Information for EudraVigilance users


The European Medicines Agency (EMA) needs to carry out essential maintenance on its IT Infrastructure systems and the HALMED ICSR e-reporting will also be affected.

The EudraVigilance Production Environment will not be available from Friday 12th of August from 18.30 p.m. onwards until Monday 15th of August, 10.00 a.m.

During the above periods the following modules of the EudraVigilance System will be unavailable:

- EudraVigilance HALMED database: acknowledgements from the EudraVigilance system should not be expected before Monday (acknowledgement type 01, 02 and 03)
- EudraVigilance Web Application (including Post-Function)
- EV Gateway.

The delay for sending SUSARs to HALMED will not have any compliance implication for the marketing authorization holders.

We apologise for any inconvenience caused by the interruption of the service.


A Dear Healthcare Professional letter to physicians concerning the prescribing of the medicinal product Myfortic (micophenolic acid) gastro-resistant tablets: post-marketing reports of pure red cell aplasia (PRCA)


In collaboration with the Agency for Medicinal Products and Medical Devices, the marketing authorisation holder in the Republic of Croatia, Novartis Hrvatska d.o.o., sent A Dear Healthcare Professional letter to prescribing physicians with the latest information on the safety of the medicinal product Myfortic (micophenolic acid) gastro-resistant tablets.