Silgard

Withdrawn

This medicine's authorisation has been withdrawn

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

Overview

The marketing authorisation for Silgard has been withdrawn at the request of the marketing-authorisation holder.

Silgard : EPAR - Summary for the public

Product information

Silgard : EPAR - Product Information

Latest procedure affecting product information: WS/1349/G

18/02/2019

This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

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).

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
• 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

AdoptedReference Number: EMA/420635/2017

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

AdoptedReference Number: EMA/762033/2015

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

AdoptedReference Number: EMA/182964/2015

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

AdoptedReference Number: EMA/184046/2015

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

AdoptedReference 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

AdoptedReference Number: EMA/CHMP/66618/2014

CHMP post-authorisation summary of positive opinion for Silgard

AdoptedReference Number: EMA/CHMP/243055/2014

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

AdoptedReference Number: EMA/363824/2013

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

AdoptedReference Number: EMA/928494/2011

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

AdoptedReference 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

AdoptedReference Number: EMEA/CHMP/280938/2008

Initial marketing authorisation documents

Silgard : EPAR - Scientific Discussion

Silgard : EPAR - Procedural steps taken before authorisation