- 15 363 16 - 17 333 18 - 44 26.770 45 - 64 16.237 65 - 75 2.438 über 75 1.672 1.678 98 363 333 26.770 16.237 2.438 1.672 0 5.000 10.000 15.000 20.000 25.000 30.000 unbekannt 5 - 11 12 - 15 16 - 17 18 - [...] AstraZeneca 1.588.519 19.080 12,01 Janssen 363.866 1.378 3,79 Nuvaxovid 6.145 16 2,60 Gesamt 18.183.683 49.589 2,73 32.974 16.456 159 Weiblich Männlich divers/inter/offen/unbekannt Bericht über Meldungen [...] ung der Personen mit vermuteten Nebenwirkungen Geschlecht Anzahl Personen Weiblich 32.974 Männlich 16.456 divers/inter/offen/unbekannt 159 Anzahl der Meldungen von vermuteten Nebenwirkungen Tabelle 3.

Referenced at:

• Reports COVID-19 Vaccination

that substantial changes be subject to authorization. What is considered a "substantial change"? "Place of actual import" - who needs a corresponding permit? Why does the date of the authorisation (WDA [Wholesale [...] found, their irreversible elimination must be initiated in a documented manner (plan of action in the course of the hearing of the parties) before a license can be issued. The authorisation is issued by the [...] reached the end of the substantive inspection. I intend to move my location. What has to be done? A relocation is a substantial change within the meaning of Section 65 of the Austrian Medicines Act (AMG). "Section

e/n - - 13 3 13 - - Pulmonalklappe/n - - 4 17 16 - - Gefäße 9 9 19 3 9 - Pericard - - - - - - - Anderes Gesamt : 17 16 - 5 - - - aufgeteilt in: Herz 17 16 - - - - - Pulmonalis- bifurkation - - - 5 8 - [...] Femur komplett 16 26 4 - - - 1 Femurkopf,- hals 1636 1620 392 582 429 - 94 Diaphyse - - 19 23 17 - 8 Corticalis - - 155 38 21 - 4 Spongiosa - - 2842 1211 8183 36 - Tibia: Tibia komplett 16 2 4 - - - 1 Diaphyse [...] Verteilung Endprodukt Ausfuhr Einfuhr Knochenmark 33 21 795 27 40 1 16 Periphere Blutstammzellen (PBSC) 900 609 7027 864 1333 6 58 Donorlymphozyten 16 13 456 18 102 2 6 Nabelschnurblut 1517 716 2998 23 666 4 19

Referenced at:

• Tissue vigilance

Dem Bundesamt für Sicherheit im Gesundheitswesen wurde von der italienischen Behörde mitgeteilt, dass es zusätzlich zu den bereits bekannt gegebenen Regionen in Genua (Region Liguria) und in Asti (Region Piemonte) zu bestätigten humanen WNV Fällen gekommen ist.Außerdem wurde in folgenden Regionen aufgrund der Auffindung von WNV NAT positive Moskitos, Vögel bzw. Pferden, für Spender von Blut und Blutkomponenten die ID WNV NAT Testungen eingeführt: Rom (Region Lazio), Matera (Region Basilicata), Süd-Sardinien, Cagliari, Sassari, Oristano und Nuoro (Region Sardinien) sowie Pordenone (Region Friuli-Venetia Giulia).

Referenced at:

• WNV Update Italy

bridging requirements for applications under Article 10a of Directive 2001/83/EC (‘well-established use’/WEU). The MWP recommendation includes a Q&A document that further clarifies the requirements for bridging [...] Zero Day MR procedures. The CMDh agreed on a new procedural advice on Zero Day MR procedures. The Zero Day procedure is a mutual recognition procedure with a shortened timetable that can be initiated in [...] February 2023 and specifies whether the requirements for a renewal, a variation or both apply. It also lists those Member States that require a full documentation in standard renewal procedures under their

Recall due to deviations from the specified values regarding appearance and pH value

against heterovariant influenza virus strain A/Fujian/2002 than a subunit and a split influenza vaccine. Vaccine 2006;24(16):3063-3065 73. O‘Hagan DT et al.: MF59 is a safe and potent vaccine adjuvant for flu [...] 8. AEFI: Überblick und Management Zum Management von AEFI sei auf die Abbildungen 3a und 3b verwiesen (Seiten 15, 16, und 17). ■ Dieses Projekt wurde durch die Medizinische Universität Wien ohne jegliches [...] Safety of thimerosal-containing vaccines: a two-phased study of computerized health maintenance organization databases. Pediatrics 2003;112(5):1039-1048 27. Hviid A et al.: Association between thimerosal

Referenced at:

• Vaccines

The EMA adopted the new recommendations for the composition of seasonal influenza vaccines for the season 2021/2022 (published 30 March 2021)

In addition to isolated cases of tampered Italian Herceptin distributed in parallel, tampered MabThera of Romanian origin has now emerged.

The spread of the Zika virus epidemic in the Americas is likely to continue as the competent vectors Aedes aegypti and Aedes albopictus mosquitoes are widely distributed there. There is also a significant increase in the number of babies born with microcephaly in the north-eastern states of Brazil, however, the magnitude and geographical spread of the increase have not yet been well characterised.

Referenced at:

• Zika virus disease epidemic: potential association with microcephaly and Guillain-Barré syndrome (first update)