The Ivermectin/Mask+ Protocol has been developed by experienced physicians treating hospitalised COVID-19 patents; at this time, it has not been adopted as a medical consensus. While clinical experience and research to-date is promising, these products have not been proven to be safe and effective by prospective, randomized double-blind, placebo-controlled studies acceptable to SA medical associations and regulatory bodies.
In relation to compounding the court order confirmed that medicines containing Ivermectin may be compounded and accessed in accordance with the provisions under the Medicines Act (section 14.4). Further, unregistered Ivermectin-containing finished pharmaceutical products for human use remain accessible only under the Programme through the authorised suppliers of such products. The Controlled Compassionate Use Programme remains firmly in place.
SAHPRA has not approved Ivermectin or the Mask+ protocol for COVID-19 and such use is considered “off-label.” Based on increasing evidence, the National Institutes of Health (NIH) recently upgraded its Ivermectin recommendation from “do not use” to “neither for nor against,” the same as for monoclonal antibodies and convalescent plasma. No treatment, however, including Ivermectin or the Mask+ Protocol, has been accepted by our public health system as proven to prevent, mitigate or treat COVID-19.
High Court Case Order