Pharmacovigilance Archives - Page 6 of 14

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....

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

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®...

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

Posted at 09:56h in

16 Oct COVID-19: Case Reporting Form (CRF) for suspected Adverse Events of Special Interest (AESI)

Posted at 09:55h in

16 Oct ALL VACCINES including COVID-19: Case Investigation Form (CIF) Adverse Events Following Immunisation (AEFI) AND Adverse Events of Special Interest (AESI)

Posted at 09:53h in

ALL VACCINES including COVID-19: CASE INVESTIGATION FORM (CIF) Adverse Events Following Immunisation (AEFI) AND Adverse Events of Special Interest (AESI). ONLY for Serious and Severe Adverse Events Following Immunisation, Clusters and Adverse Events of Special Interest...

09 Oct Vaccine Safety Surveillance (VSS) In South Africa

Posted at 10:55h in

This manual focuses on surveillance and response to Adverse Events Following Immunisation. It is guided by the policies of the National Department of Health and the South African Health Products Regulatory Authority, with recommendations from the World Health Organisation, to serve as guidelines for Vaccine Safety Surveillance. It provides guidelines and procedures for healthcare professionals at...

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...

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....

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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