Recall Letter to customers
13 Dec Clinical Trial Applications Electronic System
Posted at 14:01h
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As you may be aware, SAHPRA has embarked on a process to digitalise its business processes. A pilot electronic process is planned for new medicinal clinical trial applications for January 2024. The official launch of the system for all new medicinal clinical trial applications will...
07 Dec Medi-Guardian Newsletter November 2023
Posted at 11:11h
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As we publish our 3rd edition of the Medi-Guardian (previously VigiGuardian), let us reflect on the critical importance of pharmacovigilance as part of the product lifecycle management, our drive towards attaining maturity level three (ML3) for medicines and vaccines to effectively enable access to safe...
07 Dec Potential Missing Professional Information (PI) and Patient Information Leaflet (PIL) in Folding Boxes of Pertjeta® 420 mg/14 mL infusion (pertuzumab)
Posted at 09:24h
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Dear Healthcare Professional In collaboration with the South African Health Products Regulatory Authority (SAHPRA), Roche Products (Pty) Ltd would like to inform you of the potential missing PI and PIL in folding boxes of Perjeta® (pertuzumab) 420mg/14mL infusion....
07 Dec Potential Missing Professional Information (PI) and Patient Information Leaflet (PIL) in Folding Boxes of Hemlibra® 60 mg/0,4 mL solution for injection (emicizumab):
Posted at 09:20h
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Dear Healthcare Professional In collaboration with the South African Health Products Regulatory Authority (SAHPRA), Roche Products (Pty) Ltd would like to inform you of the potential missing PI and PIL in folding boxes of Hemlibra® (emicizumab) 60 mg/0,4 mL solution for injection. The purpose of this...
06 Dec Cannabis Pre Licence Application Status Letter
Posted at 08:44h
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Please be informed that all documents and queries for GMP and CPP certificates should now be emailed to a new dedicated email address - see download. ...
08 Nov The risk of acute tubulointerstitial nephritis (TIN) associated with proton pump inhibitors (PPIs)
Posted at 13:33h
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The Pharmaceutical Companies listed above, as directed by the South African Health Products Regulatory Authority (SAHPRA), would like to update you on the safety information regarding acute tubulointerstitial nephritis (TIN) that has been observed with the use of Pantoloc® / Topzole® (Pantoprazole), Dexilant® (Dexlansoprazole), Nexiam®...
16 Oct COVID-19: Case Reporting Form (CRF) for suspected Adverse Events of Special Interest (AESI)
Posted at 09:55h
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