An adverse effect of a medicinal product is any unfavorable and unintended reaction caused by its use.
If you have experienced an adverse effect after using a product from Molteni Farmaceutici, please contact our pharmacovigilance officer. You can report the event by phone or by sending the completed form via email or mail to the following address:
MOLTENI FARMACEUTICI POLSKA Sp. z o.o.
ul. Korzeniowskiego 39
30-214 Kraków,
MINIMUM INFORMATION
To ensure that the report is legally valid, in accordance with the updated pharmaceutical law regulations, it must include some essential data, such as:
- Patient Information (at least one of the following: initials, sex, date of birth, age, body weight)
- Adverse Effect Information (description of symptoms, including: date of onset and resolution of symptoms, information on whether the symptoms have resolved, if treatment is still ongoing, whether they persist, or if the adverse effect was severe)
- Name of the Medicinal Product suspected of causing the adverse effect (along with information on: dose, route of administration, indications, date of initiation and termination of treatment, expiration date, lot number)
- Reporter’s Information (name, surname, professional address – in the case of healthcare professionals; also phone number and email)
From a legal perspective, an adverse effect is considered severe if it results in: the patient’s death, a life-threatening situation, the need for hospitalization or prolonged hospitalization, permanent or significant disability, congenital malformations in the fetus, or any other effects that, in the physician’s judgment, are deemed severe based on their knowledge.
In accordance with Regulation (EU) 2016/679 of the European Parliament and Council of April 27, 2016, regarding the protection of individuals with regard to the processing of personal data and the free movement of such data, and repealing Directive 95/46/EC (“GDPR”), we inform you that the data controller of the personal data contained in the form is Molteni Farmaceutici Polska Sp. z o.o., located in Krakow, ul. Korzeniowskiego 39, 30-214 Krakow. You can contact the data controller in writing at the above address or via email at: rodo@molteni.com.pl. The personal data entered in the form are processed pursuant to Art. 6, par. 1, lit. c), and Art. 9, par. 2, lit. i), of the General Data Protection Regulation (GDPR, EU 2016/679 of April 27, 2016) in order to fulfill obligations related to the monitoring of the safety of medicinal products, as provided for by Art. 36e, par. 1, lit. 2 and 3 of the Pharmaceutical Law and by Reg. (EU) No. 520/2012 of June 19, 2012. The provision of the reporter’s data in the form is mandatory. The personal data provided may be disclosed to: IT service providers, entities providing consulting or legal services, as well as authorities authorized to process such data under applicable regulations. The personal data provided will be retained for the duration of the drug authorization and for 10 years from the expiration of the marketing authorization. You have the right to access your personal data, rectify it, delete it, limit its processing, and object to its processing. Additionally, you have the right to lodge a complaint with the competent supervisory authority for the protection of personal data (President of the Office for Personal Data Protection).