The South African Health Products Regulatory Authority (SAHPRA) says the registration of Soolantra 10mg/g cream formulation, which contains ivermectin, is not related to Covid-19.
“Soolantra cream is indicated for the topical treatment of moderate to severe inflammatory lesions of papulopustular rosacea in adult patients and is not for the prevention or treatment of Covid-19,” the regulator said in a statement.
It said that the registration of Soolantra cream is not in response to any of the pending court cases seeking access to ivermectin for the prevention or treatment of Covid-19.
The regulator has denied claims it reached an agreement or settlement with AfriForum in a court challenge to approve the use of Ivermectin for the treatment of Covid-19.
“To date, there is insufficient scientific evidence on the efficacy of ivermectin for the prevention or treatment of Covid-19. Thus, SAHPRA’s position, as communicated on 28 January 2021, remains as stated,” reads the statement.
It said it would continue to monitor emerging scientific data and respond accordingly, also clarifying it had not received any application for the registration of an ivermectin-containing medicine for the management of Covid-19.
Last month, AfriForum lodged an urgent court application against SAHPRA and Health Minister Dr Zweli Mkhize in a bid to have Ivermectin approved for human use.
That was after applications from medical doctors failed.
The Pretoria high court ruled that medicines containing Ivermectin may be compounded and made accessible in accordance with the provisions of section 14(4) of the act.