Pandemic influenza: news archive

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The European Medicines Agency communicated frequently on its main developments during the 2009 (H1N1) influenza pandemic.

An archive of the news related to the pandemic is available below.

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European Medicines Agency publishes final pandemic pharmacovigilance update: 19/08/2010

Following the World Health Organization's announcement that the world has moved into a post-pandemic period, the European Medicines Agency has published the last of its pandemic pharmacovigilance updates. These updates, which have been published regularly since December 2009, provide a summary of the adverse drug reactions reported in people receiving the centrally-authorised pandemic-influenza vaccines and antivirals in the European Union (EU). They also include information on the evolution of the H1N1 pandemic, the number of doses of vaccines and antivirals distributed or administered in Europe, and the medicines' benefits and risks.

The 22nd and final update includes adverse event reports received by the Agency up to 8 August 2010. By this date, at least 38.6 million people had been vaccinated with the vaccines Celvapan, Focetria or Pandemrix. The vast majority of the adverse events reported in people receiving these vaccines or the antiviral Tamiflu (oseltamivir) are considered to be non-serious. The other two vaccines, Arepanrix and Humenza, have not been marketed in the EU.

Although the pandemic is now over, as for all medicines, the Agency will continue to monitor the safety of these vaccines and antivirals closely. The Agency will publish any changes to the marketing authorisations for these medicines that may become necessary in the future.

European Commission approves use of Celvapan, Focetria and Pandemrix outside pandemic: 12/08/2010

Following the World Health Organization's announcement that the influenza pandemic is over, the European Commission approved the use of the pandemic-influenza vaccines Celvapan, Focetria and Pandemrix outside a declared influenza pandemic to protect against influenza caused by the A/H1N1 virus strain.

The Commission's decision was based on a scientific recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP), adopted on 23 April 2010 and revised on 24 June 2010. This recommendation was based on data from clinical and non-clinical studies, from post-marketing surveillance and from the use of these vaccines in at least 40 million people in the European Economic Area since September 2009.

World Health Organization announces end of influenza pandemic: 10/08/2010

On 10 August 2010, the World Health Organization (WHO) announced that the influenza pandemic is over and the world is no longer in phase 6 of pandemic alert.

Following advice from the International Health Regulation Emergency Committee, the WHO Director General declared that the pandemic (H1N1) 2009 has entered the post-pandemic phase. This advice was based on a information indicating that influenza activity worldwide has returned to levels that are normally seen for seasonal influenza.

For more information, see the announcement by the WHO.

European Commission approves Humenza for use in H1N1 pandemic: 08/06/2010

On 8 June 2010, the European Commission granted an European Union-wide marketing authorisation for the H1N1 pandemic-influenza vaccine Humenza, from Sanofi Pasteur S.A.

The Commission's authorisation decision was based on a scientific recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP), adopted on 19 February 2010.

For more information on Humenza, see the European public assessment report.

CHMP recommends marketing authorisations for Celvapan, Focetria and Pandemrix be updated to allow use outside pandemic: 23/04/2010

The Committee for Medicinal Products for Human Use (CHMP) has reviewed further information on the centrally authorised pandemic influenza vaccines Celvapan, Focetria and Pandemrix. The Committee has concluded that the additional data, which come from clinical and non-clinical studies, from post-marketing surveillance and from the use of these vaccines in at least 40 million people in the European Economic Area since September 2009, are sufficient to allow these vaccines to be used outside a declared influenza pandemic.

For more information, see the product information showing the recommended changes for Celvapan, Focetria and Pandemrix.

European Commission approves Arepanrix for use in H1N1 pandemic: 23/03/2010

On 23 March 2010, the European Commission granted an European Union-wide marketing authorisation for the H1N1 pandemic-influenza vaccine Arepanrix, from GlaxoSmithKline Biologicals.

The Commission's authorisation decision was based on a scientific recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP), adopted on 22 January 2010.

For more information on Arepanrix, see the European public assessment report.

European Medicines Agency recommends update of product information for Celvapan to include data from clinical studies: 19/03/2010

As part of its review of data from clinical studies and post-marketing experience for centrally authorised pandemic influenza vaccines, the Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended changes to the product information of Celvapan to include additional information on the vaccine’s immunogenicity and safety. The latest data show no unexpected serious safety issues. The most frequent adverse reactions that have been reported are non-serious and as expected.

For more information on Celvapan, see the European public assessment report.

CHMP recommends fifth pandemic vaccine for marketing authorisation: 19/02/2010

The Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the granting of a conditional marketing authorisation for Humenza from Sanofi Pasteur SA. This is the fifth pandemic vaccine recommended for use by the Committee, and the second to be assessed using an emergency procedure which fast-tracks the evaluation of new vaccines developed during a pandemic influenza. Information on Humenza was evaluated in an accelerated timeframe using a rolling review that started with the submission of the first available data on 23 June 2009.

A European Commission decision is expected shortly.

Immunogenicity tests for Celvapan – outcome of a meeting of vaccination experts: 19/02/2010

In the margins of the February 2010 meeting of the Agency’s Committee for Medicinal Products for Human Use (CHMP), a group of vaccination experts was convened to further analyse the variability seen in the serological tests used to measure the immune response following vaccination of children and adults with the centrally authorised pandemic vaccine Celvapan. Following discussion with the experts, the Committee concluded that the variability did not change the Committee’s view that the vaccine is sufficiently immunogenic in all age groups when administered in accordance with the approved dosage recommendation of two doses at an interval of at least three weeks.

European Medicines Agency gives opinion on compassionate use of intravenous zanamivir: 18/02/2010

The Agency’s Committee for Medicinal Products for Human Use (CHMP) has given an opinion on the compassionate use of an intravenous formulation of zanamivir, IV Zanamivir. This medicine will be used to treat critically ill patients with a life-threatening condition due to suspected or confirmed pandemic or seasonal flu, who cannot be treated with other antiviral medicines by mouth or inhalation.

IV Zanamivir is an unauthorised medicine that is a new development of zanamivir for intravenous use. It is intended for a target population that is different from that of Relenza, which is inhaled. Relenza is authorised individually by all EU Member States through the mutual-recognition procedure, co-ordinated by the Medical Products Agency in Sweden.

For more information, see the CHMP opinion on the conditions of use, conditions for distribution and target population and information on compassionate use.

European Medicines Agency recommends fourth pandemic vaccine for approval: 22/01/2010

The Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the granting of a conditional marketing authorisation for a fourth pandemic vaccine, Arepanrix from GlaxoSmithKline Biologicals. This recommendation was made using an emergency procedure which fast-tracks the evaluation of new vaccines developed during a pandemic. Information on Arepanrix was evaluated in an accelerated timeframe using a rolling review that started with the submission of the first available data on 17 July 2009. Further clinical studies in children, adolescents and adults are ongoing and results will become available from March 2010 onwards.

A European Commission decision is expected shortly.

European Medicines Agency recommends update of product information for Pandemrix to include more data from studies in children: 22/01/2010

The Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended updating the product information of Pandemrix to include additional data on immunogenicity and safety in three- to nine-year-old children after the first half dose of Pandemrix. The data confirm the expected reactogenicity and immunogenicity profile.

For more information on Pandemrix, see the European public assessment report.

European Medicines Agency recommends update of product information for Tamiflu: 22/01/2010

The Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended updating the product information for Tamiflu (oseltamivir). The updated product information gives information on the use of Tamiflu in premature infants and its use to prevent influenza in immunocompromised patients who have been exposed to the virus.

For more information on Tamiflu, see the European public assessment report.

European Medicines Agency gives opinion on compassionate use of intravenous oseltamivir: 20/01/2010

The Agency’s Committee for Medicinal Products for Human Use (CHMP) has given an opinion on the compassionate use of an intravenous formulation of oseltamivir, Tamiflu IV. This medicine will be used to treat critically ill patients with a life-threatening condition due to suspected or confirmed pandemic or seasonal flu, who cannot take authorised antivirals by mouth or inhalation.

Tamiflu IV is an unauthorised medicine that is a new development of oseltamivir for intravenous use. It is intended for a target population that is different from that of the centrally authorised medicine Tamiflu, which is taken by mouth.

For more information, see the CHMP opinion on the conditions of use, conditions for distribution and target population and information on compassionate use. A press release announcing this compassionate use opinion is also available.

European Medicines Agency publishes fourth weekly pandemic pharmacovigilance report: 23/12/2009

The European Medicines Agency has published the fourth in its series of weekly pandemic influenza pharmacovigilance update reports.

At least 28 million people including at least 218,000 pregnant women have been vaccinated to date in Europe with one of the three centrally authorised vaccines.  The most frequent adverse reactions that have been reported are non-serious and as expected. The benefit-risk balance of the pandemic vaccines and antivirals used for the current H1N1 influenza pandemic continues to be positive.

For more information, see the report.

The Agency will continue to publish these reports on a regular basis while the influenza pandemic is ongoing.

European Medicines Agency updates on pandemic medicines: 18/12/2009

The European Medicines Agency has reviewed further data on the centrally authorised pandemic medicines, the pandemic influenza vaccines Celvapan, Focetria and Pandemrix, and the antiviral Tamiflu (oseltamivir).

For more information, see the press release and the European public assessment reports for Celvapan, Focetria, Pandemrix and Tamiflu.

European Medicines Agency publishes third weekly pandemic pharmacovigilance report: 16/12/2009

The European Medicines Agency has published the third in its series of weekly pandemic influenza pharmacovigilance update reports.

At least 26 million people and 213,000 pregnant women have been vaccinated to date in Europe with one of the three centrally authorised vaccines. No unexpected serious safety issues have been identified. The most frequent adverse reactions that have been reported are non-serious and as expected. The benefit-risk balance of the pandemic vaccines and antivirals used for the current H1N1 influenza pandemic continues to be positive.

For more information, see the report.

European Medicines Agency publishes second weekly pandemic pharmacovigilance report: 09/12/2009

The European Medicines Agency has published the second in its series of weekly pandemic influenza pharmacovigilance update reports.

The benefit-risk balance of the pandemic vaccines and antivirals used for the current H1N1 influenza pandemic continues to be positive. To date, no unexpected serious safety issues have been identified. The most frequent adverse reactions that have been reported are non-serious and as expected.

For more information, see the report.

European Medicines Agency advises of risk of fever in young children following vaccination with Pandemrix: 04/12/2009

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.

For more information, see the press release and questions and answers. For more information on Pandemrix, see the European public assessment report.

European Medicines Agency publishes first weekly pandemic influenza pharmacovigilance report : 03/12/2009

The European Medicines Agency has published the first in its series of weekly pandemic influenza pharmacovigilance update reports.

These weekly reports will provide information on adverse reactions reported after the use of centrally authorised pandemic vaccines and antivirals in the European Union, and complement the information the Agency has been publishing regularly on the development and approval of medicines for use during the pandemic.

For more information, see the press release and the first weekly report.

European Medicines Agency reaffirms efficacy and safety of A/H1N1 pandemic vaccines: 20/11/2009

The European Medicines Agency has reviewed further data on the centrally authorised pandemic vaccines Celvapan, Focetria and Pandemrix. The Agency has reaffirmed the positive balance of benefits and risks of these vaccines in the context of the current A/H1N1 influenza pandemic.

The Agency also recommended further changes to the product information for Focetria and Pandemrix.

For more information, see the press release and the European public assessment reports for Celvapan, Focetria and Pandemrix.

European strategy for benefit-risk monitoring of influenza A/H1N1 vaccines adopted: 05/11/2009

The European Medicines Agency, the European Centre for Disease Prevention and Control (ECDC) and the Heads of Medicines Agencies have adopted a strategy to further strengthen the coordination of benefit-risk monitoring for influenza A/H1N1 vaccines.

For more information, see the European strategy for influenza A/H1N1 vaccine benefit-risk monitoring.

EMEA scientific committee recommends updating product information for Focetria and Pandemrix: 23/10/2009

Following its review of clinical data made available since the approval of three H1N1 influenza vaccines, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended to the European Commission that the product information for two of these vaccines, Focetria and Pandemrix, be updated.

For more information, see the press release, questions and answers and the European public assessment reports for Focetria and Pandemrix.

European Commission approves Celvapan for use in H1N1 pandemic: 12/10/2009

On 6 October 2009, the European Commission granted an European Union-wide marketing authorisation for the H1N1 pandemic-influenza vaccine Celvapan, from Baxter AG.

The Commission's authorisation decision was based on a scientific recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP), adopted on 2 October 2009.

For more information on Celvapan, see the European public assessment report.

European Medicines Agency recommends authorisation of Celvapan for use against pandemic influenza: 02/10/2009

Following the authorisation of Focetria and Pandemrix on 29 September 2009, the Agency has recommended that a third pandemic-influenza vaccine, Celvapan from Baxter, be authorised by the European Commission for use in protecting European Union citizens against pandemic influenza.

A European Commission decision is expected shortly.

For more information, see the press release.

European Medicines Agency recommends updating Tamiflu product information: 01/10/2009

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has given recommendations to update the product information for Tamiflu (oseltamivir), from Roche Registration Ltd. The updated product information gives more information on the use of Tamiflu in the treatment of influenza in children under the age of six months and in post-exposure prevention of influenza in children under the age of one year during a pandemic influenza outbreak.

In addition, the Committee has also recommended the approval of detailed instructions on the preparation and dosing of ‘extemporaneous’ formulations for children under the age of one. An extemporaneous formulation of a medicine is a formulation that is prepared just prior to use. In this instance the instructions cover how to prepare solutions to be given to young babies using Tamiflu capsules.

The recommended changes are based on guidance adopted by the CHMP in May 2009 on the use of antiviral medicines during an influenza pandemic.

For more information on Tamiflu, see the European public assessment report.

European Commission approves Focetria and Pandemrix for use in the H1N1 influenza pandemic: 30/09/2009

The European Commission has granted authorisations that will allow the influenza vaccines Focetria and Pandemrix to be used to vaccinate people against the virus causing the current H1N1 influenza pandemic.

The Commission's decision follows the scientific recommendations adopted in respect of these vaccines by the European Medicines Agency's Committee for Medicinal Products for Human Use on 24 September 2009.

For further information, see the press release from the European Commission and explanatory note on scientific considerations regarding the licensing of A(H1N1)v vaccines.

European Medicines Agency gives positive recommendations for authorisation of pandemic-influenza vaccines Focetria and Pandemrix: 25/09/2009

The European Medicines Agency has recommended to the European Commission that two vaccines against influenza A/H1N1 be granted a marketing authorisation.

The vaccines are Focetria from Novartis and Pandemrix from GlaxoSmithKline Biologicals. Decisions on the granting of European Union-wide marketing authorisations for the vaccines by the European Commission are expected shortly.

For more information, see the press release.

European Medicines Agency recommends updating the product information for Tamiflu: 31/07/2009

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted recommendations to update the product information for Tamiflu (oseltamivir) with more information on the medicine’s use in children over six months of age and in pregnant and breastfeeding women.

  • For children aged from 6 to 12 months, the CHMP has concluded that during an influenza pandemic the benefits of the use of Tamiflu outweigh the risks and recommended the extension of the currently approved indication to include this population. The recommended dose to treat this age group is 3 mg per kg body weight twice daily for five days.
  • For pregnant and breastfeeding women, the CHMP recommended the use of Tamiflu for treatment and post-exposure prophylaxis.

The CHMP’s recommendations have been forwarded to the European Commission for the adoption of a decision. The updated product information in all EU languages for Tamiflu will be published shortly.

For information on the CHMP’s recommendations, see the press release. For more information on Tamiflu, see the European public assessment report.

 

Relenza to be distributed with Rotacap/Rotahaler inhalation device during influenza pandemic: 28/07/2009

Member States of the European Union have assessed an application from the marketing authorisation holder to temporarily distribute Relenza (zanamivir) with a Rotacap/Rotahaler inhalation device instead of the authorised diskhaler. The distribution of an additional device is intended as a temporary measure during the H1N1 pandemic, because production capacity of Relenza with the approved diskhaler cannot meet the current increased demand for the medicine.

Relenza is an antiviral medicine belonging to a class of medicines called 'neuraminidase inhibitors', which also includes Tamiflu (oseltamivir), to which the A/H1N1 influenza virus ('swine flu') currently spreading around the world has shown susceptibility.

The temporary distribution of an additional device for the use of Relenza was proposed by the marketing authorisation holder to the Medical Products Agency (MPA) of Sweden, which is the reference Member State for Relenza. Following a review of the provided documentation, the MPA is recommending temporary distribution of Relenza with Rotacap/Rotahaler.

The Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMD(h)) has co-ordinated the procedure with help from the reference Member State, but it is up to the national competent authority in each country to decide whether the national distribution and use of the Relenza Rotacap/Rotahaler can be temporarily authorised during the pandemic taking into account the assessment report and recommendation by the reference Member State.

Relenza is currently authorised in all 27 European Union Member States, plus Iceland, Liechtenstein and Norway to treat or prevent influenza in adults and children from the age of five years onwards.

For more information, see the CMD(h) meeting report.

European Medicines Agency review of pandemic vaccines underway: 24/07/2009

The European Medicines Agency has started to receive data on H1N1 pandemic vaccines. The review of these data began in July, with the commitment from the Committee for Medicinal Products for Human Use (CHMP) to fast-track the review of data as vaccine manufacturers make them available.

Given the public-health threat posed by the current pandemic, the Agency’s goal is to ensure data submitted to support marketing authorisations for vaccines are reviewed as early as possible, before the beginning of the Northern hemisphere flu season, expected in September. At present the Committee is reviewing data relating to manufacture of vaccines. Additional clinical trials in adults and children are currently being initiated by the vaccine manufacturers and the results will be reviewed in the coming months as they become available.

For more information, see the press release.

Revised recommendations for pharmacovigilance plans for pandemic-influenza vaccines: 08/07/2010

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted revised recommendations for pharmacovigilance plans included in risk-management plans submitted as part of marketing-authorisation applications for pandemic-influenza vaccines.

The recommendations have been updated following the recent outbreak of the novel A/H1N1 influenza virus. They were adopted by the CHMP following discussions between the Pharmacovigilance Working Party, the Vaccine Working Party, the European Vaccine Manufacturers Association and individual vaccine manufacturers.

For more information, see the revised document: CHMP recommendations for the pharmacovigilance plan as part of the risk management plan to be submitted with the marketing authorisation application for a pandemic influenza vaccine.

Standard paediatric investigation plan adopted for pandemic-influenza vaccines: 06/07/2010

The European Medicines Agency (EMEA) and its Paediatric Committee (PDCO) have adopted guidance on a standard set of data that applicants should include in their application for a paediatric investigation plan (PIP) for a pandemic influenza vaccine, when submitted during an emergency situation (World Health Organization phase 5 or 6).

Manufacturers and marketing-authorisation holders are encouraged to anticipate and submit a request for a PIP and a waiver, or a request for modification of an existing, agreed PIP as early as possible.

For further details, see the guidance document: Standard paediatric investigation plan for non-adjuvanted or adjuvanted pandemic influenza vaccines during a pandemic.

EMEA in ongoing discussions with vaccine manufacturers: 12/06/2009

The European Medicines Agency (EMEA) is in continuous dialogue with vaccine manufacturers and European and international regulators to discuss scientific and regulatory issues relating to the development and approval of vaccines. These include necessary requirements for clinical and non-clinical data to support the authorisation of influenza A/H1N1 vaccines, as well as strain recommendations for use in vaccine manufacture.

For further details, see the press release: WHO declares influenza pandemic – European Medicines Agency initiates crisis-management plan.

WHO declares A/H1N1 influenza pandemic: 11/06/2009, 18.15 UK time

The World Health Organization (WHO) has raised its pandemic alert level for the A/H1N1 influenza virus to phase 6.

The European Medicines Agency (EMEA) has a pandemic influenza crisis-management plan in place, and has been working towards the implementation of this plan since the outbreak of the virus in April 2009.

The Agency continues to work with its European Union and international partners on a series of initiatives to facilitate the availability of antivirals and vaccines for use in an influenza pandemic situation.

Revised EU recommendation for composition of influenza vaccine : 11/06/2009

The European Medicines Agency has revised the European Union (EU) recommendation for the composition of A/H1N1 influenza vaccine to add a further strain to the list of recommended production strains.

For full details, see the EU recommendation for the emergent novel H1N1 influenza vaccine composition.

EU recommendation for composition of influenza vaccine established: 05/06/2009

The European Medicines Agency, acting through its Biologics Working Party's Influenza Working Group, has endorsed the recommendation established by the World Health Organization (WHO) for the composition of the vaccines to be prepared for use in humans against the novel influenza A (H1N1) virus.

For full details, see the EU recommendation for the emergent novel H1N1 influenza vaccine composition.

Extension of shelf-life for Relenza: 03/06/2009

The Member States of the European Union have approved the extension of the shelf-life of Relenza (zanamivir) oral inhalation powder, from five to seven years. This decision is based on experimental data that show Relenza can safely be used for an additional two years.

The extension was proposed by the marketing authorisation holder to the Medical Products Agency (MPA) of Sweden, which is the reference Member State for Relenza, and agreed by other Member States via the mutual recognition procedure.

The Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMD(h)) recommends that Relenza that is already on the market or in people's homes may — in the event of an influenza pandemic being officially declared by the World Health Organisation (WHO) — be used for up to two years after its current expiry date. Patients who have Relenza that has recently expired should not throw it away, as it might be needed during a declared influenza pandemic.

Relenza is an antiviral medicine belonging to a class of medicines called 'neuraminidase inhibitors', which also includes Tamiflu (oseltamivir), to which the A/H1N1 influenza virus currently spreading around the world has shown susceptibility.

Relenza is currently authorised in all 27 European Union Member States, plus Iceland, Liechtenstein and Norway to treat or prevent influenza in adults and children from the age of five years onwards.

For more information, see the CMD(h) meeting report announcing the approval of the extension of shelf-life of Relenza. Further information on Relenza is available in the summary of product characteristics and the patient information leaflet.

Follow-up recommendations on use of antiviral medicines in the event of an influenza A/H1N1 pandemic: 29/05/2009

The Committee has adopted a set of follow-up recommendations to its guidance on the use of Tamiflu (oseltamivir) in children under one year of age and the use of Tamiflu and Relenza (zanamivir) in pregnant and breastfeeding women in the case of a declared influenza A/H1N1. 

For more information, see the follow-up recommendations. For more information on Tamiflu, see the European public assessment report. Further information on Relenza is available in the summary of product characteristics and the patient information leaflet.

Guidance on use of antiviral medicines in the event of an influenza A/H1N1 pandemic: 08/05/2009

The European Medicines Agency has given guidance on the use of Tamiflu (oseltamivir) in children under one year of age and the use of Tamiflu and Relenza (zanamivir) in pregnant and breastfeeding women in case of a declared influenza A/H1N1 pandemic.

The Agency’s Committee for Medicinal Products for Human Use (CHMP) has concluded that during an officially declared influenza A/H1N1 pandemic, the benefits of the use of Tamiflu in children under one year old would outweigh its risks. If the medicine is prescribed to these children, the recommended dose is 2 to 3 mg per kilogram body weight.

For pregnant and breastfeeding women, the CHMP concluded that both Tamiflu and Relenza could be used during an influenza A/H1N1 pandemic.

For more information, see the press release, questions and answers, opinion and assessment report. For more information on Tamiflu, see the European public assessment report. Further information on Relenza is available in the summary of product characteristics and the patient information leaflet.

Recommendations on extension of shelf life for Tamiflu: 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 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) has recommended that Tamiflu capsules that are already on the market may be used for up to two more years after their current expiry date during a declared pandemic. Patients who have Tamiflu capsules that have recently expired should not throw them away because they might be needed during a novel influenza A/H1N1 pandemic.

For more information, see the press release, questions and answers, opinion and assessment report. For more information on Tamiflu, see the European public assessment report.

European Medicines Agency prepares for approval of pandemic vaccines: 30/04/2009, 19.30 UK time

The European Medicines Agency, together with its partners in the European Union Member States, the European Commission, the European Centre for Disease Prevention and Control (ECDC), the World Health Organization (WHO) and the European Directorate for the Quality of Medicines and Healthcare (EDQM) met today with vaccine manufacturers. The purpose of the meeting was to share information on the novel influenza virus and discuss regulatory and scientific issues concerning the development and eventual approval of vaccines for use in a pandemic situation.

For more information, see the press release.

WHO pandemic alert now at phase 5: 30/04/2009, 08.30 UK time

The World Health Organization (WHO) today increased the pandemic alert level from phase 4 to phase 5, in response to the ongoing development of the novel virus outbreak. There are six alert levels, with level 6 representing a pandemic situation.

According to the WHO, the current phase 5 "is characterized by human-to-human spread of the virus into at least two countries in one WHO region. While most countries will not be affected at this stage, the declaration of Phase 5 is a strong signal that a pandemic is imminent and that the time to finalize the organization, communication, and implementation of the planned mitigation measures is short."

For more information on the WHO pandemic alert levels, see the World Health Organization’s website.

WHO alert level raised to level 4: 29/04/2009

Although an influenza pandemic has not been declared, the World Health Organization (WHO) increased the pandemic alert from level 3 to level 4 on 27 April 2009 in response to this outbreak. There are six alert levels, with level 6 representing a pandemic situation.

For more information on the WHO pandemic alert levels, see the World Health Organization’s website.

Meeting with vaccine manufacturers: 29/04/2009

No vaccines are currently available for this novel virus. However, the Agency is liaising with vaccine manufacturers on the production of vaccines using already approved mock-up vaccines, and is hosting a meeting with vaccine manufacturers and influenza experts from across the European Union on 30 April 2009.

Antiviral medicines available in the EU: 29/04/2009

Among the antiviral medicines that are authorised in the European Union (EU) for use in an influenza outbreak, the neuraminidase inhibitors Tamiflu (oseltamivir) and Relenza (zanamivir) have shown effectiveness against the novel influenza virus.

  • Tamiflu is a centrally authorised medicine (i.e. authorised for use in all 27 EU Member States, as well as in Iceland, Liechtenstein and Norway) for the treatment and prevention of influenza. For more information, see the European public assessment report.
  • Relenza (zanamivir) is authorised in all 27 EU Member States for the treatment of influenza. The reference Member State for Relenza is Sweden. Further information on Relenza is available in the summary of product characteristics and the patient information leaflet.

The M2 inhibitors amantadine and rimantadine do not appear to be effective against the novel virus strain.

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