SAHPRA office closure during festive season
SAHPRA offices will be closed for the festive season from 12:00 on Friday, 22 December 2023 and will...
29 November, 23Looking for a document – search here:
SAHPRA offices will be closed for the festive season from 12:00 on Friday, 22 December 2023 and will...
29 November, 23Pretoria, 06 November 2023 – The South African Health Products Regulatory Authority (SAHPRA) is urgi...
06 November, 23The South African Health Products Regulatory Authority (SAHPRA) has launched its very own chatbot, R...
03 November, 23Pretoria, 26 October 2023 – The South African Health Products Regulatory Authority (SAHPRA) currentl...
26 October, 23In 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.