Adverse Event
Reporting
Merilios Global Pvt. Ltd. is committed to ensuring the safety of all patients who receive our products. Every medicine has potential benefits and risks. Whenever any medicine is used, the possible risks are weighed against the expected benefits. The full safety profile of any medicine is established only after years of research and clinical use. Continuous monitoring of the risks associated with any medicine is necessary to ensure that the benefits outweigh possible risks.
For this purpose, ‘Report any suspected adverse event to Merilios Global Pvt. Ltd. medication’ as described below.
What is an adverse event?
An adverse event is any undesirable experience associated with the use of a medicinal product in a patient. It is commonly referred to as ‘side effect’.
It includes:
Undesirable symptoms and signs e.g., headache, vomiting, abnormal ECG
Medication errors e.g., wrong dose, intravenous administration instead of intramuscular
Overdose
Misuse and Abuse
Use in pregnancy and breastfeeding
Product technical complaints e.g., discolored or deteriorated products, improper labelling
Why report adverse events?
It ensures that we don’t miss out on important data which could help us use our medicines more effectively and safely.
It helps in identifying rare adverse effects, unexpected/unknown adverse effects, drug/food interactions with medications, unknown risk factors and long-term safety profile of the medications.
What to report?
Patient particulars
This identifies the person who experienced the Adverse Event. The particulars include initials, age, sex etc.
Event particulars
These describe the symptom/sign. Additional data include onset, course and outcome of the event.
Reporter details
You should provide your name, address and phone number as you may need to be contacted for further information.
If you are not a healthcare professional, provide details of the prescribing doctor too.
Drug details
These include name, batch number, dosage etc. of the medicinal product suspected to cause the adverse event.
How to report?
You can report the Adverse Event by downloading the Adverse Event Report Form and sending it to the pharmacovigilance unit of Merilios Global Pvt. Ltd. through one of the modes provided below.