Archive

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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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 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 Hemlibra® (emicizumab) 60 mg/0,4 mL solution for injection. The purpose of this...

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08 Nov The risk of acute tubulointerstitial nephritis (TIN) associated with proton pump inhibitors (PPIs)

Posted at 13:33h in

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®...

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16 Oct ALL VACCINES including COVID-19 : Case Reporting Form (CRF) for Adverse Events Following Immunisation (AEFI)

Posted at 09:56h in

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