Archive

17 Aug SAHPRA launches the Med Safety App for self-reporting of suspected Adverse Drug Reactions by the Public and Healthcare Professionals

Posted at 12:28h in

SAHPRA is pleased to announce the launch of the Med Safety App. The Med Safety App is a mobile application (App) that is designed to simplify and promote the reporting of suspected adverse drug reactions (ADRs), including adverse events following immunisation (AEFIs) by both the...

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17 Aug COVID-19 Vaccine Janssen: Risk of Thrombosis in combination with Thrombocytopenia

Posted at 12:27h in

Janssen Pharmaceutica (Pty) Ltd, as directed by the South African Health Products Regulatory Authority (SAHPRA) would like to inform you about the risk of thrombosis in combination with thrombocytopenia, associated with the use of COVID-19 Vaccine Janssen...

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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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