Official announcements
Safety warnings
|
Blood & Tissue
|
31/08/2016
The Federal Office for Safety in Health Care has been informed by the Italian authority that WNV NAT testing will now be carried out in the province of Vicenza (Veneto Region) in addition to the regions already announced.
Safety warnings
|
Blood & Tissue
|
30/08/2016
Given the current circulation of Zika virus ,the evidence of an association between Zika virus infection during pregnancy and congenital malformations of the central nervous system (CNS), the association between Zikavirus infection and Guillain–Barré syndrome(GBS)and the risk of local vector-borne transmission in Europe during the 2016 summer season, EU/EEA Member States should consider a range of mitigation measures.
Safety warnings
|
Blood & Tissue
|
26/08/2016
The Federal Office for Safety in Health Care has been informed by the Italian authority that WNV NAT testing will now be carried out in the province of Milano (Lombardia Region) in addition to the regions already announced.
Safety warnings
|
Blood & Tissue
|
25/08/2016
The Federal Office for Public Health Safety has been informed by the Greek authority that four confirmed locally acquired malaria cases have been recorded in Greece (two in the western Peloponnese and two in central Macedonia).
Safety warnings
|
Blood & Tissue
|
23/08/2016
The Federal Office for Public Health Safety has been informed by the Italian authority that WNV NAT testing will now be carried out in the province of Ogliastra (Region of Sardinia) in addition to the regions already announced.
Safety warnings
|
Blood & Tissue
|
22/08/2016
The Federal Office for Public Health Safety has been informed by the Italian authority that WNV NAT testing will now be carried out in the provinces of Pavia and Lodi (Lombardia Region) in addition to the regions already announced.
Recall
|
Medicines
|
17/08/2016
The marketing authorization holder has informed its supplied customers in a letter dated August 2, 2016, that the above-mentioned batches of "Amiodarone 150 mg i.v. Carino" are being recalled. During a routine check of reserve samples,…
Safety warnings
|
Blood & Tissue
|
16/08/2016
The Federal Office for Safety in Health Care was informed by the Italian authority that two blood donors in the provinces of Mantova and Cremona (Lombardia Region) tested positive for WNV NAT. Furthermore, four symptomatic human WNV cases (two of which were neuroinvasive) were reported in the provinces of Verona, Rovigo (Veneto Region), and Reggio Emilia (Emilia Romagna Region).
Recall
|
Medicines
|
11/08/2016
The marketing authorization holder informed its supplied customers in a letter dated August 10, 2016, that the above-mentioned batches of Kogenate®Bayer are being recalled. Stability data for these batches indicated a faster than usual decline in…
Safety warnings
|
Blood & Tissue
|
10/08/2016
The Federal Office for Safety in Health Care has been informed by the Italian authority that WNV NAT testing will now be carried out in the province of Padova (Veneto Region) in addition to the regions already announced.