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Device/Product name
Heparin Interpharma
Active Ingredient
Heparin sodium
Date of decision
Submission type
New biological entity
What was the decision based on
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology) and clinical (pharmacology, safety and efficacy) information submitted by the sponsor. The benefit-risk profile of Heparin Interpharma 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.



Submission dossier accepted and first round evaluation commenced

4 October 2022

Delegate’s Overall benefit-risk assessment and request for Advisory Committee advice

5 September 2023

Advisory Committee meeting

5 and 6 October 2023

Registration decision (Outcome)

15 November 2023

Completion of administrative activities and registration on ARTG

24 November 2023

Number of working days from submission dossier acceptance to registration decision*


*Statutory timeframe for standard applications is 255 working days

Date of entry onto ARTG
Black triangle scheme
Dose forms
Solution for injection
5,000 international units (IU)/0.5 mL
Prefilled syringe
Pack sizes
Routes of administration
Subcutaneous and intravenous

Heparin may be given by intermittent intravenous injection, intravenous infusion or deep subcutaneous injection. It should not be given intramuscularly because of the danger of haematoma formation. A guide to dosage schedules for prophylaxis and treatment is presented in Table 1 of the Product Information.

For further information refer to the Product Information.

Pregnancy category

Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. 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. The pregnancy database 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

Heparin Interpharma (heparin sodium) was approved for the following therapeutic use:

Prophylaxis and treatment of deep vein thrombosis for use in patients 18 years and older.

What is this medicine and how does it work
Heparin is a naturally occurring mucopolysaccharide which inhibits the clotting of blood in vitro and in vivo. It enhances the rate at which antithrombin III neutralises thrombin and activated factor X (Xa). Antithrombin III also neutralises other activated coagulation factors, for example, factors IX, XI, XII and plasmin.

With low dose heparin therapy, anticoagulation appears to result from neutralisation of Xa which prevents the conversion of prothrombin to thrombin. With full dose heparin therapy, anticoagulation appears to result primarily from neutralisation of thrombin which prevents the conversion of fibrinogen to fibrin. Full dose heparin therapy also prevents the formation of a stable fibrin clot by inhibiting activation of fibrin stabilising factor.
What post-market commitments will the sponsor undertake
  • Laboratory testing & compliance with Certified Product Details (CPD)
  1. All batches of Heparin Interpharma (heparin sodium) supplied in Australia must comply with the product details and specifications approved during evaluation and detailed in the Certified Product Details (CPD).
  2. When requested by the TGA, the sponsor should be prepared to provide product samples, specified reference materials and documentary evidence to enable the TGA to conduct laboratory testing on the product. Outcomes of laboratory testing are published biannually in the TGA Database of Laboratory Testing Results
  • Certified Product Details

The Certified Product Details (CPD), as described in Guidance 7: Certified Product Details of the Australian Regulatory Guidelines for Prescription Medicines (ARGPM), in PDF format, for the above products should be provided upon registration of these therapeutic goods. In addition, an updated CPD should be provided when changes to finished product specifications and test methods are approved in a Category 3 application or notified through a self-assessable change.

A template for preparation of CPD for biological prescription medicines can be obtained from the TGA website [for the form] [for the CPD guidance].

  • 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 by searching the Australian Register of Therapeutic Goods (ARTG).

Australian Public Assessment Reports (AusPARs) can be found by searching our AusPAR dataset.

The latest news and updates regarding therapeutic goods regulation can be found on our news page.

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