01 Feb Communication to industry on metformin-containing medicines
Posted at 09:34h
in
This document has been archived....
Archive
01 Feb Communication to industry on ranitidine-containing medicines
Posted at 09:31h
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This document has been archived....
01 Feb DIPHENHYDRAMINE-CONTAINING MEDICINES
Posted at 09:29h
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SAHPRA alerts all healthcare professionals about the risk of serious heart problems, seizures, coma and death associated with the use of high doses of diphenhydramine containing medicines....
01 Feb A SIGNAL OF MYOCARDITIS / PERICARDITIS ASSOCIATED WITH PFIZER-BIONTECH’S COVID-19 VACCINE, COMIRNATY (BNT162B2)
Posted at 09:27h
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The South African Health Products Regulatory Authority (SAHPRA) would like to inform you of a signal of myocarditis / pericarditis associated with Pfizer-BioNTech’s ...
01 Feb Communication to industry on Post Marketing Reporting of ADRs guideline
Posted at 09:17h
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The South African Health Products Regulatory Authority (SAHPRA), have reviewed the Post Marketing Reporting of ADR guideline following concerns raised by the industry on version 7 of the guideline published September 2020. In addition to the review, SAHPRA conducted a webinar with holders of...
25 Jan Guideline for the handling of Dear Healthcare Professional Letters relating to medicine safety
Posted at 16:53h
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This document has been prepared to serve as a guideline to those who prepare and distribute Dear Healthcare Professional letters. It represents South African Health Products Regulatory Authority (SAHPRA) current thinking...
25 Jan Valproate Annual Risk Acknowledgement Form
Posted at 16:52h
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If you use valproate while you are pregnant, there is a significant risk of serious harm to your child which may be identified at birth or early development. This form confirms that you or your caregiver/parent/responsible person understand the risks of using valproate (contained in...
25 Jan Guideline for Adverse Drug Reactions (ADRs) Reporting for Healthcare Professionals
Posted at 16:49h
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This document has been prepared to serve as a guideline to healthcare professionals reporting adverse drug reactions, adverse event following immunisations and product quality problems. It represents South African Health Products Regulatory Authority’s (SAHPRA’s) current thinking on the safety, quality and efficacy of medicines....