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Ziextenzo

13 December 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

Submission type
New biosimilar medicine
Product name
Ziextenzo
Active ingredients
Pegfilgrastim
ATC codes
L03AA13
Decision
Approved
Date of decision
9 July 2019
Date of entry onto ARTG
6 September 2019
ARTG numbers
308367
Black Triangle Scheme
No
Sponsor
Sandoz Pty Ltd
Sponsor address
54 Waterloo Road, Macquarie Park NSW 2113
Dose forms
Solution for injection
Strength
6 mg/0.6 mL
Other ingredients
The product is formulated at pH 4.0 with 0.36 mg acetic acid, 30 mg sorbitol, 0.02 mg polysorbate 20, sodium hydroxide (if necessary for pH adjustment) in Water for Injection to 0.6 mL.
Containers
Prefilled syringe with automatic needle guard
Pack sizes
1
Routes of administration
Subcutaneous
Dosage

The recommended dosage of Ziextenzo is a single subcutaneous injection of 6 mg administered once per chemotherapy cycle, approximately 24 hours after the administration of cytotoxic chemotherapy.

For further information refer to the Product Information.

Pregnancy category

Category B3

Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed.

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?

Ziextenzo (pegfilgrastim) was approved for the following therapeutic use:

Ziextenzo is indicated for the treatment of cancer patients following chemotherapy, to decrease the duration of severe neutropenia and so reduce the incidence of infection, as manifested by febrile neutropenia.

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?

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.