Glaxosmithkline (GSK) Cervarix cervical cancer product has received marketing approval from the European Commission for all EU countries.
The vaccine, which prevents cancers related to human papillomavirus, can now be prescribed by doctors in 27 countries to women and girls aged between 10 and 25 years old.
If the price is around $100 a dose, the drug could generate revenues in $2 billion to $5 billion range in the EU, based on rival product Gardasil's performance in the US, analysts said.
GSK said a decision by the FDA on Cervarix's approval in the United States will be given in January.