Silgard

Withdrawn

This medicine's authorisation has been withdrawn

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

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The European Public Assessment Report (EPAR) for Silgard is updated to reflect that the marketing authorisation is no longer valid.

Silgard : EPAR - Summary for the public

Product information

Silgard : EPAR - Product Information

Silgard : EPAR - All Authorised presentations

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

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.

Authorisation details

• EMA product number:
  EMEA/H/C/000732
• Marketing authorisation holder:
  Merck Sharp Dohme Ltd

  Hertford Road; Hoddesdon; Hertfordshire; EN11 9BU; United Kingdom

• Marketing authorisation issued:
  19/09/2006
• Withdrawal of marketing authorisation:
  18/02/2019
• Revision:
  33

Assessment history

Changes since initial authorisation of medicine

Silgard : EPAR - Procedural steps taken and scientific information after authorisation

Silgard-H-C-732-P46-0081 : EPAR - Assessment Report

Adopted Reference Number: EMA/420635/2017

Silgard-H-C-732-A20-1421: EPAR - Assessment Report - Article 20

Adopted Reference Number: EMA/762033/2015

Silgard-H-C-732-P46-0071.1 : EPAR - Assessment Report

Adopted Reference Number: EMA/182964/2015

Silgard-H-C-732-P46-0055 : EPAR - Assessment Report

Adopted Reference Number: EMA/184046/2015

Silgard-H-C-732-P46-078 : EPAR - Assessment Report

Adopted Reference Number: EMA/128923/2015

Silgard-C-H-732-WS-523 : EPAR - Assessment Report - Variation

Adopted

Silgard-H-C-732-WS-472 : EPAR - Assessment Report - Variation

Adopted Reference Number: EMA/CHMP/66618/2014

CHMP post-authorisation summary of positive opinion for Silgard

Adopted Reference Number: EMA/CHMP/243055/2014

Silgard-H-C-732-P45-47 : EPAR - Assessment Report

Adopted Reference Number: EMA/363824/2013

Silgard-H-C-732-WS-29 : EPAR - Assessment Report - Variation

Adopted Reference Number: EMA/928494/2011

Silgard-H-C-732-II-24 : EPAR - Assessment Report - Variation

Adopted Reference Number: EMA/576183/2010

Silgard-H-C-732-II-18 : EPAR - Assessment Report - Variation

Silgard-H-C-732-II-06 : EPAR - Assessment Report - Variation

Silgard-H-C-732-II-12 : EPAR - Assessment Report - Variation

CHMP post-authorisation summary of positive opinion for Silgard

Adopted Reference Number: EMEA/CHMP/280938/2008

Initial marketing authorisation documents

Silgard : EPAR - Scientific Discussion

Silgard : EPAR - Procedural steps taken before authorisation