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Refixia

10 September 2019

The Australian Prescription Medicine Decision Summary provides a short overview of the TGA's evaluation process leading to the registration of a new prescription medicine on the Australian Register of Therapeutic Goods (ARTG).

More in-depth information about the evaluation will be available in the Australian Public Assessment Report (AusPAR) for a particular prescription medicine, which can be found on the AusPAR search page once published.

Australian prescription medicine decision summary

Summary of submission

Product name
Refixia
Active ingredients
Nonacog beta pegol
ATC codes
B02BD04
Decision
Approved
Date of decision
2 September 2019
Date of entry onto ARTG
4 September 2019
ARTG numbers
308424, 308425, 308426
Black Triangle Scheme
Yes. This product will remain in the scheme for 5 years, starting on the date the product is first supplied in Australia.
Sponsor
Novo Nordisk Pharmaceuticals Pty Ltd
Sponsor address
PO Box 7586, Baulkham Hills NSW 2153
Dose forms
Powder and solvent for injection
Strength
500 IU, 1000 IU, 2000 IU
Other ingredients

Powder: Sodium chloride, Histidine, Sucrose, Polysorbate 80, Mannitol, Sodium hydroxide (for pH adjustment), Hydrochloric acid (for pH adjustment).

Solvent: Histidine, Water for injection, Sodium hydroxide (for pH adjustment), Hydrochloric acid (for pH adjustment).

Containers
Vial (powder) and prefilled syringe (solvent)
Pack sizes
1
Routes of administration
Intravenous
Dosage

Routine prophylaxis: 40 IU/kg body weight once weekly.

Bleeding episodes: The dose and duration of the replacement therapy depends on the location and severity of the bleeding.

For further information refer to the Product Information.

What was approved?

Refixia (nonacog beta pegol) was approved for the following therapeutic use:

Treatment and prophylaxis of bleeding in patients 12 years and above with haemophilia B (congenital factor IX deficiency).

What is this medicine and how does it work?

What was the decision based on?

What steps were involved in the decision process?

What post-market commitments will the sponsor undertake?

The following specific conditions of registration apply to this approval:

  • Refixia (nonacog beta pegol) is to be included in the Black Triangle Scheme. The Product Information (PI) and Consumer Medicines Information (CMI) for Refixia must include the black triangle symbol and mandatory accompanying text for five years, which starts from the date that the sponsor notifies the TGA of supply of the product.
  • The Refixia (nonacog beta pegol) European Union-Risk Management Plan (EU-RMP) (version 4.0, dated 28 April 2017, data lock point 1 January 2016), with Australian Specific Annex (version 0.3, dated 2 April 2019), included with submission PM-2018-02720-1-6, and any subsequent revisions, as agreed with the TGA will be implemented in Australia.

    An obligatory component of risk management plans is routine pharmacovigilance. Routine pharmacovigilance includes the submission of periodic safety update reports (PSURs).

    Reports are to be provided in line with the current published list of EU reference dates and frequency of submission of PSURs until the period covered by such reports is not less than three years from the date of this approval letter.

    The reports are to at least meet the requirements for PSURs as described in the European Medicines Agency's Guideline on good pharmacovigilance practices (GVP) Module VII-periodic safety update report (Rev 1), Part VII.B Structures and processes. Note that submission of a PSUR does not constitute an application to vary the registration.

  • For all injectable products the Product Information must be included with the product.

Further information

The latest Product Information (PI) and Consumer Medicines Information (CMI) can be found at: ARTG search.

Australian Public Assessment Reports (AusPARs) can be found at: AusPAR search.

The latest news and updates regarding therapeutic goods regulation can be found at: TGA news room.