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
Accession

Accession was a born from a passion and a vision. A passion to harness the power of market access to...

Latest intelligence

Products come and go, but a pharma company’s most valuable, durable asset is its reputation, writes Duncan Mackenzie-Reid and Simon Grist
...
Erik
A quest for innovative solutions
UCB looks to the future through a PRISM...
Big data, privacy and the rise of genomic testing
Blue Latitude Health speaks to Johan Christiaanse, Marketing Director at BGI, to find out how the medical profession can overcome one of the major barriers to precision medicine – big...

Infographics