Official announcements
messages in brief
|
22/10/2020
Excipients used in the manufacture of active ingredients (such as lactose, whey, sucrose, honey, ethanol, glycerol) that may be present in trace amounts in the finished product have been re-evaluated according to the Excipients guideline and no longer need to be mentioned in the product information if they are less than or equal to a certain threshold. Above this threshold, a listing in FI and GI is required and the corresponding warnings must be mentioned in the product information.
Safety warnings
|
Blood & Tissue
|
19/10/2020
The Federal Office for Safety in Health Care was informed by the ECDC that there has been a confirmed human cases of WNV infection in Bulgaria in the province of Pazardjik.
Safety warnings
|
Blood & Tissue
|
19/10/2020
The Federal Office for Safety in Health Care has been informed by the ECDC that there has been a confirmed human cases of WNV infection in the Utrecht region of the Netherlands.
Safety warnings
|
Blood & Tissue
|
12/10/2020
The Federal Office for Safety in Health Care was informed by the ECDC that human cases of WNV infection have been recorded in Romania in addition to those already known in the Satu Mare and Ialomita regions.
Safety warnings
|
Blood & Tissue
|
12/10/2020
The Federal Office for Public Health was informed by the Italian authority that a confirmed human infection with WNV has been recorded in the province of Vicenza (Veneto).
Safety warnings
|
Blood & Tissue
|
12/10/2020
The Federal Office for Safety in Health Care has been informed by the ECDC that confirmed human cases of WNV infection have occurred in Germany in Anhalt-Bitterfeld and Halle (Saale).
messages in brief
|
05/10/2020
The new position paper focuses on managing supply bottlenecks by improving processes and transparency and serves to clarify the role of players in the distribution chain.
Enforcement
|
30/09/2020
Supposed natural product turns out to be a counterfeit
Recall
|
Medicines
|
30/09/2020
Precautionary recall because the efficacy may be reduced.
Recall
|
Medicines
|
30/09/2020
Recall of one batch of Adolorin Ibuforte 400 mg Dragees due to reduced release of the active substance.