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 acknowledgement for any case reports transmitted during this period. It is therefore absolutely necessary to…

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 "small import" of medicinal specialities from the EEA by public pharmacies according to § 11 para. 1 Z 7…

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 solution. Thus, the result is out of specification with regard to the test "Description after preparation…

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 equipment. As there could be irritation of the nasal mucosa/skin due to these particles in the nasal…

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customers in a letter dated 13.07.2015 that the above batch is being recalled as a precautionary measure because an outdated package insert was enclosed.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 Epinephrine auto-injectors are used for emergency self-treatment of anaphylaxis (severe allergic…

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 the EMA in selected literature sources and for certain active ingredients or combinations of active…

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 of the bulk product and concerns two batches in Austria, which will probably not comply with the…

As of June 25, Austrian pharmacies will be allowed to sell over-the-counter medicines over the Internet - BMG and BASG launch educational campaign

The parallel distributor has informed its supplied customers in a letter dated June 2, 2015, that the affected batch A229473D is being recalled due to a falsification of the packaging. The marketing authorization holder "Gilead Sciences International Limited" was notified by another parallel distributor of an anomaly on the packaging of batch…