European Medicines Agency recommendations on extension of shelf life for Tamiflu

Press release 08/05/2009

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.

In view of the recent outbreak of the novel influenza A/H1N1 virus, the European Medicines Agency has also reviewed ways to use Tamiflu capsules in case of a shortage. The Agency's Committee for Medicinal Products for Human Use (CHMP) recommended that Tamiflu capsules that are already on the market may be used for up to two more years after their current five-year expiry date during a declared pandemic. Patients who have Tamiflu capsules that have recently expired should not dispose of them because they might be needed during a novel influenza A/H1N1 pandemic.

The recommendations are made by the Committee as part of a wider request from Agency's Executive Director Thomas Lönngren to look into ways to prevent shortages of antiviral medicines and to ensure that the medicines are available to those who might need them. These recommendations will only apply if a pandemic has been declared by the World Health Organization (WHO).

Antiviral medicines such as Tamiflu play an important role in the management of an influenza pandemic. Unlike vaccines, which are normally not available during the early stages of a pandemic, antivirals can be used right from the onset of the pandemic. Governments worldwide have been stockpiling these medicines, including Tamiflu, to make them available to the public, in accordance with national preparedness plans.

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