Silgard
Withdrawn
This medicine's authorisation has been withdrawn
human papillomavirus vaccine [types 6, 11, 16, 18] (recombinant, adsorbed)
MedicineHumanWithdrawn
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- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 18 February 2019, the European Commission withdrew the marketing authorisation for Silgard (human papillomavirus vaccine [types 6, 11, 16, 18] (recombinant, adsorbed)) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Merck Sharp & Dohme Limited, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons.
Silgard was granted marketing authorisation in the EU on 19 September 2006 for prevention of diseases caused by specific human papillomavirus (HPV) types: cervical and anal cancer, precancerous or dysplastic lesions in the anus and female genitals, and genital warts. The marketing authorisation was initially valid for a 5-year period. It was then granted unlimited validity in 2011.
Silgard was a duplicate application to Gardasil, which is marketed in several EU countries. The marketing authorisation holder will maintain the marketing authorisation for Gardasil and Gardasil 9.
The European Public Assessment Report (EPAR) for Silgard is updated to reflect that the marketing authorisation is no longer valid.
Product information
Latest procedure affecting product information:WS/1349/G
18/02/2019
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Silgard
- Active substance
- human papillomavirus type 6 L1 protein
- human papillomavirus type 11 L1 protein
- human papillomavirus type 16 L1 protein
- human papillomavirus type 18 L1 protein
- International non-proprietary name (INN) or common name
- human papillomavirus vaccine [types 6, 11, 16, 18] (recombinant, adsorbed)
- Therapeutic area (MeSH)
- Papillomavirus Infections
- Uterine Cervical Dysplasia
- Condylomata Acuminata
- Immunization
- Anatomical therapeutic chemical (ATC) code
- J07BM01
Pharmacotherapeutic group
VaccinesTherapeutic 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.
Assessment history
News on Silgard
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