Collection of Patients' Background InformationRelenza® Sentinel Site Monitoring Program in Japan

1. Objectives To collect background information of patients receiving a prescription for Relenza® and study risk factors etc. for adverse drug reactions collected through spontaneous reporting. In particular, to characterize the types and incidences of adverse events, serious adverse events, and adverse drug reactions and to investigate risk factors for them in patient populations that are regarded to be at high risk for novel influenza A (H1N1)and in which the use experience of Relenza® has not been enough (such as pregnant women, infants, elderly persons, and those with decreased physical function) in accordance with the PFSB/SD Notification 0904, No.2 of the Safety Division, Pharmaceutical and Food Safety Bureau, MHLW, dated 4th September 2009.

To compare the data with the safety data collected in overseas sentinel site monitoring programs. 2. Planned number of patients Planned number of patients: 1,600 cases (of which 90 shall be pregnant women) 3. Target patients All patients who visit a sentinel site between the date of the contract and 31st March 2010 and are prescribed Relenza® for the purpose of either treatment or prophylaxis of influenza. 4. Planned number of sentinel sites About 20 sites, mainly obstetrics, pediatrics, and internal medicine. 5. Method 1)The sentinel sites to participate in the monitoring program will be selected from medical institutions which has adopted/purchased Relenza®. Physicians who are capable of fulfilling the objectives of the program satisfactorily will be given information concerning the purpose, target patients, data to be collected, method, etc. and asked for cooperation.

2)Upon receiving consent of the physician for cooperation, a written contract will be concluded with the head of the site (e.g., hospital director) before collection of patient background information is started.

3)All patients receiving a prescription of Relenza® during the contract term at the respective site (i.e., from the date of contract until 31st March 2010) will be included in the monitoring program. At sentinel sites with obstetrics service, all pregnant women receiving a prescription of Relenza® during the contract term at the respective site (i.e., from the date of contract until 31st March 2010) will be included in the monitoring program in order to focus on collection of data in pregnant women.

4)Physician in charge will enter the data such as the background information of the patients who have received prescription of Relenza® from the date of contract until 31st March 2010 into the electronic data collection (EDC) system, check the data, and transmit them to GlaxoSmithKline K.K.