Pharmacovigilance
What is Pharmacovigilance?
The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems.
What is an Adverse Event (AE)?
Any untoward medical occurrence in a patient administered a pharmaceutical product (including clinical trial subjects) which does not necessarily have a causal relationship with the treatment. (Refer to ICH E2A Guideline) An AE can be any unfavorable and unintended sign (e.g., abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.
Report Adverse Events
To report adverse events or other safety information regarding any Otsuka product, please contact us via:
By Phone
Business Hours：028-86083256 ext. 8071
After Hours：028-86083256, follow instructions for 24-hour hotline.
By Email
LOP-PV@cn.otsuka.com