Product Information (PI)
29 July 2014
A Product Information document (PI) provides health professionals with a summary of the scientific information relevant to the safe and effective use of a prescription or pharmacist-only medicine.
PI documents can be found by searching this website or by using the PI search database in eBusiness Services. You can enter the product name, licence details, sponsor details, active ingredient names or the ARTG number to get results.
Where available links to product information (PI) pdf documents are provided.
The information in a product information document has been written by the pharmaceutical company responsible for the medicine and has been approved by the TGA. It provides objective information about the quality, safety and effectiveness of the medicine, as demonstrated in the data provided to the TGA by the pharmaceutical company.
This information is intended to assist doctors, pharmacists and other health professionals in prescribing and dispensing medicines. In addition, this information can be used by health professionals in their consultations with patients, so that the patient can be better informed about their medicines.
A PI should contain the following information:
- Name of the medicine
- Clinical trials
- Adverse effects
- Dosage and administration
- Presentation and storage conditions
- Name and address of the sponsor
- Poison schedule of the medicine
- Date of approval
Approximately 90 per cent of registered prescription medicines have PI documents that are available through the TGA website. There are a number of reasons why a PI document may not be available including:
- the medicine is newly registered and the PI document has not yet been lodged
- the medicine is not classed as a registered prescription medicine or pharmacist-only medicine, for example it may be a listed medicine that is available without a prescription
- the medicine was "grandfathered" onto the ARTG at the time of commencement of the legislation in 1991
- the product contains excipient ingredients only but is still regulated as a "therapeutic good" e.g. water for injection.
If you are looking for a PI document that is not available on the TGA website, contact the sponsor of the medicine directly.
Content last updated: Tuesday, 29 July 2014
Content last reviewed: Tuesday, 29 July 2014
Web page last updated: Monday, 28 July 2014