Archive

10 Nov Risk Management Plans for Medicines for Human Use

Posted at 09:46h in

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...

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24 Oct Topical corticosteroids – DHCPL – Risk of withdrawal reactions

Posted at 12:37h in

2022 Oct...

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19 Aug Adverse Drug Reactions and Quality Problem Reporting Form

Posted at 13:47h in

Adverse Drug Reactions and Quality Problem Reporting Form - for both public and private sector and includes herbal products....

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18 Aug Anagrelide hydrochloride: Risk of thrombosis including cerebral infarction upon abrupt treatment discontinuation

Posted at 12:07h in

Takeda (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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17 Aug Cefepime hydrochloride – Risk of serious adverse reactions

Posted at 13:09h in

Risk of serious adverse reactions, including encephalopathy, associated with MAXIPIME (cefepime hydrochloride) particularly in patients with renal impairment who received doses that exceeded the dosage recommendations. ...

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17 Aug Valproate containing medicines – High risk of congenital abnormalities and development disorders

Posted at 13:07h in

Aspen Pharmacare, Brimpharm SA (Pty) Ltd, Adcock Ingram Limited, Sandoz SA (Pty) Ltd and Takeda (Pty) Ltd in collaboration with the South African Health Products Regulatory Authority (SAHPRA) would like to inform you of the risks related to the use of valproate containing medicines (sodium...

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17 Aug Clozapine – Induced gastrointestinal hypomotility

Posted at 13:06h in

In collaboration with the South African Health Products Regulatory Authority (SAHPRA) Novartis, Litha Pharma and Aspen Pharmacare, would like to remind you of the following labelled safety information regarding the safe use of clozapine as contained in: ...

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17 Aug Hydrochlorothiazide – Risk of non-menoloma skin cancer

Posted at 13:04h in

In collaboration with the South African Health Products Regulatory Authority (SAHPRA), the below listed companies would like to inform you of a new risk of non-melanoma skin cancer (NMSC) (basal cell carcinoma, squamous cell carcinoma) in patients treated with hydrochlorothiazide....

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17 Aug Lamotrigine – Risk of Hemophagocytic Lymphohistiocytosis

Posted at 13:03h in

In agreement with the South African Health Products Regulatory Authority (SAHPRA), Aurobindo Pharma (Pty) Ltd would like to inform you of the following important information regarding the risk of Hemophagocytic Lymphohistiocytosis (HLH) associated with the use of lamotrigine containing medicines....

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17 Aug Hyoscine Butylbromide – Risk of adverse effects in patients with underlying cardiac disease

Posted at 13:02h in

lngelheim Pharmaceuticals (Pty) Ltd and Sanofi-Aventis South Africa (Pty) Ltd in collaboration with SAHPRA wish to inform you of the following safety information update regarding the use of hyoscine butylbromide injection as contained in BUSCOPAN 20 mg/1 ml ampoules and BUSCOPAN COMPOSITUM 20 mg/2,5 g...

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