SAHPRA registers Soolantra 10mg/g Cream- An ivermectin formulation

19 March 2021

On 16 March 2021 SAHPRA registered Soolantra 10mg/g cream formulation, which contains ivermectin. The holder of the certificate of registration is Galderma South Africa. 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 registration of Soolantra Cream is not in response to any of the current pending court cases regarding access to ivermectin for the prevention or 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. SAHPRA will continue to monitor emerging scientific data in this regard and will respond accordingly. SAHPRA has received no application for the registration of an ivermectin-containing medicine for the management of COVID-19.

Where medical practitioners wish to prescribe a finished pharmaceutical product (such as a tablet) for a patient at risk of or diagnosed with COVID-19, they will still need to apply for access to an unregistered medicine in terms of section 21. Further, SAHPRA’s Ivermectin Controlled Compassionate Use Programme, which relies on section 21 of the Act, remains in place.

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