Report adverse reaction
Pursuant to the Act on Pharmaceutical Law of 6th September 2001, the marketing authorization holder is obliged, i. a., to keep a register of adverse reactions related to the relevant product.
An adverse reaction to a medicinal product is defined as any adverse and unintended effect of such product.
If you would like to report an adverse reaction to the application of our drug, please print and fill in one of the forms attached.
- In order to download the form for the patient or guardian, please download the I am a patient/patien's guardian form.
- In order to download the form for a person pursuing a medical profession, please download the I am a person pursuing a medical profession form.
We encourage you to provide as detailed description of the reaction as possible, specifying all available information.
Please send the report in one of the following ways:
- By post at :
Recordati Polska sp. z o.o.
ZGŁOSZENIE DZIAŁANIA NIEPOŻĄDANEGO
ul. Królewska 16
- By fax at: +48 22 206 84 51.
- By e-mail at: SafetyPoland@recordati.com
We would like to inform you that the e-mail address is provided only for sending information regarding adverse reactions which appear after application of medicinal products of Recordati Polska sp. z o.o.
Please send general notices at: email@example.com.
We would like to ensure you that the requirement of providing personal data and contact details of the person reporting results from the need to secure the possibility to complete the case information required for its assessment. Recordati Polska sp. z o.o. is obliged to confidentiality and the data is not disclosed to third parties.
The reports can also be sent directly to the Office for Registration of Medicinal Products, Medical Devices and Biocides, according to the information published on the Office website: http://dn.urpl.gov.pl/dn-zgloszenia-dzialan-niepozadanych.