Archive

17 Aug Dopaminergic Medicines used in the treatment of Parkinson’s Disease: Risk of Dopamine Dysregulation Syndrome

Posted at 12:25h in

MSD (Pty) Ltd, as directed by the South African Health Products Regulatory (SAHPRA) would like to inform healthcare professionals about the risk of dopamine dysregulation syndrome (DDS) associated with the use of dopamine containing medicines in the treatment of Parkinson’s Disease. The Professional...

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17 Aug Selective Serotonin Reuptake Inhibitors (SSRIS) and Serotonin–Norepinephrine Reuptake Inhibitors (SNRIS) associated with the risk of Postpartum Haemorrhage

Posted at 11:51h in

Novartis as directed by the South African Health Products Regulatory Authority (SAHPRA) would like to inform you about the increased incidence of intraocular inflammation (IOI) and related adverse events including retinal vasculitis (RV) and retinal vascular occlusion (RO) associated with (brolucizumab) when administered at 4...

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17 Aug COVID-19 Vaccine Janssen

Posted at 11:50h in

Janssen Pharmaceutica (Pty) Ltd, as directed by the South African Health Products Regulatory Authority (SAHPRA) would like to inform you about new safety information that has resulted in contraindication of the COVID-19 Vaccine Janssen in individuals with a history of Capillary Leak Syndrome (CLS). ...

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17 Aug SAHPRA Statement on Adverse Events Following Immunisation (AEFIs) with COVID 19 Vaccines

Posted at 11:47h in

The South African Health Products Regulatory Authority (SAHPRA) has a mandate to oversee the safety, efficacy and quality of all medicines registered in South Africa, including vaccines....

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17 Aug COMIRNATY® (COVID-19 mRNA Vaccine) -Warning regarding rare cases of Myocarditis and Pericarditis

Posted at 11:44h in

Pfizer South Africa, in collaboration with the South African Health Products Regulatory Authority (SAHPRA) wish to inform you of the warning regarding rare cases of myocarditis and pericarditis reports that were noted following the use of COVID-19 mRNA vaccines, including Comirnaty® (Covid- 19 mRNA vaccine)....

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17 Aug VSIQQ® (Brolucizumab) – A Requirement to Discontinue Treatment with Vsiqq® in Patients who Develop Retinal Vasculitis and/or Retinal Vascular Occlusion, Typically in the Presence of Intraocular Inflammation

Posted at 11:43h in

Novartis, as directed by the South African Health Products Regulatory Authority (SAHPRA), would like to inform you about the requirement to discontinue treatment with Vsiqq® in patients who develop retinal vasculitis and/or retinal vascular occlusion. Retinal vasculitis and retinal vascular occlusion are immune-mediated events, which...

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17 Aug Topical Corticosteroid – Risk of Withdrawal Reactions – Aspen

Posted at 11:42h in

The following holders of certificates of registration (HCRs), Aspen Pharmacare, GlaxoSmithKline (Pty) Ltd and Glenmark Pharmaceuticals South Africa (Pty) Ltd, in collaboration with the South African Health Products Regulatory Authority (SAHPRA), wish to draw your attention to the following important safety information associated with topical...

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08 Aug Electronic Submission Of Adverse Drug Reaction (ADR) Reports – E2b Reporting

Posted at 14:04h in

For over a decade, ADR reports have been submitted to the National Adverse Drug Events Monitoring Centre (NADEMC) via fax. These reports were previously captured on the ADRI database. The ADRI database restricted electronic reporting by both applicants and healthcare professionals, and direct uploading of...

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02 Aug VigiGuardian Newsletter July 2022

Posted at 10:20h in

The aim of this newsletter is to disseminate regulatory information on post-marketing surveillance and pharmacovigilance activities rendered by SAHPRA, which includes responsibilities of the SAHPRA Pharmacovigilance unit, reporting tools and pharmacovigilance systems in the country....

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17 Jun Summary of Medicines Safety Regulatory Decisions

Posted at 09:03h in

This document provides an overview of the safety regulatory decisions taken by SAHPRA on the safety concerns discussed during January – March 2022. This includes a summary of regulatory decisions, where safety concerns were reviewed and concluded, and those safety concerns that are not concluded...

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