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null In what language does Fimea enter the reports into the EudraVigilance database?

In what language does Fimea enter the reports into the EudraVigilance database?

All the E2B fields are entered as numeric codes and the decodes appear in English. Only the narrative -the description of the ADR- is entered in the language it which it was reported to Fimea (Finnish, Swedish, English).

The MAHs are encouraged to submit to the EudraVigilance database the information on the medication and the reported ADR terms in as much detail as possible, including the reaction as reported in the original language.

24 Jan 2018