ALPROLIX

Main information

  • Trade name:
  • ALPROLIX eftrenonacog alfa (rhu) 2000 IU powder for injection vial and diluent pre-filled syringe
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ALPROLIX eftrenonacog alfa (rhu) 2000 IU powder for injection vial and diluent pre-filled syringe
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 209225
  • Last update:
  • 10-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

209225

ALPROLIX eftrenonacog alfa (rhu) 2000 IU powder for injection vial and diluent pre-filled syringe

ARTG entry for

Medicine Registered

Sponsor

Bioverativ Australia Pty Ltd

Postal Address

Level 27 AMP Centre 50 Bridge Street,Sydney, NSW, 2000

Australia

ARTG Start Date

1/05/2014

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. ALPROLIX eftrenonacog alfa (rhu) 2000 IU powder for injection vial and diluent pre-filled syringe

Product Type

Composite Pack

Effective date

22/06/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

ALPROLIX is a long-acting anti-haemophilic factor (recombinant) indicated in adults and children with haemophilia B (congenital factor IX deficiency) for:

- control and prevention of bleeding episodes

- routine prophylaxis to prevent or reduce the frequency of bleeding episodes

- perioperative management (surgical prophylaxis)

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Multiple containers

Glass Type I Clear

48 Months

Store at 2 to 8

degrees Celsius

Not recorded

Do not Freeze

Protect from Light

Reconstituted Solution

see label for shelf life

Refrigerate

Pack Size/Poison information

Pack Size

Poison Schedule

1s (vial + diluent)

exempt from scheduling - Appendix A; prescription medicine

Components

1. syringe

Dosage Form

Injection, diluent for

Route of Administration

Intravenous Infusion

Visual Identification

Clear, colorless solution, essentially free of visible particles

2. vial adaptor

Dosage Form

Drug delivery system

Route of Administration

Intravenous

Visual Identification

3. vial

Dosage Form

Injection, powder for

Route of Administration

Intravenous Infusion

Visual Identification

White to off-white powder to cake

Active Ingredients

Public Summary

Page 1 of

Produced at 27.11.2017 at 10:40:50 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

eftrenonacog alfa

2000 IU

© 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 2 of

Produced at 27.11.2017 at 10:40:50 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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4-9-2018

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4-9-2018

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27-8-2018

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27-8-2018

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Beromun (BELPHARMA s.a.)

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27-8-2018

Aranesp (Amgen Europe B.V.)

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22-8-2018

Luveris (Merck Europe B.V.)

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22-8-2018

Pergoveris (Merck Europe B.V.)

Pergoveris (Merck Europe B.V.)

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Europe -DG Health and Food Safety

8-8-2018

GONAL-f (Merck Europe B.V.)

GONAL-f (Merck Europe B.V.)

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Europe -DG Health and Food Safety

6-8-2018

ReFacto AF (Pfizer Europe MA EEIG)

ReFacto AF (Pfizer Europe MA EEIG)

ReFacto AF (Active substance: Moroctocog alfa ) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5374 of Mon, 06 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/232/T/146

Europe -DG Health and Food Safety

2-8-2018

EU/3/18/2046 (Italfarmaco S.p.A.)

EU/3/18/2046 (Italfarmaco S.p.A.)

EU/3/18/2046 (Active substance: Givinostat) - Orphan designation - Commission Decision (2018)5278 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/062/18

Europe -DG Health and Food Safety

30-7-2018

NovoEight (Novo Nordisk A/S)

NovoEight (Novo Nordisk A/S)

NovoEight (Active substance: turoctocog alfa) - Centralised - 2-Monthly update - Commission Decision (2018)5093 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2719/II/23

Europe -DG Health and Food Safety

25-7-2018

Bemfola (Gedeon Richter Plc.)

Bemfola (Gedeon Richter Plc.)

Bemfola (Active substance: follitropin alfa) - Centralised - Yearly update - Commission Decision (2018)4989 of Wed, 25 Jul 2018

Europe -DG Health and Food Safety