EMA

European Medicines Agency launches new website

The European Medicines Agency (EMA) unveiled its new corporate website, the site has been completely redesigned and rebuilt to optimize usability for the Agency's key online audiences and build on existing activities to improve openness and transparency. The Agency website now receives an average of half a million unique visits per month and is a key resource for patients, healthcare professionals, regulators and those interested in the regulation and safety of medicines in the European Union.

European Medicines Agency starts review of rosiglitazone-containing medicines

The European Medicines Agency has started a review of the rosiglitazone-containing anti-diabetes medicines Avandia, Avandamet and Avaglim, to determine whether new data on the risk of cardiovascular problems have an impact on their benefit-risk profile. The review by the Agency's Committee for Medicinal Products for Human Use (CHMP) follows the recent publication of further studies on the cardiovascular safety of rosiglitazone.

Call for expression of interest for health professional and patient organisations representatives

The European Commission is looking for three representatives from patient organisations and three representatives from healthcare professional organisations to join the Paediatric Committee (PDCO) as full members for a new three-year mandate. This call is intended to replace the members who were appointed for the period starting on 1 August 2008. Current members may reapply.

European Medicines Agency and European Network of Centres for Pharmacoepidemiology & Pharmacovigilance (ENCePP) launch 'ENCePP studies'

On 8 June 2010 the European Medicines Agency and the European Network of Centres for Pharmacoepidemiology & Pharmacovigilance (ENCePP) launched 'ENCePP studies'. Building on the foundations of the ENCePP network of Excellence, 'ENCePP studies' is a seal for EU-based, benefit/risk or risk studies that are carried out in compliance with the ENCePP code of conduct for independence and transparency and its methodological research standards and are entered into a publicly available electronic register before their start.

New certification procedure designed to help small and medium-sized enterprises developing innovative medicines

The European Medicines Agency's Committee for Advanced Therapies (CAT) adopted the first opinion on the certification of experimental data generated for an advanced therapies medicinal product (ATMP) under development by a small and medium-sized enterprise (SME).

New Visual identity of the European Medicines Agency

The Agency unveiled its new visual identity on 8 December 2009. The new identity was developed primarily to ensure that the communications materials of the Agency are based on professionally designed templates, and created with a consistent look and feel. Communication with the public is an important aspect of the Agency's work, a second objective for developing the new visual identity was to ensure that the Agency's materials communicate to the public a clearer message about its role and activities.

European Medicines Agency advises of risk of fever in young children following vaccination with Pandemrix

The European Medicines Agency is warning that young children may experience fever after their second dose of the pandemic influenza vaccine Pandemrix. Prescribers and parents should monitor the temperature of the vaccinated child and, if necessary, take measures to lower the fever (e.g. giving an antipyretic such as paracetamol). However, the Agency noted that the second dose increases the immune response against pandemic influenza.

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