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 13, 2018, giving patients, physicians, healthcare professionals, nurses, pharmacists, scientists,…

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 anniversary. Chaired by DI Dr. Christa Wirthumer-Hoche, important topics were discussed, such as the agreement…

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 precautionary measure.

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 the changeover, the selection page for the individual eServices has also been expanded. For example,…

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 Module V, Revision 2, and an overview on current issues and news from the PRAC will conclude the event.…

The marketing authorization holder has informed its supplied customers in a letter dated May 25, 2018, that a blister strip of another product from the same active ingredient group has been discovered in batch W28311 in a single package. As a precautionary measure, the affected batch is therefore being recalled due to this possible submixture.

Important information about leaking syringes with some Glaxo SmithKline vacc ines Affected vaccines: Boostrix, Boostrix Polio, Engerix-B, Havrix, Infanrix hexa, Menjugate, Priorix, Priorix-Tetra, Tetanol Pur, Twinrix (adult and pediatric), Varilrix.Leaking syringes have been reported with the above vaccines in the course of vaccine preparation or…

The marketing authorization holder has informed its supplied customers in a letter dated April 23, 2018, that a reduced ethanol content was detected during routine release testing. Therefore, the batch 7F307A on the market is recalled as a precautionary measure.

The European Medicines Agency ( EMA) has launched registration for the public consultation. The consultation will take place on 13/06/2018 at the EMA premises. It will be an opportunity for patients, physicians, healthcare professionals, nurses, pharmacists, scientists, and any other interested parties to share their views and experiences with…

World Hemophilia Day 2018 Hemophilia is a congenital, lifelong increased bleeding tendency in which a deficiency or complete absence of certain blood components (clotting factors) leads to a disturbance of normal hemostasis. Approximately 850, predominantly male, individuals are affected in Austria. A distinction is made between hemophilia A and…