European Medicines Agency recommends extending the therapeutic indication of Cervarix
Extension concerns the prevention of premalignant genital (cervical, vulvar and vaginal) lesions causally related to certain oncogenic HPV types
On 21 February 2013, the European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a variation to the terms of the marketing authorisation for the medicinal product Cervarix. The marketing authorisation holder for this medicinal product is GlaxoSmithKline Biologicals S.A. They may request a re examination of the CHMP opinion, provided that they notify the European Medicines Agency in writing of their intention within 15 days of receipt of the opinion.
The CHMP adopted an extension to the therapeutic indication for the prevention of premalignant genital (cervical, vulvar and vaginal) lesions causally related to certain oncogenic Human Papillomavirus (HPV) types. Cervarix is human papillomavirus (types 16, 18) recombinant, adjuvanted, adsorbed vaccine.
Detailed conditions for the use of this product will be described in the updated summary of product characteristics, which will be published in the revised European public assessment report, and will be available in all official European Union languages after the variation to the marketing authorisation has been granted by the European Commission.
For information, the full indication for Cervarix will be as follows:
Cervarix is a vaccine for use from the age of 9 years for the prevention of premalignant genital (cervical, vulvar and vaginal) lesions and cervical cancer causally related to certain oncogenic Human Papillomavirus (HPV) types.
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