Macopharma announces that after the second Marketing Authorisation of the THERAFLEX Methylene Blue (MB)-Plasma in Germany by the Paul-Ehrlich-Institute
(PEI) to the Blood Centre of the German Red Cross chapters of NSTOB/ Springe, also SwissMedic, the responsible authority for marketing approval in Switzerland and also the Austrian Drug Surveillance Institute (ARGES) have given their principal agreement to use this procedure for virus inactivation of single units of therapeutic human plasma.
While SwissMedic has given a marketing approval to Macopharma directly, the Transfusion Centres in Switzerland, who will use this procedure, will need to demonstrate plasma factor quality and stability data obtained in their individual centres.
The Austrian Authorities, however, have given their first authorisation to the Transfusion Centre of the University Clinics of Innsbruck. Other Centres in Austria who will use the THERAFLEX procedure will receive approval upon individual application.
The Macopharma THERAFLEX Methylene Blue Procedure is highly effective to inactivate all enveloped viruses tested and effective against some non- enveloped viruses like Parvo B19. This procedure replaces the quarantine and retest procedure for fresh frozen plasma which is in use in many countries.
The THERAFLEX MB-Plasma Procedure has been in use since more than 10 years.
More than 4 Million plasma have been used clinically in Europe since, with an excellent safety record.