GARDASIL®, the first vaccine against cervical cancer, vaginal and vulvar pre-cancers, and warts, has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in Europe.
The CHMP recommends that GARDASIL, developed by Merck (MRK), be approved for the immunization of children and adolescents aged 9 to 15 years and of adult females aged 16 to 26 years.
The recommendation will be submitted to the European Commission, and if approval is granted, Gardasil may be distributed in the 25 countries belonging to the EU.
The vaccine will be marketed by Sanofi Pasteur MSD (SPMSD) or Merck Sharp & Dohme (as either GARDASIL or SILGARD®).
Gardasil has been approved by US Food and Drug Administration in June.
Source: Merck
Comment Preview