SAHPRA website now has a revamped navigation
The Communications and Public Relations Unit has re-evaluated the navigation of the South Afric...
08 August, 22Looking for a document – search here:
The Communications and Public Relations Unit has re-evaluated the navigation of the South Afric...
08 August, 2204 August 2022 On 31 March 2021, SAHPRA approved the use of the COVID-19 Vaccine Janssen for individ...
04 August, 22Pretoria, 22 July 2022 – SAHPRA CEO, Dr Boitumelo Semete-Makokotlela, clinched a Management Aw...
22 July, 2221 July 2022 Johannesburg – The Radiation Control Unit of the South African Health Products Regulato...
21 July, 22In collaboration with the South African Health Products Regulatory Authority (SAHPRA), Roche Product...
10 November, 20SAHPRA alerts all healthcare professionals about the risk of serious heart problems, seizures, coma ...
01 November, 20The South African Health Products Regulatory Authority (SAHPRA), in collaboration with other regulat...
12 October, 20The South African Health Products Regulatory Authority (SAHPRA), in collaboration with other regulat...
12 October, 20Following Test results that indicated levels of increased N-nitroso-varenicline that exceed the Acceptable Daily Intake (ADI) threshold of 733 ng/day calculated by Pfizer, based on ICH M7 guidance, Pfizer Laboratories (Pty) Ltd in South Africa took the decision to initiate a voluntary recall on Champix, batch 18069 and notified SAHPRA Regulatory Compliance Units. Recall process: Recall letter distributed to all healthcare professionals via medpages.
The products are being recalled due to quality defect: the presence of a mutagenic impurity above the threshold limit observed during analysis, as requested by the European Directorate for the Quality of Medicines and Healthcare (EDQM) on new Azido impurities [the presence of Azido (5-AMBBT) mutagesic impurity beyond total threshold limit was observed during analysis].
The products are being recalled due to quality defect: the tablet description should be cross-scored, but instead the tablet has only a single score.
How can you get the #MedSafetyApp? Go to either the Apple or Google Play Store. Search for “Medsafety”. For any additional information on what to report and how to report, please call 012 501 0311. #SAHPRA #SupportingHealthcare #SupportingPublic https://medsafety.sahpra.org.za/