Product NameLicence HolderSummary of Approved ChangesDate of NDA Approval
Dolutegravir sodium (Tivicay®)Glaxosmithkline Pharmaceutical Kenya LtdThe frequency of the adverse event of increased weight has been revised from uncommon (one in a thousand) to common (one in a hundred).23rd June 2023
Maraviroc (Celsentri®)Glaxosmithkline Pharmaceutical Kenya LtdUnder the warning and precautions section, the transmission risk statement has been removed to reflect current information.22nd June 2023
Dolutegravir sodium (Tivicay®)Glaxosmithkline Pharmaceutical Kenya LtdUpdate to the pregnancy and lactation sections of the Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL) of Tivicay to include new information following the DolPHIN-1 study, that DTG (within Tivicay) can be transferred via placenta and breast milk.21st June 2023
Dapaglifozin (Forxiga®)Astrazeneca Pharmaceuticals LpUpdate to the section on special warnings and precautions for use - Chronic kidney disease: There is no experience with dapagliflozin for the treatment of chronic kidney disease in patients without diabetes who do not have albuminuria.20th June 2023
Abacavir sulfate + Lamivudine (Kivexa®)Glaxo Operations UK LtdExcipients - KIVEXA tablets contain sunset yellow Aluminium lake (E110) which may cause allergic type reactions.16th June 2023
Dolutegravir 50 mg/Rilpivirine 25 mg (Juluca®)GlaxoSmithKline Pharmaceutical Kenya LtdAdverse drug reactions: The frequency of occurenece of the event of weight gain has been revised from uncommon (1 in 1000) to common (1 in 100)16th June 2023
Diclofenac sodium (Voltaren®)Norvatis Pharma Stein AgUpdate to section 9: Pregnancy, lactation, females and males of reproductive potential: If an NSAID is necessary from the 20th week gestation to the end of the 2nd trimester, limit the use to the lowest effective dose and shortest duration possible. If Voltaren treatment extends beyond 48 hours, consider monitoring with ultrasound for oligohydroamnios. If oligohydroamnios occurs, discontinue Voltaren and follow up according to clinical practice.16th June 2023
Dolutegravir sodium (Tivicay® 5 mg)Glaxosmithkline Pharmaceutical Kenya LtdUpdate to adverse reactions section: The frequency of the weight increase event has been revised from uncommon to common. Text on transmissibility of HIV whiole using Tivicay has been removed.16th June 2023
Dolutegravir/Rilpivirine 50 mg/25 mg (Juluca®)Glaxosmithkline Pharmaceutical Kenya LtdRemoval of transmission of HIV infection text. Update of frequency of weight gain from uncommon to common.16th June 2023
Amoxicillin+Clavulanic acid (Augmentin®/Clavulin®/Amoxil®)Glaxosmithkline Pharmaceutical Kenya LtdAddition of a warning statement related to Kounis syndrome as a new adverse drug reaction. [Hypersensitivity reactions can also progress to Kounis syndrome, a serious allergic reaction that can result in myocardial infarction. Presenting symptoms of such reactions can include chest pain in association with an allergic reaction to Augmentin). Amendment to indication terminology to add AECOPD.14th June 2023
Gabogola® syrupGabogola AgenciesRevised the indication to "helps in relief of cough and sore throat". Deleted whooping cough and bronchitis as indications. Product use restricted to children 5 years and above. Botanical name corrected to Mangifera indica.8th June 2023
Multi-ingredient (Vitaglobin® syrup)Health care LtdChange of brand name from Vitaglobin syrup to Vitaforte syrup.7th June 2023
Esomeprazole (Nexium®)Astrazeneca UK LimitedUpdate to special warnings and precautions for use to include a potential side effect - DRESS (Drug rash with eosinophilia and systemic symptoms).7th June 2023
Raltegravir potassium (Isentress®)MSD (Pty) Ltd.Update to precautions and warnings to include "Iron salts (to treat and prevent iron deficiency anaemia). You should wait at least two hours between taking iron salts and taking Isentress as these medicines may reduce Isentress efficacy."2nd June 2023
Fosfomycintrometamol (Fosmol®)Pharma Bavaria Internacional (PBI)Fosfomycin given into a vein should now only be used for treating certain serious infections such as those affecting the heart, lungs, blood and brain or those that are difficult to treat such as complicated infections of the abdomen, urinary tract, bone, joint or of the skin and soft tissue.
Fosfomycin, for use by mouth, can continue to be used for treating uncomplicated cystitis in women and adolescent girls. Fosfomycin granules (which contain fosfomycin trometamol) can also continue to be used in men undergoing biopsy of the prostate.
Intramuscular fosfomycin and fosfomycin granules for children (2 g) are suspended as there is no clear evidence that they are sufficiently effective for their currently authorised uses.		1st June 2023
Diminaene aceturate + Antipyrine + Vitamin B12 (Piroplasmin®)Vapco (Veterinary & Agricultural Products Manufacturing Company Ltd)Addition of the statement "Toxic to Camels" on the product label and outer carton.1st June 2023
Fluconazole (Fucol®)Cipla Limited Addition of QR code for patients to access summary of product characteristics electronically.1st June 2023
Domperidone (Motilium®)Janssen-Cilag-Domaine De MaigremontWarnings: Motilium is not suitable for use among children weighing less than 35 kg. The efficacy of domperidone has not been demonstrated in children less than or equal to 12 years of age.25th May 2023
Pantoprazole + Domperidone (Pentariv-D®)Royal Pharma 2011 Limited Product name has cahnged from Pentariv-D to Pan-D25th May 2023
AmoxicillinSinopharm Weiqida Pharmaceutical Co,. LtdChange of product name from Amoxicillin to Gulamox4th May 2023
Bedaquiline fumarate (Sirturo®)Janssen-Cilag International NvAddition of dose recommendations to include approved bedaquiline-containing drug regimens.11th May 2023
Guaifenesin (Benylin® wet cough)Johnson&Johnson Pty LtdThe manufacturers have added a patient information leaflet containin g the professional information in lay man's terms as required by other regulators.11th May 2023
Human Insulin (Actrapid®, Insulatard®, Mixtard®)Novo Nordisk A/SUse of second generation Achromobacter Lyticus Protease (2G ALP) enzyme which is produced without raw materials of animal origin in the manufacture of drug substance without compromising product quality27th March 2023
Desogestrel/Ethinyl estradiol (Marvelon®)N.V. Organon-Kloosterstraat 6. 5349 AB OSSIn patients treated with glecaprevir/pibrentasvir, elevated ALT was observed in women using ethinylestradiol-containing medications such as Combined Hormonal Contraceptives27th March 2023
Sodium valproate (Epilim Chrono®)Sanofi Aventis KenyaIn children requiring doses higher than 40 mg/kg/day, clinical chemistry and haematological parameters should be monitored. In the pregnancy section, the following update was made: Available data suggest that anti-epileptic polytherapy including valproate shows an increased risk of major congenital malformations and neuro-developmental disorders in both valproate monotherapy and polytherapy compared to the population not exposed to valproate. 24th March 2023
Sodium valproate (Epilim 200®)Sanofi Aventis Kenya24th March 2023
Artemether + Lumefantrine (Glumac®)Shanghai Fosun Pharmaceutical Development Co. LtdPregnancy
During the first three months of pregnancy use Glumac Dispersible Tablets only with medical advice. Later in pregnancy Glumac Dispersible Tablets can be used.
Breast-feeding
The actives of Glumac Dispersible Tablets appear in low amounts in human milk, but at therapeutic doses no effects on the breast-fed baby are anticipated. Glumac Dispersible Tablets can be used during breast-feeding.
Fertility
There is no information on the effects of Glumac Dispersible Tablets on fertility in humans. 		24th March 2023
Insulin detemir (Levemir Flexpen®)Novo NordiskUse of second generation Achromobacter Lyticus Protease (2G ALP) enzyme which is produced without raw materials of animal origin and used in the manufacture of drug substance.10th March 2023
Montelukast sodium(Denk-air®)Denk PharmaEnuresis has been added as an uncommon undesirable effect among children using this medicine.6th March 2023
Zolendronic acid (Zometa®)Norvatis Pharma Services IncUnder the section: Pregnancy, lactation, females and males of reproductive potential: Infertility – a correction was made in the lowest dose tested in rats where impact to fertility was observed from 0.1 mg/kg/day to 0.01 mg/kg/day.3rd March 2023
AnastrozoleNVS KenyaDepression has been added as a common side effect in the system organ class of psychiatric disorders, under the undesirable effects section.21st February 2023
Diphenhydramine hydrochloride (Benylin®) Johnson & JohnsonThe instruction "should not be used among children 2 years and below" hasd been revised to "should not be used among children below 6 years of age". maximum of four doses per
day should not be exceeded.
The dosage instructions have been revised to: Children 6 to 12 years:
Two 5 ml medicine
measures (10 ml) every 3 hours.
Children below 6 years of age:
Not recommended		17th February 2023
Artemether+Lumefantrine (Lumartem®)Quality Chemical Industries LimitedDecreased appetite (very common=more than 1/10), angioedema (unknown frequency), gait disturbance (common = less than 1/100, more than 1/10)) and insomnia (common= less than 1/100, more than 1/10) added to the list of undesirable effects.17th February 2023
Mebendazole (Vermox®)Johnson&JohnsonA study indicated a possible relationship between SJS/TEN and the concomitant use of VERMOX® 500 mg and metronidazole. Further data on interactions are not available. Therefore, concomitant use of VERMOX®500 mg and metronidazole should be avoided. Patients with high parasitic burdens when treated with VERMOX® 500 mg have manifested diarrhea and abdominal pain.15th February 2023
Human insulin (Mixtard 30®)Novo NordiskUse of second generation Achromobacter Lyticus Protease (2G ALP) enzyme which is produced without raw materials of animal origin and used in the manufacture of drug substance.15th February 2023
Cephalexin monohydrate (Axcel Cephalexin®)Abacus PharmaSerious and occasionally fatal hypersensitivity reactions (including anaphylactoid and severe cutaneous adverse reactions) have been reported in patients receiving therapy with beta-lactams. Before initiating therapy with Axcel Cephalexin Capsule, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, carbapenems or other beta-lactam agents. If an allergic
reaction occurs, Axcel Cephalexin Capsule must be discontinued immediately and appropriate alternative therapy instituted.		15th February 2023
Insulin aspart (Novomix®) Novo NordiskUse of second generation Achromobacter Lyticus Protease (2G ALP) enzyme which is produced without raw materials of animal origin and used in the manufacture of drug substance.9th February 2023
Human insulin (Actrapid®)Novo Nordisk Pharma-Novo AlleUse of second generation Achromobacter Lyticus Protease (2G ALP) enzyme which is produced without raw materials of animal origin and used in the manufacture of drug substance.31st January 2023
Isophane insulin (human) (Insulatard®)Novo NordiskAddition of the text below under Skin and
subcutaneous tissue disorders: Patients must
be instructed to perform continuous
rotation of the injection site to reduce the
risk of developing lipodystrophy and
cutaneous amyloidosis		31st January 2023
Insulin detemir (Levemir®)Novo NordiskUse of second generation Achromobacter Lyticus Protease (2G ALP) enzyme which is produced without raw materials of animal origin and used in the manufacture of drug substance.31st January 2023
Insulin aspart (Novorapid®)Novo NordiskUse of second generation Achromobacter Lyticus Protease (2G ALP) enzyme which is produced without raw materials of animal origin and used in the manufacture of drug substance.31st January 2023
Sevoflurane (Ultane®)Abbvie Pty LtdThe package insert has been updated under the section of warnings and special precautions to include "the occurrence of bradycardia in patients with Down Syndrome"23rd January 2023
Diclofenac sodium (Diclac®)NVS KenyaDiclofenac systemic formulations:
Changes were made to Section 9: Pregnancy, lactation, females and males of reproductive potential to align with the PLLR (Pregnancy Labelling Lactation Rule) format. Within the PLLR changes, the following recommendations related to dosage and monitoring are considered as safety related and mandatory for implementation.
“If an NSAID is necessary from the 20th week gestation to the end of the 2nd trimester, limit the use to the lowest effective dose and shortest duration possible (see section 4 Dosage regimen and administration). If Voltaren treatment extends beyond 48 hours, consider monitoring with ultrasound for oligohydramnios. If oligohydramnios occurs, discontinue Voltaren and follow up according to clinical practice”.		20th January 2023
Artemether Lumefantrine (Lumartem®)Cipla LtdDecreased appetite (very common=more than 1/10), angioedema (unknown frequency), gait disturbance (common = less than 1/100, more than 1/10)) and insomnia (common= less than 1/100, more than 1/10) added to the list of undesirable effects.17th January 2023
Goserelin 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
Dolutegravir + Abacavir + Lamivudine (Triumeq®)GlaxoSmithKline Pharmaceutical Kenya Ltd.Update of SmPC to include human transfer of dolutegravir via placenta and breast milk.13th December 2022
Tamoxifen (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
Insulin 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
Zolendronic 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
Dolutegravir 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
Zinc 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
Desloratadine (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
Tramadol 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
Clopidogrel (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
Levonogestrel (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
Capecitabine (Sandoz® Capecitabine)Sandoz GMBH KenyaUpdate of core data sheet to include angioedema among the adverse drug reactions under section 4.8.19th October 2022
Loperamide 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
Dolutegravir 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
Darunavir (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
Iopromide (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
Nebivolol 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
Clarithromycin (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
Dapaglifozin (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
Ceftriaxone 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
Dihydroartemisinin+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
Amlodipine besilate (Amlo®)GETZ Pharma (Pvt) LimitedChange in brand name from Amlo to Lopicard 10 mg3rd August 2022
Vitamin B1+B2+B6+Niacinamide (Vitamin B Complex®)Rene Industries LimitedChange of product name from vitamin B complex to Becoren tablets29th July 2022
Acetyl salicylic acid (Aspirin tablets®)Rene Industries LimitedChange of product name from Aspirin tablets to Aspiren tablets29th July 2022
Levoplant (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
Rivaroxaban (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
Levonogestrel (Mirena)Bayer East Africa LtdDosage and method of administration, Warnings/precautions, Fertility, pregnancy and lactation, Undesirable effects and Pharmacodynamic properties 10th June 2022
Vidagliptin/Metformin (Galvus Met)NorvatisSection 7 updated with the post marketing adverse drug reaction of cutaneous vasculitis with a frequency of “unknown”.8th June 2022
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.1st June 2022
Etonogestrel (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
5-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
Medroxyprogesterone 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
Metformin (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
Efavirenz (Stocrin)MSD (Pty) LtdUpdate of drug interaction between metamizole and efavirenz.22nd March 2022
Anastrozole (Arimidex)Astrazeneca UK LimitedIncluded depression and osteoporosis as adverse reactions under the undesirable effects section.18th March 2022
Candesartan + Hydrochlorothiazide (Atacand Plus)Astrazeneca UK LimitedIncluded additional warning related to non-melanoma skin cancer.15th March 2022
Hydroxycarbamide (Hydroxyurea)Sandoz GMBH KenyaUpdate of undesirable effects to include haemolytic anaemia.15th March 2022
Magnesium 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
Raltegravir (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
Dapirivine (Dapiring)IPM South Africa NPCData on antiviral activity of Dapirivine on hepatitis E virus24th February 2022
Elvitegravir+Cobistat+Emtricitabine+Tenofovir alafenamideGilead Sciences IncDrug-drug interactions between cobistat containing products and cutaneously administered products.9th February 2022
Ticagrelor (Brilinta)Astrazeneca SwedenUpdates to sections 4.4 and 4.831st January 2022
Dapaglifozin (Forxiga)Astra Zeneca Sweden)Section on undesirable effects updated to add Fournier’s gangrene as a very rare adverse reaction.31st January 2022
Diclofenac 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
Dihydrostreptomycin 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