S/N | Product Name | Licence Holder | Summary of Approved Changes | Date of NDA Approval |
---|---|---|---|---|
1 | (TRIUMEQ®) | |||
2 | Dapagliflozin | Astrazeneca UK Ltd. | 1. Addition of treatment of heart failure in adult’s indication as a result of the DELIVER study. | 10th March 2025 |
3 | (FORXIGA®) | 2. Update of the SmPc to reflect changes made in EU FORXIGA SmPc as a result of Deliver approval and addition of Lithium drug-drug interaction in section 4.5 of the core data sheet. | ||
4 | Vildagliptin/Metformin | Norvatis Pharma AG | Update to the SmPc in section 7 ( Adverse drug reaction) to include a post marketing ADR “Cholectstitis” with frequency “Not Known” | 14th March 2025 |
5 | (GALVUS MET) | KENYA | ||
6 | Etravirine | Janssen-Cilag International NV | Change in the SmPc labelling, or package leaflet due to the following safety concerns that are approved by the EU; | 18th March 2025 |
7 | (INTELENCE) | BELGIUM | 1. In section 4.4 Special warnings and precautions for use – Removal of the disease information relating to sexual transmission of HIV | |
8 | 2. In section 4.6 Fertility , pregnancy and lactation – Amendment of the section related to breast feeding. | |||
9 | Vidagliptin | Norvartis AG | Update to the SmPc in section 7 to include a post marketing ADR “Cholecystitis” with frequency “Not Known”. | 18th March 2025 |
10 | (VIDAGLIPTIN® | KENYA | ||
11 | ||||
12 | Dolutegravir Sodium | VIIV Healthcare UK Limited. | Update in the prescribing information regarding Neural Tube defects in sections of “Antiretroviral Pregnancy Registry (APR), Clinical studies, Pregnamcy and Lactation” to replace the old data with new data obtained from the Tsepamo and Eswatini ( Botswana) birth outcome surveillance studies, i.e., | 19th March 2025 |
13 | (TIVICAY) | · There were no increased risk of neural tube defects with dolutegravir exposure at conception. | ||
14 | · The prevalence of neural tube defects in infants born to womwn taking dolutegravir at conception in the two studies did not differ significantly fronm the background rate in women without HIV or other exposure groups. | |||
15 | · The APR data was amended based on the January 23 data. | |||
16 | Dolutegravir Sodium + Rilpivirine Hydrochloride | VIIV Healthcare UK Limited. | Update in the prescribing information regarding Neural Tube defects in sections of “Antiretroviral Pregnancy Registry (APR), Clinical studies, Pregnamcy and Lactation” to replace the old data with new data obtained from the Tsepamo and Eswatini (Botswana) birth outcome surveillance studies, i.e., | 19th March 2025 |
17 | (JULUCA) | · There was no increased risk of neural tube defects with dolutegravir exposure at conception. | ||
18 | · The prevalence of neural tube defects in infants born to womwn taking dolutegravir at conception in the two studies did not differ significantly fronm the background rate in women without HIV or other exposure groups. | |||
19 | · The APR data was amended based on the January 23 data. | |||
20 | Triploridine HCL/ Pseudoephedrine/Guaiphenisin | Glaxosmithkline Limited. | Update to the SmPc to add a warning related to Acute Systemic Vasocontrictive events i.e, the existing warning related to ischaemic colitis, posterior reversible encephalopathy/ reversible celebral vasoconstriction syndrome (RCVS) has been widened to include the term “Acute systemic vasoconstrictive events” and impart more clarity on signs and symptoms. | 19th March 2025 |
21 | (ACTIFED WET COUGH AND COLD) | KENYA | ||
22 | Fexinidazole | Sanofi – Aventis South Africa (Pty) Ltd. | Change of therapeutic indication involving extension of indication to include treatment of both first stage (Haemo-Lymphatic) and second stage meningoencephalitis) of human African trypanosomiasis (HAT) due to trypanosome brucei rhodensiense | 6th February 2025 |
23 | (FEXINIDAZOLE WINTHROP®) | |||
24 | Finerenone | Bayer East Africa Ltd. | Update in the sections 4.1,4.8,5.1 and 5.8 of the SmPc based on the data from FIGARO-DKD phase 3 study, pooled analysis from the FIGARO-DKD and FIDELIO – DKD studies, as well as the phase 1 drug interaction study of finerenone with rosuvastatin. Some notable changes include: | 10th February 2025 |
25 | (FIRIALTAA®) | 1. Inclusion of study results for renal and cardiovascular events. | ||
26 | 2. Addition of hyperuricaemia as a common undesirable effect. | |||
27 | 3. Additional primary and secondary time- to – event endpoints. | |||
28 | Bevacizumab | F. Hoffmann La-Roche | Clarification of the warning and precautions: Hypersensitivity reactions/infusion reactions to include anaphylactic shock. | 21st February 2025 |
29 | (AVASTIN®) | SWITZERLAND | ||
30 | Dolutegravir + Abacavir + Lamivudine | VIIV Healthcare UK Limited. | Update of the SmPc involving TSC 3- Sections: Clinical studies, pregnancy and lactation – NTD wording updated in view of Tsepamo March 2022 and Eswantini September 2022 data and APR wording updated in view of January 2023 data. | 27th February 2025 |
31 | Sanofi – Aventis South Africa (Pty) Ltd. | Change of therapeutic indication involving extension of indication to include treatment of both first stage (Haemo-Lymphatic) and second stage meningoencephalitis) of human African trypanosomiasis (HAT) due to trypanosome brucei rhodensiense | 6th February 2025 | 31st December 2024 |
32 | 31st December 2024 | |||
33 | Bayer East Africa Ltd. | Update in the sections 4.1,4.8,5.1 and 5.8 of the SmPc based on the data from FIGARO-DKD phase 3 study, pooled analysis from the FIGARO-DKD and FIDELIO – DKD studies, as well as the phase 1 drug interaction study of finerenone with rosuvastatin. Some notable changes include: | 10th February 2025 | 31st December 2024 |
34 | 1. Inclusion of study results for renal and cardiovascular events. | 20th December 2024 | ||
35 | 2. Addition of hyperuricaemia as a common undesirable effect. | 20th December 2024 | ||
36 | 3. Additional primary and secondary time- to – event endpoints. | 18th December 2024 | ||
37 | F. Hoffmann La-Roche | Clarification of the warning and precautions: Hypersensitivity reactions/infusion reactions to include anaphylactic shock. | 21st February 2025 | 18th December 2024 |
38 | SWITZERLAND | 17th November 2024 | ||
39 | VIIV Healthcare UK Limited. | Update of the SmPc involving TSC 3- Sections: Clinical studies, pregnancy and lactation – NTD wording updated in view of Tsepamo March 2022 and Eswantini September 2022 data and APR wording updated in view of January 2023 data. | 27th February 2025 | 11th December 2024 |
40 | 11th December 2024 | |||
41 | Astrazeneca UK Ltd. | 1. Addition of treatment of heart failure in adult’s indication as a result of the DELIVER study. | 10th March 2025 | 11th December 2024 |
42 | 2. Update of the SmPc to reflect changes made in EU FORXIGA SmPc as a result of Deliver approval and addition of Lithium drug-drug interaction in section 4.5 of the core data sheet. | |||
43 | Norvatis Pharma AG | Update to the SmPc in section 7 ( Adverse drug reaction) to include a post marketing ADR “Cholectstitis” with frequency “Not Known” | 14th March 2025 | |
44 | KENYA | |||
45 | Janssen-Cilag International NV | Change in the SmPc labelling, or package leaflet due to the following safety concerns that are approved by the EU; | 18th March 2025 | |
46 | BELGIUM | 1. In section 4.4 Special warnings and precautions for use – Removal of the disease information relating to sexual transmission of HIV | 11th December 2024 | |
47 | 2. In section 4.6 Fertility , pregnancy and lactation – Amendment of the section related to breast feeding. | 11th December 2024 | ||
48 | Norvartis AG | Update to the SmPc in section 7 to include a post marketing ADR “Cholecystitis” with frequency “Not Known”. | 18th March 2025 | |
49 | KENYA | |||
50 | 11th December 2024 | |||
51 | VIIV Healthcare UK Limited. | Update in the prescribing information regarding Neural Tube defects in sections of “Antiretroviral Pregnancy Registry (APR), Clinical studies, Pregnamcy and Lactation” to replace the old data with new data obtained from the Tsepamo and Eswatini ( Botswana) birth outcome surveillance studies, i.e., | 19th March 2025 | |
52 | · There were no increased risk of neural tube defects with dolutegravir exposure at conception. | 12th December 2024 | ||
53 | · The prevalence of neural tube defects in infants born to womwn taking dolutegravir at conception in the two studies did not differ significantly fronm the background rate in women without HIV or other exposure groups. | 12th December 2024 | ||
54 | · The APR data was amended based on the January 23 data. | 12th December 2024 | ||
55 | VIIV Healthcare UK Limited. | Update in the prescribing information regarding Neural Tube defects in sections of “Antiretroviral Pregnancy Registry (APR), Clinical studies, Pregnamcy and Lactation” to replace the old data with new data obtained from the Tsepamo and Eswatini (Botswana) birth outcome surveillance studies, i.e., | 19th March 2025 | 12th December 2024 |
56 | · There was no increased risk of neural tube defects with dolutegravir exposure at conception. | 05th December 2024 | ||
57 | · The prevalence of neural tube defects in infants born to womwn taking dolutegravir at conception in the two studies did not differ significantly fronm the background rate in women without HIV or other exposure groups. | 05th December 2024 | ||
58 | · The APR data was amended based on the January 23 data. | 05th December 2024 | ||
59 | Glaxosmithkline Limited. | Update to the SmPc to add a warning related to Acute Systemic Vasocontrictive events i.e, the existing warning related to ischaemic colitis, posterior reversible encephalopathy/ reversible celebral vasoconstriction syndrome (RCVS) has been widened to include the term “Acute systemic vasoconstrictive events” and impart more clarity on signs and symptoms. | 19th March 2025 | 05th December 2024 |
60 | KENYA | 05th December 2024 | ||
61 | Amoxicillin + potassium clavulanate (DAFRACLAV®) | Dafra Pharma GMBG Muhlenberg7 4052 Basel, SWITZERLAND | Addition of an API (Pottassium Clavulanate, diluted) | 05th December 2024 |
62 | Terbinafine Hydrochloride (TERBINAFORCE 250®) | Mankind Pharma Limited | Extension of Finished Pharmaceutical Product shelf- life from 24 months to 36 months | 05th December 2024 |
63 | Algicic acid + Magnesium Hydroxide + Alminium Hydroxide + Magnesium trisilicate _ Simeticone (ULGICID® (CHERRY FLAVOUR) | Prisma Pharma FZE | Shelf- life extension from 24 months to 29 months | 05th December 2024 |
64 | Esometrazole (NEXIUM 40 ®) | Astrazeneca UK Limited | Extension of Finished Pharmaceutical Product shelf- life from 24 months to 30 months | 02nd December 2024 |
65 | Ciprofloxacin (BACTIFLOX NEO 500®) | Acino Pharma AG | Change in the SmPC and the PIL resulting from adaptation to the originator and safety signal of the fluoroquinolones update | 02nd December 2024 |
66 | Sevoflurane | Piramal Enterprises Ltd | Change of product name from Sevoflurane to Sojourn | 28th November 2024 |
67 | Misoprostol (MISOCLEAR®) | Pharm Access Africa Ltd. | Extension of Finished Pharmaceutical Product shelf- life from 24 months to 30 months | 14th November 2024 |
68 | Diclofenac sodium (DTNAPAR AQ® 1ML) | Troikaa Pharmaceuticles Limited | Extension of shelf life of Dynapar AQ from 24 months to 36 months | 28th November 2024 |
69 | Cefuroxime Sodium (CEFUZIME 750®) | Gulf Pharmaceutical Industries | Change in the description after reconstitution from yellowish color clear solution, free of particles for both IM and IV administration to white to brownish white suspension for IM and Yellowish color clear solution, free of particles for IV. | 11th December 2024 |
70 | Chloramphenicol Palmitate | Abacus Pharma (Africa) Limited | Change in statement in storage conditions from " Do not store above 25°C" to store at a temperature not exceeding 30°C in a dry place, and extension of FPP shelf life from 24 months to 36 months | 4th December 2024 |
71 | Amoxicillin + Clavulanic Acid (CLAVULIN® ) | Glaxosmithkline Pharmaceutical Kenya Ltd | Change in product information including; | |
72 | Addition of details on drug induced enterocolitis to the section of warnings and precautions, and under the section of adverse drug reactions. | 30th October 2024 | ||
73 | Addition of linear IgA disease to the ADR section | 30th October 2024 | ||
74 | Addition of cross reference under skin reactions in the section of ADRs. | |||
75 | Addition of information on the interaction of penicillins and methotrexate under the section of interactions. | 30th October 2024 | ||
76 | Acetyl salicylic acid (ASPIRIN®) | Royal Pharma 2011 limited | Reduction of FPP shelf life from 36 months to 24 months | 28th October 2024 |
77 | Amoxicillin + Clavulanic Acid (CLAVULIN® 1G and 625 MG) | Glaxosmithkline Pharmaceutical Kenya Ltd | Submission of an updated version for the prescribing information involving; | 25th October 2024 |
78 | Addition of symmetrical drug - related intertriginous and flexural exanthema (SDRIFE) also known as baboon syndrome as a new ADR. | 25th June 2024 | ||
79 | Conversion of non-core safety information to core safety information ADRs to core safety information including; reversible hyperactivity, dizziness, headache, convulsions, pruritus, prolongation of bleeding time and prothrombin time and indigestion. | 25th June 2024 | ||
80 | Amoxicillin + Clavulanic Acid (AUGMENTIN®) | Glaxosmithkline Pharmaceutical Kenya Ltd | Addition of symmetrical drug - related intertriginous and flexural exanthema (SDRIFE) also known as baboon syndrome as a new ADR. | 25th June 2024 |
81 | Conversion of non-core safety information to core safety information ADRs to core safety information including; reversible hyperactivity, dizziness, headache, convulsions, pruritus, prolongation of bleeding time and prothrombin time and indigestion. | 25th June 2024 | ||
82 | Dolutegravir Sodium Tablet for Oral Suspension (Dispersible Tablets) 10 MG | Macleods Pharmaceuticals Ltd | Extension of FPP shelf life from 24 months to 36 months. | 14th June 2024 |
83 | Diclofenac Sodium (DICLO-DENK®) | Denk Pharma GmbH & Co. KG. | Addition of a warning that the Diclo-Denk 50 contains lactose on the folding box. | 14th June 2024 |
84 | Levonorgestrel (MIRENA®) | Bayer East Africa Ltd. | Modification to the SmPC including the extension of the duration of use of Mirena in the indication from 6 years to 8 years. | 29th May 2024 |
85 | Aflibercept (EYLEA®) | Bayer East Africa Ltd. | Modification to the SmPC to allow the individualization of the treatment posology of intravitreal aflibercept in diabetic macular edema due to pharmacovigilance data. | 14th June 2024 |
86 | Rosuvastatin Calcium (R0ZITTA® 10) | Dar Al Dawa Development and Investment Co.Ltd. | Extension of shelf life for the FPP from 24 months to 36 months. | 14th June 2024 |
87 | Dapoxetine Hydrochloride (ANDOPOXETINE® 60MG) | Al Andalous for Pharmaceutical Industries. | Extension of shelf life for the FPP from 24 months to 36 months. | 7th June 2024 |
88 | Moxifloxacin Hydrochloride 400mg (AVELOX®) | Bayer East Africa Ltd. | Extension of shelf- life for the FPP from 48 months to 60 months. | 5th June 2024 |
89 | Amoxicillin + Clavulanic Acid (MAGNABIOTIC®) | Wide Spectrum Enterorises (U) Ltd. | Addition of sterile water for injection as a diluent in the pack. | 24th May 2024 |
90 | Mebendazole | Abacus Pharma (Africa) Limited | change in storage conditions from Do not store above 25°C to store at a temperature not exceeding 30°C in a dry place. | 21st May 2024 |
91 | Alfuzosin Hydrochoride (PROSTALEN®) | Exphar sa | Extension of shelf life for FPP from 24 months to 36 months) | 13th May 2024 |
92 | Atracurium (TROYCURIUM) | Troikaa Pharmaceuticles Limited | Extension of shelf life the FPP from 18 months to 24 months) | 30th April 2024 |
93 | Artesunate (ASUNATE®) | Abacus Parenteral Drugs Limited. | Extension of shelf life of sodium chloride diluent from 36 months to 60 months and shelf life of sodium bicarbonate diluent from 36 months to 48 months. | 16th April 2024 |
94 | Ondansetron hydrochloride (EMITINO - 8 INJECTION) | Cachet Pharmaceuticals Private Ltd. | Extension of the shelf life of finished pharmaceutical product from 24 months to 36 months. | 26th March 2024 |
95 | Clindamycin Palmitate (DALACIN C®) | Pfizer Laboratories Ltd. | Correction of the storage conditions for the drug product to align with the currently registered label information i.e., from Store below 30°C to store below 25°C and reduction of shelf life From 36 months to 24 months. | 7th March 2024 |
96 | Diclofenac Sodium (OLFEN® - 75 SR) | Acino Pharma AG | Reduction of FPP shelf life from 60 months to 36 months | 26th February 2024 |
97 | Dolutegravir Sodium Lamivudine Tenofovir Disoproxil fumarate. | Lupin Limited | Extension of shelf - life from 24 months to 36 months. | 13th February 2024 |
98 | Indomethacin (INDOCAP®-25) | Abacus Pharma (Africa) Limited | Change in the labelled storage conditions from "store in a cool dry place below 25°C, protect from sunlight" to Store in a cool dry place below 30°C, Protect from sunlight. | 24th January 2024 |
99 | Lansoprazole + Tinidazole + Clarithromycin (PYLO KIT®) | Cipla Limited | Change in the composition of an immediate - release solid oral dosage form including deletion of excipients (Isopropyl alcohol) | 4th January 2024 |
100 | Oxytetracycline hydrochloride (TETROXY LA®) | Bimeda Chemical Export | Extension of shelf life from 24 months to 36 months | 4th January 2024 |
101 | Change in storage conditions from "Do not store above 25°C" to "Store below 30°C. Protect from sunlight". | 6th December 2023 | ||
102 | Human Insulin of Recombinant DNA origin (GENSULIN®) | Biotin S.A -Macierzysz | Change in the manufacturing process of insulin drug substance involving removal of triton X-100 from the manufacturing process. | 7th November 2023 |
103 | Sodium Valporate (Controlled release) (VALCONTIN 200®) | Modi - Mundipharma Private Limited | Addition of the following indications; Mania/Bipolar and for prophylaxis of migraine to the indication in epilepsy. | 7th November 2023 |
104 | Update od safety information in the SmPC from section 4 to 9. | 19th October 2023 | ||
105 | Azithromycin (ZITHRIN®) | Renata Limited | Extension of FPP shelf life from 24 months to 36 months. | 7th November 2023 |
106 | Clopidogrel Bisulfate (ANTIPLEX®) | Dar Al Dawa Development and Investment Co.Ltd. | Extension of FPP shelf life from 24 months to 36 months. | 2nd November 2023 |
107 | Tramadol Hydrichloride (RAMGIC®) | MSN Laboratories Private Limited | Extension of FPP shelf life from 24 months to 36 months. | 19th October 2023 |
108 | Sodium Valproate Controlled Release (Valcontin®) | Modi Mundipharma Pvt. Ltd | Addition of the following indications: In Mania/Bipolar; Prophylaxis of Migraine | 12th October 2023 |
109 | Nebivolol hydrochloride + Hydrochlorothiazide (Nebilet®) | Menarini International Operations Luxembourg S.A | Update to Sections 4.4 and 4.8 of the SmPC and section 2 of the PIL; Warnings and precautions to include; Non-melanoma skin cancer and choroidal effusion, acute myopia and secondary anfle-closure glaucoma. | 4th October 2023 |
110 | Amlodipine | Novartis Pharma Services Inc | Update to section 4.9 of the SmPC to include a write up on overdose that manifests as non-cardiogenic pulmonary oedema. | 28th September 2023 |
111 | Artemether + Lumefantrine (Coartem®) | Novartis Pharma Services Inc | Route of administration added on primary packaging | 22nd September 2023 |
112 | Amoxicillin+ Clavulanic Acid (Augmentin®, Clavulin®) | Glaxosmithkline Pharmaceutical Kenya Limited | Addition of drug induced enterocolitis to the section of warnings and precautions and adverse reactions. Addition of linear IgA disease adverse reactions section. Addition of information of the intreaction of penicillins and methotrexate under the section of interactions. | 22nd September 2023 |
113 | Human Albumin (Albunorm®) | Octapharma Ag. | Update of SmPC and PIL to include a warning on sodium in Albunorm 20% | 28th August 2023 |
114 | Bedaquiline Fumarate (Sirturo®) | Janssen-Cilag International Nv | Update of section 4.6 of the SmPC in order to update information on breast-feeding based on new literature. | 18th August 2023 |
115 | Polio virus; (Mahoney) type 1-inactive+(MEF-1) type 2-inactive + (saukett) tyoe 3 inactive | Sanofi Aventis South Africa Pty Ltd | SmPC update: Syncope (fainting) can occur following, or even before, any vaccination as a psychogenic response to the needle injection. Procedures should be put in plaace to prevent any injury due to fainting and to manage syncopal reactions. PIL Update: Fainting can occur following, or even before any needle injection. Also, talk to your doctor or nurse if you or your child has fainted during a previous injection. | |
116 | Empaglifozin+Metformin hydrochloride (Flozicard XR 10 mg/100mg®) | Cipla Ltd | Change of product name from Empaglifozin and Metformin hydrochloride extended-release tablets 10 mg/1000 mg to Flozicard XR 10 mg/1000 mg | |
117 | Cabotegravir (Apretude®) | Glaxosmithkline Pharmaceutical Kenya Limited | Addition of hypersensitivity to adverse reactions, warnings and precautions. | |
118 | Human Insulin (Humulin Mixture®) | Lily France SA | Addition of cutaneous amyloidosis and lipodystrophy information. Addition of hyperglycaemia and hypoglycaemia information related to site of injections. | |
119 | Betamethasone disodium phosphate + Betamethasone dipropionate (Diprofos®) | MSD (Pty) Ltd | Update: Studies have shown an increased risk of neonatal hypoglycaemia following antenatal administration of a short course of betamethasone to women at risk for late preterm delivery. Update: Phaeochromocytoma crisis, which can be fatal, has been reported after administration of systemic corticosteroids. Corticosteroids should only be administered to patients with suspected or identified phaeochromocytom after an appropriate risk/benefit evaluation. | |
120 | Darunavir (Prezista®) | Janssen Ortho LLC | Crystal neuropathy added to adverse reactions. | |
121 | Oxytocin Acetate (Oxytocin 10 IU®) | Minapharm Pharmaceutical& Chemical Industries | Removal of subcutaneous as a route of administration. | |
122 | Ebola Zaire vaccine (Ervebo®) | MSD (Pty) Ltd | Extension to the existing indication of ervebo vaccine to include vaccination of infants aged 1 year and older. | 16th August 2023 |
123 | Desloratadine (Aeriallerg®) | Pharma International Co. Ltd | Weight increase and increased appetite added to list of possible side effects. | 9th August 2023 |
124 | 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. | 3rd August 2-23 |
125 | Isoflurane (Isotroy®) | Troikaa Pharmaceuticals Limited | In precautions: Added a section for paediatric use to include the warning on paediatric neurotoxicity. | |
126 | 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. | |
127 | 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. | |
128 | 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. | |
129 | 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". | |
130 | 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). | |
131 | 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. | |
132 | 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. | 3rd August 2023 |
133 | 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. | 3rd August 2023 |
134 | Desloratadine (Aerius®) | MSD (Pty) Ltd | Change in the summary of product characteristics and patient information leaflet of Aerius to include depressed mood and eye dryness with a frequency of “unknown” in sections 4.8 (undesirable effect) of the SmPC and section 4 (Possible side effects) of the PIL. | |
135 | Rivaroxaban (Xarelto®) | Bayer Healthcare Ag | To add a new ADR (‘eosinophilic pneumonia) with the frequency ‘very rare’ to the SmPC/PIL due to new pharmacovigilance data. | |
136 | Carbamazepine (Tegretol®) | Novartis Pharma Services Inc | Update to SmPC and PIL as follows: Section 6: Warnings and precautions: Addition of angioedema and anaphylaxis under hypersensitivity reactions. Section 8: Interactions: Addition of biviracetam under agents that may raise the active metabolite carbamazepine-10, 11-epoxide plasma levels. Section 9: Pregnancy, lactation, females and males of reproductive potential: addition of risk of neurodevelopmental disorders among children exposed to carbamazepine during pregnancy. | 3rd August 2022 |
137 | Diclofenac sodium (Diclo-denk®) | Denk Pharma GmbH & Co. Kg | Addition of a warning that the product contains lactose to the folding box. | 29th July 2022 |
138 | Sodium valproate Ph, Eur (Epilim®) | Sanofi Winthrop Industries | Update of section 5.3 in the SmpC to indicate the potential for impairment of fertility in males from non-clinical data (exposure in adults and juveniles). | 29th July 2022 |
139 | Fexinidazole (Fexinidazole Winthrop®) | Sanofi Aventis Kenya Limited | Update of PIL and SmPC to add suicidal ideation to the neuropsychiatric adverse reactions in section 4.8. · Reinforcement of warnings and widening of contraindication “diabetic ketoacidosis” to “any type of metabolic acidosis”. · New details on interaction between Metformin and OCT ½ substrates/inhibitors. | 14th July 2023 |
140 | Rituximab (Rilast®) | Hetero Labs Limited | Pemphigus Vulgaris (PV) has been added as a new therapeutic indication to Rilast 100. | 6th July 2023 |
141 | Diclofenac sodium (Diclodyne®) suppository | Bliss Gvs Pharma Ltd | Change in brand name from Diclodyne to Lofnac-100 | |
142 | Diatrizoic acid (Urografin®) | Bayer East Africa Ltd | Additional information on thyroid dysfunction has been added to the special warnings and precautions as follows: It is necessary to carry out a careful benefit/risk assessment, especially in patients with diagnosed or suspected hyperthyroidism or goitre, as iodinated contrast media can interfere with thyroid function or aggravate or induce hyperthyroidism and thyroid storm. | |
143 | Fexinidazole Winthrop | Sanofi Aventis Kenya Limited | Update of Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL) to include warnings and precaution that cases of severe irreversible hepatotoxicity/acute liver failure have been reported in patients with Cockayne syndrome. | |
144 | Dihydroartemisinin + Piperaquine 40/320 (Ridmal®) | Ajanta Pharma Limited | Revision of dosage instructions by body weight as per updates to the reference product (D-Artepp) as follows: | 6th July 2023 |
145 | Body weight (kg) Daily dose (mg) Total tablets | |||
146 | 11 to less than 17 One 40/320 mg tablet per day 3 | 6th July 2023 | ||
147 | 17 to less than 25 One and a half 40/320 mg tablets per day 4.5 | |||
148 | 25 to less than 36 Two 40/320 mg tablets per day 6 | |||
149 | 36 to less than 60 Three 40/320 mg tablets per day 9 | |||
150 | 60 to less than 80 Four 40/320 tablets per day 12 | 6th July 2023 | ||
151 | Over 80 Five 40/320 tablets a day 15 | 30th June 2023 | ||
152 | Candesartan+Hydrochlorothiazide (Atacand® Plus) | Astra Zeneca Ab | Update of SmPC/PI sections; 4.4 Special warnings and precautions,4.8 Undesirable effects to include: Acute respiratory distress syndrome (ARDS): Very rare severe cases of ARDS have been reported after taking hydrochlorothiazide. Pulmonary oedema usually develops within minutes to hours after hydrochlorothiazide intake. | 30th June 2023 |
153 | Dapaglifozin (Forxiga®) | Astrazeneca UK Limited | Addition of indication: Treatment of heart failure in adults as a result of DELIVER study. Addition of a Lithium drug-drug interaction in section 4.4. | 30th June 2023 |
154 | Metformin (Glucophage®) 500 mg | Merck (Pty) Ltd | Update of SmPC and PIL to include: | |
155 | · Lifting of contraindication: chronic heart failure | |||
156 | · Lifting of contraindication: moderate renal impairment | 15th June 2022 | ||
157 | · Lifting of contraindication: concomitant use with iodinated contrast materials | 14th June 2022 | ||
158 | · Removal of interaction with ACE inhibitors. | 10th June 2022 | ||
159 | · Initiation of treatment in patients with CKD stage 3b (previously not recommended). | 8th June 2022 | ||
160 | · Reinforcement of warnings and widening of contraindication “diabetic ketoacidosis” to “any type of metabolic acidosis”. | 1st June 2022 | ||
161 | · New details on interaction between Metformin and OCT ½ substrates/inhibitors. | 27th May 2022 | ||
162 | Bisoprolol hemifumarate (Concor-5®) | Merck (Pty) Ltd | Update of SmpC and PIL to include a rare but possible side effect i.e. skin and subcutaneous tissue hypersensitivity reactions can occur presenting with (itching, temporary flush, rash and angioedema). | 25th May 2022 |
163 | Ceftriaxone (Vaxcel®) 500 mg | Kotra Pharma SDN | Updates to sections on pregnancy and lactation [Ceftriaxone crosses the placental barrier. Safety in human pregnancy has not been established. Low concentrations of Ceftriaxone excreted in human milk, caution should be exercised when Ceftriaxone is administered to a nursing woman] | 28th April 2022 |
164 | Use in paediatric populations: Studies have shown that Ceftriaxone, like some other cephalosporins, can displace bilirubin from serum albumin. Therefore, caution should be exercised when considering Ceftriaxine treatment in hyperbilirubinaemia in neonates. Ceftriaxone should not be used in neonates (especially premature) at risk of developing bilirubin encephalopathy. During prolonged treatment, the blood profile should be checked at regular intervals. | 26th April 2022 | ||
165 | Caution in individuals hypersensitive to penicillins: Serious and occasionally fatal hypersensitivity reactions have been reported in patients receiving therapy with beta-lactams. Before initiating therapy with Ceftriaxone, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporinbs, carbapenems or other beta lactams. If an allergic reaction occurs, Ceftriaxone MUST be discontinued and appropriate alternative therapy instituted. | 22nd March 2022 | ||
166 | Amlodipine besilate (Amlo®) | GETZ Pharma (Pvt) Limited | Change in brand name from Amlo to Lopicard 10 mg | 18th March 2022 |
167 | Vitamin B1+B2+B6+Niacinamide (Vitamin B Complex®) | Rene Industries Limited | Change of product name from vitamin B complex to Becoren tablets | 15th March 2022 |
168 | Acetyl salicylic acid (Aspirin tablets®) | Rene Industries Limited | Change of product name from Aspirin tablets to Aspiren tablets | 15th March 2022 |
169 | Ibuprofen 400 mg (Ibuprofen Denk®) | Denk Pharma Gmbh & Company Kg | Safety signal: Ibuprofen; ketoprofen; and fixed-dose combinations – serious exacerbation of infections. | 10th March 2022 |
170 | Cyclosporin (Neoral®) | Novartis Kenya Limited | · Addition of caution related to effect on driving and using machines | 24th February 2022 |
171 | · Addition of Drug-Drug interactions with mycophenolate mofetil and eltrombopag | 24th February 2022 | ||
172 | · Addition of maximum human dose as per current standards. | 9th February 2022 | ||
173 | 31st January 2022 | |||
174 | Paracetamol (Tamin®) | Elda International DMCC | Updates to 4.4.and 4.5 i.e. interactions with other drugs to include a caution when paracetamol is concomitantly administered with Flucloxacillin – it causes an increased risk of HAGMA (high anion gap metabolic acidosis), particularly in patients at risk (renal impairment, sepsis, malnutrition, those using the maximum daily dose and other sources of glutathione deficiency (including chronic alcoholism). | 31st January 2022 |
175 | Recommendation: Close monitoring, including measurement of urinary 5-oxoproline. | 19th January 2022 | ||
176 | Diphenhydramine HCl+Ammonium Chlroide+Codeine phosphate (Benylin® with Codeine) | Johnson&Johnson Pty Ltd | · Dosage made more restrictive – only indicated for adults now. | 19th January 2022 |
177 | · Risk of death in ultra-rapid metabolizers of codeine is included. | |||
178 | · Interactions: CNS depressants may cause additive CNS and respiratory depression. | |||
179 | · Effects on ability to drive made more explicit. | |||
180 | Esomeprazole (as Magnesium trihydrate) (Nexium®) | Astrazeneca UK Limited | New information under sections of special warnings: a potential side effect, DRESS (Drug Rash with Eosinophilia and Systemic Symptoms) has been added. | |
181 | Sevoflurane | Piramal Enterprises Ltd | Change of product name from Sevoflurane 250 ml to Sojourn 250 ml | |
182 | Ephedrine hydrochloride (Ephedrine Aguettant®) | Laboratoire Aguettant | Addition of Takatsubo syndrome as an undesirable effect. | |
183 | Rilpirivine (Edurant®) | Janssen-Cilag International N.V | · Deletion of warning on fat redistribution. | |
184 | · Deletion of statement on the use of contraception in women of childbearing potential. | |||
185 | ||||
186 | Levoplant (Levonogestrel) | Pharm Access Africa Ltd | PIL and SmPC updated to replace an incorrectly listed common undesirable effect from “a viral infection called chikungunya” to “viral infection” and include contact information for ADR reporting. | |
187 | Rivaroxaban (Xarelto) | Bayer East Africa Ltd | Dosage and method of administration: In patients after a successful revascularisation procedure of the lower limb (surgical or endovascular including hybrid procedures) due to symptomatic PAD, treatment should not be started until haemostasis is achieved, For patients who are unable to swallow whole tablets, Xarelto tablet may be crushed and mixed with water or apple puree immediately prior to use and administered orally.The crushed tablet may also be given through gastric tubes Special warnings and precautions for use: Patients with malignant disease may simultaneously be at higher risk of bleeding and thrombosis. The individual benefit of antithrombotic treatment should be weighed against risk for bleeding in patients with active cancer dependent on tumour location, antineoplastic therapy and stage of disease. Tumours located in the gastrointestinal or genitourinary tract have been associated with an increased risk of bleeding during rivaroxaban therapy. In patients with malignant neoplasms at high risk of bleeding, the use of rivaroxaban is contraindicated Undesirable effects, Overdose, Pharmacokinetic properties, Shelf life and Special precautions for disposal: Rivaroxaban tablets may be crushed and suspended in 50 mL of water and administered via a nasogastric tube or gastric feeding tube after confirming gastric placement of the tube. Afterwards, the tube should be flushed with water. Since rivaroxaban absorption is dependent on the site of active substance release, administration of rivaroxaban distal to the stomach should be avoided, as this can result in reduced absorption and thereby, reduced active substance exposure. Enteral feeding is not required immediately after administration of the 2.5 mg tablets | |
188 | Levonogestrel (Mirena) | Bayer East Africa Ltd | Dosage and method of administration, Warnings/precautions, Fertility, pregnancy and lactation, Undesirable effects and Pharmacodynamic properties | |
189 | Vidagliptin/Metformin (Galvus Met) | Norvatis | Section 7 updated with the post marketing adverse drug reaction of cutaneous vasculitis with a frequency of “unknown”. | |
190 | Dapivirine (DapiRing) | International Partnership for Microbicides | •A description of what a normal Dapivirine Vaginal Ring looks like and what to do if the ring is damaged or broken or looks different to what is expected. • An instruction that the Dapivirine Vaginal Ring should only be inserted into the vagina. • The Dapivirine Vaginal Ring may only protect from HIV-1 during vaginal sex and does not protect from HIV-1 infection during anal sex or other forms of sexual contact as well as other ways of becoming infected with HIV (e.g., sharing needles when using recreational drugs). • The Dapivirine Vaginal Ring does not protect a man from getting HIV-1 infected. | |
191 | Etonogestrel (Implanon NXT) | MSD (Pty) Ltd | Label update to reflect PRAC mandated change regarding “suicidality”, New images and instructions for insertion and removal of the implant and Alignment of PIL and SmPC regarding patient age. | |
192 | 5-Fluorouracil | Sandoz GMBH Kenya | Contraindications: Due to the potentially mutagenic and carcinogenic effect, increased safety rules apply to nursing personnel and physicians. Pregnant personnel is to be excluded from handling fluorouracil. Special warnings and precautions for use: Stress cardiomyopathy (takotsubo syndrome) added to cardiotoxic effects. Cardiac function should be regularly monitored during treatment with fluorouracil. Pregnancy and lactation: Women of childbearing potential should be advised to avoid becoming pregnant and use an effective method of contraception during treatment with fluorouracil and at least 6 months afterwards. If the drug is used during pregnancy, or if the patient becomes pregnant while taking the drug, the patient should be fully informed of the potential hazard to the foetus and genetic counselling is recommended. Fluorouracil should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.Fertility: Men treated with fluorouracil are advised not to father a child during and for up to 3 months following cessation of treatment. and Undesirable side effects updated to include: Pneumatosis intestinalis, Lactic acidosis and Cutaneous lupus erythematosus (Frequency: Not known). | |
193 | Medroxyprogesterone acetate (Triclofem) | Mission Pharma A/S | Alignment of SmPC with WHO PAR - Therapeutic Indications: Triclofem is used for long-term contraception in women aged over 18 years. It can also be used for short-term contraception to cover specific periods when: the woman’s male partner is awaiting vasectomy to become effective. Posology and administration: Triclofem is given intramuscularly every 12 weeks. Contraindications: Triclofem must not be used in case the woman: has hypersensitivity to medroxyprogesterone acetate or to any of the excipients, is pregnant, has hormone-dependent malignancy of breast or genital organs, has undiagnosed abnormal uterine bleeding, has a history of severe hepatic disease and liver function tests have not returned to normal, has significant hypertension (systolic pressure of 160 mmHg or higher, diastolic pressure of 100 mmHg or higher), has had diabetes for longer than 20 years or has complications of the disease (circulatory, renal, nervous or ophthalmic). | |
194 | Metformin (Glucophage) | Merck Pty Ltd | Expansion of indication to prevent Type 2 Diabetes Mellitus in patients with prediabetes and at least one additional risk factor – second line to lifestyle changes, Lifting of contraindication in heart failure, Lifting of contraindication in moderate renal failure, Lifting of contraindication against concomitant use with iodinated contrast materials, Initiation of treatment in patients with CKD stage 3b (previously not recommended), Reinforcement of warnings and widening of contraindication from “diabetic ketoacidosis” to “any type of metabolic acidosis” (such as fatty acidosis, diabetic ketoacidosis) and New details on interaction between Metformin and Organic Cation ½ Transporter substrates/inhibitors. | |
195 | Efavirenz (Stocrin) | MSD (Pty) Ltd | Update of drug interaction between metamizole and efavirenz. | |
196 | Anastrozole (Arimidex) | Astrazeneca UK Limited | Included depression and osteoporosis as adverse reactions under the undesirable effects section. | |
197 | Candesartan + Hydrochlorothiazide (Atacand Plus) | Astrazeneca UK Limited | Included additional warning related to non-melanoma skin cancer. | |
198 | Hydroxycarbamide (Hydroxyurea) | Sandoz GMBH Kenya | Update of undesirable effects to include haemolytic anaemia. | |
199 | Magnesium hydroxide + Aluminium hydroxide + Simethicone (Maalox Plus) | Sanofi Aventis Kenya Limited | Update to section 4.5 on interactions with other medicinal products and other forms of interaction and section 2.6: fertility, pregnancy and lactation. | |
200 | Raltegravir (Isentress) | MSD (PTY) Limited | Update of precautions and warnings to include advice to wait at least two hours between taking iron salts and taking Isentress, as these medicines may reduce Isentress efficacy. | |
201 | Dapirivine (Dapiring) | IPM South Africa NPC | Data on antiviral activity of Dapirivine on hepatitis E virus | |
202 | Elvitegravir+Cobistat+Emtricitabine+Tenofovir alafenamide | Gilead Sciences Inc | Drug-drug interactions between cobistat containing products and cutaneously administered products. | |
203 | Ticagrelor (Brilinta) | Astrazeneca Sweden | Updates to sections 4.4 and 4.8 | |
204 | Dapaglifozin (Forxiga) | Astra Zeneca Sweden) | Section on undesirable effects updated to add Fournier’s gangrene as a very rare adverse reaction. | |
205 | Diclofenac potassium (Voltaren and Cataflam products) | Novartis Pharma Services Inc | Update to section 09: Women of child bearing potential, pregnancy, breastfeeding and fertility to include the risk of fetal renal impairment with subsequent oligohydramnios when NSAIDS are used from week 20 of pregnancy onwards. | |
206 | Dihydrostreptomycin sulphate+Penicillin G monohydrate (Pen & Strep) | Norbrook Laboratories Limited | Update of storage conditions to include “Use the product within 2 months when removed from the refrigerator. |