| S/N | Product Name | Licence Holder | Summary of Approved Changes | Date of NDA Approval |
|---|---|---|---|---|
| 1 | Trimethoprim + Sulfamethoxazole (Septrin®) | Beta Healthcare International Ltd | Addition of text under contraindications to demonstrate Trimethoprim-sulfamethoxazole must not be given in combination with dofelitide; addition of tect to section 4.5 to illustrate the consequences (serious ventricular arrhythmias associated with QT prolongation, including torsades de pointes) of taking both drugs together; addition of text under 4.8 undesirable effcets to note acute generalised exanthematous pustulosis (AGEP) as a potential adverse event associated with trimethoprim-sulfamethoxazole. | 26th March 2024 |
| 2 | Isoflurane (Isotroy®) | Troikaa Pharmaceuticals Limited | In precautions: Added a section for paediatric use to include the warning on paediatric neurotoxicity. | 7th March 2024 |
| 3 | Paracetamol (Infulgan®) | Yuria-Pharm Llc Manufacturing Site | Update of PIL and SmPC in the following sections: warnings and precautions, taking or using other medicines, pregnancy and possible side effects. | 26th February 2024 |
| 4 | Tadalafil (Titanafil 5®) | Acino AG | Update to SmPC and PIL involving: Exclusion of the indication for urinary symptoms associated with a common condition called benign prostatic hyperplasia. | 13th February 2024 |
| 5 | Amlodipine (Amlodipine 5 mg tablets) | Novartis Pharma Services Inc | Update of section 4.9 (overdose) for the CDS to include non-cardiogenic pulmonary oedema as a consequence of amlodipine overdose that may manifest with delayed onset (24-48 hours post ingestion) and require ventilatory support. | 24th January 2024 |
| 6 | Etonogestrel (Implanon NXT®) | Organon South Africa (Pty) Ltd | Undesirable effects updated to include information on possible vasovagal reactions, and the PIL updated to include wording that "after insertion of the implant the patient might feel faint". | 4th January 2024 |
| 7 | Ibuprofen + Pseudoephedrine HCL (Sinutab 3-way®) | Johnson & Johnson Pty Ltd | Update in the SmPC of Sinutab 3 way to include safety updates in the following sections - the contraindications, warnings and special precautions, interactions, side effects and known symptoms of overdose. Contraindications: Do not take Sinutab: If you are pregnant (20 weeks or more), trying to become pregnant or are breastfeeding; Do not give SINUTAB® 3-WAY to children that are younger than 12 years of age; If you are taking digoxin (used to treat heart conditions). | 4th January 2024 |
| 8 | Sodium valproate Ph. Eur. (Epilim Chrono®) | Sanofi Aventis Kenya Limited | Update of Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL) to include potential for reproductive toxicity following exposure to valproate in childhood. | 6th December 2023 |
| 9 | Diclofenac sodium (Diclo-denk®) | Denk Pharma Gmbh &Co Kg | Update of SmPC and PIL to add information on what to know before you use Diclo-denk rectal, warnings and precautions, other medicines and possible side effects sections. | 7th November 2023 |
| 10 | Azithromycin monohydrate (Azithro-denk®) | Denk Pharma Gmnh & Co Kg | Update to product SmPC and PIL to add QT prolongation in the warning and precautions section 2 for the PIL and 4.4 for the SmPC. | 7th November 2023 |
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