PRODUCT SAFETY

It is our ethical and regulatory responsibilities to monitor the safety of our medicines and medical devices for as long as they are used by patients and consumers anywhere in the world. iNova collects information about side effects or adverse events as our ongoing commitment to the safety of our products.

If you experience any side effects, please talk to your doctor, pharmacist or nurse.

REPORTING SIDE EFFECT

A side effect is any unwanted medical occurrence in a patient who has been given a pharmaceutical product that may or may not have been caused by treatment with the product. A side effect can therefore be any unfavourable and unintended sign, symptom, or disease associated with the use of the product.

If you or the person you are reporting on behalf of are currently suffering from severe side effects, you should contact your local doctor or other medical health professional before reporting the side effect.

Side effects (“Adverse events”) must be reported in accordance with local regulatory requirements.

To report side effects, you can email to Drugsafety@inovapharma.com

When submitting in an e-mail format, please provide the following information in your email to ensure it is handled in a manner consistent with the applicable local laws:

  • Name of the drug:
    Description of when the patient started the medication, including dosing strength and frequency (amount and how often, e.g. 40mg twice daily). Any action taken with the medication (e.g. reduced dose, stopped) and impact of that action on the side effect.
  • The side effect associated with the drug:
    Description of when the patient started the medication, including dosing strength and frequency (amount and how often, e.g. 40mg twice daily). Any action taken with the medication (e.g. reduced dose, stopped) and impact of that action on the side effect.
  • Your name (optional):
    Please note that your personal identifying information (e.g. name, email address, phone number) will not be shared with the health authorities. iNova or its agents may contact you via email or phone for further information about the side effect. If you do not wish to be contacted, you should indicate this in your email. You will receive an email confirmation with the Report Reference number for your records if you supply an email address.
  • Information about the person who experienced the side effect:
    Any other medical conditions currently ongoing. Medications currently taken (name, dosing strength, frequency, and when medication was started). Gender and age of the person taking medication (optional).

(“optional” – you don’t have to answer them. The more information you can give us, the more we can understand about the side effect and help others with similar issues.)

iNova will share the details of your reported side effect with the Health Authorities in your country and in countries around the world as mandated by law; no personally identifiable details 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.
iNova will not share any of your private information with marketing programs, email distribution lists, or third parties except as outlined as above (See Privacy tab for more information).

PRODUCT QUALITY COMPLAINTS

iNova is committed to maintain the highest quality standards to ensure product and consumer safety of all our products at all times.

REPORTING PRODUCT QUALITY CONCERNS

iNova is committed to meeting customer requirements and aims to be aware of any problems users may encounter with our products. This can be any issue related to e.g. product appearance, packaging, and other product defects. The more information we receive will ensure that we can conduct effective investigation and follow-up.

To report a Product Quality Matter, please click HERE