Special Approval granted by BfArM for the Medical Device, LeiProtect®

The use of LeiProtect® has been legalized on August 28th, 2017 (91.1.07-5640-S-006/16) by the BfArM according to § 11 of the Medical Device Regulation (MPG). It is used to protect leishmaniasis skin lesions from superinfections, thus promoting their healing, and to prevent sand-flies from sucking blood in the lesions.

This special approval of LeiProtect® produced by a GMP-certified original equipment manufacturer (OEM) is for the time being valid to produce 2 x 30 kg of LeiProtect®. After September 30th, 2018, our NPO will file for a final approval of LeiProtect®.

There are no Medical Device Regulations (MDR) in most leishmania endemic countries. However, the Health Ministries can validate CE approved medical devices and our NPO can then out-license the production of LeiProtect® to members of the Pasteur Institute network for economic local production.