Report an adverse reaction to a medicine

In the interests of patients’ health and in accordance with the applicable legal requirements set out in the “Pharmaceutical Law” of 6 September 2001, Voxel S.A., as the Responsible Entity, is obliged, as part of its pharmacovigilance activities, to collect all information concerning adverse reactions arising from the use of the company’s medicinal products.

Should you experience an adverse reaction following the use of a medicinal product manufactured by Voxel S.A., please report the adverse reaction using one of the following options:

• telephone contact:  (+48)  697700071 (24h)
• contact fax:  (+48) 32 6060519
• contact-mail:  dziennikqppv@voxel.pl

You can report an adverse reaction using the form. To do so, please complete the form below:

Download documents:

Once you have completed the form, please sign it, print it out and send it by post and/or by fax and/or by email to:

Voxel S.A.
Person Responsible for Monitoring Adverse Reactions
54 Wrocławska Street
40-217 Katowice
Woj. Śląskie

We will review your enquiry; should we have any further questions, a company representative will contact you to request further information.

Healthcare professionals should report any suspected adverse reactions via the Department for the Monitoring of Adverse Reactions to Medicinal Products at the Office for the Registration of Medicinal Products, Medical Devices and Biocidal Products:

Al. Jerozolimskie 181C, 02-222 Warszawa,
tel.: + 48 22 49-21-301, fax: +48 22 49-21-309,

Website: https://smz.ezdrowie.gov.pl

NOTE: The telephone and fax numbers and email address provided are not intended for the purpose of providing medical advice or consultations. If you have any questions or concerns, please seek advice from a doctor.

In order to assess the adverse reaction as thoroughly as possible, we would be grateful if you could provide as much information as possible relating to the adverse reaction, including at least:

1. patient details (age, gender, initials)
2. the reporter’s details; in the case of a healthcare professional (full name, profession, place of work, contact telephone number),
3. details of the medicinal product (name of the medicine being taken),
4. description of the reaction.

The data controller for the personal data provided in the form is Voxel S.A., ul. Wielicka 265, 30-663 Kraków.

Your personal data is processed on the basis of Article 6(1)(c) and Article 9(2)(i) of the General Data Protection Regulation (GDPR, EU 2016/679 of 27 April 2016). The personal data provided is processed solely for the purpose of fulfilling obligations relating to the monitoring of the safety of medicinal products in accordance with Regulation (EU) No 520/2012 of 19 June 2012. The provision of the reporter’s personal data is necessary for the report to be accepted. The recipients of your personal data will be limited to entities authorised to receive personal data under the law. You have the right to access your data and the right to rectify it. Your personal data will be retained for the entire duration of the medicinal product’s marketing authorisation and for a period of 10 years following the expiry of that authorisation. Contact details of the Data Protection Officer for further information:

e-mail iod@voxel.pl

Data Protection Officer, Voxel S.A., 54 Wrocławska Street, 40-217 Katowice

You have the right to lodge a complaint with the President of the Office for Personal Data Protection if you consider that the processing of your personal data infringes the provisions of the GDPR.

Full details regarding the protection of personal data, including a breakdown of your rights, are available on our website’s homepage. 

Please direct any enquiries regarding medical information (other than those relating to the reporting of adverse reactions) about our medicinal products to the following address: mpk@voxel.pl or by telephone (+48) 697700071.