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22/03/2016
Recently, pyrrolizidine alkaloids have also been detected in herbal preparations made from plants that do not biosynthesize pyrrolizidine alkaloids. Studies suggest that contamination with weeds may be responsible. Since even very few individuals of…
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18/03/2016
At the European Medicines Agency (EMA) Management Board meeting in London on March 17, 2016, Christa Wirthumer-Hoche was elected Chair of the EMA Management Board for a three-year term. DI Dr. Wirthumer-Hoche is Head of AGES Medical Market…
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04/12/2015
As of 1st January 2016 it will be mandatory for companies submitting applications for European and National Procedures (human and veterinary) to use the electronic application form (eAF). Please find further information at…
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27/11/2015
A re-examination of the safety and efficacy of human papillomavirus vaccines (HPV vaccines) has been completed. After evaluation of the current data by the Pharmacovigilance Risk Assessment Committee (PRAC), no causal association between the HPV…
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22/10/2015
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…
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29/09/2015
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…
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27/08/2015
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…
Safety warnings
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01/07/2015
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…
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30/06/2015
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…
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23/06/2015
As of June 25, Austrian pharmacies will be allowed to sell over-the-counter medicines over the Internet - BMG and BASG launch educational campaign