S/NProduct NameLicence HolderSummary of Approved ChangesDate of NDA Approval
1Sodium 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.6th December 2023
2Diclofenac 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.7th November 2023
3Azithromycin 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.7th November 2023
4Desloratadine (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.19th October 2023
5Rivaroxaban (Xarelto®)Bayer Healthcare AgTo add a new ADR (‘eosinophilic pneumonia) with the frequency ‘very rare’ to the SmPC/PIL due to new pharmacovigilance data.7th November 2023
6Carbamazepine (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.2nd November 2023
7Diclofenac sodium (Diclo-denk®)Denk Pharma GmbH & Co. KgAddition of a warning that the product contains lactose to the folding box.19th October 2023
8Sodium 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).12th October 2023
9Fexinidazole (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.4th October 2023
10Rituximab (Rilast®)Hetero Labs LimitedPemphigus Vulgaris (PV) has been added as a new therapeutic indication to Rilast 100. 28th September 2023
11Diclofenac sodium (Diclodyne®) suppositoryBliss Gvs Pharma LtdChange in brand name from Diclodyne to Lofnac-10022nd September 2023
12Diatrizoic 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.22nd September 2023
13Fexinidazole 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.28th August 2023
14Dihydroartemisinin + Piperaquine 40/320 (Ridmal®)Ajanta Pharma LimitedRevision of dosage instructions by body weight as per updates to the reference product (D-Artepp) as follows: 18th August 2023
15Body weight (kg) Daily dose (mg) Total tablets
1611 to less than 17 One 40/320 mg tablet per day 3
1717 to less than 25 One and a half 40/320 mg tablets per day 4.5
1825 to less than 36 Two 40/320 mg tablets per day 6
1936 to less than 60 Three 40/320 mg tablets per day 9
2060 to less than 80 Four 40/320 tablets per day 12
21Over 80 Five 40/320 tablets a day 15
22Candesartan+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.16th August 2023
23Dapaglifozin (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 4.4.9th August 2023
24Metformin (Glucophage®) 500 mgMerck (Pty) LtdUpdate of SmPC and PIL to include:3rd August 2-23
25·        Lifting of contraindication: chronic heart failure
26·        Lifting of contraindication: moderate renal impairment
27·        Lifting of contraindication: concomitant use with iodinated contrast materials
28·        Removal of interaction with ACE inhibitors.
29·        Initiation of treatment in patients with CKD stage 3b (previously not recommended).
30·        Reinforcement of warnings and widening of contraindication “diabetic ketoacidosis” to “any type of metabolic acidosis”.
31·        New details on interaction between Metformin and OCT ½ substrates/inhibitors.
32 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).3rd August 2023
33Ceftriaxone (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] 3rd August 2023
34Use 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.
35Caution 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.
36Amlodipine besilate (Amlo®)GETZ Pharma (Pvt) LimitedChange in brand name from Amlo to Lopicard 10 mg3rd August 2022
37Vitamin B1+B2+B6+Niacinamide (Vitamin B Complex®)Rene Industries LimitedChange of product name from vitamin B complex to Becoren tablets29th July 2022
38Acetyl salicylic acid (Aspirin tablets®)Rene Industries LimitedChange of product name from Aspirin tablets to Aspiren tablets29th July 2022
39Ibuprofen 400 mg (Ibuprofen Denk®)Denk Pharma Gmbh & Company KgSafety signal: Ibuprofen; ketoprofen; and fixed-dose combinations – serious exacerbation of infections. 14th July 2023
40Cyclosporin (Neoral®)Novartis Kenya Limited·        Addition of caution related to effect on driving and using machines6th July 2023
41·        Addition of Drug-Drug interactions with mycophenolate mofetil and eltrombopag
42·        Addition of maximum human dose as per current standards.
44Paracetamol (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).6th July 2023
45Recommendation: Close monitoring, including measurement of urinary 5-oxoproline.
46Diphenhydramine HCl+Ammonium Chlroide+Codeine phosphate (Benylin® with Codeine)Johnson&Johnson Pty Ltd·        Dosage made more restrictive – only indicated for adults now.6th July 2023
47·        Risk of death in ultra-rapid metabolizers of codeine is included.
48·        Interactions: CNS depressants may cause additive CNS and respiratory depression.
49·        Effects on ability to drive made more explicit.
50Esomeprazole (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.6th July 2023
51SevofluranePiramal Enterprises LtdChange of product name from Sevoflurane 250 ml to Sojourn 250 ml30th June 2023
52Ephedrine hydrochloride (Ephedrine Aguettant®)Laboratoire AguettantAddition of Takatsubo syndrome as an undesirable effect.30th June 2023
53Rilpirivine (Edurant®) Janssen-Cilag International N.V·        Deletion of warning on fat redistribution.30th June 2023
54·        Deletion of statement on the use of contraception in women of childbearing potential.
56Levoplant (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.15th June 2022
57Rivaroxaban (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
14th June 2022
58Levonogestrel (Mirena)Bayer East Africa LtdDosage and method of administration, Warnings/precautions, Fertility, pregnancy and lactation, Undesirable effects and Pharmacodynamic properties 10th June 2022
59Vidagliptin/Metformin (Galvus Met)NorvatisSection 7 updated with the post marketing adverse drug reaction of cutaneous vasculitis with a frequency of “unknown”.8th June 2022
60Dapivirine (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.1st June 2022
61Etonogestrel (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.27th May 2022
625-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).25th May 2022
63Medroxyprogesterone 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).28th April 2022
64Metformin (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.26th April 2022
65Efavirenz (Stocrin)MSD (Pty) LtdUpdate of drug interaction between metamizole and efavirenz.22nd March 2022
66Anastrozole (Arimidex)Astrazeneca UK LimitedIncluded depression and osteoporosis as adverse reactions under the undesirable effects section.18th March 2022
67Candesartan + Hydrochlorothiazide (Atacand Plus)Astrazeneca UK LimitedIncluded additional warning related to non-melanoma skin cancer.15th March 2022
68Hydroxycarbamide (Hydroxyurea)Sandoz GMBH KenyaUpdate of undesirable effects to include haemolytic anaemia.15th March 2022
69Magnesium 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.10th March 2022
70Raltegravir (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.24th February 2022
71Dapirivine (Dapiring)IPM South Africa NPCData on antiviral activity of Dapirivine on hepatitis E virus24th February 2022
72Elvitegravir+Cobistat+Emtricitabine+Tenofovir alafenamideGilead Sciences IncDrug-drug interactions between cobistat containing products and cutaneously administered products.9th February 2022
73Ticagrelor (Brilinta)Astrazeneca SwedenUpdates to sections 4.4 and 4.831st January 2022
74Dapaglifozin (Forxiga)Astra Zeneca Sweden)Section on undesirable effects updated to add Fournier’s gangrene as a very rare adverse reaction.31st January 2022
75Diclofenac 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.19th January 2022
76Dihydrostreptomycin 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.19th January 2022