 |
answer text |
<p>To extend the indication of Avastin, the Marketing Authorisation Holder (Roche
Registration GmbH) would need to submit the results of relevant clinical trials and
other information to the European Medicines Agency (EMA) to demonstrate acceptable
safety and efficacy and a positive balance of benefit to risk. At present, as Avastin
has a European Community Marketing Authorisation, a national submission to the Medicines
and Healthcare products Regulatory Agency to extend the indication is not possible.</p><p>There
has not been any recent positive opinion from the EMA for a new indication of Avastin
to be submitted to the European Commission and the EMA has not published any pending
extension of indication applications.</p>
|
 |
