Please login to the form below

Not currently logged in
Email:
Password:

GSK's H1N1 vaccine gains EU approval

GlaxoSmithKline has confirmed that it has been granted a marketing authorisation by the European Commission for its H1N1 vaccine

GlaxoSmithKline (GSK) has confirmed that it has been granted a marketing authorisation for Pandemrix, its H1N1 vaccine, from the European Commission.

Jean Stéphenne, president of GlaxoSmithKline Biologicals, said: "Following the Commission's approval we expect to commence shipments of Pandemrix to European governments from next week [w/c October 5]."

The European Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion and recommended approval of Pandemrix on September 25. Trials of the vaccine began in August and demonstrated that after one dose the vaccine can provide a strong immune response that exceeds the immunogenic criteria defined by international licensing authorities for a pandemic influenza vaccine.

1st October 2009

Share

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
Wisepress

Wisepress is a medical bookseller promoting and selling books worldwide, both online and via the 200 European medical conferences that...

Latest intelligence

Is China ready for a pharmaceutical gold rush?
Some describe doing business in China as akin to the 1990s internet boom – so how stable is its future?...
AstraZeneca’s oncology renaissance
Susan Galbraith played a key role in restoring AstraZeneca’s place in cancer drug development – she talks about the future of oncology and why there’s more to be done to...
Navigating the antibiotic resistance crisis
Blue Latitude Health speaks to Tara DeBoer, PhD, Postdoctoral Researcher and CEO of BioAmp Diagnostics to explore the antimicrobial resistance crisis, and learn how a simple tool could support physicians...

Infographics