European Medicines Agency recommendations on extension of shelf life for Tamiflu

The European Medicines AgencyThe 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.

  • More information is available in a question-and-answer document.
  • Tamiflu is a centrally authorised medicine for the treatment and prevention of influenza in adults and children over the age of one year. The European public assessment report for Tamiflu is available here.
  • The assessment report of the CHMP with recommendations on the usability of expired Tamiflu in the event of a pandemic is available here.
  • A separate press release with information on the Agency's guidance on use of antiviral medicines in case of a novel influenza A/H1N1 pandemic is available here.
  • An EMEA review of influenza antiviral medicinal products for use in pandemics is available here.
  • More information on the work of the European Medicines Agency in relation to pandemic influenza vaccines is available here.
  • The European Commission and the European Centre for Disease Prevention and Control (ECDC) are responsible for the coordination of the European response to the public health threats posed by the influenza outbreak. The European Medicines Agency is working closely with them to support their work. An overview of the activities of the European Commission can be found at: http://ec.europa.eu/health/ph_threats/com/Influenza/influenza_en.htm Information about the work of the ECDC can be found at: http://ecdc.europa.eu/
  • Information about the work of the WHO can be found at: http://www.who.int/en/
  • This press release, together with other information about the work of the EMEA, is available on the EMEA website: http://www.emea.europa.eu/

Most Popular Now

AZD7442 PROVENT Phase III prophylaxis trial met pr…

Positive high-level results from the PROVENT Phase III pre-exposure prophylaxis trial showed AstraZeneca's AZD7442 achieved a statistically significant reduction in the i...

Lilly and Lycia Therapeutics enter into strategic …

Eli Lilly and Company (NYSE: LLY) and Lycia Therapeutics, Inc. today announced a multi-year research collaboration and licensing agreement focused on the discovery, devel...

SK bioscience and GSK start Phase 3 trial of adjuv…

SK bioscience (SK) and GlaxoSmithKline plc (GSK) today announced the initiation of a Phase 3 clinical study of SK's COVID-19 vaccine candidate, GBP510, in combination wit...

New study examines 'Achilles heel' of cancer tumou…

Researchers at the University of British Columbia's faculty of medicine and BC Cancer Research Institute have uncovered a weakness in a key enzyme that solid tumour cance...

AI algorithm solves structural biology challenges

Determining the 3D shapes of biological molecules is one of the hardest problems in modern biology and medical discovery. Companies and research institutions often spend ...

Blood vessels produce growth factor that promotes …

Blood vessels supply tumors with nutrients and, on the other hand, enable cancer cells to spread throughout the body. The settlement of circulating tumor cells in a dista...

A drug costing less than €2 a day helps in the tre…

Metoprolol, a drug widely used to treat cardiovascular disease, is beneficial when administered to COVID-19patients. This is the finding of a study by investigators at th...

Can a heartburn drug help doctors treat COVID-19?

In the early days of the COVID-19 pandemic, doctors in Wuhan noticed something surprising. Many of the elderly patients who survived the virus were poor: not exactly the ...

Rheumatoid arthritis treated with implanted cells …

With a goal of developing rheumatoid arthritis therapies with minimal side effects, researchers at Washington University School of Medicine in St. Louis have genetically ...

No serious health effects linked to mRNA COVID-19 …

Federal and Kaiser Permanente researchers combing the health records of 6.2 million patients found no serious health effects that could be linked to the 2 mRNA COVID-19 v...

Gut bacteria and flavonoid-rich foods are linked a…

Flavonoid-rich foods, including berries, apples, pears and wine, appear to have a positive effect on blood pressure levels, an association that is partially explained by ...

One in three Americans had COVID-19 by the end of …

A new study published in the journal Nature estimates that 103 million Americans, or 31 percent of the U.S. population, had been infected with SARS-CoV-2 by the end of 20...