What's new
Newsletters "UptoDate" of BASG/AGES MEA are published monthly and contain the latest articles from the last month (link to subscription page).
For the RSS feed with daily notification of updates, use the link: RSS feed to "what's new".
Search narrowed by
Searched for basg.
messages in brief
|
26/11/2018
The WHO-National Control Laboratory Network for Biologicals was established to facilitate the availability of WHO pre-qualified vaccines. The WHO pre-qualification programme provides independent opinion/advice on the quality, safety and efficacy of…
Safety warnings
|
Medicines
|
23/11/2018
Recall of certain lots of "Valsartan/HCT ratiopharm 80 mg/12.5 mg Film-Coated Tablets" and "Valsartan/HCT ratiopharm 160 mg/25 mg Film-Coated Tablets" containing valsartan active ingredient manufactured by "Mylan Laboratory Limited".
Safety warnings
|
messages in brief
|
23/11/2018
"Valsartan/HCT ratiopharm 80 mg/12.5 mg Film-Coated Tablets" and "Valsartan/HCT ratiopharm 160 mg/25 mg Film-Coated Tablets" (active ingredient: valsartan) have been approved for the treatment of hypertension since August 16, 2013. In the course of…
messages in brief
|
19/11/2018
To summarize legal provisions, requirements regarding content as well as information how to submit and handle Mock-Ups a new Guidance Document was set up, which can be found under…
Safety warnings
|
Medicines
|
25/10/2018
No acute danger, recall purely as a precautionary measure
Safety warnings
|
messages in brief
|
25/10/2018
Situation in Austria: The Federal Office for Safety in Health Care has received information that several packages of the drug Jakavi 15 mg tablets, for which there is an urgent suspicion of counterfeiting, have entered the legal distribution chain as…
Safety warnings
|
Medical devices
|
11/09/2018
The Federal Office for Safety in Health Care (BASG) has been informed that "LOGIMED Medizinische Spezialprodukte Gesellschaft m.b.H., Gösserstraße 11, 8700 Leoben" (Logimed), which was liquidated in 2011, has no legal successor who continues to fulfil the manufacturer obligations arising from the Medical Devices Act (MPG), Federal Law Gazette No. 657/1996, as amended. These obligations include Post Market Surveilance System (PMS), which includes the investigation of incidents and, where appropriate, the initiation of safety corrective actions in the field.
Safety warnings
|
messages in brief
|
03/08/2018
The European Medicines Agency (EMA) is currently conducting an investigation into the potential health effects on patients who have taken valsartan medicines containing the impurity NDMA. NDMA is an impurity found in the active ingredient valsartan,…
Safety warnings
|
Medicines
|
03/08/2018
Preliminary risk assessment of NDMA for patients
messages in brief
|
30/07/2018
New versions of the electronic Application Forms (eAF v. 1.23) and related documents are available via the EMA-website ( http://esubmission.ema.europa.eu/eaf/ ). Specific information from the BASG are published on…