What's new
Newsletters "UptoDate" of BASG/AGES MEA are published monthly and contain the latest articles from the last month (link to subscription page).
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Searched for "active".
Recall
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Medicines
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26/06/2017
The marketing authorization holder has informed its supplied customers in a letter dated June 21, 2017, that in the course of stability tests a trend towards a decrease of the active ingredient "Ambroxol hydrochloride" towards the end of the term has…
19/05/2017
Diese Gebührenverordnung findet Anwendung auf alle Anbringen, die ab dem 01.06.2017 beim BASG eingegangen sind.
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10/04/2017
Advice) V.3.a bei im EWR neuen Wirkstoffen ("new active substances"), sowie Biosimilars 8959 EURO V.3.b bei im EWR bekannten Wirkstoffen ("existing active substances") 5600 EURO 4) Anlage V.7 wird wie folgt
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Enforcement
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06/04/2017
For the past few years informations concerning a substance called “GcMAF” have been circulating the internet. Several online sources denote GcMAF as harmless treatment for diverse illnesses, such as autism, different viral infections (HIV, Hepatitis B and C, influenza, etc.), chronic fatigue syndrome, autoimmune diseases (ALS, MS, etc.) and especially various cancers.
messages in brief
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29/03/2017
The International Coalition of Medicines Regulatory Agencies (ICMRA) admitted the Federal Office for Healthcare Safety/AGES Medical Market Surveillance as an associate member on March 20, 2017. ICMRA is a forum composed globally of the heads of a…
28/02/2017
with BASG / AGES MEA necessary resources, staff and infra- structure. When carrying out sovereign activities, the employees of AGES MEA are acting on behalf of BASG. Responsibilities of AGES MEA include providing
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Recall
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Medicines
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23/02/2017
The marketing authorization holder has informed its supplied customers in a letter dated 22.2.2017 that a possible contamination with another active ingredient has been discovered at the manufacturer. For this reason, a recall of the above-mentioned…
messages in brief
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21/02/2017
Since toxic pyrrolizidine alkaloids (PAs) were detected in high concentrations in herbal medicinal products produced from plants that do not biosynthesize PAs themselves, in March 2016 BASG published risk-minimizing measures that were to be…
Safety warnings
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messages in brief
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30/01/2017
New recommendations for levonorgestrel emergency contraceptives in case of interactions with CYP3A4-inducing drugs. In Austria, the current recommendations of the European Medicines Agency are being implemented following a technical review of…
15/12/2016
Beratung (Scientific Advice) V.3.a bei neuen Wirkstoffen ("new active substances") 8959 EURO V.3.b bei bekannten Wirkstoffen ("existing active substances") 5600 EURO V.4 Labortechnische Analysen für andere
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