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

21-9-2018

Pending EC decision:  Jivi, damoctocog alfa pegol, Opinion date: 20-Sep-2018

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7-9-2018

Orphan designation:  Recombinant human beta-glucuronidase (vestronidase alfa),  for the: Treatment of mucopolysaccharidosis type VII (Sly syndrome)

Orphan designation: Recombinant human beta-glucuronidase (vestronidase alfa), for the: Treatment of mucopolysaccharidosis type VII (Sly syndrome)

On 21 March 2012, orphan designation (EU/3/12/973) was granted by the European Commission to NDA Regulatory Science Ltd, United Kingdom, for recombinant human beta-glucuronidase for the treatment of mucopolysaccharidosis type VII (Sly syndrome).

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Pending EC decision:  Veyvondi, vonicog alfa, Opinion date: 28-Jun-2018

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Europe - EMA - European Medicines Agency

17-5-2018

Orphan designation:  Efgartigimod alfa,  for the: Treatment of myasthenia gravis

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FDA - U.S. Food and Drug Administration

14-11-2018

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FDA - U.S. Food and Drug Administration

29-10-2018

Replagal (Shire Human Genetic Therapies AB)

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2-10-2018

PegIntron (Merck Sharp and Dohme B.V.)

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Europe -DG Health and Food Safety

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Vimizim (Active substance: elosulfase alfa) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6491 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/002779/T/0026

Europe -DG Health and Food Safety

2-10-2018

ViraferonPeg (Merck Sharp and Dohme B.V.)

ViraferonPeg (Merck Sharp and Dohme B.V.)

ViraferonPeg (Active substance: Peginterferon alfa-2b) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6477 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/329/T/128

Europe -DG Health and Food Safety

2-10-2018

IntronA (Merck Sharp and Dohme B.V.)

IntronA (Merck Sharp and Dohme B.V.)

IntronA (Active substance: Interferon alfa-2b) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6487 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/281/T/116

Europe -DG Health and Food Safety

24-9-2018

Kanuma (Alexion Europe SAS)

Kanuma (Alexion Europe SAS)

Kanuma (Active substance: sebelipase alfa) - Centralised - Yearly update - Commission Decision (2018)6245 of Mon, 24 Sep 2018

Europe -DG Health and Food Safety

24-9-2018

Ovitrelle (Merck Europe B.V.)

Ovitrelle (Merck Europe B.V.)

Ovitrelle (Active substance: Choriogonadotrophin alfa) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6220 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/320/T/75

Europe -DG Health and Food Safety

4-9-2018

Epoetin alfa Hexal (Hexal AG)

Epoetin alfa Hexal (Hexal AG)

Epoetin alfa Hexal (Active substance: epoetin alfa) - Centralised - 2-Monthly update - Commission Decision (2018)5857 of Tue, 04 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/726/II/WS/1406

Europe -DG Health and Food Safety

4-9-2018

Binocrit (Sandoz GmbH)

Binocrit (Sandoz GmbH)

Binocrit (Active substance: epoetin alfa) - Centralised - 2-Monthly update - Commission Decision (2018)5856 of Tue, 04 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/725/II/WS/1406

Europe -DG Health and Food Safety

4-9-2018

Abseamed (Medice Arzneimittel PUtter GmbH and Co KG)

Abseamed (Medice Arzneimittel PUtter GmbH and Co KG)

Abseamed (Active substance: epoetin alfa) - Centralised - 2-Monthly update - Commission Decision (2018)5860 of Tue, 04 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/727/WS/1406

Europe -DG Health and Food Safety

4-9-2018

VEYVONDI (Baxalta Innovations GmbH)

VEYVONDI (Baxalta Innovations GmbH)

VEYVONDI (Active substance: vonicog alfa) - Centralised - Authorisation - Commission Decision (2018)5866 of Tue, 04 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4454

Europe -DG Health and Food Safety

27-8-2018

Mepsevii (Ultragenyx Germany GmbH)

Mepsevii (Ultragenyx Germany GmbH)

Mepsevii (Active substance: vestronidase alfa) - Centralised - Authorisation - Commission Decision (2018)5714 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4438

Europe -DG Health and Food Safety

27-8-2018

Beromun (BELPHARMA s.a.)

Beromun (BELPHARMA s.a.)

Beromun (Active substance: Tasonermin (Tumor Necrosis Factor alfa-1a)) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5699 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/206/T/40

Europe -DG Health and Food Safety

27-8-2018

Aranesp (Amgen Europe B.V.)

Aranesp (Amgen Europe B.V.)

Aranesp (Active substance: darbepoetin alfa) - Centralised - Yearly update - Commission Decision (2018)5707 of Mon, 27 Aug 2018

Europe -DG Health and Food Safety

22-8-2018

Luveris (Merck Europe B.V.)

Luveris (Merck Europe B.V.)

Luveris (Active substance: Lutropin alfa) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5631 of Wed, 22 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/000292/T/0077

Europe -DG Health and Food Safety

22-8-2018

Pergoveris (Merck Europe B.V.)

Pergoveris (Merck Europe B.V.)

Pergoveris (Active substance: follitropin alfa / lutropin alfa) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5629 of Wed, 22 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/000714/T/0059

Europe -DG Health and Food Safety

8-8-2018

GONAL-f (Merck Europe B.V.)

GONAL-f (Merck Europe B.V.)

GONAL-f (Active substance: Follitropin alfa) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5445 of Wed, 08 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/71/T/140

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

11-6-2018

BeneFIX (Pfizer Limited)

BeneFIX (Pfizer Limited)

BeneFIX (Active substance: Nonacog alfa) - Centralised - Yearly update - Commission Decision (2018)3778 of Mon, 11 Jun 2018

Europe -DG Health and Food Safety

11-6-2018

ALPROLIX (Swedish Orphan Biovitrum AB (publ))

ALPROLIX (Swedish Orphan Biovitrum AB (publ))

ALPROLIX (Active substance: eftrenonacog alfa) - Centralised - Yearly update - Commission Decision (2018)3776 of Mon, 11 Jun 2018

Europe -DG Health and Food Safety

18-5-2018

Ovaleap (Teva B.V.)

Ovaleap (Teva B.V.)

Ovaleap (Active substance: Follitropin alfa) - Centralised - Renewal - Commission Decision (2018)3154 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2608/R/23

Europe -DG Health and Food Safety

16-5-2018

Elonva (Merck Sharp and Dohme B.V.)

Elonva (Merck Sharp and Dohme B.V.)

Elonva (Active substance: corifollitropin alfa) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3049 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1106/T/40

Europe -DG Health and Food Safety