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23 July 2021

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

Submission type
New biological entity
Product name
Active ingredients
ATC codes
Date of decision
6 July 2021
Date of entry onto ARTG
14 July 2021
Original publication date
22 July 2021
ARTG numbers
341752, 341753 and 341754
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
BioMarin Pharmaceutical Australia Pty Ltd
Sponsor address
119 Willoughby Road, Crows Nest NSW 2065
Dose forms
Solution for injection
2.5 mg/0.5 mL, 10 mg/0.5 mL and 20 mg/mL
Other ingredients
Trometamol, trometamol hydrochloride, sodium chloride, cinnamic acid and water for injections
Pre-filled syringe
Pack sizes
1 (applicable to all strengths) and 10 (only applicable to 20 mg/mL syringes)
Routes of administration

Treatment with Palynziq should be directed by physicians experienced in the management of phenylketonuria (PKU) and in the context of a multidisciplinary team, including dietician.

Dosage is based on blood phenylalanine level of the patient.

For further information refer to the Product Information.

Pregnancy category


Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.

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?

Palynziq (pegvaliase) was approved for the following therapeutic use:

Palynziq is indicated for the treatment of patients with phenylketonuria (PKU) aged 16 years and older who have inadequate blood phenylalanine control despite prior management with available treatment options.

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?

  • Palynziq (pegvaliase) is to be included in the Black Triangle Scheme. The Product Information and Consumer Medicines Information for Palynziq 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 Palynziq European Union (EU)-risk management plan (RMP), version 3.0, dated 6 October 2020, data lock point 17 April 2019), with Australian Specific annex (version 0.2, dated 5 March 2021) included with Submission PM-2020-04119-1-3, and any subsequent revisions, as agreed with the TGA will be implemented in Australia.

    An obligatory component of RMP 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.

  • For all injectable products the Product Information must be included with the product as a package insert.

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.