Novartis, during its portfolio review (Tegretol S® oral suspension included) observed the possibility of exceeding defined permitted daily exposure (PDE) when the product is taken above 1200 mg/day in adult patients because of the quantity of sorbitol in the formulation. Sorbitol is one of the...
Policy Position of SAHPRA on Enabling Local Manufacture
SAHPRA as an organ of state and a public entity is required to align itself with the national imperatives to support the national response in public health emergencies through supporting local manufacturers of health products.
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This communication is intended to provide an update to industry stakeholders concerning Mpox (formerly monkeypox) diagnostic tests in South Africa....
The DHCP letter is intended to inform healthcare professionals about the risks of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) associated with the use of pseudoephedrine-containing medicines. Pseudoephedrine-containing medicines are contraindicated in patients with severe or uncontrolled hypertension, or with severe acute or...
The DHCP letter is intended to inform healthcare professionals about the risks of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) associated with the use of pseudoephedrine-containing medicines. Pseudoephedrine-containing medicines are contraindicated in patients with severe or uncontrolled hypertension, or with severe acute or...
This document is intended to provide communication to the HCRs for orally administered phenylephrine-containing medicines. The Advisory Clinical Committee discussed the communication from the United States Food and Drug Administration (US-FDA) regarding the efficacy of orally administered phenylephrine as a nasal decongestant. This communication emanates from...
This document is intended to provide communication to The Holder of Certificate of Registration for Codeine containing products. The Advisory Clinical Committee (ACC) reviewed data submitted by HCRs to support the continued use of codeine in children under 12 years and concluded that there is evidence...
This FAQs document is intended to provide communication to the API suppliers to assist them with adequately addressing the most common queries received by SAHPRA....
This communication provides guidance which represents the current thinking of the South African Health Products Regulatory Authority (SAHPRA) on this topic. It does not establish any rights for any person and is not binding on SAHPRA or the public. You can use an alternative approach...
This guideline is intended to provide guidance to applicants who intend to apply as co-applicants for the registration of a medicine. It represents the current thinking of the South African Health Products Regulatory Authority (SAHPRA) on managing applications for registration where there is more than...