Archive

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 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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04 Oct Golimumab SIMPONI® 50 mg: Important Changes to the Instructions For Use (IFU) for the SmartJect® Autoinjector/Pre-filled Pen

Posted at 13:41h in

Dear Healthcare Professional Janssen Pharmaceutica, the holder of the certificate of registration for Simponi 50 mg in agreement with the South African Health Products Regulatory Authority (SAHPRA) would like to inform you of the steps taken to reduce the risks associated with the administration of the...

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11 Sep Section 36 approval – KLACID XL

Posted at 13:49h in

The DHCPL is intended to inform healthcare professionals that Abbott Labs is experiencing a delay in production from the manufacturing site and anticipates shortages of Klacid XL in emerging markets....

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17 Jul Section 36 Approval – MeasBio Vaccine

Posted at 13:35h in

To ensure continuity of supply of MeasBio for use in South Africa. Biovac obtained a Section 36 exemption from SAHPRA to supply the MeasBIO vaccine and the diluent for MeasBio packed in Indonesian National Agency for Food and Drug Control (NA-DFC) approved labelling with the...

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14 Jun Bupropion Containing Medicines – Risk Of Brugada Syndrome (Adcock, Tev, Acino, and SunPharma)

Posted at 09:20h in

The following pharmaceutical companies, Adcock Ingram Limited, Teva Pharmaceuticals, Acino Pharma and Ranbaxy Pharmaceuticals, 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 bupropion-containing medicines registered in South Africa. The...

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12 Jun Bupropion containing medicines – Risk of of Brugada Syndrome (GSK)

Posted at 12:19h in

GSK South Africa, in collaboration with the SAHPRA, would like to draw your attention to the following important safety information associated with bupropion-containing medicines, registered in South Africa....

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