Information regarding the unapproved drug "Reniale
For the product Reniale, which according to the manufacturer is intended for the treatment of patients after removal of kidney cancer, a manufacturing authorization was granted by the Federal Office for Safety in Health Care on January 24, 2014. In this context, the Federal Office for Safety in Health Care takes the liberty to state that this approval is not the official approval of the product.
Furthermore, the BASG dissociates itself from the statements on the homepage of the manufacturer VACCENTIS AG, according to which the product"...represents(s) the first choice of treatment after removal of renal cell carcinoma...", "...It can prevent the development of new metastases after removal of the kidney or parts of the kidney andisdistinguished by a generally very good tolerability...", as well as that"...Reniale is currently the only drug worldwide with comprehensive documentation of the success story (is)...".
In the view of the Federal Office for Safety in Health Care, these statements are not sufficiently substantiated and, due to the lack of approval for the product, have never been reviewed by the authorities.
Queries (technical): Dr. Christoph Baumgärtel, Tel.: 050555/36004 E-mail: christoph.baumgaertel@ages.at Queries (for media): Communications Management, Tel.: 050555/25000 E-mail: presse@ages.at
