Environmental Risk Assessment Environmental Risk Assessment (ERA) human Gelten die Bestimmungen betreffend ERA auch für rein nationale Zulassungen? Environmental Risk Assessment veterinär Wann ist ein [...] Guideline on the environmental-risk assessment of medicinal products for human use 01 June 2006 EMEA/CHMP/SWP/4447/00 Corr 2 Questions and answers on the Guideline on the environmental risk assessment of medicinal [...] Zulassungen? Die Anforderungen sind für alle Verfahrensarten gleich. Environmental Risk Assessment veterinär Das Environmental Risk Assessment (ERA) soll entsprechend der beiden Guidelines VICH GL6 (CVMP/VI

Am 30.11.2018 wurde ein Entwurf der neuen EMA Leitlinie zum Environmental Risk Assessment humaner Arzneimittel auf der Homepage der EMA veröffentlicht. Gleichzeitig hat die öffentliche Kommentierungsphase, die am 30.06.2019 endet, begonnen. Der Zweck…

Italy is currently experiencingfour clusters of autochthonous chikungunya cases in the cities of Anzio,Latina and Rome in the Lazio region,and the city of GuardavalleMarinain theCalabria region. Autochthonous transmissionof mosquito-borne infectionsis not unexpectedin areas where Aedes albopictusmosquitoes are established and at a time when environmental conditions are favouring mosquito abundance and activity.

Verlinkt bei:

• Clusters of autochthonous chikungunya cases in Italy: First Update

Two related clusters involving autochthonous transmission of chikungunya virus have been detected in the cities of Anzio and Rome, two areas located 60 km apart in the Lazio region of Italy. Transmission of this type, in areas where Aedes albopictusmosquitoes are established and at a time when environmental conditions are suitable for increased mosquito abundance and activity, is not unexpected.

Verlinkt bei:

• Clusters of autochthonous chikungunya cases in Italy

Das Bundesamt für Sicherheit im Gesundheitswesen möchte auf das aktuelle Rapid Risk Assessment der ECDC (European Centre for Disease Prevention and Control) zu den Affenpocken hinweisen.

Symptoms associated with Zika virus (ZIKV) infection are generally mild and most people who become infected do not develop any symptoms. However, since the 2015‒2017 epidemic in the Americas, ZIKVhas been recognised asbeingassociated with severe neurological disorders

Verlinkt bei:

• Zika virus transmission worldwide

Dem Bundesamt für Sicherheit im Gesundheitswesen wurde von der portugiesischen Behörde mitgeteilt, dass ein Ausbruch der Legionärskrankheit(Legionellose) in Portugal verzeichnet wurde.

Chikungunya case in Spain without travel history to endemic areas

Verlinkt bei:

• Chikungunya case in Spain without travel history to endemic areas
• Chikungunya Karibik Süd-Amerika

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.

Verlinkt bei:

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

European Union/European Economic Area(EU/EEA)Member States should consider a range of mitigation measures

Verlinkt bei:

• Zika virus disease epidemic ninth update