Belotero

Main information

  • Trade name:
  • Belotero Balance Lidocaine - Synthetic-fluid tissue reconstructive material, anaesthetic
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Belotero Balance Lidocaine - Synthetic-fluid tissue reconstructive material, anaesthetic
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220902
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220902

Merz Australia Pty Ltd - Belotero Balance Lidocaine - Synthetic-fluid tissue reconstructive material,

anaesthetic

ARTG entry for

Medical Device Included Class III

Sponsor

Merz Australia Pty Ltd

Postal Address

Level 3,244 Coward street,Mascot, NSW, 2020

Australia

ARTG Start Date

7/03/2014

Product category

Medical Device Class III

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

Anteis SA

18 Chemin des Aulx

Plan-Les-Ouates, , CH-1228

Switzerland

Products

1. Belotero Balance Lidocaine - Synthetic-fluid tissue reconstructive material, anaesthetic

Product Type

Single Device Product

Effective date

2/03/2016

GMDN

47887 Synthetic-fluid tissue reconstructive material, anaesthetic

Functional description

A sterile, non-pyrogenic, viscoelastic, colourless, transparent cross-linked sodium hyaluronate gel of

non-animal origin, in a physiological buffer. Contains 0.3% lidocaine hydrochloride. Pack contains 1 sterile

27G½" needle and 1 sterile 30G½" needle.

Intended purpose

An injectable resorbable filler implant indicated to fill moderate facial wrinkles and folds as well as for lip

enhancement. It is also suitable for correction of facial atrophic scars. The presence of lidocaine reduces

local pain associated to the injection of the gel and improves patient's comfort during and immediately after

injection.

Variant information

Volume (mL) 0.6 and 1.0

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 02:49:13 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