Herpes

Main information

  • Trade name:
  • Herpes simplex virus (HSV) (Human herpesvirus 1 & 2) IVDs
  • Class:
  • - IVD Class 3
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Herpes simplex virus (HSV) (Human herpesvirus 1 & 2) IVDs
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221591
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221591

Vela Diagnostics Australia Pty Ltd - Herpes simplex virus (HSV) (Human herpesvirus 1 & 2) IVDs

ARTG entry for

Medical Device Included - IVD Class 3

Sponsor

Vela Diagnostics Australia Pty Ltd

Postal Address

Level 9 Avaya House 123 Epping Road,NORTH RYDE, NSW, 2113

Australia

ARTG Start Date

24/03/2014

Product category

Medical Device Class 3

Status

Active

Approval area

Conditions

- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,

Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations

2002 for relevant information.

- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal

offence; and civil penalties may apply.

Manufacturers

Name

Address

Vela Operations Singapore Pte Ltd

2-4/5/6 The Kendall 50 Science Park Road

Science Park II, , 117406

Singapore

Products

1. Herpes simplex virus (HSV) (Human herpesvirus 1 & 2) IVDs

Product Type

Effective date

24/03/2014

GMDN

CT749 Herpes simplex virus (HSV) (Human herpesvirus 1 & 2) IVDs

Intended purpose

For in vitro diagnostic use in the detection and differentiation of Herpes simplex virus (HSV) (Human

herpesvirus 1 & 2)

Specific Conditions

No Specific Conditions included on Record

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 10.11.2017 at 12:34:33 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

30-7-2018

Zalmoxis (MolMed S.p.A.)

Zalmoxis (MolMed S.p.A.)

Zalmoxis (Active substance: Allogeneic T cells genetically modified with a retroviral vector encoding for a truncated form of the human low affinity nerve growth factor receptor (?LNGFR) and the herpes simplex I virus thymidine kinase (HSV-TK Mut2)) - Centralised - Renewal - Commission Decision (2018)5118 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2801/R/10

Europe -DG Health and Food Safety

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Hiprabovis IBR Marker Live (Laboratorios Hipra, S.A.)

Hiprabovis IBR Marker Live (Laboratorios Hipra, S.A.)

Hiprabovis IBR Marker Live (Active substance: Live gE- tk- double-gene deleted Bovine Herpes Virus type 1 (BoHV-1), strain CEDDEL) - Centralised - Yearly update - Commission Decision (2018)4520 of Wed, 11 Jul 2018

Europe -DG Health and Food Safety

18-4-2018

EU/3/18/2012 (IDEA Innovative Drug European Associates Limited)

EU/3/18/2012 (IDEA Innovative Drug European Associates Limited)

EU/3/18/2012 (Active substance: Genetically modified replication-incompetent herpes simplex virus-1 expressing collagen VII) - Orphan designation - Commission Decision (2018)2408 of Wed, 18 Apr 2018 European Medicines Agency (EMA) procedure number: EMA/OD/244/17

Europe -DG Health and Food Safety