Active-support

Main information

  • Trade name:
  • Active-support bandage
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Active-support bandage
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222195
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222195

Sutherland Medical Pty Limited - Active-support bandage

ARTG entry for

Medical Device Included Class 1

Sponsor

Sutherland Medical Pty Limited

Postal Address

PO Box 1194,HUNTINGDALE, VIC, 3166

Australia

ARTG Start Date

9/04/2014

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

Synergy Health UK Ltd

1 Western Avenue Matrix Park Buckshaw

Village

Chorley, Lancashire, PR77NB

United Kingdom

Products

1. Active-support bandage

Product Type

Single Device Product

Effective date

9/04/2014

GMDN

10279 Active-support bandage

Intended purpose

Tubular close weave bandage for the retention of dressings.

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 09.11.2017 at 10:28:15 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

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16-3-2019

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15-3-2019

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Pemetrexed Accord (Active substance: pemetrexed) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)1669 of Wed, 27 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/4072/T/06

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EU/3/13/1154 (Diamond ROC EOOD)

EU/3/13/1154 (Diamond ROC EOOD)

EU/3/13/1154 (Active substance: Fosbretabulin tromethamine) - Transfer of orphan designation - Commission Decision (2019)2145 of Wed, 20 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003817

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EU/3/18/2101 (TMC Pharma (EU) Limited)

EU/3/18/2101 (TMC Pharma (EU) Limited)

EU/3/18/2101 (Active substance: Setmelanotide) - Transfer of orphan designation - Commission Decision (2019)2155 of Tue, 19 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004764

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EU/3/16/1703 (TMC Pharma (EU) Limited)

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EU/3/16/1703 (Active substance: Setmelanotide) - Transfer of orphan designation - Commission Decision (2019)2154 of Tue, 19 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004730

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19-3-2019

EU/3/16/1688 (TMC Pharma (EU) Limited)

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EU/3/16/1688 (Active substance: Setmelanotide) - Transfer of orphan designation - Commission Decision (2019)2153 of Tue, 19 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004734

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19-3-2019

EU/3/18/2052 (Dicerna Ireland Limited)

EU/3/18/2052 (Dicerna Ireland Limited)

EU/3/18/2052 (Active substance: Synthetic double-stranded siRNA oligonucleotide directed against lactate dehydrogenase A mRNA and containing four modified nucleosides which form a ligand cluster of four N-acetylgalactosamine residues) - Transfer of orphan designation - Commission Decision (2019)2156 of Tue, 19 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004770

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19-3-2019

EU/3/10/823 (Amryt Pharmaceuticals Designated Activity Company)

EU/3/10/823 (Amryt Pharmaceuticals Designated Activity Company)

EU/3/10/823 (Active substance: Lomitapide) - Transfer of orphan designation - Commission Decision (2019)2152 of Tue, 19 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004233

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18-3-2019

EU/3/16/1633 (Diamond ROC EOOD)

EU/3/16/1633 (Diamond ROC EOOD)

EU/3/16/1633 (Active substance: Fosbretabulin tromethamine) - Transfer of orphan designation - Commission Decision (2019)2151 of Mon, 18 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003815

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18-3-2019

EU/3/15/1587 (Diamond ROC EOOD)

EU/3/15/1587 (Diamond ROC EOOD)

EU/3/15/1587 (Active substance: Combretastatin A1 diphosphate) - Transfer of orphan designation - Commission Decision (2019)2149 of Mon, 18 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003811

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18-3-2019

EU/3/15/1584 (Diamond ROC EOOD)

EU/3/15/1584 (Diamond ROC EOOD)

EU/3/15/1584 (Active substance: Variant of recombinant human fibroblast growth factor 19) - Transfer of orphan designation - Commission Decision (2019)2148 of Mon, 18 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003801

Europe -DG Health and Food Safety

18-3-2019

EU/3/14/1329 (Diamond ROC EOOD)

EU/3/14/1329 (Diamond ROC EOOD)

EU/3/14/1329 (Active substance: Variant of recombinant human fibroblast growth factor 19) - Transfer of orphan designation - Commission Decision (2019)2147 of Mon, 18 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003809

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18-3-2019

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18-3-2019

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18-3-2019

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Europe -DG Health and Food Safety

18-3-2019

EU/3/16/1742 (Worphmed Srl)

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15-3-2019

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15-3-2019

Intrarosa (Endoceutics S.A.)

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15-3-2019

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15-3-2019

Zoledronic acid Accord (Accord Healthcare S.L.U.)

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15-3-2019

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15-3-2019

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15-3-2019

EU/3/06/349 (Vectura Ireland Limited)

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Europe -DG Health and Food Safety

15-3-2019

EU/3/15/1597 (Otsuka Pharmaceutical Netherlands B.V.)

EU/3/15/1597 (Otsuka Pharmaceutical Netherlands B.V.)

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15-3-2019

EU/3/11/936 (BPL Bioproducts Laboratory GmbH)

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Europe -DG Health and Food Safety

15-3-2019

EU/3/16/1800 (Boyd Consultants Limited)

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Europe -DG Health and Food Safety

15-3-2019

EU/3/16/1629 (Boyd Consultants Limited)

EU/3/16/1629 (Boyd Consultants Limited)

EU/3/16/1629 (Active substance: Exenatide) - Transfer of orphan designation - Commission Decision (2019)2110 of Fri, 15 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005191

Europe -DG Health and Food Safety

15-3-2019

EU/3/14/1396 (Boyd Consultants Limited)

EU/3/14/1396 (Boyd Consultants Limited)

EU/3/14/1396 (Active substance: Adenovirus serotype 5 containing partial E1A deletion and an integrin-binding domain) - Transfer of orphan designation - Commission Decision (2019)2109 of Fri, 15 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005074

Europe -DG Health and Food Safety

15-3-2019

EU/3/11/895 (Boyd Consultants Limited)

EU/3/11/895 (Boyd Consultants Limited)

EU/3/11/895 (Active substance: Hydroxy-propyl-beta-cyclodextrin) - Transfer of orphan designation - Commission Decision (2019)2108 of Fri, 15 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005321

Europe -DG Health and Food Safety

14-3-2019

Aivlosin (ECO Animal Health Europe Limited)

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Aivlosin (Active substance: Tylvalosin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)2091 of Thu, 14 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/V/C/83/T/77

Europe -DG Health and Food Safety

14-3-2019

Reconcile (Pegasus Laboratories Ireland Limited)

Reconcile (Pegasus Laboratories Ireland Limited)

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Europe -DG Health and Food Safety

14-3-2019

Suprelorin (VIRBAC S.A.)

Suprelorin (VIRBAC S.A.)

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Europe -DG Health and Food Safety

13-3-2019

Luminity (Lantheus EU Limited)

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Europe -DG Health and Food Safety

13-3-2019

Qarziba (EUSA Pharma (Netherlands) B.V.)

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Europe -DG Health and Food Safety

13-3-2019

Cresemba (Basilea Pharmaceutica Deutschland GmbH)

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Europe -DG Health and Food Safety

13-3-2019

Stayveer (Janssen Pharmaceutica N.V.)

Stayveer (Janssen Pharmaceutica N.V.)

Stayveer (Active substance: bosentan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)2065 of Wed, 13 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/2644/T/25

Europe -DG Health and Food Safety

13-3-2019

Varuby (TESARO Bio Netherlands B.V.)

Varuby (TESARO Bio Netherlands B.V.)

Varuby (Active substance: rolapitant) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)2068 of Wed, 13 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/4196/T/15

Europe -DG Health and Food Safety

13-3-2019

Senshio (Shionogi B.V.)

Senshio (Shionogi B.V.)

Senshio (Active substance: ospemifene) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)2066 of Wed, 13 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/2780/T/26

Europe -DG Health and Food Safety

13-3-2019

Slenyto (RAD Neurim Pharmaceuticals EEC SARL)

Slenyto (RAD Neurim Pharmaceuticals EEC SARL)

Slenyto (Active substance: melatonin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)2064 of Wed, 13 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/4425/T/04

Europe -DG Health and Food Safety

13-3-2019

Actrapid (Novo Nordisk A/S)

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Actrapid (Active substance: Insulin human (rDNA)) - Centralised - Yearly update - Commission Decision (2019)2070 of Wed, 13 Mar 2019

Europe -DG Health and Food Safety

13-3-2019

Herceptin (Roche Registration GmbH)

Herceptin (Roche Registration GmbH)

Herceptin (Active substance: trastuzumab) - Centralised - Yearly update - Commission Decision (2019) 2059 of Wed, 13 Mar 2019

Europe -DG Health and Food Safety

13-3-2019

INOmax (Linde Healthcare AB)

INOmax (Linde Healthcare AB)

INOmax (Active substance: Nitric oxide) - Centralised - Yearly update - Commission Decision (2019)2060 of Wed, 13 Mar 2019

Europe -DG Health and Food Safety

13-3-2019

Ferriprox (Apotex Europe B.V.)

Ferriprox (Apotex Europe B.V.)

Ferriprox (Active substance: Deferiprone) - Centralised - 2-Monthly update - Commission Decision (2019)2057 of Wed, 13 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/236/II/0126/G

Europe -DG Health and Food Safety

13-3-2019

Praluent (Sanofi-Aventis groupe)

Praluent (Sanofi-Aventis groupe)

Praluent (Active substance: alirocumab) - Centralised - 2-Monthly update - Commission Decision (2019)2058 of Wed, 13 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/3882/II/0042

Europe -DG Health and Food Safety

13-3-2019

Updated GMP licence application e-forms

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GMP Licence submission e-forms will be updated on the TBS portal from 15 March 2019 to support the revised fees and charges model

Therapeutic Goods Administration - Australia

12-3-2019

Quinolone and fluoroquinolone medicinal products for systemic and inhalation use

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Quinolone and fluoroquinolone medicinal products for systemic and inhalation use (Active substance: nalidixic acid, pipemidic acid, cinoxacin, enoxacin, pefloxacin, lomefloxacin, ciprofloxacin, levofloxacin, ofloxacin, moxifloxacin, norfloxacin, prulifloxacin, rufloxacin, flumequine) - Community Referrals - Art 31 - Commission Decision (2019)2050 of Tue, 12 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/A-31/1452/C/2789

Europe -DG Health and Food Safety

11-3-2019

EU/3/14/1337 (ESPL Regulatory Consulting Limited)

EU/3/14/1337 (ESPL Regulatory Consulting Limited)

EU/3/14/1337 (Active substance: Acamprosate calcium) - Transfer of orphan designation - Commission Decision (2019)1944 of Mon, 11 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004283

Europe -DG Health and Food Safety

8-3-2019

EU/3/12/968 (Clinical Network Services (NL) B.V.)

EU/3/12/968 (Clinical Network Services (NL) B.V.)

EU/3/12/968 (Active substance: Human monoclonal antibody targeting Staphylococcus aureus alpha-toxin) - Transfer of orphan designation - Commission Decision (2019)1940 of Fri, 08 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004447

Europe -DG Health and Food Safety

8-3-2019

EU/3/17/1894 (Granzer Regulatory Consulting and Services)

EU/3/17/1894 (Granzer Regulatory Consulting and Services)

EU/3/17/1894 (Active substance: Recombinant human antibody directed against misfolded human superoxide dismutase 1) - Transfer of orphan designation - Commission Decision (2019)1943 of Fri, 08 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004025

Europe -DG Health and Food Safety

8-3-2019

EU/3/14/1281 (Vertex Pharmaceuticals (Ireland) Limited)

EU/3/14/1281 (Vertex Pharmaceuticals (Ireland) Limited)

EU/3/14/1281 (Active substance: 1-(2,2-difluoro-1,3-benzodioxol-5-yl)-N-{1-[(2R)-2,3-dihydroxypropyl]-6-fluoro-2-(1-hydroxy-2-methylpropan-2-yl)-1H-indol-5-yl}cyclopropanecarboxamide) - Transfer of orphan designation - Commission Decision (2019)1953 of Fri, 08 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004132

Europe -DG Health and Food Safety

8-3-2019

EU/3/08/563 (Vertex Pharmaceuticals (Ireland) Limited)

EU/3/08/563 (Vertex Pharmaceuticals (Ireland) Limited)

EU/3/08/563 (Active substance: Recombinant derivative of C3 transferase) - Transfer of orphan designation - Commission Decision (2019)1952 of Fri, 08 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004115

Europe -DG Health and Food Safety

8-3-2019

EU/3/15/1487 (Leadiant GmbH)

EU/3/15/1487 (Leadiant GmbH)

EU/3/15/1487 (Active substance: Reduced oxydised N-acetyl heparin) - Transfer of orphan designation - Commission Decision (2019)1951 of Fri, 08 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004452

Europe -DG Health and Food Safety

8-3-2019

EU/3/16/1757 (Imago BioSciences B.V.)

EU/3/16/1757 (Imago BioSciences B.V.)

EU/3/16/1757 (Active substance: N-[(2S)-5-{[(1R,2S)-2-(4-fluorophenyl)cyclopropyl]amino}-1-(4-methylpiperazin-1-yl)-1-oxopentan-2-yl]-4-(1H-1,2,3-triazol-1-yl)benzamide, bis-tosylate salt) - Transfer of orphan designation - Commission Decision (2019)1954 of Fri, 08 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003424

Europe -DG Health and Food Safety