Archive

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):

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...

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

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®...

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

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...

11 Sep Section 36 approval – KLACID XL

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....

17 Jul Section 36 Approval – MeasBio Vaccine

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...

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

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...

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

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....

21 May Synthroid – Range of tablets: Typing error in Professional Information (PI) and Patient Information Leaflet (PIL)

The DHCPL is intended to inform healthcare professionals (HCPs) about a typing error in the PI and PIL. The Synthroid products with PI and PIL with the typing error will not be distributed in the country for human use. Thus, Abbot applied for a Section...

20 Apr Gabapentinoids – Risk of Serious Breathing Difficulty

In collaboration with the South African Health Products Regulatory Authority (SAHPRA), the listed companies (logo’s above), would like to inform you about the risk of serious breathing difficulty associated with the use of gabapentinoids (gabapentin and pregabalin)....

12 Apr DHCPL_Section 36 approval – Measbio vaccine