Archive

11 Sep Section 36 approval – KLACID XL

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

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)

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)

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....

21 May Synthroid – Range of tablets: Typing error in Professional Information (PI) and Patient Information Leaflet (PIL)

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...

20 Apr Gabapentinoids – Risk of Serious Breathing Difficulty

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)....

12 Apr DHCPL_Section 36 approval – Measbio vaccine

24 Oct Topical corticosteroids – DHCPL – Risk of withdrawal reactions

2022 Oct...

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

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....

17 Aug Cefepime hydrochloride – Risk of serious adverse reactions

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. ...