Official announcements
Recall
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Medicines
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29/09/2008
The following quality defect has been identified in the drug product Ionsys (Fentanyl) 40 microgram per dose iontophoretic transdermal system: A defect in the IONSYS systems may potentially cause the system to self-activate. See related files.
Replacement
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Medicines
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18/08/2008
Exchange of unbuffered and weakly buffered infusion solutions. See associated files.
Medicines
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18/01/2008
Communication from the Federal Office for Safety in Health Care on Gardasil. You related file.
Recall
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Medicines
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06/11/2007
Information on the suspension of marketing of parenterally administrable drug products containing aprotinin. See related files.
Recall
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Medicines
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31/08/2007
Information on market withdrawal of Clobutinol-containing drugs (Silomat®) up to and including patient level. See related files.
Medicines
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01/01/2006
Information on processing open registration and amendment requests submitted prior to Jan. 1, 2006. See related file.
messages in brief
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01/01/1970
The new RMS Flyer 2018 has been published on the BASG website: https://www.basg.gv.at/en/news-center/public-information-campaigns/austria-as-rms/rms-flyer/ . Looking forward to be the RMS for your products in the upcoming future!
messages in brief
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01/01/1970
Following the EMA Management Board confirmation and announcement in May 2017 that the database has achieved full functionality, the new version of EudraVigilance will go live on 22 November 2017 with enhanced functionalities for reporting and…
messages in brief
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01/01/1970
According to eSubmission-Roadmap purely national variation and renewal applications have to be submitted mandatorily in eCTD/VNeeS format after January 1, 2019. Please find further information at https://www.basg.gv.at/en/eservices/ectdvnees/ .