Silgard

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human papillomavirus vaccine [types 6, 11, 16, 18] (recombinant, adsorbed)

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Silgard. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Silgard.

This EPAR was last updated on 28/06/2018

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)
  • Papillomavirus Infections
  • Uterine Cervical Dysplasia
  • Condylomata Acuminata
  • Immunization
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

17/05/2018 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

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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.

Assessment history

Changes since initial authorisation of medicine

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