S/NProduct NameLicence HolderSummary of Approved ChangesDate of NDA Approval
1Goserelin acetate (Zoladexla®)Astra Zeneca UK LtdAddition of a new indication i.e. management of oestrogen-receptor (ER) positive early and advanced breast cancer in pre- and perimenopausal women.13th December 2022
2Dolutegravir + Abacavir + Lamivudine (Triumeq®)GlaxoSmithKline Pharmaceutical Kenya Ltd.Update of SmPC to include human transfer of dolutegravir via placenta and breast milk.13th December 2022
3Tamoxifen (Novadex®)Astra Zeneca UK LtdA warning on toxic epidermal necrolysis and a risk of exacerbation of hereditary angioedema with tamoxifen. The adverse reaction of 'Depression' and 'toxic epidermal necrolysis' with a frequency of rare and exacerbation of hereditary angioedema with a frequency of not known under section 4.8.13th December 2022
4Insulin Lispro (Humalog®)Eli Lilly Export S.AAdditional text regarding patients not sharing needles, information on reporting of adverse drug reactions; replacing information regarding use of Humalog with a pump infusion set.25th November 2022
5Zolendronic acid (Zometa®)Norvatis Pharma Services IncThe infertility section was updated to clarify that fertility is decreased in rats dosed subcutaneously with 0.01 mg/kg/day of zolendronic acid. There are no data available in humans.17th November 2022
6Dolutegravir Sodium+Rilpirivine Hydrochloride (Juluca®)GlaxoSmithKline Pharmaceutical Kenya Ltd.Update 1: TSC 3-Sections: Pregnancy and Lactation - Update to include human data on transfer of DTG via placenta and breast milk based on the population pharmacokinetic analysis of the DolPHIN-1 study. Dolutegravir readily crosses the placenta in humans. In HIV infected pregnant women, the median (range) of foetal umbilical cord concentrations of dolutegravir were 1.28 (1.21 to 1.28) fold greater compared with maternal peripheral plasma concentrations. There is insufficient information on the effects of dolutegravir on neonates.17th November 2022
7Zinc chloride + denatured alcohol menthol 95% + thymol (Tartar Control Listerine® AntisepticJohnson & Johnson Pty LtdSection 4.6: Fertility, pregnancy and lactation: There are no adequate and well-controlled studies in pregnant women. However, because with recommended use only small volumes of Tartar Control Listerine® Antiseptic would be expected to be swallowed, it is considered unlikely that the recommended use of Tartar Control Listerine® Antiseptic will present a risk to the pregnant woman or foetus. It is not known whether Tartar Control Listerine® Antiseptic is excreted in human breast milk. However because with recommended use only small volumes would be expected to be swallowed, it is considered unlikely that the recommended use will present a risk to the infant.14th November 2022
8Desloratadine (Aerius®)MSD (Pty) LtdUpdate of section 4.8 of the SmPC to reflect increased incidence of new onset seizure in patients 0 to 19 years.3rd November 2022
9Tramadol hydrochloride + Paracetamol (Tramapa Fort®)Ferrer International4.4. Special warnings and precautions for use: Sleep related breathing disorders - Opioids can cause sleep-related breathing disorders including central sleep apnoea (CSA) and sleep-related hypoxemia. Opioid use increases the risk of CSA in a dose dependent fashion. In patients who present with CSA, consider decreasing the total opioid dosage.3rd November 2022
10Clopidogrel (Clopidogrel Norvatis Access®)Sandoz NVS KenyaSmPC and PIL update for section 4.4; "Special warnings and precautions for use" following update of the same to the innovator product.20th October 2022
11Levonogestrel (Mirena®)Bayer East Africa LtdUpdate of the paragraph on expulsion in section 4.4 (special warning and precaution for use ) of Mirena SmPC with respect to factors associated with an increased risk of expulsion.20th October 2022
12Capecitabine (Sandoz® Capecitabine)Sandoz GMBH KenyaUpdate of core data sheet to include angioedema among the adverse drug reactions under section 4.8.19th October 2022
13Loperamide HCL (Imodium®)Janssen-Cilag Pharmaceutical (Pty) LtdOverdose: Upon cessation, cases of drug withdrawal syndrome have been observed in individuals abusing, misusing or intentionally overdosing with excessively large doses of Loperamide.14th October 2022
14Dolutegravir sodium (Tivicay®)GlaxoSmithKline Pharmaceutical Kenya Ltd.Update of safety information to include human data on transfer of DTG via placenta and breast milk based on the population pharmacokinetic analysis of the DolPHIN-1 study in sections; before you (take/use), product, pregnancy and lactation and ATC code update.5th October 2022
15Darunavir (Prezista®)Janssen-Cilag Pharmaceutical (Pty) LtdSmPC Section 4.5 update: Added text to address co-administration of cutaneously administered corticosteroids sensitive to CYP3A inhibition.3rd October 2022
16Iopromide (Ultravist®)Bayer East Africa LimitedSCARS added to undesirable side effects. Severe cutaneous adverse reactions (SCARs) including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalised exanthematous pustulosis (AGEP), which can be life-threatening of fatal, exfoliative dermatitis, Stevens-Johnson syndrome (SJS), have been reported with unknown frequency in association with iopromide administration.

Patients should be advised of the signs and symptoms and monitored closely for skin reactions.
In children, the initial presentation of a rash can be mistaken for an infection, and physicians should consider the possibility of a reaction to iopromide in children that develop signs of rash and fever.

Most of these reactions occurred within 8 weeks (AGEP 1-12 days, DRESS 2-8 weeks, SJS/TEN 5 days up to 8 weeks).
If the patient has developed a serious reaction such as SJS, TEN, AGEP or DRESS with the use of iopromide, iopromide must not be readministered in this patient at any time.
21st September 2022
17Nebivolol hydrochloride (Nebilet®)A.Menarini Manufacturing Logistics and ServicesUrticaria has been added to the list of undesirable side effects. An additional statement that preclinical and clinical evidence in hypertensive patients has not shown that nebivolol has a detrimental effect on erectile function.12th September 2022
18Clarithromycin (Cleron 500®)Delorbis Pharmaceuticals LimitedA warning that use of any antimicrobial therapy, such as clarithromycin, to treat H. pylori infection may select for drug-resistant organisms.9th September 2022
19Dapaglifozin (Forxiga®)Astra Zeneca Ab-Se-151 85 Sode-taljeUpdate and revision of the prescribing information to include modified posology for chronic kidney disease and update to special population section to include clarification regarding renal impairment.1st September 2022
20Ceftriaxone sodium (Ceftriaxone sandoz®)Novartis Pharma Services IncUpdate of section 4.8: Undesirable effects: Hepatitis and hepatitis cholestatic have been added as new adverse drug reactions.31st August 2022
21Dihydroartemisinin+Piperaquine phosphate (Dpiriv®)Royal Pharma 2011 LimitedChange of product name from Dpiriv 90/720 to Rolxin 90/720 with subsequent change in pack label and design.3rd August 2022
22Amlodipine besilate (Amlo®)GETZ Pharma (Pvt) LimitedChange in brand name from Amlo to Lopicard 10 mg3rd August 2022
23Vitamin B1+B2+B6+Niacinamide (Vitamin B Complex®)Rene Industries LimitedChange of product name from vitamin B complex to Becoren tablets29th July 2022
24Acetyl salicylic acid (Aspirin tablets®)Rene Industries LimitedChange of product name from Aspirin tablets to Aspiren tablets29th July 2022
25Levoplant (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
26Rivaroxaban (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
27Levonogestrel (Mirena)Bayer East Africa LtdDosage and method of administration, Warnings/precautions, Fertility, pregnancy and lactation, Undesirable effects and Pharmacodynamic properties 10th June 2022
28Vidagliptin/Metformin (Galvus Met)NorvatisSection 7 updated with the post marketing adverse drug reaction of cutaneous vasculitis with a frequency of “unknown”.8th June 2022
29Dapivirine (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
30Etonogestrel (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
315-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
32Medroxyprogesterone 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
33Metformin (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
34Efavirenz (Stocrin)MSD (Pty) LtdUpdate of drug interaction between metamizole and efavirenz.22nd March 2022
35Anastrozole (Arimidex)Astrazeneca UK LimitedIncluded depression and osteoporosis as adverse reactions under the undesirable effects section.18th March 2022
36Candesartan + Hydrochlorothiazide (Atacand Plus)Astrazeneca UK LimitedIncluded additional warning related to non-melanoma skin cancer.15th March 2022
37Hydroxycarbamide (Hydroxyurea)Sandoz GMBH KenyaUpdate of undesirable effects to include haemolytic anaemia.15th March 2022
38Magnesium 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
39Raltegravir (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
40Dapirivine (Dapiring)IPM South Africa NPCData on antiviral activity of Dapirivine on hepatitis E virus24th February 2022
41Elvitegravir+Cobistat+Emtricitabine+Tenofovir alafenamideGilead Sciences IncDrug-drug interactions between cobistat containing products and cutaneously administered products.9th February 2022
42Ticagrelor (Brilinta)Astrazeneca SwedenUpdates to sections 4.4 and 4.831st January 2022
43Dapaglifozin (Forxiga)Astra Zeneca Sweden)Section on undesirable effects updated to add Fournier’s gangrene as a very rare adverse reaction.31st January 2022
44Diclofenac 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
45Dihydrostreptomycin 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