The Federal Office for Safety in Health Care was informed by the Danish authority that it was informed by the Danish tissue bank "European Sperm Bank (formerly Nordic Cryobank)" (DK267572) about the disease of a sperm donor. Investigations showed that sperm donor 8311 / Bonne is heterozygous for mutation c.1062 + 5G> A in the FAH gene and thus a carrier of tyrosinemia type 1 (hepatorenal tyrosinemia, HT-1).

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…

The Federal Office for Safety in Health Care has been notified by the Danish authority that it has been informed by the Danish tissue bank Cryos International ApS (DK257551) about the disease of a 2-year-old child conceived with semen from donor 8151. The report of the disease describes a child with autism spectrum disorder (ASD).

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…

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…

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…

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…

Osurnia is indicated for the treatment of acute otitis externa and acute exacerbations of recurrent otitis externa caused by Staphylococcus pseudointermedius and Malassezia pachydermatis.

Shopping on the internet offers, in addition to seemingly unlimited choices and convenient time savings, one thing above all: anonymity. In particular, "sensitive" goods, such as sexual enhancers or lifestyle products, are often purchased via Internet retailers to avoid supposedly embarrassing moments at the doctor's or pharmacy. However, this means that one's own health is often (unknowingly) put at an incalculable risk.

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),…