European Medicines Agency Recommends a Variation to the Terms of the Marketing Authorisation for Two HPV Vaccines

Extension of indication concerns prevention of pre-malignant anal lesions and anal cancers

On 25 April 2014, 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 products Gardasil and Silgard. The CHMP adopted extension of indication to prevention of premalignant anal lesions and anal cancers causally related to certain oncogenic Human Papillomavirus (HPV) types.

Extension of indications for Gardasil

Gardasil is a recombinant, adsorbed HPV vaccine against types 6, 11, 16, and 18. The marketing authorisation holder for this medicinal product is Sanofi Pasteur MSD, SNC. 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 full indication for Gardasil will be as follows:

"Gardasil is a vaccine for use from the age of 9 years for the prevention of:

  • premalignant genital lesions (cervical, vulvar and vaginal), premalignant anal lesions, cervical cancers and anal cancers causally related to certain oncogenic Human Papillomavirus (HPV) types
  • genital warts (condyloma acuminata) causally related to specific HPV types.

The use of Gardasil should be in accordance with official recommendations.”

Note: The text in bold represents the new or the amended indication.

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.

Extension of indications for Silgard

Silgard is a recombinant, adsorbed HPV vaccine against types 6, 11, 16, and 18. The marketing authorisation holder for this medicinal product is Merck Sharp & Dohme Limited. 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 full indication for Silgard will be as follows:

"Silgard is a vaccine for use from the age of 9 years for the prevention of:

  • premalignant genital lesions (cervical, vulvar and vaginal), premalignant anal lesions, cervical cancers and anal cancers causally related to certain oncogenic Human Papillomavirus (HPV) types
  • genital warts (condyloma acuminata) causally related to specific HPV types.

The use of Silgard should be in accordance with official recommendations.”

Note: The text in bold represents the new or the amended indication.

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.