🇪🇺 Silgard in European Union

EMA authorised Silgard on 19 September 2006

Marketing authorisation

EMA — authorised 19 September 2006

  • Application: EMEA/H/C/000732
  • Marketing authorisation holder: Merck Sharp Dohme Ltd
  • Local brand name: Silgard
  • Indication: 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. See sections 4.4 and 5.1 for important information on the data that support this indication. The use of Silgard should be in accordance with official recommendations.
  • Status: withdrawn

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Other Other approved in European Union

Frequently asked questions

Is Silgard approved in European Union?

Yes. EMA authorised it on 19 September 2006.

Who is the marketing authorisation holder for Silgard in European Union?

Merck Sharp Dohme Ltd holds the EU marketing authorisation.