Silgard
human papillomavirus vaccine [types 6, 11, 16, 18] (recombinant, adsorbed)
Table of contents
Overview
The marketing authorisation for Silgard has been withdrawn at the request of the marketing-authorisation holder.
Authorisation details
| Product details | |
|---|---|
| Name |
Silgard
|
| Agency product number |
EMEA/H/C/000732
|
| Active substance |
|
| International non-proprietary name (INN) or common name |
human papillomavirus vaccine [types 6, 11, 16, 18] (recombinant, adsorbed)
|
| Therapeutic area (MeSH) |
|
| Anatomical therapeutic chemical (ATC) code |
J07BM01
|
| Publication details | |
|---|---|
| Marketing-authorisation holder |
Merck Sharp Dohme Ltd
|
| Revision |
33
|
| Date of issue of marketing authorisation valid throughout the European Union |
19/09/2006
|
| Contact address |
Hertford Road
Hoddesdon Hertfordshire EN11 9BU United Kingdom |
Product information
18/02/2019 Silgard - EMEA/H/C/000732 - WS/1349/G
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).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Vaccines
Therapeutic 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.