ORGANOSYN LTD. has the system of pharmacovigilance, which is aimed:
- To study any adverse reactions that arise at patients;
- To monitor the efficiency of medicinal products;
- To perform the collection, analysis and to generalize the information about safety;
- To perform post-marketing studies.
The realization of pharmacovigilance in Ukraine is governed by the order from MHC of Ukraine, dd. 27.12.2006 No. 898 “About Approval of Procedure for Performance of Vigilance for Adverse Reactions of Medicinal Products, Allowed for Medical Application”, which is harmonized with WHO requirements (current version).
Pharmacovigilance is the science and actions, related to detection, assessment, understanding and prevention from undesired reactions or any other problems that concern medicinal products (WHO).
Individual notification about undesired reaction is a notification that describes a suspected undesired reaction, related to prescription of one or some medicinal products (or agents) to a certain patient.
Undesired medicinal reaction is the reaction of organism to a medicinal product, related to application of a medicinal product in recommended doses.
Undesired phenomenon is any unfavorable changes in health status of a patient, to whom a medicinal product has been prescribed, regardless of cause-effect relations with its application.
Serious reaction is an undesired medicinal reaction, which includes any from mentioned below:
- Death;
- Alarm condition of a patient;
- Hospitalization or its continuation;
- Stable apparent disability (invalidity);
- Congenital developmental anomaly.
Spontaneous notification is the notification, provided by medical specialists or a consumer at their own initiative, which contains the description of one or some suspected undesired medicinal reactions at a patient, who has received one or some medicinal
products, and which is not the result from any study or organized data collection.
Target spontaneous notification is the way that provides with monitoring and registration of all or certain aspects of safety in application of medicinal products in a certain group of patients, who are treated1.
Dear patients and colleagues, if you have any information on adverse drug reaction and/or lack of efficacy of ORGANOSYN LTD. medical product, please fill the form, provided below.
Thank you in advance for your information. Any information, submitted by you, is important for us and quality of our products!