BioCentury
ARTICLE | Politics & Policy

CHMP issues positive opinions

October 22, 2004 7:00 AM UTC

The EMEA's CHMP issued positive opinions on MAAs for three biologic products. The positive opinions included Avastin bevacizumab from Roche (SWX:ROCZ) to treat metastatic carcinoma of the colon or rectum; Fendrix hepatitis B recombinant DNA vaccine from GlaxoSmithKline (LSE:GSK GSK) to prevent HBV infection in patients with renal insufficiency from the age of 15 years onwards; and Quintanrix for primary vaccination of infants and for booster vaccination of young children against diphtheria, tetanus, pertussis, HBV and invasive disease caused by Haemophilus influenzae type B, also from GSK. ...