Adverse-Event Report

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Adverse Event (AE)

An AE is any untoward medical occurrence in a patient administered an Vins Bioproducts Limited (VINS) product and which is not necessarily caused by the VINS product. An AE can therefore be any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, combination product, or medical device, whether or not considered related to the product. This includes:

    • Any clinically significant worsening of a pre-existing condition;
    • An AE that has been associated with the discontinuation of the use of a product; and
    • Any lack or loss of intended effect.

What to Report

When reporting an AE, other safety finding or product complaint, you will
need to have the following information ready:

The identifiable patient:
    • The person who has taken or been administered the product (e.g. age, gender, etc.), in compliance with local privacy laws.
An identifiable reporter:
    • The source that reported the event (e.g. patient, health care provider, friend, etc.), in compliance with local privacy laws.
The medicinal product:
    • Vins Bioproducts limited product name, indication and lot number if
      known.
The reportable event:
    • Description of the AE, other safety finding or product complaint.


You should still report AE, other safety findings and product complaints even if you do not have all the required information. Please report as much relevant information as possible.

Why should you report complaints and side effects to Vins Bioproducts Limited?

Although our products are tested extensively in clinical trials before they are authorized, not everything is known about their side effects until they have been used by many people over time. Vins Bioproducts Limited routinely monitors the safety of all our products. By reporting complaints and side effects, you are giving us important feedback which will ultimately help us take appropriate actions and to provide better instructions for how to use our products.

Adverse event reporting:

We encourage consumers, health care professionals to report any discomfort / adverse events experienced / observed by them after consuming/administering any Vins Bioproducts Limited product.
To report, you may select any one of the following options:

    • Please dial: 040-23354550
    • Please download the adverse event reporting form (Click here to download), fill and send it to us in any one of the following ways:
    • Submit the completed form to our company representative –
    • Send the completed form to: Corporate Office address

806, Essjay House, Road No.: 3,
Banjara Hills, Hyderabad –
500 034,Telangana, India
Phone: 23353540,
Fax: 91-40-23350410

    • Scan and E-mail the completed form to: pharmacovigi@vinsbio.in

For information about known risks and benefits of specific Vins Bioproducts Limited Products, please visit our VINS product websites to review prescribing information, including important safety information.