Adverse events
It is iNova’s ethical and regulatory responsibilities to monitor the safety of our medicines for as long as they are used by patients and consumers anywhere in the world. iNova collects information about adverse events as our ongoing commitment to the safety of our products. Our pharmacovigilance team monitors, evaluates, detects, collects and responds to drug safety hazards as well as reporting safety information to the various Partners, Global Health and Regulatory Authorities.
An adverse event is any unintended/untoward medical occurrence in a patient associated with the use of a product, and there does not necessarily have to be a causal relationship with the treatment.
Adverse event examples (this is a non-exhaustive list):
- Worsening of pre-existing medical condition
- Unintended symptoms experienced during the use of an iNova product
- Unfavourable or unintended sign or disease
- Abnormal laboratory finding
- Lack of therapeutic effect with the use of an iNova product
- Drug abuse / overdose
- Pregnancy / lactation exposure
- Off-label use
- Drug interactions
Please report ALL adverse events to drugsafety@inovapharma.com as soon as you become aware of them. All reports are handled confidentially. Thank you for your assistance.
iNova may share your reported adverse event with third parties that we engage to process adverse events and enquiries on our behalf. iNova may also use the information to maintain records of reports and to investigate or follow up on your report. If you are providing us with someone else’s personal information, you confirm that you have obtained their consent to do so. iNova will share the details of your reported side effect with the various Partners, Health and Regulatory Authorities in your country and in countries around the world as mandated by law; no personally identifiable details in that instance will be shared.
If iNova receives information regarding a side effect with another company’s product, we are mandated by Health Authority regulations to share that information with that company. You may be contacted by that company for additional information regarding the side effect with their product.
You can view further details on how we manage personal information in our privacy policy at www.inovapharma.com.au/privacy-policy/. If you have any questions or concerns regarding the management of your personal information, please contact privacy@inovapharma.com.
