To Report Adverse Effect

Adverse Event Reporting

At VIATRIS^® we see healthcare not as it is, but as it should be. Viatris empowers people worldwide to live healthier at every stage of life. Protecting patients and consumer health by ensuring the quality and safety of our products is at the heart of how we operate across our network.

What is an Adverse Event?

An Adverse Event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.

Why report Adverse Event to Viatris?

• Adverse Event reporting helps Viatris to identify unknown adverse events with the product
• Reporting leads to regular review of safety database for new risks or signals
• Adverse Event reports help to provide current and accurate updates on safety profiles of the drugs
• Adverse Event reports help to identify different profiles of known adverse reactions with regards to severity, nature, or outcome
• However, all consumers or patients are advised to contact their doctor or healthcare professional for advice on medicines or any health matter/medical emergencies.

What does Adverse Event include?

Adverse Event includes undesirable medical condition that can be symptoms (for example nausea, chest pain), signs (for example tachycardia, enlarged liver) or the abnormal results of an investigation (for example laboratory findings, electrocardiogram). Apart from the Adverse event scenarios stated above, the below listed special situation scenarios should also be reported which may or may not be associated with an adverse event:

1. Special situation reports such as product exposure (including maternal, paternal or fetal exposure) associated with a pregnancy,
2. Trans-mammary exposure of an infant (transmission via breast milk) to a medicinal product,
3. Drug overdose,
4. Abuse or misuse,
5. Off-label use,
6. Withdrawal syndrome,
7. Occupational exposure after release as finished product,
8. Medication errors (i.e. inappropriate medication use),
9. Lack of therapeutic efficacy,
10. Suspected transmission of an infectious agent,
11. An unexpected therapeutic or clinical benefit from use of the product & Interactions (Drug-Drug or Drug-Food interactions).

What to report?

Reporting adverse events is an important part of our commitment to patient safety. The minimum standard information required for reporting a case:

• Identifiable reporter (name, address and contact details of the person reporting the adverse event for potential follow‐up by Viatris if required)
• Identifiable patient (initials, sex, age, or age group of the patient who experience adverse event)
• Adverse Event experience description, any sign symptom and outcome of adverse event etc.
• The associated Viatris medicinal product taken by the patient, for the adverse event is being reported
• If you do not have all the details listed above, please still report the Adverse Event. In addition, you can report any other details you have about the Adverse Event.

Who can report ADR & how to report ADR?

All the Healthcare professionals like doctors, dentists, nurses, pharmacists and non-healthcare patients, consumers, friends, relatives etc. should report the adverse events to Viatris. You can report the Adverse Event by using the Adverse Event Report Form.

Contact Viatris Patient Safety at

E-mail: pv.india@viatris.com

What to report?

• Provide as many details as possible to help company analyze the reports better
• Viatris is committed towards maintaining patient/reporter’s confidentiality
• The reported adverse event will be shared by Viatris with the National Health Authority as required for the company to comply with the regulatory requirements
• Submission of a report does not constitute an admission that medical personnel or manufacturer or the product caused or contributed to the adverse reaction

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