Safety warnings | Blood & Tissue | 01/07/2021
The Federal Office for Safety in Health Care has been informed by the Italian authority that a human WNV case has occurred in the province of La Spezia (Liguria Region). ID WNV NAT testing for donations of blood and blood components has been introduced.
messages in brief | 30/06/2021
This issue of RMS NEWS again contains current and relevant news for our applicants for marketing authorisations with Austria as RMS.
Safety warnings | Medicines | 28/06/2021
Decrease in plasma donations with simultaneous increase in demand for immunoglobulins.
Safety warnings | Blood & Tissue | 28/06/2021
The Federal Office for Safety in Health Care has been informed by the Danish authority that it has been informed by the Danish tissue bank European Sperm Bank (DK257572) that three children have contracted distal arthrogryposis (DA) in connection with the use of semen from sperm donor 8466-BENT.
messages in brief | 17/06/2021
Up-to-date information from the May 17-20 meeting on new approvals, extensions of indication, newly published EPARs and recently started procedures.
Safety warnings | Blood & Tissue | 14/06/2021
The Federal Office for Safety in Health Care has been informed by the Danish authority that it has been informed by the Danish tissue bank Cryos International (DK257551) that the sperm donations of the donor ALMAR are associated with the diagnosis of ADHD (Attention Deficit Hyperactivity Disorder) in three children.
Safety warnings | Blood & Tissue | 07/06/2021
The Federal Office for Safety in Health Care has received an update from the European Commission regarding suspected adverse reactions to COVID-19 vaccine and the safety of SoHO.
messages in brief | 02/06/2021
On May 28, 2021, the use "for active immunization of individuals 12 years of age and older" was extended by the EMA.
Recall | Medicines | 27/05/2021
Recall of one affected batch of Vistabel because there is a risk of incorrect dilution and administration of double dose.
messages in brief | 25/05/2021
As of 22.5.2021, the function "Withdrawal according to §23 AMG" will be available in the area "Overview Medicinal Products".