Pharmacovigilance is defined by the World Health Organization (WHO) as ’the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem’.
All medicinal products in the EU are subject to a strict testing and assessment of their quality, efficacy and safety before being authorised. Once placed on the market they continue to be monitored so to assure that any aspect which could impact the safety profile of a medicine is detected and assessed and that necessary measures are taken. Furthermore, if a medicine is labelled with the black triangle, this means that it is being monitored even more intensively than other medicines.
Regardless of your position (health professional, patient, etc.) by reporting a suspected adverse drug reaction, you actively contribute to the ongoing monitoring of the safety and quality of our medicinal products.
If you wish to report a suspected adverse reaction related to our drugs, please contact us at:
Tel: +30 210 8771 500
Hema-Onco / I&I Division: +30 210 6826 277
CNS & Specialty Division: +30 210 6834 361
Hema-Onco / I&I Division: email@example.com
CNS & Specialty Division: pharmacovigilance-CS@genesispharma.com
or by post at the following address:
GENESIS Pharma S.A.
(att: Pharmacovigilance Department)
274 Kifissias Avenue,Halandri
152 32 Athens
Τ: +357 22 769946
F: +357 22 769978
F: +357 22 753058
T: +359 2 969 3227
F: +359 2 969 3228
T: +40 72 454 38 76
F: +40 21 403 40 75
T: + 38 515588297
F: + 38 512420860
All information collected during the reporting of an adverse reaction is confidential and anonymised, regarding both the reporter and the patient.
The European Union (EU) has introduced a new process to label medicines that are being monitored particularly closely by regulatory authorities. These medicines have a black inverted triangle displayed in their package leaflet and are described as being under 'additional monitoring'.
Read more about the black triangle in the pdf file
or watch the following video (source: http://www.ema.europa.eu/ema)