What's new
Information from the previous month appears monthly in the newsletter “What'sNew” (link to registration page).
For the RSS feed with daily notifications of updates, use the link: RSS feed for “What'sNew”.
10/06/2025
Referenced at:
Sertraline New
PRAC signal recommendation
|
06/06/2025
Risk for Multiple acyl-coenzyme A dehydrogenase deficiency (MADD). Further information and amendments to the product information can be found on the EMA website.
Safety warnings
|
Blood & Tissue
|
06/06/2025
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 2 offspring of the sperm donor 8860 RUMLE have been diagnosed with DiGeorge syndrome (22q11 deletion syndrome).
The donor/gametes were permanently blocked.
06/06/2025
Dem Bundesamt für Sicherheit im Gesundheitswesen wurde von der dänischen Behörde mitgeteilt, dass sie von der dänischen Gewebebank European Sperm Bank (DK257572) darüber informiert wurde, dass bei 2 Nachkommen des Samenspenders 8860 RUMLE das DiGeorge Syndrom (22q11 Deletionssyndrom) diagnostiziert wurde.
Der Spender/die Spendergameten wurden permanent gesperrt.
Referenced at:
CHMP Monthly News
|
04/06/2025
Up-to-date information from the 19.05.-22.05.2025 meeting on new approvals, extensions of indication, newly published EPAR's and recently started procedures.
04/06/2025
STILISTISCHE BELANGE Stilistische Belange Dokument-Nr.: L_LCM_VIE_REGA_Z44_08 Gültig ab: 06.06.2025 1/5 Institut LCM Abteilung REGA STILISTISCHE BELANGE Nationale Vorgaben für FI/GI/KE (Produktinforma
Referenced at:
Sulfamethoxazole, trimethoprim (cotrimoxazole) New
PRAC signal recommendation
|
03/06/2025
Risk for Circulatory shock. Further information and amendments to the product information can be found on the EMA website.
messages in brief
|
02/06/2025
To better monitor and, if necessary, counteract supply shortages of medicinal products at EU level, the European Shortages Monitoring Platform (ESMP) was established by the EMA in accordance with the Regulation (EU) 2022/123. The full version of the platform was launched in January 2025.
Recall
|
Medicines
|
02/06/2025
Recall due to visible particles in solution