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333120, 333121, 333122, 333123, 333124, 333125
333120, 333121, 333122, 333123, 333124, 333125
333120, 333121, 333122, 333123, 333124, 333125
333120, 333121, 333122, 333123, 333124, 333125
333120, 333121, 333122, 333123, 333124, 333125
333120, 333121, 333122, 333123, 333124, 333125
Device/Product name
Cutaquig
Active Ingredient
Human normal immunoglobulin (human immunoglobulin G)
Date of decision
Published
Submission type
New biological entity
ATC codes
J06BA02
Decision
Approved
What was the decision based on
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Cutaquig was considered favourable for the therapeutic use approved.
What steps were involved in the decision process

Registration timeline

The following table summarises the key steps and dates for this application.

Description Date
Submission dossier accepted and first round evaluation commenced 30 April 2020
First round evaluation completed 30 September 2020
Sponsor provides responses on questions raised in first round evaluation 30 November 2020
Second round evaluation completed 12 January 2021
Delegate's overall benefit-risk assessment 25 March 2021
Sponsor's pre-Advisory Committee response Not applicable
Advisory Committee meeting Not applicable
Registration decision (Outcome) 21 April 2021
Completion of administrative activities and registration on ARTG 3 May 2021
Number of working days from submission dossier acceptance to registration decision* 199

*Statutory timeframe for standard applications is 255 working days

Date of entry onto ARTG
Original publication date
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
Dose forms
Solution for subcutaneous injection
Strength
16.5% (165 mg/mL) solution available as 8 g/48 mL, 3.3 g/20 mL, 4 g/24 mL, 1 g/6 mL, 2 g/12 mL or 1.65 g/10 mL
Other ingredients
Maltose, polysorbate 80, water for injections
Containers
Vial
Pack sizes
1, 10 or 20
Routes of administration
Subcutaneous injection
Dosage

Replacement therapy should be initiated under the supervision of a healthcare professional experienced in the treatment of immunodeficiency.

In replacement therapy the dosage may need to be individualised for each patient dependent on the pharmacokinetic and clinical response.

For further information refer to the Product Information.

Pregnancy category
This therapeutic good is exempted from pregnancy categorisation.The use of any medicine during pregnancy requires careful consideration of both risks and benefits by the treating health professional. This must not be used as the sole basis of decision making in the use of medicines during pregnancy. The TGA does not provide advice on the use of medicines in pregnancy for specific cases. More information is available from obstetric drug information services in your State or Territory.
What was approved

Cutaquig (human normal immunoglobulin) was approved for the following therapeutic use:

Replacement therapy in adults and children in:

  • Primary immunodeficiency diseases (PID)
  • Symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment
What is this medicine and how does it work
Cutaquig contains mainly immunoglobulin G (IgG) with a broad spectrum of antibodies against infectious agents. It contains the IgG antibodies present in the normal population. It is usually prepared from pooled plasma from not fewer than 1000 donations.Cutaquig has a distribution of IgG subclasses closely proportional to that in native human plasma. Adequate doses of this medicinal product may restore abnormally low IgG levels to the normal range.
What post-market commitments will the sponsor undertake
  • Cutaquig (human normal immunoglobulin) is to be included in the Black Triangle Scheme. The Product Information (PI) and Consumer Medicines Information (CMI) for Cutaquig 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 Cutaquig European Union (EU)-risk management plan (RMP) (version 01.3, dated 12 December 2018, data lock point 31 October 2018), with Australian specific Annex (version 01, dated 1 April 2020), included with submission PM-2020-00473-1-2, 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 the 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.

  • It is a condition of registration that all batches of Cutaquig imported into/manufactured in Australia must comply with the product details and specifications approved during evaluation and detailed in the Certified Product Details (CPD).
  • It is a condition of registration that up to 5 initial batches of Cutaquig imported into/manufactured in Australia is not released for sale until samples and/or the manufacturer's release data have been assessed and endorsed for release by the TGA Laboratories Branch. Outcomes of laboratory testing are published biannually in the TGA Database of Laboratory Testing Results.
  • The sponsor should be prepared to provide product samples, reference materials and documentary evidence as defined by the TGA Laboratories branch. The sponsor must contact Biochemistry Testing for specific material requirements related to batch release testing/assessment of the product.
  • For all injectable products the Product Information must be included with the product as a package insert.

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