Official announcements
Recall
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Medicines
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05/07/2018
The marketing authorization holder has informed its supplied customers in a letter dated 05.07.2018 that an impurity was detected during the review at the active ingredient level. This impurity is classified as potentially carcinogenic. Therefore, a…
Recall
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Medicines
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05/07/2018
In a letter dated July 5, 2018, the marketing authorization holder informed its customers that the active ingredient manufacturer had detected the production-related impurity N-nitrosodimethylamine (NDMA) in the active ingredient valsartan.…
Recall
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Medicines
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05/07/2018
The marketing authorization holder has informed its customers in a letter dated December 31, 2009, that a production-related impurity has arisen at the active ingredient manufacturer during a synthesis step. This impurity is N-nitrosodimethylamine…
Recall
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Medicines
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05/07/2018
The marketing authorization holder informed its supplied customers in a letter dated December 31, 2009, that a production-related impurity occurred during a synthesis step at the active ingredient manufacturer's. The impurity is…
messages in brief
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29/06/2018
The Federal Office for Safety in Health Care (BASG) was obligated within the framework of a conciliation procedure pursuant to Section 14 of the Federal Disability Equality Act (Bundes-Behindertengleichstellungsgesetz) to request the holders of…
messages in brief
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26/06/2018
The European Medicines Agency ( EMA) held the public consultation on the impact of potential adverse reactions to fluoroquinolones, a group of antibiotics commonly prescribed in the European Union (EU) (such as ciprofloxacin, ofloxacin, etc.) on June…
messages in brief
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15/06/2018
On the occasion of the 100th meeting of the EMA Management Board, it was not only a matter of efficiently dealing with an extensive agenda, but also of bringing together all former Management Board Chairs and EMA Directors in view of this…
Recall
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Medicines
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12/06/2018
The marketing authorization holder has informed its supplied customers in a letter dated 11.06.2018 that visible particles were found in part of a production batch during quality control. For this reason, the above batch is being recalled as a…
messages in brief
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09/06/2018
As of 6/20/2018, you will find a redesigned interface when logging in to PHAROS eServices. Please take note of this in your daily work. The login data will not change. If you have any questions, please contact basg-eservices@ages.at In the course of…
messages in brief
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29/05/2018
During this event PHV experts of the BASG will provide an overview on ICSR-Reporting, Signal-Management, the implementation of PHV-issues, as well as an update on PSUR, PSUSAs und ACOs. A Report about our experience in the implementation of GVP…