Silgard

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

Overview
Authorisation details
Product information
Assessment history

Withdrawn

This medicine is now withdrawn from use in the European Union.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The marketing authorisation for Silgard has been withdrawn at the request of the marketing-authorisation holder.

List item

Silgard : EPAR - Summary for the public (PDF/556.71 KB)

First published: 11/08/2008
Last updated: 02/04/2019
- Bulgarian
  (PDF/701.82 KB)
- Croatian
  (PDF/605.32 KB)
- Czech
  (PDF/636.1 KB)
- Danish
  (PDF/554.76 KB)
- Dutch
  (PDF/580.36 KB)
- Estonian
  (PDF/550.61 KB)
- Finnish
  (PDF/590.72 KB)
- French
  (PDF/581.12 KB)
- German
  (PDF/557.67 KB)
- Greek
  (PDF/691.22 KB)
- Hungarian
  (PDF/655.15 KB)
- Italian
  (PDF/554.77 KB)
- Latvian
  (PDF/661.09 KB)
- Lithuanian
  (PDF/608.16 KB)
- Maltese
  (PDF/664.08 KB)
- Polish
  (PDF/634.02 KB)
- Portuguese
  (PDF/578.72 KB)
- Romanian
  (PDF/584.8 KB)
- Slovak
  (PDF/664.82 KB)
- Slovenian
  (PDF/652.39 KB)
- Spanish
  (PDF/579 KB)
- Swedish
  (PDF/554.75 KB)

More detail is available in the summary of product characteristics

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)	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

18/02/2019 Silgard - EMEA/H/C/000732 - WS/1349/G

List item

Silgard : EPAR - Product Information (PDF/1.46 MB)

First published: 25/09/2009
Last updated: 02/04/2019
- Bulgarian
  (PDF/2.57 MB)
- Croatian
  (PDF/1.56 MB)
- Czech
  (PDF/2.22 MB)
- Danish
  (PDF/1.45 MB)
- Dutch
  (PDF/1.61 MB)
- Estonian
  (PDF/1.44 MB)
- Finnish
  (PDF/1.49 MB)
- French
  (PDF/1.54 MB)
- German
  (PDF/1.59 MB)
- Greek
  (PDF/2.71 MB)
- Hungarian
  (PDF/2.2 MB)
- Icelandic
  (PDF/1.47 MB)
- Italian
  (PDF/1.6 MB)
- Latvian
  (PDF/2.23 MB)
- Lithuanian
  (PDF/1.5 MB)
- Maltese
  (PDF/2.32 MB)
- Norwegian
  (PDF/1.44 MB)
- Polish
  (PDF/2.28 MB)
- Portuguese
  (PDF/1.56 MB)
- Romanian
  (PDF/1.58 MB)
- Slovak
  (PDF/2.2 MB)
- Slovenian
  (PDF/2.13 MB)
- Spanish
  (PDF/1.55 MB)
- Swedish
  (PDF/1.49 MB)

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.

List item

Silgard : EPAR - All Authorised presentations (PDF/493.13 KB)

First published: 05/09/2007
Last updated: 02/04/2019
- Bulgarian
  (PDF/570.4 KB)
- Czech
  (PDF/550.1 KB)
- Danish
  (PDF/488.88 KB)
- Dutch
  (PDF/492.97 KB)
- Estonian
  (PDF/487.32 KB)
- Finnish
  (PDF/491.71 KB)
- French
  (PDF/488.1 KB)
- German
  (PDF/481.35 KB)
- Greek
  (PDF/609.95 KB)
- Hungarian
  (PDF/546.57 KB)
- Italian
  (PDF/485.69 KB)
- Latvian
  (PDF/535.39 KB)
- Lithuanian
  (PDF/527.3 KB)
- Maltese
  (PDF/555.36 KB)
- Polish
  (PDF/534.97 KB)
- Portuguese
  (PDF/484.98 KB)
- Romanian
  (PDF/522.22 KB)
- Slovak
  (PDF/534.56 KB)
- Slovenian
  (PDF/553.01 KB)
- Spanish
  (PDF/490.26 KB)
- Swedish
  (PDF/491.13 KB)

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.

Silgard

Table of contents

Overview

Silgard : EPAR - Summary for the public (PDF/556.71 KB)

Authorisation details

Product information

Silgard : EPAR - Product Information (PDF/1.46 MB)

Contents

Silgard : EPAR - All Authorised presentations (PDF/493.13 KB)

Pharmacotherapeutic group

Therapeutic indication

Assessment history

Changes since initial authorisation of medicine

Silgard : EPAR - Procedural steps taken and scientific information after authorisation (PDF/804.35 KB)

Silgard-H-C-732-P46-0081 : EPAR - Assessment Report (PDF/751.27 KB)

Silgard-H-C-732-A20-1421: EPAR - Assessment Report - Article 20 (PDF/1.64 MB)

Silgard-H-C-732-P46-0071.1 : EPAR - Assessment Report (PDF/1.9 MB)

Silgard-H-C-732-P46-0055 : EPAR - Assessment Report (PDF/1.58 MB)

Silgard-H-C-732-P46-078 : EPAR - Assessment Report (PDF/1.68 MB)

Silgard-C-H-732-WS-523 : EPAR - Assessment Report - Variation (PDF/1.31 MB)

Silgard-H-C-732-WS-472 : EPAR - Assessment Report - Variation (PDF/1.29 MB)

CHMP post-authorisation summary of positive opinion for Silgard (PDF/74.44 KB)

Silgard-H-C-732-P45-47 : EPAR - Assessment Report (PDF/607.85 KB)

Silgard-H-C-732-WS-29 : EPAR - Assessment Report - Variation (PDF/999.01 KB)

Silgard-H-C-732-II-24 : EPAR - Assessment Report - Variation (PDF/828.4 KB)

Silgard-H-C-732-II-18 : EPAR - Assessment Report - Variation (PDF/1.28 MB)

Silgard-H-C-732-II-06 : EPAR - Assessment Report - Variation (PDF/896.14 KB)

Silgard-H-C-732-II-12 : EPAR - Assessment Report - Variation (PDF/848.15 KB)

CHMP post-authorisation summary of positive opinion for Silgard (PDF/486.83 KB)

Initial marketing-authorisation documents

Silgard : EPAR - Scientific Discussion (PDF/535.49 KB)

Silgard : EPAR - Procedural steps taken before authorisation (PDF/43.21 KB)

News

More information on Silgard

Public statement on Silgard: Withdrawal of the marketing authorisation in the European Union (PDF/66.42 KB)

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