Archive

23 May Communication to Industry – Summary of Medicine Safety Regulatory Decisions

Posted at 11:48h in

This document provides an overview of the safety regulatory decisions taken by the South African Health Products Regulatory Authority (SAHPRA) during July - September 2023. This includes a summary of regulatory decisions, where safety concerns were reviewed and concluded, and those safety concerns that are...

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21 May Risk of intrathecal administration error associated with intravenous (IV) tranexamic acid – Pfizer and other collaborators

Posted at 14:32h in

Healthcare professionals are drawn to the attention about the risk of error in the administration of IV tranexamic acid. Tranexamic acid is for IV use only. However, there is a potential for confusion of tranexamic acid with other injectables which could result in inadvertent intrathecal...

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02 May Recommended Calculations of Contraception Duration After Completion of Therapy with Genotoxic Anticancer Medicines (Sanofi and Other Collaborators)

Posted at 06:29h in

In collaboration with the South African Health Products Regulatory Authority (SAHPRA), the companies listed below would like to inform you about recommended calculations of contraception duration after completion of therapy with genotoxic anticancer medicines (including potential metabolites)....

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02 May Important Medicine Safety Information Section 36 Approval – Phenylephrine Hydrochloric Injectiontm

Posted at 06:25h in

In collaboration with the South African Health Products Regulatory Authority (SAHPRA), Abbott Laboratories SA (Pty) Ltd, would like to inform you that Phenylephrine hydrochloric injectionTM has been up scheduled from Schedule 1 to Schedule 4 status. However, Abbott is experiencing unforeseen delays in the implementation...

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30 Apr Recommended Calculations of Contraception Duration after Completion of Therapy with Genotoxic Anticancer Medicines (Sun Pharma and Other Collaborators)

Posted at 11:13h in

In collaboration with the South African Health Products Regulatory Authority (SAHPRA), the companies listed in the attached document would like to inform you about recommended calculations of contraception duration after completion of therapy with genotoxic anticancer medicines (Including potential genotoxic metabolites)....

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06 Mar Pharmacovigilance Process of Issuing Safety Recommendations to Applicants/HCRS For Implementation

Posted at 11:16h in

Kindly note that this communication serves to communicate two (2) processes that the SAHPRA Pharmacovigilance (PV) unit has revised. You are urged to take note of these revisions....

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19 Jan Pharmacare and Multiple Collaborators DHCPL: Valaciclovir/Aciclovir – Containing Medicines – Risk of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)

Posted at 12:09h in

Dear Healthcare Professional, Aspen Pharmacare, Adcock Ingram Limited, Pharma Dynamics and Sandoz SA (Pty) Ltd, in collaboration with the South African Health Products Regulatory Authority (SAHPRA), would like to draw your attention to the following important safety information associated with the use of valaciclovir/aciclovir-containing medicines registered...

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10 Jan Valaciclovir-Aciclovir-Containing Medicines Risk of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)

Posted at 08:28h in

Dear Healthcare Professional, In collaboration with the South African Health Products Regulatory Authority (SAHPRA), the below listed companies would like to inform you about the risk of drug reaction with eosinophilia and systemic symptoms (DRESS) associated with the use of valaciclovir/aciclovir- containing medicines....

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07 Dec Medi-Guardian Newsletter November 2023

Posted at 11:11h in

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...

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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 in

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....

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