The German Medicines Act (AMG) stipulates that once a medicine has been authorised, experience of its use must be continuously and systematically collected and evaluated.
As a pharmaceutical company, AxioNovo GmbH is legally required to report adverse drug reactions. Serious and hitherto unknown adverse reactions in particular are of major importance to the overall assessment of a medicinal product. New information concerning the safety of medicinal products can continue to emerge very long after they have been authorised.
Reporting adverse drug reactions
Adverse drug reactions (including suspected cases) can be reported here to the Pharmacovigilance department of AxioNovo GmbH.
ADR reporting form (online form)
The information in online reports is encrypted for secure transmission.
ADR reporting form (PDF form)
The PDF version of the form can be completed and saved on a computer and transmitted by email (suaw@axionovo.de) or fax (+49 521-9883518) to the Pharmacovigilance department of AxioNovo GmbH.