Heparin Interpharma
Registration timeline
The following table summarises the key steps and dates for this application.
Description | Date |
|---|---|
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* | 214 |
*Statutory timeframe for standard applications is 255 working days
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.
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.
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.
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.
- Laboratory testing & compliance with Certified Product Details (CPD)
- 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).
- 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.