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23/01/2017
Information on user registration and submission of sales and delivery notifications as well as ways to contact us can be found here . Please note the deadline for submission by the end of March 2017.
Safety warnings
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14/12/2016
Stem cell and other cell therapies are associated with great hopes, both among physicians and patients. Great progress is expected, especially in the treatment of difficult-to-treat and chronic diseases. For this very reason, however, it is…
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30/11/2016
EU Regulation 536/2014 is expected to standardize the approval procedure for clinical trials throughout the EU from fall 2018. These are an essential part of drug development and, not least, provide objective proof of the effect and side effects of…
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07/11/2016
AGES Medical Market Surveillance launches a social media campaign from November 7 - 11, 2016 to increase willingness to report adverse reactions. Vienna (OTS) - In addition to positive effects, medicinal products can also have potential side effects.…
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02/11/2016
Legal trade in pharmaceutical specialties via the Internet was made possible in Austria in 2015 by an amendment to the Austrian Medicines Act and linked to legal requirements. Technical features on the drug provider's website enable consumers to…
Safety warnings
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17/10/2016
Several cases of accidental overdose associated with Levetiracetam - Oral Solution have been reported throughout Europe. The majority of cases involved children between 6 months and 11 years of age. Many of these unintentional medication errors…
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27/06/2016
VAC2VAC (Vaccine batch to vaccine batch comparison by consistency testing) is a research and development project in which new, innovative tests for the quality control of human and veterinary vaccines are being developed. The primary goal of the…
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13/06/2016
For detailed information, please contact us and EMA .
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26/04/2016
Please note the changed BIC for transfers to the accounts of the Federal Office for Safety in Health Care (BASG) / AGES Medizinmarktaufsicht. (The IBAN numbers do not change). Account details for fee advances: BAWAG P.S.K. AG IBAN: AT59 6000 0000…
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04/04/2016
Due to legal requirements (Reg. (EC) 726/2004, Article 25a), EMA is obliged to set up a database for periodic safety update reports (PSUR) and the associated opinions. All PSUR procedures must be submitted electronically (according to Reg. 726/2004,…