Messages in brief
BASG OMCL plans to join the WHO-National Control Laboratory Network for Biologicals
Production-related contamination with N-nitrosodiethylamine (NDEA) in the active ingredient valsartan from the manufacturer "Mylan Laboratory Limited".
"Valsartan/HCT ratiopharm 80 mg/12.5 mg Film-Coated Tablets" and "Valsartan/HCT ratiopharm 160 mg/25 mg Film-Coated Tablets" (active ingredient:…
Mock-Up-Guidance Document
To summarize legal provisions, requirements regarding content as well as information how to submit and handle Mock-Ups a new Guidance Document was set…
Recall of Jakavi 15 mg tablets due to suspected counterfeiting
Situation in Austria: The Federal Office for Safety in Health Care has received information that several packages of the drug Jakavi 15 mg tablets,…
Possible longer usability of "EpiPen 300 microgram solution for injection in a ready-to-use pen" to alleviate the current supply shortage
Information is provided on the possibility of prolonged usability of certain batches of "EpiPen 300 microgram solution for injection in a ready-to-use…
Valsartan medication review - update.
The European Medicines Agency (EMA) is currently conducting an investigation into the potential health effects on patients who have taken valsartan…
Electronic Application Forms eAF - new version 1.23
New versions of the electronic Application Forms (eAF v. 1.23) and related documents are available via the EMA-website (http://esubmission.ema.europa.…
Recall of drugs containing the active ingredient valsartan from the Chinese manufacturer Zhejiang Huahai Pharmaceutical
A batch-related recall of medicines containing valsartan, the active ingredient of which was produced by the Chinese manufacturer Zhejiang Huahai…
Request for barrier-free provision of information for use
The Federal Office for Safety in Health Care (BASG) was obligated within the framework of a conciliation procedure pursuant to Section 14 of the…
Fluoroquinolones: summary of the public hearing of 13.06.2018.
The EuropeanMedicines Agency (EMA) held the public consultation on the impact of potential adverse reactions to fluoroquinolones, a group of…
