Pharmacovigilance – Nikopharm

Pharmacovigilance

The pharmacovigilance process remains ongoing throughout the life cycle of a medicinal product.

Continuous monitoring and timely detection of adverse events are of key importance for the safety of the medicinal products and it also allows to evaluate the balance when the benefit outweights the potential risks of using medicinal products.

In order to monitor the effect of a medicinal product on human body, Nikopharm has implemented a pharmacovigilance system (in accordance with the requirements of the Order of the Ministry of Health of Ukraine dated December 27, 2006 No. 898 (as amended) "Pharmacovigilance procedure").

It is important for us to maintain effecient feedback with you to obtain safety information of Nikopharm medicinal products.

We will appreciate any information about:

- adverse reactions;
- lack of efficacy;
- off-label using;
- overdose or misuse;
- interaction with other medicines;
- using during pregnancy and lactation;
- incorrect prescription and using;
- unexpected therapeutic effect;
- unwanted effects of medicinal products during the professional activities;
- complaints about the quality of medicinal products that caused an adverse reaction;
- any other safety and efficacy information of the company's medicinal products.

The report should contain at least the following information:

- the tradename of the suspected medicinal product;
- description of the adverse reaction and / or a lack of efficacy indication;
- information about the patient who experienced an adverse reaction (full name (initials), age, gender or other important information);
- contact details and information about the person providing the report (doctor, patient, relative or representative of the patient).

If you have information about adverse reactions, lack of efficacy or other safety issues associated with the use of our medicinal products, you can contact us in any convenient way:

- via patient/ healthcare worker Feedback Form on our website;

- via e-mail: vigilance@nikopharm.com.ua;

- via phone: +38(050) 250-33-46 (24/7).

The information provided remains strictly confidential and is not subject to disclosure, except as required by law.

By informing us, you confirm your consent to the processing of personal data.


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