EMA

WHO declares influenza pandemic - European Medicines Agency initiates crisis-management plan

The European Medicines Agency (EMEA)

Following the declaration of an influenza pandemic by the World Health Organization (WHO) on 11 June 2009, the European Medicines Agency (EMEA) has initiated its pandemic crisis-management plan. The plan allows for the accelerated assessment of influenza vaccines and antivirals, as well as their intensive safety monitoring when used during a pandemic.

EU-wide recall of Raptiva (efalizumab) to be initiated

The European Medicines Agency (EMEA)

The European Medicines Agency has agreed to an EU-wide recall of all of the remaining batches of Raptiva, from Merck Serono. This means that within the next few days all batches of Raptiva will be recalled from wholesalers, pharmacies and hospitals. Following this, the medicine will no longer be available anywhere in the European Union.

Public statement on possible interaction between clopidogrel and proton pump inhibitors

The European Medicines Agency (EMEA)

The European Medicines Agency is aware of studies suggesting that clopidogrel may be less effective in patients receiving proton pump inhibitor (PPI). This could result in patients being at an increased risk of thrombotic events, including acute myocardial infarction (heart attack).

European Medicines Agency recommendations on extension of shelf life for Tamiflu

The European Medicines Agency (EMEA)

The European Medicines Agency has recommended that the shelf life of Tamiflu capsules should be extended from five to seven years. Once formally approved by the European Commission, this will apply to all newly manufactured Tamiflu capsules.

EMEA-coordinated PROTECT project has been accepted for funding by the Innovative Medicines Initiative Joint Undertaking

The European Medicines Agency (EMEA)

The PROTECT project (Pharmacoepidemiological Research on Outcomes of Therapeutics by a European ConsorTium) has been accepted for funding by the Innovative Medicines Initiative Joint Undertaking (IMI JU). PROTECT is a collaborative European project aiming to develop innovative methods in pharmacoepidemiology and pharmacovigilance.

EMEA, EC and Health Canada agree implementation plan for confidentiality arrangement

The European Medicines Agency (EMEA)

The European Medicines Agency, the European Commission and Health Canada, the Canadian regulatory authority for medicines, have agreed on an implementation plan for their confidentiality arrangement. The implementation plan details the process for both regular and ad-hoc exchanges of information, and describes the process for monitoring the progress of the implementation plan. It also foresees an exchange programme for staff to promote mutual learning and sharing of regulatory experience.

Schering-Plough Europe withdraws its marketing authorisation application for Cylatron

The European Medicines Agency (EMEA)

The European Medicines Agency (EMEA) has been formally notified by SP Europe of its decision to withdraw its application for a centralised marketing authorisation for the medicine Cylatron (peginterferon alfa-2b), 200 micrograms /0.5 ml, 300 micrograms /0.5 ml and 600 micrograms/0.5 ml. Cylatron was expected to be used for the adjuvant treatment of patients with stage III melanoma as evidenced by microscopic, non-palpable nodal involvement.

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