safety in Health Care (BASG) takes the liberty of making the following correction: The procedure in question is an official procedure of the…
messages in brief
|
03/01/2018
AGES MEA experts are continuously working on the third revision of the international guideline ICH S5(R2) "Detection of Toxicity to Reproduction for Medicinal Products & Toxicity to Male Fertility", which has now been made available for public…
messages in brief
|
06/12/2017
AGES MEA experts took the rapporteur role for the development of the new EMA document: "Reflection Paper on statistical methodology for the comparative assessment of quality attributes in drug development" (EMA/CHMP/138502/2017). Over the past 2.5…
messages in brief
|
07/11/2017
As of November 1, 2017, parts of the Mutual Recognition Agreement (MRA) between the EU and the US entered into force. This agreement updates the original, unratified 1998 agreement and enables mutual recognition of inspection results (Good…
messages in brief
|
25/09/2017
Vienna (OTS) - The Ministry of Health and AGES Medizinmarktaufsicht/Federal Office for Safety in Health Care Austria, together with the Ministry of the Interior and the Ministry of Finance, were again able to seize numerous illegal medicines this…
messages in brief
|
19/09/2017
EMA launches survey for patients and healthcare professionals on knowledge of reporting adverse reactions - Federal Office for Safety in Health Care (BASG) recommends participation The European Medicines Agency (EMA) has launched a -> Survey survey…
Safety warnings
|
messages in brief
|
11/08/2017
The medicinal product "Melphalan Koanaa 50 mg i.v. powder and solvent for the preparation of a solution for injection or infusion" (active substance Melphalan) does not have a valid marketing authorization in Austria, but was placed on the market by…
Safety warnings
|
messages in brief
|
05/07/2017
NovoPen Echo and NovoPen 5 are used for insulin therapy in people with diabetes. It has been noted that the insulin cartridge holder may tear or break in certain lots of NovoPen Echo and NovoPen 5 insulin pens. Using a pen with a torn/broken…
Safety warnings
|
messages in brief
|
29/06/2017
Measures at EU level A Europe-wide review of Symbioflor E. coli drops by the European Medicines Agency (EMA) has shown that the drops can continue to be used for the treatment of irritable bowel syndrome (IBS) in adults. However, the medicinal…
messages in brief
|
06/06/2017
The spontaneous reporting system for adverse drug reactions is of enormous importance for the early identification of new risks of medicinal products. However, its functioning depends crucially on the cooperation of all healthcare professionals. In…