S/NProduct NameLicence HolderSummary of Approved ChangesDate of NDA Approval
1(TRIUMEQ®)
2DapagliflozinAstrazeneca 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.
4Vildagliptin/MetforminNorvatis Pharma AGUpdate 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
6EtravirineJanssen-Cilag International NVChange in the SmPc labelling, or package leaflet due to the following safety concerns that are approved by the EU;18th March 2025
7(INTELENCE)BELGIUM1.     In section 4.4 Special warnings and precautions for use – Removal of the disease information relating to sexual transmission of HIV
82.     In section 4.6 Fertility , pregnancy and lactation – Amendment of the section related to breast feeding.
9VidagliptinNorvartis AGUpdate to the SmPc in section 7 to include a post marketing ADR “Cholecystitis” with frequency “Not Known”.18th March 2025
10(VIDAGLIPTIN®KENYA
11
12Dolutegravir SodiumVIIV 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.
16Dolutegravir Sodium + Rilpivirine HydrochlorideVIIV 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.
20Triploridine HCL/ Pseudoephedrine/GuaiphenisinGlaxosmithkline 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
22FexinidazoleSanofi – 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 rhodensiense6th February 2025
23(FEXINIDAZOLE WINTHROP®)
24FinerenoneBayer 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.
262.     Addition of hyperuricaemia as a common undesirable effect.
273.     Additional primary and secondary time- to – event endpoints.
28BevacizumabF. Hoffmann La-RocheClarification of the warning and precautions: Hypersensitivity reactions/infusion reactions to include anaphylactic shock.21st February 2025
29(AVASTIN®)SWITZERLAND
30Dolutegravir + Abacavir + LamivudineVIIV 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
31Sanofi – 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 rhodensiense6th February 202531st December 2024
3231st December 2024
33Bayer 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
341.     Inclusion of study results for renal and cardiovascular events.20th December 2024
352.     Addition of hyperuricaemia as a common undesirable effect.20th December 2024
363.     Additional primary and secondary time- to – event endpoints.18th December 2024
37F. Hoffmann La-RocheClarification of the warning and precautions: Hypersensitivity reactions/infusion reactions to include anaphylactic shock.21st February 202518th December 2024
38SWITZERLAND17th November 2024
39VIIV 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 202511th December 2024
4011th December 2024
41Astrazeneca UK Ltd.1.     Addition of treatment of heart failure in adult’s indication as a result of the DELIVER study.10th March 202511th December 2024
422.     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.
43Norvatis Pharma AGUpdate to the SmPc in section 7 ( Adverse drug reaction) to include a post marketing ADR “Cholectstitis” with frequency “Not Known”14th March 2025
44KENYA
45Janssen-Cilag International NVChange in the SmPc labelling, or package leaflet due to the following safety concerns that are approved by the EU;18th March 2025
46BELGIUM1.     In section 4.4 Special warnings and precautions for use – Removal of the disease information relating to sexual transmission of HIV11th December 2024
472.     In section 4.6 Fertility , pregnancy and lactation – Amendment of the section related to breast feeding.11th December 2024
48Norvartis AGUpdate to the SmPc in section 7 to include a post marketing ADR “Cholecystitis” with frequency “Not Known”.18th March 2025
49KENYA
5011th December 2024
51VIIV 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
55VIIV 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 202512th 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
59Glaxosmithkline 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 202505th December 2024
60KENYA05th December 2024
61Amoxicillin + potassium clavulanate (DAFRACLAV®)Dafra Pharma GMBG Muhlenberg7 4052 Basel, SWITZERLANDAddition of an API (Pottassium Clavulanate, diluted)05th December 2024
62Terbinafine Hydrochloride (TERBINAFORCE 250®)Mankind Pharma LimitedExtension of Finished Pharmaceutical Product shelf- life from 24 months to 36 months05th December 2024
63Algicic acid + Magnesium Hydroxide + Alminium Hydroxide + Magnesium trisilicate _ Simeticone (ULGICID® (CHERRY FLAVOUR)Prisma Pharma FZEShelf- life extension from 24 months to 29 months05th December 2024
64Esometrazole (NEXIUM 40 ®)Astrazeneca UK LimitedExtension of Finished Pharmaceutical Product shelf- life from 24 months to 30 months02nd December 2024
65Ciprofloxacin (BACTIFLOX NEO 500®)Acino Pharma AGChange in the SmPC and the PIL resulting from adaptation to the originator and safety signal of the fluoroquinolones update02nd December 2024
66SevofluranePiramal Enterprises LtdChange of product name from Sevoflurane to Sojourn28th November 2024
67Misoprostol (MISOCLEAR®)Pharm Access Africa Ltd.Extension of Finished Pharmaceutical Product shelf- life from 24 months to 30 months14th November 2024
68Diclofenac sodium (DTNAPAR AQ® 1ML)Troikaa Pharmaceuticles LimitedExtension of shelf life of Dynapar AQ from 24 months to 36 months28th November 2024
69Cefuroxime Sodium (CEFUZIME 750®)Gulf Pharmaceutical IndustriesChange 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
70Chloramphenicol PalmitateAbacus Pharma (Africa) LimitedChange 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 months4th December 2024
71Amoxicillin + Clavulanic Acid (CLAVULIN® ) Glaxosmithkline Pharmaceutical Kenya LtdChange in product information including;
72Addition of details on drug induced enterocolitis to the section of warnings and precautions, and under the section of adverse drug reactions.30th October 2024
73Addition of linear IgA disease to the ADR section30th October 2024
74Addition of cross reference under skin reactions in the section of ADRs.
75Addition of information on the interaction of penicillins and methotrexate under the section of interactions.30th October 2024
76Acetyl salicylic acid (ASPIRIN®)Royal Pharma 2011 limitedReduction of FPP shelf life from 36 months to 24 months28th October 2024
77Amoxicillin + Clavulanic Acid (CLAVULIN® 1G and 625 MG)Glaxosmithkline Pharmaceutical Kenya LtdSubmission of an updated version for the prescribing information involving;25th October 2024
78Addition of symmetrical drug - related intertriginous and flexural exanthema (SDRIFE) also known as baboon syndrome as a new ADR.25th June 2024
79Conversion 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
80Amoxicillin + Clavulanic Acid (AUGMENTIN®)Glaxosmithkline Pharmaceutical Kenya LtdAddition of symmetrical drug - related intertriginous and flexural exanthema (SDRIFE) also known as baboon syndrome as a new ADR.25th June 2024
81Conversion 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
82Dolutegravir Sodium Tablet for Oral Suspension (Dispersible Tablets) 10 MGMacleods Pharmaceuticals LtdExtension of FPP shelf life from 24 months to 36 months.14th June 2024
83Diclofenac 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
84Levonorgestrel (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
85Aflibercept (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
86Rosuvastatin 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
87Dapoxetine Hydrochloride (ANDOPOXETINE® 60MG)Al Andalous for Pharmaceutical Industries.Extension of shelf life for the FPP from 24 months to 36 months.7th June 2024
88Moxifloxacin Hydrochloride 400mg (AVELOX®)Bayer East Africa Ltd.Extension of shelf- life for the FPP from 48 months to 60 months.5th June 2024
89Amoxicillin + Clavulanic Acid (MAGNABIOTIC®)Wide Spectrum Enterorises (U) Ltd.Addition of sterile water for injection as a diluent in the pack.24th May 2024
90MebendazoleAbacus Pharma (Africa) Limitedchange 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
91Alfuzosin Hydrochoride (PROSTALEN®)Exphar saExtension of shelf life for FPP from 24 months to 36 months)13th May 2024
92Atracurium (TROYCURIUM)Troikaa Pharmaceuticles LimitedExtension of shelf life the FPP from 18 months to 24 months)30th April 2024
93Artesunate (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
94Ondansetron 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
95Clindamycin 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
96Diclofenac Sodium (OLFEN® - 75 SR)Acino Pharma AGReduction of FPP shelf life from 60 months to 36 months26th February 2024
97Dolutegravir Sodium Lamivudine Tenofovir Disoproxil fumarate.Lupin LimitedExtension of shelf - life from 24 months to 36 months.13th February 2024
98Indomethacin (INDOCAP®-25)Abacus Pharma (Africa) LimitedChange 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
99Lansoprazole + Tinidazole + Clarithromycin (PYLO KIT®)Cipla LimitedChange in the composition of an immediate - release solid oral dosage form including deletion of excipients (Isopropyl alcohol)4th January 2024
100Oxytetracycline hydrochloride (TETROXY LA®)Bimeda Chemical ExportExtension of shelf life from 24 months to 36 months4th January 2024
101Change in storage conditions from "Do not store above 25°C" to "Store below 30°C. Protect from sunlight".6th December 2023
102Human Insulin of Recombinant DNA origin (GENSULIN®)Biotin S.A -MacierzyszChange in the manufacturing process of insulin drug substance involving removal of triton X-100 from the manufacturing process.7th November 2023
103Sodium Valporate (Controlled release) (VALCONTIN 200®)Modi - Mundipharma Private LimitedAddition of the following indications; Mania/Bipolar and for prophylaxis of migraine to the indication in epilepsy.7th November 2023
104Update od safety information in the SmPC from section 4 to 9.19th October 2023
105Azithromycin (ZITHRIN®)Renata LimitedExtension of FPP shelf life from 24 months to 36 months.7th November 2023
106Clopidogrel Bisulfate (ANTIPLEX®)Dar Al Dawa Development and Investment Co.Ltd.Extension of FPP shelf life from 24 months to 36 months.2nd November 2023
107Tramadol Hydrichloride (RAMGIC®)MSN Laboratories Private LimitedExtension of FPP shelf life from 24 months to 36 months.19th October 2023
108Sodium Valproate Controlled Release (Valcontin®)Modi Mundipharma Pvt. LtdAddition of the following indications: In Mania/Bipolar; Prophylaxis of Migraine12th October 2023
109Nebivolol hydrochloride + Hydrochlorothiazide (Nebilet®)Menarini International Operations Luxembourg S.AUpdate 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
110Amlodipine Novartis Pharma Services IncUpdate to section 4.9 of the SmPC to include a write up on overdose that manifests as non-cardiogenic pulmonary oedema.28th September 2023
111Artemether + Lumefantrine (Coartem®)Novartis Pharma Services IncRoute of administration added on primary packaging22nd September 2023
112Amoxicillin+ Clavulanic Acid (Augmentin®, Clavulin®)Glaxosmithkline Pharmaceutical Kenya LimitedAddition 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
113Human Albumin (Albunorm®)Octapharma Ag.Update of SmPC and PIL to include a warning on sodium in Albunorm 20%28th August 2023
114Bedaquiline Fumarate (Sirturo®)Janssen-Cilag International NvUpdate of section 4.6 of the SmPC in order to update information on breast-feeding based on new literature.18th August 2023
115Polio virus; (Mahoney) type 1-inactive+(MEF-1) type 2-inactive + (saukett) tyoe 3 inactive Sanofi Aventis South Africa Pty LtdSmPC 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.
116Empaglifozin+Metformin hydrochloride (Flozicard XR 10 mg/100mg®)Cipla LtdChange of product name from Empaglifozin and Metformin hydrochloride extended-release tablets 10 mg/1000 mg to Flozicard XR 10 mg/1000 mg
117Cabotegravir (Apretude®)Glaxosmithkline Pharmaceutical Kenya LimitedAddition of hypersensitivity to adverse reactions, warnings and precautions.
118Human Insulin (Humulin Mixture®)Lily France SAAddition of cutaneous amyloidosis and lipodystrophy information. Addition of hyperglycaemia and hypoglycaemia information related to site of injections.
119Betamethasone disodium phosphate + Betamethasone dipropionate (Diprofos®)MSD (Pty) LtdUpdate: 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.
120Darunavir (Prezista®)Janssen Ortho LLCCrystal neuropathy added to adverse reactions.
121Oxytocin Acetate (Oxytocin 10 IU®)Minapharm Pharmaceutical& Chemical IndustriesRemoval of subcutaneous as a route of administration.
122Ebola Zaire vaccine (Ervebo®)MSD (Pty) LtdExtension to the existing indication of ervebo vaccine to include vaccination of infants aged 1 year and older.16th August 2023
123Desloratadine (Aeriallerg®)Pharma International Co. LtdWeight increase and increased appetite added to list of possible side effects.9th August 2023
124Trimethoprim + Sulfamethoxazole (Septrin®)Beta Healthcare International LtdAddition 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
125Isoflurane (Isotroy®)Troikaa Pharmaceuticals LimitedIn precautions: Added a section for paediatric use to include the warning on paediatric neurotoxicity.
126Paracetamol (Infulgan®)Yuria-Pharm Llc Manufacturing SiteUpdate of PIL and SmPC in the following sections: warnings and precautions, taking or using other medicines, pregnancy and possible side effects.
127Tadalafil (Titanafil 5®)Acino AGUpdate to SmPC and PIL involving: Exclusion of the indication for urinary symptoms associated with a common condition called benign prostatic hyperplasia.
128Amlodipine (Amlodipine 5 mg tablets)Novartis Pharma Services IncUpdate 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.
129Etonogestrel (Implanon NXT®)Organon South Africa (Pty) LtdUndesirable 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".
130Ibuprofen + Pseudoephedrine HCL (Sinutab 3-way®)Johnson & Johnson Pty LtdUpdate 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).
131Sodium valproate Ph. Eur. (Epilim Chrono®)Sanofi Aventis Kenya LimitedUpdate of Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL) to include potential for reproductive toxicity following exposure to valproate in childhood.
132Diclofenac sodium (Diclo-denk®)Denk Pharma Gmbh &Co KgUpdate 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
133Azithromycin monohydrate (Azithro-denk®)Denk Pharma Gmnh & Co KgUpdate 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
134Desloratadine (Aerius®)MSD (Pty) LtdChange 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.
135Rivaroxaban (Xarelto®)Bayer Healthcare AgTo add a new ADR (‘eosinophilic pneumonia) with the frequency ‘very rare’ to the SmPC/PIL due to new pharmacovigilance data.
136Carbamazepine (Tegretol®)Novartis Pharma Services IncUpdate 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
137Diclofenac sodium (Diclo-denk®)Denk Pharma GmbH & Co. KgAddition of a warning that the product contains lactose to the folding box.29th July 2022
138Sodium valproate Ph, Eur (Epilim®)Sanofi Winthrop IndustriesUpdate 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
139Fexinidazole (Fexinidazole Winthrop®)Sanofi Aventis Kenya LimitedUpdate 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
140Rituximab (Rilast®)Hetero Labs LimitedPemphigus Vulgaris (PV) has been added as a new therapeutic indication to Rilast 100. 6th July 2023
141Diclofenac sodium (Diclodyne®) suppositoryBliss Gvs Pharma LtdChange in brand name from Diclodyne to Lofnac-100
142Diatrizoic acid (Urografin®)Bayer East Africa LtdAdditional 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.
143Fexinidazole Winthrop Sanofi Aventis Kenya LimitedUpdate 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.
144Dihydroartemisinin + Piperaquine 40/320 (Ridmal®)Ajanta Pharma LimitedRevision of dosage instructions by body weight as per updates to the reference product (D-Artepp) as follows: 6th July 2023
145Body weight (kg) Daily dose (mg) Total tablets
14611 to less than 17 One 40/320 mg tablet per day 36th July 2023
14717 to less than 25 One and a half 40/320 mg tablets per day 4.5
14825 to less than 36 Two 40/320 mg tablets per day 6
14936 to less than 60 Three 40/320 mg tablets per day 9
15060 to less than 80 Four 40/320 tablets per day 126th July 2023
151Over 80 Five 40/320 tablets a day 1530th June 2023
152Candesartan+Hydrochlorothiazide (Atacand® Plus)Astra Zeneca AbUpdate 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
153Dapaglifozin (Forxiga®)Astrazeneca UK LimitedAddition 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
154Metformin (Glucophage®) 500 mgMerck (Pty) LtdUpdate of SmPC and PIL to include:
155·        Lifting of contraindication: chronic heart failure
156·        Lifting of contraindication: moderate renal impairment15th June 2022
157·        Lifting of contraindication: concomitant use with iodinated contrast materials14th 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) LtdUpdate 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
163Ceftriaxone (Vaxcel®) 500 mgKotra Pharma SDNUpdates 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
164Use 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
165Caution 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
166Amlodipine besilate (Amlo®)GETZ Pharma (Pvt) LimitedChange in brand name from Amlo to Lopicard 10 mg18th March 2022
167Vitamin B1+B2+B6+Niacinamide (Vitamin B Complex®)Rene Industries LimitedChange of product name from vitamin B complex to Becoren tablets15th March 2022
168Acetyl salicylic acid (Aspirin tablets®)Rene Industries LimitedChange of product name from Aspirin tablets to Aspiren tablets15th March 2022
169Ibuprofen 400 mg (Ibuprofen Denk®)Denk Pharma Gmbh & Company KgSafety signal: Ibuprofen; ketoprofen; and fixed-dose combinations – serious exacerbation of infections. 10th March 2022
170Cyclosporin (Neoral®)Novartis Kenya Limited·        Addition of caution related to effect on driving and using machines24th February 2022
171·        Addition of Drug-Drug interactions with mycophenolate mofetil and eltrombopag24th February 2022
172·        Addition of maximum human dose as per current standards.9th February 2022
17331st January 2022
174Paracetamol (Tamin®)Elda International DMCCUpdates 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
175Recommendation: Close monitoring, including measurement of urinary 5-oxoproline.19th January 2022
176Diphenhydramine 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.
180Esomeprazole (as Magnesium trihydrate) (Nexium®)Astrazeneca UK LimitedNew information under sections of special warnings: a potential side effect, DRESS (Drug Rash with Eosinophilia and Systemic Symptoms) has been added.
181SevofluranePiramal Enterprises LtdChange of product name from Sevoflurane 250 ml to Sojourn 250 ml
182Ephedrine hydrochloride (Ephedrine Aguettant®)Laboratoire AguettantAddition of Takatsubo syndrome as an undesirable effect.
183Rilpirivine (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
186Levoplant (Levonogestrel)Pharm Access Africa LtdPIL 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.
187Rivaroxaban (Xarelto)Bayer East Africa LtdDosage 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
188Levonogestrel (Mirena)Bayer East Africa LtdDosage and method of administration, Warnings/precautions, Fertility, pregnancy and lactation, Undesirable effects and Pharmacodynamic properties
189Vidagliptin/Metformin (Galvus Met)NorvatisSection 7 updated with the post marketing adverse drug reaction of cutaneous vasculitis with a frequency of “unknown”.
190Dapivirine (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.
191Etonogestrel (Implanon NXT)MSD (Pty) LtdLabel 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.
1925-FluorouracilSandoz GMBH KenyaContraindications: 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).
193Medroxyprogesterone acetate (Triclofem)Mission Pharma A/SAlignment 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).
194Metformin (Glucophage)Merck Pty LtdExpansion 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.
195Efavirenz (Stocrin)MSD (Pty) LtdUpdate of drug interaction between metamizole and efavirenz.
196Anastrozole (Arimidex)Astrazeneca UK LimitedIncluded depression and osteoporosis as adverse reactions under the undesirable effects section.
197Candesartan + Hydrochlorothiazide (Atacand Plus)Astrazeneca UK LimitedIncluded additional warning related to non-melanoma skin cancer.
198Hydroxycarbamide (Hydroxyurea)Sandoz GMBH KenyaUpdate of undesirable effects to include haemolytic anaemia.
199Magnesium hydroxide + Aluminium hydroxide + Simethicone (Maalox Plus)Sanofi Aventis Kenya LimitedUpdate to section 4.5 on interactions with other medicinal products and other forms of interaction and section 2.6: fertility, pregnancy and lactation.
200Raltegravir (Isentress)MSD (PTY) LimitedUpdate 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.
201Dapirivine (Dapiring)IPM South Africa NPCData on antiviral activity of Dapirivine on hepatitis E virus
202Elvitegravir+Cobistat+Emtricitabine+Tenofovir alafenamideGilead Sciences IncDrug-drug interactions between cobistat containing products and cutaneously administered products.
203Ticagrelor (Brilinta)Astrazeneca SwedenUpdates to sections 4.4 and 4.8
204Dapaglifozin (Forxiga)Astra Zeneca Sweden)Section on undesirable effects updated to add Fournier’s gangrene as a very rare adverse reaction.
205Diclofenac potassium (Voltaren and Cataflam products)Novartis Pharma Services IncUpdate 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.
206Dihydrostreptomycin sulphate+Penicillin G monohydrate (Pen & Strep)Norbrook Laboratories LimitedUpdate of storage conditions to include “Use the product within 2 months when removed from the refrigerator.