16 Oct COVID-19: Case Reporting Form (CRF) for suspected Adverse Events of Special Interest (AESI)
Posted at 09:55h
in
Archive
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...
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...
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....
02 Jun Communication to Industry – Summary of Medicine Safety Regulatory Decisions
Posted at 13:22h
in
This document provides an overview of the safety regulatory decisions taken by SAHPRA during April - July 2022....
21 May Synthroid – Range of tablets: Typing error in Professional Information (PI) and Patient Information Leaflet (PIL)
Posted at 20:50h
in
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...