Medicine

Main information

  • Trade name:
  • Medicine administration kit, percutaneous, non-medicated, single-use
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Medicine administration kit, percutaneous, non-medicated, single-use
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221856
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221856

Shire Australia Pty Ltd - Medicine administration kit, percutaneous, non-medicated, single-use

ARTG entry for

Medical Device Included Class IIa

Sponsor

Shire Australia Pty Ltd

Postal Address

Level 39 Grosvenor Place,225 George Street,Sydney, NSW, 2000

Australia

ARTG Start Date

1/04/2014

Product category

Medical Device Class IIa

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

Baxter Healthcare Corporation Cellular

Therapies Division

1700 Rancho Canejo Boulevard

THOUSAND OAKS, CALIFORNIA, 91320

United States Of America

Products

1. Medicine administration kit, percutaneous, non-medicated, single-use

Product Type

Procedure Pack

Effective date

1/04/2014

GMDN

45158 Medicine administration kit, percutaneous, non-medicated, single-use

Intended purpose

Administration set for administration of coagulation products.

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 11:34:34 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

25-3-2019


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Europe -DG Health and Food Safety

15-3-2019

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Europe -DG Health and Food Safety

15-3-2019

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15-3-2019

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Europe -DG Health and Food Safety

15-3-2019

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15-3-2019

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Europe -DG Health and Food Safety

15-3-2019

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Europe -DG Health and Food Safety

14-3-2019


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14-3-2019

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14-3-2019

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14-3-2019

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Europe -DG Health and Food Safety

13-3-2019

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13-3-2019

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Europe -DG Health and Food Safety

13-3-2019

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Europe -DG Health and Food Safety

13-3-2019

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Europe -DG Health and Food Safety

13-3-2019

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Europe -DG Health and Food Safety

13-3-2019

Ferriprox (Apotex Europe B.V.)

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Europe -DG Health and Food Safety

13-3-2019

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Europe -DG Health and Food Safety

12-3-2019

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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

Today is the last day to provide comments to the #DigitalHealth #FDAPrecertPilot working model. Input will help shape the @US_FDA's next steps to build the #Pre-Cert program. Submit comments to the docket:  https://www.regulations.gov/docket?D=FDA-2017-N-

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FDA - U.S. Food and Drug Administration

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)

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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