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Mein Fall ist nicht bei den 286 der EMA

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Registriert: 07.11.2016, 17:40

Mein Fall ist nicht bei den 286 der EMA


Beitragvon spacerat » 12.10.2019, 03:44

Der von Ihnen gemeldete Fall ist nicht bei den 286 Fällen dabei. Näheres entnehmen Sie bitte der Antwort der ema:

“Thank you for your request of 26 May 2019 regarding the handling of a report DE-AMK204358.

We would like to advise you that the above report was part of the qualitative review of the 2,141 serious adverse events identified in the European Union (from 1995 to 2016) through Eudravigilance where a (fluoro)quinolone was the suspected medicine and where the case had one of the following characteristics:
1) Seriousness disabling
2) Reaction outcome Resolved with sequelae
3) Duration of at least one adverse reaction > or =30 days

This case was taken into due consideration for the overall assessment of the benefit-risk balance of (fluoro)quinolone medicinal products. However, due to confounding factors (like concomitant medication or underlying disease) the case was not further analysed and was therefore not included in the 286 cases that were used for causality assessment. The case is one of the 195 confounded cases as specified on p.9 of the published assessment report: ... ort_en.pdf
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