Official announcements
Safety warnings
|
Medical devices
|
28/07/2025
The Federal Office for Safety in Health Care (BASG) has been informed about the counterfeit product "NovoFine Plus 32G 4mm" with the batch number NE61324-2 from the manufacturer Novo Nordisk A/S.
Safety warnings
|
Medical devices
|
28/07/2025
The Federal Office for Safety in Health Care (BASG) has been informed that the following products have been counterfeited:
- Unbreakable by TCS
- IFlex by TCS
- Karadent by TCS
CHMP Monthly News
|
24/07/2025
Up-to-date information from the 16.06.-19.06.2025 meeting on new approvals, extensions of indication, newly published EPAR's and recently started procedures.
Safety warnings
|
Medical devices
|
18/07/2025
The Federal Office for Safety in Health Care (BASG) warns against the disinfection system with peroxide 3 % from the manufacturer DISOP S.A. Only certain batch numbers are affected.
Recall
|
Medicines
|
17/07/2025
Recall due to possible microbial contamination
Recall
|
Medicines
|
16/07/2025
Recall due to possible microbial contamination
messages in brief
|
14/07/2025
Publication of a joint declaration by the competent national EU authorities to the EU Commission.
Safety warnings
|
Blood & Tissue
|
10/07/2025
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 Cryos International - Aarhus ApS that the donor BLICHER has been diagnosed with ADHD. As there is a slightly increased risk (1-12%) of ADHD in donor conceived children, the donor gametes are blocked.
messages in brief
|
02/07/2025
Starting in July 2025, BASG/AGES MEA will provide an Excel export of the packages available in our database for each human medicinal product. This is also intended to support data entries in SPOR-PMS and XEVMPD (Article 57). Detailed information can be found in the following guide (L_Z34).