Pseudoephedrine-containing medicines – Risks of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS)

11 Jun Pseudoephedrine-containing medicines – Risks of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS)

Posted at 14:46h in

Haleon South Africa (SA), in collaboration with the South African Health Products Regulatory Authority (SAHPRA), would like to inform you about the risks of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) associated with the use of pseudoephedrine-containing medicines....

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10 Jun Communication to Industry – SAHPRA Updates Regarding the Use of Yohimbine in Veterinary Medicine

Posted at 16:05h in

This communication to industry was developed to express SAHPRA’s view that the therapeutic use of yohimbine in animals may be in the public interest and to outline the steps that SAHPRA is taking to place the product in the schedules....

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04 Jun SAHPRA Engagement Portal – Launch Update

Posted at 11:36h in

The South African Health Products Regulatory Authority (SAHPRA) provides the following key updates on the SAHPRA Engagement Portal....

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29 May Phenylephrine – Lack of Effectiveness of Oral Preparations as Nasal Decongestant

Posted at 22:05h in

This document is intended to provide communication to the HCRs for orally administered phenylephrine containing medicines regarding the Authority's intent to classify these medicines as undesirable due to concerns about their efficacy....

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23 May Anviro® (Valaciclovir – Containing Medicine)– Risk of Drug Reaction With Eosinophilia and Systemic Symptoms (Dress)

Posted at 10:29h in

In collaboration with the South African Health Products Regulatory Authority (SAHPRA), Zydus would like to inform you about the risk of drug reaction with eosinophilia and systemic symptoms (DRESS) associated with the use of Anviro® (valaciclovir) tablets....

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05 May SAHPRA Engagement Portal – Variation, Renewal and Response Applications

Posted at 16:17h in

The South African Health Products Regulatory Authority (SAHPRA) is providing key updates on the SAHPRA Engagement Portal....

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30 Apr SAHPRA Engagement Portal – Important Updates

Posted at 16:12h in

The South African Health Products Regulatory Authority (SAHPRA) is providing key updates on the SAHPRA Engagement Portal....

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30 Apr Anagrelide hydrochloride: Risk of thrombosis including cerebral infarction upon abrupt treatment discontinuation

Posted at 14:04h in

Key Oncologies (Pty) Ltd, as directed by the South African Health Products Regulatory Authority (SAHPRA), wish to inform you about the risk of thrombosis, including cerebral infarction, upon abrupt treatment discontinuation of anagrelide hydrochloride....

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30 Apr Topical Corticosteroids – Risk of Withdrawal Reactions

Posted at 14:02h in

Organon South Africa (Pty) Ltd, as directed by the South African Health Products Regulatory Authority (SAHPRA), would like to inform you of the risk of withdrawal reactions associated with inappropriate and long-term use of topical corticosteroids....

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29 Apr Bioequivalence studies performed by Contract Research Organisation (Synapse Labs Pvt. Ltd)

Posted at 14:45h in

The communication is directed at applicants or holders of certificates of registration (HCRs) using Synapse Labs Pvt. Ltd to conduct their bioequivalence (BE) studies.   It provides information on deficiencies detected by the European Medicines Agency regarding critical deficiencies for BE studies conducted by Synapse Labs Pvt....

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