March 2022

S/NProduct NameLicence HolderSummary of Approved ChangesDate of Approval
1Efavirenz (Stocrin)MSD (Pty) LtdUpdate of drug interaction between metamizole and efavirenz.22nd March 2022
2Anastrozole (Arimidex)Astrazeneca UK LimitedIncluded depression and osteoporosis as adverse reactions under the undesirable effects section.18th March 2022
3Candesartan + Hydrochlorothiazide (Atacand Plus)Astrazeneca UK LimitedIncluded additional warning related to non-melanoma skin cancer.15th March 2022
4Hydroxycarbamide (Hydroxyurea)Sandoz GMBH KenyaUpdate of undesirable effects to include haemolytic anaemia.15th March 2022
5Magnesium 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
6Raltegravir (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
7Dapirivine (Dapiring)IPM South Africa NPCData on antiviral activity of Dapirivine on hepatitis E virus24th February 2022
8Elvitegravir+Cobistat+Emtricitabine+Tenofovir alafenamideGilead Sciences IncDrug-drug interactions between cobistat containing products and cutaneously administered products.9th February 2022
9Ticagrelor (Brilinta)Astrazeneca SwedenUpdates to sections 4.4 and 4.831st January 2022
10Dapaglifozin (Forxiga)Astra Zeneca Sweden)Section on undesirable effects updated to add Fournier’s gangrene as a very rare adverse reaction.31st January 2022
11Diclofenac 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
12Dihydrostreptomycin 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