EMA

EMEA makes recommendations to minimise risk of nephrogenic systemic fibrosis with gadolinium-containing contrast agents

The European Medicines Agency (EMEA) has adopted a set of recommendations aimed at minimising the risk of nephrogenic systemic fibrosis (NSF) with gadolinium-containing contrast agents in patients at risk of developing the condition. Gadolinium-containing contrast agents are used in patients undergoing magnetic resonance imaging (MRI) or magnetic resonance angiography (MRA) scans.

European Medicines Agency 2009 mid-year report shows it is still on target, despite influenza pandemic activities

The European Medicines Agency is performing on target despite the increase of activities relating to the influenza pandemic. This was the message given by the Agency's Executive Director, Thomas Lönngren, when he presented the mid-year report to the Management Board at its meeting on 1 October 2009.

European Medicines Agency implements internal reorganisation

The European Medicines Agency has begun implementing a series of changes to its internal organisation aimed at improving the functioning of the Agency and the way in which it delivers its core tasks. The changes will be introduced gradually from September to December 2009.

European Medicines Agency recommends authorisation of additional vaccine for influenza pandemic (H1N1) 2009

The European Medicines Agency has recommended to the European Commission that an additional vaccine against influenza A(H1N1) ('swine flu'), Celvapan from Baxter, be granted a marketing authorisation. Adoption of an authorisation decision by the European Commission is expected shortly. This recommendation follows the authorisation of Focetria, from Novartis, and Pandemrix, from GlaxoSmithKline, by the European Commission on 29 September 2009.

European Medicines Agency recommends authorisation of two vaccines for influenza pandemic (H1N1) 2009

The European Medicines Agency has recommended to the European Commission that two vaccines against influenza A(H1N1) ('swine flu') be granted a marketing authorisation. Vaccines are one of the most important tools in the management of an influenza pandemic, helping to reduce illness and deaths by building up immune protection against the pandemic flu virus.

The bacterial challenge - time to react

There is a need for more development of antibiotics that are effective against multidrug-resistant bacteria. That is the conclusion of a new report prepared jointly by the European Centre for Disease Prevention and Control (ECDC) and the European Medicines Agency (EMEA) with contributions from the international network Action on Antibiotic Resistance (ReAct).

EMEA and FDA launch Good Clinical Practice Initiative

The European Medicines Agency and the FDA have agreed to launch a joint initiative to collaborate on international Good Clinical Practice (GCP) inspection activities. This initiative comes under the scope of the confidentiality arrangements between the European Commission, the European Medicines Agency and the US FDA. The objectives of the initiative include the sharing of information on inspection planning, policy and outcomes and the conduct of collaborative inspections.

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