login
login
Image header Agence Europe
Europe Daily Bulletin No. 9091
Contents Publication in full By article 21 / 38
GENERAL NEWS / (eu) eu/medicines

EMEA recommends no change for Tamiflu safety information

Brussels, 16/12/2005 (Agence Europe) - A review by the European Medicines Agency (EMEA) of new safety information for the flagship flu jab Tamiflu (produced by Swiss pharmaceuticals company Roche) has concluded that no change to the product safety information is required. In November, a report from Japan on the suicides of several teenagers taking oseltamivir (the scientific name for Tamiflu) led the US FDA and the EMEA to request further information from Roche. The EU's Committee for Medicinal Products for Human Use (CHMP) examined the information provided by Roche at its 12-14 December meeting, concluding that 'there is no safety signal relating to psychiatric disorders while taking Tamiflu'. The CHMP decided that close monitoring of psychiatric disorders, established for Tamiflu in February 2003 on request by the EMEA following an assessment of information supplied by Roche in November 2002, should continue. In a press release issued on 12 December, Roche announces that it has identified 12 additional partners to enhance its production network (manufacturing Tamiflu under licence). The first sub-licence for China has been granted to Shanghai Pharmaceutical Group. Roche notes that 'based on current orders received from governments around the world, its capacity to produce 300 million treatments by 2007 is significantly ahead of demand.'

Contents

THE DAY IN POLITICS
GENERAL NEWS