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PHARMACOVIGILANCE

The priority of «BIOLIK PHARMA LLC» Company’s activity is a care of patients’. In order to improve the safety and efficacy of medicines, the holder of registration certificates of which is BIOLIK PHARMA LLC, in accordance with international requirements and current regulatory documents of Ukraine, the company has implemented a pharmacovigilance system. This system collects information about adverse reactions (AR) after using medicines, adverse events after immunization/ tuberculin skin testing (AE), and lack of efficacy (LOE) of medicines.

Adverse reaction is any undesirable negative reaction that occurs when medicines are used in the usual recommended doses.

Timely detection of adverse reactions makes it possible to continuously assess the balance between the benefit and possible risks of medicines for which the Company is a registration certificates holder, as well as to develop and take measures for improving the safety of medicines.

Dear consumers, healthcare professionals!

In case of an adverse reaction or lack of therapeutic efficacy of medicines, the holder of the registration certificate of which is BIOLIK PHARMA LLC, please inform us in any way convenient for you:

– fill in one of the proposed electronic report cards:

Reporting adverse drug reaction (AR) / lack of efficacy (LOE)/ adverse event after immunization / tuberculin skin testing (AE) for a healthcare professional;

Reporting adverse drug reaction (AR) / lack of efficacy (LOE)/ adverse event after immunization / tuberculin skin testing (AE) for a patient.

– send a message by fax: +38 (057) 704-87-74;

– send a message to the e-mail address: farmnadzor@biolik.com.ua;

– contact the Qualifed Person responsible for pharmacovigilance by phone:

                +38 (057) 704-87-88 (c 8-00 to 16-28);

                +38 (050) 400-62-07 (round the clock).

 

Please inform us in cases:

– adverse drug reaction;

– lack of drug efficacy;

– incorrect drug prescription and/ or wrong usage;

– drug overdose;

– undesirable drug interaction;

– adverse drug reaction during pregnancy / breastfeeding;

– unexpected therapeutic effect;

– suspected case of the infection transmission by the drug;

– adverse event after immunization or tuberculin skin testing.

The contact data provided by you are not subject to disclosure and will be used only to contact you for information clarification.

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