SUSPECTED ADVERSE DRUG REACTION REPORTING
Medical professionals are obliged by law to report any suspected adverse reactions that can be attributed to the application or the use of certain medication to the Marketing Authorization Holder or the nationally competent authority, that is, the National Institute of Pharmacy and Nutrition (OGYÉI) in Hungary.
Not only medical professionals but also patients and/or their relatives or any person can report suspected adverse reactions in possible relation to the medication.
Individual case safety reporting regarding suspected adverse reactions of the medication continues to be the primary tool for national competent authorities to gather information about the possible risks of medications so that they can take measures to maintain the safe usage of the medicine, and to ensure that the benefits continuously outweigh the possible risks of certain treatments for patients.
The more information is collected about certain medication, the more its safe application can be sustained. Therefore, you are kindly requested to report any suspected adverse reactions that you experience or hear of with regard to our vaccine as described below.
Electronically:
Suspected adverse drug reaction reporting – for patients
Suspected adverse drug reaction reporting – for medical professionals
By conventional means:
Postal address: 1506 Budapest, P.O. Box: 112
Phone: +36-26-336597 extension 1
Mobile: +36-20-419 7102
Fax: +36-26-536051