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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...

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)....

This document has been prepared to serve as a guideline to the holders of certificate of registration/applicants on the Authority’s requirements regarding risk management plans for medicines, including biological medicines, in South Africa. It represents SAHPRA’s current thinking on the safety, quality and efficacy of...