The Federal Agency informs about recommendations of the Committee for Risk Assessment and Pharmacovigilance (PRAC, BASG initial notification 13.3.2015) and the subsequent decision within the European risk assessment procedure according to Article 31…

The marketing authorization holder informed its supplied customers in a letter dated September 17, 2015, that a slight shortfall in the protein content (PNU) was detected during internal quality control and that the affected batches of the Fusarium…

Dear registration holder,due to a technical malfunction in the period from 20.09.2015 (15h) until 28.09.2015 (12h) an electronic transmission of adverse event reports to BASG/AGES MEA was not possible. Therefore, you did not receive an…

Small import" of medicinal specialities according to § 11 para. 1 Z 7 of the Austrian Medicinal Products Import ActThe Federal Office for Safety in Health Care takes the liberty to state with regard to the exceptional provision of the so-called…

The marketing authorization holder informed its supplied customers in a letter dated August 25, 2015, that a different number of small particles was observed in some bottles of the above-mentioned batches after preparation of the ready-to-use…

The marketing authorization holder has informed its supplied customers in a letter dated 21.08.2015 that the batches listed above were manufactured with an active ingredient batch that may be contaminated with particles of the manufacturing…

The marketing authorization holder has informed its supplied customers in a letter dated 13.07.2015 that the above batch is being recalled as a precautionary measure because an outdated package insert was enclosed.

The European Medicines Agency (EMA) recommends new measures to ensure the safe and successful use of epinephrine auto-injectors. Introduction of new training material Patients should always carry two auto-injectors for safety. Measures at EU level…

On May 12, 2015, the European Medicines Agency (EMA) announced that - in accordance with Article 27 of Regulation (EC) No. 726/2004 - starting on July 1, 2015, the search for suspected ADRs published in the scientific literature will be conducted by…

In a letter dated June 26, 2015, the marketing authorization holder informed its customers that ongoing stability tests have revealed values outside the specification for the degradation product ketolactam. The reason lies in a too long holding time…