BioCentury
ARTICLE | Clinical News

Tamiflu oseltamivir regulatory update

April 13, 2015 7:00 AM UTC

EMA’s CHMP recommended approval of an expanded label for Tamiflu oseltamivir from Roche to include treatment of influenza in infants ages <1 who have symptoms typical of influenza when influenza virus is circulating in the community . Tamiflu is approved in the EU for the indication in patients ages >=1 and for post-exposure prevention of influenza in patients ages >=1 who had contact with a clinically diagnosed influenza case. The neuraminidase inhibitor is also approved to treat influenza or for post-exposure prevention of influenza in infants ages <1 during a pandemic influenza outbreak. ...