Transcription of REGISTER OF MARKETING AUTHORISATIONS - 2018
1 ZAMBIA MEDICINES REGULATORY AUTHORITY. REGISTER OF MARKETING AUTHORISATIONS - 2018. MEDICINES FOR HUMAN USE. S/No Product Name Generic Name Category of Dosage Form MARKETING MARKETING Authorisation Holder Distribution Authorisation Number Miconazole Nitrate Ceam - 1 A Pharma Miconazole Nitrate 20mg POM Cream Topical 046/002 1 A Pharma Gmbh, Germany 1 cream 2 Cetirizine 10 - 1 A Pharma tablets Cetirizine Dihydrochloride 10mg POM Tablet Uncoated 046/003 1 A Pharma Gmbh, Germany 3 Ateblock - 25 tablets Atenolol 25mg POM Tablet Uncoated 116/001 AB Lifesciences, India 4 Ateblock - 50 tablets Atenolol 50mg POM Tablet Uncoated 116/002 AB Lifesciences.
2 India 5 Ateblock - 100 tablets Atenolol 100mg POM Tablet Uncoated 116/003 AB Lifesciences, India 6 Nosieze tablets Carbamazepine 400mg POM Tablet Uncoated 116/004 AB Lifesciences, India 7 Neumox Capsules Amoxicillin Trihydrate 500mg POM Capsule Oral 116/006 AB Lifesciences, India Sodium Lactate + Sodium POM Solution for 316/001 Abacus Parenteral Drugs Ltd, RL-500 Compound Sodium Lactate Chloride + Potassium Chloride + infusion India 8 Infusion Calcium Chloride Dihydrate Sodium Chloride POM Solution for 316/002 Abacus Parenteral Drugs Ltd, 9 NS - 500 Sodium Chloride BP Infusion infusion India Dextrose POM Solution for 316/003 Abacus Parenteral Drugs Ltd, 10 DS-500 Glucose Infusion infusion India Betamethasone Soduim POM Solution for 316/004 Abacus Parenteral Drugs Ltd, 11 X-Beta Eye/Ear Drops Phosphate w/v Topical Use India Betamethasone Soduim POM Solution for 316/005 Abacus Parenteral Drugs Ltd, X- Beta - N Eye/Ear Drops Phosphate w/v + Neomycin Topical Use India 12 sulphate w/v Neomycin Sulphate w/v + POM Solution for 316/006 Abacus Parenteral Drugs Ltd.
3 X-Sone -N Eye/Ear Drops Dexamethasone Phosphate Topical Use India 13 w/v Sodium Chloride w/v P Solution for 316/007 Abacus Parenteral Drugs Ltd, 14 Abnal Nasal Drops Topical Use India Mannitol 20 %w/v POM Solution for 316/008 Abacus Parenteral Drugs Ltd, 15 Abtol 20% Intravenous Infusion infusion India Lopinavir 80mg + Ritonavir POM Solution for Oral 128/002 Abbott Laboratories (Pty) Ltd, 16 Kaletra Solution 20mg, per 5ml Use South Africa Clarithromycin 125mg POM Granules for 128/004 Abbott Laboratories (Pty) Ltd, 17 Klacid P 125 Granules for Suspension Suspension South Africa Clarithromycin 250mg POM Granules for 128/005 Abbott Laboratories (Pty) Ltd, 18 Klacid P 250 Granules for Suspension Suspension South Africa Page 1 of 296.
4 ZAMBIA MEDICINES REGULATORY AUTHORITY. REGISTER OF MARKETING AUTHORISATIONS - 2018. Isoflurane w/w POM Solution for 128/015 Abbott Laboratories (Pty) Ltd, 19 Forane Liquid Inhalation South Africa Lopinavir 200mg + Ritonavir POM Tablet Film 128/026 Abbott Laboratories (Pty) Ltd, 20 Aluvia 250/50mg tablets 50mg Coated South Africa Lopinavir 100mg + Ritonavir POM Tablet Film 128/027 Abbott Laboratories (Pty) Ltd, 21 Aluvia 100/25mg tablets 25mg Coated South Africa Sevoflurane 100% v/v POM Solution for 128/029 Abbott Laboratories (Pty) Ltd, 22 Ultane Liquid Inhalation South Africa Ritonavir USP 100mg POM Tablet, Film 128/030 Abbott Laboratories (Pty)
5 Ltd, 23 Norvir 100 tablets Coated South Africa Racecaggherdotril 100mg POM Capsule, Oral 128/031 Abbott Laboratories (Pty) Ltd, 24 Hidrasec Capsules South Africa Racecaggherdotril 30mg POM Powder for 128/032 Abbott Laboratories (Pty) Ltd, Hidrasec Children Sachets Suspension, South Africa 25 Oral Racecaggherdotril 10mg POM Powder for 128/033 Abbott Laboratories (Pty) Ltd, Hidrasec Infant Sachets Suspension, South Africa 26 Oral Survanta Intratracheal Suspension, 4ml Total Phospholipids 25mg, per POM Suspension, 128/034 Abbott Laboratories (Pty) Ltd, 27 Vial ml Intratracheal South Africa Mifepristone 200mg + POM Tablet, 296/001 Acme Formulation Pvt Ltd, India 28 Mariprist Combikit tablets Misoprostal 200mcg Uncoated 29 Misoclear tablets Misoprostal 200mcg POM Tablet Uncoated 296/002 Acme Formulation Pvt Ltd, India Mannitol 20% w/v POM Solution, 097/004 Adcock Ingram Pharmaceuticals 30 Sabax Osmitrol 20% Injection Infusion Ltd, South Africa Sodium Chloride w/v POM Solution, 097/005 Adcock Ingram Pharmaceuticals 31 Sabax Sodium Chloride Injection Infusion Ltd, South Africa Sabax Glucose 5% + Sodium Chloride Dextrose 5 %w/v + Soduim POM Solution.
6 097/006 Adcock Ingram Pharmaceuticals 32 Injection Chloride %w/v Infusion Ltd, South Africa Sodium chloride + Sodium POM Solution, 097/007 Adcock Ingram Pharmaceuticals Sabax Ringer Lactate Injection lactate + Potassium chloride + Infusion Ltd, South Africa 33 Calcium chloride Peritoneal dialysis solution POM Solution, 097/008 Adcock Ingram Pharmaceuticals 34 Sabax Dianeal Injection, Injection Ltd, South Africa Peritoneal dialysis solution POM Solution, 097/009 Adcock Ingram Pharmaceuticals 35 Sabax Dianeal Injection, Injection Ltd, South Africa Peritoneal dialysis solution POM Solution, 097/010 Adcock Ingram Pharmaceuticals 36 Sabax Dianeal Injection, Injection Ltd, South Africa Page 2 of 296.
7 ZAMBIA MEDICINES REGULATORY AUTHORITY. REGISTER OF MARKETING AUTHORISATIONS - 2018. Paracetamol 250mg + Ibuprofen P Capsule Oral 097/011 Adcock Ingram Pharmaceuticals 37 Myprodol Capsules 200mg + Codeine 10mg Ltd, South Africa Paracetamol 250mg + Ibuprofen P Suspension for 097/012 Adcock Ingram Pharmaceuticals 38 Lotem Suspension 200mg Oral Use Ltd, South Africa Caffeine 30 mg + Codeine 10 mg P Tablet oral 111/005 Adcock Ingram Pharmaceuticals Syndol tablets + Doxylamine 5 mg + Ltd, South Africa 39 Paracetamol 450 mg Paracetamol 450 mg + Codeine P Tablet oral 111/008 Adcock Ingram Pharmaceuticals phosphate 10 mg + Doxylamine Ltd.
8 South Africa Betapyn tablets succinate 5 mg + Caffeine 40 alkaloid 50 mg Cetylpyridinium chloride mg + GS Lozenges 111/009 Adcock Ingram Pharmaceuticals 41 Medikeel A Throat Lozenges benzocaine 12 mg Ltd, South Africa Benzocaine 10 mg + GS Lozenges 111/014 Adcock Ingram Pharmaceuticals 42 Cepacol Throat Regular Lozenges Cetylpyridinium chloride mg Ltd, South Africa Theophylline mg + POM Syrup 111/022 Adcock Ingram Pharmaceuticals Hydroxyethyl Theophylline Ltd, South Africa mg + Diphenhydramine HCl Alcophyllex Mixture mg + Ammonium Chloride 120 mg + Sodium Citrate 50. 43 mg/5 ml Cetylpyridinium Chloride 50 mg + GS Solution for 111/023 Adcock Ingram Pharmaceuticals 44 Cepacol Antibacterial Mouthwash Alcohol % v/v Topical Use Ltd, South Africa Cetylpyridinium Chloride mg GS Lozenges 111/024 Adcock Ingram Pharmaceuticals 45 Cepacol Throat Menthol Lozenges + Benzyl Alcohol mg Ltd, South Africa Terbutaline + Ammonium P Syrup 111/025 Adcock Ingram Pharmaceuticals Bronchoped Syrup Chloride 60mg + Sodium Citrate Ltd, South Africa 46 25mg Sodium bicarbonate + P Granules for 111/026 Adcock Ingram Pharmaceuticals Citro Soda Orange Granules Tartaric acid 856mg + Citric acid Suspension Ltd.
9 South Africa 47 702mg + Sodium citrate 613mg Sodium bicarbonate + P Granules for 111/027 Adcock Ingram Pharmaceuticals Citro Soda Granules Tartaric acid 856mg + Citric acid Suspension Ltd, South Africa 48 702mg + Sodium citrate 613mg Sennosides dry extract 60% eq. P Tablet Uncoated 111/028 Adcock Ingram Pharmaceuticals 49 Adco-Senna tablets to Senoside A & B Ltd, South Africa Lignocaine Hydrochloride 20mg POM Solution for 111/029 Adcock Ingram Pharmaceuticals 50 Locaine A Injection + Adrenaline Tartrate 12ug/ml Injection Ltd, South Africa Page 3 of 296. ZAMBIA MEDICINES REGULATORY AUTHORITY. REGISTER OF MARKETING AUTHORISATIONS - 2018.
10 Efavirenz 600mg POM Tablet Film 111/030 Adcock Ingram Pharmaceuticals 51 Adco - Efavirenz 600 tablets Coated Ltd, South Africa Efavirenz 200mg POM capsule Oral 111/031 Adcock Ingram Pharmaceuticals 52 Adco Efavirenz 200 Capsules Ltd, South Africa Medi - keel A Blackcurrant Throat Benzocaine + P Lozenges 111/032 Adcock Ingram Pharmaceuticals 53 Lozenges Cetylpyridinium Ltd, South Africa Medi - Keel A Honey and Lemon Throat Benzocaine + P Lozenges 111/033 Adcock Ingram Pharmaceuticals 54 Lozenges Cetylpyridinium Ltd, South Africa Theophylline 100mg + Etofyline P Syrup 111/034 Adcock Ingram Pharmaceuticals Actophlem Cough Syrup 10mg + Diphenylpyramine 8mg + Ltd, South Africa 55 Ammonium 720mg Prednisolone 15mg/5ml POM Syrup 111/035 Adcock Ingram Pharmaceuticals 56 Prelone Syrup Ltd, South Africa Dextromethophan Hydrobromide P Syrup 111/036 Adcock Ingram Pharmaceuticals 57 Dilinct Dry Cough Syrup Ph.
