Archive

02 Jul Recommended Calculation of Contraception Duration After Completion of Therapy to Minimise Risk of Embryotoxicity and Teratogenicity Associated With the Use of Halaven® (Eribulin Mesylate)

Posted at 18:10h in

Eisai Pharmaceuticals Africa (Pty) Ltd, in collaboration with the South African Health Products Regulatory Authority (SAHPRA) would like to inform you about the recommended calculations of contraception duration after completion of therapy with Halaven® (eribulin mesylate), including its potential genotoxic metabolites....

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27 Jun DHCPL – IV Tranexamic Acid Risk of Intrathecal Administration Error – PharmaDynamics and other collaborators

Posted at 08:31h in

PharmaDynamics and other collaborators, would like to warn healthcare professionals about the risk of intrathecal administration of intravenous (IV) tranexamic acid, which may result in serious lifethreatening injuries, including seizures, cardiac arrhythmias, paraplegia, permanent neurological injury, and death. There have been reports of IV tranexamic...

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21 Jun Pseudoephedrine-containing Medicines – Risk of Posterior Reversible Encephalopathy Syndrome (PRES) and Reversible Cerebral Vasoconstriction Syndrome (RCVS)

Posted at 13:59h in

Acino Pharma (Pty) Ltd, Adcock Ingram Limited, Aspen Pharmacare, Cipla Medpro, Ranbaxy Pharmaceuticals (Pty) Ltd and Pharmaceutical Contractors (Pty) Ltd, in collaboration with the South African Health Products Regulatory Authority (SAHPRA), would like to draw your attention to the risk of posterior reversible encephalopathy syndrome...

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19 Jun Gavreto (pralsetininb) DHCPL- Removal from the Pharmaceutical Market

Posted at 09:46h in

The DHCP letter initiated by Roche is intended to inform healthcare professionals about deregistration of approved indications for Gavreto® (pralsetinib) and removal from the South African pharmaceutical market....

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31 May DHCPL – Instruction for use for Sybrava Inclisiran single-dose pre-filled syringe

Posted at 14:42h in

This DHCP letter is initiated by Norvatis and is intended to inform healthcare professionals about important new user handling instructions for the Sybrava® (inclisiran) single-dose pre-filled syringe injection, to reduce the risks associated with administration of the product....

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30 May A Signal Of Myocarditis / Pericarditis Associated With Pfizer-BioNTech’s Covid-19 Vaccine, Comirnaty (Bnt162b2)

Posted at 15:23h in

The South African Health Products Regulatory Authority (SAHPRA) would like to inform you of a signal of myocarditis/pericarditis associated with Pfizer-BioNTech’s Covid-19 vaccine, Comirnaty® (BNT162b2). The Pfizer/BioNTech Comirnaty® Vaccine was approved by SAHPRA in March 2021. The authorisation was done in terms of Section 21...

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30 May SAHPRA Statement on Adverse Events Following Immunisation (AEFIs) with COVID 19 Vaccines

Posted at 15:21h 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. The National Department of Health (NDoH) Expanded Programme on Immunisation (EPI) is responsible for the COVID-19 vaccination programme,...

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

Posted at 12:20h in

This document provides an overview of the safety regulatory decisions taken by the South African Health Products Regulatory Authority (SAHPRA) during April to June 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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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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