Alembic Pharmaceuticals Limited (APL) is focused for patient safety. One of the important approaches in patient safety practice requires constant evaluation of benefit- risk profile of a medicine for prevention of harm to patients caused by medicinal products. To better understand safety profile of our product, we collect Adverse Events (AE) through various sources, evaluate them and report them to the Agency.
An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign, symptom, or disease associated with the use of the product.