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Pharmacovigilance

Pharmacovigilance (pharmacovigilance) is a set of activities related to scientific research and activities aimed at identifying, assessing and understanding possible adverse effects of medical use of medicines, preventing their occurrence and protecting patients. One of our key objectives is to provide consumers with high-quality, effective and safe medicines, the benefits of which exceed the possible risks.

The procedure for carrying out pharmacovigilance activities is set out in the Technical Code of Practice TCP 564-2015 (33050) ‘Good Pharmacovigilance Practice. Good Pharmacovigilance Practice (GVP)’, which was introduced in the Republic of Belarus for the first time and came into force on 15.08.2015.

To monitor the safety and efficacy of our medicines, we have established a Pharmacovigilance Department. In accordance with international standards, the manufacturer/registration certificate holder is responsible for the safety of manufactured medicines, therefore it is obliged to continuously monitor the safety of its products and, taking into account new information, regularly re-evaluate the benefit/risk ratio.

The priority tasks of EKZON's Pharmacovigilance Service are to prevent undesirable consequences of the use of registered medicinal products of our production, to contribute to the protection of patients' health and public health. That is why the collection of information related to the safety and efficacy of our medicines is an important part of our work.

If side effects are detected, our specialists will look for the cause and do everything necessary to minimise and prevent the occurrence of side effects in the future. We would be grateful for any information on the detection of atypical manifestations or side effects or lack of efficacy in the use of medicines manufactured by us.

If you have any information regarding any (suspected) adverse reaction or lack of efficacy when using medicinal products manufactured by JSC ‘EKZON’, please inform us by phone and e-mail and/or by filling in the form on the links below.

We guarantee the confidentiality of the information sent by you, except for cases stipulated by law.

Before completing the form, please read the terms and definitions from TCP 564-2015 (33050).

Contacts of Exon's Pharmacovigilance Service
We are located at
225612, Republic of Belarus, Brest region, Drohichin, Lenina str., 202
Hotline
+375 1644 2 00 04
E-mail
pharmaconadzor@ekzon.by
Lead pharmacovigilance specialist of the enterprise
Raisa Aleksandrovna Anishchenko
Report problems associated with the use of the drug
You can fill out an electronic adverse reaction/lack of therapeutic efficacy report form.
A healthcare or pharmaceutical professional reporting an adverse reaction
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Treatment
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Message
Patient information
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Specify the gender of the patient
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Impaired liver function
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Impaired renal function
Suspected drug
Other medications taken at the same time
Indicate "no" if no other medication was taken
Result of discontinuing the suspected drug
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Assessing causation
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Exodus
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Measures taken
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Criteria for classifying as serious adverse reactions (check the box if it fits)
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Whether a recurrence of an adverse reaction has been noted after a second prescription of the medication
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The suspected drug is used in
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Important additional information
Clinical, laboratory, radiological, and autopsy findings, including blood (tissue) drug concentrations, if any, associated with an adverse reaction (please provide dates)
For congenital abnormalities, list all other medications taken during pregnancy and the date of the last menstruation (indicate "no" if no such medications exist)