Messages in brief
Correction to APA message "APA0151 5 WI 0205 WB/CI" dated Thursday, April 12, 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…
AGES Experts as Rapporteurs for Revision of ICH Guideline on Reproductive Toxicology
AGES MEA experts are continuously working on the third revision of the international guideline ICH S5(R2) "Detection of Toxicity to Reproduction for…
AGES Experts as Rapporteurs for EMA Reflection Paper
AGES MEA experts took the rapporteur role for the development of the new EMA document: "Reflection Paper on statistical methodology for the…
Austria is among first participating member states in new mutual GMP inspection agreement between EU and US
As of November 1, 2017, parts of the Mutual Recognition Agreement (MRA) between the EU and the US entered into force. This agreement updates…
Pangea X Interpol: Austria's great success also in the 10th year of the operation against pharmaceutical crime
Vienna (OTS) - The Ministry of Health and AGES Medizinmarktaufsicht/Federal Office for Safety in Health Care Austria, together with the Ministry of…
Adverse reaction reporting - EMA launches survey
EMA launches survey for patients and healthcare professionals on knowledge of reporting adverse reactions - Federal Office for Safety in Health Care…
Recall "Melphalan Koanaa 50 mg i.v. Powder and solvent for solution for injection or solution for infusion" (active ingredient melphalan)
The medicinal product "Melphalan Koanaa 50 mg i.v. powder and solvent for the preparation of a solution for injection or infusion" (active substance…
Important safety information for refillable insulin pens NovoPen Echo or NovoPen 5 - Replacing the cartridge holder
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…
Symbioflor E. coli - drops recommended only for irritable bowel syndrome and for adults
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…
Adverse event reporting - reporting morale slightly increased
The spontaneous reporting system for adverse drug reactions is of enormous importance for the early identification of new risks of medicinal products.…
