| Product Name | Licence Holder | Summary of Approved Changes | Date of Approval |
|---|---|---|---|
| Galvus Met | Norvatis | Section 7 updated with the post marketing adverse drug reaction of cutaneous vasculitis with a frequency of unknown. | 8th June 2022 |
| 5-Fluorouracil | Sandoz GMBH Kenya | Contraindications | 25th May 2022 |
| Special warnings and precautions for use | |||
| Fertility, pregnancy and lactation | |||
| Undesirable side effects. | |||
| Dapiring | International Partnership for Microbicides | Change of Patient Information Leaflet according to EMA recommendations to include Clinical Study Report Version 2.0. | 1st June 2022 |
| Glucophage | Merck Pty Ltd | Expansion of indication to prevent Type 2 Diabetes Mellitus in patients with prediabetes and at least one additional risk factor second line to lifestyle changes. | 26th April 2022 |
| Lifting of contraindication in heart failure. | |||
| Lifting of contraindication in moderate renal failure. | |||
| Lifting of contraindication on contraindication for 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). | |||
| New details on interaction between Metformin and Organic Cation ½ Transporter substrates/inhibitors. | |||
| Implanon NXT | MSD (Pty) Ltd | Label update to reflect PRAC mandated change regarding suicidality. | 27th May 2022 |
| New images and instructions for insertion and removal of the implant. | |||
| Alignment of PIL and SmPC regarding patient age. | |||
| Levoplant | Pharm Access Africa Ltd | PIL and SmPC updated to replace an incorrectly listed common undesirable effect from a viral infection called chikungunya to viral infection and include contact information for ADR reporting. | 15th June 2022 |
| Mirena | Bayer East Africa Ltd | Dosage and method of administration | 10th June 2022 |
| Warnings/precautions | |||
| Fertility, pregnancy and lactation | |||
| Undesirable effects | |||
| Pharmacodynamic properties | |||
| Pharmacokinetic properties | |||
| Triclofem | Mission Pharma A/S | Alignment of SmPC with WHO PAR | 28th April 2022 |
| Xarelto | Bayer East | Dosage and method of administration | 14th June 2022 |
| Africa Ltd | Special warnings and precautions for use | ||
| Undesirable effcets | |||
| Overdose | |||
| Pharmacokinetic properties | |||
| Shelf life | |||
| Special precautions for disposal |
| S/N | Product Name | Licence Holder | Summary of Approved Changes | Date of Approval |
|---|---|---|---|---|
| 1 | Efavirenz (Stocrin) | MSD (Pty) Ltd | Update of drug interaction between metamizole and efavirenz. | 22nd March 2022 |
| 2 | Anastrozole (Arimidex) | Astrazeneca UK Limited | Included depression and osteoporosis as adverse reactions under the undesirable effects section. | 18th March 2022 |
| 3 | Candesartan + Hydrochlorothiazide (Atacand Plus) | Astrazeneca UK Limited | Included additional warning related to non-melanoma skin cancer. | 15th March 2022 |
| 4 | Hydroxycarbamide (Hydroxyurea) | Sandoz GMBH Kenya | Update of undesirable effects to include haemolytic anaemia. | 15th March 2022 |
| 5 | Magnesium hydroxide + Aluminium hydroxide + Simethicone (Maalox Plus) | Sanofi Aventis Kenya Limited | Update to section 4.5 on interactions with other medicinal products and other forms of interaction and section 2.6: fertility, pregnancy and lactation. | 10th March 2022 |
| 6 | Raltegravir (Isentress) | MSD (PTY) Limited | Update of precautions and warnings to include advice to wait at least two hours between taking iron salts and taking Isentress, as these medicines may reduce Isentress efficacy. | 24th February 2022 |
| 7 | Dapirivine (Dapiring) | IPM South Africa NPC | Data on antiviral activity of Dapirivine on hepatitis E virus | 24th February 2022 |
| 8 | Elvitegravir+Cobistat+Emtricitabine+Tenofovir alafenamide | Gilead Sciences Inc | Drug-drug interactions between cobistat containing products and cutaneously administered products. | 9th February 2022 |
| 9 | Ticagrelor (Brilinta) | Astrazeneca Sweden | Updates to sections 4.4 and 4.8 | 31st January 2022 |
| 10 | Dapaglifozin (Forxiga) | Astra Zeneca Sweden) | Section on undesirable effects updated to add Fourniers gangrene as a very rare adverse reaction. | 31st January 2022 |
| 11 | Diclofenac potassium (Voltaren and Cataflam products) | Novartis Pharma Services Inc | Update to section 09: Women of child bearing potential, pregnancy, breastfeeding and fertility to include the risk of fetal renal impairment with subsequent oligohydramnios when NSAIDS are used from week 20 of pregnancy onwards. | 19th January 2022 |
| 12 | Dihydrostreptomycin sulphate+Penicillin G monohydrate (Pen & Strep) | Norbrook Laboratories Limited | Update of storage conditions to include Use the product within 2 months when removed from the refrigerator. | 19th January 2022 |
| S/N | Product Name | Licence Holder | Summary of Approved Changes | Date of Approval |
|---|---|---|---|---|
| 1 | Iopromide (Ultravist®) | Bayer East Africa Limited | SCARS 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 |
| 2 | Nebivolol hydrochloride (Nebilet®) | A.Menarini Manufacturing Logistics and Services | Urticaria 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 |
| 3 | Clarithromycin (Cleron 500®) | Delorbis Pharmaceuticals Limited | A warning that use of any antimicrobial therapy, such as clarithromycin, to treat H. pylori infection may select for drug-resistant organisms. | 9th September 2022 |
| 4 | Dapaglifozin (Forxiga®) | Astra Zeneca Ab-Se-151 85 Sode-talje | Update 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 |
| 5 | Ceftriaxone sodium (Ceftriaxone sandoz®) | Novartis Pharma Services Inc | Update of section 4.8: Undesirable effects: Hepatitis and hepatitis cholestatic have been added as new adverse drug reactions. | 31st August 2022 |
| 6 | Dihydroartemisinin+Piperaquine phosphate (Dpiriv®) | Royal Pharma 2011 Limited | Change of product name from Dpiriv 90/720 to Rolxin 90/720 with subsequent change in pack label and design. | 3rd August 2022 |
| 7 | Amlodipine besilate (Amlo®) | GETZ Pharma (Pvt) Limited | Change in brand name from Amlo to Lopicard 10 mg | 3rd August 2022 |
| 8 | Vitamin B1+B2+B6+Niacinamide (Vitamin B Complex®) | Rene Industries Limited | Change of product name from vitamin B complex to Becoren tablets | 29th July 2022 |
| 9 | Acetyl salicylic acid (Aspirin tablets®) | Rene Industries Limited | Change of product name from Aspirin tablets to Aspiren tablets | 29th July 2022 |
| 10 | Levoplant (Levonogestrel) | Pharm Access Africa Ltd | PIL and SmPC updated to replace an incorrectly listed common undesirable effect from a viral infection called chikungunya to viral infection and include contact information for ADR reporting. | 15th June 2022 |
| 11 | Rivaroxaban (Xarelto) | Bayer East Africa Ltd | Dosage and method of administration: In patients after a successful revascularisation procedure of the lower limb (surgical or endovascular including hybrid procedures) due to symptomatic PAD, treatment should not be started until haemostasis is achieved, For patients who are unable to swallow whole tablets, Xarelto tablet may be crushed and mixed with water or apple puree immediately prior to use and administered orally.The crushed tablet may also be given through gastric tubes Special warnings and precautions for use: Patients with malignant disease may simultaneously be at higher risk of bleeding and thrombosis. The individual benefit of antithrombotic treatment should be weighed against risk for bleeding in patients with active cancer dependent on tumour location, antineoplastic therapy and stage of disease. Tumours located in the gastrointestinal or genitourinary tract have been associated with an increased risk of bleeding during rivaroxaban therapy. In patients with malignant neoplasms at high risk of bleeding, the use of rivaroxaban is contraindicated Undesirable effects, Overdose, Pharmacokinetic properties, Shelf life and Special precautions for disposal: Rivaroxaban tablets may be crushed and suspended in 50 mL of water and administered via a nasogastric tube or gastric feeding tube after confirming gastric placement of the tube. Afterwards, the tube should be flushed with water. Since rivaroxaban absorption is dependent on the site of active substance release, administration of rivaroxaban distal to the stomach should be avoided, as this can result in reduced absorption and thereby, reduced active substance exposure. Enteral feeding is not required immediately after administration of the 2.5 mg tablets | 14th June 2022 |
| 12 | Levonogestrel (Mirena) | Bayer East Africa Ltd | Dosage and method of administration, Warnings/precautions, Fertility, pregnancy and lactation, Undesirable effects and Pharmacodynamic properties | 10th June 2022 |
| 13 | Vidagliptin/Metformin (Galvus Met) | Norvatis | Section 7 updated with the post marketing adverse drug reaction of cutaneous vasculitis with a frequency of unknown. | 8th June 2022 |
| 14 | 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 |
| 15 | Etonogestrel (Implanon NXT) | MSD (Pty) Ltd | Label update to reflect PRAC mandated change regarding suicidality, New images and instructions for insertion and removal of the implant and Alignment of PIL and SmPC regarding patient age. | 27th May 2022 |
| 16 | 5-Fluorouracil | Sandoz GMBH Kenya | Contraindications: Due to the potentially mutagenic and carcinogenic effect, increased safety rules apply to nursing personnel and physicians. Pregnant personnel is to be excluded from handling fluorouracil. Special warnings and precautions for use: Stress cardiomyopathy (takotsubo syndrome) added to cardiotoxic effects. Cardiac function should be regularly monitored during treatment with fluorouracil. Pregnancy and lactation: Women of childbearing potential should be advised to avoid becoming pregnant and use an effective method of contraception during treatment with fluorouracil and at least 6 months afterwards. If the drug is used during pregnancy, or if the patient becomes pregnant while taking the drug, the patient should be fully informed of the potential hazard to the foetus and genetic counselling is recommended. Fluorouracil should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.Fertility: Men treated with fluorouracil are advised not to father a child during and for up to 3 months following cessation of treatment. and Undesirable side effects updated to include: Pneumatosis intestinalis, Lactic acidosis and Cutaneous lupus erythematosus (Frequency: Not known). | 25th May 2022 |
| 17 | Medroxyprogesterone acetate (Triclofem) | Mission Pharma A/S | Alignment of SmPC with WHO PAR - Therapeutic Indications: Triclofem is used for long-term contraception in women aged over 18 years. It can also be used for short-term contraception to cover specific periods when: the womans 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 |
| 18 | Metformin (Glucophage) | Merck Pty Ltd | Expansion of indication to prevent Type 2 Diabetes Mellitus in patients with prediabetes and at least one additional risk factor second line to lifestyle changes, Lifting of contraindication in heart failure, Lifting of contraindication in moderate renal failure, Lifting of contraindication against concomitant use with iodinated contrast materials, Initiation of treatment in patients with CKD stage 3b (previously not recommended), Reinforcement of warnings and widening of contraindication from diabetic ketoacidosis to any type of metabolic acidosis (such as fatty acidosis, diabetic ketoacidosis) and New details on interaction between Metformin and Organic Cation ½ Transporter substrates/inhibitors. | 26th April 2022 |
| 19 | Efavirenz (Stocrin) | MSD (Pty) Ltd | Update of drug interaction between metamizole and efavirenz. | 22nd March 2022 |
| 20 | Anastrozole (Arimidex) | Astrazeneca UK Limited | Included depression and osteoporosis as adverse reactions under the undesirable effects section. | 18th March 2022 |
| 21 | Candesartan + Hydrochlorothiazide (Atacand Plus) | Astrazeneca UK Limited | Included additional warning related to non-melanoma skin cancer. | 15th March 2022 |
| 22 | Hydroxycarbamide (Hydroxyurea) | Sandoz GMBH Kenya | Update of undesirable effects to include haemolytic anaemia. | 15th March 2022 |
| 23 | Magnesium hydroxide + Aluminium hydroxide + Simethicone (Maalox Plus) | Sanofi Aventis Kenya Limited | Update to section 4.5 on interactions with other medicinal products and other forms of interaction and section 2.6: fertility, pregnancy and lactation. | 10th March 2022 |
| 24 | Raltegravir (Isentress) | MSD (PTY) Limited | Update of precautions and warnings to include advice to wait at least two hours between taking iron salts and taking Isentress, as these medicines may reduce Isentress efficacy. | 24th February 2022 |
| 25 | Dapirivine (Dapiring) | IPM South Africa NPC | Data on antiviral activity of Dapirivine on hepatitis E virus | 24th February 2022 |
| 26 | Elvitegravir+Cobistat+Emtricitabine+Tenofovir alafenamide | Gilead Sciences Inc | Drug-drug interactions between cobistat containing products and cutaneously administered products. | 9th February 2022 |
| 27 | Ticagrelor (Brilinta) | Astrazeneca Sweden | Updates to sections 4.4 and 4.8 | 31st January 2022 |
| 28 | Dapaglifozin (Forxiga) | Astra Zeneca Sweden) | Section on undesirable effects updated to add Fourniers gangrene as a very rare adverse reaction. | 31st January 2022 |
| 29 | Diclofenac potassium (Voltaren and Cataflam products) | Novartis Pharma Services Inc | Update to section 09: Women of child bearing potential, pregnancy, breastfeeding and fertility to include the risk of fetal renal impairment with subsequent oligohydramnios when NSAIDS are used from week 20 of pregnancy onwards. | 19th January 2022 |
| 30 | Dihydrostreptomycin sulphate+Penicillin G monohydrate (Pen & Strep) | Norbrook Laboratories Limited | Update of storage conditions to include Use the product within 2 months when removed from the refrigerator. | 19th January 2022 |
