Silgard
human papillomavirus vaccine [types 6, 11, 16, 18] (recombinant, adsorbed)
Table of contents
Withdrawn
This medicine is now withdrawn from use in the European Union.
Overview
The marketing authorisation for Silgard has been withdrawn at the request of the marketing-authorisation holder.
This EPAR was last updated on 02/04/2019
Authorisation details
| Product details | |
|---|---|
| Name |
Silgard
|
| Agency product number |
EMEA/H/C/000732
|
| Active substance |
human papillomavirus type 11 L1 protein / human papillomavirus type 16 L1 protein / human papillomavirus type 18 L1 protein / human papillomavirus type 6 L1 protein
|
| 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 | |
Product information
18/02/2019 Silgard - EMEA/H/C/000732 - WS/1349/G
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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Pharmacotherapeutic group
Pharmacotherapeutic group
Vaccines
Therapeutic indication
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.