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Italian Medicines Agency Agenzia Italiana del Farmaco

The RAM System

The RAM System

The RAM system (Adverse reactions to medicines database) allows access to data relating to reports recorded since 2002, organised by year of entry in the National Network and updated on a quarterly basis.

Spontaneous reports of suspected adverse reactions are an important source of information for pharmacovigilance activities, as they allow to detect potential safety signals associated with the use of the medicines in order to make them safer, to the benefit of all patients.

1) How to perform the search

  • by trade name of the medicinal product indicated as suspected in the report;
  • By name of the active substance or combinations of active substances indicated as suspected in the report (in this way the system will add all reports concerning medicinal products containing that or those active substances).

2) Search results

Search results are displayed in five screens:

  • The first provides the total number of reports recorded in the RNF broken down by year;

In the following screens the year shall be selected on the upper right drop-down menu:

  • The second screen provides the number and percentage of reports by severity level;
  • The third is the number and percentage of reports by sex and age group of subjects who have experienced the reaction/s;
  • The fourth displays number and percentage of aggregated adverse reactions classified by System Organ Class (SOC)
  • The fifth shows the number and percentage of aggregated adverse reactions in more detail (PT – Preferred Term).

The total number of adverse reactions may be equal to or greater than the total number of reports as one or more adverse reactions can be described within each report.

Link Access to RAM system

Nested Applications

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