Patch

Main information

  • Trade name:
  • Patch, eye
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Patch, eye
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217254
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217254

Optimed Pty Ltd - Patch, eye

ARTG entry for

Medical Device Included Class 1

Sponsor

Optimed Pty Ltd

Postal Address

Unit 1a 7-9 Orion Road,LANE COVE, NSW, 2066

Australia

ARTG Start Date

13/11/2013

Product category

Medical Device Class 1

Status

Active

Approval area

Medical Devices

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

Lianyungang Tiannuo Optical Instrument Co

No 3 JinQiao Road Dapu Industrial Park

Lianyungang, Jiangsu, 222000

China

Products

1. Patch, eye

Product Type

Single Device Product

Effective date

13/11/2013

GMDN

35715 Patch, eye

Intended purpose

To provide temporary occlusion for the eye in the treatment of Amblyopia, diplopia or as a occluder for

vision or field testing.

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 02:45:36 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

3-4-2017

Illegally imported medicines bought from Biovea.com

Illegally imported medicines bought from Biovea.com

In recent days, a number of people have contacted the Danish Medicines Agency because medicines they bought online from Biovea have been seized. The seized medicines were dispatched from the USA, and import of medicine from the USA is illegal for Danish citizens. More information and good advice.

Danish Medicines Agency

15-7-2014

Changed procedure for information on duplicate closed and nullified closed cases (updated)

Changed procedure for information on duplicate closed and nullified closed cases (updated)

The new process for dispatching adverse reaction reports (ASPR) will be implemented on 12 and 13 July 2014.

Danish Medicines Agency

6-5-2014

Guidance material to doctors and users of contraceptive pills

Guidance material to doctors and users of contraceptive pills

The EU Pharmacovigilance Risk Assessment Committee (PRAC) recently completed a review of the risk of blood clots (VTE) with contraceptive pills and other combined hormonal contraceptives. Combined hormonal contraceptives contain two types of hormone, oestrogen and progesterone, and are available as pills, transdermal patches and vaginal rings.

Danish Medicines Agency

There are no news related to this product.