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From the European Medicines Agency.
TAMIFLU.
Authorised by the European Commission on 20 June 2002 for use in all European Union Member States as an antiviral medicine for the prevention or treatment of influenza.
As for testing of Tamiflu. Here is an extract about how it was studied and finally approved for use.
Tamiflu has been compared with placebo (a dummy treatment) in studies in the treatment of flu (2,413 adults and adolescents, 741 elderly patients and 1,033 children aged one year or above). The effectiveness was measured using a score card to record symptoms (feeling feverish, muscle pain, headache, sore throat, cough, overall discomfort and runny nose).
In the prevention of flu, Tamiflu was studied in patients who had been exposed to the disease when one of their family members contracted flu (962 cases) or during an epidemic (1,562 subjects aged between 16 and 65 years, and 548 elderly subjects in nursing homes). The studies measured the number of cases of flu, proven by laboratory tests. A study also looked at using Tamiflu in a family setting (277 families) for both the treatment of the person with flu, and the treatment or prevention of flu in those in contact with him or her.
In children aged between six months and one year, a small study has been carried out to show that the recommended dose of Tamiflu produces similar levels of the medicine in the blood as the doses that are effective in older children and in adults.
The benefits that were found.
In the treatment studies in adults, Tamiflu reduced the duration of the illness from an average of 5.2 days for patients taking placebo, to 4.2 days for patients taking Tamiflu. The average reduction in the length of the disease in children aged one to six years was 1.5 days.
In the prevention studies, Tamiflu reduced the incidence of flu among the people in contact with a flu sufferer. In the study carried out during an epidemic, 1% of the people taking Tamiflu developed flu after contact, compared with 5% of those taking placebo. In families with one person with flu, 7% of the family members in the household developed flu when receiving prevention with Tamiflu, compared with 20% with no prevention treatment.
Why has Tamiflu been approved ?
The Committee for Medicinal Products for Human Use (CHMP) decided that Tamiflu’s benefits are greater than its risks for the treatment and prevention of influenza.
TAMIFLU.
Authorised by the European Commission on 20 June 2002 for use in all European Union Member States as an antiviral medicine for the prevention or treatment of influenza.
As for testing of Tamiflu. Here is an extract about how it was studied and finally approved for use.
Tamiflu has been compared with placebo (a dummy treatment) in studies in the treatment of flu (2,413 adults and adolescents, 741 elderly patients and 1,033 children aged one year or above). The effectiveness was measured using a score card to record symptoms (feeling feverish, muscle pain, headache, sore throat, cough, overall discomfort and runny nose).
In the prevention of flu, Tamiflu was studied in patients who had been exposed to the disease when one of their family members contracted flu (962 cases) or during an epidemic (1,562 subjects aged between 16 and 65 years, and 548 elderly subjects in nursing homes). The studies measured the number of cases of flu, proven by laboratory tests. A study also looked at using Tamiflu in a family setting (277 families) for both the treatment of the person with flu, and the treatment or prevention of flu in those in contact with him or her.
In children aged between six months and one year, a small study has been carried out to show that the recommended dose of Tamiflu produces similar levels of the medicine in the blood as the doses that are effective in older children and in adults.
The benefits that were found.
In the treatment studies in adults, Tamiflu reduced the duration of the illness from an average of 5.2 days for patients taking placebo, to 4.2 days for patients taking Tamiflu. The average reduction in the length of the disease in children aged one to six years was 1.5 days.
In the prevention studies, Tamiflu reduced the incidence of flu among the people in contact with a flu sufferer. In the study carried out during an epidemic, 1% of the people taking Tamiflu developed flu after contact, compared with 5% of those taking placebo. In families with one person with flu, 7% of the family members in the household developed flu when receiving prevention with Tamiflu, compared with 20% with no prevention treatment.
Why has Tamiflu been approved ?
The Committee for Medicinal Products for Human Use (CHMP) decided that Tamiflu’s benefits are greater than its risks for the treatment and prevention of influenza.