EMA

European Medicines Agency recommends withdrawal of dextropropoxyphene-containing medicines

Finalising a review of the safety and efficacy of dextropropoxyphene-containing medicines, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that their risks, particularly the risk of potentially fatal overdose, are greater than their benefits. The Committee therefore recommended that the marketing authorisations for these medicines be withdrawn across the European Union.

European Medicines Agency launches public consultation on new transparency policy

The European Medicines Agency is inviting comments on its draft transparency policy until 25 September 2009. Since its inauguration in 1995, the Agency has worked continuously to improve the transparency of its operations, often extending the levels of transparency beyond the existing legal requirements. Bringing together all these initiatives, the new draft transparency policy describes for the first time in one comprehensive document the Agency's vision on its level of openness towards its stakeholders.

European public health agencies evaluate antibiotic resistance of Staphylococcus aureus

The European Food Safety Authority (EFSA), the European Centre for Disease Control and Prevention (ECDC) and the European Medicines Agency (EMEA) have published today a joint Scientific Report on meticillin resistant Staphylococcus aureus (MRSA) in livestock, pets and foods.

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

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 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 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 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.

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