Official announcements
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messages in brief
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29/01/2013
Combined oral contraceptives (COCs) are divided into four generations depending on the type of progestogen they contain. The European Medicines Agency (EMA) is evaluating the need for a change in the indication of third- and fourth-generation…
messages in brief
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20/11/2012
The "Guideline on good pharmacovigilance practices", Module VI obliges marketing authorization holders, among other things, to monitor the local medical press. Publications relating to any adverse drug reactions are to be identified and fed into the…
messages in brief
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16/11/2012
In order to achieve the highest possible level of health protection, very high quality requirements are placed on the manufacture of medicinal products. As a result, only drugs whose quality, efficacy and safety are guaranteed are released for…
messages in brief
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23/10/2012
Unless marketing authorization holders have made use of the legal provision (Section 94 c (10) of the Austrian Medicines Act) and submitted the required renewal documents for a specific medicinal product to AGES Medizinmarktaufsicht by June 30, 2012,…
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05/10/2012
The BMG, BMI, BMF and BASG participated in this year's action week. The operation took place this year from 25.09. to 02.10.2012. In total, more than 100 countries worldwide participated in the organized action. The aim was to simultaneously and in a…
Safety warnings
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messages in brief
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10/09/2012
The active ingredient desmopressin (contained in various preparations) is approved for the treatment of primary enuresis nocturna, for the treatment of vasopressin-sensitive central diabetes insipidus, and for the treatment of nocturia associated…
Safety warnings
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messages in brief
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05/09/2012
Ukrain is a medicinal product made from celandine extracts produced by the pharmaceutical company Nowicky Pharma. The drug was advertised in the EU as an alternative cancer treatment without a valid marketing authorization. In Austria, Nowicky Pharma…
messages in brief
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30/08/2012
In accordance with Section 1 (3b) of the Austrian Medicines Act, Federal Law Gazette No. 185/1983, as amended, the following official demarcation has been made in response to questions submitted to the Federal Office for Safety in Health Care with…
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09/07/2012
The following innovations are planned throughout Europe: Risk and risk managementAll medicinal products carry known and unknown risks at the time of their authorization. The previous version of Regulation 726/2004 already takes this knowledge into…