Information on AE Reporting

WHAT IS AE (AE)?
An “adverse event” means any untoward medical occurrence (including a symptom or disease or an abnormal laboratory finding) during treatment with an investigational drug or a pharmaceutical product in a patient or an trial subject that does not necessarily have relationship with treatment being given.

WHAT IS SERIOUS ADVERSE EVENT (SAE)?
A “serious adverse event” is any untoward medical occurrence in a patient or trial subject, which does not have a causal relationship with the treatment, and:

• • is fatal, and/or

• • is life-threatening for the subject, and/or

• • makes hospital admission or an extension of the admission necessary, and/or

• • causes persistent or significant invalidity or work disability, and/or

• • manifests itself in a congenital abnormality or malformation, and/or

• Could, according to the person that carries out the research, have developed to a serious undesired medical event, but was however prevented due to premature interference.

WHAT IS ADVERSE DRUG REACTION (ADR)?
The World Health Organization defines an Adverse Drug Reaction as “any response to a drug which is noxious and unintended, and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of disease, or for the modification of physiological function”.

WHAT TO REPORT?
Following events can be reported to the Pharmacovigilance department of centaur pharmaceuticals Pvt Ltd.

• • Death or Life-threatening

• • Hospitalization (initial or prolonged)

• • Disability (significant, persistent or permanent)

• • Medically significant event (if the event is considered serious by physician)

• • Congenital anomaly

• • Required intervention to prevent permanent impairment or damage.

• • Lack of efficacy connected with the use of a medical device or drug product.

• All suspected drug interactions

All known or unknown, serious, non-serious, frequent or rare reaction caused due to use of vaccine or drug must be reported.

WHO CAN REPORT?
All healthcare professionals (Clinicians, Dentists, Pharmacists and Nurses etc) and consumers can report adverse drug reactions